2022 Delaware Code
Title 16 - Health and Safety

Part I

Local Boards of Health; Health Programs

Part II

Regulatory Provisions Concerning Public Health

Part III

Vital Statistics

Part IV

Food and Drugs

Part V

Mental Health

Part VI

Safety

Part VII

Building and Plumbing

Part VIII

Hospitals and Other Health Facilities

Part IX

Individuals with Disabilities

Part X

Paramedic and Other Emergency Medical Service Systems

Part XI

Delaware Health Care Commission

Part XII

Emergency Services

Part XIII

Delaware Health Information Network

Part XIV

Community Firearm Recovery Program


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Legislative Council, General Assembly State of Delaware Title 16 Health and Safety NOTICE: The Delaware Code appearing on this site is prepared by the Delaware Code Revisors and the editorial staff of LexisNexis in cooperation with the Division of Research of Legislative Council of the General Assembly, and is considered an official version of the State of Delaware statutory code. This version includes all acts enacted as of October 7, 2022, up to and including 83 Del. Laws, c. 448. DISCLAIMER: With respect to the Delaware Code documents available from this site or server, neither the State of Delaware nor any of its employees, makes any warranty, express or implied, including the warranties of merchantability and fitness for a particular purpose, or assumes any legal liability or responsibility for the usefulness of any information, apparatus, product, or process disclosed, or represents that its use would not infringe privately-owned rights. Please seek legal counsel for help on interpretation of individual statutes. Title 16 - Health and Safety Part I Local Boards of Health; Health Programs Chapter 1 Department of Health and Social Services Subchapter I General Provisions § 101. Definitions. As used in this title, unless otherwise provided or the context requires a different meaning: (1) “County Public Health Administrator” means the Division of Public Health employee responsible for managing the operations of all public health programs within an assigned county. (2) “Department” means the Department of Health and Social Services. (3) “Director” means the Director of the Division of Public Health, or such persons as may be designated by the Director. (4) “Division” means the Division of Public Health. (5) “Peace Officer” means any public officer authorized by law to make arrests in a criminal case. (6) “Secretary” means the Secretary of the Department of Health and Social Services or such persons as may be designated by the Secretary. (16 Del. C. 1953, § 101; 57 Del. Laws, c. 591, § 1; 70 Del. Laws, c. 149, § 17; 70 Del. Laws, c. 186, § 1.) § 102. Headquarters. The Department shall establish headquarters in the City of Dover and if no suitable place shall be provided in the State House or in other state property, the Department shall have authority to select some suitable place for the establishment of such headquarters. (33 Del. Laws, c. 57, § 3; 34 Del. Laws, c. 69, § 1; Code 1935, § 744; 43 Del. Laws, c. 91, § 1; 16 Del. C. 1953, § 104; 70 Del. Laws, c. 544, § 4.) § 103. Deputy state health officers — Appointment; term; compensation; removal. (a) Subject to the approval of the Department, the Secretary shall appoint for each county in the State a deputy state health officer, who shall be a person trained and experienced in public health. Each deputy state health officer shall be appointed for a term of 4 years and shall devote full time to the duties of office. The deputy health officer shall receive such compensation as is fixed by the Department and necessary expenses, which shall be paid monthly out of state funds. (b) The Department may remove deputy state health officers for cause, upon charges and after a hearing, and may appoint a suitable person to fill any unexpired term. (33 Del. Laws, c. 57, § 2; 34 Del. Laws, c. 69, § 1; Code 1935, § 744; 43 Del. Laws, c. 91, § 1; 16 Del. C. 1953, § 107; 57 Del. Laws, c. 591, § 3; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 544, § 5.) § 104. Deputy state health officers — Powers and duties. The deputy state health officers for and under the direction of the Department shall enforce the laws of the State pertaining to the public health, shall enforce all rules, regulations and orders adopted or promulgated by the Department in accordance with law, shall undertake such other duties as may be assigned to them by the Department and shall supervise all public health matters within their respective counties, and in the City of Wilmington, but not in other incorporated cities or towns having duly constituted boards of health. The governing authorities of any incorporated city or town, other than the City of Wilmington, may by resolution duly adopted and approved by the Department designate a deputy state health officer to act as health officer of such incorporated city or town, and the deputy health officer shall then exercise the powers and perform the duties of the local board of health. (33 Del. Laws, c. 57, § 2; 34 Del. Laws, c. 69, § 1; Code 1935, § 744; 43 Del. Laws, c. 91, § 1; 16 Del. C. 1953, § 108; 57 Del. Laws, c. 245; 57 Del. Laws, c. 591, § 4; 70 Del. Laws, c. 149, § 18; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 544, § 6.) § 105. Authorization to receive federal funds; disposition. (a) The Department may apply for and receive funds made available to the Department by any agency or department of the federal government authorized to make grants-in-aid of any of the present or future health programs undertaken, maintained or proposed by the Department, namely, maternal and child health, aid to crippled children, venereal disease control, public health work under 42 U.S.C. § 246 and other health programs that may be developed. (b) All moneys received from any federal agency or department, as provided in this section, shall be paid into the State Treasury and shall be for the use of the Department. The moneys so received shall be used solely for the purpose or purposes for which the grant or grants shall have been made and for no other purpose. (45 Del. Laws, c. 84, §§ 1, 2; 16 Del. C. 1953, § 110; 70 Del. Laws, c. 149, § 19; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 544, § 7.) Page 1 Title 16 - Health and Safety § 106. Prosecutions and proceedings for violations; disposition of fines. All prosecutions and proceedings instituted by the Department or Division for the violation of any law or laws to be enforced by the Department or Division, or for the violation of any order or regulation of the Department or Division shall be instituted by the Secretary or the Secretary’s designated representative. All laws prescribing the modes of procedure and penalties or judgments applicable to local boards of health shall apply to the Department or Division and the violation of its laws and orders. All fines or judgments collected or received shall be paid over to the State Treasurer, and applied to the General Fund of the State. (22 Del. Laws, c. 642, § 12; 22 Del. Laws, c. 327, § 7; Code 1915, § 744; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 750; 43 Del. Laws, c. 91, § 1; 16 Del. C. 1953, § 112; 57 Del. Laws, c. 591, § 5; 70 Del. Laws, c. 149, §§ 20, 21; 70 Del. Laws, c. 186, § 1.) § 107. Neglect of duty; penalty. (a) Whoever refuses, fails or neglects to perform the duties required under this chapter, or violates, neglects or fails to comply with the duly adopted regulations or orders of the Department of Health and Social Services, shall be fined not less than $100 and not more than $1000, together with costs, unless otherwise provided by law. (b), (c) [Repealed.] (d) (1) Notwithstanding the foregoing, whoever refuses, fails or neglects to perform duties required of trained and certified individuals and firms under § 122(3)t. of this title, or who violates, neglects or fails to comply with duly adopted regulations or orders of the Department regarding the standards for regulation of lead-based paint, including the training and certification of companies and workers engaged in lead-based paint activities, work practice standards and the accreditation of lead-based paint hazard training programs, shall be subject to a criminal penalty up to $10,000 per day, together with costs, for every day from and after the effective date of an order of the Department specifically directing compliance until such time compliance has been achieved. The Justice of the Peace Courts shall have jurisdiction to adjudicate offenses under this subsection. (2) In appropriate cases, Department-issued orders concerning lead-based paint activities and duties imposed by law upon such persons engaged in lead-based paint activities governed by this code may be compelled by mandamus or injunction. (3) At the discretion of the Department, in lieu of criminal action pursuant to paragraph (d)(1) of this section, the Secretary shall be authorized to impose an administrative penalty of up to $10,000 per violation in accordance with the Administrative Procedures Act [Chapter 101 of Title 29] against any person or entity who violates the provisions of this chapter or the regulations promulgated pursuant to it. Assessment of an administrative penalty shall be determined by the nature, circumstances, extent and gravity of the violation or violations, ability of the violator to pay, any prior history of such violations, the degree of culpability, economic benefit or savings (if any) resulting from the violation, and such other matters as justice may require. Under this paragraph, each day a violation continues constitutes a separate violation. (4) The Department shall have the authority to collect administrative penalties. All fees and penalties assessed by the Department under this subsection are hereby appropriated to the Department to carry out the purposes of § 122(3)t. of this title. (5) In the event of nonpayment of the administrative penalty after all legal appeals have been exhausted, a civil action may be brought by the Secretary in Superior Court for the collection of the administrative penalty, including interest, attorney fees and costs. In a civil action to collect the administrative penalty, the validity, amount and appropriateness of such administrative penalty shall not be subject to review. (6) In the event of nonpayment of the criminal penalty after all legal appeals have been exhausted, a civil action may be brought by the Secretary in Superior Court for the collection of the criminal penalty, including interest, attorney fees and costs. In a civil action to collect the criminal penalty, the validity, amount and appropriateness of such criminal penalty shall not be subject to review. (e) All fees, fines, costs, and penalties assessed by the Department pursuant to this subsection shall be retained by the Department in order to defray associated costs. Superior Court shall have original jurisdiction to adjudicate criminal offenses under this subsection. Penalties sought or imposed pursuant to this section do not prohibit charges applicable under other titles of the Code, including but not limited to criminal fees, fines, costs, and penalties. (19 Del. Laws, c. 642, § 9; Code 1915, § 743; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 749; 43 Del. Laws, c. 91, § 1; 16 Del. C. 1953, § 113; 63 Del. Laws, c. 126, § 1; 70 Del. Laws, c. 49, § 2; 70 Del. Laws, c. 149, §§ 22, 23; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 544, § 8; 73 Del. Laws, c. 269, § 1; 74 Del. Laws, c. 78, § 1; 79 Del. Laws, c. 146, § 1; 79 Del. Laws, c. 154, § 1; 80 Del. Laws, c. 258, § 8.) § 108. Jurisdiction of offenses; justices of the peace. Justices of the peace shall have jurisdiction of offenses under this part and Part II of this title, except in cases where exclusive jurisdiction of any such offense is expressly vested in another court. (16 Del. C. 1953, § 114.) § 109. Appeals. From the decision of a justice of the peace exercising jurisdiction conferred by § 108 of this title, an appeal shall be allowed to the Court of Common Pleas of the same county. (16 Del. C. 1953, § 115; 69 Del. Laws, c. 423, § 18.) Page 2 Title 16 - Health and Safety § 110. Transfer of Wilmington Department of Health personnel to state service. Any former or present employee of the State Division of Public Health who was employed by the Wilmington Department of Health in the conduct of public health matters within the City of Wilmington and was so employed at the time the responsibility for the conduct of public health matters within the City of Wilmington was transferred to the State Division of Public Health (then State Board of Health) in implementation of Senate Bill No. 133 of the 125th General Assembly shall, subject to merit system maximums: (1) Be authorized to transfer vacation leave and sick leave then accumulated; (2) Receive full credit for the time employed by the City of Wilmington in computing seniority for merit system purposes; and (3) Receive full credit for time so employed and compensated in computing the number of years service required to receive pension benefits and in computing the amount of such pension benefits under Chapter 55 of Title 29. (59 Del. Laws, c. 386, § 1; 70 Del. Laws, c. 186, § 1.) § 111. Retaliation or discrimination against complainants; immunities and other protections. Notwithstanding any law or regulation to the contrary, any psychiatric nursing or treatment facility owned by or operated by the Department shall be subject to the provisions of §§ 1117, 1135 and 1154 of this title whether or not such facility is licensed as a longterm care facility. (77 Del. Laws, c. 203, § 1.) Subchapter II Powers and Duties Generally; Regulations and Orders § 121. Successor to powers of abolished health and welfare agencies. All the rights, powers, duties, obligations and authority belonging to or vested in the Child Welfare Commission, the Tuberculosis Commission or the State Health and Welfare Commission, prior to May 21, 1941, are transferred to and vested in the Department as successor to those commissions. The Department is clothed with all the power and authority necessary for the competent discharge of the duties imposed upon it. (33 Del. Laws, c. 57, §§ 4, 9; 34 Del. Laws, c. 69, § 1; Code 1935, § 744; 43 Del. Laws, c. 91, § 1; 16 Del. C. 1953, § 121; 70 Del. Laws, c. 544, § 9.) § 122. Powers and duties of the Department of Health and Social Services. The Department shall have the following general powers and duties: (1) Supervision of all matters relating to the preservation of the life and health of the people of the State. (2) Supreme authority in matters of quarantine; it may declare and enforce such quarantine, when necessary and where no quarantine exists, and may modify, relax or abolish it, where it has been established. (3) Adopt, promulgate, amend, and repeal regulations consistent with law, which regulations shall not extend, modify or conflict with any law of this State or the reasonable implications thereof, and which shall be enforced by all state and local public health officials, to do all of the following: a. Prevent and control the spread of all diseases that are dangerous to the public health; b. Prevent and control nuisances which are or may be detrimental to the public health; c. Provide for the sanitary protection of all drinking water supplies which are furnished to and used by the public, including the establishment of primary maximum contaminant levels, operational requirements and public notice requirements. Primary maximum contaminant levels mean a maximum contaminant level which involves a biological, chemical or physical characteristic of drinking water that may adversely affect the health of the consumer. A public water supplier means any person who owns or operates 1 or more public water systems. A public water system means a water supply system for the provision to the public of water for human consumption through pipes or other constructed conveyances either directly from the user’s free-flowing outlet or indirectly by the water being used to manufacture ice, foods and beverages or that supplies water for potable or domestic purposes to employees, tenants, members, guests or the public at large in commercial offices, industrial areas, multiple dwellings or semi-public buildings including, but without limitation, rooming and boarding houses, motels, tourist cabins, mobile home parks, restaurants, hospitals and other institutions, or offers any water for sale for potable domestic purposes. A dwelling unit means 1 or more rooms arranged for the use of 1 or more individuals as a single housekeeping unit, with cooking, living, sanitary and sleeping facilities. A person shall include corporations, companies, associations, firms, municipally owned water utilities, partnerships, societies and joint stock companies, as well as individuals. In addition, the following provisions shall apply: 1. No public water system shall operate without a duly licensed public water supply operator. The Department shall have the authority to exempt the owners of seasonal public water systems, restaurants, hotels and similar businesses from the requirement to operate with a licensed public water supply operator. The Department shall have the exclusive power to grant or deny any such Page 3 Title 16 - Health and Safety license and shall adopt regulations setting the requirements, including any acceptable performance or an examination for obtaining and retaining any such license. The Department shall assess an annual licensure fee of $50 per operator. A. The Department shall create an Advisory Council to assist the Secretary in implementing the requirements of this paragraph (3)c.1. B. The Department shall have the authority to create a temporary variance program for water systems upon the loss of their operator. C. All decisions of the Secretary with regard to issuance or renewal of a variance pursuant to paragraph (3)c.1.B. of this section shall be final and conclusive. Where the applicant for issuance or renewal of a variance is in disagreement with the action of the Secretary, such applicant may appeal the Secretary’s decision to the Superior Court within 30 days of the postmarked date of the copy of the decision mailed to the holder. The appeal shall be decided on the record and shall proceed as provided in §§ 10142-10145 of Title 29. 2. The Department shall have the authority to monitor the water quality of public water systems for secondary drinking water quality standards. The Secretary shall have the authority to establish, after public hearing, minimum secondary drinking water quality standards for all public water suppliers serving more than 500 service connections within the state. In determining the total number of service connections, all public water systems operated, managed or owned wholly or in part by the public water supplier within the State shall be added together. Secondary drinking water quality standards involve a biological, chemical or physical characteristic of water that may adversely affect the taste, odor, color or appearance (aesthetics) which may affect public confidence or acceptance of the drinking water. These standards shall include but are not limited to chlorides, copper, iron, manganese, sulfate, total dissolved solids and other standards as determined by the Secretary. Such standards shall be at least as stringent as those adopted by the United States Environmental Protection Agency under the Safe Drinking Water Act [42 U.S.C. § 300f et seq.]. A certificate of noncompliance shall be issued to any public water supplier that serves more than 500 service connections whose public water system violates secondary drinking water quality standards as adopted by the Department. Such certificate shall require the public water supplier to report within 60 days what measures have been or will be taken to bring the public water system into compliance. Should any public water supplier serving more than 500 service connections within the State fail, without good cause, to meet secondary drinking water quality standards pursuant to this section for a period of time greater than 7 consecutive days, or should the public water supplier have a history of a recurring problem, the Secretary shall file a report with the Public Service Commission detailing such failure or such a history of a recurring problem. The Public Service Commission may utilize the report as cause to review the public water supplier’s ability to provide adequate service under its present certificate of public convenience and necessity and may also use such report as a factor in considering any application by the water system supplier’s for any further certificate. In addition, for public water systems operated by public utilities which are subject to the jurisdiction of the Public Service Commission under § 203C of Title 26, the Commission may utilize such report as cause to review the appropriate rates to be charged by the utility in light of the quality of service being provided. 3. The Department shall ensure that all new community and nontransient noncommunity public water systems commencing operation after October 1, 1999, demonstrate technical, managerial and financial capacity to operate in compliance with state regulations Governing Public Drinking Water Systems and the federal Safe Drinking Water Act [42 U.S.C. § 300f et seq.]. It is the purpose of this subparagraph to ensure that the Department has adequate information about the background of applicants or regulated parties for the purposes of processing permits. This includes the ability to identify applicants or regulated parties with histories of environmental violations or criminal activities and/or associations; or applicants who cannot demonstrate the required responsibility, expertise or competence which is necessary for the proper operation or activity permitted by the Department. 4. Whoever refuses, fails or neglects to perform the duties required of public water suppliers under paragraph (3)c. of this section; or who violates, neglects or fails to comply with duly adopted regulations or orders of the Department of Health and Social Services regarding the duties of public water suppliers, shall be subject to a judicially imposed penalty of up to $10,000 per day, together with costs, for every day from and after the effective date of an order of the Department of Health and Social Services, specifically directing compliance until such compliance has been achieved. Observance of orders of the Department of Health and Social Services concerning public water suppliers may also be compelled by mandamus or injunction, in appropriate cases, or by an action to compel the specific performance of the orders so made, or of the duties imposed by law upon such public water supplier. The Department of Health and Social Services may investigate the financial operations of a public water supplier to the extent necessary to enter an adequate compliance order. 5. In lieu of judicially imposed penalties, the Secretary may impose administrative penalty upon any public water supplier who refuses, fails or neglects to perform the duties required of it under paragraph (3)c. of this section. The administrative penalty shall be as follows: A. For a system serving a population of more than 10,000 people the administrative penalty shall be not less than $1,000 nor more than $10,000 per day per violation; and B. For any other system, the administrative penalty shall be not less than $100 nor more than $10,000 per day per violation. Assessment of an administrative penalty shall be determined by the nature, circumstances, extent and gravity of the violation, or violations, ability of the violator to pay, any prior history of such violations, the degree of culpability, economic benefit or savings (if any) resulting from the violation and such other matters as justice may require. Page 4 Title 16 - Health and Safety In the event of nonpayment of the administrative penalty after all legal appeals have been exhausted, a civil action may be brought by the Secretary in any court of competent jurisdiction, including any Justice of the Peace Court, for collection of the administrative penalty, including interest, attorneys’ fees and costs, and the validity, amount and appropriateness of such administrative penalty shall not be subject to review. 6. Drinking water contaminant notification. — A. As used in this section, “Drinking water contaminant” means any physical chemical, biological or radiological substance or matter in drinking water, the presence of which is confirmed by 2 or more samples taken at the same location at different times, using recognized practices and procedures, which substance exceeds the minimum drinking water quality standards established in accordance with paragraph (3)c. of this section. B. Public notification of drinking water contaminants shall be categorized as either an Immediate Notice (Tier 1), Notice as soon as possible (Tier 2) or 90-day Notice (Tier 3). A Tier 1 drinking water contaminant notification is required when there is an acute risk to human health arising from the presence of drinking water contaminants in drinking water provided by a public drinking water supplier. A Tier 2 drinking water contaminant notification is required when a public water system provides drinking water containing levels of a contaminant that exceed federal or state drinking water standards, but does not pose an acute risk to human health or the public drinking water supplier fails to monitor and report water quality information to the Department in accordance with regulations. A Tier 3 drinking water notification is required when a public drinking water system provides water which otherwise does not comply with federal or state drinking water standards, but the noncompliance does not pose a risk to human health. C. In the event of a Tier 1, Tier 2 or Tier 3 drinking water contaminant incident, the public drinking water supplier shall immediately notify the Department. If the Department deems it necessary, the public drinking water supplier shall also notify its affected customers in accordance with paragraph (3)c.6.D. of this section and Department regulations and such notice shall include, to the maximum extent practicable, the following information: I. A description of the violation or situation, including contaminant levels, if applicable; II. When the violation or situation occurred; III. Recognized potential adverse health effects using standard health effects language as approved by the Division of Public Health; IV. The affected population; V. Whether alternative drinking water supplies should be used; VI. What action consumers should take; VII. What the public drinking water provider is doing to correct the violation or situation; VIII. When the public drinking water provider expects the system to return to compliance or the situation to be resolved; IX. The name, business address and phone number of the public drinking water system owner or operator; and X. A statement encouraging distribution of the notice to others, where applicable. D. For Tier 1 drinking water contaminant incidents, the information listed in paragraphs (3)c.6.C.I. through X. of this section above, shall be made available to affected customers by the public drinking water supplier, if the Department deems it necessary, as soon as possible but no later than 24 hours after the contamination is reported. For Tier 2 drinking water contaminant incidents, the information listed in paragraphs (3)c.6.C.I. through X. of this section above shall be made available to affected customers by the public drinking water supplier, if the Department deems it necessary, as soon as practical but within 14 calendar days after the contamination is reported. For Tier 3 drinking water contaminant incidents, the information listed in paragraphs (3)c.6.C.I. through X. of this section above shall be made available to affected customers by the public drinking water supplier, if the Department deems it necessary, as soon as practical, but within 90 calendar days after the contamination is reported. E. In accordance with the public notification timelines established under paragraph (3)c.6.C. of this section, the public drinking water supplier shall also provide the same notification to all of the following: I. The elected Council or Levy Court members of the county in which the contamination occurred. II. The elected Council members of the municipality in which the contamination occurred. III. The State Representatives and Senators in whose district the contamination occurred. IV. Any community or civic group or individual that notifies the public drinking water supplier that they desire to receive such information. V. If the contamination occurred in a manufactured home community, the Department of Justice and the Delaware Manufactured Home Relocation Authority. F. The public drinking water supplier is not required to report the results of tests for the presence of drinking water contaminants to the Department in cases where the Division of Public Health performs the potable water analyses. G. In the event the public drinking water supplier is unable to provide public notification of a Tier 1, Tier 2 or Tier 3 drinking water contaminant incident, as required by this section, such public drinking water supplier shall be responsible for paying for the cost of any such advertisements and notices made on its behalf by the Department. Page 5 Title 16 - Health and Safety 7. Regulatory and compliance information, public drinking water system performance and public information. A. The Department shall develop a Safe Drinking Water Information System that will include general information about public drinking water systems under the Department’s regulatory jurisdiction as defined by this title. The System shall provide the public with information that indicates when a public drinking water system has been inspected, what violations are detected, when the public drinking water system comes back into compliance, and any enforcement action that results from violations. The Department shall also publish on the Department web site all Tier 1, Tier 2 and Tier 3 drinking water contaminant public notifications as soon as possible, but within 1 business day of the release of the notification to the public. B. Delaware public drinking water systems that are identified as a community water system by the Division of Public Health, shall prepare and issue each year, on or before July 1, an annual water quality report to customers served by their drinking water system. The water quality reports shall be provided by parcel post return receipt requested to the Department and the Division of the Public Advocate. In addition, the public drinking water supplier shall notify its customers of the availability of the annual water quality report and provide copies of the report to all individuals, health-care providers or organizations requesting it. The water quality report shall include such information as may be prescribed by the Division of Public Health, including, but not limited to, any environmental violations or enforcement actions taken against the public drinking water supplier by federal, state or local regulatory authorities and the name and contact information of the public drinking water supplier representative. The reports may also include any voluntary activities undertaken by the drinking water supplier to reduce health risks from identified contaminants, including source water assessments, installation of new treatment processes, or such similar environmental improvements undertaken within the previous year or planned for the next 5 years. C. Any records, reports or information obtained pursuant to this chapter and any permits, permit applications and related documentation shall be available to the public for inspection and copying in accordance with Chapter 100 of Title 29. d. Provide for the sanitary control of public swimming pools except that no regulation currently existing or hereafter adopted shall require a life guard to be on duty at any pool of any motel,hotel or private campground facility; e. Regulate plumbing in the interests of the public health; f. Provide for the sanitary production, distribution and sale of market milk and dairy products and other foods; g. Provide for the sanitary control of tourist camps, trailer camps and other public camps; h. Protect and promote the health of all mothers and children; i. Provide for proper sanitation, ventilation and hygiene in schools and for sanitary and health requirements for food handlers in the schools not less stringent than the requirements for food handlers in public eating places; j. Protect and promote the public health generally in this State, and carry out all other purposes of the laws pertaining to the public health; k. Provide the mechanism for yearly medical examination of all persons engaged in the preparation and service of food and drink for human consumption in commercial establishments or public and private educational institutions where such persons come in physical contact with the food and drink prepared or served, such examinations to include whatever tests the Director of the Division of Public Health of the State Department of Health and Social Services shall deem necessary; l. Provide the mechanism for medical examinations of all applicants for food handling employment if such employment involves preparation of food and drink for human consumption in commercial establishments or public and private educational institutions where such persons come in physical contact with the food or drink prepared or served, such examinations to include whatever tests the Director of the Division of Public Health of the State Department of Health and Social Services shall deem necessary; m. Establish standards for quality assurance in the operation of hospice programs, which shall include, but not be limited to establishing and implementing standardized protocol with respect to the safe disposal of unused prescription medication following the death of an in-home hospice patient, and control the practice of such programs. Upon receipt of an application for license and the application fee of $100, the Department shall issue a license if the hospice meets requirements established under this chapter. A license, unless sooner suspended or revoked, shall be renewed annually upon filing by the licensee and payment of an annual licensure fee of $50. A provisional license, as authorized by the Department, shall be issued when health requirements are not met and a licensure fee of $50 has been submitted. A hospice which has been issued a provisional license shall resubmit the application fee for reinspection prior to the issuance of an annual license; n. Prevent and control the spread of vaccine-preventable diseases in children, including regulation of nonpublic elementary and secondary schools and daycare and other preschool facilities; provided, however, that nothing in this paragraph shall require medical treatment for the minor child of any person who is a member of a recognized church or religious denomination and whose religious convictions, in accordance with the tenets and practices of the person’s church or religious denomination, are against medical treatment for disease; o. Establish standards for public health quality assurance in the operation of home health agency programs and regulate the public health practice of such programs. 1. A home health agency is any business entity or subdivision thereof, whether public or private, proprietary or not-for-profit, which provides home health-care services. Page 6 Title 16 - Health and Safety A. Home health-care services include but are not limited to the following: I. Licensed nursing; II. Physical therapy; III. Speech therapy; IV. Audiology; V. Occupational therapy; VI. Nutrition; VII. Social Services; or VIII. Home health aides. B. Home health agencies shall provide: I. Two or more home health-care services, 1 of which must be either licensed nursing services or home health aide services; or II. Home health aide services exclusively which shall include, but not be limited to: (A) Feeding; (B) Bathing; (C) Dressing; (D) Grooming; and (E) Incidental household services. 2. For purposes of this paragraph (3)o., the following shall also apply: A. Home health agency services are provided directly through employees of the agency or through contract arrangements, including those contracts with individuals considered to be independent contractors. B. Home health agency services are provided to individuals primarily in their home or private residence. C. All home health agency services must be supervised by a registered nurse. D. Home health agencies shall utilize written financial agreements between the agency and the consumer. These agreements shall minimally include: I. Description of services purchased and the associated cost; II. Acceptable method of payment or payments for these services; and III. Outline of the billing procedures. All payments by the consumer for services rendered shall be made directly to the agency or its billing representative and no payments shall be made to or in the name of individual employees/contractors/subcontractors of the agency. 3. A home health agency does not include: A. Any visiting nurse service or home health service conducted by and for those who rely upon spiritual means through prayer alone for healing in accordance with the tenets and practices of a registered church or religious denomination. B. An agency which solely provides services as defined in Chapter 94 of this title. C. An agency which provides staffing exclusively to other agencies (including but not limited to nursing facilities, home health agencies, and hospitals). 4. Upon receipt of an application for licensure and the nonrefundable application fee of $500, the Department shall issue a license if the home health agency meets the requirements established under this chapter. A license, unless sooner suspended or revoked, shall be renewed annually upon filing by the licensee and payment of an annual licensure fee of $300. 5. A provisional license, as authorized by the Department, shall be issued when health requirements are not met and a licensure fee of $300 has been submitted. A home health agency which has been issued a provisional license shall resubmit the application fee ($500) for reinspection prior to the issuance of an annual license. 6. [Repealed.] 7. The Department may request the Superior Court to impose a civil penalty of not more than $10,000 for a violation of this subsection or a regulation adopted pursuant to it. In lieu of seeking a civil penalty, the Department, in its discretion, may impose an administrative penalty of not more than $10,000 for a violation of this subsection or a regulation adopted pursuant to it. Under this subparagraph, each day a violation continues constitutes a separate violation. 8. In determining the amount of any civil or administrative penalty imposed pursuant to paragraph (3)o.7. of this section, the Court or the Department shall consider the following factors: A. The seriousness of the violation, including the nature, circumstances, extent and gravity of the violation and the threat or potential threat to the health or safety of a consumer or consumers; B. The history of violations committed by the person or the person’s affiliate(s), employee(s), or controlling person(s); C. The efforts made by the agency to correct the violation or violations; Page 7 Title 16 - Health and Safety D. The culpability of the person or persons who committed the violation or violations; E. Any misrepresentation made to the Department; and F. Any other matter that affects the health, safety or welfare of a consumer or consumers. 9. The Department shall have the authority to collect administrative penalties. Any fees or civil or administrative penalties collected by the Department under this section are hereby appropriated to the Department to carry out the purposes of this section. 10. In the event of nonpayment of the administrative penalty after all legal appeals have been exhausted, a civil action may be brought by the Secretary in Superior Court for collection of the administrative penalty, including interest, attorney fees and costs. In a civil action to collect the administrative penalty the validity, amount and appropriateness of such administrative penalty shall not be subject to review. p. Establish standards for quality assurance in the operation of freestanding birthing centers, freestanding surgical centers, and freestanding emergency departments; and to grant licenses for the operation of such facilities to persons, associations or organizations meeting those standards and paying the appropriate license fee established by the Department. Upon receipt of an application for license and the application fee of $150 for freestanding birthing centers, $250 for freestanding surgical centers, and $250 for freestanding emergency departments, the Department shall issue a license if the facility meets the requirements established under this chapter. A license unless sooner suspended or revoked, shall be renewed annually upon filing by the licensee and payment of an annual licensure fee of $75 for freestanding birthing centers, $150 for freestanding surgical centers, and $150 for freestanding emergency departments. A provisional license as authorized by the Department shall be issued when health requirements are not met and a licensure fee of $75 for freestanding birthing centers, $150 for freestanding surgical centers, and $150 for freestanding emergency departments has been submitted. Only licensed facilities may use the terms birthing, surgical or emergency in their name or advertising as approved by the Department. For each facility which has been issued a provisional license, there shall be resubmission of the application fee for reinspection prior to the issuance of an annual license. When appropriate, the Department should use the established standards for Medicare reimbursement in setting standards; provided, however, that nothing contained in this subparagraph shall be construed to authorize the Department to expand or limit the scope of practice afforded to professionals under other chapters of this title or other provisions of Delaware law or lawful regulations of the Department. For the purpose of this chapter, the following definitions shall apply to those facilities: 1. “Freestanding birthing center” means a public or private facility, other than a hospital, which is established for the purpose of delivering babies and providing immediate postpartum care. 2. “Freestanding emergency department” means a facility, physically separate from a hospital, which is established, maintained and operated for the purpose of providing immediate and emergent care to individuals suffering from a life-threatening medical condition, and which is subject to the following requirements: A. Services are provided 24 hours per day, 7 days per week on an outpatient basis for medical conditions that include those manifested by symptoms of sufficient severity that, in the absence of immediate medical attention, could result in any of the following: I. Placing the patient’s health in jeopardy. II. Serious impairment to bodily functions. III. Serious dysfunction of any bodily organ or part. IV. Development or continuance of severe pain. B. The freestanding emergency department shall maintain the services, staff, equipment and drugs necessary to provide an initial evaluation and stabilization of a patient of any age who presents with symptoms as noted herein. I. There shall be a full time physician serving as director of the freestanding emergency department who is board-certified in emergency medicine. II. Each physician practicing in the freestanding emergency department shall be licensed to practice medicine in the State and: (A) Be board-certified in emergency medicine; or (B) Be board-eligible for certification in emergency medicine and attain certification within 3 years of completion of a residency program; or (C) Have at least 3 years of full-time clinical experience in emergency medicine within the past 5 years, be American Board of Medical Specialties or American Osteopathic Association certified in a medical specialty, and hold current certifications in advanced cardiac life support, advanced pediatric life support and advanced trauma life support. III. Resident physicians and nonphysician providers may work in the freestanding emergency department as long as there are procedures in place for prompt consultation and communication with a physician on-site who meets the criteria in paragraph (3)p.2.B.II. of this section. IV. All registered nurses practicing in the freestanding emergency department shall be licensed as a registered nurse in the State and hold, or attain within 6 months of hire, certifications, or equivalents as approved by the Department, in advanced cardiac life support and pediatric advanced life support. Page 8 Title 16 - Health and Safety V. There must be at least 1 physician, who meets the requirements of paragraph (3)p.2.B.II. of this section, and 1 registered nurse, with current certifications, or equivalents as approved by the Department, in advanced cardiac life support and pediatric advanced life support, present in the freestanding emergency department at all times. VI. Each freestanding emergency department shall provide on-the-premises clinical laboratory services and diagnostic radiology services to meet a patient’s emergency needs, including provision of results, during all hours of operation. (A) Radiological services must include X ray, computed tomography scan, and ultrasound. (B) Clinical laboratory services must include collection and processing. C. Patient transfer agreements, including a plan for transportation, must be in effect with 1 or more general acute care hospitals that provide basic or comprehensive emergency medical services wherein patients requiring more definitive care will be expeditiously transferred to receive prompt hospital care. D. Each freestanding emergency department shall participate in the Delaware Health Information Network as data senders and end users by January 27, 2017. E. To receive emergency medical services patients, the freestanding emergency department must comply with the requirements and procedures for medical command facility designation set forth by the Division of Public Health’s Office of Emergency Medical Services. F. Each freestanding emergency department must maintain malpractice insurance coverage. G. A freestanding emergency department is exempt from licensure requirements if all of the following are satisfied: I. The freestanding emergency department is owned and operated by a hospital licensed under Chapter 10 of this title. II. The freestanding emergency department is a service of such hospital deemed by an accreditation organization as approved by the Centers for Medicare and Medicaid Services. 3. “Freestanding surgical center” means a place other than a hospital or the office of a physician, dentist or podiatrist or professional association thereof, which is maintained and operated for the purpose of providing surgery and surgical diagnosis and treatment by persons licensed to practice medicine and surgery, dentistry or podiatry in the State, and which shall have an attending staff. q. 1. Establish standards for quality assurance in the operation of prescribed pediatric extended care facilities, and to grant permits for the operation of such facilities to persons, associations or organizations which have been approved in accordance with Chapter 93 of this title and which pay the appropriate permit fee established by the Department. The amount to be charged for the fee imposed under this subparagraph shall approximate and reasonably reflect the costs necessary to defray the expenses of the Department. 2. Upon receipt of an application for license and the application fee of $100, the Department shall issue a license if the prescribed pediatric extended care center meets the requirement established under this chapter. A license, unless sooner suspended or revoked, shall be renewed annually upon filing by the licensee and payment of an annual licensure fee of $50. A provisional license as authorized by the Department shall be issued when health requirements are not met and a licensure fee of $50 has been submitted. For each home health agency which has been issued a provisional license, there shall be resubmission of the application fee for reinspection prior to the issuance of an annual license. r. Provide for the sanitary control, specifically addressing drinking water, human waste disposal and control of other vectors of human disease, of mobile/manufactured home parks and other housing of similar usage, which consist of more than 3 dwelling units or lots located on the same or adjacent properties served by a common water and/or sewage disposal system, and which are held out to the public for rent or lease. s. 1. Establish standards for regulation in the operation of adult day care facilities, and grant licenses for the operation of such facilities to persons, associations or organizations which have been approved in accordance with this title and which pay the appropriate permit fee established below. 2. Upon receipt of an application for a license, and the application fee of $100, the Secretary of the Department of Health and Social Services shall issue a license if the prescribed adult day care facility meets the requirements established under this title. The Secretary shall be authorized to issue restricted, provisional and other types of licenses and to revoke or suspend any license in accordance with department regulations. A license, unless sooner suspended or revoked, shall be renewed annually upon filing by the licensee and payment of an annual licensure fee of $50, provided that an applicant meets requirements as outlined in the regulations. t. 1. Establish standards for regulation of lead-based paint hazard control activities, including the training and certification of workers engaged in lead-based paint activities, the establishment of work standards for lead-based paint hazard control and the accreditation of lead-based paint hazard training programs. 2. Individuals meeting the minimum qualifications established by regulation who are engaged in lead-based paint activities shall obtain a license issued by the Department of Health and Social Services upon receipt of an application and an annual license fee of $25 for workers; $50 for supervisors, dust-wipe technicians, renovators, project designers, contractors, inspectors and risk assessors. As of the date of enactment of implementing regulations, renovators and dust-wipe technicians meeting federal certification requirements must become licensed by the Department upon expiration of their current certification period. Page 9 Title 16 - Health and Safety 3. All courses offered in Delaware by training providers for individuals engaged in lead-based paint activities shall be approved by the State Department of Health and Social Services. The training provider shall pay an annual fee of $200 for each type of course for which training will be provided. 4. In general. — Not later than 120 days after the date of enactment of an opt-out provision in Federal regulations in the future, and subject to paragraph (3)t.4.A. of this section, in promulgating any regulation relating to renovation or remodeling activities in target housing in which the owner resides, the State shall include a provision that permits the owner to authorize the renovation or remodeling contractor to forego compliance with that federal regulation. A. Restriction. — The Administrator shall only permit an owner of target housing to forgo compliance with a regulation under this paragraph if: I. No pregnant woman or child under the age of 6 resides in the target housing as of the date on which the renovation or remodeling commences; and II. The owner submits to the renovation or remodeling contractor written certification that: (A) The renovation or remodeling project is to be carried out at the target housing of the owner; (B) No pregnant woman or child under the age of 6 resides in the target housing as of the date on which the renovation or remodeling commences; and (C) The owner acknowledges that, in carrying out the project, the renovation or remodeling contractor will be exempt from employing the work practices required by a regulation promulgated under this paragraph. B. Limitation of contractor liability. — A contractor that receives written certification described in paragraph (3)t.4.A.II. of this section shall be exempt from liability resulting from any misrepresentation of the owner of the target housing. u. 1. Promulgate and enforce standards to regulate food establishments which may include, but are not limited to, restaurants, caterers, temporary food vendors, grocery stores, food vending machines, ice manufacturers and cottage industries that prepare or handle food for human consumption whenever it is determined that said food represents a hazard to the public health. Notwithstanding any regulation to the contrary, the owner of a food establishment or beer garden may permit leashed dogs in the owner’s beer garden or on the owner’s licensed outdoor patio. 2. To perform these functions, the Division of Public Health shall have the authority to collect reasonable fees necessary to defray costs of functions identified in paragraph (3)u.1. of this section. 3. For each facility required by regulations to hold a permit, the following fee shall be assessed: FOOD ESTABLISHMENT PERMIT Type of Establishment Public Eating Place Retail Food Store Ice Manufacturers Commercial Food Processors Vending Machine Location Fee $100 $100 $30 $30 $25 4. For each facility required by regulation to have a plan review, the following fee shall be assessed: FOOD ESTABLISHMENT PLAN REVIEW Square Footage 1000 or less 1001-5000 5001-10000 10001-15000 15001-above Fee $50 $100 $150 $200 $250 5. Churches, schools, fire companies and other nonprofit organizations are exempt from these fees. v. Establish standards for public health assurance in the practice of cosmetology and barbering and in the operation of beauty salons, schools of cosmetology, schools of electrology, schools of nail technology and schools of barbering, and for the investigation of complaints involving unsanitary or unsafe practices or conditions in such professions or facilities. For purposes of this chapter, the terms “cosmetology,” “beauty salon,” “school of cosmetology,” “school of electrology,” “school of nail technology” and “school of barbering” shall have the same meanings as provided in § 5101 of Title 24. Nothing contained in this subparagraph shall be construed to authorize the Department to expand or limit the scope of practice afforded to professionals under other provisions of Delaware law. Page 10 Title 16 - Health and Safety w. Establish standards for the sanitary operation of tattoo parlors and body piercing establishments. For purposes of this paragraph, “tattoo parlor” means a person or business that makes permanent marks on human skin by puncturing the skin and inserting an indelible color or by producing scarring. For purposes of this paragraph, “body piercing establishment” means a person or business that perforates any human body part or human tissue and places a foreign object in the perforation for nonmedical purposes except for a person or business that perforates only ears. Upon receipt of an application for a permit and a permit fee of $100, the Department of Health and Social Services shall issue a permit to a tattoo parlor or body piercing establishment if it meets the requirements established under Department regulations. The Secretary shall be authorized to issue restricted, provisional and other types of permits and to revoke or suspend any permit in accordance with Department regulations. A permit, unless sooner suspended or revoked, shall be renewed annually upon filing by the permittee and payment of an annual permit fee of $100, provided that an applicant meets the requirements set forth in Department regulations. x. Establish standards for regulation of the operation of personal assistance services agencies, and grant licenses for the operation of such Agencies to persons, associations or organizations that have been approved in accordance with this title and that pay the appropriate licensure fee. 1. A “personal assistance services agency” is any business entity or subdivision thereof, whether public or private, proprietary or not-for-profit, which refers direct care workers to provide personal assistance services to individuals primarily in their home or private residence. 2. “Personal assistance services” means the provision of services that do not require the judgment and skills of a licensed nurse or other professional. The services are limited to individual assistance with, or supervision of, activities of daily living, homemaker services, companion services, and those other services as set out in § 1921(a)(15) of Title 24. 3. A personal assistance services agency does not include: A. An agency providing skilled professional health-care services. B. An agency which provides services as defined in Chapter 94 of this title. C. An agency which provides staffing exclusively to other agencies (including but not limited to, nursing facilities, home health agencies, and hospitals). 4. Upon receipt of an application for licensure and the nonrefundable application fee of $250, the Department shall issue a license if the personal assistance services agency meets the requirements established under this paragraph. The Department shall be authorized to revoke or suspend any license in accordance with Department regulations. A license is not transferable from person to person or entity to entity. 5. A license, unless sooner suspended or revoked, shall be renewed annually upon filing by the licensee and payment of an annual licensure fee of $100, provided that an applicant meets requirements as outlined in the Department’s regulations. 6. The Department shall not issue a license to any applicant, nor shall it renew any previously issued license, unless, together with the proper licensure fee, application, and evidence of compliance with Department regulations, the personal assistance services agency/applicant has included: A. Evidence that the personal assistance services agency is complying with the State’s criminal background check policy as set forth in § 1145 of this title. B. Evidence that the personal assistance services agency is complying with the State’s drug testing policy as set forth in § 1146 of this title. C. Evidence that the personal assistance services agency discloses to its consumers the personal assistance services agency’s and the direct care worker’s status with respect to attendant tax, workers’ compensation, and liability insurance obligations. 7. The Department may request the Superior Court to impose a civil penalty not to exceed $5,000 for a violation of this subsection or a regulation adopted pursuant to it. In lieu of seeking a civil penalty, the Department, in its discretion, may impose an administrative penalty not to exceed $5,000 for a violation of this subsection or a regulation adopted pursuant to it. Under this subparagraph, each day a violation continues constitutes a separate violation. 8. In determining the amount of any civil or administrative penalty imposed pursuant to paragraph (3)x.7. of this section, the Court or the Department shall consider the following factors: A. The seriousness of the violation, including the nature, circumstances, extent and gravity of the violation and the threat or potential threat to the health and safety of a consumer or consumers; B. The history of violations committed by the person or person’s affiliate(s), employee(s), or controlling person(s); C. The efforts made by the Personal Assistance Services Agency to correct the violation or violations; D. The culpability of the person or persons whom committed the violation or violations; E. Any misrepresentation made to the Department; and F. Any other matter that affects the health, safety, or welfare of a consumer or consumers. 9. In the event of nonpayment of the administrative penalty after all legal appeals have been exhausted, a civil action may be brought by the Secretary in Superior Court for collection of the administrative penalty, including interest, attorney fees and costs. Page 11 Title 16 - Health and Safety In a civil action to collect the administrative penalty the validity, amount and appropriateness of such administrative penalty shall not be subject to review. 10. The Department shall have the authority to collect licensure fees and administrative penalties. Any licensure fees or civil or administrative penalties collected by the Department under this subsection are hereby appropriated to the Department to carry out the purposes of this subsection. 11. The Department shall have the power to promulgate rules and regulations necessary to implement the provisions of this subsection. y. Establish standards with respect to safety and sanitary conditions of any facility defined in paragraph (3)y.3.C. of this section and investigate and inspect any such facility for unsafe or unsanitary conditions upon receipt of a complaint by a patient or facility employee in accordance with this paragraph, or upon the occurrence of any adverse event in connection with any such facility. The Department may share information hereunder with the Department of State, Division of Professional Regulation in accordance with applicable law. 1. The Department may make and enforce such orders as it deems necessary to protect the health and safety of the public hereunder. Without limitation of the foregoing, if the Department determines during the course of any investigation or inspection that any facility hereunder poses a substantial risk to the health or safety of any person, the Department may order that such facility be closed until such time as it no longer poses a substantial risk. 2. No later than March 31, 2012, the Department shall adopt regulations to strengthen the oversight of facilities hereunder. 3. For purposes of this paragraph (3)y.: A. “Adverse event” means: I. The death or serious injury of any patient at a facility; II. A reasonable determination by the Department that death or serious injury may result from any unsafe or unsanitary condition at a facility; or III. The initiation of any criminal investigation arising out of or relating to any diagnosis, treatment or other medical care at a facility. I. The death or serious injury of any patient at a facility; II. A reasonable determination by the Department that death or serious injury may result from any unsafe or unsanitary condition at a facility; or III. The initiation of any criminal investigation arising out of or relating to any diagnosis, treatment or other medical care at a facility. B. “Complaint” means a complaint filed by a patient or facility employee in writing, in such format as the Department shall require. C. “Facility” means a location at which any office-based surgery is performed, but does not include any hospital, as defined in § 1001(3) of this title, or any freestanding birthing center, freestanding surgical center, or freestanding emergency center, as such terms are defined in paragraph (3)p. of this section. D. “Office-based surgery” means any medical procedure, including dental and podiatric procedures, including any of the following: I. Surgical abortions. II. Procedures in which the facility utilizes anesthesia, major conduction anesthesia, or sedation. III. Procedures in which the spine (i.e. epidural, facet joint) is the target of an injection. IV. Procedures in which the accepted standard of care requires anesthesia, major conduction anesthesia, or sedation. E. “Patient” means a person who has received diagnosis, treatment or other medical care at a facility or such person’s spouse, as well as any parent, legal guardian, or legal custodian of such person who is under 18 years of age or any legal guardian or legal custodian of such person who is an adult. When deemed necessary by the Department, such regulations may provide for the issuance of permits to persons engaged in the occupations or businesses so regulated and the revocation for cause of the permits. z. Establish standards for a facility accreditation program. — 1. A. To operate in this State, any facility not licensed by the Department where office-based surgery is performed must maintain accreditation by an accrediting organization approved by the Department. For an accrediting organization to be approved it must be entirely independent from the facility and there shall be no conflict of interest. For purposes of this paragraph (3)z., “facility” and “office-based surgery” mean as defined in paragraph (3)y. of this section. All such offices or facilities must register with the Department utilizing a form created for this purpose by the Department. B. I. An accrediting organization shall report to the Department, at a minimum, all of the following regarding facilities the organization has accredited under this paragraph: (A) Findings of surveys. (B) Findings of complaint and incident investigations. (C) Data for all facilities that perform office-based surgery. II. Documents provided under this paragraph (3)z.1.B. are not public records under the Freedom of Information Act, Chapter 100 of Title 29. Page 12 Title 16 - Health and Safety 2. All facilities where office-based surgery is performed shall submit proof of the facility’s accreditation, as required, to the Department. Any newly opened facility where office-based surgery is performed shall submit proof of the facility’s accreditation to the Department within 12 months of the first day of operation of such facility. 3. After each survey of any facility hereunder by an approved accrediting organization, the facility must submit the accrediting organization’s survey report to the Department within 30 days in a form satisfactory to the Department. 4. If the facility fails to maintain current accreditation or if the accreditation is revoked or is otherwise no longer valid, the facility shall immediately cease to operate. 5. The Department shall promulgate regulations pursuant to this paragraph, and shall form a stakeholder group for the purposes of advising the Department on the content of the regulations. The stakeholder group shall be chaired by the Director of Public Health or his or her designees, and shall include, but not be limited to, the following: the Director of the Division of Professional Regulations, or his or her designee; the Director of Health Facilities Licensing and Certification, or his or her designee; 4 representatives from the physician community, to be appointed by the Medical Society of Delaware, whose specialties include, but are not limited to: dermatology, plastic surgery, anesthesia and pain management; a representative from the Delaware Podiatric Medical Association; a representative from the Delaware State Dental Society; a representative from the Delaware chapter of the American College of Obstetricians and Gynecologists; a representative from the Delaware chapter of the American College of Surgeons; and 1 or more members of the public who shall represent the interests of patients. 6. No later than March 31, 2012, the Department shall adopt regulations for the accreditation program herein described. aa. Establish standards for public health quality assurance in the operation of dialysis centers and regulate the public health practice of such programs, which shall include but not be limited to a standard requirement for all dialysis machines to be connected to an emergency power source so that all dialysis machines will operate for at least 4 hours following a power shutdown or outage. In addition, the emergency power source must be in working condition at all times and the dialysis center must conduct and document at least a monthly test of those emergency power sources. For purposes of this section, a “dialysis center” means an independent or hospital-based unit approved to furnish outpatient dialysis services directly to end stage renal disease (ESRD) patients maintenance dialysis services, or home dialysis training and support services, or both to end stage renal disease patients. To perform these functions, the Department shall have the authority to collect and retain reasonable fees necessary to defray costs of these functions. At all times there must be a facility that meets the requirements of this section in each of the following locations: the City of Wilmington, New Castle County, Kent County, and Sussex County. Dialysis centers operating as of July 1, 2015, are to be compliant with all aspects of this section immediately but may be granted a hardship exemption to immediate compliance but only until at the latest January 1, 2021. Hardship exemptions may be granted for facilities in long term leases, other issues regarding real estate, and any other reason as determined by the Department. Dialysis centers that are newly constructed or relocated after July 1, 2015, must be compliant with all aspects of this section prior to occupancy. 1. The amount charged for each fee imposed under this section shall approximate and reasonably reflect all costs necessary to defray the expenses incurred by the Department. There shall be a separate fee charged for each service or activity, but no fee shall be charged for a purpose not specified in this chapter. The application fee shall not be combined with any other fee or charge. At the beginning of each calendar year, the Department, or any other state agency acting on its behalf, shall compute for each separate service or activity the appropriate fees for the coming year. 2. Upon receipt of an application for licensure and the nonrefundable application fee, the Department shall issue a license if the dialysis center meets the requirements established under this chapter. A license, unless sooner suspended or revoked, shall be renewed annually upon filing by the licensee and payment of an annual licensure fee. 3. A provisional license, as authorized by the Department, shall be issued when health requirements are not met and a licensure fee has been submitted. A dialysis center which has been issued a provisional license shall resubmit the application fee for reinspection prior to the issuance of an annual license. 4. The Department may impose sanctions singly or in combination when it finds a licensee or former licensee has: A. Violated any of these regulations; B. Failed to submit a reasonable timetable for correction of deficiencies; C. Failed to correct deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Department; D. Exhibited a pattern of cyclical deficiencies which extends over a period of 2 or more years; E. Engaged in any conduct or practices detrimental to the welfare of the patients; F. Exhibited incompetence, negligence or misconduct in operating the dialysis center or in providing services to patients; G. Mistreated or abused patients cared for by the dialysis center; H. Violated any statutes relating to medical assistance or Medicare reimbursement for those facilities who participate in those programs; or I. Refused to allow the Department access to the dialysis center or records for the purpose of conducting inspections/surveys/ investigations as deemed necessary by the Department. 5. Disciplinary sanctions include any of the following: Page 13 Title 16 - Health and Safety A. Permanent revocation of a license which extends to: I. The dialysis center; II. Any owner; III. Officers/directors, partners, managing members or members of a governing body who have a financial interest of 5% or more in the dialysis center; and IV. Corporation officers. B. Suspension of a license; C. A letter of reprimand; D. Placement on provisional status with the following requirements: I. Report regularly to the Department upon the matters which are the basis of the provisional status; II. Limit practice to those areas prescribed by the Department; III. Suspend operations; E. Refusal of a license; F. Refusal to renew a license; and/or G. Other disciplinary action as appropriate. 6. The Department may request the Superior Court to impose a civil penalty of not more than $10,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation. A. In lieu of seeking a civil penalty, the Department, in its discretion, may impose an administrative penalty of not more than $10,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation. B. In determining the amount of any civil or administrative penalty imposed, the Court or the Department shall consider the following factors: I. The seriousness of the violation, including the nature, circumstances, extent and gravity of the violation and the threat or potential threat to the health or safety of a patient; II. The history of violations committed by the person or the person’s affiliate, agent, employee or controlling person; III. The efforts made by the dialysis center to correct the violation or violations; IV. Any misrepresentation made to the Department; and V. Any other matter that affects the health, safety or welfare of a patient. 7. Imposition of disciplinary action. — Before any disciplinary action is taken the following shall occur: A. The Department shall give 20 calendar days written notice to the holder of the license, setting forth the reasons for the determination. B. The disciplinary action shall become final 20 calendar days after the mailing of the notice unless the licensee, within such 20-calendar-day period, shall give written notice of the dialysis center’s desire for a hearing. C. If the licensee gives such notice, the dialysis center shall be given a hearing before the Secretary of the Department or her or his designee and may present such evidence as may be proper. D. The Secretary of the Department or her or his designee shall make a determination based upon the evidence presented. E. A written copy of the determination and the reasons upon which it is based shall be sent to the dialysis center. F. The decision shall become final 20 calendar days after the mailing of the determination letter unless the licensee, within the 20-calendar-day period, appeals the decision to the appropriate court of the State. 8. Order to immediately suspend a license. — A. In the event the Department identifies activities which the Department determines present an immediate jeopardy or imminent danger to the public health, welfare or safety requiring emergency action, the Department may issue an order temporarily suspending the licensee’s license, pending a final hearing on the complaint. No order temporarily suspending a license shall be issued by the Department, with less than 24 hours prior written or oral notice to the licensee or the licensee’s attorney so that the licensee may be heard in opposition to the proposed suspension. An order of temporary suspension under this section shall remain in effect for a period not longer than 60 calendar days from the date of the issuance of said order, unless the suspended licensee requests a continuance of the date for the final hearing before the Department. If a continuance is requested, the order of temporary suspension shall remain in effect until the Department has rendered a decision after the final hearing. B. The licensee, whose license has been temporarily suspended, shall be notified forthwith in writing. Notification shall consist of a copy of the deficiency report and the order of temporary suspension pending a hearing and shall be personally served upon the licensee or sent by mail, return receipt requested, to the licensee’s last known address. C. A licensee whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Department shall schedule the hearing on an expedited basis provided that the Department receives the licensee’s written request for an expedited hearing within 5 calendar days from the date on which the licensee received notification of the Department’s decision to temporarily suspend the licensee’s license. Page 14 Title 16 - Health and Safety D. As soon as possible, but in no event later than 60 calendar days after the issuance of the order of temporary suspension, the Department shall convene for a hearing on the reasons for suspension. In the event that a licensee, in a timely manner, requests an expedited hearing, the Department shall convene within 15 calendar days of the receipt by the Department of such a request and shall render a decision within 30 calendar days. E. In no event shall an order of temporary suspension remain in effect for longer than 60 calendar days unless the suspended licensee requests an extension of the order of temporary suspension pending a final decision of the Department. Upon a final decision of the Department, the order of temporary suspension may be vacated in favor of the disciplinary action ordered by the Department. 9. Application for licensure after revocation or voluntary surrender of a license in avoidance of revocation action. — A. The application for license after termination of rights to provide services shall follow the procedure for initial licensure application. B. In addition to the licensure application, the dialysis center must also submit and obtain approval of a detailed plan of correction regarding how the dialysis center intends to correct the deficient practices that led to the original termination action. Submission of evidence supporting compliance with the plan and cooperation with Department monitoring during probationary and provisional licensure status is required for reinstatement to full licensure status. C. Upon successful completion of the probationary period, the dialysis center will be granted a provisional license for a period no less than 1 year but no greater than 2 years. The provisional period will be identified by the Department after having considered the circumstances that created the original action for license revocation. D. A license will be granted to the dialysis center after the provisional licensure period if: I. The dialysis center has remained in substantial compliance with these rules and regulations; and II. The dialysis center fulfilled the expectations of the detailed plan of correction that was created to address the deficient practices that gave rise to the license termination action. E. A license will not be granted after the probationary or provisional licensure period to any dialysis center that is not in substantial compliance with these rules and regulations. bb. Regulate the training and educational qualifications for the certification of animal welfare officers. The Department shall: 1. Develop requirements for certification and curricula preparing a person for certification; 2. Develop criteria and standards for evaluating educational programs preparing a person for training and certification; including in conjunction with the Delaware Department of Agriculture and the Delaware Department of Natural Resources and Environmental Control concerning livestock, poultry, and wildlife for animal welfare officers; 3. Approve such programs that meet the requirements of this chapter and of the Department; 4. Deny or withdraw approval from educational programs for failure to meet approved curricula or other criteria; 5. Certify and renew certification of duly qualified applicants; 6. Keep current a registry of all persons certified as animal welfare officers in the State; 7. Establish requirements for mandatory continuing education and certification renewal; and 8. Impose disciplinary sanctions and conduct hearings upon charges that may result in disciplinary sanctions outlined in this chapter in conformance with the Administrative Procedures Act, Chapter 101 of Title 29, and the Freedom of Information Act [Chapter 100 of Title 29]. When deemed necessary by the Department, such regulations may provide for the issuance of permits to persons engaged in the occupations or businesses so regulated and the revocation for cause of the permits. (4) Make careful inquiry as to the cause of disease, especially when contagious, infectious, epidemic or endemic, and take prompt action to control or suppress it. (5) Make careful study of the reports of births and deaths, the sanitary condition and effects of localities, employments, the personal and business habits of the people and the relation of the diseases of animals and man; make and execute orders necessary to protect the people against diseases of the lower animals; and collect and preserve such information in respect to such matters and kindred subjects as may be useful in the discharge of its duties, and for dissemination among the people. (6) When requested by public authorities, or when it deems best, advise officers of the state, county or local governments in regard to drainage, and the location, drainage, ventilation and sanitary provisions of any public institution, building or public place. (7) Promulgation and enforcement of reasonable rules and regulations relating to safety, sanitation and adequate shelter as affecting the welfare and health of railroad trainworkers, engineworkers, yardworkers, maintenance of way employees, highway crossing watches, clerical, platform, freight house and express employees. No rules and regulations shall be issued by the Department under this subdivision unless the Department has held hearings with regard thereto and both the employers and the employees affected have been given a full opportunity to present evidence as to the necessity and reasonableness of the proposed rules and regulations. (8) Collection of fees to support the Conrad State 30/J-1 Visa Waiver Program. — Pursuant to the Department of Health and Social Services authority under this title to assess fees for services, the Bureau of Health Planning and Resources Management, Delaware Division of Public Health, Department of Health and Social Services, shall charge, collect and retain site application and physician Page 15 Title 16 - Health and Safety application fees to support the Bureau of Health Planning and Resources Management in administering the Conrad State 30/J-1 Visa Waiver Program. The Bureau of Health Planning and Resources Management within the Delaware Division of Public Health shall charge a nonrefundable processing fee of $200 to each sponsoring site submitting a site application at the time the application is submitted. A nonrefundable processing fee of $250 shall be charged to each pre-approved site to process the waiver request application for each J-1 physician that the site plans to employ. (9) No person shall operate any health-care agency or facility without a license from the Department of Health and Social Services if such health-care agency or facility is required to obtain a license under this title. The Department may make and enforce such orders as it deems necessary to protect the health and safety of the public hereunder. Without limitation of the foregoing, if the Department determines that a health-care agency or facility is operating without a required license, the Department may order that such agency or facility be closed. a. Whoever refuses, fails or neglects to close after notification from the Department regarding the requirement for licensure shall be subject to an administrative penalty of $5,000 per day, together with costs, for every day that they remain open from and after the effective date of notification from the Department. b. In the event of nonpayment of the administrative penalty after all legal appeals have been exhausted, a civil action may be brought by the Secretary in any court of competent jurisdiction, including any Justice of the Peace Court, for collection of the administrative penalty, including interest, attorneys’ fees and costs, and the validity, amount and appropriateness of such administrative penalty shall not be subject to review. (10) The powers and duties of the Department are subject to the powers and duties granted other entities in Title 20. Provisions of Title 20 which conflict with provisions of this section shall take precedence over this section. (19 Del. Laws, c. 642, § 3; 22 Del. Laws, c. 327, § 3; Code 1915, § 738; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 745; 43 Del. Laws, c. 91, § 1; 16 Del. C. 1953, § 122; 50 Del. Laws, c. 312, § 1; 51 Del. Laws, c. 80, § 1; 52 Del. Laws, c. 103; 56 Del. Laws, c. 284; 56 Del. Laws, c. 383, § 1; 56 Del. Laws, c. 389, §§ 1, 2; 57 Del. Laws, c. 743; 57 Del. Laws, c. 751, § 2; 58 Del. Laws, c. 52, § 1; 63 Del. Laws, c. 332, § 1; 64 Del. Laws, c. 471, § 1; 65 Del. Laws, c. 69, § 1; 65 Del. Laws, c. 301, § 1; 66 Del. Laws, c. 397, § 1; 67 Del. Laws, c. 266, §§ 1, 2, 3, 4; 67 Del. Laws, c. 344, § 6; 68 Del. Laws, c. 200, § 1; 69 Del. Laws, c. 302, § 7; 69 Del. Laws, c. 452, § 1; 70 Del. Laws, c. 150, § 1; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 267, § 1; 70 Del. Laws, c. 405, § 1; 70 Del. Laws, c. 470, § 1; 70 Del. Laws, c. 536, § 1; 70 Del. Laws, c. 544, §§ 2, 3, 10-20; 71 Del. Laws, c. 85, §§ 1, 2; 71 Del. Laws, c. 322, § 1; 71 Del. Laws, c. 441, § 1; 72 Del. Laws, c. 124, § 1; 72 Del. Laws, c. 181, § 1; 72 Del. Laws, c. 402, § 4; 73 Del. Laws, c. 10, § 1; 73 Del. Laws, c. 118, §§ 1-5; 73 Del. Laws, c. 193, § 4; 73 Del. Laws, c. 347, § 1; 73 Del. Laws, c. 355, § 2; 74 Del. Laws, c. 78, §§ 2, 3; 75 Del. Laws, c. 286, § 1; 75 Del. Laws, c. 308, § 1; 78 Del. Laws, c. 15, § 1; 78 Del. Laws, c. 80, §§ 1, 2; 78 Del. Laws, c. 303, § 5; 79 Del. Laws, c. 92, § 1; 79 Del. Laws, c. 150, § 1; 79 Del. Laws, c. 153, § 1; 79 Del. Laws, c. 154, § 1; 79 Del. Laws, c. 375, §§ 2, 5; 79 Del. Laws, c. 424; § 1; 80 Del. Laws, c. 13, § 1; 80 Del. Laws, c. 72, § 1; 80 Del. Laws, c. 83, § 2; 80 Del. Laws, c. 119, §§ 1, 2; 80 Del. Laws, c. 123, § 1; 80 Del. Laws, c. 235, § 1; 80 Del. Laws, c. 248, § 8; 80 Del. Laws, c. 258, § 7; 80 Del. Laws, c. 404, § 1; 81 Del. Laws, c. 305, § 1; 81 Del. Laws, c. 417, § 1; 82 Del. Laws, c. 100, § 1; 82 Del. Laws, c. 141, § 17; 82 Del. Laws, c. 237, § 1; 83 Del. Laws, c. 341, § 9.) § 123. Reports from public institutions, Division of Professional Regulation and resorts; penalties. (a) The Department of Health and Social Services may require reports and information from all public dispensaries, asylums, prisons and schools and from the managers, principals and officers thereof, and from all other public institutions, their officers and managers, and from the proprietors, managers, lessees and occupants of all places of public resort in the State but such reports and information shall only be required concerning matters and particulars in respect of which the Department of Health and Social Services may need information for the proper discharge of its duties. (b) If any proprietor, manager, principal, superintendent, officer or physician in charge refuses and neglects to make a report when requested to do so by the Department of Health and Social Services, that person shall be fined not less than $5.00 nor more than $25, together with costs. (c) The Delaware Division of Public Health and the Delaware Health Care Commission shall be authorized to request and receive licensing data (including, but not limited to, names, addresses, and license type) to the extent that the data is collected and electronically stored for the purpose of issuing and maintaining professional licenses by the Division of Professional Regulation. Licensing data shall only be used for the purpose of conducting official state business, which may include measuring and tracking the supply of licensed health care professionals in the State. The Delaware Division of Public Health and the Delaware Health Care Commission may share licensing data with their contractors to carry out the purpose of this subsection. The boards affected shall include but not be limited to: (1) Delaware State Board of Medical Licensure and Discipline; (2) Delaware State Board of Dentistry and Dental Hygiene; (3) Delaware State Board of Nursing; (4) Delaware State Board of Professional Counselors; (5) Delaware State Board of Examiners of Psychologists; Page 16 Title 16 - Health and Safety (6) Delaware State Board of Clinical Social Work Examiners; (7) Delaware State Board of Podiatry; (8) Delaware State Board of Chiropractic; (9) Delaware State Board of Occupational Therapy Practice; (10) Delaware State Board of Examiners in Optometry; (11) Delaware State Board of Pharmacy; (12) Delaware State Examining Board of Physical Therapists and Athletic Trainers; (13) Delaware State Board of Examiners of Speech/Language Pathologists, Audiologists and Hearing Aid Dispensers; (14) Delaware State Board of Examiners of Nursing Home Administrators; and (15) Delaware State Committee of Dietetics/Nutrition. (d) All data must be submitted in a standardized electronic format as determined by the Division of Public Health in consultation with the Division of Professional Regulation and the Delaware Health Care Commission. Data must be submitted within 20 business days of a request. (e) For the purposes of measuring, tracking and projecting supply and demand of health-care professionals, the requesting entity shall provide to the Division of Professional Regulation any health workforce report developed from the data. (f) Any individual data provided pursuant to this section shall be confidential. No public employee, commission member, or contractor acting on behalf of a state agency or employee of such a contractor may: (1) Use any data provided pursuant to this section for any purpose other than the statistical, forecasting, and program purposes for which the data is furnished. (2) Make public any of the data provided pursuant to this section that would allow the identity of any individual to be inferred by either direct or indirect means. (3) Retain any personal data as provided in this section that is received by the Delaware Division of Public Health, the Delaware Health Care Commission or any contractor acting on behalf of these entities. Any personal data must be destroyed within 30 days of completion of its intended purpose as described in this section. (g) An intentional violation of subsection (f) of this section shall result in the imposition of a fine of not less than $1,000 nor more than $20,000 or imprisonment of not less than 30 days nor more than 6 months, or both. Justices of the Peace shall have jurisdiction of offenses under this section. (19 Del. Laws, c. 642, § 3; 22 Del. Laws, c. 327, § 3; Code 1915, § 738; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 745; 43 Del. Laws, c. 91, § 1; 16 Del. C. 1953, § 123; 70 Del. Laws, c. 149, §§ 24-26; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 544, §§ 21, 22; 75 Del. Laws, c. 228, §§ 1-5; 77 Del. Laws, c. 319, § 1; 77 Del. Laws, c. 463, § 3.) § 124. Fluoridation of a water supply. (a) In order to protect the dental health of all citizens, especially children, the Department of Health and Social Services shall promulgate rules to provide for the addition of fluoride to all municipal water supplies by the owners or official custodians thereof. Such rules shall provide for the addition of fluoride to the water supplies so as to maintain a fluoride content of not less than that currently specified by the Department’s regulations. (1) By November 15, 1998, each municipal water system shall provide to the Department an estimate of the total capital costs to install the required fluoridation treatment and additional operating costs for the ongoing operation for fluoridation treatment. (2) Subsection (b) of this section shall not apply to those municipalities which are required to comply with the mandates of subsection (a) of this section. (b) The Division of Public Health shall not require any water supply to be fluoridated which has not been fluoridated before March 26, 1974, until approval of such fluoridation is first obtained in the following manner by the users of such water supply: (1) When the Division determines that it is in the best interest of the users of a given water supply that such supply shall be fluoridated, it shall notify the administrator, owner or person who controls the water supply and the local government which it serves. Within 60 days from the receipt of such notice, the governing body of the majority of people involved shall conduct a referendum among the people served by the water supply to determine whether or not such fluoridation shall take place. Prior to any such referendum the Division shall conduct an educational program in the community affected on the fluoridation process. The costs of the referendum shall be borne by the said governing body. (2) Notice of the referendum shall be by the publication of a formal notice embodying the notice received from the Division. Such notice shall be published at least 3 times in a newspaper of general circulation in the area served by the water supply, the last publication to be at least 3 days before the referendum. Such notice shall also include the time and place of voting for the various voting districts involved. (3) Eligible voters at such referendum shall be any natural person who uses the water supply daily and who is 18 years of age or older. Each such person shall be entitled to 1 vote. Page 17 Title 16 - Health and Safety (4) If the area serviced by the water supply has an established local government such government shall conduct the referendum. If 2 or more towns or municipalities are served by the water supply, the referendum shall be conducted simultaneously in each town or municipality by the governing body of that town or municipality. If the governing body is a county and not a town or municipality, the county shall be responsible for all costs of the referendum. The Department of Elections shall conduct the referendum. The referendum shall be by secret ballot and the choice for each voter shall be “For Fluoridation” and “Against Fluoridation.” The water supply shall not be fluoridated if the majority of the ballots cast are against fluoridation. (5) After a referendum is held, the matter shall be deemed to have been conclusively decided for a period of 3 years from the date of the referendum. (6) This section shall apply to any municipality within this State that has held a referendum on the question of fluoridation within the last 3 years commencing from March 26, 1974. Those municipalities that have voted not to fluoridate shall not be required to do so, except as provided by this section. (59 Del. Laws, c. 276, § 2; 70 Del. Laws, c. 150, § 2; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 361, § 1.) § 125. Preservation of public health within incorporated towns; local sanitation matters; expenses. (a) The Department of Health and Social Services, in addition to other powers possessed by it, may preserve the public health within all incorporated towns and within 1 mile of the water supply thereof. (b) The Department of Health and Social Services may also make and enforce orders in local sanitation matters, when in the judgment of the Department of Health and Social Services such action is necessary for the protection of the public health and the local boards of health have neglected or refused to act with sufficient promptness or efficiency, or when or where such local board has not been established. All expenses so incurred shall be paid by the city, or town or county for which services are rendered upon bill presented to the treasurer of such city, town or county by the Department of Health and Social Services. (19 Del. Laws, c. 642, § 3; 22 Del. Laws, c. 327, § 3; Code 1915, § 738; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 66, § 1; 34 Del. Laws, c. 69, § 1; Code 1935, §§ 745, 858; 43 Del. Laws, c. 91, § 1; 16 Del. C. 1953, § 124; 57 Del. Laws, c. 591, §§ 6, 7; 59 Del. Laws, c. 276, § 1; 70 Del. Laws, c. 149, §§ 28, 29, 30; 70 Del. Laws, c. 186, § 1.) § 126. Regulations and orders of Department and Secretary — Effect; distribution. (a) Regulations and orders promulgated or issued by the Department of Health and Social Services in accordance with authority conferred upon it have the force and effect of law and supersede all local ordinances and regulations which are inconsistent therewith. (b) Municipalities and local public health officials may with the consent and approval of the Secretary of the Department of Health and Social Services or the Secretary’s designee adopt such ordinances or regulations in addition to the regulations or orders of the Secretary of the Department of Health and Social Services or the Secretary’s designee as are consistent with the law and the purposes set forth in this chapter. (c) A copy of every regulation or order of the Department of Health and Social Services, giving the date that it takes effect, shall be filed with the Secretary of State, and copies of such regulations or orders shall be issued by the Department of Health and Social Services in pamphlet form for general distribution. (19 Del. Laws, c. 642, § 3; 22 Del. Laws, c. 327, § 3; Code 1915, § 738; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 745; 43 Del. Laws, c. 91, § 1; 46 Del. Laws, c. 312, § 1; 16 Del. C. 1953, § 125; 59 Del. Laws, c. 276, § 1; 70 Del. Laws, c. 149, §§ 31, 32, 33; 70 Del. Laws, c. 186, § 1.) § 127. Regulations and orders of Department and Secretary — Duty of enforcement; penalty. (a) All local boards of health, health authorities and officials, officers of the State and county institutions, police officers, sheriffs, constables and all other officers and employees of the State, or of any county, city or town thereof, shall enforce such quarantine orders, and such rules, regulations and orders as are adopted by the Department of Health and Social Services. (b) In the event of failure or refusal on the part of any member of the local boards or other official or person mentioned in this section so to act, the member shall be fined not more than $50 for the first offense and not more than $100 for the second and each succeeding offense. (19 Del. Laws, c. 642, § 3; 22 Del. Laws, c. 327, § 3; Code 1915, § 738; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 745; 43 Del. Laws, c. 91, § 1; 16 Del. C. 1953, § 126; 59 Del. Laws, c. 276, § 1; 70 Del. Laws, c. 149, § 34; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 544, § 23.) § 128. Powers as advisory board; investigations; abatement of nuisances. (a) The Department of Health and Social Services shall be an advisor to the authorities of the State in all matters pertaining to public hygiene. It may make special inspections of hospitals, prisons, asylums, almshouses and other public institutions, and may investigate the cause of any special disease or mortality in any part of the State, and may make such regulations and may adopt such measures, including quarantine, vaccination, etc., as it deems most efficient to eradicate all infectious diseases. (b) In localities where there are no local boards of health, or where the same shall refuse or neglect to act, the Department may investigate all complaints made in writing, and if it shall find a nuisance to exist it shall order the same to be abated in a reasonable time. In such Page 18 Title 16 - Health and Safety cases the Secretary of the Department of Health and Social Services or the Secretary’s designee shall have all power and remedies given by law to local boards. (19 Del. Laws, c. 642, § 4; 22 Del. Laws, c. 98, § 1; Code 1915, § 739; 29 Del. Laws, c. 49, § 1; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 746; 16 Del. C. 1953, § 127; 57 Del. Laws, c. 591, §§ 8-11; 59 Del. Laws, c. 276, § 1; 70 Del. Laws, c. 149, §§ 35-37; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 544, § 24.) § 129. Threatened epidemics; appointment of officers to enforce regulations and orders. With the exception of circumstances encompassed by Title 20, when any contagious or infectious disease shall become or threaten to become epidemic, and the local authorities shall neglect or refuse to enforce efficient measures for its prevention, the Secretary or the Secretary’s designee may appoint a medical officer and such assistants as the Department or Division may require and authorize such medical officer to enforce such orders or regulations as the Secretary deems necessary. Provisions of Title 20 which conflict with provisions of this section shall take precedence over this section. (19 Del. Laws, c. 642, § 11; 22 Del. Laws, c. 327, § 6; Code 1915, § 742; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 748; 16 Del. C. 1953, § 128; 57 Del. Laws, c. 591, § 12; 59 Del. Laws, c. 276, § 1; 70 Del. Laws, c. 149, §§ 38-40; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 544, § 25; 73 Del. Laws, c. 355, § 3.) § 130. Reporting of potential or existing public health emergencies. (a) Except as otherwise indicated in this chapter or Title 20, the Secretary of Health and Social Services or the Secretary’s designee shall be responsible for implementing all measures designed to address potential contagious diseases or infectious diseases in this State. (b) A health-care provider shall report all cases of persons who harbor any illness or health condition that may be potential causes of a public health emergency. Reportable illnesses and health conditions include, but are not limited to, the diseases caused by the biological agents listed in 42 C.F.R. § 72.3 and symptoms of those diseases, and any illnesses or health conditions identified by the Division of Public Health as notifiable diseases. (c) In addition to the foregoing requirements, a pharmacist shall report any unusual or increased prescription rates, unusual types of prescriptions, or unusual trends in pharmacy visits that may be potential causes of a public health emergency. Prescription-related events that require a report include, but are not limited to: (1) An unusual increase in the number of prescriptions to treat fever, respiratory or gastrointestinal complaints; (2) An unusual increase in the number of prescriptions for antibiotics; and (3) Any prescription that treats a disease that is relatively uncommon or may be associated with bioterrorism. (d) Reports pursuant to subsections (b) and (c) of this section shall be made electronically or in writing within 24 hours to the Division of Public Health, or within such time less than 24 hours as may be established by the Division of Public Health by regulation. The report shall include as much of the following information as is available: the patient’s name, date of birth, sex and current address (including city and county); the name and address of the health-care provider or medical examiner and of the reporting individual, if different; and any other information needed to locate the patient for follow-up. For cases related to animal or insect bites, the suspected locating information of the biting animal or insect and the name and address of any known owner shall be reported (e) Every veterinarian, livestock owner, veterinary diagnostic laboratory director or other person having a vocation that primarily involves the care of animals shall report animals having or suspected of having any disease that may be potential causes of a public health emergency. The report shall be made within 24 hours to the Department of Agriculture and shall include as much of the following information as is available: the suspected locating information of the animal, the name and address of any known owner, and the name and address of the reporting individual. The Department of Agriculture shall promulgate regulations implementing this subsection. The Department of Agriculture shall provide written or electronic notice to the Division of Public Health of any reports received pursuant to this subsection within 24 hours of receipt of said report, and such notice shall contain all information provided in the report. (f) For the purposes of this section, the definition of “health care provider” shall include out-of-state medical laboratories, provided that such laboratories have agreed to the reporting requirements of this State. Results must be reported by the laboratory that performs the test, but an in-state laboratory that sends specimens to an out-of-state laboratory is also responsible for reporting results. (g) Definitions from § 3132 of Title 20 shall apply to this section. (73 Del. Laws, c. 355, § 5; 70 Del. Laws, c. 186, § 1.) § 131. Survey of hospitals and health centers — Required. (a) The Secretary or the Secretary’s designee shall: (1) Make a survey of the location, size and character of all existing public and private (proprietary as well as nonprofit) hospitals and health centers in the State; (2) Evaluate the sufficiency of such hospitals and health centers to supply the necessary physical facilities for furnishing adequate hospital, clinical and similar services to all the people of the State; and (3) Compile such data and conclusions, together with a statement of the additional facilities necessary, in conjunction with existing structures to supply such services. Page 19 Title 16 - Health and Safety (b) The Secretary or the Secretary’s designee shall utilize, so far as practicable, any appropriate reports, surveys and plans prepared by other state agencies. (45 Del. Laws, c. 88, § 1; 16 Del. C. 1953, § 130; 59 Del. Laws, c. 276, § 1; 70 Del. Laws, c. 149, §§ 43, 44; 70 Del. Laws, c. 186, § 1.) § 132. Acceptance of federal grants. The Secretary or the Secretary’s designee may apply for and accept on behalf of the State, may deposit with the State Treasurer and may expend for the purposes for which granted or advanced, any grant or advance made by the United States or by any agency or officer thereof to assist in meeting the cost of carrying out the purposes of § 131 of this title. (45 Del. Laws, c. 88, § 2; 16 Del. C. 1953, § 131; 59 Del. Laws, c. 276, § 1; 70 Del. Laws, c. 149, § 45; 70 Del. Laws, c. 186, § 1.) § 133. Cancer; Delaware Cancer Consortium. (a) The Division of Public Health may use any money appropriated to it for the purpose of the detection of cancer, for research in cancer and for other purposes related to cancer prevention and control. (b) The Delaware Cancer Consortium (“Consortium”) shall coordinate cancer prevention and control activities in the State of Delaware. The Consortium will: (1) Provide advice and support to state agencies, cancer centers, cancer control organizations and health care practitioners regarding their role in reducing mortality and morbidity from cancer. (2) Facilitate collaborative partnerships among public health agencies, cancer centers and all other interested agencies and organizations to carry out recommended cancer control strategies. (3) On at least a biennial basis, analyze the burden of cancer in Delaware and progress toward reducing cancer incidence and mortality. (c) The Consortium’s priorities and advocacy agenda shall be dictated by the recommendations contained in “Turning Commitment Into Action — Recommendations of the Advisory Council on Cancer Incidence and Mortality,” published in April, 2002. (d) The Consortium’s permanent membership shall be as follows: (1) Two representatives of the Delaware House of Representatives and 2 representatives of the Delaware State Senate (1 selected by each caucus); (2) One representative of the Governor’s office; (3) The Secretary of the Department of Health and Social Services or the Secretary’s designee; (4) One representative of the Department of Natural Resources and Environmental Control; (5) One representative of the Medical Society of Delaware to be appointed by the Governor; (6) One professor from Delaware State University or the University of Delaware, to be appointed by the Governor; (7) Two physicians with relevant medical knowledge, to be appointed by the Governor; (8) One representative of a Delaware hospital cancer center to be appointed by the Governor; (9) Three public members with relevant professional experience and knowledge, to be appointed by the Governor. (e) Appointees to the Consortium shall serve at the pleasure of the person or entity that appointed them. (f) The Consortium’s permanent members may enact procedures to appoint additional persons to the Consortium. (g) The Consortium shall have a chair and a vice-chair, to be appointed from among the permanent members by the Governor and to serve at the pleasure of the Governor. Staff support for the Consortium shall be provided by the Delaware Division of Public Health. (47 Del. Laws, c. 194, §§ 1, 3; 16 Del. C. 1953, § 132; 59 Del. Laws, c. 276, § 1; 70 Del. Laws, c. 149, §§ 46, 47; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 544, §§ 26, 27; 74 Del. Laws, c. 191, §§ 1, 2.) § 134. Sanitary facilities of public eating places; permits; approval of construction; inspection; fee. (a) No person shall operate any public eating place unless the Department of Health and Social Services shall approve the sanitary facilities thereof and issue a permit therefor. (b) Any person who proposes to erect or construct a building to be used as a public eating place or to alter, enlarge, reconstruct or convert an existing building for such purpose shall submit plans and specifications for such work, including a plot of the land detailing the sanitary facilities to be provided to the Department of Health and Social Services and no work shall be undertaken until the said Department of Health and Social Services shall approve the sanitary arrangements and facilities proposed in such plans and specifications. (c) The Department of Health and Social Services shall initiate a procedure for the inspection of public eating places prior to the issuance of the permit required under this section. There shall be no fee required for inspection; however, in the event that reinspection must be initiated in any given year, the Department shall establish a restaurant inspection fee, payable upon or prior to inspection, in the following manner: (1) The sum of $50 shall be required for a second inspection; (2) The sum of $100 shall be required for a third inspection; Page 20 Title 16 - Health and Safety (3) The sum of $150 shall be required for each subsequent inspection. (d) Notwithstanding the provisions of § 6102 of Title 29, the Division shall be allowed to retain and expend the portion of these fees up to the level authorized to fund the cost of the Department of Health and Social Services in connection with its duties hereunder. (e) The restaurant permit shall not be issued prior to the public eating place receiving a satisfactory rating in inspection as defined in the State of Delaware regulations governing public eating places. (f) The following entities shall be exempt from the restaurant inspection fee established in subsection (c) of this section: (1) Churches; (2) Fire halls; (3) Schools; (4) Government agencies; (5) Health care institutions; or (6) Any nonprofit organization. (16 Del. C. 1953, § 133; 56 Del. Laws, c. 382, § 1; 59 Del. Laws, c. 276, § 1; 67 Del. Laws, c. 272, § 1; 70 Del. Laws, c. 149, §§ 48, 49, 226; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 544, §§ 28-30.) § 135. Services to public water systems. (a) The Department will provide services to public water as follows: (1) Analyze drinking water for chemical and microbiological content. (2) Inspect public water systems. (3) Review plans for new systems and major improvements to existing systems. (4) Provide technical assistance to public water system as needed. (5) Provide a program to approve the qualifications and competency of laboratories conducting chemical and microbiological testing of potable water. (6) Provide a program to approve the qualifications and competence of potable water distribution and treatment plant operators in charge of operating public water systems. (b) The Department of Health and Social Services shall initiate the following fees for the above services. The fees imposed under this section reasonably and approximately reflect the costs necessary to defray the expenses of the Department: (1) COMMUNITY WATER SUPPLIES Service Connections 1-49 connections 50-199 connections 200-499 connections 500-999 connections 1000-1999 connections 2000-4999 connections 5000-9999 connections 10,000-29,999 connections 30,000 and above Fee $50 $100 $250 $400 $500 $1000 $1500 $2000 $3000 (2) NON-COMMUNITY SUPPLIES $25 (3) NON-TRANSIENT NON-COMMUNITY SUPPLIES $50 (67 Del. Laws, c. 269, § 1; 70 Del. Laws, c. 149, § 50; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 544, § 31.) § 136. Healthy Lifestyles and Tobacco-Related Disease Prevention Fund. (a) A Healthy Lifestyles and Tobacco-Related Disease Prevention Fund (hereinafter in this section, the “Fund”) is established within the Division of Public Health of the Department of Health and Social Services. (b) The Fund shall be used by the Public Health Director to encourage Delawareans to seek preventative health care, live healthy lifestyles, and to avoid unhealthy behavior, in particular, tobacco use. To that end, the Director shall: develop and implement programs to encourage healthy lifestyles and to promote avoidance of tobacco, alcohol and drug abuse; and provide Delawareans with accurate and understandable information regarding their health, including, but not limited to, information regarding the dangers of tobacco, alcohol and drug use; the preventive care Delawareans should seek to avoid and/or detect adverse health conditions, in particular cancer; and the effects of diet and physical exercise on health. (c) The Director shall prepare an annual plan for use of the Fund, which shall be approved or modified by the Secretary of the Department. Page 21 Title 16 - Health and Safety (d) The Fund shall operate within the limits of general fund appropriations made to it. The Fund may retain any unexpended funds on a fiscal year-to-year basis; provided however, that any funds in excess of $250,000 in the Fund at the end of any fiscal year shall be reverted to the general fund absent specific legislation authorization to the contrary. (71 Del. Laws, c. 421, § 1.) § 137. Delaware Health Fund. (a) This section shall be referred to as the “Delaware Health Act of 1999.” (b) A special fund of the State is hereby created in the Department of Finance to be known as the “The Delaware Health Fund.” All annual payments received pursuant to the master settlement agreement entered into by the State and the participating tobacco manufacturers shall be deposited or transferred into the Delaware Health Fund. All other moneys, including gifts, bequests, grants or other funds from private or public sources specifically designated for the Delaware Health Fund shall be deposited or transferred to the Delaware Health Fund. Moneys in the Delaware Health Fund may be saved and deposited in an interest bearing savings or investment account. Interest or other income earned on the moneys in the Delaware Health Fund shall be deposited or transferred into the Delaware Health Fund. The Delaware Health Fund shall not lapse or revert to the General Fund. (c) Moneys from the Delaware Health Fund shall be expended for Delaware citizens in accordance with any 1 or more of the following: (1) Expanding access to health care and health insurance for citizens of Delaware that lack affordable health care due to being uninsured or under insured; (2) Making long-term investments to enhance health-care infrastructure which meets a public purpose; (3) Promoting healthy lifestyles, including the prevention and cessation of the use of tobacco, alcohol and other drugs by the citizens of Delaware; (4) Promoting preventive care for Delawareans in order to detect and avoid adverse health conditions, particularly cancer and other tobacco-related diseases; (5) Working with the medical community by providing funding for innovative and/or cost effective testing regimens to detect and identify lesser-known but devastating and costly illnesses, such as sarcoidosis and hemochromatosis, fibromyalgia, lupus, Lyme disease and chronic fatigue immune deficiency syndrome; (6) Promoting a payment assistance program for prescription drugs to Delaware’s low income senior and disabled citizens who are ineligible for, or do not have, prescription drug benefits or coverage through federal state or private sources; (7) Promoting a payment assistance program to Delaware’s citizens who suffer from debilitating chronic illnesses, such as diabetes and kidney disease which are characterized by onerous recurring costs for equipment, tests and therapy; and/or (8) Such other expenditures as are deemed necessary in the best interests of the citizens of Delaware provided they shall be made for health-related purposes. (d) No moneys shall be expended from the Delaware Health Fund except pursuant to an appropriation incorporated in the State’s annual appropriations act. (e) Expenditures from the Delaware Health Fund shall not be used to supplant any State expenditures appropriated in Fiscal Year 1999 for purposes consistent with those outlined in subsection (c) of this section. (f) The transfer of funds appropriated from the Delaware Health Fund shall be administered as approved in the annual appropriation act or bond bill. (g) There is hereby established The Delaware Health Fund Advisory Committee comprised of the Secretary of the Department of Health and Social Services, 2 members of the Senate designated by the President Pro Tempore, 2 members of the House of Representatives designated by the Speaker of the House of Representatives, the Chair of the Health Care Commission or the Chair may designate a board member or staff person of the Health Care Commission, 3 members of the public to be appointed and to serve at the pleasure of the Governor, 1 member of the public appointed by the President Pro Tempore of the Senate to serve at the pleasure of the President Pro Tempore of the Senate, and 1 member of the public appointed by the Speaker of the House of Representatives to serve at the pleasure of the Speaker of the House of Representatives. No public member appointed to this Advisory Committee shall be directly associated with or represent 1 any organization or entity that will be a recipient or beneficiary of the Delaware Health Fund. The Secretary of the Department of Health and Social Services shall serve as the Chairperson of the Committee. Each year, the Committee will make recommendations, consistent with the purposes outlined in subsection (c) of this section, to the Governor and the General Assembly by November 15 for appropriating moneys expected to be received in the next fiscal year. The Committee shall, in the process of developing these recommendations, seek input from the public and private agencies concerned with the intended purposes of the Delaware Health Fund as described in subsection (c) of this section and conduct public hearings as necessary to provide an opportunity for public comment. The Committee shall also utilize the Delaware Health Care Commission to provide research relating to future health-care needs of Delaware citizens and data relating to past health-care programs in Delaware. (h) The Secretary of the Department of Health and Social Services shall report to the Governor and the General Assembly on the second Tuesday of every January concerning expenditures, savings and investment accounts under the Delaware Health Fund for the previous fiscal year and to what extent those expenditures accomplished their intended purpose. (72 Del. Laws, c. 198, § 1; 82 Del. Laws, c. 64, § 39.) Page 22 Title 16 - Health and Safety § 138. Community-based Naloxone access program. The Department shall: (1) Promote the safe use of Naloxone to reduce deaths from opioid overdoses. (2) Make education and training programs on the safe use of Naloxone available to people who hold doses of Naloxone for friends and family members who have an addiction to opioids. (3) Establish a community-based Naloxone access program after researching best practices and obtaining grant funding. At a minimum, a community-based Naloxone access program will require participants to complete an approved training and education program prior to receiving doses of Naloxone and/or administering Naloxone. Naloxone may be distributed to people who complete the requirements set forth for this program. (79 Del. Laws, c. 266, § 1.) § 139. Certification and procedures for animal welfare officers. (a) A person who acts as a certified animal welfare officer without certification from the Department is subject to penalties pursuant to § 107 of this title. For purposes of this subchapter, “animal welfare officer” means any person qualified to act pursuant to § 1325 of Title 11 and § 3041F of this title. (b) The Department may, by endorsement and without written examination, certify an animal welfare officer who has completed a training program that meets the educational requirements for certification defined by the Department and if, in the opinion of the Department or its designee, the applicant meets the qualifications specified by this chapter for an animal welfare officer. (c) Dog control and animal cruelty educational programs. — (1) Any organization or institution desiring to conduct an animal welfare officer education program shall apply to the Department and submit satisfactory evidence that it is ready and qualified to instruct students in the prescribed basic curriculum for certifying animal welfare officers and that it is prepared to meet other standards which may be established by the Department. (2) If the Department determines that any approved educational program is not maintaining the standards required by this chapter and by the Department, written notice thereof, specifying the deficiency and the time within which the same shall be corrected, shall immediately be issued to the program. The Department shall withdraw such programs approval if it fails to correct the deficiency. The organization or institution may reapply for approval to the Department once the program meets standards established by the Department. (d) The Department may impose sanctions defined in this chapter singly or in combination when it finds a certified or former certified animal welfare officer committed any offense described below: (1) Engages in fraud or deceit in procuring or attempting to procure a certification/license; (2) Is guilty of a crime against person or property; (3) Has been found by an employer to be unfit or incompetent; (4) Has had a certification or license to serve as an animal welfare officer suspended or revoked in any jurisdiction; or (5) Has wilfully or negligently violated this chapter. (e) The Department shall establish procedures for documenting all complaints and conducting investigations of complaints filed against animal welfare officers that may result in sanctions. (f) Disciplinary sanctions are as follows: (1) Permanently revoke a certification or license to be an animal welfare officer; (2) Refuse a certification or certification renewal; (3) Suspend a certification or license; (4) Place a certification or license on probationary status and require licensee to: report regularly to the Department upon the matters which are the basis of probation; limit practice to those areas prescribed by the Department; or continue or renew professional education until satisfactory degree of skill has been attained in those areas which are the basis of the probation; (5) Issue a letter of reprimand; and (6) Require additional training. (79 Del. Laws, c. 375, §§ 3, 5; 80 Del. Laws, c. 248, § 9.) § 140. Lyme Disease Education Oversight Board [Expires Aug. 29, 2024, pursuant to 80 Del. Laws, c. 402, § 2]. (a) The Lyme Disease Education Oversight Board (“the Board”) is established to implement health-care professional education on Lyme disease to improve understanding of the disease. For administrative and budgetary purposes only, the Board shall be placed within the Department of Health and Social Services. The Delaware Division of Public Health shall provide staff support for the Board. (b) The Board shall consist of 9 members who possess the qualifications and are appointed as follows: (1) The Governor shall appoint: Page 23 Title 16 - Health and Safety a. Two members who are advocates for the prevention and treatment of Lyme disease, such as a Lyme disease patient or patient advocate. b. One member who is licensed to practice medicine in Delaware. c. One member who is licensed to practice nursing in Delaware. d. One member who is a licensed health-care professional other than physicians or nurses. e. One member who has knowledge and experience in the licensure and regulation of health care. (2) The Pro Tempore of the Delaware State Senate shall appoint 1 member of the Lyme Disease Prevention Task Force established by Senate Joint Resolution No. 10 of the 147th General Assembly. Upon the resignation or replacement of that member, the Pro Tempore shall appoint a member to represent the public at large. (3) The Speaker of the Delaware House of Representatives shall appoint 1 member of the Lyme Disease Prevention Task Force established by Senate Joint Resolution No. 10 of the 147th General Assembly. Upon the resignation or replacement of that member, the Speaker shall appoint a member to represent the public at large. (4) The Director of the Division of Public Health, or the Director’s designee. (c) The Board shall: (1) Determine the content of Lyme disease medical education materials, ensuring quality and balanced medical education by including the philosophies of the Centers For Disease Control, the guidelines established by the International Lyme and Associated Diseases Society, as well as the latest scientific evidence and research. (2) Educate health-care professionals in the State that Lyme disease can be diagnosed clinically based on history and physical examination, and serologic antibody testing can confirm, but is not required to make, a clinical diagnosis. (3) Educate health-care professionals to develop a high level of awareness of Lyme disease. (4) In conjunction with the Medical Society of Delaware and the Delaware Nurses Association, develop continuing medical education credits and nursing continuing education units on Lyme disease and encourage health-care professionals to take the continuing education courses as soon as reasonably practicable. (5) Host continuing medical education and nursing continuing education trainings in all 3 counties and, if reasonably practicable, at hospitals to encourage the largest possible attendance by health-care professionals. (6) Deliver education in a variety of methods, using professional associations, medical journals, radio, Internet, conferences, and linking medical training with a public awareness campaign. (d) Appointment terms for the Board are as follows: (1) The members appointed by the Pro Tempore of the Senate and the Speaker of the House and the member who is an advocate for the prevention and treatment of Lyme disease are appointed for an initial term of 3 years. (2) The member who is licensed to practice medicine and the member who is licensed to practice nursing are appointed for an initial term of 2 years. (3) The member who is a health-care professional other than physician or nurse and the member who has knowledge and experience in the licensure and regulation of health care are appointed for an initial term of 1 year. (4) After the initial terms, members are appointed or reappointed for terms of 3 years, but each appointing authority may appoint or reappoint members for a term of less than 3 years to ensure that no more than 3 members’ terms expire annually. (e) The Board shall select a Chair and Vice Chair from among its members. (f) A majority of members appointed to the Board shall constitute a quorum to conduct official business. (g) If a vote by the Board results in a tie, the Board’s Chair may vote a second time to break the tie. (h) Members of the Board shall serve without compensation, except that they shall be reimbursed for reasonable and necessary expenses incident to their duties as members of the Board excluding mileage. The Department shall pay such expenses. (i) The Department shall submit to the Governor and the General Assembly an annual report that contains, at a minimum, all of the following information: (1) The title, description, and schedule of continuing medical education and nursing continuing education courses related to Lyme disease education. (2) Attendance of continuing medical education and nursing continuing education courses by the health-care professional population. (3) Specific accounting of fees and costs. (80 Del. Laws, c. 402, § 1.) § 140A. Diabetes; prevention and control; report. The Division of Medicaid and Medical Assistance, Division of Public Health, and the Human Resources Management Section of the Office of Management and Budget, referred to collectively as “the agencies” throughout this section, shall submit, by June 30 every 2 years, a comprehensive joint report to the General Assembly that includes all of the following: (1) Data reflecting the prevalence and burden of diabetes in the State. Page 24 Title 16 - Health and Safety (2) Activities related to diabetes programs and initiatives throughout the State in the fiscal years following the most recent prior biennial report. (3) An estimate of the financial impact of diabetes on each of the agencies. (4) The number of people impacted or served by each of the agencies with regard to diabetes, including programs and initiatives designed to reach individuals with diabetes and prediabetes. (5) A description of each of the agencies’ implemented programs and activities aimed at improving diabetes care and preventing the disease, and an assessment of the expected benefits and outcomes for each program and activity. (6) Current funding levels for each of the agencies to implement programs and activities aimed at reaching individuals with diabetes and prediabetes. (7) Each of the agencies’ individual plans, including recommendations to address the prevention and control of diabetes, the intended outcomes of the recommendations, and estimates of the funding and time required to implement the recommendations. (81 Del. Laws, c. 177, § 1.) § 140B. Default beverages offered in children’s meals. (a) A restaurant offering children’s meals for sale that include a beverage must offer as a default beverage with the children’s meal 1 or more of the following: (1) Water, sparkling water, or flavored water that has no added sugar, corn syrup, or other natural or artificial sweeteners. (2) Flavored or unflavored whole milk, nonfat or low-fat 1% or 2% dairy milk or no-dairy beverage that is nutritionally equivalent to fluid milk in a serving of 8 ounces or less. (3) One hundred percent fruit juice or vegetable juice, combination of fruit juice and vegetable juice, or fruit juice or vegetable juice combined with water or carbonated water that has no added natural or artificial sweetener, in a serving size of 8 ounces or less. (b) For purposes of this section: (1) “Children’s meal” means a combination of food and beverage, sold together at a single price by a restaurant, primarily intended for consumption by children. (2) “Default beverage” means a beverage automatically included or offered as part of a children’s meal absent a specific request for a substitute or alternate beverage by the purchaser of the children’s meal. (3) “Restaurant” means a commercial establishment that serves food to customers for consumption on or off the premises. (c) The Department shall promulgate and enforce standards to regulate this section as empowered under § 122(3)u.1. of this title. The standards shall reflect that enforcement of this section, when considered separate from other violations, may not result in fines, fees or other monetary penalties. (d) Nothing in this section shall prohibit a restaurant from selling, or a customer from purchasing, an alternative to the default beverage if requested by the purchaser of the children’s meal. (82 Del. Laws, c. 100, § 2.) Subchapter III Pathological and Bacteriological Laboratory § 141. Establishment and supervision. The Secretary or the Secretary’s designee may establish and supervise a pathological and bacteriological laboratory and equip it with any appliances necessary to make it safe and reliable. It shall be used to accomplish any or all means of protecting the citizens of the State against the spread of disease. (21 Del. Laws, c. 240, §§ 1, 2; Code 1915, §§ 782, 783; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 808; 16 Del. C. 1953, § 141; 70 Del. Laws, c. 149, § 51; 70 Del. Laws, c. 186, § 1.) § 142. Election of Pathologist and Bacteriologist. The Pathologist and Bacteriologist shall be employed by the Department of Health and Social Services. (21 Del. Laws, c. 240, § 5; Code 1915, § 786; 29 Del. Laws, c. 49, § 1; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 811; 16 Del. C. 1953, § 142; 70 Del. Laws, c. 544, § 32.) § 143. Duties of Pathologist and Bacteriologist. The Pathologist and Bacteriologist shall conduct the routine work of the laboratory and shall make all examinations and analyses, etc., that may be necessary under the direction of the Secretary or the Secretary’s designee for all the purposes that may be required to fully execute the intent of this chapter. This section shall not be so construed as to interrupt or limit the power of full control and management of the laboratory by the Secretary or the Secretary’s designee. (21 Del. Laws, c. 240, § 3; 22 Del. Laws, c. 135, § 1; Code 1915, § 784; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 809; 16 Del. C. 1953, § 143; 70 Del. Laws, c. 149, § 52; 70 Del. Laws, c. 186, § 1.) Page 25 Title 16 - Health and Safety § 144. Medical practitioners to report contagious diseases; use of laboratory for examination and diagnosis; other uses. (a) All physicians, dentists, veterinary surgeons or others practicing medicine or surgery or any branch thereof under the laws of this State shall be required to give prompt notice to the local or Division of Public Health of any and all cases of contagious or infectious disease that may come under their professional notice and shall have free access to the work of the laboratory for the determination of the diagnosis of any doubtful or suspicious case, by forwarding (prepaid) a sufficient sample of urine, blood, sputum or other substance of such case to the Pathologist and Bacteriologist for examination. The Pathologist and Bacteriologist shall examine the substance so sent and report to the physician, dentist or others sending the same the result of the examination without any unnecessary delay and without further charge. The physician, dentist or others shall report the result immediately as required by this subsection. (b) The Department of Health and Social Services may also make full provisions for the free use of the laboratory for the examination of any matter or substance so as to determine the diagnosis of diseases neither contagious nor infectious, and either local or constitutional and for the examination of water or food supply for any citizen of the State. (21 Del. Laws, c. 240, § 4; Code 1915, § 785; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 810; 16 Del. C. 1953, § 144; 70 Del. Laws, c. 147, §§ 2, 3; 70 Del. Laws, c. 149, § 53; 70 Del. Laws, c. 186, § 1.) § 145. Examinations to determine cause of death. The Pathologist and Bacteriologist, whenever requested by the Attorney General, shall make any and all examinations of any person or persons or any organ or organs or any part or parts of any person or persons with the view of determining the cause or causes of death and make a prompt report without charge to the State or any county thereof. (22 Del. Laws, c. 135, § 3; Code 1915, § 787; Code 1935, § 812; 16 Del. C. 1953, § 145.) Subchapter IV Emily P. Bissell Hospital § 151. Powers and duties of Department of Health and Social Services. The Department of Health and Social Services may: (1) Promote a careful study of conditions regarding tuberculosis throughout the State; (2) Educate public opinion as to the causes and prevention of tuberculosis; (3) Arouse general interest in securing adequate provision for the proper care of tuberculosis patients in their homes and by means of sanatoria; and (4) Send such tuberculosis patients as require treatment to Emily P. Bissell Hospital for such treatment. (25 Del. Laws, c. 74, § 4; Code 1915, § 828; 29 Del. Laws, c. 53, § 1; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 820; 16 Del. C. 1953, § 151; 51 Del. Laws, c. 136; 70 Del. Laws, c. 149, § 54; 70 Del. Laws, c. 186, § 1.) § 152. Payment of costs of maintenance. The Division of Public Health shall pay for the care, treatment and maintenance of all hospitalized patients who enter the Emily P. Bissell Hospital for the diagnosis, treatment and cure of tuberculosis and other chronic diseases amenable to treatment, rehabilitation, or both who, in the discretion of the Secretary of the Department of Health and Social Services need financial support. Those patients who are required to pay for such care, treatment and maintenance shall make direct payment to the Emily P. Bissell Hospital. Direct payment shall be made to the Emily P. Bissell Hospital by health insurance companies or health benefit payment plans by which any patient has health coverage. (25 Del. Laws, c. 74, § 4; Code 1915, § 828; 29 Del. Laws, c. 53, § 1; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 820; 16 Del. C. 1953, § 152; 51 Del. Laws, c. 136; 58 Del. Laws, c. 444; 70 Del. Laws, c. 150, § 3; 70 Del. Laws, c. 186, § 1.) § 153. County clinics. The Secretary of the Department of Health and Social Services shall establish throughout the State, at least 1 clinic in each county for the diagnosis and treatment of tuberculosis and other chronic pulmonary diseases, such as fungus disease, sarcoidosis, bronchiectasis and bronchial asthma and for the purpose of maintaining such clinics shall employ such qualified persons as may be necessary to take charge thereof and pay them such reasonable compensation as may be necessary. (25 Del. Laws, c. 74, § 5; Code 1915, § 829; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 821; 16 Del. C. 1953, § 153; 51 Del. Laws, c. 136; 70 Del. Laws, c. 149, § 55; 70 Del. Laws, c. 186, § 1.) § 154. Admittance to Emily P. Bissell Hospital. The Division of Public Health may admit such persons to the institution known as the Emily P. Bissell Hospital for the prevention and treatment of tuberculosis and other chronic diseases which are amenable to treatment, rehabilitation or both, as in the judgment of the Page 26 Title 16 - Health and Safety Division may be proper and may provide for the care, treatment and support of such persons under such rules and regulations as may be from time to time established by the Division. (33 Del. Laws, c. 57, § 12; 34 Del. Laws, c. 67, § 1; 34 Del. Laws, c. 69, § 1; Code 1935, § 823; 16 Del. C. 1953, § 154; 49 Del. Laws, c. 65, § 3; 51 Del. Laws, c. 136; 58 Del. Laws, c. 444; 70 Del. Laws, c. 150, § 4; 70 Del. Laws, c. 186, § 1.) § 155. Accounting of all funds received by the hospital. The Secretary of the Department of Health and Social Services, administrator of the Emily P. Bissell Hospital, shall keep or have kept true and accurate account of all moneys received for board, care and attention of patients by the hospital and all moneys arising from any source other than the annual appropriation made to the hospital by the State. All such funds shall be considered as revenue to the State and shall be paid to the State Treasurer for deposit into the General Fund, except as provided in § 6102(a) of Title 29. (16 Del. C. 1953, § 155; 51 Del. Laws, c. 136; 55 Del. Laws, c. 320; 70 Del. Laws, c. 149, § 56; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 544, § 33.) § 156. Annual account and report to Governor. The Secretary of the Department of Health and Social Services shall furnish annually to the Governor a full account of its expenditures and disbursements under this subchapter. It shall also at the same time report to the Governor the work of the Secretary of the Department of Health and Social Services for the year, including the number of persons treated, the results of treatment, as nearly as can be ascertained and such other information as may be of public interest and value. Such report shall at all times be open to the inspection of the citizens of the State in the office of the Secretary of State. (25 Del. Laws, c. 74, § 6; Code 1915, § 830; 29 Del. Laws, c. 53, § 1; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 822; 16 Del. C. 1953, § 156; 51 Del. Laws, c. 136; 70 Del. Laws, c. 149, § 57; 70 Del. Laws, c. 186, § 1.) § 157. Rights of patients. Each patient of the Hospital shall be entitled to all the patient rights set forth in subchapter II of Chapter 11 of this title, and all sections in said subchapter II shall apply to the patients of the Emily P. Bissell Hospital. (61 Del. Laws, c. 373, § 4.) Subchapter V Child Welfare Services; Indigent Children With Physical Disabilities § 161. Powers and duties of Department. The Department of Health and Social Services shall develop the child welfare activities conducted by the Child Welfare Commission before its abolition and maintain a traveling child health center to serve the sparsely settled sections of the State. The Department of Health and Social Services shall cooperate with state, county and local officials bodies in the development of such child welfare work as the Department of Health and Social Services may believe will materially advance the best interests of the children of the State. The Department of Health and Social Services shall make a study of the needs of children a definite part of its work and shall make recommendations for executive and legislative action in matters relating to children. (32 Del. Laws, c. 63, § 3; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 813; 16 Del. C. 1953, § 161; 70 Del. Laws, c. 149, § 58; 70 Del. Laws, c. 186, § 1.) § 162. Cooperation of departments and officers. Every official department and public officer in the State, excepting the members of the General Assembly and the judiciary, in possession of information relating to the purposes of this subchapter shall, upon request of the Department of Health and Social Services, cooperate with it in carrying out the purposes of this subchapter. (32 Del. Laws, c. 63, § 4; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 814; 16 Del. C. 1953, § 162; 70 Del. Laws, c. 149, § 59; 70 Del. Laws, c. 186, § 1.) § 163. Employment of personnel and registered trained nurse. (a) The Department of Health and Social Services may employ such agents, assistants, clerical force and specially qualified persons as it finds necessary or expedient for carrying out the purposes of this subchapter. (b) The Department of Health and Social Services may employ a registered trained nurse to educate and supervise the midwives of the State. Such nurse shall devote the entire time, under the general direction of the Department of Health and Social Services, to an investigation of the methods employed by the midwives, to instructing the midwives so that they will not be a menace to the life and health of either mother or infant, to an investigation of deaths following midwife cases, to an investigation of all violations of the laws by midwives and to an investigation of the reports of births throughout the State. (32 Del. Laws, c. 43, § 1; 32 Del. Laws, c. 63, § 6; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 816; 16 Del. C. 1953, § 163; 70 Del. Laws, c. 149, §§ 60, 61; 70 Del. Laws, c. 186, § 1.) Page 27 Title 16 - Health and Safety § 164. Federal aid; authority to expend appropriation. If any bill shall be enacted by the United States appropriating moneys to assist the states in protecting the health of mothers and children, and if the Department of Health and Social Services is doing such work at the time the federal aid becomes available, the Department of Health and Social Services shall designate and authorize to be spent such portion of its appropriation as may be necessary to meet the offer of the federal government, if the Department of Health and Social Services shall be recognized by the federal body administering the act as the state body with which it will cooperate. Only such an amount of the Department of Health and Social Services’ appropriation may be designated and spent for the purposes described in this section as will leave at least $15,000 annually for the execution of the duties of the Department of Health and Social Services under this subchapter, other than those which conform with such a federal act which may be enacted. (32 Del. Laws, c. 63, § 5; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 815; 16 Del. C. 1953, § 164; 70 Del. Laws, c. 149, §§ 62, 63; 70 Del. Laws, c. 186, § 1.) § 165. Indigent children with physical disabilities program. The Department of Health and Social Services is designated as the agency for and on behalf of this State to administer a program of services for indigent children with physical disabilities or who are suffering from conditions which lead to physical disabilities, and to supervise the administration of such services included in the program not administered directly by it. The purpose of such program shall be to develop, extend and improve services for locating such children and for providing for medical, surgical, corrective and for such other services and care, and for facilities for diagnosis, hospitalization and after-care. (Code 1935, § 819A; 41 Del. Laws, c. 85, § 1; 16 Del. C. 1953, § 165; 70 Del. Laws, c. 149, § 64; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 179, §§ 147-149.) § 166. Indigent children with physical disabilities program — Powers and duties of Secretary. In carrying out § 165 of this title the Secretary or the Secretary’s designee may: (1) Formulate and administer a detailed plan or plans for the purposes specified in § 165 of this title, and make such rules and regulations as may be necessary or desirable for the administration of such plans and this subchapter. Any such plan shall make provision for: a. Financial participation by the State subject to § 164 of this title; b. Administration of the plan by the Secretary or the Secretary’s designee may, and supervision by the Secretary or the Secretary’s designee of the administration of those services included in the state program which are not administered directly by it; c. Maintenance of records and preparation of reports of services rendered; d. Cooperation with medical, health, nursing and welfare groups and organizations and with any agency of the State charged with the administration of laws providing for vocational rehabilitation of children with physical disabilities; e. Carrying out the purposes specified in § 165 of this title. (2) Receive and expend in accordance with such plans all funds made available to the Secretary or the Secretary’s designee by the federal government, the State or its political subdivisions, or from other sources, for such purposes. (3) Cooperate with the federal government, through its appropriate agency, or instrumentality, in developing, extending and improving such services, and in the administration of such plans. (4) Cooperate with any individual or organization which may have been or shall be formed in the State for the purpose of improving services for children with physical disabilities. (5) Expend such portions of its funds as may be necessary for carrying out the state plan in such a way as to meet the matching requirements of the federal government or any organization which may have been or shall be formed for the purpose of improving services for children with physical disabilities of the State. (Code 1935, § 819A; 41 Del. Laws, c. 85, § 1; 16 Del. C. 1953, § 166; 70 Del. Laws, c. 149, § 65; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 179, §§ 150-152.) § 167. Indigent children with physical disabilities program — Duties of State Treasurer upon receipt of federal funds. In the event of the receipt of funds from the federal government or from other sources for the purposes of § 165 or 166 of this title the State Treasurer shall: (1) Receive such funds; (2) Act as custodian of such funds; (3) Keep them in a special account to be known as the “Fund for Children With Physical Disabilities;” and (4) Disburse these funds upon orders signed by the Secretary or the Secretary’s designee. (Code 1935, § 819A; 41 Del. Laws, c. 85, § 1; 16 Del. C. 1953, § 167; 70 Del. Laws, c. 149, § 66; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 179, §§ 153, 154.) Page 28 Title 16 - Health and Safety Subchapter VI Oral Hygienists § 171. Establishment of Corps of Oral Hygienists [Repealed]. (37 Del. Laws, c. 62, § 1; Code 1935, § 827; 16 Del. C. 1953, § 171; 70 Del. Laws, c. 149, § 67; 70 Del. Laws, c. 186, § 1; repealed by 78 Del. Laws, c. 229, § 2, effective Apr. 19, 2012.) § 172. Composition; qualifications; compensation [Repealed]. (37 Del. Laws, c. 62, § 2; Code 1935, § 828; 16 Del. C. 1953, § 172; 70 Del. Laws, c. 149, § 68; 70 Del. Laws, c. 186, § 1; repealed by 78 Del. Laws, c. 229, § 2, effective Apr. 19, 2012.) § 173. Duties of Corps members [Repealed]. (37 Del. Laws, c. 62, § 3; Code 1935, § 829; 16 Del. C. 1953, § 173; 70 Del. Laws, c. 149, § 69; 70 Del. Laws, c. 186, § 1; repealed by 78 Del. Laws, c. 229, § 2, effective Apr. 19, 2012.) Subchapter VII Optometric Clinics § 181. Establishment of optometric clinics. The Department of Health and Social Services shall establish 1 optometric clinic in Sussex County, 1 in Kent County and 1 in New Castle County. (16 Del. C. 1953, § 181; 50 Del. Laws, c. 388, § 1; 70 Del. Laws, c. 149, § 70; 70 Del. Laws, c. 186, § 1.) § 182. Appointment of optometrists. Each optometric clinic shall be supervised and directed by 1 optometrist or 1 eye physician, duly licensed to practice optometry under the laws of this State, to be appointed by the Secretary or the Secretary’s designee to carry out this subchapter and shall serve during the pleasure of the Secretary or the Secretary’s designee and receive such compensation for services rendered as shall be determined by the Secretary or the Secretary’s designee. (16 Del. C. 1953, § 182; 50 Del. Laws, c. 388, § 1; 55 Del. Laws, c. 284, § 1; 70 Del. Laws, c. 149, § 71; 70 Del. Laws, c. 186, § 1.) § 183. Services performed by clinics. The clinics shall render and perform, free of charge, optometric services as shall be ordered and directed by the Secretary or the Secretary’s designee for those persons who upon application to the Secretary or the Secretary’s designee are found to be unable to pay for such services either in whole or in part. (16 Del. C. 1953, § 183; 50 Del. Laws, c. 388, § 1; 70 Del. Laws, c. 149, § 72; 70 Del. Laws, c. 186, § 1.) Subchapter VIII Warnings to Pregnant Women § 190. Required warning of possible use effects of alcohol, cocaine, marijuana, heroin or other narcotics. (a) The Director of the Division of Public Health shall require any and all persons under its jurisdiction who treat, advise or counsel pregnant women to post and give written and verbal warnings to said pregnant women as to the possible problems, complications and injuries which may result to themselves and/or to the fetus from their consumption or use of alcohol, cocaine, marijuana, heroin or other narcotics during their pregnancy. (b) The form and content of such warnings will be as prescribed by the Division of Public Health. (68 Del. Laws, c. 78, § 1; 70 Del. Laws, c. 147, §§ 4, 5; 70 Del. Laws, c. 186, § 1.) Subchapter IX Healthy Mothers and Children § 195. Division of Public Health; use of funds. The Division of Public Health may use any money appropriated to it for the purpose of improving the health of mothers, expectant mothers and infants, for related research, and for other purposes related to the prevention and improvement of the health of mothers, expectant mothers and infants. (75 Del. Laws, c. 224, § 1; 70 Del. Laws, c. 186, § 1.) Page 29 Title 16 - Health and Safety § 196. Delaware Healthy Mother and Infant Consortium. (a) The Delaware Healthy Mother and Infant Consortium (“Consortium”) is hereby established and shall coordinate efforts to prevent infant mortality and improve the health of women of childbearing age and infants in the State. (b) The Consortium’s initial priorities and agenda shall be the recommendations contained in the report entitled “Reducing Infant Mortality in Delaware — Recommendations of the Infant Mortality Task Force,” released in May 2005, or its successor. (c) The Consortium will: (1) Provide advice and support to state agencies, hospitals and health-care practitioners regarding their roles in reducing infant mortality and improving the health of women of childbearing age and infants. (2) Facilitate collaborative partnerships among public health agencies, hospitals, health-care practitioners and all other interested agencies and organizations to carry out recommended infant mortality improvement strategies. (3) Recommend standards of care to ensure healthy women of childbearing age and infants. (4) Coordinate efforts to address health disparities related to the health of women of childbearing age and infants. (5) Oversee development and implementation of research activities to better understand causes of infant mortality. (6) Coordinate efforts to prevent conditions and behaviors that lead to unhealthy women of childbearing age and infants. (7) Meet semi-annually with the Secretary of Health and Social Services to review progress, priorities, and barriers related to the Consortium’s purpose. (8) Recommend legislation and regulations that will enhance the health of women of childbearing age and infants. (9) On an annual basis issue a report to the Governor on the status of the health of women of childbearing age and infants and progress in implementing recommendations of the Infant Mortality Task Force. (d) The Consortium’s permanent membership shall be as follows: (1) Two representatives of the Delaware House of Representatives and 2 representatives of the Delaware State Senate (1 selected by each caucus); (2) One representative of the Governor’s office; (3) The Secretary of the Department of Children, Youth, and Their Families, or the Secretary’s designee; (4) The Secretary of the Department of Health and Social Services or the Secretary’s designee; (5) The Director of the Division of Medicaid and Medical Assistance or the Director’s designee; and (6) Fifteen additional members approved by the Governor who shall represent the medical, social service and professional communities as well as the general public. (e) The Consortium’s permanent members may enact procedures to appoint additional persons to the Consortium. The Consortium, by rule and regulation, shall establish categories of membership, specify voting rights for each category, designate the number needed for a quorum to transact business, provide for election of officers, and adopt such procedures as are necessary to carry out the business of the Consortium. (f) Appointees to the Consortium shall serve at the pleasure of the individual or entity that appointed them. (g) The Consortium shall have a chair and a vice chair, to be designated from among permanent members by the Governor and who shall serve as president and vice-president at the pleasure of the Governor. Staff support for the Consortium shall be provided by the Delaware Division of Public Health. (75 Del. Laws, c. 224, § 1; 70 Del. Laws, c. 186, § 1; 83 Del. Laws, c. 383, § 1.) § 197. Delaware Perinatal Quality Collaborative. (a) (1) The Delaware Perinatal Quality Collaborative (“Collaborative”) is established to improve pregnancy outcomes for women and newborns by addressing all of the following: a. Obstetrical blood loss management. b. Pregnant women with substance use disorder. c. Infants born with neonatal abstinence syndrome. d. Advancing evidence-based clinical practices and processes through quality care review, audit, and continuous quality improvement. e. Developing, in collaboration with other stakeholders, guidelines for bias and cultural competency training for hospitals and birthing centers to address disparities in health outcomes. (2) The Collaborative shall function in cooperation with the Delaware Healthy Mother and Infant Consortium. (b) The Collaborative is comprised of the following members: (1) The Chair of the Delaware Healthy Mother and Infant Consortium. (2) The Chair of the Maternal and Child Death Review Commission. (3) The President of the Delaware Healthcare Association. Page 30 Title 16 - Health and Safety (4) The Chair of the Delaware Chapter of the American College of Obstetricians and Gynecologists. (5) The President of the Board of Directors of the Delaware Chapter of the American Academy of Pediatrics. (6) The President of the Board of Directors of the Delaware Chapter of the American Academy of Family Physicians. (7) The Chair of the Delaware Chapter of the Association of Women’s Health, Obstetric and Neonatal Nurses. (8) One member, appointed by the Governor in consultation with the Chair of the Collaborative, who is a consumer advocate for patient-centered care and is committed to and interested in reducing maternal morbidity and mortality. (9) A licensed midwife, appointed by the Governor in consultation with the Chair of the Midwifery Advisory Council, who is a nonvoting member. (10) Seven members, appointed by the Governor to represent both of the following: a. Hospitals, as defined in § 1001 of this title, that provide childbirth and delivery services. b. Freestanding birthing centers, as defined in § 122(3)p.1. of this title. (c) (1) An appointed member serves at the pleasure of the appointing authority. (2) A member who serves by virtue of position may designate another individual to serve in the member’s place, at the member’s pleasure. a. A member making a designation under this paragraph (c)(2) must provide the designation in writing to the Chair. b. A designee of a member who serves by virtue of position has the same duties and rights as the member who serves by virtue of position. (d) The Governor may consider a member to have resigned if the member is absent for 3 consecutive, regular meetings. (e) (1) The Collaborative shall annually elect a Chair and a Vice-Chair. (2) A majority of the voting members of the Collaborative constitutes a quorum. A vacant position is not counted for quorum purposes. (3) The approval of a majority of the voting members present at a meeting with quorum is required for the Collaborative to take official action. (4) The Collaborative may adopt rules and by-laws necessary for its operation. (5) The Collaborative shall meet at the call of the Chair, or as provided by by-laws adopted by the Collaborative, but must meet at least once a year. (f) (1) Each member of the Collaborative shall comply with the provisions under Chapter 58 of Title 29. (2) The members of the Collaborative serve without compensation. However, members may be reimbursed for reasonable and necessary expenses incident to their duties as members of the Collaborative, to the extent that funds are available. (3) The Collaborative’s expenditures must be made under Chapter 69 of Title 29. (g) The Collaborative shall do all of the following: (1) Maintain a core set of quality improvement projects based on best practices and interventions that have a measurable impact on health outcomes. (2) Identify performance metrics to set statewide quality benchmarks. (3) Support the use of real-time hospital and facility-based data to perform rapid-cycle quality improvement and advocate for realtime data at a state level. (4) Share successes of quality improvement projects at hospitals and facilities. (h) The Collaborative may do all of the following: (1) Develop a responsive, real time, risk-adjusted, statewide perinatal data system. (2) Access timely, accurate, and standardized information and utilize perinatal data to drive quality improvement initiatives. (3) Develop a collaborative, confidential data-sharing network, including public and private obstetric and neonatal providers, insurers, and public health professionals, to support a system for peer review, bench marking, and continuous quality improvement activities for perinatal care. (4) Conduct other activities the Collaborative considers necessary to carry out the intent of the General Assembly as expressed in this section. (i) The Collaborative is constituted as an independent public instrumentality. For administrative and budgetary purposes only, the Collaborative is placed within the Department of Health and Social Services, Division of Public Health. (j) (1) The Collaborative is not a public body under Chapter 100 of Title 29. (2) The meetings of the Collaborative are closed to the public unless otherwise determined by the Chair of the Collaborative, except that the Collaborative shall hold at least 2 public meetings each year to receive comment on the general state of pregnancy outcomes for women and newborns in this State. (3) The Collaborative shall provide an annual report to the General Assembly containing recommendations for improving pregnancy outcomes for women and newborns in this State. Page 31 Title 16 - Health and Safety (4) Any document received or generated by the Collaborative is not a public record under Chapter 100 of Title 29 and is confidential under § 1768(b) of Title 24. Notwithstanding the foregoing, documents received from the public at, agendas for, or minutes of the Collaborative’s public meetings are a “public record” under Chapter 100 of Title 29, unless determined not to be “public record” under § 10002 of Title 29. (5) The Collaborative is a peer review committee under § 1768(a) of Title 24. (k) (1) The Collaborative shall create a subcommittee tasked with developing, issuing, and revising appropriate guidelines for cultural competency training programs consistent with best practices for use by hospitals and freestanding birthing centers in employee training and education programs, for maternal healthcare as well as other fields of healthcare. (2) The subcommittee membership shall consist of the following members who shall be appointed by the Chair of the Collaborative: a. Four members of the Collaborative. The Chair may appoint more or fewer members as needed to carry out the mission of the subcommittee. b. Six representatives of major Delaware hospital systems, from a slate of nominees to be provided by the Delaware Healthcare Association. At least 1 hospital system representative shall be a staff nurse. c. Two members from the Medical Society of Delaware. d. Three members of the community. (3) In making appointments to the subcommittee the Chair shall endeavor to include members that represent the diversity of the State in regard to disability, race, sexual orientation, gender identity, socioeconomic status, and experience of bias and discrimination. (4) The subcommittee shall present initial guidelines by July 1, 2023. Each year thereafter, the subcommittee shall review maternal health outcomes, maternal deaths, and disparities for different demographic groups, and determine if the training guidelines should be revised. (5) Meetings of the subcommittee are open to the public. (6) The Department of Health and Social Services shall provide staff support to the subcommittee. (82 Del. Laws, c. 260, § 1; 70 Del. Laws, c. 186, § 1; 83 Del. Laws, c. 65, § 1; 83 Del. Laws, c. 364, § 2; 83 Del. Laws, c. 367, § 1.) Page 32 Title 16 - Health and Safety Part I Local Boards of Health; Health Programs Chapter 2 Congenital Disabilities Program and Early Intervention Services Subchapter I Congenital Disabilities Surveillance, Registration and Treatment Program § 201. Purpose. The intent of the General Assembly is to require the establishment and maintenance of a congenital disabilities surveillance system and registry for the State. (1) Surveillance system and registry. — Responsibility for establishing and maintaining the system and registry is delegated to the Department of Health and Social Services, along with the authority to exercise certain powers to implement the system and registry. To ensure an accurate and continuing source of data concerning congenital disabilities, the General Assembly by this subchapter requires certain health care practitioners and all hospitals and clinical laboratories to make available to the Department of Health and Social Services information contained in the medical records of patients who have a suspected or confirmed congenital disability diagnosis. All confirmed congenital disabilities shall be classified and coded using the medically recognized system of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), as well as the 6-digit modified British Pediatric Association system (BPA/ICD-9), and all subsequent revisions to these publications which are used by the Centers for Disease Control and Prevention. It is intended that the product of these efforts will be a central data bank of accurate, precise and current information regarding all congenital disabilities diagnosed or treated, or both, in this State. (2) This subchapter in no way affects the rights, liabilities, or duties of the Secretary of the Department of Health and Social Services or of persons or guardians of persons requesting services under this subchapter from the operation of laws or prior existing laws and, in particular, § 7940 of Title 29. (60 Del. Laws, c. 63, § 1; 71 Del. Laws, c. 86, § 1; 71 Del. Laws, c. 286, § 3; 78 Del. Laws, c. 179, § 157; 83 Del. Laws, c. 213, § 3.) § 202. Definitions. The following words, terms and phrases, when used in this subchapter, shall have the meanings ascribed to them in this section, except where the content clearly indicates a different meaning. (1) “Congenital disability” means any structural or biochemical abnormality, regardless of cause, diagnosed at any time before or after birth, that requires medical or surgical intervention or that interferes with normal growth or development. (2) “Department” means the Department of Health and Social Services. (3) “Registry” means a central data bank containing collected, classified, coded and stored data relating to congenital disabilities in children under age 5. (4) “Surveillance” means the process of identifying and investigating congenital disabilities in children under age 5. (71 Del. Laws, c. 86, § 1; 71 Del. Laws, c. 286, § 3; 78 Del. Laws, c. 179, § 158.) § 203. Congenital Disabilities Surveillance and Registry Program. (a) The Department may adopt, promulgate, amend, and repeal any rules and regulations necessary to accomplish the purpose of this subchapter. These rules and regulations may include the following provisions: (1) The establishment and maintenance of an up-to-date registry that shall document every diagnosis or treatment, or both, of any congenital disability in any child under age 5 in this State. (2) a. The establishment of a procedure for reporting to the Department, within 30 days of initial diagnosis or treatment, every occurrence of a congenital disability in any child under age 5 in this State. The procedure must include the reporting of specified information, through a combined system of active and passive surveillance, on every child under age 5 with 1 or more congenital disabilities. Specified information is deemed necessary and appropriate to accomplish the purpose of this subchapter and in accordance with the recommendations from the Centers for Disease Control and Prevention, for any of the following reasons: 1. To identify risk factors for congenital disabilities. 2. To investigate the causes and prevalence of congenital disabilities. 3. To develop preventive strategies to decrease occurrences of congenital disabilities. 4. To analyze incidences, prevalence and trends of congenital disabilities through epidemiological studies. 5. To investigate the morbidity and mortality rates resulting from congenital disabilities. Page 33 Title 16 - Health and Safety b. Those required to report to the Department occurrences of congenital disabilities include all of the following: 1. Any physician, surgeon, dentist, podiatrist, or other health-care practitioner who diagnoses or provides treatment, or both, for children under age 5 with congenital disabilities. 2. The designated representative of any hospital, dispensary, or other similar public or private institution that diagnoses or provides treatment, or both, for children under age 5 with congenital disabilities. 3. The designated representative of any clinical laboratory that performs any test which identifies children under age 5 with congenital disabilities. (3) The establishment of a procedure for the publication and distribution of forms, instructions, and notices required by this subchapter or necessary to accomplish the purpose of this subchapter. (4) The establishment of a procedure to obtain follow-up information from those required to report occurrences of congenital disabilities under this subchapter. Any follow-up information, including family, physician, hospital, or laboratory contact deemed necessary by the Department, must be submitted to the Department at least 1 time each year by those required to report occurrences of congenital disabilities. (5) The establishment of a procedure to refer the parent, custodian, or guardian of a child under age 3 who is reported to the registry under this subsection to the Department of Education for services under Chapter 31A of Title 14. (b) The provisions of this subchapter and any rules or regulations issued under this subchapter do not apply to any person or private institution that, as an exercise of religious freedom, treats the sick or suffering by spiritual means through prayer alone. (c) A parent, custodian, or guardian of an infant having any congenital disability may refuse disclosure to the surveillance system and registry of the infant’s name and identifying information on the grounds that such congenital disability identification is contrary to the religious tenets and practices of the infant’s parent, custodian, or guardian. (71 Del. Laws, c. 86, § 1; 71 Del. Laws, c. 286, § 3; 78 Del. Laws, c. 179, §§ 159, 160; 83 Del. Laws, c. 213, § 3.) § 204. Confidentiality of reports. (a) Any report of the diagnosis or treatment, of a congenital disability made under this subchapter may not be divulged nor made public in any way that might tend to disclose the identity of the person or family of the person to whom it relates. However, patient-identifying information may be exchanged with the Department of Education and among authorized agencies as approved by the Department and upon receipt by the Department of satisfactory assurances by those agencies of the preservation of the confidentiality of such information. (b) No individual or organization providing information to the Department in accordance with this subchapter may be deemed to be liable for or held liable for divulging confidential information. (71 Del. Laws, c. 86, § 1; 71 Del. Laws, c. 286, § 3; 78 Del. Laws, c. 179, § 161; 83 Del. Laws, c. 213, § 3.) § 205. Compulsion prohibited. Nothing in this subchapter may be construed to compel any person to submit to any medical or public health examination, treatment, or supervision. (71 Del. Laws, c. 86, § 1; 71 Del. Laws, c. 286, § 3; 83 Del. Laws, c. 213, § 3.) § 206. Violations. Any person or entity who is required to report the diagnosis or treatment, or both, of any congenital disability in any child under age 5 and who violates any provision of this subchapter shall be fined up to $100 for each violation. Justices of the Peace Courts shall have jurisdiction of any offense under this subchapter. (71 Del. Laws, c. 86, § 1; 71 Del. Laws, c. 286, § 3; 78 Del. Laws, c. 179, § 162.) § 207. Early intervention services; collaborating agency. The Department, as a collaborating agency, shall provide vision services to children who are eligible for early intervention services under Chapter 31A of Title 14. (83 Del. Laws, c. 213, § 3.) Subchapter II Infants And Toddlers Early Intervention Program § 210. Short title [Transferred]. Transferred to § 3101A of Title 14 by 83 Del. Laws, c. 213, § 2, effective Sept. 30, 2021. § 211. Purpose [Transferred]. Transferred to § 3102A of Title 14 by 83 Del. Laws, c. 213, § 2, effective Sept. 30, 2021. Page 34 Title 16 - Health and Safety § 212. Definitions [Transferred]. Transferred to § 3103A of Title 14 by 83 Del. Laws, c. 213, § 2, effective Sept. 30, 2021. § 213. Powers and duties [Transferred]. Transferred to § 3104A of Title 14 by 83 Del. Laws, c. 213, § 2, effective Sept. 30, 2021. § 214. Cooperation of participating agencies [Transferred]. Transferred to § 3108A of Title 14 by 83 Del. Laws, c. 213, § 2, effective Sept. 30, 2021. § 215. Individualized family service plan [Transferred]. Transferred to § 3107A of Title 14 by 83 Del. Laws, c. 213, § 2, effective Sept. 30, 2021. § 216. Procedural safeguards [Transferred]. Transferred to § 3109A of Title 14 by 83 Del. Laws, c. 213, § 2, effective Sept. 30, 2021. § 217. Interagency Coordinating Council [Transferred]. Transferred to § 3111A of Title 14 by 83 Del. Laws, c. 213, § 2, effective Sept. 30, 2021. § 218. Regulations [Transferred]. Transferred to § 3112A of Title 14 by 83 Del. Laws, c. 213, § 2, effective Sept. 30, 2021. Subchapter III Autism Surveillance and Registration § 221. Purpose. The intent of the General Assembly is to establish and maintain an autism surveillance system and registry for the State. Responsibility for establishing and maintaining the system and registry is delegated to the Department of Health and Social Services, along with the authority to exercise certain powers to implement the system and registry. To ensure an accurate and continuing source of data concerning autism, the General Assembly by this subchapter requires certain health-care practitioners and all hospitals and clinical laboratories to make available to the Department of Health and Social services information contained in the medical records of patients who have a suspected or confirmed autism diagnosis. All confirmed autism shall be classified and coded using the medically recognized system of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), as well as the 6-digit modified British Pediatric Association system (BPA/ICD-9), and all subsequent revisions to these publications which are used by the Centers for Disease Control and Prevention. It is intended that the product of these efforts will be a central data bank of accurate, precise and current information regarding all autism diagnosed or treated, or both, in this State. (74 Del. Laws, c. 387, § 1.) § 222. Definitions. The following words, terms and phrases, when used in this subchapter, shall have the meanings ascribed to them in this section, except where the content clearly indicates a different meaning: (1) “Autism” means any structural or biochemical abnormality, regardless of cause, diagnosed at any time before or after birth, that requires medical or surgical intervention or that interferes with normal growth or development. (2) “Department” means the Department of Health and Social Services. (3) “Registry” means a central data bank containing collected, classified, coded and stored data relating to autism in children. (4) “Surveillance” means the process of identifying and investigating autism in children. (74 Del. Laws, c. 387, § 1.) § 223. Autism Surveillance and Registry Program. (a) The Department may adopt, promulgate, amend and repeal any rules and regulations necessary to accomplish the purpose of this subchapter. These rules and regulations may include provisions for: (1) The establishment and maintenance of an up-to-date registry that shall document every diagnosis or treatment, or both, of autism in any child in this State; (2) a. The establishment of a procedure for reporting to the Department, within 30 days of initial diagnosis of every occurrence of autism in any child in this State. The procedure shall include the reporting of specified information, through a combined system of active and passive surveillance, on every child under 18 years of age with autism. Specified information shall be deemed necessary and appropriate to accomplish the purpose of this subchapter and in accordance with the recommendations from the Centers for Disease Control and Prevention, for the following reasons: Page 35 Title 16 - Health and Safety 1. To identify risk factors for autism; 2. To investigate the causes and prevalence of autism; 3. To develop preventive strategies to decrease occurrences of autism; 4. To analyze incidences, prevalence and trends of autism through epidemiological studies; or 5. To investigate the morbidity and mortality rates resulting from autism; b. Those required to report to the Department occurrences of autism shall include: 1. Any physician, surgeon, dentist, podiatrist or other health care practitioner who diagnoses a child with autism; 2. The designated representative of any hospital, dispensary or other similar public or private institution that diagnoses or provides treatment, or both, for children with autism; (3) The establishment of a procedure for the publication and distribution of forms, instructions and notices required by this subchapter or necessary to accomplish the purpose of this subchapter; and (4) The establishment of a procedure to obtain follow-up information from those required to report occurrences of autism pursuant to this subchapter. Any follow-up information, including family, physician, hospital or laboratory contact deemed necessary by the Department, shall be submitted to the Department at least 1 time each year by those required to report occurrences of autism. (b) The provisions of this subchapter and any rules or regulations issued pursuant to this subchapter shall not apply to any person or private institution that, as an exercise of religious freedom, treats the sick or suffering by spiritual means through prayer alone. (c) A parent, custodian or guardian of an infant having any autism may refuse disclosure to the surveillance system and registry of the infant’s name and identifying information on the grounds that such autism identification is contrary to the religious tenets and practices of the infant’s parent, custodian or guardian. (74 Del. Laws, c. 387, § 1.) § 224. Confidentiality of reports. (a) Any report of the diagnosis of autism made pursuant to this subchapter shall not be divulged nor made public in any way that might tend to disclose the identity of the person or family of the person to whom it relates. However, patient-identifying information may be exchanged among authorized agencies as approved by the Department and upon receipt by the Department of satisfactory assurances by those agencies of the preservation of the confidentiality of such information. (b) No individual or organization providing information to the Department in accordance with this subchapter shall be deemed to be liable for or held liable for divulging confidential information. (74 Del. Laws, c. 387, § 1.) § 225. Compulsion prohibited. Nothing in this subchapter shall be construed to compel any person to submit to any medical or public health examination, treatment or supervision. (74 Del. Laws, c. 387, § 1.) § 226. Violations. Any person or entity who is required to report the diagnosis or treatment, or both, of autism in any child and who violates any provision of this subchapter shall be fined up to $100 for each violation. Justices of the Peace Courts shall have jurisdiction of any offense under this subchapter. (74 Del. Laws, c. 387, § 1.) Page 36 Title 16 - Health and Safety Part I Local Boards of Health; Health Programs Chapter 3 Local Boards of Health § 301. Appointment and membership outside Wilmington; vacancies and removal. (a) The common council of every city and the commissioners of every incorporated town in the State, except in the City of Wilmington, shall appoint in January of each year, a local board of health for such city or town to consist of not less than 3 nor more than 7 persons of whom at least 1 should be a physician duly authorized to practice medicine and who shall hold office until their successors are appointed. In case there be a port physician appointed by the Governor, the port physician shall be a member of the local board ex officio. (b) In case the common council or the commissioners are unsuccessful in securing persons to act on the local board, then the common council or the commissioners are and shall be the local board of health for such city or town and shall perform all duties and offices the local board should perform, and be subject to all laws applicable to local boards of health. (c) All vacancies occurring in any local board by death or otherwise shall be filled by the city council or town commissioners as the case may be. The same authorities may remove for sufficient cause any member of the local board in their respective jurisdictions. (16 Del. Laws, c. 345, §§ 1, 2, 15; Code 1915, §§ 745, 763; 29 Del. Laws, c. 49, § 1; Code 1935, §§ 753, 769; 16 Del. C. 1953, § 301; 70 Del. Laws, c. 186, § 1.) § 302. Officers; meetings; quorum; secretary. (a) The local boards of health shall elect annually from among their own members a president and a secretary. The local board shall meet not less than once in every 3 months. A majority of the local board shall form a quorum to do business; a less number may adjourn. (b) The secretary of the local board shall keep the minutes of the meetings of the local board, and shall perform all such duties as shall be assigned to the Secretary by the local board, for which services he shall receive such compensation as the city council or commissioners of the respective cities or towns may determine. (16 Del. Laws, c. 345, §§ 1, 2, 14; Code 1915, §§ 745, 762; 29 Del. Laws, c. 49, § 1; Code 1935, §§ 753, 768; 16 Del. C. 1953, § 302; 70 Del. Laws, c. 186, § 1.) § 303. General powers; quarantine regulations. Each local board of health may make orders and regulations concerning: (1) The place and mode of quarantine; (2) The examination and purification of vessels, boats and other craft not under quarantine; (3) The treatment of vessels, articles or persons thereof; (4) The regulation of intercourse with infected places; (5) The apprehension, separation and treatment of emigrants and other persons who shall have been exposed to any infectious or contagious disease; and (6) Regulating and prohibiting or preventing all communication or intercourse with all houses, tenements and places and the persons occupying the same in which there shall be any person who shall have been exposed to such contagious or infectious disease. (16 Del. Laws, c. 345, § 12; Code 1915, § 754; Code 1935, § 762; 16 Del. C. 1953, § 303.) § 304. Public laundries and washhouses; supervision, inspection and regulation; violations and penalties. (a) The local boards of health of the respective towns and cities of this State (where such towns and cities have local boards of health) shall supervise all public laundries and public washhouses within such towns and cities and shall not permit the employment by any public laundry or public washhouse of any person suffering with an infectious or contagious disease. The local board shall not allow any person to sleep in such public laundry or public washhouse, or in any room adjoining and opening into such public laundry or public washhouse. Every room in such laundry or washhouse that is used for the purpose of washing or drying clothes shall be properly ventilated and drained and shall be used for no purposes other than those specified. The floors of all rooms in public laundries or public washhouses used for the purpose of washing clothes, shall be made of cement or other mineral substance, and shall be so arranged as to be easily drained. (b) The local board of any town or city within the State shall upon request of any citizen in such town or city inspect or cause to be inspected any public laundry or public washhouse, and if the same is found in an unsanitary condition shall direct the owner thereof to make the same in a sanitary condition. Upon the owner’s failure to do so, the local board shall cause the place to be closed and shall post a notice upon the front door thereof and the place shall not be reopened until the owner or manager thereof receives a certificate from the local board certifying that the place has been put in a sanitary condition. (c) A public laundry or public washhouse within the meaning of this section shall be any place within any town or city of this State now or hereafter required by the laws of the State to be licensed for the conduct of its business or any branch thereof. Nothing in this section shall apply to the laundering or washing of clothes in any private residence or hotel. Page 37 Title 16 - Health and Safety (d) Whoever violates this section shall for each offense be fined not less than $50 nor more than $100. Every day during which such violation shall be persisted in after notice from the local board in any town or city of the State shall constitute a separate offense. (16 Del. Laws, c. 345, § 3; 18 Del. Laws, c. 33, § 1; 22 Del. Laws, c. 328, §§ 1, 2; Code 1915, § 746; 28 Del. Laws, c. 59, § 1; Code 1935, § 754; 43 Del. Laws, c. 91, § 1; 16 Del. C. 1953, § 304; 70 Del. Laws, c. 186, § 1.) § 305. Cleansing or closing unfit dwellings; recovery of expenses. (a) Any local board of health when satisfied after an examination that any cellar, room, tenement or building within its jurisdiction occupied as a dwelling place has become, by reason of the number of occupants or want of cleanliness or other cause, unfit for such purpose, and a cause of nuisance or sickness to the occupants or the public may direct the owner or owners, or occupants thereof, to have the premises properly cleansed, or if it see fit, may require the occupants to remove or quit the premises within such time as the local board deems reasonable. (b) If the person or persons so notified neglect or refuse to comply with the direction of the local board, it may cause the premises to be properly cleansed at the expense of the owners or may remove the occupants forcibly and close up the premises. The premises shall not again be occupied as a dwelling place without permission, in writing, of the local board. If such owner or owners refuse to pay the expenses incident to the execution of such orders, the treasurer of the local board, or the city council, or town commissioners, shall recover the same with interest and costs from the person who ought to have paid the same, as debts of like amount are recoverable. (16 Del. Laws, c. 345, § 4; Code 1915, § 747; Code 1935, § 755; 16 Del. C. 1953, § 305.) § 306. Cleansing diseased places; recovery of expenses. Each local board of health may in case of the prevalence or of reasonable ground to apprehend the prevalence of malignant disease within its jurisdiction direct especially the cleaning of houses, cellars, yards, docks or other such places as the local board shall consider requisite or prudent for the preservation of the public health or for the mitigation of disease. If such direction shall not be observed and fulfilled within the time prescribed, by the person or persons to whom the directions were given, the local board shall order an officer of the local board, or some other person or persons to carry the same into effect, and the expense thereof shall be paid by the person or persons to whom the direction was given unless the local board shall otherwise order. If payment of the expense shall not be made on demand, the treasurer of the local board, city council or town commissioners shall pay the same and shall recover the same with interest and costs from the person who ought to have paid the same, as debts of like amount are recoverable. (16 Del. Laws, c. 345, § 8; Code 1915, § 750; Code 1935, § 758; 16 Del. C. 1953, § 306.) § 307. Neglected privy well; penalty. If any owner, agent or tenant of any property in any town or city suffers the privy well thereon to be so full that any 2 members of the local board of health declare the same to be a nuisance, such owner, the owner’s agent and tenant in possession or any of them shall be responsible and after notice unless such privy is cleansed within one week after such notice shall for every offense be fined not less than $1 nor more than $20, with costs of suit, and stand committed to the county jail until the same be paid or until discharged by law. (16 Del. Laws, c. 345, § 10; 18 Del. Laws, c. 33, § 3; Code 1915, § 752; Code 1935, § 760; 16 Del. C. 1953, § 307; 70 Del. Laws, c. 186, § 1.) § 308. Slaughterhouse; use as nuisance; penalty. Whoever uses a slaughterhouse or place belonging thereto within a city or town limits, after the local board of health has pronounced the same noisome or having used such slaughterhouse shall not on the requirement of the local board immediately and effectually cleanse the same shall be fined not less than $15 nor more than $25, with costs of suit, and stand committed to the county jail till the same be paid or until discharged by law. (16 Del. Laws, c. 345, § 11; 18 Del. Laws, c. 33, § 4; Code 1915, § 753; Code 1935, § 761; 16 Del. C. 1953, § 308.) § 309. Placing or maintaining offensive matters in public places; penalty. Whoever casts into any street, lane or alley or suffers to run or be washed from any slaughterhouse, stable, privy, yard or place in his or her possession into any street, lane or alley of any city or town having a local board of health any blood, garbage, carrion, dead animal, dung, filth or noisome or offensive matter, or whoever suffers any skins, rags or other matter to be in a noisome or offensive state within or upon property in the person’s possession within the city or town limits or deposits in any of its lots, streets, lanes or alleys or near any dwelling house any contents of any slaughterhouse or stable or any matter in a noisome state, or having deposited or put such offensive substances in such places shall not immediately remove the same on the requirement of the local board shall be fined not less than $5.00 nor more than $20, with costs of suit, and stand committed to the county jail till the same be paid or until discharged by law. (16 Del. Laws, c. 345, § 9; 18 Del. Laws, c. 33, § 2; Code 1915, § 751; Code 1935, § 759; 16 Del. C. 1953, § 309; 70 Del. Laws, c. 186, § 1.) § 310. Abatement of nuisances. (a) Each local board of health may direct: Page 38 Title 16 - Health and Safety (1) That any noisome matter whether vegetable, animal or otherwise within the boundaries of its respective city or town or within 1 mile thereof or any vessel then having or having recently had any contagious disease on board which according to the opinion of the local board may be the occasion of sickness or ill health be removed or remedied by the person to whom the same belongs, or in whose possession, or upon whose property it is; (2) That any place in such city or town or within 1 mile of the boundaries thereof being in such filthy or noxious state that according to the opinion of the local board it may be the occasion of sickness or ill health be cleansed by such persons to whom the same belongs, or in whose possession it is; (3) That any reservoir of stagnant water or other nuisance or unwholesome thing in such city or town, or within 1 mile of the boundaries thereof which according to the opinion of the local board may be the occasion of sickness or ill health, be abated, removed or remedied by the person to whom the same belongs or in whose possession or on whose property it is; and (4) It may remove any hogpens in such city or town which in the opinion of the local board it is deemed necessary or conducive to public health to remove. (b) If it appears to the local board that any of the nuisances mentioned in this section are caused or produced by any person or persons other than those on whose premises the nuisances exist or that the nuisance or nuisances are caused or produced by water or filthy noisome or unwholesome matter flowing or running from the premises of any other person or persons or from premises which may be in that person’s or those persons’ occupation, the local board shall then give directions to cleanse, remove, abate or remedy the same to the person or persons causing or producing such nuisance or nuisances or to the person or persons from whose premises or from premises which may be in that person’s or those persons’ occupation the same shall flow or run. (c) Where the Secretary of Health and Social Services determines, in accordance with subchapter II of Chapter 16 of Title 24, that a public nuisance exists, the Secretary shall have all the powers granted by this chapter to local boards of health. The Secretary may also apply to a court under §§ 311, 312 and any other sections of this title to enter the premise and remove health hazards, and to do any other act permitted a local board of health, so long as such act is consonant with the provisions and intent of said subchapter II of Chapter 16 of Title 24. (16 Del. Laws, c. 345, § 3; 18 Del. Laws, c. 33, § 1; 22 Del. Laws, c. 328, §§ 1, 2; Code 1915, § 746; 28 Del. Laws, c. 59, § 1; Code 1935, § 754; 16 Del. C. 1953, § 310; 68 Del. Laws, c. 134, § 2; 70 Del Laws, c. 186, § 1.) § 311. Entry for destruction or removal of nuisances. Whenever a local board of health thinks it necessary for the preservation of the lives and health of the citizens to enter a place, building or vessel within its jurisdiction for the purpose of examining into and destroying, removing or preventing any nuisance, source of filth or cause of sickness and is refused such entry, any member of the local board may make complaint, under oath, to any justice of the peace of the county, stating the facts of the case as far as the board member has knowledge thereof. Such justice of the peace shall thereupon issue a warrant directed to the sheriff or any constable of the county commanding the sheriff or constable to take sufficient aid and being accompanied by 2 or more members of the local board, between the hours of sunrise and sunset, repair to the place where such nuisance, source of filth or cause of disease may exist and destroy, remove or prevent the same, under the direction of such members of the local board. (16 Del. Laws, c. 345, § 6; Code 1915, § 748; Code 1935, § 756; 16 Del. C. 1953, § 311; 70 Del Laws, c. 186, § 1.) § 312. Removal of infected persons; taking possession of condemned premises. Any justice of the peace, on application under oath, showing cause therefore by a local board of health or any authorized member thereof shall issue a warrant, under the justice of the peace’s own hand, directed to the sheriff or any constable of the sheriff’s or constable’s own county requiring the sheriff or constable, under the direction of the local board, to remove any person or persons infected with contagious disease or to take possession of condemned houses or lodgings. (16 Del. Laws, c. 345, § 7; Code 1915, § 749; Code 1935, § 757; 16 Del. C. 1953, § 312; 70 Del Laws, c. 186, § 1.) § 313. Care of persons having infectious or contagious disease. The local board of health may procure suitable places for the reception of persons under quarantine and persons sick with the Asiatic or malignant cholera or any other malignant of infectious or contagious disease. In all cases where sick persons cannot otherwise be provided for, the local board may procure for them proper medical and other attendance and necessaries. (16 Del. Laws, c. 345, § 13; Code 1915, § 755; Code 1935, § 763; 16 Del. C. 1953, § 313.) § 314. Common carriers; submission to regulations and examination of health officers; penalty for false statements. (a) Whenever quarantine is declared, all railroads, steamboats or other common carriers and the owners, consignees or assignees of any railroad, steamboat or other vehicle used for the transportation of passengers, baggage or freight, shall submit to: (1) Any rules or regulations imposed by any board of health or health officer; (2) Any examination required by the board of health or health officer; Page 39 Title 16 - Health and Safety (3) Any examination required by the health authorities respecting any circumstance or event touching the health of the crew, operatives or passengers, and the sanitary condition of the baggage and freight. (b) Any owner, consignee or assignee or other person interested, who makes any unfounded statement or declaration respecting the points under examination shall be subject to the penalties provided in § 317 of this title. (16 Del. Laws, c. 345, § 19; 22 Del. Laws, c. 328, § 5; Code 1915, § 758; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 764; 16 Del. C. 1953, § 314.) § 315. Temporary structures for isolation purposes; disinfection of property. The State Board of Health or any local board of health may erect any temporary wooden buildings or field hospitals necessary for the isolation or protection of persons or freight supposed to be infected and may employ nurses, physicians and laborers sufficient to operate the same properly and sufficient police to guard the same. The board of health may cause the disinfection, renovation or complete destruction of bedding, clothing or other property belonging to corporations or individuals, when such action seems to the board necessary or a reasonable precaution against the spread of contagious or infectious diseases. (16 Del. Laws, c. 345, § 20; 22 Del. Laws, c. 328, § 6; Code 1915, § 759; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 765; 16 Del. C. 1953, § 315.) § 316. Venue; continuance of nuisance as offense. An offense charged under this chapter shall be construed and held to have been committed in any county whose inhabitants are or have been injured or aggrieved thereby. The continuance of any offense for 5 days after prosecution commenced therefor shall be deemed an additional offense. (16 Del. Laws, c. 345, § 21; 22 Del. Laws, c. 328, § 7; Code 1915, § 760; Code 1935, § 766; 16 Del. C. 1953, § 316.) § 317. Penalties; corporations. (a) Whoever violates this chapter, except as otherwise therein prescribed or any regulation of the board of health made in pursuance thereof, or obstructs or interferes with the execution of any such order, or wilfully or illegally omits to obey any such order, or neglects or refuses to comply with any requirements of this chapter, except as otherwise therein prescribed shall be fined not more than $100 or imprisoned not more than 30 days, or both. (b) No person shall be imprisoned under this section for the first offense and the prosecution shall always be as for a first offense, unless the affidavit upon which the prosecution is instituted contains the allegation that the offense is a second or a repeated offense. (c) If such violation, obstruction, interference or omission be by a corporation, the corporation shall be subject to the fine, and any officer of such corporation having authority over the matter, and permitting such violation shall be subject to fine and imprisonment or both, as heretofore provided. (16 Del. Laws, c. 345, § 3; 18 Del. Laws, c. 33, § 1; 22 Del. Laws, c. 328, §§ 1, 2; Code 1915, § 746; 28 Del. Laws, c. 59, § 1; Code 1935, § 754; 16 Del. C. 1953, § 317.) Page 40 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 5 Contagious Diseases Generally Subchapter I General Guidelines § 501. Report of contagious diseases — To Department. (a) Local boards of health authorities and physicians in rural districts or other localities where there are no health officials shall report to the Department of Health and Social Services the existence of any case of contagious or infectious diseases which may come under their observation. (b) Whoever violates this section shall be subject to the penalties provided in § 107 of this title. (19 Del. Laws, c. 642, § 11; 22 Del. Laws, c. 327, § 6; Code 1915, § 742; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 748; 16 Del. C. 1953, § 501; 70 Del. Laws, c. 149, § 73; 70 Del. Laws, c. 186, § 1.) § 502. Report of contagious diseases — To local boards. Every physician or other person having knowledge of any person who is suffering from any disease dangerous to the public health, which the Department of Health and Social Services may require to be reported shall report the same to the local health board or official nearest his place of residence, giving the name, age, sex and color of the patient and the house or place where the patient may be found. (16 Del. Laws, c. 345, § 17; 22 Del. Laws, c. 328, § 3; Code 1915, § 756; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; 37 Del. Laws, c. 60, § 1; Code 1935, § 751; 16 Del. C. 1953, § 502; 70 Del. Laws, c. 149, § 74; 70 Del Laws, c. 186, § 1.) § 503. Unreported contagious disease. When complaint is made or there is a reasonable belief of the existence of an infectious or contagious disease in a building or facility which has not been reported as required by § 502 of this title, the Secretary of Health and Social Services or the Secretary’s designee shall inspect or cause the relevant building or facility to be inspected and, on discovering that such disease exists, shall immediately make a report as described in § 130 of this title. (16 Del. Laws, c. 345, § 17; 22 Del. Laws, c. 328, § 3; Code 1915, § 756; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; 37 Del. Laws, c. 60, § 1; Code 1935, § 751; 16 Del. C. 1953, § 503; 70 Del. Laws, c. 186, § 1; 73 Del. Laws, c. 355, § 6.) § 504. Notifiable diseases. The Division of Public Health may by regulation declare any disease to be a notifiable disease, as that term is used in § 130(b) of this title. (16 Del. Laws, c. 345, § 17; 22 Del. Laws, c. 328, § 3; Code 1915, § 756; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; 37 Del. Laws, c. 60, § 1; Code 1935, § 751; 16 Del. C. 1953, § 504; 70 Del. Laws, c. 149, § 76; 70 Del Laws, c. 186, § 1; 73 Del. Laws, c. 355, § 7.) § 505. Communicable diseases; regulations; quarantine. (a) From the list of notifiable diseases referred to in § 504 of this title, the Director of the Division of Public Health or the Director’s designee may at any time declare certain diseases to be communicable and may by regulation lay down the procedure which is to be followed by the patient or person suffering therefrom, the parents of the patient, the householder, by the physician attending on the patient or any individual brought into contact with or responsible for the care or maintenance of the patient in order that the transference of the disease to other individual or individuals may be prevented. (b) The regulation respecting the communicable diseases shall provide for: (1) Quarantine or isolation of the patient, of any person or persons who have been exposed to the patient and therefore liable to have contracted the disease or of any carrier of the disease; (2) Placarding by a suitable sign intended to be recognizable by the public, the premises, house, tenement or room in which the person ill of or exposed to the disease, may be; (3) Any other matter relating to the care of and due to the illness of the patient from such a communicable disease while the patient is living and ill from the disease or to the disposal of his body when dead; (4) Removal of the patient from and the patient’s return to school; and (5) Any other matter or procedure of interest in the protection of the public. (c) The powers and duties of the Division under this section are subject to the powers and duties granted other entities in Title 20. Provisions of Title 20 which conflict with provisions of this section shall take precedence over this section. (16 Del. Laws, c. 345, § 18; 22 Del. Laws, c. 328, § 4; Code 1915, § 757; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; 37 Del. Laws, c. 60, § 2; Code 1935, § 752; 43 Del. Laws, c. 91, § 1; 16 Del. C. 1953, § 505; 70 Del. Laws, c. 147, § 6; 70 Del. Laws, c. 186, § 1; 73 Del. Laws, c. 355, § 8.) Page 41 Title 16 - Health and Safety § 506. Due process rights of quarantined individuals. The Division of Public Health shall afford persons who are quarantined pursuant to § 505 of this title the same due process rights as those afforded to persons who are quarantined pursuant to § 3136 of Title 20. (73 Del. Laws, c. 355, § 9.) § 507. Diphtheria antitoxin and immunizing materials; distribution; regulations; penalty for false certification. (a) The State Board of Health may procure and distribute free to any physician for use in this State diphtheria antitoxin and all necessary material for immunizing persons against diphtheria. No such antitoxin shall be furnished until after certification by the physician of the name and address of the person for whom the antitoxin is desired. The name and address of all persons immunized shall be filed with the State Board by the physician who performs the immunization. (b) The State Board may make such rules and regulations as it deems necessary for the carrying into effect of this section and such rules shall have the force of law. (c) Whoever makes false certification in order to procure any of the antitoxin referred to in subsection (a) of this section or sells or attempts to sell such antitoxin or immunizing materials shall be fined not less than $5.00 nor more than $50. (d) The Division of Public Health may contract for hepatitis B vaccinations for immunizing individuals who volunteer for ambulance companies and/or volunteer fire companies. No such vaccination shall be furnished until after certification as to the person for whom the vaccination is desired, including the individual’s name, address and that the individual is a member in good standing of a volunteer fire company or of a volunteer ambulance company. The name and address of all persons immunized shall be filed with the Division of Public Health. The Division of Public Health may promulgate reasonable rules and regulations regarding the immunization of volunteer firefighters and individuals who volunteer for ambulance companies. (26 Del. Laws, c. 74; 27 Del. Laws, c. 86; Code 1915, § 769; 32 Del. Laws, c. 40, § 1; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 775; 16 Del. C. 1953, § 507; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 562, § 1.) § 508. Tracking of potential or existing public health emergencies. The Division of Public Health shall ascertain the existence of cases of an illness or health condition which may be potential causes of a public health emergency; shall investigate all such cases for sources of infection and shall ensure that they are subject to proper control measures; and shall define the distribution of the illness or health condition. To fulfill these duties, the Division of Public Health shall perform the following: (1) Acting on information developed in accordance with § 130 of this title or other reliable information, the Division shall identify all individuals thought to have been exposed to an illness or health condition which may be a potential cause of a public health emergency. (2) The Division shall counsel and interview such individuals as appropriate to assist in the positive identification of exposed individuals and develop information relating to the source and spread of the illness or health condition. Such information includes the name and address (including city and county) of any person from whom the illness or health condition may have been contracted and to whom the illness or health condition may have spread. (3) The Division may close, evacuate or decontaminate any facility or decontaminate or destroy any material when the Division reasonably believes that it is more likely than not that such facility or material may seriously endanger the public health. However, to the extent practicable and consistent with the protection of public health, prior to the destruction of any material pursuant to this paragraph, the Division shall institute appropriate civil proceedings against the material to be destroyed in accordance with the existing laws and rules of the Superior Court or any rules that may be developed by the Superior Court. Additionally, a person whose property is destroyed pursuant to this paragraph is entitled to seek compensation pursuant to the procedures and restrictions of § 3145 of Title 20. (4) An order of the Division given to effectuate the purposes of this section shall be enforceable immediately. (5) Whenever any agency of the State learns of a case of a reportable illness or health condition, an unusual cluster, or a suspicious event, it shall immediately notify the Division. (6) Whenever the Division learns of a case of a reportable illness or health condition, an unusual cluster, or a suspicious event that it reasonably believes has the potential to be caused by bioterrorism, it must immediately notify the public safety authority and federal health and public safety authorities. (7) Definitions from § 3132 of Title 20 shall apply to this section. (73 Del. Laws, c. 355, § 10.) § 509. Vaccination for meningococcal disease. (a) The purpose of this section is to prevent the contraction and spread of bacterial meningococcal disease among students in postsecondary educational institutions. The intent of this section is that postsecondary educational institutions and students who wish to enroll in postsecondary educational institutions follow the recommendations of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention in preventing meningococcal disease. Page 42 Title 16 - Health and Safety (b) As used in this section, “campus housing” means any space, in a building, over which a postsecondary educational institution has control and is intended for postsecondary educational institution students, where group sleeping accommodations are provided in 1 room, or in a series of closely associated rooms, for persons not members of the same family group, including dormitories and sorority or fraternity houses. (c) This section applies to all of the following: (1) A postsecondary educational institution that has campus housing. (2) A student who has accepted admission and intends to enroll in a postsecondary educational institution that has campus housing. (d) A student who wishes to enroll in a post-secondary educational institution shall submit to the postsecondary educational institution documentation confirming that, within the 5 years prior to the date of enrollment, the student received vaccination against meningococcal disease. The student: (1) Shall submit the documentation prior to enrollment. (2) May submit the documentation in any of the following methods: a. As a written statement signed by the health-care professional who administered the vaccination. b. Within the medical records the student submits to the post-secondary educational institution for admission or enrollment purposes. c. In any other manner that the postsecondary educational institution requires. (e) A postsecondary educational institution shall deny enrollment to any student who has not received vaccination against meningococcal disease or been granted an exemption under subsection (f) of this section. (f) A student seeking an exemption from the requirements of subsection (d) of this section shall submit a written request for exemption to the postsecondary educational institution. A postsecondary educational institution: (1) May develop its own policies and procedures regarding requests for exemption, including under what circumstances the postsecondary educational institution will grant a student’s request for exemption. (2) Shall include in its policies and procedures under paragraph (f)(1) of this section the requirement that, if a student who submits a request for exemption is a minor, the student’s parent or guardian shall sign the request for exemption. (3) May develop its own policies and procedures to grant students additional time to submit vaccination documentation, as long as the policies and procedures require that the documentation is submitted within the first semester of enrollment. (g) A postsecondary educational institution shall: (1) Provide information about meningococcal disease to all students who have accepted admission, after the student has paid an initial deposit toward tuition. Such information shall include notice of both of the following: a. The availability and benefits of vaccination against meningococcal disease. b. The requirement under subsection (d) of this section that a student receive vaccination against meningococcal disease within 5 years prior to the student’s enrollment in the postsecondary educational institution. (2) Develop procedures for facilitating, receiving, and recording student responses to the information provided about meningococcal disease and the requirement for vaccination against meningococcal disease, including a student’s vaccination record. (3) Determine the appropriate office and position within the office of the postsecondary educational institution to receive, record, maintain, make determinations about, and notify students regarding the outcome of their requests for exemption. (73 Del. Laws, c. 72, § 1; 80 Del. Laws, c. 312, § 1.) § 510. Immunizations containing mercury. (a) A vaccine containing mercury may not be made available to a medical provider in this State for administration to children under 8 years of age or to pregnant women, or to both. A vaccine containing mercury may not be administered to a child who is under 8 years of age or to a pregnant woman, or to both, notwithstanding the expiration date of the vaccine. (b) Subsection (a) of this section does not apply if: (1) The Director is informed by a person authorized to sell or to administer a vaccine that a mercury-free vaccine against a specific disease is not available to a child under 8 years of age or to a pregnant woman, or to both, in a medically necessary period of time, and the Director determines that an FDA-approved, mercury-free vaccine is not manufactured or cannot be obtained from other medical providers, manufacturers, distributors, agencies, jurisdictions, or by any other means within the medically necessary period of time; or (2) The Director determines that an emergency or epidemic exists necessitating the vaccination of groups of individuals within the State, including children under 8 years of age or pregnant women, or both, and an FDA-approved mercury-free vaccine is not manufactured, or the quantity is insufficient and additional mercury-free vaccine cannot be obtained from other medical providers, manufacturers, distributors, agencies, jurisdictions, or by any other means within the medically necessary period of time; or (3) The Director determines that a shortage of vaccine exists which could threaten the health of groups of individuals within the State, including children under 8 years of age or pregnant women, or both, and additional mercury-free vaccine cannot be obtained Page 43 Title 16 - Health and Safety from other medical providers, manufacturers, distributors, agencies, jurisdictions, or by any other means within the medically necessary period of time. (c) A determination made pursuant to subsection (b) of this section is enforceable for a timeperiod specified by the Director. The Director shall rescind the timeperiod when the Director determines that a sufficient amount of the FDA-approved, mercury-free vaccine is available. (d) (1) If the Director determines that subsection (a) of this section does not apply pursuant to subsection (b) of this section, the Division shall report the determination within 72 hours by a posting on the Division of Public Health website. If paragraph (b)(1) of this section applies, the Division shall report the specific disease, the vaccine, the time-period for which the vaccine containing mercury is approved, and the number of individuals under 8 years of age or pregnant receiving the vaccine containing mercury. (2) If paragraph (b)(2) or (b)(3) of this section applies, the Division shall report the specific disease, the vaccine, and the timeperiod for which the vaccine containing mercury is approved. (3) The Division shall issue and disseminate for public review an annual report listing all determinations made pursuant to this section, without revealing the identity of any persons denied or given a vaccine. (e) A vaccine containing mercury may not be administered to a child under 8 years of age until a parent or legal guardian of the child has been informed by the person administering the vaccine that the vaccine contains mercury, that the person administering the vaccine believes the vaccine to be medically necessary, and that the Director of Public Health or the Director’s designee has made a formal determination that the vaccine may be administered due to the existence of any of the circumstances described in subsection (b) of this section. If the parent or legal guardian of a child cannot be reached in the period of time deemed medically necessary by the person administering the vaccine, the parent or guardian must be notified in writing at the earliest possible time that the vaccine administered contained mercury, that the person administering the vaccine believed the vaccine to be medically necessary, and that the Director of Public Health or the Director’s designee made a formal determination that the vaccine may be administered due to the existence of any of the circumstances described in subsection (b) of this section. (f) A vaccine containing mercury may not be administered to a pregnant woman until she has been informed by the person administering the vaccine that it contains mercury, that the person administering the vaccine believes the vaccine to be medically necessary, and that the Director of Public Health or the Director’s designee has made a formal determination that the vaccine may be administered due to the existence of any of the circumstances described in subsection (b) of this section. (75 Del. Laws, c. 144, §§ 1-3; 70 Del. Laws, c. 186, § 1; 76 Del. Laws, c. 132, § 1; 76 Del. Laws, c. 229, § 1.) Subchapter II Tuberculosis Control § 520. Definitions. As used in this title, unless otherwise provided or the context requires a different meaning: (1) “County Public Health Administrator” means the Division of Public Health employee responsible for managing the operations of all public health programs within an assigned county. (2) “Designated transport personnel” means such personnel as designated by the Director to transport persons with tuberculosis to and from treatment and/or detention facilities, and other sites as ordered by the Director. (3) “Directly Observed Therapy (DOT)” means treatment in which health care providers or other designated persons observe patients ingesting anti-TB medications. (4) “Director” means the Director of the Division of Public Health, or such persons as may be designated by the Director. (5) “Division” means the Division of Public Health or its authorized representatives, which includes therein all of the responsibilities afforded the State Board of Health as it appears elsewhere in this title. (6) “Peace officer” means any public officer authorized by law to make arrests in a criminal case. (7) “Tuberculosis (TB)” means a disease caused by Mycobacterium tuberculosis that is in the active stage as demonstrated by clinical, bacteriologic and/or radiographic evidence. Such persons who have not completed a course of anti-TB treatment are considered to have active TB and might be infectious. (8) “Voluntary treatment” means a person voluntarily taking medications as prescribed and following the recommendations of the attending physician or the Division for the management of tuberculosis. (69 Del. Laws, c. 305, § 1.) § 521. Reporting by health-care providers. (a) Physicians, pharmacists, nurses, hospital administrators, medical examiners, morticians, laboratory administrators and others who provide health-care services to persons with tuberculosis or suspected tuberculosis shall report the following to the Division within 2 working days of its occurrence: (1) Confirmed or suspected tuberculosis; Page 44 Title 16 - Health and Safety (2) The results for any person whose sputa, gastric contents or other specimens submitted for examination reveal the presence of tubercle bacilli; (3) The occurrence of drug-resistant tuberculosis, even if the confirmed or suspected tuberculosis had been previously reported; (4) Persons with tuberculosis who have demonstrated an inability to or an unwillingness to adhere to a prescribed treatment regimen, who refuse medication or who show other evidence of not taking medications as prescribed. (b) Physicians, pharmacists, nurses, hospital administrators, medical examiners, morticians, laboratory administrators and others who provide health-care services to tuberculosis patients shall make their records available to the inspection of the Division when so requested in order to carry out the provisions of this title. (69 Del. Laws, c. 305, § 1.) § 522. Division investigates reported cases of tuberculosis. Whenever the Division shall discover, as a result of its own investigation or as a result of any report required by this chapter that any person may have tuberculosis, the Division shall investigate or further investigate the circumstances and if, after investigation, the Division is of the opinion that a case of tuberculosis has been found, the Division shall interview, or cause to be interviewed, said person in order to investigate the source and spread of the disease and in order to require said person to submit to examination and treatment as necessary. The Division shall keep record of all interventions with said persons. (69 Del. Laws, c. 305, § 1.) § 523. Voluntary treatment. Whenever the Division shall discover as a result of its own investigation or as a result of any report required by this chapter that any person has tuberculosis, the Division shall encourage the person to take voluntary treatment to meet the minimum requirements prescribed by the Division. (69 Del. Laws, c. 305, § 1.) § 524. Public health power to examine and order treatment. (a) Subject to the provisions of § 526 of this title, a person with tuberculosis or a person reasonably suspected of being diseased with or exposed to tuberculosis shall report for a complete examination or treatment, as appropriate, to a physician licensed under Title 24, or shall submit to an examination or treatment, as appropriate, at a public health facility. When a person has been diagnosed as having tuberculosis or has been determined to have been exposed to tuberculosis, said person shall continue to be prescribed treatment until such time as that treatment is no longer required as determined by the Director. (b) Subject to the provisions of § 526 of this title, the Division shall examine or cause to be examined, or treat or cause to be treated, any person who will not respond to voluntary treatment for tuberculosis. The County Public Health Administrator shall go before the Director for a Director’s order for involuntary examination and/or treatment of said person. (69 Del. Laws, c. 305, § 1.) § 525. Types of involuntary treatment: Outpatient examination and treatment, directly observed therapy, hospitalization and residential isolation. (a) Subject to the provisions of § 526 of this title, the Director shall order, as medically appropriate, a person with tuberculosis to undergo outpatient examination and treatment, directly observed therapy, hospitalization or isolation from the general public in the home, as a result of the threat of harm to the person and the probable spread of tuberculosis, until such time as the disease is cured or the risk of infection to the general public is eliminated or reduced in such a manner that a substantial threat to the public’s health and welfare no longer exists. (b) Subject to the provisions of § 526 of this title, a person who is infected with tuberculosis but is not infectious to others, and is a danger to himself or herself by resistance to treatment, and who refuses to adhere to a treatment regimen or to complete treatment, may be ordered by the Director to undergo outpatient examination and treatment, directly observed therapy, hospitalization or isolation from the general public in the home, as a result of the increased risk that said persons will develop drug-resistant tuberculosis, which may pose a serious threat to the person and the general public. (69 Del. Laws, c. 305, § 1; 70 Del. Laws, c. 186, § 1.) § 526. Conditions under which orders can be issued by Director. (a) No person may be ordered to undergo outpatient examination and treatment, directly observed therapy, hospitalization or isolation from the general public in the home, except upon the order of the Director following a hearing where it is proven by clear and convincing evidence: (1) That there is a danger to the health of the person or that the public health and welfare are substantially endangered by the person; (2) That the person has been counseled about tuberculosis, the significant threat tuberculosis poses to the public and methods to minimize the risk to the public, and, despite said counseling, indicates an intent by words or action to endanger himself or herself and/ or expose the public to infection from tuberculosis; and Page 45 Title 16 - Health and Safety (3) That all other reasonable means of achieving voluntary compliance with the treatment have been exhausted and no less restrictive alternative exists. (b) The hearing required under subsection (a) of this section shall provide the person with the rights to present evidence, to crossexamine witnesses and to be represented by legal counsel. If the person is unable to employ counsel, the Division shall petition the Superior Court to forthwith appoint legal counsel for representation in proceedings authorized by this subchapter. Further, the person shall be given at least 5 working days prior written notification of the time and place of hearing, a copy of documentary evidence to be presented, a list of the proposed actions to be taken and the reasons for each said action; and shall be given a verbatim transcript of the hearing on request for appeal purposes. (c) The Director shall order isolation in an alternative facility, if in the Director’s judgment isolation in the person’s usual residence is inappropriate because of the possible infection of other persons living in or around that residence. (d) The Division, as appropriate, shall consult with legal counsel, designated transport personnel and peace officers concerning any necessary infection control procedures to be taken during any interviews, hearings, transports or detention. (e) An order requiring outpatient examination and treatment, directly observed therapy, hospitalization or isolation from the public in the home shall be maintained until, in the opinion of the attending physician or the County Public Health Administrator, the person is cured or said person is no longer a substantial threat to himself or herself or to the public health. Once the County Public Health Administrator finds the person no longer needs treatment, the County Public Health Administrator will petition the Director to dismiss the order. Once the matter is dismissed, said order cannot be reinstated unless the person is afforded all of the rights conferred in subsection (a) of this section. (f) Any person who undergoes outpatient examination and treatment, directly observed therapy, hospitalization or isolation from the public in the home, or confinement, as a result of an order entered under this subchapter, may at any time petition the Director for immediate release and termination of the order. (g) Any person petitioning the Director for immediate release and termination of the order entered under the authority of this subchapter shall show that the person is entitled to relief from the original order, or that: (1) The person no longer poses an imminent and substantial threat to himself or herself or the public’s health and welfare; and (2) The person will voluntarily continue with prescribed medications and treatment, if medically necessary, to reduce the risk of infection to the public. (h) When considering a petition for imminent and substantial threat and prior to making any said release, the Director shall consult the County Public Health Administrator and the patient’s physician, if any, concerning the patient’s medical condition and other related factors that may affect the present and future danger to the patient or the public that may be caused by the release of the patient. (i) Upon granting a petition for immediate release, the Director shall advise the County Public Health Administrator and other persons as may be appropriate about those conditions the Director believes reasonably necessary to protect the patient or public from tuberculosis infection and disease. (j) The Director shall, for a period not exceeding 3 months, review the patient’s medical status provided to the Director by written report of the health care provider and determine whether a further hearing should be held for additional involuntary treatment within 14 working days of receipt of a written report of the medical status, and all rights pursuant to § 526(b) of this title will apply. (k) No peace officer, public health employee or medical doctor shall be subject to civil damages or criminal penalties for any harm resulting from that person’s functions under this section unless such harm was intentional or the result of wilful and wanton misconduct on the person’s part. (69 Del. Laws, c. 305, § 1; 70 Del Laws, c. 186, § 1.) § 527. Order for emergency treatment. (a) The County Public Health Administrator shall file a petition before the Director requesting that emergency treatment be ordered for a person infected with, or reasonably suspected of having, tuberculosis when the County Public Health Administrator has clear and convincing evidence, documented as facts in the petition, that: (1) The person has tuberculosis or is reasonably suspected of having tuberculosis; (2) The person poses an imminent and substantial threat to that person’s own self or the public health and welfare; and (3) The person is unable, for whatever reason, to sufficiently protect that person’s own health or that of the public or there is evidence that a person will act in such a way as to recklessly disregard the person’s own health or the public’s health; and (4) The person is not likely to appear at a hearing scheduled pursuant to § 526 of this title; or (5) The person provides evidence by words or action that the person is likely to leave the jurisdiction prior to the hearing date; or (6) The person is likely to continue to expose the public to the risk of tuberculosis and, therefore, a hearing pursuant to § 526 of this title does not protect the public. (b) No emergency treatment order shall be issued unless the Director finds that: (1) The County Public Health Administrator has also requested in the emergency treatment petition a hearing pursuant to § 526 of this subchapter, as well as its subparts, to consider the examination, treatment or placement of the person with tuberculosis or reasonably suspected to have tuberculosis, providing all due process rights as stated in § 526 of this title; Page 46 Title 16 - Health and Safety (2) The County Public Health Administrator presents clear and convincing evidence that a substantial threat to the person or the public’s health and welfare exists unless the emergency treatment order is issued; (3) The County Public Health Administrator has no other reasonable alternative means of reducing the threat to the individual or public’s health and welfare. (c) When issuing an emergency treatment order, the Director shall direct a peace officer or other designated transport personnel to immediately transport the person with tuberculosis as so ordered by the Director. The peace officer shall take into custody and isolate the person in such a manner as required by the Director. The Division will notify the peace officer or other designated transport personnel concerning any necessary infection control procedures to be taken. (d) In no case shall an emergency treatment order continue for more than 5 working days. (69 Del. Laws, c. 305, § 1; 70 Del Laws, c. 186, § 1.) § 528. Service of notice and processes; duties of the peace officer. (a) All notices required to be given, warrants, petitions, processes issued and orders entered pursuant to this subchapter shall be served by a peace officer of proper jurisdiction. (b) The Director, in ordering directly observed therapy, hospitalization or isolation pursuant to this subchapter, shall when necessary direct the peace officer to take the person into their custody and immediately deliver them to the director of the facility named on the order. The Division shall consult with the peace officer concerning any necessary infection control procedures to be taken. (69 Del. Laws, c. 305, § 1.) § 529. Right to appeal. Any person who is aggrieved by the entry of an order pursuant to this subchapter shall have 15 days within which to appeal the order to Superior Court. The Court shall convene a hearing as soon as practicable, but no later than 15 working days from the filing of the appeal. The Court shall receive the records of the administrative hearing, hear additional evidence at the request of either party and conduct a de novo review of the order. An appeal does not stay treatment. (69 Del. Laws, c. 305, § 1.) § 530. Exercise of religious freedom. Nothing in this subchapter shall be construed to authorize or empower the medical treatment of any person who desires treatment by prayer or spiritual means, in the exercise of religious freedom; provided however, that said person shall be isolated or quarantined, or both, at the patient’s expense, and while so quarantined or so isolated, or both, shall comply with all applicable sanitary rules, laws and regulations. (69 Del. Laws, c. 305, § 1.) § 531. Confidentiality. All information held by the Division relating to known or suspected cases of tuberculosis or exposure to tuberculosis shall be strictly confidential. Said information shall not be released or made public upon subpoena or otherwise, except that release may be made under the following circumstances: (1) Release is made of medical or epidemiological information for statistical purposes so that no person can be identified; or (2) Release is made of medical or epidemiological information with the consent of all persons identified in the information released; or (3) Release is made of medical or epidemiological information to medical personnel, appropriate state agencies or state courts to the extent required to enforce the provisions of this chapter and related rules and regulations concerning the control and treatment of tuberculosis; or (4) Release is made of medical or epidemiological information to medical personnel in a medical emergency to the extent necessary to protect the health or life of the named party or group of persons; or (5) Release is made during the course of civil or criminal litigation to a person allowed access to said records by a court order which is issued in compliance with the following provisions: a. No court of this State shall issue such order unless the court finds that the person seeking the records and information has demonstrated a compelling need for such records which cannot be accommodated by other means. In assessing compelling need, the court shall weigh the need for disclosure against the privacy interest of the subject and the public interest which may be disserved by disclosure which deters future testing and treatment or which may lead to discrimination. b. Pleadings pertaining to disclosure of such records shall substitute a pseudonym for the true name of the subject of the records. The disclosure to the parties of the subject’s true name shall be communicated confidentially, in documents not filed with the court. c. Before granting any such order, the court shall provide the subject whose records are in question with notice and a reasonable opportunity to participate in the proceedings if the subject is not already a party. d. Court proceedings as to disclosure of such records shall be conducted in camera unless the subject agrees to a hearing in open court or unless the court determines that a public hearing is necessary to the public interest and the proper administration of justice. Page 47 Title 16 - Health and Safety e. Upon issuance of an order to disclose such records, the court shall impose appropriate safeguards against unauthorized disclosure, which shall specify the persons who may have access to the information, the purposes for which the information shall be used and appropriate prohibition on future disclosures. (69 Del. Laws, c. 305, § 1; 70 Del. Laws, c. 186, § 1.) § 532. Health emergencies. The provisions of this subchapter are subject to the provisions of Title 20. Provisions of Title 20 which conflict with provisions of this subchapter shall take precedence over this subchapter. (73 Del. Laws, c. 355, § 11.) Page 48 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 6 Streptococcal Detection Program § 601. Enumeration of streptococcal infections. Streptococcal infections are declared to be contagious, infectious, communicable and dangerous to the public health. (60 Del. Laws, c. 491, § 1.) § 602. General powers of Secretary. (a) The Secretary of the Department of Health and Social Services shall make such rules and regulations as in his or her judgment are necessary for the detection of the disease and for the care, control and treatment of persons infected therewith, as the Secretary from time to time deems advisable. (b) The Secretary may operate the program through the Infectious Disease Laboratory of the Wilmington Medical Center and shall make it available to the general public through cooperating physicians and public school systems in the State. (60 Del. Laws, c. 491, § 1; 70 Del. Laws, c. 186, § 1.) Page 49 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 7 Sexually Transmitted Diseases Subchapter I Sexually Transmitted Disease Prevention and Control § 701. Definitions. (a) “Director” means the Director of the Division of Public Health or the Director’s authorized deputies within their respective jurisdictions. (b) “Expedited partner therapy” means the clinical practice of treating the sex partners of patients diagnosed with a sexually transmitted disease without clinical assessment of the partners. (c) “Health-care practitioner” means a physician or an individual licensed and authorized to prescribe under Title 24. (d) “Health-care professional” means any physician, nurse, laboratory or blood bank technologist or technician, and any others whose professions involve the diagnosis, care, or treatment of individuals or the testing of bodily specimens for the purpose of finding evidence of disease. (e) “Health facility” means a hospital, nursing home, clinic, blood bank, blood center, sperm bank, laboratory, or other health-care institution whether public or private. (f) “Invasive medical procedures” means surgical entry into tissues, cavities, or organs. (g) “Sexually transmitted diseases” or “STD” (formerly referred to as “venereal diseases”), means diseases designated by the Department of Health and Social Services as reportable through rules and regulations published by the Department of Health and Social Services under § 702 of this title upon finding that such disease meets both of the following: (1) Cause significant morbidity and mortality. (2) Can be screened, diagnosed, and treated in a public health control program, or if not, are a major public health concern such that surveillance of disease occurrence is in the public interest. (h) “Suspect” means an individual falling into 1 or more of the following categories: (1) An individual having positive laboratory or clinical findings of an STD. (2) An individual in whom epidemiologic evidence indicates an STD may exist. (3) An individual identified as a sexual contact of an STD case. (66 Del. Laws, c. 334, § 1; 70 Del. Laws, c. 149, § 78; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 277, § 1; 81 Del. Laws, c. 393, § 1.) § 702. Reporting of STDs. (a) A physician or any other health-care professional who diagnoses, suspects or treats a reportable STD and every administrator of a health facility or state, county or city prison in which there is a case of a reportable STD shall report such case to the Division of Public Health specifying the infected person’s name, address, age, sex and race as well as the date of onset, name and stage of disease, type and amount of treatment given and the name and address of the submitting health professional within 1 working day. Certain STDs, which shall be identified by the Department of Health and Social Services, shall be reported in number only and in a manner determined by the Department of Health and Social Services. (b) Any person who is in charge of a clinical or hospital laboratory, blood bank, mobile unit or other facility in which a laboratory examination of any specimen derived from a human body yields microscopical, cultural, serological or other evidence suggestive of a reportable STD shall notify the Division of Public Health of its findings within 1 working day. The Department of Health and Social Services may require the notification to contain any information necessary to achieve the purposes of this chapter including the tests performed and the results, the name, age, race, sex and address of the persons from whom the specimen was obtained, the reason why the test was performed and the name and address of the physician and that of the processing clinical laboratory. Certain STDs, which shall be identified by the Department of Health and Social Services, shall be reported in number only and in a manner determined by the Department of Health and Social Services. (c) The Department of Health and Social Services shall prescribe the form and method of reporting to the Division of Public Health which may be in writing, by telephone, by electronic data transmission or by other means. (d) All reports and notifications made pursuant to this section are confidential and protected from release except under the provisions of §§ 710 and 711 of this title. From information received from laboratory notifications, the Division of Public Health may contact attending physicians. The Division of Public Health shall inform the attending physician, if the notification indicates the person has an attending Page 50 Title 16 - Health and Safety physician, before contacting a person from whom a specimen was obtained. However, if delays resulting from informing the physician may enhance the spread of the STD, or otherwise endanger the health of either individuals or the public, the Division of Health may contact the person without first informing the attending physician. (e) Any laboratory which examines specimens for the purpose of finding evidence of an STD shall permit the Division of Public Health to examine the records of said laboratory in order to evaluate compliance with this section. (f) Any health-care professional or other person making the reports required by this section shall be free of any liability or any cause of action arising out of the making of such report if such health-care professional or other person acts without malice and has made a reasonable effort to obtain the facts upon which the report is based. (Code 1915, § 740A; 30 Del. Laws, c. 53, §§ 1-6; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 778; 16 Del. C. 1953, § 702; 66 Del. Laws, c. 334, § 1; 70 Del. Laws, c. 149, §§ 79, 80; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 277, § 1.) § 703. Examination, investigation and treatment of suspected persons. The Director shall, when in the Director’s own judgment it is necessary to protect the public health, make examinations of persons reasonably suspected of being infected with an STD of a communicable nature; examine medical records of suspect or diagnosed cases which may be maintained by a health facility or health-care professional; require persons infected with an STD of a communicable nature to report for treatment to a health-care professional, public or private, qualified to provide treatment and continue treatment until cured, if possible, and also, when in the Director’s own judgment it is necessary to protect the public health, may issue an order seeking to examine, isolate or quarantine persons infected with an STD of a communicable nature or persons suspected of being infected with an STD. (Code 1915, § 740A; 30 Del. Laws, c. 53, §§ 1-6; Code 1935, § 778; 16 Del. C. 1953, § 703; 66 Del. Laws, c. 334, § 1; 70 Del Laws, c. 186, § 1; 78 Del. Laws, c. 277, § 1.) § 703A. Expedited partner therapy. (a) A health-care practitioner who makes a clinical diagnosis of a sexually transmitted disease may provide expedited partner therapy for the treatment of the sexually transmitted disease in accordance with established medical practices and profession guidances published by professional medical organizations, including the Centers for Disease Control, if, in the judgment of the health-care practitioner, the sexual partner is unlikely or unable to present for comprehensive health-care, including evaluation, testing, and treatment for sexually transmitted diseases. Expedited partner therapy is limited to a sexual partner who may have been exposed to a sexually transmitted disease within the previous 60 days and who is able to be contacted by the patient. (b) A health-care practitioner who provides expedited partner therapy shall provide counseling for the patient, including advice that all symptomatic individuals, and in particular women with symptoms suggestive of pelvic inflammatory disease, are encouraged to seek medical attention. The health-care practitioner shall also provide written materials, provided by the Department of Health and Social Services, to be given by the patient to the sexual partner. The written materials must include the following: (1) A warning that a woman who is pregnant or might be pregnant should immediately contact a health-care professional for an examination. (2) Information about the antibiotic and dosage provided or prescribed that contains clear and explicit allergy and side effect warnings, including a warning that a sexual partner who has a history of allergy to the antibiotic or the pharmaceutical class of antibiotic should not take the antibiotic and should be immediately examined by a health-care professional. (3) Information about the treatment and prevention of sexually transmitted diseases. (4) The requirement of abstinence until a period of time after treatment to prevent infecting others. (5) Notification of the importance of the sexual partner’s receiving examination and testing for the human immunodeficiency virus and other sexually transmitted diseases and information regarding available resources. (6) Notification of the risk to the sexual partner, others, and the public health if the sexually transmitted disease is not completely and successfully treated. (7) The responsibility of the sexual partner to inform that individual’s sexual partners of the risk of sexually transmitted disease and the importance of prompt examination and treatment. (8) Advice to seek medical attention if symptoms of an allergic reaction arise. (c) A health-care practitioner who provides expedited partner therapy in good faith, without fee or compensation, and who provides counseling and written materials as required under this section, is not subject to civil or professional liability in connection with the provision of the expedited partner therapy, counseling, and materials, unless it is established that the health-care practitioner acted with unreasonable care, wilfully, wantonly, or by gross negligence. (d) A health-care practitioner is not subject to civil or professional liability for choosing not to provide expedited partner therapy. (e) Notwithstanding any other provision of law or regulation to the contrary, a pharmacist licensed to practice pharmacy in this State may recognize a prescription authorized by this section as valid. (f) A pharmacist or pharmacy is not subject to civil or professional liability for filling a prescription ordered under this section unless it is established that the pharmacist or pharmacy acted with unreasonable care, wilfully, wantonly, or by gross negligence. Page 51 Title 16 - Health and Safety (g) The label of any drug prescribed, or records created under this section are not required to contain the name of the patient’s sexual partner. (h) All information under this section is confidential and privileged except for reports required under this chapter and under the provisions of §§ 710 and 711 of this title. (81 Del. Laws, c. 393, § 2; 70 Del. Laws, c. 186, § 1.) § 704. Procedure for apprehension, commitment, treatment and quarantine of an infected person. (a) Orders directed to persons with an STD of a communicable nature or restrictive measures on individuals with a communicable STD, as described in this section and in § 705 of this title shall be used when other measures to protect the public health have failed, including reasonable efforts, which shall be documented, to obtain the voluntary cooperation of the individual who may be subject to such an order. (b) When the Director knows or has reason to believe, because of medical or epidemiological information, that a person has an STD of a communicable nature and is a danger to the public health, the Director may issue an order to: (1) Require the person to be examined and tested to determine whether the person has an STD of a communicable nature; (2) Require the person with an STD of a communicable nature to report to a qualified health care professional for counseling on the disease and for information on how to avoid infecting others; (3) Direct a person with an STD of a communicable nature to cease and desist from specified conduct which endangers the health of others when the Director has determined that reliable information exists to believe that such person has been ordered to report for counseling as provided in paragraph (b)(2) of this section and continues to demonstrate behavior which endangers the health of others. (c) If a person violates a cease and desist order issued pursuant to paragraph (b)(3) of this section and it is shown that the person is a danger to others, the Director may enforce the cease and desist order by imposing such restrictions upon the person as are necessary to prevent the specific conduct which endangers the health of others. Any restriction shall be in writing, setting forth the name of the person to be restricted and the initial period of time, not to exceed 3 months, during which the order shall remain effective, the terms of the restrictions and such other conditions as may be necessary to protect the public health. The Director shall review appeals for reconsideration from the subject of the order issued pursuant to this subsection. (d) (1) Any order by the Director pursuant to subsection (b) or (c) of this section shall indicate to the subject of the order the grounds and provisions of the order and notify such person that if the person refuses to comply with the order the person has a right to be present at a judicial hearing in the Justice of the Peace Court to review the order and that the person may have an attorney appear on the person’s behalf in said hearing. Notice of any order by the Director shall either be by personal service or by prepaid certified mail, return receipt requested, at the subject’s last known address. (2) If the subject of the order refuses to comply with the order the Director may petition the Justice of the Peace Court for an order of compliance with such order. If an order of compliance is requested, the Court shall hear the matter within 10 days after the request. Notice of the place, date and time of the court hearing shall be made by personal service or, if the person is not available, shall be mailed to the subject of the order by prepaid certified mail, return receipt requested, at the person’s last known address. The burden of proof shall be on the Director to show by clear and convincing evidence that the specified grounds exist for the issuance of the order and for the need for compliance and that the terms and conditions imposed are necessary to protect the public health. Upon conclusion of the hearing, the Court shall issue appropriate orders affirming, modifying or dismissing the order. (3) If the Director does not petition the Justice of the Peace Court for an order of compliance within 30 days after the subject of the order refuses to comply, the Director’s order shall expire automatically and upon application to the Director by the subject of the order, the fact that the order was issued shall be expunged from the records of the Division of Public Health. (e) Any hearing conducted pursuant to this section shall be closed and confidential, and any transcripts or records relating thereto shall also be confidential. (Code 1915, § 740A; 30 Del. Laws, c. 53, §§ 1-6; Code 1935, § 778; 45 Del. Laws, c. 86, § 1; 16 Del. C. 1953, § 704; 66 Del. Laws, c. 334, § 1; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 277, § 1.) § 705. Emergency public health procedures. (a) When the procedures of § 704 of this title have been exhausted or cannot be satisfied as a result of threatened criminal behavior and the Director knows or has reason to believe, because of medical or epidemiological information, that a person has an STD of a communicable nature and that such person presents an imminent danger to the public health, the Director may bring an action in the Justice of the Peace Court, seeking the following relief: (1) An injunction prohibiting such person from engaging in or continuing to engage in specific conduct which endangers the public health; (2) Other appropriate court orders including, but not limited to, an order to take such person into custody, for a period not to exceed 72 hours, and place such person in a facility designated or approved by the Director. (b) A custody order issued pursuant to subsection (a) of this section for the purpose of counseling and testing to determine whether such person has an STD of a communicable nature shall provide for the immediate release from custody and from the facility of any person who tests negative and may provide for counseling or other appropriate measures to be imposed on any person who tests positive. The subject Page 52 Title 16 - Health and Safety of the order shall be given notice of the order promptly, personally and confidentially, stating the grounds and provisions of the order and notifying such person that if that person refuses to comply with such order that person has a right to be present at a hearing to review the order and that such person may have an attorney appear on that person’s own behalf at the hearing. If such person contests testing or treatment, no invasive medical procedures shall be carried out prior to a hearing being held pursuant to subsection (c) of this section. Nothing in this section shall be construed to deny a person, as an exercise of religious freedom, the right to rely solely on spiritual means through prayer to prevent or cure disease, provided that the person complies with all control measures, other than treatment, imposed by the health authority or the department that are reasonable and necessary to prevent the introduction, transmission and spread of the disease. (c) Any order issued by the Justice of the Peace Court pursuant to subsection (a) or (b) of this section shall be subject to review in a court hearing. Notice of the place, date and time of the court hearing shall be given promptly, personally and confidentially to the subject of the court order by the sheriff of the appropriate county or by special process server appointed by the Court. Such hearing shall be conducted by the Court no later than 48 hours after the issuance of the order. Such person has a right to be present at the hearing and may have an attorney appear on that person’s own behalf at the hearing. Upon conclusion of the hearing, the Court shall issue appropriate orders affirming, modifying or dismissing the order. (d) The burden of proof shall be on the Director to show by clear and convincing evidence that grounds exist for the issuance of any court order pursuant to subsection (a), (b) or (c) of this section. (e) Any hearing conducted by the Justice of the Peace Court pursuant to subsection (a), (b) or (c) of this section shall be closed and confidential, and any transcripts or records relating thereto shall also be confidential. (f) Any order entered by the Justice of the Peace Court pursuant to subsection (a), (b) or (c) of this section shall impose terms and conditions no more restrictive than necessary to protect the public health. (66 Del. Laws, c. 334, § 1; 70 Del Laws, c. 186, § 1; 78 Del. Laws, c. 277, § 1.) § 706. Examination and treatment of prisoners. (a) Prison authorities of any state, county or city prison shall ensure that all persons confined or imprisoned in their respective prisons are provided services for the examination, treatment and cure, if possible, of STDs as may be required according to accepted medical practice. Prison medical staff shall adhere to current STD medical protocols established by the Division of Public Health for persons confined or imprisoned; shall inform the Division of Public Health when a person or persons infected with or suspected to have an STD is released from prison without appropriate treatment, counseling or examination; and shall allow the Division of Public Health to examine medical records or other medical information to ensure that appropriate STD medical practices are followed. (b) Prison authorities of any state, county or city prison shall make available to the Division of Public Health such portion of any state, county or city prison as may be necessary to isolate or quarantine persons known or suspected to have an STD of a communicable nature under the provisions of §§ 703, 704 and 705 of this title, provided that no other suitable place for such isolation or quarantine is available, and shall cooperate with the Division of Public Health in the provision of care and treatment to such persons. (Code 1915, § 740A; 30 Del. Laws, c. 53, §§ 1-6; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 778; 16 Del. C. 1953, § 705; 66 Del. Laws, c. 334, § 1; 78 Del. Laws, c. 277, § 1.) § 707. Rules and regulations of Department. (a) The Department of Health and Social Services shall make such rules and regulations as may in its judgment be necessary to carry out the provisions of this chapter, including rules and regulations designating STDs to be reported, providing for the control and treatment of persons isolated or quarantined, and such other rules and regulations, not in conflict with the provisions of this chapter, concerning the control of STDs, and concerning the care, treatment and quarantine of persons infected therewith, as it may from time to time deem advisable. (b) All rules and regulations made pursuant to this chapter shall have the force and effect of law. (c) The Department of Health and Social Services shall create the written materials required under § 703A of this title. (Code 1915, § 740A; 30 Del. Laws, c. 53, §§ 1-6; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 778; 16 Del. C. 1953, § 706; 66 Del. Laws, c. 334, § 1; 70 Del. Laws, c. 149, § 81; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 277, § 1; 81 Del. Laws, c. 393, § 3.) § 708. Prenatal standard tests for syphilis, gonorrhea, chlamydia and other STDs. (a) Every health-care professional qualified to attend a pregnant woman in this State during gestation shall take or cause to be taken suitable specimens of such woman and submit such specimens to an approved laboratory for standard tests for syphilis and gonorrhea, chlamydia and other such tests for STDs as may be designated by the Department of Health and Social Services. Every other person permitted by law to attend upon pregnant women in the State but not permitted by law to take such specimens shall cause such specimens of such pregnant woman to be taken by a qualified health-care professional and submitted to an approved laboratory for standard tests for gonorrhea, syphilis and chlamydia and other such tests for STDs as may be designated by the Department of Health and Social Services. The specimens shall be taken at the time of the first examination relating to the current pregnancy and a second specimen during the third trimester of pregnancy which is in addition to or exclusive of the test taken at delivery. Every pregnant woman shall permit the specimens to be taken by a qualified health care professional as herein provided. However, the Director or the Director’s authorized deputy within Page 53 Title 16 - Health and Safety the county wherein any person affected by this section resides may waive the requirements of this section if the Director or deputy is satisfied by written affidavit or other notarized written proof that the tests required by this section are contrary to the tenets and practices of the religious teachings of which the applicant is an adherent, and that the public health and welfare would not be injuriously affected by such waiver. (b) The term “approved laboratory” means a laboratory approved for this purpose by the Department of Health and Social Services. Standard tests for syphilis, chlamydia and gonorrhea are ones recognized as such by the Department of Health and Social Services. (c) The laboratory tests required by this section shall be made on request without charge by the Department of Health and Social Services. (42 Del. Laws, c. 87, § 2; 16 Del. C. 1953, § 707; 66 Del. Laws, c. 334, § 1; 70 Del. Laws, c. 149, §§ 82, 83; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 277, § 1.) § 709. Authority to perform venipuncture. Notwithstanding any other provision of law, a person employed by or detailed to the Division of Public Health as an STD case investigator may perform venipuncture or skin puncture for the purpose of withdrawing blood for test purposes, even though the STD case investigator is not otherwise licensed to withdraw blood; provided that such person meets all the following requirements: (1) The person works under the direction of licensed physician. (2) The person has been trained by a licensed physician in the proper procedures to be employed when withdrawing blood, in accordance with training requirements established by the Division of Public Health, and has a statement signed by the instructing physician that such training has been completed. (66 Del. Laws, c. 334, § 1; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 277, § 1.) § 710. Minors — Treatment, consent, and liability for payment for care. Any health facility or health-care professional may examine and provide treatment for an STD for any minor if such facility or professional is qualified to provide such examination or treatment. Consent to examination and treatment by a minor shall be controlled by §§ 707 and 708 of Title 13. The health-care professional in charge or other appropriate authority of the health facility or the healthcare professional concerned shall prescribe an appropriate course of treatment for such minor. The fact of consultation, examination and treatment of such minor shall be strictly confidential and shall not be divulged by the facility or the health-care professional, including sending of a bill for such services to any persons other than the minor, except as follows: (1) To persons providing consent pursuant to § 707 of Title 13 or persons informed of the minor’s testing and treatment under § 708 of Title 13; (2) As is necessary to comply with the requirements of Chapter 9 of this title relating to child abuse investigations; or (3) As is necessary to comply with the requirements of this chapter concerning the control and treatment of STDs, as well as the permitted dissemination of records and information under § 711 of this title. (66 Del. Laws, c. 334, § 1; 78 Del. Laws, c. 277, § 1.) § 711. Confidentiality of records and information. All information and records held by the Division of Public Health relating to known or suspected causes of STD, including infection with human immunodeficiency virus (HIV), the virus causing Acquired Immunodeficiency Syndrome (AIDS), shall be strictly confidential. Such information shall not be released or made public upon subpoena or otherwise, except that release may be made under the following circumstances: (1) Release is made of medical or epidemiological information for statistical purposes so that no person can be identified; (2) Release is made of medical or epidemiological information with the consent of all persons identified in the information released; (3) Release is made of medical or epidemiological information to medical personnel, appropriate state agencies, including the Maternal and Child Death Review Commission, or state courts to the extent required to enforce the provisions of this chapter and related rules and regulations concerning the control and treatment of STDs, or as related to child abuse investigations pursuant to Chapter 9 of this title, or as related to Maternal and Child Death Review Commission investigations pursuant to subchapter II of Chapter 3 of Title 31; (4) Release is made of medical or epidemiological information to medical personnel in a medical emergency to the extent necessary to protect the health or life of the named party; or (5) Release is made during the course of civil or criminal litigation to a person allowed access to said records by a court order which is issued in compliance with the following provisions: a. No court of this State shall issue such order unless the court finds that the person seeking the records and information has demonstrated a compelling need for such records which cannot be accommodated by other means. In assessing compelling need, the court shall weigh the need for disclosure against the privacy interest of the subject and the public interest which may be disserved by disclosure which deters future testing and treatment or which may lead to discrimination. b. Pleadings pertaining to disclosure of such records shall substitute a pseudonym for the true name of the subject of the records. The disclosure to the parties of the subject’s true name shall be communicated confidentially, in documents not filed with the court. Page 54 Title 16 - Health and Safety c. Before granting any such order, the court shall provide the subject whose records are in question with notice and a reasonable opportunity to participate in the proceedings if the subject is not already a party. d. Court proceedings as to disclosure of such records shall be conducted in camera unless the subject agrees to a hearing in open court or unless the court determines that a public hearing is necessary to the public interest and the proper administration of justice. e. Upon the issuance of an order to disclose such records, the court shall impose appropriate safeguards against unauthorized disclosure, which shall specify the persons who may have access to the information, the purposes for which the information shall be used, and appropriate prohibitions on future disclosures. (66 Del. Laws, c. 334, § 1; 70 Del. Laws, c. 186, § 1; 75 Del. Laws, c. 361, §§ 1, 2; 78 Del. Laws, c. 277, § 1; 80 Del. Laws, c. 187, § 2; 83 Del. Laws, c. 364, § 2.) § 712. Custodian of records. No Department of Public Health and Social Services or local health department officer or employee shall be examined in a civil, criminal, special or other proceeding as to the existence or contents of pertinent records for a person examined or treated for an STD or HIV infection by the Division of Public Health, or of the existence of contents of such reports received from a private health-care professional or private health facility, without the consent of the person examined and treated for such diseases, except where the information in such records is disclosed pursuant to § 710 or § 711(2), (3) or (5) of this title. (66 Del. Laws, c. 334, § 1; 70 Del. Laws, c. 149, § 84; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 277, § 1.) § 713. Penalties; jurisdiction. (a) Except for § 702 of this title, whoever violates this chapter or any lawful rule or regulations made by the Department of Health and Social Services under § 707 of this title, or fails to obey any lawful order issued by the Director under this chapter shall be fined not less than $100 nor more than $1,000. (b) Whoever violates § 702 of this title shall be fined not less than $25 and not more than $200 for each offense. (c) Each separate day that a violation of this chapter as defined under subsections (a) and (b) of this section continues shall be deemed a separate offense for penalty purposes. (d) Justices of the peace shall have jurisdiction of offenses under this chapter. (Code 1915, § 740A; 30 Del. Laws, c. 53, §§ 1-6; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 778; 16 Del. C. 1953, § 709; 66 Del. Laws, c. 334, § 1; 70 Del. Laws, c. 149, § 85; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 277, § 1.) Subchapter II HIV Testing and Counseling § 714. Definitions. For purposes of this subchapter the following definitions shall apply: (1) “AIDS” shall mean Acquired Immunodeficiency Syndrome, a stage of HIV illness. (2) “Approved laboratory” shall mean a laboratory approved by the Department for the purpose of performing standard tests for HIV as recognized as such by the Department. (3) “Clinical setting” shall mean prenatal clinics, hospital emergency departments, urgent care clinics, inpatient services, substance abuse treatment clinics, public health clinics, nursing homes, community clinics, correctional health-care facilities, blood banks, blood centers, sperm banks, primary care settings, and other public or private settings as defined by the Division. (4) “Health-care provider” shall mean any nurse, physician, dentist or other dental worker, optometrist, podiatrist, chiropractor, laboratory or blood bank technologist or technician, phlebotomist, dialysis personnel, emergency health-care provider (including any paramedic, emergency medical technician, law-enforcement personnel or firefighter), others whose activities involve contact with patients, their blood or corpses, and other public or private providers as defined by the Division. (5) “Health facility” shall mean a hospital, nursing home, clinic, blood bank, blood center, sperm bank, laboratory, or other healthcare institution. (6) “HIV” shall mean the Human Immunodeficiency Virus, a virus that can be transmitted sexually and that is identified as the causative agent of AIDS. (7) “HIV-related tests” shall mean HIV tests, CD4 cell count tests, viral load tests, or any other tests related to HIV. (8) “HIV test” shall mean a test to detect HIV infection. (9) “Informed consent” means consent of the subject of the test or subject’s legal guardian to the performance of HIV testing by a health-care provider who has informed the subject or the subject’s legal guardian both verbally and in writing, to an extent reasonably comprehensive to general lay understanding, of the nature of the proposed testing and of the risks and alternatives to testing which a reasonable person would consider material to the decision whether or not to undergo testing. (10) “Invasive medical procedure” shall mean any procedure involving surgical entry into tissues, cavities, or organs. Page 55 Title 16 - Health and Safety (11) “Legal guardian” shall mean a person appointed by a court to assume legal authority for another who has been found incompetent or, in the case of a minor, a person who has legal custody of the minor. (12) “Manner known to transmit HIV” shall mean parenteral exposure to blood or blood products including but not limited to injection through the skin, sexual exposure, or exposure as otherwise determined by the Division. (13) “Nonclinical setting” shall mean community-based organizations (CBO), outreach and education settings, mobile vans, and other settings as defined by the Division. (14) “Person” shall mean any natural person, partnership, association, joint venture, trust, public, or private corporation, or health facility. (15) “Prevention counseling” shall mean an interactive process of assessing risk, recognizing specific behaviors that increase the risk for acquiring or transmitting HIV, and developing a plan to take specific steps to reduce risks. (16) “Release of test results” shall mean a written authorization for disclosure of test results, which is signed, dated and specifies to whom disclosure is authorized and the time period during which the release is to be effective. (17) “Routine/opt-out testing” shall mean that the general consent for medical care shall encompass testing for HIV and that testing may be performed as a part of routine care unless it is declined and that declination is noted in the medical record. A separate consent for HIV testing is not required. (18) “Test counseling” shall include information that includes an explanation of the testing process/procedure, the meaning of possible test results, and provision of resources for additional information about relevant infections. The information may be provided orally or in writing and the subject of the counseling given the opportunity to ask questions. (66 Del. Laws, c. 336, § 1; 71 Del. Laws, c. 458, § 1; 78 Del. Laws, c. 277, § 2.) § 715. Consent for HIV testing. (a) A health-care provider or other person who performs HIV testing services in a clinical setting may provide routine/opt-out testing provided that the following occurs: (1) The subject is informed, orally or in writing, that routine/opt-out HIV testing is encompassed by the general consent for medical services. (2) The subject is given the opportunity to refuse consent to HIV testing at each instance of testing. Documentation of such refusal shall be noted in the subject’s medical record. (3) The subject is provided HIV test counseling, orally or in writing, at the first instance of testing and by request thereafter. (b) The health-care provider or other person who performs HIV testing services in a nonclinical setting must obtain written documentation of informed consent at each instance of HIV screening. (1) Informed consent to an HIV test in a nonclinical setting shall consist of a voluntary agreement executed by the subject of the test or the subject’s legal guardian. (2) At each instance of testing, the subject of the test must be offered HIV test counseling and prevention counseling prior to consent for HIV testing. (c) Notwithstanding any other provision of law, a minor 12 years of age or older may consent or refuse consent to be a subject of HIVrelated testing and to counseling relevant to the test. The consent or refusal of the minor shall be valid and binding as if the minor had achieved majority, and shall not be voidable, nor subject to later disaffirmance, because of minority. (d) Notwithstanding subsection (a) of this section the provisions of subsections (b) and (c) of this section do not apply when: (1) Knowledge of such test results is necessary for medical diagnostic purposes to provide appropriate emergency care or treatment and the subject of the test is unable to grant or withhold consent. (2) The testing is done for the purposes of research; provided that the test is performed in a manner by which the identity of the test subject is not known and may not be retrieved by the researcher. (3) A health-care provider or health-care facility procures, processes, distributes or uses: a. Blood; b. A human body part donated for a purpose specified under the Uniform Anatomical Gift Act (Chapter 27 of this title); or c. Semen provided prior to July 11, 1988, for the purpose of artificial insemination, and such test is necessary to assure the medical acceptability of such gift or semen for the purposes intended. (4) The health of a health-care worker has been threatened during the course of a health-care worker’s duties, as a result of exposure to blood or body fluids of the patient in a manner known to transmit HIV. (5) It is necessary to control the transmission of HIV infection as may be allowed pursuant to this chapter as it relates to sexually transmitted diseases, or § 6523(b) of Title 11 as it relates to the Department of Correction. (6) Testing is ordered by a court of competent jurisdiction within the confines of civil or criminal litigation where the results of an HIV-related test of a party, or a person in the custody or under the legal control of another party, is relevant to the ultimate issue of culpability and/or liability. Said order must be issued in compliance with the following provisions: Page 56 Title 16 - Health and Safety a. No court of this State shall issue such order unless the court finds that there is a compelling need for such test results, which cannot be accommodated by other means. In assessing compelling need, the court shall weigh the need for testing and disclosure of the test results against the privacy interest of the test subject and the public interest, which may be disserved, by disclosure which deters future testing or which may lead to discrimination. b. Pleadings pertaining to ordering of an HIV-related test shall substitute a pseudonym for the true name of the subject of the test. The true name shall be communicated confidentially, in documents not filed with the court. c. Before granting any such order, the court shall provide the subject of the test with notice and a reasonable opportunity to participate in the proceedings if the individual is not already a party. d. Court proceedings as to disclosure of test results so ordered shall be conducted in camera unless the subject of the test agrees to a hearing in open court or unless the court determines that a public hearing is necessary to the public interest and the proper administration of justice. (e) Any person on whom an HIV-related test was performed without first having obtained informed consent pursuant to paragraphs (d) (1), (4) and (5) of this section shall be given notice promptly, personally and confidentially that a test sample was taken and the results of such test may be obtained upon request. (f) At the time of learning the test result, the subject of the test or the subject’s legal guardian shall be provided with counseling for coping with the emotional consequences of learning the result, for understanding the interpretation of the test result, for understanding measures for preventing infection to others, to urge the voluntary notification of sexual and needle-sharing partners of the risk of infection and the availability of any appropriate health-care services, including mental health-care and appropriate social and supportive services. (66 Del. Laws, c. 336, § 1; 70 Del. Laws, c. 186, § 1; 77 Del. Laws, c. 109, § 1; 78 Del. Laws, c. 277, § 2.) § 716. HIV testing of pregnant women. (a) A perinatal care provider may provide routine/opt-out testing pursuant to § 715(a) of this title. (1) In addition to the provisions of this subsection, a licensed health-care provider who renders the primary prenatal care for a pregnant woman must offer HIV testing upon intake to perinatal services, during the third trimester, and at intake into labor and delivery if the result of previous test are not available or documented in the patient’s chart. (2) In addition to the provisions this subsection, a licensed health-care provider who renders the primary prenatal care for a pregnant woman must also counsel a pregnant woman that is found to be HIV-infected, orally or in writing, about the dangers to her fetus and about the treatment options for maintaining her health and reducing chances of transmission of HIV to her fetus. (b) A pregnant woman shall have the right to refuse consent to testing HIV infection at any instance of testing and to refuse any recommended treatment. Documentation of such refusal shall be maintained in the patient’s medical record. All other provisions of this subchapter shall apply to such counseling, testing, and disclosure, which take place pursuant to this section. (70 Del. Laws, c. 520, § 1; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 458, § 1; 75 Del. Laws, c. 434, § 1; 77 Del. Laws, c. 109, § 2; 78 Del. Laws, c. 277, § 2.) § 717. Confidentiality. (a) No person may disclose or be compelled to disclose the identity of any person upon whom an HIV-related test is performed, or the results of such test in a manner which permits identification of the subject of the test, except to the following person: (1) The subject of the test or the subject’s legal guardian. (2) Any person who secures a legally effective release of test results executed by the subject of the test or the subject’s legal guardian. (3) An authorized agent or employee of a health facility or health-care provider if the health facility or health-care provider itself is authorized to obtain the test results, the agent or employee provides patient care or handles or processes specimens of body fluids or tissues, and the agent or employee has a medical need to know such information to provide health-care to the patient. (4) Health-care providers providing medical care to the subject of the test, when knowledge of the test results is necessary to provide appropriate emergency care or treatment. (5) When part of an official report to the Division as may be required by law or regulation. (6) A health facility or health-care provider which procures, processes, distributes or uses: a. Blood; b. A human body part from a deceased person donated for a purpose specified under the Uniform Anatomical Gift Act [Chapter 27 of this title]; or c. Semen provided prior to July 11, 1988, for the purpose of artificial insemination. (7) Health facility staff committees or accreditation or oversight review organizations which are conducting program monitoring, program evaluation or service reviews, including the Maternal and Child Death Review Commission conducting reviews pursuant to Title 31. (8) Pursuant to Chapter 9 of this title as it relates to investigation of child abuse. Page 57 Title 16 - Health and Safety (9) Pursuant to subchapter I of this chapter as it relates to sexually transmitted diseases and their control. (10) A person allowed access to said record by a court order which is issued in compliance with § 715(d)(6) of this title. Upon the issuance of an order to disclose test results, the court shall impose appropriate safeguards against unauthorized disclosure, which shall specify the persons who may have access to the information, the purposes for which the information shall be used and appropriate prohibitions on future disclosures. (11) Pursuant to Chapter 12A of this title as it relates to notification of emergency medical care providers. (b) No person to whom the results of an HIV-related test have been disclosed pursuant to subsection (a) of this section shall disclose the test results to another person except as authorized by subsection (a) of this section. (c) The provisions in this section shall not interfere with the transmission of information as may be necessary to obtain third-party payment for medical care related to HIV infection or with the documentation of cause of death on death certificates. (66 Del. Laws, c. 336, § 1; 68 Del. Laws, c. 415, § 2; 70 Del. Laws, c. 186, § 1; 75 Del. Laws, c. 361, § 3; 78 Del. Laws, c. 277, § 2; 80 Del. Laws, c. 187, § 3; 83 Del. Laws, c. 364, § 2.) § 718. Enforcement of subchapter. (a) Any person aggrieved by a violation of this subchapter shall have a right of action in the Superior Court and may recover for each violation: (1) Against any person who negligently violates a provision of this subchapter, damages of $1,000 or actual damages, whichever is greater. (2) Against any person who intentionally or recklessly violates a provision of this subchapter, damages of $5,000 or actual damages, whichever is greater. (3) Reasonable attorneys’ fees. (4) Such other relief, including an injunction, as a court may deem appropriate. (b) Any action under this subchapter is barred unless the action is commenced within 3 years after the cause of action accrues. A cause of action will accrue when the injured party becomes aware of an unauthorized disclosure pursuant to § 717 of this title, or that an HIVrelated test has been conducted without informed consent pursuant to § 715 of this title. (c) The Attorney General may maintain a civil action to enforce this subchapter in which a Court may order any relief authorized by subsection (a) of this section. (d) Nothing in this subchapter shall be construed to impose civil liability or criminal sanction for disclosure of an HIV-related test result in accordance with any reporting requirement by the Division. (66 Del. Laws, c. 336, § 1; 70 Del. Laws, c. 520, § 1; 71 Del. Laws, c. 458, § 1; 78 Del. Laws, c. 277, § 2.) Page 58 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 8 Inflammation of Eyes of Newborn § 801. Definition of inflammation of eyes of newborn. Any inflammation, swelling, or redness in either 1 or both eyes of any infant, either apart from or together with any unnatural discharge from the eye or eyes of such infant, independent of the nature of the infection, if any, occurring any time within 2 weeks after the birth of such infant, shall be known as inflammation of the eyes of the newborn. (29 Del. Laws, c. 51, § 1; Code 1935, § 779; 16 Del. C. 1953, § 901.) § 802. Reporting existence of disease; investigation. Any physician, surgeon, obstetrician, midwife, nurse, maternity home or hospital of any nature, parent, relative and any persons attendant on or assisting in any way whatsoever, any infant or the mother of an infant at childbirth, or any time within 2 weeks after childbirth, knowing the condition defined in § 801 of this title to exist, within 6 hours thereafter shall report such fact to the local health officer of the city, town, village or whatever other political division there may be, within which the infant or the mother of any such infant may reside. The local health officer shall investigate or have investigated, each case as filed with the officer in pursuance with the law and any other such case as may come to the local health officer’s attention. (29 Del. Laws, c. 51, § 2; Code 1935, § 779; 16 Del. C. 1953, § 902; 70 Del Laws, c. 186, § 1.) § 803. Treatment of eyes on birth. (a) The Department of Health and Social Services shall regulate the type of prophylactic treatment to be employed against inflammation of the eye or eyes of the newborn, the conditions under which such prophylaxis will be employed and the diseases for which reporting is required. Such regulation shall conform with standards promulgated by the United States Center for Disease Control, United States Public Health Service. A record of the prophylactic used and details thereof shall be recorded on the birth certificate. (b) Nothing in this section shall require medical treatment for the minor child of any person who is a member of a recognized church or religious denomination and whose religious convictions, in accordance with the tenets and practices of the person’s church or religious denomination, are against medical treatment for disease. (29 Del. Laws, c. 51, § 3; 32 Del. Laws, c. 42; 40 Del. Laws, c. 97, § 1; Code 1935, § 779; 16 Del. C. 1953, § 903; 64 Del. Laws, c. 119, § 1; 70 Del. Laws, c. 149, § 86; 70 Del. Laws, c. 186, § 1.) § 804. Penalties. Whoever being a physician, surgeon, midwife, obstetrician, nurse, parent, relative or person attendant upon or assisting at the birth of any infant, violates this chapter, shall be fined not less than $5.00 nor more than $100. (29 Del. Laws, c. 51, § 4; Code 1935, § 779; 16 Del. C. 1953, § 904.) Page 59 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 8A Universal Newborn and Infant Hearing Screening, Tracking, and Intervention § 801A. Short title. This chapter shall be known and may be cited as the “Universal Newborn and Infant Hearing Screening, Tracking, and Intervention Act.” (75 Del. Laws, c. 116, § 1; 78 Del. Laws, c. 389, § 1.) § 802A. Legislative findings and purpose. The General Assembly hereby finds and declares that: (1) Significant hearing loss is 1 of the most common major abnormalities present at birth and, if undetected, will impede the child’s speech, language, and cognitive development. (2) Screening by high-risk characteristics alone (e.g., family history of deafness) only identifies approximately 50% of newborns with significant hearing loss. (3) Reliance solely on physician and/or parental observation fails to identify many cases of significant hearing loss in newborns and infants. (4) There is evidence that children with hearing loss, who are identified at birth and receive intervention services shortly thereafter, have significantly better learning capacity than children who are identified with hearing loss later than 6 months after birth. (5) Legislation is needed to provide for the early detection of hearing loss in newborns and infants and to prevent or mitigate the developmental delays associated with late identification of hearing loss. (75 Del. Laws, c. 116, § 1; 78 Del. Laws, c. 389, § 1.) § 803A. Definitions. For the purposes of this chapter: (1) “Child” means a person up to 21 years of age. (2) “Early intervention” and/or “follow-up care” means the early intervention services described in Part C and Part B of the Individuals with Disabilities Education Act (IDEA) [20 U.S.C. § 1431 et seq. and 20 U.S.C. § 1411 et seq.], as well as any necessary hearing and medical services for the diagnosis and management of newborn, infant, or child hearing loss. (3) “False negative rate” means the proportion of infants not identified as having a significant hearing loss by the screening process who are ultimately found to have a significant hearing loss. (4) “False positive rate” means the proportion of infants identified as having a significant hearing loss by the screening process who are ultimately found to not have a significant hearing loss. (5) “Family” or “families” means a birth parent(s), stepparent(s), adoptive parent(s), legal guardian(s), or other legal custodian of a newborn, infant, or child. (6) “Family-centered” means the beliefs, values, and practices that emphasize the essential role of the family in all aspects of the decision-making and intervention process regarding the young child. (7) “Health-care insurer” means any entity regulated by the Insurance Commissioner, including, but not limited to, health-care insurers; health, hospital or medical service plan corporations; or health maintenance organizations. Health-care insurer does not include self-insured plans or groups regulated by the Employee Retirement Income Security Act of 1974 (ERISA) (29 U.S.C. § 1001 et seq.), to the extent that state regulation of such plans is preempted by ERISA. (8) “Health insurance policy” means any health insurance policy, contract, plan, or evidence of coverage issued by a health-care insurer, which provides medical coverage on an expense incurred, service or prepaid basis. (9) “Hearing screening test” means automated auditory brain stem response, otoacoustic emissions, or another appropriate screening test approved by the Department of Health and Social Services. (10) “Hospital” means a health care facility or birthing center licensed in this State that provides obstetrical services, or provides inpatient newborn services. (11) “Infant” means a child who is not a newborn and has not attained the age of 1 year. (12) “Lead agency” means the Department of Health and Social Services. (13) “Newborn” means a child up to 28 days old. (14) “Parent” means a natural parent, stepparent, adoptive parents, guardian, or custodian of a newborn or infant. Page 60 Title 16 - Health and Safety (15) “Significant hearing loss” means a hearing loss equivalent to or greater than a 35-decibel hearing loss (35-dB HL) in the better ear. (16) “Surveillance and tracking system” means a monitoring and referral system and procedures designed for the collection and transmission of information and data necessary to implement timely and appropriate follow-up of infants identified through hearing screening programs. (75 Del. Laws, c. 116, § 1; 78 Del. Laws, c. 389, § 1.) § 804A. Newborn and infant hearing screening programs. (a) As a condition of its licensure, each hospital shall establish a Universal Newborn Hearing Screening (UNHS) program. Each UNHS program shall: (1) Provide a hearing screening test for every newborn born in the hospital, for identification of hearing loss, regardless of whether or not the newborn has known risk factors suggesting hearing loss. (2) Develop screening protocols and select screening method or methods designed to detect newborns and infants with a significant hearing loss. (3) Provide for appropriate training and monitoring of the performance of individuals responsible for performing hearing screening tests. These individuals shall be trained properly in: a. The performance of the tests required by this chapter; b. The risks of the tests, including psychological stress for the parent or parents; c. Infection control practices; and d. The general care and handling of newborns and infants in hospital settings. e. [Repealed.] (4) Perform the hearing testing prior to the newborn’s discharge; if the newborn is expected to remain in the hospital for a prolonged period, testing shall be performed prior to the date on which the child attains the age of 3 months. (5) Develop and implement procedures for documenting the results of all hearing screening tests and the scheduling of follow-up appointments to help reduce loss to follow-up. (6) Inform the newborn’s or infant’s parents and primary care physician, if 1 is designated, of the results of the hearing screening test, or if the newborn or infant was not successfully tested. Whenever possible, such notification shall occur prior to discharge; if this is not possible, notification shall occur no later than 10 days following the date of testing. Notification shall include information regarding appropriate follow-up for a screening failure or a missed screening, and referral information for confirmatory testing. If a hearing screening test indicates the possibility of a significant hearing loss, the hospital shall ensure that the physician or other person attending the newborn or infant is made aware of the community resources available for confirmatory testing and process of referral to early intervention services. (7) Collect performance data specified by the Division of Public Health to ensure that each UNHS program is in compliance with this section, including the number of infants born, the proportion of all infants screened, the referral rate, the follow-up rate, the falsepositive rate, and the false-negative rate. a. Testing performance standards. — 1. Each UNHS program should have a false-positive rate of 5% or less. 2. Each UNHS program should have a false-negative rate of 5% or less. b. Oversight responsibility. — The Division of Public Health shall exercise oversight responsibility for UNHS programs, including establishing a performance data set and reviewing performance data collected pursuant thereto by each hospital. (b) Audiologists shall report all results of newborn, infant, and child hearing screenings and/or testing to the state EHDI program at the Division of Public Health. Reporting of results must be the same day as testing if at all possible. If this is not possible, results must be reported no later than 10 days following the testing date. Notification shall include information regarding appropriate follow-up for a screening failure or a missed screening, and referral information for confirmatory testing if not already complete. (75 Del. Laws, c. 116, § 1; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 389, § 1; 81 Del. Laws, c. 79, § 21.) § 805A. Surveillance and tracking system. It is recognized that is necessary to provide surveillance, tracking and monitoring of newborns, infants, and children identified through newborn hearing screening in order to make referrals, render appropriate follow-up care and better establish linkages between hearing screening programs, audiological services, and early intervention programs. To facilitate the reporting, tracking, and monitoring of newborns, infants, and children who have or are suspected to have hearing loss, a state EHDI surveillance and tracking system tracks, monitors, and refers newborns, infants, and children through diagnostic and early intervention. The system shall be utilized by qualified professionals, including those at other State agencies, involved in the detection, treatment, diagnosis, and/or referral of newborns, infants, or children with or suspected of having hearing loss. The reporting requirements shall be designed to be as simple as possible and easily completed by nonprofessional persons when necessary. Page 61 Title 16 - Health and Safety The following persons who act in compliance with this section are not civilly or criminally liable for furnishing information required by this section: a hospital, clinical laboratory or other health-care facility; an audiologist; an administrator; officer or employee of a hospital or other health-care facility; and physician or employee of a physician. (78 Del. Laws, c. 389, § 1.) § 806A. Provision of early intervention services and follow-up care. The lead agency or its designee shall ensure that hearing loss is diagnosed by 3 months of age, or earlier, and infants with confirmed hearing loss receive comprehensive early intervention services by 6 months of age, or earlier. (1) The lead agency shall refer all children with any degree of diagnosed hearing loss, whether a measurable delay is present, to determine if they are eligible under Part C of the Individuals with Disabilities Education Act (IDEA) [20 U.S.C. § 1431 et seq.] by virtue of their diagnosis. (2) Professionals involved in the care and treatment of the newborns, infants, and children must document all early intervention, follow-up, and treatment services, including but not limited to further diagnoses, recommendations, observations, test results, and referrals, in order to reduce the number of newborns, infants, and children lost to follow-up. (3) Early intervention services shall be provided by individuals with the knowledge, skills, and experience to address the ongoing assessment, implementation, and evaluation of services that support families and promote child development. (4) Family-centered services may be provided in a variety of different settings, including the home, school, community centers, daycare center, hospital or clinic, depending on the needs of the child, family, and availability of resources in the community. (5) Lack of resources may not be the basis for denial of services. (78 Del. Laws, c. 389, § 1.) § 807A. Family resources. Families shall be provided with unbiased information in a family-centered, culturally competent manner and offered the full range of early intervention services and treatment options available for hearing loss. Opportunities for early intervention shall be consistent with the child’s needs, family’s goals, and preferences, and be provided in a seamless, unambiguous manner to ensure informed transitions through services. Appropriate early intervention opportunities may include information regarding amplification options, such as hearing aids or cochlear implants, aural habilitation and communication options (manual language, spoken language, total communication), and family support. (78 Del. Laws, c. 389, § 1.) § 808A. Early Hearing Detection and Intervention (EHDI) Advisory Board. There shall be established an Early Hearing Detection and Intervention Advisory Board (“Board”) that will advise the Secretary on issues relating to the newborn hearing evaluation, intervention, treatment, and follow-up care for infants and children with hearing loss. Members shall be appointed by the Governor and serve 3-year terms that are renewable. The Board shall have 12 members. (1) The Department shall provide administrative support services required for the Board. Members shall receive no compensation for their services as members. (2) The Board shall act by majority vote and as required by this State’s Administrative Procedures Act [Chapter 101 of Title 29]. The Board shall have the authority to adopt rules to implement this chapter. (3) The Board membership shall consist of 1 of each the following: Audiologist; Speech-language pathologist; Pediatrician/neonatologist; Otolaryngologist; Neonatal nurse; The Secretary of the Department of Health and Social Services or designee; An adult who is deaf or hard of hearing; Parent of a child with a hearing loss; Teacher of children with hearing loss; A representative from the designated agency responsible for the Individuals with Disabilities Education Act (IDEA) Part C [20 U.S.C. § 1431 et seq.]; A representative from the Department of Education Early Childhood Workgroup; and A representative from the Statewide Programs for Deaf and Hard of Hearing. (78 Del. Laws, c. 389, § 1.) Page 62 Title 16 - Health and Safety § 809A. Civil and criminal immunity and penalties. (a) No physician shall be civilly or criminally liable for failure to conduct hearing screening testing. (b) No physician or hospital acting in compliance with this chapter shall be civilly or criminally liable for any acts taken in conformity herewith, including without limitation furnishing information required to be furnished hereunder. (c) A hospital that has not established or implemented an UNHS program in accordance with this chapter shall be subject to sanction by the Division of Public Health as provided by law for licensure violations. (75 Del. Laws, c. 116, § 1; 78 Del. Laws, c. 389, § 1.) § 810A. Confidentiality. The Division of Public Health and all other persons to whom data is submitted in accordance with this chapter shall keep such information confidential. No publication or disclosure of information shall be made except in the form of statistical or other studies which do not identify individuals, except as specifically consented to in writing the by the parent or parents of a tested child. (75 Del. Laws, c. 116, § 1; 78 Del. Laws, c. 389, § 1.) § 811A. Delivery of policy. If a health insurance policy provides coverage or benefits to a resident of this State, it shall be deemed to be delivered in this State within the meaning of this chapter, regardless of whether the health-care insurer issuing or delivering said policy is located inside or outside of the State. (75 Del. Laws, c. 116, § 1; 78 Del. Laws, c. 389, § 1.) Page 63 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 8B Down Syndrome Information § 801B. Provision of information relating to Down Syndrome. (a) For the purposes of this section, the term “Down Syndrome” shall mean a chromosomal condition caused by an error in cell division that results in the presence of an extra whole or partial copy of chromosome 21. A hospital, as that term is defined in § 803A of this title, physician, health-care provider, nurse midwife or genetic counselor who renders prenatal care, postnatal care or genetic counseling shall, upon receipt of a positive test result from a test for Down Syndrome, provide the expectant or new parent with information provided by the department under subsection (b) of this section. (b) The Department shall make available to a person who renders prenatal care, postnatal care or genetic counseling to parents who receive a prenatal or postnatal diagnosis of Down Syndrome the following: (1) Up-to-date evidence-based, written information about Down Syndrome that has been reviewed by medical experts and national Down Syndrome organizations; provided, however, that the written information provided shall include physical, developmental, educational and psychosocial outcomes, life expectancy, clinical course and intellectual and functional development and treatment options; and (2) Contact information regarding first call programs and support services, including information hotlines specific to Down Syndrome, resource centers or clearinghouses, national and local Down Syndrome organizations, and other educational and support programs. The Department may also make such information available to any other person who has received a positive test result from a test for Down Syndrome. (c) The Department shall meet annually with representatives of the Down Syndrome Association of Delaware to ensure the information made available by the department is up to date. (d) The Department shall submit a report by January 31 of each year to the Co-Chairs of the Joint Finance Committee detailing the persons to whom the information required by subsection (b) of this section has been distributed. (79 Del. Laws, c. 218, § 1.) Page 64 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 8C Screening of Newborn Infants for Metabolic, Hematologic, Endocrinologic, Immunologic, and Certain Structural Disorders § 801C. Short title. This chapter shall be known and may be cited as the “Newborn Screening Program.” (80 Del. Laws, c. 96, § 1.) § 802C. Definitions. (a) “Blood specimen for metabolic, hematologic, endocrinologic, and immunologic disorders” means a dried blood spot on a special filter paper utilized for screening (not diagnostic) tests to establish the likely presence of metabolic, hematologic, endocrinologic, or immunologic disorders. (b) “Certain structural disorders” includes critical congenital heart defects and other structural disorders. (c) “Endocrinologic disorder” means the absence or deficiency of a hormone resulting in interference with normal health, growth or development. These disorders include, but are not limited to congenital hypothyroidism and congenital adrenal hyperplasia. (d) “Hematologic disorder” means, a condition in which a variation in 1 or more of the hemoglobin structural genes or in 1 or more of the genes involved in hemoglobin synthesis produces a variation in hemoglobin structure or synthesis, which results in variation in hemoglobin function. These disorders include, but are not limited to, sickle cell anemia, sickle beta thalassemia, beta thalassemia, alpha thalassemia, hemoglobin C disease and other clinically important variations in hemoglobin structure or synthesis. (e) “Immunologic disorder” means, a condition in which a variation in the quantity or function of white blood cells results in deficiency of immune function. These disorders include, but are not limited to, severe combined immunodeficiency disorder. (f) “Kit” means any or all parts of the combined materials, laboratory filter paper specimen forms, Newborn Screening Program brochure, and/or other components provided by the state Newborn Screening Program for the purposes of collection of the blood spot specimen and for submission of the blood spot specimen for laboratory screening. (g) “Metabolic disorder” means a disorder caused by a genetic alteration, which results in a defect in the structure or function of a specific enzyme or other protein. These disorders include, but are not limited to, phenylketonuria (PKU), galactosemia, maple syrup urine disease (MSUD), and medium chain acyl-CoA dehydrogenase (MCAD) deficiency. (h) “Newborn infant” means any infant born in the State who is under 4 weeks of age. (i) The “Newborn Screening Advisory Committee” means a committee, established through this chapter, convened to provide advice and guidance to the Director of Public Health. (j) “Satisfactory specimen” means a blood spot specimen on which an accurate laboratory analysis for the various disorders can be performed. (80 Del. Laws, c. 96, § 1.) § 803C. Newborn Screening Advisory Committee. There shall be established Newborn Screening Advisory Committee (“Committee”) that will advise the Director of the Division of Public Health on issues relating to the newborn screening program, including intervention, treatment, and follow-up care for infants and children with metabolic, hematologic, endocrinologic, immunologic and certain structural disorders. Members shall be appointed by the Governor and serve 3-year terms that are renewable. The Committee shall have 13 members. (1) The Department of Health and Social Services shall provide administrative support services required for the Committee. Members shall receive no compensation for their services as members. (2) The Committee shall act by majority vote and as required by this State’s Administrative Procedures Act, Chapter 101 of Title 29. The Committee shall meet at least 3 times annually. (3) The Committee membership shall consist of: 3 individuals, or parents of individuals, affected by disorders identified by the screening panel; an ethicist; an attorney not employed by the State; 3 pediatric physicians; the Medical Director for the Division of Public Health, or his or her designee; the Laboratory Director for the Division of Public Health, or his or her designee; a representative from the Department of Services for Children Youth and their Families; the Chair of the Midwifery Advisory Council, or his or her designee; and a member of the public. (4) The Committee shall elect a Chairperson to serve for at least 1 year from those members appointed by the Governor. A majority of the membership of the Committee shall constitute a quorum to transact its business. (80 Del. Laws, c. 96, § 1; 70 Del. Laws, c. 186, § 1.) Page 65 Title 16 - Health and Safety § 804C. Newborn Screening Program. (a) The Department of Health and Social Services shall adopt rules and regulations under and pursuant to this State’s Administrative Procedures Act, Chapter 101 of Title 29, to carry out the objectives of this chapter. All prior regulations and rules promulgated by the Delaware Division of Public Health in regard to the screening of newborn infants for diseases shall remain in full force and effect until amended or repealed by the Department. (b) All hospitals, birthing centers and other birth attendants shall obtain a satisfactory specimen within 24 to 48 hours of age and shall perform, or arrange for, screening for critical congenital heart defects. (c) The Division of Public Health shall provide results to the physician on record. (d) The Director of the Division of Public Health, with advice from the Committee, will determine which disorders shall be on the screening panel. (e) Blood specimens for metabolic, hematologic, endocrinologic, and immunologic disorders will be destroyed after screening and testing is complete. Screening and testing includes confirmation of any diagnosis. (f) Records obtained from screenings will be retained by the Division of Public Health. (g) Fees. — (1) (1) The Newborn Screening Program shall bill the birth facility or individual attending the birth for services provided for each newborn screened under these regulations including but not limited to, the cost of the kits for collection of specimens, the laboratory fee for analysis, and administrative costs. The amount billed will be determined by the Director of the Division of Public Health in consultation with the Advisory Committee and the program staff. The fee will be determined in July of each year based on the cost of the program. All fees collected as a result of billing are hereby appropriated to, and shall be retained by, the Newborn Screening Program to defray operating expenses associated with this chapter, operation of the Program, and programming to ensure the optimal health and development across the lifespan of the maternal and child health population. (2) No Delaware newborn shall be denied testing for hereditary disorders because of inability of the newborn’s parent or legal guardian to pay the fee. (80 Del. Laws, c. 96, § 1; 83 Del. Laws, c. 167, § 1.) § 805C. Parental options. (a) All newborns in Delaware shall have a satisfactory specimen taken within 24 to 48 hours of age and shall be screened for metabolic, hematologic, endocrinologic, immunologic and certain structural disorders. Parents may elect not to participate in any of the following: (1) Screening to be performed; (2) The blood spot to be stored following testing; and/or (3) The results of the screen to be securely shared electronically through a health information exchange so that health-care providers can appropriately access information. (b) The informed consent process shall assure that the parent or guardian who elects that a newborn shall not be tested understands the consequences of such a decision, including the inability to prevent developmental delay and death. Language conveying such information shall be recommended by the Committee for approval by the Division Director. (c) There will be no research utilizing the stored blood specimens or the stored data without parental consent, except for populationbased studies in which all identifying information is removed. (80 Del. Laws, c. 96, § 1; 83 Del. Laws, c. 167, § 1.) § 806C. Confidentiality. (a) No person may disclose or be compelled to disclose the identity of any person upon whom a blood specimen for metabolic, hematologic, endocrinologic, immunologic and certain structural disorders screen is performed, or the results of such test in a manner which permits identification of the subject of the test, except to the following person: (1) The subject of the test or the subject’s legal guardian. (2) Any person who secures a legally effective release of test results executed by the subject of the test or the subject’s legal guardian. (3) For purposes of diagnosis, treatment or follow-up. (4) As authorized by court order. (5) To a medical examiner authorized to conduct an autopsy on a child or an inquest on the death of a child. (6) Health facility staff committees or accreditation or oversight review organizations which are conducting program monitoring, program evaluation or service reviews, including the Maternal and Child Death Review Commission conducting reviews pursuant to Title 31. (7) Individuals who have access to an electronic medical record (EMR), in which the information is retained pursuant to § 1203(a) (6) of this title, or a health information exchange. (8) Pursuant to Chapter 9 of this title as it relates to investigation of child abuse. Page 66 Title 16 - Health and Safety (b) No person to whom the results of a blood specimen for metabolic, hematologic, endocrinologic, immunologic and certain structural disorders screen have been disclosed pursuant to subsection (a) of this section shall disclose the test results to another person except as authorized by subsection (a) of this section. (c) The provisions in this section shall not interfere with the transmission of information as may be necessary to obtain third-party payment for medical care related to a metabolic, hematologic, endocrinologic, immunologic, or certain structural disorders or with the documentation of cause of death on death certificates. (80 Del. Laws, c. 96, § 1; 80 Del. Laws, c. 187, § 16; 83 Del. Laws, c. 167, § 1; 83 Del. Laws, c. 364, § 2.) Page 67 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 8D Maternal Mental Health § 801D. Policy. The maternal mental health-care policy of this State shall serve to increase the likelihood that a woman who has given birth and demonstrates symptoms of maternal depression will receive the necessary mental health treatment. The goal of this policy is to provide sufficient resources of information and support, including patient screening soon after childbirth, for women with maternal depression to decrease child abuse or neglect and the need for inpatient treatment. (80 Del. Laws, c. 293, § 1; 70 Del. Laws, c. 186, § 1.) § 802D. Definitions. As used in this chapter: (1) “Maternal depression” means a wide range of emotional and psychological reactions that a woman may experience during pregnancy or after childbirth, as the range of reactions is defined in the Diagnostic and Statistical Manual of Mental Disorders. The reactions may include: feelings of despair or extreme guilt; prolonged sadness; lack of energy; difficulty concentrating; fatigue; extreme changes in appetite; or thoughts of suicide or harming the baby. (2) “Maternal health-care provider” means a physician, midwife, advanced practice registered nurse, registered nurse, physician assistant, or other health-care practitioner acting within his or her lawful scope of practice while attending a woman who presents with signs of maternal depression. (80 Del. Laws, c. 293, § 1; 70 Del. Laws, c. 186, § 1.) § 803D. Maternal depression materials and information. (a) The Department shall develop written materials and information about maternal depression. (1) The materials and information shall include the symptoms and methods of coping with maternal depression and treatment resources. (2) The Department shall periodically review the materials and information to determine their effectiveness and ensure they reflect the most up-to-date and accurate information. (3) The Department shall post on its website the materials and information. (4) The Department may make available or distribute the materials and information in physical form upon request. (b) Maternal health-care providers shall do all of the following: (1) Provide the materials and information developed under subsection (a) of this section to any woman who presents with signs of maternal depression. (2) Encourage any woman who presents with signs of maternal depression to share the materials and information with her baby’s family members or caregivers and her family members and caregivers. (c) Hospitals and other health-care facilities shall do all of the following: (1) Provide, upon discharge, the materials and information developed under subsection (a) of this section to any woman who presents with signs of maternal depression. (2) Encourage any woman who presents with signs of maternal depression to share the materials and information with her baby’s family members or caregivers and her family members and caregivers. (d) The Behavioral Health Commission shall assess and recommend improvements to the materials and information developed under subsection (a) of this section, in an effort to create greater statewide resources. (80 Del. Laws, c. 293, § 1; 70 Del. Laws, c. 186, § 1.) § 804D. Maternal depression screening. Maternal health-care providers shall begin evaluations and take action when they recognize symptoms of maternal depression in a woman or family, including when care for a baby suffers or other symptoms as defined in the Diagnostic and Statistical Manual of Mental Disorders. (80 Del. Laws, c. 293, § 1; 70 Del. Laws, c. 186, § 1.) § 805D. Enforcement. The Department may develop regulations governing compliance under this chapter. (80 Del. Laws, c. 293, § 1.) Page 68 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 9 Abuse of Children Subchapter I Reports and Investigations of Abuse and Neglect § 901. Purpose. The child welfare policy of this State shall serve to advance the best interests and secure the safety of the child, while preserving the family unit whenever the safety of the child is not jeopardized. The child welfare policy of this State extends to all child victims, whether victims of intrafamilial or extrafamilial child abuse and neglect. To that end this chapter, among other things, does all of the following: (1) Provides for comprehensive, multidisciplinary investigative and protective services for abused and neglected children. (2) Mandates that reports of child abuse or neglect be made to the appropriate authorities. (3) Requires various agencies in Delaware’s child protection system to work together to ensure the safety of children who are the subject of reports of abuse or neglect by conducting coordinated multidisciplinary investigations where required, judicial proceedings and family assessments, and by providing necessary services. (4) Provides for the protection of children in facilities or organizations primarily concerned with child welfare and care that are required to be licensed under Delaware law by requiring the Delaware Department of Justice to notify any such facility where an employee of, or other person associated with, the facility has been charged with or convicted of an offense involving child sexual abuse. This chapter also provides for the protection of children in facilities or organizations primarily concerned with child welfare and care that are required to be licensed under Delaware law by requiring the Delaware Department of Justice to notify any such facility where an employee of, or other person associated with, the facility has been charged with or convicted of an offense involving child sexual abuse. (16 Del. C. 1953, § 1001; 58 Del. Laws, c. 154; 60 Del. Laws, c. 494, § 1; 68 Del. Laws, c. 440, § 1; 71 Del. Laws, c. 199, § 2; 78 Del. Laws, c. 403, § 1; 81 Del. Laws, c. 144, § 1.) § 902. Definitions. As used in this chapter: (1) “Abuse” or “abused child” means as defined in § 901 of Title 10. (2) “Baby” means a child not more than 14 days old, except that for a safe haven under § 907A(b) of this title and the safe haven’s employees and volunteers, “baby” means a child reasonably believed to be not more than 14 days old. (3) “Child” means any person who has not reached that person’s own eighteenth birthday. (4) “Child Protection Registry” or “Registry” means a collection of information as described in Subchapter II of this chapter about persons who have been substantiated for abuse or neglect as provided in Subchapter II of this chapter or who were substantiated between August 1, 1994, and February 1, 2003. (5) “Children’s advocacy center” means a child forensic interviewing center that employs best practices by applying and adhering to nationally recognized standards, and assists in the response to multidisciplinary cases. (6) “Child welfare proceeding” means any Family Court proceeding and subsequent appeal therefrom involving custody, visitation, guardianship, termination of parental rights, adoption or other related petitions that involve a dependent, neglected or abused child or a child at risk of same as determined by the Family Court. (7) “Conviction” or “convicted” means entry of a plea of guilty or nolo contendere, regardless of whether the plea was subsequently discharged or dismissed under the first offenders domestic violence diversion program pursuant to § 1024 of Title 10, or under the first offenders controlled substances diversion program pursuant to § 4767 of this title, or of a Robinson plea, or of a probation before judgment discharge without judgment of conviction notwithstanding the provisions of § 4218(g) of Title 11, or a finding of guilt after trial, or a finding of not guilty after trial as a result of the defense of mental disease or defect pursuant to Title 11, or adjudication of delinquency for conduct which if committed by an adult, would constitute a crime; or “conviction” or “convicted” under similar proceedings of another state, territory or jurisdiction. (8) “Death” means the loss of life of a child. (9) “Department” means the Department of Services for Children, Youth and Their Families. (10) “Director” means the Director of the Division of Family Services or the Director of the Division of Management Support Services of the Department of Services for Children, Youth and Their Families. (11) “Division” means the Division of Family Services of the Department of Services for Children, Youth and Their Families. (12) “Extrafamilial child abuse or neglect” means child abuse or neglect committed by an individual who is not a member of the child’s family or household, but does not include institutional child abuse or neglect. Page 69 Title 16 - Health and Safety (13) “Family assessment and services” means a case management approach by the Division of Family Services that provides for a prompt assessment of a child and the child’s family and the circumstances of the reported incident, including the known history of the child or the alleged perpetrator, when there has been a report to the Department that the child was a victim of abuse or neglect, or at risk of maltreatment by a person responsible for that child’s care, custody or control. Family assessment and services shall be used in conjunction with the investigation approach defined in paragraph (20) of this section but may not supplant it in circumstances which require an investigation. The family assessment response shall focus on the integrity and preservation of the family and shall assess the status of the child and the family in terms of the risk of abuse and neglect and, if necessary, plan and provide for the provision of community-based services to reduce the risk and to otherwise support the family. (14) “Good faith” shall be presumed in the absence of evidence of malice or wilful misconduct. (15) “Human trafficking” means as defined in § 787 of Title 11. (16) “Institutional Abuse Investigation Unit” means the unit within the Department that investigates allegations of institutional child abuse and neglect. (17) “Institutional child abuse or neglect” means as defined in § 901 of Title 10. (18) “Internal information system” means the Department’s system of maintaining information related to all reports of abuse, neglect, investigations, family assessments, services and other relevant information. (19) “Intrafamilial child abuse or neglect” means as defined in § 901 of Title 10. (20) “Investigation” means the collection of evidence in response to a report of abuse, neglect, or risk of maltreatment of a child by a person responsible for that child’s care, custody or control in order to determine if a child has been abused, neglected, or is at risk of maltreatment. The Department shall develop protocols for its investigations that focus on ensuring the well-being and safety of the child. The Department may conduct an investigation in response to any report of abuse, neglect, or risk of maltreatment but shall conduct an investigation as enumerated under § 906(e)(3) of this title. (21) “Investigation Coordinator” means an attorney licensed to practice law in this State employed by the Office of the Child Advocate, who is authorized to independently track each reported case of alleged child abuse or neglect within the Department’s internal information system and who is responsible for monitoring each reported case involving the death of, serious physical injury to, or allegations of sexual abuse of a child from inception to final criminal and civil disposition. (22) “Multidisciplinary case” means a comprehensive investigation by the multidisciplinary team for any child abuse or neglect report involving death, serious physical injury, physical injury, human trafficking of a child, torture or sexual abuse, which if true, would constitute a criminal violation against a child, or an attempt to commit any such crime, even if no crime is ever charged. (23) “Multidisciplinary team” means a combination of the following entities as required by law to investigate or monitor multidisciplinary cases: the Division, the Department’s Institutional Abuse Investigation Unit, the appropriate law-enforcement agency, the Department of Justice, and the Investigation Coordinator. “Multidisciplinary team” may also include others deemed necessary for an effective multidisciplinary response, such as medical personnel, the Division of Forensic Science, a children’s advocacy center, the Division of Prevention and Behavioral Health Services, mental health experts, and the child’s attorney. (24) “Multidisciplinary tracking system” means an electronic system which the Investigation Coordinator utilizes to track and monitor each case involving the death of, or serious injury to, a child, or allegations of sexual abuse of a child, from inception to final criminal and civil disposition. (25) “Near death” means a child in serious or critical condition as a result of child abuse or neglect as certified by a physician. (26) “Neglect” means as defined in § 901 of Title 10. (27) “Physical injury” means as defined in § 1100 of Title 11. (28) “Report” means the communication of an allegation of child abuse or neglect to the Department pursuant to § 903 or § 905 of this title. (29) “Serious physical injury” means as defined in § 1100 of Title 11. (30) “Sexual abuse” means as defined in § 901 of Title 10. (31) “Special Investigator” means a Department employee, appointed by the Secretary, who performs abuse and neglect investigations and possesses additional qualifications and authority as defined by § 9016 of Title 29. (32) “Substantiation” means a finding by a preponderance of the evidence that abuse or neglect has occurred. (33) “Those responsible for the care, custody and control of the child” or “care, custody and control” means as defined in § 901 of Title 10. (60 Del. Laws, c. 494, § 1; 64 Del. Laws, c. 213, § 1; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 199, § 3; 72 Del. Laws, c. 179, § 3; 72 Del. Laws, c. 469, § 4; 73 Del. Laws, c. 187, §§ 2, 8; 73 Del. Laws, c. 412, §§ 2-5; 75 Del. Laws, c. 376, § 1; 76 Del. Laws, c. 136, §§ 14-16; 78 Del. Laws, c. 13, § 60; 78 Del. Laws, c. 403, § 2; 79 Del. Laws, c. 336, § 1; 80 Del. Laws, c. 187, § 5; 80 Del. Laws, c. 219, § 1; 80 Del. Laws, c. 238, § 1; 81 Del. Laws, c. 144, § 2; 83 Del. Laws, c. 228, § 1; 83 Del. Laws, c. 242, § 2.) § 902A. Registration; procedure; notice [Repealed]. Repealed by 73 Del. Laws, c. 412, § 6, effective February 1, 2003. Page 70 Title 16 - Health and Safety § 903. Reports required. (a) Any person, agency, organization or entity who knows or in good faith suspects child abuse or neglect shall make a report in accordance with § 904 of this title. For purposes of this section, “person” shall include, but shall not be limited to, any physician, any other person in the healing arts including any person licensed to render services in medicine, osteopathy or dentistry, any intern, resident, nurse, school employee, social worker, psychologist, medical examiner, hospital, health-care institution, the Medical Society of Delaware or law-enforcement agency. In addition to and not in lieu of reporting to the Department, any such person may also give oral or written notification of said knowledge or suspicion to any police officer who is in the presence of such person for the purpose of rendering assistance to the child in question or investigating the cause of the child’s injuries or condition. (b) The Department shall inform any person required to report under this section of the person’s right to obtain information concerning the disposition of the report. The Department shall make information on the general disposition of the report available through the Department report line to any person required to report under this section. (16 Del. C. 1953, § 1002; 58 Del. Laws, c. 154; 60 Del. Laws, c. 494, § 1; 72 Del. Laws, c. 179, § 4; 77 Del. Laws, c. 320, § 1; 81 Del. Laws, c. 144, § 3; 83 Del. Laws, c. 228, § 1.) § 904. Nature and content of report; to whom made. (a) Any report of child abuse or neglect required to be made under this chapter must be made by contacting the Child Abuse and Neglect Report Line for the Department of Services for Children, Youth and Their Families. An immediate oral report must be made by telephone or otherwise. Reports and the contents thereof including a written report, if requested, must be made in accordance with the rules and regulations of the Department. An individual with knowledge of child abuse or neglect or knowledge that leads to a good faith suspicion of child abuse or neglect may not rely on another individual who has less direct knowledge to call the aforementioned report line. (b) When a written report is made by a person required to report under § 903 of this title, the Department shall contact the person who made such report within 48 hours of the receipt of the report in order to ensure that full information has been received and to obtain any additional information, including medical records, which may be relevant to the contents of the report. (c) When 2 or more persons who are required to report under § 903 of this title have joint knowledge of a known or suspected instance of child abuse or neglect, the telephone report may be made by 1 person with joint knowledge who was selected by mutual agreement of those persons involved. The report must include all persons with joint knowledge of the known or suspected instance of child abuse or neglect at the time the report is made. Any person who has knowledge that the individual who was originally designated to report has failed to do so shall immediately make the report required under § 903 of this title. (16 Del. C. 1953, § 1003; 58 Del. Laws, c. 154; 60 Del. Laws, c. 494, § 1; 64 Del. Laws, c. 108, §§ 4, 11; 77 Del. Laws, c. 320, § 2; 80 Del. Laws, c. 84, § 1; 81 Del. Laws, c. 144, § 4; 83 Del. Laws, c. 228, § 1.) § 905. Telephone reports, Child Protection Registry and information. (a) The Department shall establish and maintain a 24-hour statewide toll-free telephone report line operating at all times and capable of receiving all reports of alleged abuse and neglect of a child. (b) The Department shall maintain a Child Protection Registry and an internal information system. The Department shall keep unsubstantiated reports in the internal information system. (c) Every report of child abuse or neglect made to the Department shall be entered in the Department’s internal information system. (d) Upon receipt of a report on any multidisciplinary case, the Department shall notify the appropriate law-enforcement agency and shall provide a detailed description of the report received. Notwithstanding any provision of the Delaware Code to the contrary, to the extent the law-enforcement agency with primary jurisdiction over the case is unable to assist, the primary law-enforcement agency may request another law-enforcement agency with jurisdiction to exercise such jurisdiction. Upon request, the other law-enforcement agency may exercise such jurisdiction. (e) Although reports may be made anonymously, the Department shall in all cases, after obtaining relevant information regarding alleged abuse or neglect, request the name and address of any person making a report. (f) Upon receipt of a report, the Department shall immediately communicate such report to its appropriate staff, after a check has been made with the internal information system to determine whether previous reports have been made regarding actual or suspected abuse or neglect of the subject child, or any reports regarding any siblings, family members, or the alleged perpetrator, and such information as may be contained from such previous reports. Such relevant information as may be contained in the internal information system must also be forwarded to the appropriate Department staff. (g) Upon receipt of a report of death, serious physical injury or sexual abuse, or any other report requested by the Investigation Coordinator, the Department shall notify the Investigation Coordinator of the report, in sufficient detail to permit the Investigation Coordinator to undertake the Investigation Coordinator’s duties, as specified in § 906 of this title. (16 Del. C. 1953, § 1004; 58 Del. Laws, c. 154; 60 Del. Laws, c. 494, § 1; 64 Del. Laws, c. 108, § 4; 68 Del. Laws, c. 440, § 2; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 199, § 4; 73 Del. Laws, c. 412, §§ 26, 27; 77 Del. Laws, c. 320, § 3; 78 Del. Laws, c. 403, § 3; 81 Del. Laws, c. 144, § 5; 83 Del. Laws, c. 228, § 1.) Page 71 Title 16 - Health and Safety § 906. State response to reports of abuse or neglect. (a) The State’s child protection system shall seek to promote the safety of children and the integrity and preservation of their families by conducting investigations or family assessments in response to reports of child abuse or neglect. The system shall endeavor to coordinate community resources and provide assistance or services to children and families identified to be at risk, and to prevent and remedy child abuse and neglect. (b) It is the policy of this State that the investigation and disposition of cases involving child abuse or neglect shall be conducted in a comprehensive, integrated, multidisciplinary manner that does all of the following: (1) Provides civil and criminal protections to the child and the community. (2) Encourages the use of collaborative decision-making and case management to reduce the number of times a child is interviewed and examined to minimize further trauma to the child. (3) Provides safety and treatment for a child and his or her family by coordinating a therapeutic services system. (4) Requires a multidisciplinary team response for all multidisciplinary cases. The State, with assistance from the Child Protection Accountability Commission, shall implement a memorandum of understanding among agencies and entities to ensure implementation of the multidisciplinary response to such cases. (c) (1) In implementing the Investigation Coordinator’s role in the child protection system, the Investigation Coordinator, or the Investigation Coordinator’s staff, shall do all of the following: a. Have electronic access and the authority to track within the Department’s internal information system each reported case of alleged child abuse or neglect. b. Monitor each case involving the death of, serious physical injury to, or allegations of sexual abuse of a child from inception to final criminal and civil disposition, and provide information as requested on the status of each case to the Division, the Department, the Delaware Department of Justice, a children’s advocacy center, and the Office of Child Advocate. c. Within 5 business days of the receipt of a report concerning allegations of child abuse or neglect by a person known to be licensed or certified by a Delaware agency or professional regulatory organization, forward a report of such allegations to the appropriate Delaware agency or professional regulatory organization. d. Report every case involving the death or near death of a child due to abuse or neglect to the Department of Justice and the Child Protection Accountability Commission under § 932(a) of this title and every case involving the death of a child to the Maternal and Child Death Review Commission. e. Provide information to the Child Protection Accountability Commission (CPAC), as requested by CPAC, regarding the status, trends, and outcomes of any case or cases of child abuse or neglect that are reported to the Department. Reports to CPAC may not disclose the identities of the child, alleged perpetrators, or others involved in the case or cases. f. Participate as a member of the multidisciplinary team for cases outlined in paragraph (c)(1)b. of this section, and keep the team regularly apprised of the status and findings of the Investigation Coordinator. (2) All information and records received, prepared, or maintained by the Investigation Coordinator, or the Investigation Coordinator’s staff, are confidential and exempt from the provisions of the Freedom of Information Act, Chapter 100 of Title 29. However, the disclosure of case specific data and information to the multidisciplinary team is authorized to ensure a comprehensive, integrated, multidisciplinary response to child abuse cases. (3) The Investigation Coordinator, and the Investigation Coordinator’s staff, as state employees, are entitled to immunity in accordance with § 4001 of Title 10. (d) In implementing law-enforcement’s role in the child protection system, the law-enforcement agency investigating a report of child abuse or neglect shall do all of the following: (1) Report every case of child abuse or neglect to the Department as required by § 903 of this title. (2) Provide information as necessary to the Investigation Coordinator to permit case tracking, monitoring, and reporting by the Investigation Coordinator. (3) Notify the Department of Justice upon receipt of a report of death or serious physical injury of a child. (4) Notify the multidisciplinary team as to whether it will be exercising jurisdiction in the case, or will be requesting another lawenforcement agency with jurisdiction to exercise such jurisdiction. Upon request, the other law-enforcement agency may exercise such jurisdiction. (5) Promptly conduct a criminal investigation for any multidisciplinary case. (6) Coordinate with the multidisciplinary team to secure forensic interviews and medical examinations, where applicable, and to conduct interviews while considering the criminal investigation together with the Department’s statutory duties to promptly assess child safety. Absent good cause, children ages 3 through 12, and all suspected child victims of human trafficking, must be interviewed in a children’s advocacy center. (7) Participate as a member of the multidisciplinary team, and keep the team regularly apprised of the status and findings of its investigation. Page 72 Title 16 - Health and Safety (8) Comply with the reporting requirements to the Board of Medical Licensure and Discipline under § 1730(b)(2) and § 1731A of Title 24, and to further report to the Board within 30 days of the closure of a criminal investigation or the arrest of a person who is licensed to practice medicine under Chapter 17, Title 24. (e) In implementing the Department’s role in the child protection system, the Department shall do all of the following: (1) Receive and maintain reports pursuant to the provisions of §§ 903 and 905 of this title. (2) Forward reports to the appropriate Department staff, who shall determine, through the use of protocols developed by the Department, whether an investigation or the family assessment and services approach should be used to respond to the allegation. The protocols for making this determination shall be developed by the Department and shall give priority to ensuring the well-being and safety of the child. (3) Conduct an investigation on a multidisciplinary case that involves intrafamilial or institutional child abuse or neglect, human trafficking of a child, or death of a child 3 years of age or less that appears to be sudden, unexpected, and unexplained. The Department may investigate any other report. (4) [Repealed.] (5) Ensure that every case involving the death or near death of a child due to abuse or neglect is reported to the Child Protection Accountability Commission and every case involving the death of a child to the Maternal and Child Death Review Commission. (6) Ensure that all cases involving allegations of child abuse or neglect by a person known to be licensed or certified by a Delaware agency or professional regulatory organization, have been reported to the appropriate Delaware agency or professional regulatory organization and the Investigation Coordinator in accordance with the provisions of this section. (7) Have authority to secure a medical examination of a child, and any siblings or other children in the child’s household without the consent of those responsible for the care, custody, and control of the child, if the child has been reported to be a victim of abuse or neglect; provided, that such case is classified as an investigation pursuant to paragraph (e)(3) of this section and the Director or the Director’s designee gives prior authorization for such examination upon finding that such examination is necessary to protect the health and safety of the child. If such a medical examination is authorized under this section, the Department is authorized to transport the child to the medical examination. Medical examinations under this paragraph are covered under § 3557 of Title 18. (8) At a minimum, investigate the nature, extent, and cause of the abuse or neglect; collect evidence; identify the alleged perpetrator; determine the names and condition of other children and adults in the home; assess the home environment, the relationship of the subject child to the parents or other persons responsible for the child’s care, and any indication of incidents of physical violence against any other household or family member; perform background checks on all adults in the home; and gather other pertinent information. (9) In the family assessment and services approach, assess service needs of the family from information gathered from the family and other sources. The Department shall identify and provide for services for families where it is determined that the child is at risk of abuse or neglect. The Department shall document its attempt to provide voluntary services and the reasons these services are important to reduce the risk of future abuse or neglect. If the family refuses to accept or avoids the proffered services, the Department may refer the case for investigation or terminate services. (10) Commence an immediate investigation if at any time during the family assessment and services approach the Department determines that an investigation as delineated in paragraph (e)(3) of this section is required or is otherwise appropriate. The Department staff who have conducted the assessment may remain involved in the provision of services to the child and family. (11) Conduct a family assessment and services approach on reports initially referred for an investigation, if it is determined that a complete investigation is not required. The reason for the termination of the investigative process must be documented. (12) Assist the child and family in obtaining services, if at any time during the investigation it is determined that the child or any member of the family needs services. (13) Identify local services and ongoing medical needs, and assist with access to those services for children and families where there is risk of abuse or neglect. (14) Update the internal information system at regular intervals during the course of the investigation. At the conclusion of the investigation, the internal information system must be updated to include a case finding. (15) [Repealed.] (16) Upon completion of an investigation or family assessment and services approach, if the Department suspects that the report was made maliciously or for the purpose of harassment, the Department shall refer the report and any evidence of malice or harassment to the appropriate law-enforcement agency. (17)-(20) [Repealed.] (21) Upon the receipt of a report concerning allegations of abuse or neglect against a person known by the Department to be licensed by any of the boards listed in § 8735 of Title 29, forward reports to the Division of Professional Regulation. For any entity the Department is notified of that is not included in § 8735 of Title 29, the Department shall forward a report of such allegations to the appropriate Delaware agency or professional regulatory organization. (22) Coordinate with the multidisciplinary team to secure forensic interviews and medical examinations, where applicable, and to conduct interviews while considering the criminal investigation together with the Department’s statutory duties to promptly assess Page 73 Title 16 - Health and Safety child safety. Absent good cause, children ages 3 through 12, and all suspected child victims of human trafficking, shall be interviewed in a children’s advocacy center. (23) Participate as a member of the multidisciplinary team, and keep the team regularly apprised of the status and findings of its investigation. (f) In implementing the Department of Justice’s role in the child protection system, it shall do all of the following: (1) Report every case of child abuse or neglect to the Department pursuant to § 903 of this title. (2) Ensure that every case involving the death or near death of a child due to abuse or neglect is reported to the Child Protection Accountability Commission and every case involving the death of a child to the Maternal and Child Death Review Commission. (3) Provide information as necessary to the Investigation Coordinator to permit case tracking, monitoring and reporting by the Investigation Coordinator. (4) Ensure that all cases involving allegations of child abuse or neglect by a person known to be licensed or certified by a Delaware agency or professional regulatory organization, have been reported to the appropriate Delaware agency or professional regulatory organization and the Investigation Coordinator in accordance with provisions of this section. (5) Participate as a member of the multidisciplinary team, and keep the team regularly apprised of the status and findings of its prosecution. (g) (1) If a criminal prosecution for child sexual abuse or exploitation or human trafficking of a child is initiated by the Department of Justice against a person employed by or associated with a facility or organization required to be licensed or whose staff personnel are required to be licensed under Delaware law whose primary concern is that of child welfare and care, the Department of Justice shall notify such employer within 48 hours. (2) Any violations of this subsection shall be dealt with administratively by the Attorney General and the penalty provisions of § 914 of this title shall not apply hereto. (h) If a criminal prosecution for abuse or neglect is initiated by the Department of Justice pursuant to a report under this chapter and incarceration of the person who is the subject of the report is ordered by the court, the Department of Justice shall keep the Department informed of actions taken by the courts which result in the release of any such individual. (71 Del. Laws, c. 199, § 5; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 424, § 8; 72 Del. Laws, c. 173, § 5; 73 Del. Laws, c. 412, § 28; 77 Del. Laws, c. 318, § 6; 77 Del. Laws, c. 320, §§ 4, 5; 78 Del. Laws, c. 403, § 4; 78 Del. Laws, c. 406, § 1; 79 Del. Laws, c. 336, § 2; 80 Del. Laws, c. 187, § 6; 80 Del. Laws, c. 219, § 1; 81 Del. Laws, c. 144, § 6; 83 Del. Laws, c. 228, § 1; 83 Del. Laws, c. 364, § 2.) § 907. Temporary emergency protective custody. (a) A police officer, nurse practitioner, or a physician who reasonably suspects that a child is in imminent danger of suffering serious physical harm or a threat to life as a result of abuse or neglect and who reasonably suspects the harm or threat to life may occur before the Family Court can issue a temporary protective custody order may take or retain temporary emergency protective custody of the child without the consent of the child’s parents, guardian, or others legally responsible for the child’s care. (b) Any person taking a child into temporary emergency protective custody under this section shall immediately notify the Department, in the county in which the child is located, of the person’s actions and make a reasonable attempt to advise the parents, guardians, or others legally responsible for the child’s care. In notifying the Department, such person shall set forth the identity of the child and the facts and circumstances which gave such person reasonable cause to believe that there was imminent danger of serious physical harm or threat to the life of the child. Upon notification that a child has been taken into temporary emergency protective custody, the Department shall immediately respond in accordance with § 906 of this title to secure the safety of the child which may include ex parte custody relief from the Family Court if appropriate. (c) Temporary emergency protective custody for purposes of this section may not exceed 4 hours and must cease upon the Department’s response pursuant to subsection (b) of this section. (d) For the purposes of this section, “temporary emergency protective custody” means temporary placement within a hospital, medical facility, or such other suitable placement; provided, however, that an abused or neglected child may not be detained in temporary custody in a secure detention facility. (e) A Department investigator conducting an investigation pursuant to § 906 of this title has the same authority as that granted to a police officer, nurse practitioner, or physician in subsection (a) of this section, subject to all the same conditions as those listed in subsections (a) through (d) of this section, provided that the child in question is located at a school, day care facility, or child care facility at the time that the authority is initially exercised. In no other case may an employee of the Department exercise custody under this section. (71 Del. Laws, c. 199, § 5; 70 Del. Laws, c. 186, § 1; 72 Del. Laws, c. 173, § 7; 81 Del. Laws, c. 144, § 7; 83 Del. Laws, c. 228, § 1.) § 907A. Safe Arms for Babies. (a) The General Assembly finds and declares all of the following: (1) The abandonment of a baby is an irresponsible act by a parent and places the baby at risk of injury or death from exposure, actions by other individuals, and harm from animals. Page 74 Title 16 - Health and Safety (2) Delivering a live baby to a safe place is far preferable to a baby being killed or abandoned by a parent. (3) The purpose of this section is not to circumvent the responsible action of a parent who adheres to the process of placing a baby for adoption, but to prevent the unnecessary risk of harm to or death of that baby by a desperate parent who would otherwise abandon or cause the death of that baby. (4) Medical information about the baby and the baby’s parents is critical for the adoptive parents and every effort should be made, without risking the safe placement of the baby, to obtain that medical information and provide counseling information to the parents. (5) If this section does not result in the safe placement of babies or is abused by a parent attempting to circumvent the process of adoption, it should be repealed. (b) If a baby is surrendered alive and unharmed, an individual may voluntarily surrender the baby directly to an employee or volunteer of 1 of the following designated safe havens: (1) An emergency department of a hospital, inside the emergency department. (2) A police station, inside the police station. For the purposes of this paragraph (b)(2), “police station” does not include a Delaware State Police station. (c) (1) A safe haven under subsection (b) of this section may take temporary emergency protective custody of a baby who is surrendered under this section. (2) Except as otherwise required under paragraph (c)(4) of this section, a safe haven under subsection (b) of this section may not ask or require an individual who surrenders the baby to provide any information pertaining to the individual’s identity. (3) If the identity of the individual is known to the safe haven under subsection (b) of this section, the safe haven shall keep the identity confidential. (4) A safe haven under subsection (b) of this section shall do 1 of the following: a. Make reasonable efforts to directly obtain pertinent medical history information pertaining to the baby and the baby’s family. b. Attempt to provide the individual with a postage paid medical history information questionnaire. (d) A safe haven under subsection (b) of this section shall attempt to provide the following to an individual surrendering a baby at the safe haven: (1) Information about the Safe Arms Program. (2) Information about adoption and counseling services, including information that confidential adoption services are available and information about the benefits of engaging in a regular, voluntary adoption process. (3) Brochures with telephone numbers and websites for public or private agencies that provide counseling or adoption services. (e) A safe haven under subsection (b) of this section shall attempt to provide an individual surrendering a baby with the number of the baby’s identification bracelet to aid in linking the individual to the baby at a later date, if reunification is sought. The identification number is an identification aid only and does not permit the individual possessing the identification number to take custody of the baby on demand. (f) If an individual possesses an identification number linking the individual to a baby surrendered at a safe haven under subsection (b) of this section and parental rights have not already been terminated, possession of the identification number creates a presumption that the individual has standing to participate in an action. Possession of the identification number does not create a presumption of maternity, paternity, or custody. (g) (1) A safe haven under subsection (b) of this section that takes a baby into temporary emergency protective custody under this section shall immediately notify the Department and the State Police of the safe haven’s actions. (2) The Department shall obtain ex parte custody and physically appear at the safe haven under subsection (b) of this section within 4 hours of notification under this subsection unless there are exigent circumstances. (3) Immediately after being notified of the surrender, the State Police shall submit an inquiry to the Missing Children Information Clearinghouse established under subchapter III of Chapter 85 of Title 11. (h) The Department shall notify the public that a baby has been abandoned and taken into temporary emergency protective custody by placing notice prominently on the Division’s website and publishing notice to that effect in a newspaper of statewide circulation. (1) The notice must be published at least 3 times over a 3-week period immediately following the surrender of the baby unless the Department has relinquished custody. (2) The notice, at a minimum, must contain the place, date, and time where the baby was surrendered; the baby’s sex, race, approximate age, identifying marks, and any other information the Department deems necessary for the baby’s identification. (3) The notice must include a statement that unless the surrendering individual manifests an intent to exercise parental rights and responsibilities within 30 days of the abandonment, both of the following apply: a. The abandonment of the baby is the surrendering individual’s irrevocable consent to the termination of all parental rights, if any, of the individual on the ground of abandonment. b. The abandonment of the baby is the surrendering individual’s irrevocable waiver of any right to notice of or opportunity to participate in any termination of parental rights proceeding involving the baby. Page 75 Title 16 - Health and Safety (i) When an individual who surrenders a baby under this section manifests a desire to remain anonymous, the Department may not initiate or conduct an investigation to determine the identity of the individual, and a court may not order an investigation unless there is good cause to suspect child abuse or neglect other than the act of surrendering the baby. (j) The Department of Health and Social Services shall do all of the following: (1) Establish a public information program to promote safe placement alternatives for babies, the confidentiality offered to birth parents, and information regarding adoption procedures. This program must include the use of a 24-hour, toll free hotline to assist in making information about the intent, purposes, and operation of this section as widely available as possible. (2) Adopt a handout to be distributed to a safe haven under subsection (b) of this section. The handout must be furnished to an individual who surrenders the care or custody of a baby to the safe haven. The handout must advise the individual of the availability of counseling services and must elicit from the individual via a postage prepaid questionnaire relevant health history of the baby and the baby’s parents. (3) Provide a safe haven under subsection (b) of this section with information about relevant social service agencies to be made available to an individual who voluntarily surrenders a baby under this section. (73 Del. Laws, c. 187, §§ 3, 8; 70 Del. Laws, c. 186, § 1; 75 Del. Laws, c. 376, § 1; 83 Del. Laws, c. 228, § 1; 83 Del. Laws, c. 242, § 1.) § 908. Immunity from liability, and special reimbursement to safe havens for expenses related to certain babies [Effective until Jan. 8, 2023]. (a) Any person participating in good faith in the making of a report or notifying police officers pursuant to this chapter; assisting in a multidisciplinary case as required by § 906(b)(4) of this title; performing a medical examination without the consent of those responsible for the care, custody, and control of a child pursuant to § 906(e) of this title; or exercising emergency protective custody in compliance with § 907 of this title has immunity from any liability, civil or criminal, that might otherwise exist, and such immunity extends to participation in any judicial proceeding resulting from the above actions taken in good faith. This section does not limit the liability of any health-care provider for personal injury claims due to medical negligence that occurs as a result of any examination performed pursuant to this chapter. (b) (1) Except for negligence or intentional acts, a safe haven under § 907A(b) of this title that, or an employee or volunteer of the safe haven who, accepts temporary emergency protective custody of a baby under § 907A of this title is absolutely immune from civil and administrative liability for any act of commission or omission in connection with the acceptance of that temporary emergency protective custody or the provision of care for the baby while the baby is in the safe haven’s temporary emergency protective custody. (2) If a safe haven under § 907A(b) of this title accepts temporary emergency protective custody of a baby under § 907A of this title, the State shall reimburse the safe haven for eligible, medically necessary costs under the Medicaid Fee for Service Program. (16 Del. C. 1953, § 1005; 58 Del. Laws, c. 154; 60 Del. Laws, c. 494, § 1; 71 Del. Laws, c. 199, § 5; 72 Del. Laws, c. 179, § 5; 73 Del. Laws, c. 187, §§ 4, 5, 8; 75 Del. Laws, c. 376, § 1; 78 Del. Laws, c. 403, § 4; 81 Del. Laws, c. 144, § 8; 83 Del. Laws, c. 242, § 3.) § 908. Immunity from liability, and special reimbursement to safe havens for expenses related to certain babies [Effective Jan. 8, 2023]. (a) Any person, including an agency, organization, or entity, participating in good faith in the making of a report or notifying police officers pursuant to this chapter; assisting in a multidisciplinary case as required by § 906(b)(4) of this title; performing a medical examination without the consent of those responsible for the care, custody, and control of a child under § 906(e) of this title; or exercising emergency protective custody in compliance with § 907 of this title is immune from any liability, civil or criminal, that might otherwise exist, and such immunity extends to participation in any judicial proceeding resulting from the above actions taken in good faith. This section does not limit the liability of any health-care provider for personal injury claims due to medical negligence that occurs as a result of any examination performed pursuant to this chapter. (b) (1) Except for negligence or intentional acts, a safe haven under § 907A(b) of this title that, or an employee or volunteer of the safe haven who, accepts temporary emergency protective custody of a baby under § 907A of this title is absolutely immune from civil and administrative liability for any act of commission or omission in connection with the acceptance of that temporary emergency protective custody or the provision of care for the baby while the baby is in the safe haven’s temporary emergency protective custody. (2) If a safe haven under § 907A(b) of this title accepts temporary emergency protective custody of a baby under § 907A of this title, the State shall reimburse the safe haven for eligible, medically necessary costs under the Medicaid Fee for Service Program. (16 Del. C. 1953, § 1005; 58 Del. Laws, c. 154; 60 Del. Laws, c. 494, § 1; 71 Del. Laws, c. 199, § 5; 72 Del. Laws, c. 179, § 5; 73 Del. Laws, c. 187, §§ 4, 5, 8; 75 Del. Laws, c. 376, § 1; 78 Del. Laws, c. 403, § 4; 81 Del. Laws, c. 144, § 8; 83 Del. Laws, c. 242, § 3; 83 Del. Laws, c. 448, § 1.) § 909. Privileged communication not recognized; judicial proceedings; disclosure of information [Effective until Jan. 8, 2023]. (a) No legally recognized privilege, except that between attorney and client and that between priest and penitent in a sacramental confession, applies to situations involving known or suspected child abuse, neglect, exploitation, or abandonment and does not constitute Page 76 Title 16 - Health and Safety grounds for failure to report as required by § 903 of this title or to give or accept evidence in any judicial proceeding relating to child abuse or neglect. (b) In any judicial proceeding involving the custody of a child, the fact that a report has been made pursuant to § 903 or § 905 of this title is not be admissible unless offered by the Department as a party or as a friend of the court. However, this subsection does not prohibit the introduction of evidence from independent sources to support the allegations that may have caused a report to have been made. (c) To protect the privacy of the family and the child named in a report, the Department shall establish guidelines concerning the disclosure of information concerning the abuse and neglect involving a child. The Department may require persons to make written requests for access to records maintained by the Department. The Department may only release information to persons who have a legitimate public safety need for such information or a need based on the health and safety of a child subject to abuse, neglect or the risk of maltreatment, and such information may be used only for the purpose for which the information is released. (16 Del. C. 1953, § 1007; 55 Del. Laws, c. 50, § 1; 58 Del. Laws, c. 154; 60 Del. Laws, c. 494, § 1; 71 Del. Laws, c. 199, § 5; 81 Del. Laws, c. 144, § 9; 83 Del. Laws, c. 228, § 1.) § 909. Privileged communication not recognized [Effective Jan. 8, 2023]. (a) No legally recognized privilege, except that between attorney and client and that between priest and penitent in a sacramental confession, applies to situations involving known or suspected child abuse, neglect, exploitation, or abandonment and does not constitute grounds for failure to report as required by § 903 of this title or to give or accept evidence in any judicial proceeding relating to child abuse or neglect. (b), (c) [Repealed.] (16 Del. C. 1953, § 1007; 55 Del. Laws, c. 50, § 1; 58 Del. Laws, c. 154; 60 Del. Laws, c. 494, § 1; 71 Del. Laws, c. 199, § 5; 81 Del. Laws, c. 144, § 9; 83 Del. Laws, c. 228, § 1; 83 Del. Laws, c. 448, § 2.) § 910. Court orders to compel. (a) Whenever an investigation has been opened with the Department pursuant to § 906 of this title for potential abuse or neglect of a child, the Department shall have the authority to petition for an order from the Family Court: (1) To obtain access to the child, or children, and the residence of child, or children; or (2) To compel the appearance of a person at an office of the Department in furtherance of the investigation; or (3) To compel compliance with a treatment plan previously agreed to by a child’s parent or guardian, if noncompliance with the plan endangers a child’s safety; or (4) To compel completion of a substance abuse or mental health evaluation by the parent or guardian or completion of a developmental health screening for the child or children. (b) The Family Court shall issue such an order upon the Department establishing by a preponderance of evidence that it provided written notice of its intent to file the petition and: (1) For petitions requesting relief under paragraph (a)(1), (a)(2), or (a)(3) of this section: a. That the Department has in good faith attempted on at least 2 separate prior occasions, at least 1 of which was by written communication sent by certified mail, return receipt requested, to contact the person in question without success; or b. That a child is in actual danger or there is an imminent risk of danger due to the Department’s inability to communicate with the person or see the child or the child’s residence; (2) For petitions requesting relief under paragraph (a)(4) of this section, the investigation has revealed that substance abuse, mental health conditions, or developmental delays may be factors placing the child at risk of abuse or neglect. (c) The Family Court shall enforce noncompliance with such an order pursuant to § 925(3) of Title 10. (d) Petitions filed pursuant to this section may be granted on an ex parte basis if a child is at risk of imminent physical danger, provided that the Family Court shall consider all requests pursuant to paragraphs (a)(1), (a)(2) and (a)(3) of this section within 2 business days of the request being made. The Family Court shall consider all petitions filed under paragraph (a)(4) of this section within 10 business days of the filing. (e) For petitions filed under paragraph (a)(4) of this section against any parent or guardian who is indigent, that indigent parent or guardian shall have the right to request a Court-appointed attorney authorized to practice law in this State to represent the parent or guardian at no cost to that parent or guardian. (71 Del. Laws, c. 199, § 6; 72 Del. Laws, c. 173, § 6; 80 Del. Laws, c. 95, § 1; 83 Del. Laws, c. 228, § 1.) § 911. Training and information. (a) The Department shall, on a continuing basis, undertake and maintain programs to inform all persons required to report abuse or neglect pursuant to § 903 of this title and the public of the nature, problem and extent of abuse and neglect, and of the remedial and therapeutic services available to children and their families and to encourage self-reporting and the voluntary acceptance of such services. (b) The Department shall conduct ongoing training programs to advance the purpose of this section. Page 77 Title 16 - Health and Safety (c) The Department shall continuously publicize the existence of the 24-hour report-line to those required to report abuse or neglect pursuant to § 903 of this title of their responsibilities and to the public the existence of the 24-hour statewide toll-free telephone number to receive reports of abuse or neglect. (71 Del. Laws, c. 199, § 6; 83 Del. Laws, c. 228, § 1.) § 912. Confidentiality; disclosure of records [Effective Jan. 8, 2023]. (a) To protect the privacy of the family and the child named in a report, the Department shall establish guidelines concerning the disclosure of information concerning abuse, neglect, or risk of maltreatment involving a child. The Department may require a person to make a written request for access to a record that the Department maintains. The Department may release information only to a person who has a legitimate public safety need for the information or a need based on the health and safety of a child subject to abuse, neglect, or the risk of maltreatment. The information may be used only for the purpose for which the information is released. (b) A member of a multidisciplinary team may share all information and each record received, prepared, or maintained by or amongst members of the multidisciplinary team to carry out the responsibilities of the multidisciplinary team under law to protect children from abuse and neglect as authorized by the federal Child Abuse Prevention and Treatment Act (42 U.S.C. § 5106a(b)(2)). A multidisciplinary team record is confidential and may be disclosed to a person, including an entity, beyond the multidisciplinary team only as authorized by law or court rule. This chapter does not preclude a member of a multidisciplinary team from asserting a privilege available under the law related to the disclosure of information or a record. (c) (1) In a Family Court civil proceeding, excluding a juvenile delinquency proceeding, a party may access a record that a children’s advocacy center creates and maintains and is related to a forensic interview and use the record in a court proceeding, but only if the Family Court has found all of the following: a. The record is relevant under the Family Court rules governing discovery. b. Access to the record will minimize trauma to the child. c. Access to the record is in the best interest of the child. (2) a. A subpoena for a record may not be served on a children’s advocacy center. Access to a record under paragraph (c)(1) of this section must be requested by a written motion filed with the Family Court and properly served on each party to the action and the Department of Justice Special Victims Unit for the county in which the action is pending. The party filing the motion may request that the motion be considered on an expedited basis in accordance with the Court’s rules and procedures. b. The Department of Justice has standing to respond to a motion filed under this section. c. If, after review of the motion and response to the motion, if any, the Family Court finds that the party who filed the motion failed to a make a prima facie showing under paragraph (c)(1) of this section, the Court shall dismiss the motion. d. If the Family Court determines that a prima facie showing under paragraph (c)(1) of this section has been made, the Court shall order the children’s advocacy center that conducted the forensic interview to produce the record to the Court for a confidential review as the Court determines is appropriate. e. If, after a confidential review of a requested record, the Family Court finds that the motion satisfies paragraph (c)(1) of this section by a preponderance of the evidence, the Court shall permit access to the record, subject to a protective order under paragraph (c)(4) of this section. (3) This subsection does not preclude a member of a multidisciplinary team from obtaining a record under subsection (b) of this section and using the record in a Family Court civil proceeding. (4) A Family Court order entered under this subsection that permits access to a record that a children’s advocacy center creates or maintains and is related to a forensic interview the center conducts must include a protective order that does at least all of the following: a. Protects the identity of the child interviewee and any other child whose identity the Court determines should be protected. b. Protects the confidentiality of the information contained in the record. c. Limits the dissemination of the record and the information contained in the record to the person that the Family Court authorizes to receive or review the record. (83 Del. Laws, c. 448, § 3.) § 913. Child under treatment by spiritual means not neglected. No child who in good faith is under treatment solely by spiritual means through prayer in accordance with the tenets and practices of a recognized church or religious denomination by a duly accredited practitioner thereof shall for that reason alone be considered a neglected child for the purposes of this chapter. (16 Del. C. 1953, § 1006; 58 Del. Laws, c. 154; 60 Del. Laws, c. 494, § 1.) § 914. Penalty for violation. (a) Whoever violates § 903 of this title shall be liable for a civil penalty not to exceed $10,000 for the first violation, and not to exceed $50,000 for any subsequent violation. Page 78 Title 16 - Health and Safety (b) In any action brought under this section, if the court finds a violation, the court may award costs and attorneys’ fees. (16 Del. C. 1953, § 1008; 58 Del. Laws, c. 154; 60 Del. Laws, c. 494, § 1; 77 Del. Laws, c. 121, § 1; 77 Del. Laws, c. 320, § 6.) Subchapter II Child Protection Registry § 921. Child Protection Registry; purpose. The Department shall maintain a Child Protection Registry which contains information about persons who have been substantiated for abuse or neglect as provided in this subchapter or who were substantiated between August 1, 1994, and February 1, 2003. The primary purpose of the Child Protection Registry is to protect children and to ensure the safety of children in child care, health care and public educational facilities. This subchapter must be liberally construed so that these purposes may be realized. (73 Del. Laws, c. 412, § 7; 83 Del. Laws, c. 228, § 1.) § 922. Entry on the Child Protection Registry. The Child Protection Registry must indicate “substantiated for abuse” or “substantiated for neglect” and the Child Protection Level as designated in § 923 of this subchapter for any person who: (1) Based on the same incident of abuse or neglect on which the substantiation proceeding is premised, has been convicted of any criminal offense set out in § 923 of this subchapter or any offense specified in the laws of another state, the United States or any territory of the United States which is the same as or equivalent to any of the offenses set out in § 923 of this title. (2) Has been found by the Family Court, in a child welfare proceeding brought by the Department or in which the Department is a party, by a preponderance of the evidence to have abused or neglected a child. (3) Fails to make a timely written request for a hearing as provided in § 924(a)(2) of this title after being given notice by the Department of its intent to substantiate the person for abuse or neglect and enter the person on the Registry. (4) Is entered on the Registry by order of the Family Court in a proceeding on a Petition for Substantiation as described in § 925 or § 925A of this title. (5) Was substantiated for abuse or neglect between August 1, 1994, and February 1, 2003. (73 Del. Laws, c. 412, § 7; 79 Del. Laws, c. 314, § 1; 83 Del. Laws, c. 228, § 1.) § 923. Child Protection Levels. (a) A person who has been substantiated for abuse or neglect pursuant to this subchapter must be entered on the Child Protection Registry. The Department shall develop regulations that assess the risk of future harm to children from acts of abuse or neglect and designate Child Protection Levels. (b) The following paragraphs describe the 4 child protection levels: (1) Child Protection Level I. — A person who is substantiated for abuse or neglect for any of the following must be designated to Child Protection Level I: a. An incident of abuse or neglect, including emotional neglect, presenting a low risk of future harm to children; or b. Conviction of a violation of compulsory school attendance requirements or truancy when based on the same incident of abuse or neglect as alleged in the Notice of Intent to Substantiate pursuant to § 924 of this title. A person who is substantiated for abuse or neglect at Child Protection Level I must not be reported in response to a Child Protection Registry check made pursuant to Chapter 3 of Title 31 or Chapter 85 of Title 11 for that incident or conviction. The person is eligible for employment in a child-serving entity as defined in § 309 of Title 31 or health-care facility as defined in § 8563 of Title 11 . (2) Child Protection Level II. — A person who is substantiated for abuse or neglect for any of the following must be designated to Child Protection Level II: a. An incident of abuse or neglect, including severe emotional neglect, presenting a moderate risk of future harm to children; or b. Conviction of interference with custody when based on the same incident of abuse or neglect as alleged in the Notice of Intent to Substantiate pursuant to § 924 of this title. A person who is substantiated for abuse or neglect at Child Protection Level II must be reported for a period of 3 years as “substantiated for abuse” or “substantiated for neglect” in response to a Child Protection Registry check made pursuant to Chapter 85 of Title 11 or Chapter 3 of Title 31. The person must remain on the Registry for a period of 3 years, but the person is eligible for employment in a child-serving entity as defined in Chapter 3 of Title 31, or health-care facility as defined in Chapter 85 of Title 11, while the person is on the Registry at Child Protection Level II; and a prospective employer making a Child Protection Registry check must be so informed. If the person is not substantiated for abuse or neglect while on the Registry, the person on the Registry at Child Protection Level II is automatically removed from the Registry after 3 years and must not be reported in a Child Protection Registry check for that incident or conviction. Page 79 Title 16 - Health and Safety (3) Child Protection Level III. — A person who is substantiated for abuse or neglect for any of the following must be designated to Child Protection Level III: a. An incident of abuse or neglect presenting a high risk of future harm to children, including but not limited to: physical injury, nonorganic failure to thrive, malnutrition, or abandonment of a child 13 to 17 years of age; or b. Conviction of any of the following crimes when based on the same incident of abuse or neglect as alleged in the Notice of Intent to Substantiate pursuant to § 924 of this title: offensive touching, menacing, reckless endangering in the second degree, assault in the third degree, child abuse in the third degree, terroristic threatening, unlawful administration of drugs or controlled substances, indecent exposure in the first or second degree, sexual harassment, unlawful imprisonment in the second degree, abandonment of a child, or misdemeanor endangering the welfare of a child. A person who is substantiated for abuse or neglect at Child Protection Level III must be reported for a period of 7 years as “substantiated for abuse” or “substantiated for neglect” in response to a Child Protection Registry check made pursuant to Chapter 85 of Title 11 or Chapter 3 of Title 31. The person is ineligible for employment in a child-serving entity as defined in Chapter 3 of Title 31, or health-care facility as defined in Chapter 85 of Title 11, while the person is on the Child Protection Registry at Child Protection Level III. If the person is not substantiated for a different incident of abuse or neglect while on the Registry, the person entered on the Registry at Child Protection Level III is automatically removed from the Registry after 7 years and is, thereafter, eligible for employment in a child care facility, health-care facility or public school, and must not be reported in a Child Protection Registry check for that incident or conviction. (4) Child Protection Level IV. — A person who is substantiated for abuse or neglect for any of the following must be designated to Child Protection Level IV: a. An incident of abuse or neglect presenting the highest risk of future harm to children, including but not limited to serious physical injury, sexual abuse, torture, criminally negligent treatment, or abandonment of a child 12 years of age or younger (but not including the voluntary surrender of a baby pursuant to the Safe Arms for Babies program as provided in § 907A of this title); or b. Conviction of any of the following crimes when based on the same incident of abuse or neglect as alleged in the Notice of Intent to Substantiate pursuant to § 924 of this title: vehicular assault, vehicular homicide, criminally negligent homicide, assault in the first degree, assault in the second degree, reckless endangering in the first degree, unlawful imprisonment in the first degree, child abuse in the first degree, child abuse in the second degree, murder, manslaughter, murder by abuse or neglect, incest, rape, unlawful sexual contact, sexual extortion, sexual solicitation of a child, felony sex offender unlawful sexual conduct against a child, felony sexual abuse of a child by a person in a position of trust, authority or supervision in the first degree or second degree, trafficking of persons and involuntary servitude, bestiality, continuous sexual abuse of a child, possession of child pornography, unlawfully dealing in child pornography, felony endangering the welfare of a child, dangerous crime against a child, kidnapping, coercion, dealing in children, unlawful dealing with a child, sexual exploitation of a child, or promoting suicide. A person who is substantiated for abuse or neglect at Child Protection Level IV must be reported as “substantiated for abuse” or “substantiated for neglect” in response to a Child Protection Registry check made pursuant to Chapter 85 of Title 11 or Chapter 3 of Title 31. The person is ineligible for employment in a child-serving entity as defined in Chapter 3 of Title 31 or health-care facility as defined in Chapter 85 of Title 11. In addition, the person may not be removed from the Registry and must be reported in a Registry check for the incident or conviction, except as provided in § 929(c) of this title. (c) A person who is substantiated for an incident of abuse or neglect while on the Child Protection Registry is ineligible for automatic removal from the Registry, but may be removed from the Registry by order of the Family Court as provided in § 929 of this title. If a person is substantiated for abuse or neglect while on the Registry, the imposed conditions for each incident must be completed consecutively, with the conditions for the most restrictive Child Protection Level or Levels being completed before those for the less restrictive level or levels. A person who has partially completed a level when assigned to a more restrictive level is given credit for that partial completion when that person has completed the conditions for the more restrictive level or levels. (73 Del. Laws, c. 412, § 7; 70 Del. Laws, c. 186, § 1; 79 Del. Laws, c. 314, § 1; 80 Del. Laws, c. 154, § 3; 83 Del. Laws, c. 228, § 1.) § 924. Notice of Intent to Substantiate; process. (a) In response to a report where abuse or neglect of a child is alleged, as required by § 906 of this title, the Department’s Division of Family Services shall conduct an investigation into the facts and circumstances of the alleged abuse or neglect, and the Department’s Institutional Abuse Investigation Unit shall conduct an investigation of an allegation of institutional abuse or neglect of a child. (1) If the Department determines from its investigation not to substantiate the person for abuse or neglect, the person may not be entered on the Child Protection Registry for that reported incident. The Department shall indicate in its internal information system that the incident is unsubstantiated, and so notify the person in writing. The Department shall develop regulations for classifying unsubstantiated cases in its internal information system. (2) If the Department determines from its investigation that it intends to substantiate the person for abuse or neglect and enter an adult person on the Child Protection Registry, it shall give written notice to the person by certified mail, return receipt requested, at that person’s last known address. The written notice must: Page 80 Title 16 - Health and Safety a. Briefly describe the alleged incident of abuse or neglect. b. Advise the person that the Department intends to substantiate the allegations and enter the person on the Child Protection Registry for the incident of abuse or neglect at a designated Child Protection Level. c. State the consequences of being entered on the Registry at the designated level, including whether the person will be reported as substantiated for abuse or neglect in response to a Child Protection Registry check made pursuant to Chapter 85 of Title 11 or Chapter 3 of Title 31. d. Inform the person of that person’s own right to request a hearing in the Family Court before the person is entered on the Child Protection Registry. e. Further advise that the person will be entered on the Registry for the incident at the designated Child Protection Level unless, within 30 days of the date of mailing of the notice, the person responds to the Department in writing, requesting a hearing in the Family Court on the Department’s intent to substantiate the person for abuse or neglect and enter the person on the Registry. f. Contain a written form for the person to return to the Department to request a hearing. (3) If the Department determines from its investigation that it intends to substantiate a child and enter the child on the Child Protection Registry, it shall give written notice to the child and the child’s parent, guardian, and legal custodian by certified mail, return receipt requested, at the child’s last known address. The written notice must: a. Briefly describe the alleged incident of abuse or neglect. b. Advise the child that the Department intends to substantiate the allegations and enter the child on the Child Protection Registry for the incident of abuse or neglect at a designated Child Protection Level. c. State the consequences of being entered on the Registry at the designated level, including whether the child will be reported as substantiated for abuse or neglect in response to a Child Protection Registry check made pursuant to Chapter 85 of Title 11 or Chapter 3 of Title 31. d. Inform the child that a hearing will be held in the Family Court before the child is entered on the Child Protection Registry. e. Provide notice to the child’s guardian ad litem or attorney if the child is in DSCYF custody. (4) If the Department determines from its investigation that it intends to enter a person on the Child Protection Registry as a result of a conviction of an enumerated offense set forth in § 923 of this title, the Department shall send a Notice of Substantiation to the person informing them of the substantiation and notifying them of the right to file a Petition for Limited Purpose Hearing. The Petition for Limited Purpose Hearing shall be filed by the person in Family Court within 30 days of the Notice of Substantiation, shall include a copy of the Notice of Substantiation, and shall set forth why the person alleges the conviction does not meet the requirements set forth in § 922(1) of this title. A Limited Purpose Hearing shall be limited to determining whether the conviction meets the requirements of § 922(1) of this title. If a Petition for Limited Purpose Hearing is not filed within 30 days of the Notice of Substantiation, the person shall remain automatically placed on the registry pursuant to § 922(1) of this title. (b) A person, other than a child, who fails to request a hearing as provided in subsection (a) of this section must, at the expiration of 30 days from the date of mailing of the notice of intent to substantiate the allegations of abuse or neglect and enter the person on the Registry, be entered on the Child Protection Registry at the Child Protection Level designated in the notice. (c) The Department shall file a Petition for Substantiation before any child is entered on the Child Protection Registry, regardless of the written request of the child. (73 Del. Laws, c. 412, § 7; 70 Del. Laws, c. 186, § 1; 79 Del. Laws, c. 314, § 1; 80 Del. Laws, c. 154, § 3; 83 Del. Laws, c. 228, § 1.) § 925. Petition for substantiation. (a) If a person responds to the Department and requests a hearing in the Family Court before being entered on the Registry, as provided in § 924 of this title, the Department shall, unless the automatic stay provisions of § 927 of this title apply, file in the Family Court no later than 45 days after receipt of the written request, or in the case of a child, no later than 45 days after the notice of intent to substantiate was sent to the child, a petition for substantiation which requests that the Court substantiate the abuse or neglect and enter the person on the Child Protection Registry at a Child Protection Level designated by the Court. (b) The petition for substantiation must be filed in the county in which the alleged incident leading to the petition occurred. (c) The Family Court may, upon motion by the Department or sua sponte, enter an order that places the person on the Registry at a designated Child Protection Level pending a final order on the petition for substantiation. (d) The Family Court shall appoint counsel for any unrepresented child against whom a petition for substantiation has been filed. (73 Del. Laws, c. 412, § 7; 79 Del. Laws, c. 314, § 1; 83 Del. Laws, c. 228, § 1.) § 925A. Grounds for substantiation. (a) Unless otherwise provided in this subchapter, no person shall be placed on the registry unless the Court finds by a preponderance of the evidence after a hearing on the merits, or accepts the agreement of the parties, that: Page 81 Title 16 - Health and Safety (1) The person committed an act of abuse or neglect; and (2) The act of abuse or neglect was based on the same incident as alleged in the Notice of Intent to Substantiate. (b) Should the elements of subsection (a) of this section be met, the Court shall also determine by a preponderance of the evidence after a hearing on the merits or accept the agreement of the parties, the risk of future harm the person poses to children and designate the person to the appropriate Child Protection Level set forth in § 923 of this title. If the person is convicted of an enumerated crime when based on the same incident of abuse or neglect as alleged in the Notice of Intent to Substantiate, the person is automatically entered on the Child Protection Registry at the level designated by § 923 of this title. (c) An order of substantiation may not be stayed pending appeal. (d) If the Family Court finds that the person has not committed an act of abuse or neglect based on the same incident as alleged in the Notice of Intent to Substantiate, the person may not be entered on the Registry for that incident, and the Department shall indicate in its internal information system that the incident is unsubstantiated. (e) If a child welfare proceeding is pending in which the Department has requested a finding of abuse or neglect against a party and entry on the Registry for the same incident, the Family Court shall decide the issues of substantiation and entry on the Registry as provided in § 926 of this title without the necessity of a response to the notice of intent to substantiate or a separate Petition for Substantiation. (f) If the Department fails to file a Petition for Substantiation within 45 days of receipt of a person’s written request for a hearing as provided in § 924 of this title and a child welfare proceeding based on the same incident of abuse or neglect is not pending, the person may not be entered on the Child Protection Registry for the incident of abuse or neglect indicated in the notice of intent to substantiate. (79 Del. Laws, c. 314, § 1; 83 Del. Laws, c. 228, § 1.) § 926. Finding of abuse or neglect in child welfare proceeding; binding effect. In every child welfare proceeding brought by the Department or in which the Department is a party and in which the Department has requested a finding of abuse or neglect and entry on the Registry, the Family Court shall make findings pursuant to § 925A of this title. The findings of the Family Court are final and binding, and work as issue or claim preclusion for the same incident of abuse or neglect in substantiation proceedings. (73 Del. Laws, c. 412, § 7; 79 Del. Laws, c. 314, § 1; 83 Del. Laws, c. 228, § 1.) § 927. Automatic stay of substantiation proceedings. (a) Proceedings under §§ 925 and 925A of this title, including the duty to file a Petition for Substantiation, are automatically stayed in any matter in which a criminal or delinquency proceeding involving the same incident of abuse or neglect is pending. The time to file a Petition for Substantiation under § 925 of this title shall begin upon conclusion of the criminal or delinquency proceeding. (b) Conviction of a crime involving the same incident of abuse or neglect is final, binding and determinative of the issue of abuse or neglect and of the person’s entry on the Registry at the Child Protection Level designated for such offense. (c) Upon conclusion of a criminal or delinquency proceeding involving the same allegations or facts as those alleged in the incident of abuse or neglect, if the accused is acquitted of the charge or the charge is dismissed and the Department intends to pursue substantiation, the acquittal or dismissal does not automatically work as issue or claim preclusion against a civil finding of abuse or neglect, nor does it prevent the taking of evidence, notwithstanding any other law to the contrary. (73 Del. Laws, c. 412, § 7; 79 Del. Laws, c. 314, § 1; 83 Del. Laws, c. 228, § 1.) § 928. Persons entered on the Registry between August 1, 1994, and February 1, 2003. (a) The Department shall review each case substantiated for abuse or neglect that was placed on the Central Registry (also known as the Central Child Abuse Registry, the Child Abuse Registry and the Central Abuse Registry) between August 1, 1994, and February 1, 2003, and designate each case to a Child Protection Level in accordance with the regulations developed pursuant to § 923 of this title. (b) A person who has been entered on the Child Protection Registry for the time prescribed in the designated Child Protection Level for the person’s incident of abuse or neglect must be automatically removed from the Child Protection Registry, provided that the person has not been substantiated for an incident of abuse or neglect while on the Child Protection Registry. The Department shall notify the person of the removal. (c) The Department shall notify a person who does not qualify for automatic removal from the Child Protection Registry of the Child Protection Level to which the person has been designated and of the consequences of designation to that level, including whether the person will be reported as substantiated for abuse or neglect in a Child Protection Registry check pursuant to Chapter 85 of Title 11 or Chapter 3 of Title 31. (73 Del. Laws, c. 412, § 7; 79 Del. Laws, c. 314, § 1; 80 Del. Laws, c. 154, § 3; 83 Del. Laws, c. 228, § 1.) § 929. Removal of name from the Child Protection Registry. (a) A person who has been entered on the Child Protection Registry at Child Protection Level II or Level III will be automatically removed from the Registry under § 923 of this title, provided that the person has not been substantiated for an incident of abuse or neglect while on the Registry. Page 82 Title 16 - Health and Safety (b) A person who has been entered on the Child Protection Registry at Child Protection Level II or Level III may file a Petition for Removal in the Family Court prior to the expiration of the time designated for the level. The Family Court shall have the discretion to remove the person from the registry. In making this determination, the Court shall consider all relevant factors, including: (1) The nature and circumstances of the original substantiated incident; (2) Any substantiated incidents of abuse or neglect while on the Registry; (3) The criminal history of the person, including whether the person’s criminal record of arrest or conviction of the incident leading to placement on the Registry was expunged; (4) Compliance with the terms of probation, if applicable; (5) The risk, if any, the registrant poses to the victim, the community and to other potential victims; (6) The impact of registration and employer notification on the victim, community and other potential victims; (7) The rehabilitation, if any, of the person, or successful completion of a program of evaluation and treatment including any courtordered or division-recommended case plan; and (8) The adverse impact of registration on the person and the rehabilitative process, including the impact on employment opportunities. (c) A person who was entered on the Child Protection Registry at any level as a child, may, at any time after his or her eighteenth birthday, file a Petition for Removal in the Family Court. The Family Court shall have the discretion to remove the person from the registry. In making this determination, the Court shall consider all relevant factors, including those in § 929(b) of this title. (d) A Petition for Removal from the Registry must be filed in the Family Court in the county in which the substantiation occurred. A copy of the petition must be served on the Department, which may file an objection or answer to the petition within 30 days after being served. In every case, the Department shall inform the Court whether or not the person applying for removal has been substantiated for abuse or neglect while on the Child Protection Registry. The Family Court may, in its discretion, dispose of a Petition for Removal without a hearing. (e) Removal from the Child Protection Registry means only that the person’s name has been removed from the Registry and may no longer be reported to employers pursuant to Chapter 85 of Title 11 or Chapter 3 of Title 31. Notwithstanding removal from the Registry, the person’s name and other case information remains in the Department’s internal information system as substantiated for all other purposes, including the Department’s use of the information for historical, treatment, and investigative purposes, foster and adoptive parent decisions, reporting to law-enforcement authorities, the Department of Education Office of Child Care Licensing’s use for childcare licensing decisions, or any other purpose set forth in § 906(e) of this title. (73 Del. Laws, c. 412, § 7; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 403, § 4; 79 Del. Laws, c. 314, § 1; 80 Del. Laws, c. 154, § 3; 83 Del. Laws, c. 228, § 1; 83 Del. Laws, c. 280, § 7.) Subchapter III Child Protection Accountability Commission § 931. The Child Protection Accountability Commission. (a) The Delaware Child Protection Accountability Commission is hereby established. The Commission shall consist of 24 members with the at-large members and the Chair appointed by the Governor. Members of the Commission serving by virtue of position may appoint a designee to serve in their stead. The Commission shall be comprised of the following: (1) The Secretary of the Department of Services for Children, Youth and Their Families. (2) The Director of the Division of Family Services. (3) Two representatives from the Attorney’s General Office, appointed by the Attorney General. (4) Two members of the Family Court, appointed by the Chief Judge of the Family Court. (5) One member of the House of Representatives, appointed by the Speaker of the House. (6) One member of the Senate, appointed by the President Pro Tempore of the Senate. (7) The Secretary of the Department of Education. (8) The Director of the Division of Prevention and Behavioral Health Services. (9) The Chair of the Domestic Violence Coordinating Council. (10) The Superintendent of the Delaware State Police. (11) The Chair of the Maternal and Child Death Review Commission. (12) The Investigation Coordinator, as defined in § 902 of this title. (13) One youth or young adult who has experienced foster care in Delaware, appointed by the Secretary of the Department. (14) One representative from the Office of Defense Services, appointed by the Chief Defender. (15) Eight at-large members appointed by the Governor with 1 person from the medical community, 1 person from the Interagency Committee on Adoption who works with youth engaged in the foster care system, 1 person from a law-enforcement agency other than Page 83 Title 16 - Health and Safety the State Police, and 5 persons from the child protection community. The law-enforcement representative may designate a proxy as needed. (b) The Commission is designated as a “citizen review panel” as required under the federal Child Abuse Prevention and Treatment Act, 42 U.S.C. § 5106a(c) and the “state task force” as required under the federal Children’s Justice Act, 42 U.S.C. § 5106c(c). The Commission may delegate tasks to its committees, workgroups, and panels as necessary to accomplish its duties. The Commission’s purpose is to monitor Delaware’s child protection system to best ensure the health, safety, and well-being of Delaware’s abused, neglected, and dependent children. To that end, the Commission shall meet on a quarterly basis and shall: (1) Examine and evaluate the policies, procedures, and effectiveness of the child protection system and make recommendations for changes therein, focusing specifically on the respective roles in the child protection system of the Division of Family Services, the Division of Prevention and Behavioral Health Services, the Office of the Attorney General, the Family Court, the medical community, and law-enforcement agencies. (2) Recommend changes in the policies and procedures for investigating and overseeing the welfare of abused, neglected, and dependent children. (3) Advocate for legislation and make legislative recommendations to the Governor and General Assembly. (4) Access, develop, and provide quality training to the Division of Family Services, Deputy Attorneys General, Family Court, lawenforcement officers, the medical community, educators, day-care providers, and others on child protection issues. (5) Review and make recommendations concerning the well-being of Delaware’s abused, neglected, and dependent children including issues relating to foster care, adoption, mental health services, victim services, education, rehabilitation, substance abuse, and independent living. (6) Provide the following reports to the Governor: a. An annual summary of the Commission’s work and recommendations, including work of the Office of the Child Advocate, with copies thereof sent to the General Assembly. b. A quarterly written report of the Commission’s activities and findings, in the form of minutes, made available also to the General Assembly and the public. (7) Investigate and review deaths or near deaths of abused or neglected children solely for the purposes provided in § 932 of this title. (8) Coordinate with the Maternal and Child Death Review Commission to provide statistics and other necessary information to the Maternal and Child Death Review Commission related to the Commission’s investigation and review of deaths of abused or neglected children. (9) Meet annually with the Maternal and Child Death Review Commission to jointly discuss any findings or recommendations released to the public from reviews conducted under § 932 of this title. This meeting shall be open to the public. (10) Administer the Ivyane D.F. Davis Scholarship Fund as required by § 3463 of Title 14 and the federal Chafee Educational and Training Vouchers as requested by the Department of Services for Children, Youth and Their Families. (11) Adopt rules or regulations for the administration of its duties or this subchapter, as it deems necessary. (c) The Child Advocate shall serve as the Executive Director of the Commission, and the Office of the Child Advocate shall provide staff support to the Commission. The Office of the Child Advocate shall assist the Commission in investigating and reviewing the deaths or near deaths of abused or neglected children under § 932 of this title and in administering scholarship funds, in addition to performing any other duties assigned by the Commission. The Child Advocate shall hire employees or contract for services as necessary to assist the Commission in performing its duties under this subchapter, within the limitations of funds appropriated by the General Assembly or obtained from other sources. (71 Del. Laws, c. 199, § 6; 70 Del. Laws, c. 186, § 1; 73 Del. Laws, c. 116, §§ 1-3, 5[4]; 76 Del. Laws, c. 97; 77 Del. Laws, c. 327, § 210(a); 77 Del. Laws, c. 383, §§ 1-3; 79 Del. Laws, c. 322, § 1; 80 Del. Laws, c. 26, § 5; 80 Del. Laws, c. 187, § 8; 81 Del. Laws, c. 143, § 1; 81 Del. Laws, c. 280, § 55; 83 Del. Laws, c. 364, § 2; 83 Del. Laws, c. 413, § 6.) § 932. Investigation and review of the death or near death of an abused or neglected child. (a) The Attorney General, the Department of Services for Children, Youth and Their Families, and any other state or local agency with responsibility for investigating child deaths shall report to the Commission any death or near death of a child who is determined to have been abused or neglected within 14 days of that determination. (b) The Commission Chair shall appoint a committee to review all investigations under this section and a panel to conduct the investigations under this section. The members of such committee and panel, together with any staff, contractors, or volunteers designated to assist the committee and panel are considered agents of the Commission under § 935 of this title. (c) Within 6 months of any report to the Commission under subsection (a) of this section, the Commission shall conclude an investigation and review of the facts and circumstances of the death or near death incident through the committee and panel appointed under subsection (b) of this section. For good cause shown to the Commission, the 6-month period for the completion of an investigation and review under this subsection may be extended to 9 months. If the need for an extension under this subsection is attributable to an ongoing criminal prosecution, an initial review must occur, but a final review of the case may be deferred for a period of up to 6 months following the Page 84 Title 16 - Health and Safety completion of the prosecution. In cases in which the time for the Commission’s complete investigation and review is extended under this subsection, the Commission may issue initial findings or recommendations if it determines that such are necessary under the circumstances. (d) No person identified by the Attorney General’s office as a potential witness in any criminal prosecution arising from the death or near death of an abused or neglected child shall be questioned, deposed, or interviewed by or for the Commission in connection with its investigation and review of such death or near death until the completion of the prosecution. (e) Notwithstanding any requirement of § 931(b) of this title to the contrary, the Commission shall, if necessary, make system-wide findings or recommendations arising from an investigation and review conducted under this section. (1) The Commission shall provide its findings or recommendations, if any, to the Governor, the General Assembly, and the public within 20 days of the approval of the findings or recommendations made under this section. (2) All summary information, findings, or recommendations released by the Commission under this subsection shall comply with applicable state and federal confidentiality provisions, including those set forth in § 934 of this title and § 9017(e) of Title 29. (3) Notwithstanding any provision of this subchapter to the contrary, no summary information, finding, or recommendation released by the Commission under this subsection shall specifically identify any individual or nongovernmental agency, organization, or entity. (4) In addition to the Commission’s release of findings or recommendations, the Commission may release to the public summary information and findings resulting from reviews of child deaths and near deaths due to abuse and neglect. The Commission may release summary information only upon completion of the prosecution and only if such release complies with paragraph (e)(2) of this section. Such release to the public of summary information does not supplant the obligation of the State to comply with any request for public disclosure of information on child deaths and near deaths due to abuse or neglect made under 42 U.S.C. § 5106a(b). (f) Notwithstanding this section or § 931(b)(7) of this title, the Maternal and Child Death Review Commission may review deaths of abused or neglected children, for good cause shown, as determined by the agreement of the Commission and the Maternal and Child Death Review Commission. (g) For purposes of this subsection, “completion of the prosecution” means the decision to file no information or seek no indictment, conviction or adjudication, acquittal, dismissal of an information or indictment by a court, the conditional dismissal under a program established by Delaware law or a court, or the nolle prosequi of an information or indictment by the Attorney General. (80 Del. Laws, c. 187, § 9; 81 Del. Laws, c. 143, § 2; 83 Del. Laws, c. 364, § 2.) § 933. Power and authority of investigations and reviews. (a) In connection with any investigation and review conducted under § 931(b)(7) of this title, the Commission, by and through its staff, committee, and panel, has power and authority to do all of the following: (1) Administer oaths and affirmations to any person related to the death or near death under review. (2) Issue subpoenas to compel the attendance of witnesses whose testimony is related to the death or near death under review. (3) Issue subpoenas to compel the production of records related to the death or near death under review. (b) The Commission may delegate its power and authority in subsection (a) of this section to the Child Advocate, who may further delegate the power and authority to any attorney employed by, contracting with, or volunteering for the Office of the Child Advocate. (c) A subpoena issued under subsection (a) of this section may be enforced or challenged only in the Family Court. (1) All proceedings before the Family Court and all records of such proceedings conducted under this subsection are private. (2) In a proceeding under this subsection (c), the Family Court may impose reasonable restrictions, conditions, or limitations on the access to proceedings and records of proceedings to preserve the confidentiality set forth in § 934 of this title. (80 Del. Laws, c. 187, § 9; 81 Del. Laws, c. 143, § 3.) § 934. Confidentiality of records related to investigations and reviews. (a) The records of the Commission, committee, panel, and its staff, contractors and volunteers, including original documents and documents produced in the investigation and review process with regard to the facts and circumstances of each death or near death, are confidential and may not be released to any person except as expressly provided by this subchapter. Such records may be used by the Commission, committee, panel, and its staff, contractors and volunteers only in the exercise of the proper functions of the Commission and its staff. Such records, together with the summary information, findings, and recommendations therefrom are not public records, are not available for Court subpoena or subject to discovery, are not admissible into evidence or otherwise in any civil, criminal, administrative, or judicial proceeding, and are not considered binding under claim or issue preclusion doctrines. Except where constitutional provisions require otherwise, statements, records, or information are not subject to any statute or rule that would require those statements, records, or information to be disclosed in the course of a civil, criminal, or administrative trial, or associated discovery. Aggregate statistical data compiled by the Commission or its staff, however, may be released at the discretion of the Commission or its staff. (b) No person in attendance at a meeting of the Commission, or any of its committees or panels, is required to testify as to what transpired at such meeting in any forum including any civil, criminal, administrative, or judicial proceeding. (80 Del. Laws, c. 187, § 9; 81 Del. Laws, c. 143, § 4.) Page 85 Title 16 - Health and Safety § 935. Immunity from suit related to investigations and reviews. (a) Members of the Commission and their agents or employees, including committee and panel members, contractors, and volunteers are not subject to, and are immune from, claims, suits, liability, damages, or any other recourse, civil or criminal, arising from or relating to any act, omission, proceeding, decision, determination, finding, or recommendation made in the performance of their duties under §§ 932 and 933 of this title. For the immunity provided by this subsection to apply, the members of the Commission or their agents or employees must have acted in good faith and without malice in carrying out the responsibilities, authority, duties, powers, and privileges of the offices conferred upon them by this subchapter or by any other provisions of the Delaware law, federal law or regulations, or duly adopted rules and regulations of the Commission. Complainants shall bear the burden of proving malice or a lack of good faith to defeat the immunity provided by this subsection. (b) No organization, institution, or person furnishing information, data, reports, or records to the Commission or its staff with respect to any subject examined or treated by such organization, institution, or person, by reason of furnishing such information, shall be liable in damages to any person or subject to any other recourse, civil or criminal. (80 Del. Laws, c. 187, § 9; 81 Del. Laws, c. 143, § 5.) Page 86 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 9A [Omitted.] (81 Del. Laws, c. 257, § 1.) Page 87 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 9B Infants with Prenatal Substance Exposure. (81 Del. Laws, c. 257, § 1.) § 901B. Purpose. The child welfare policy of this State shall serve to advance the best interests and secure the safety and well-being of an infant with prenatal substance exposure, while preserving the family unit whenever the safety of the infant is not jeopardized. To further this policy, this chapter: (1) Requires that notifications of infants with prenatal substance exposure be made to the Division by the health-care provider involved in the delivery or care of the infant. (2) Requires a coordinated, service-integrated response by various agencies in this State’s health and child welfare systems to work together to ensure the safety and well-being of infants with prenatal substance exposure by developing, implementing, and monitoring a Plan of Safe Care that addresses the health and substance use treatment needs of the infant and affected family or caregiver. (81 Del. Laws, c. 257, § 1.) § 902B. Definitions. As used in this chapter: (1) “Division” is as defined in § 902 of this title. (2) “Family assessment and services” is as defined in § 902 of this title. (3) “Health-care provider” is as defined in § 714 of this title. (4) “Infant with prenatal substance exposure” means a child not more than 1 year of age who is born with and identified as being affected by substance abuse or withdrawal symptoms or a fetal alcohol spectrum disorder. The health-care provider involved in the delivery or care of the infant shall determine whether the infant is affected by the substance exposure. (5) “Internal information system” is as defined in § 902 of this title. (6) “Investigation Coordinator” is as defined in § 902 of this title. (7) “Plan of Safe Care” or “Plan” means a written or electronic plan to ensure the safety and well-being of an infant with prenatal substance exposure following the release from the care of a health-care provider by addressing the health and substance use treatment needs of the infant and affected family or caregiver, and monitoring these plans to ensure appropriate referrals are made and services are delivered to the infant and affected family or caregiver. The monitoring of these plans may be time limited based upon the circumstances of each case. (8) “Substance abuse” means the chronic, habitual, regular, or recurrent use of alcohol, inhalants, or controlled substances as identified in Chapter 47 of this title. (9) “Withdrawal symptoms” means a group of behavioral and physiological features in the infant that follow the abrupt discontinuation of a drug that has the capability of producing physical dependence. Withdrawal symptoms resulting exclusively from a prescription drug used by the mother or administered to the infant under the care of a prescribing medical professional, in compliance with the directions for the administration of the prescription as directed by the prescribing medical professional, its compliance and administration verified by the health-care provider involved in the delivery or care of the infant, and no other risk factors to the infant are present, is not included in the definition and does not warrant a notification to the Division under § 903B of this title. (81 Del. Laws, c. 257, § 1.) § 903B. Notification to Division; immunity from liability. (a) The health-care provider who is involved in the delivery or care of an infant with prenatal substance exposure shall make a notification to the Division by contacting the Division report line as identified in § 905 of this title. (b) When 2 or more persons who are required to make a notification have joint knowledge of an infant with prenatal substance exposure, the telephone notification may be made by 1 person with joint knowledge who was selected by mutual agreement of those persons involved. The notification must include all persons with joint knowledge of an infant with prenatal substance exposure at the time the notification is made. Any person who has knowledge that the individual who was originally designated to make the notification has failed to do so, shall immediately make a notification. (c) A notification made under this section is not to be construed to constitute a report of child abuse or neglect under § 903 of this title, unless risk factors are present that would jeopardize the safety and well-being of the infant. (d) The immunity provisions under § 908 of this title will also apply to this chapter. (81 Del. Laws, c. 257, § 1.) Page 88 Title 16 - Health and Safety § 904B. Notification information. (a) Upon receipt of a notification of an infant with prenatal substance exposure, the Division shall enter it into the Division’s internal information system. (b) Upon receipt of a notification of an infant with prenatal substance exposure, the Division shall notify the office of the Investigation Coordinator of the notification in sufficient detail to permit the Investigation Coordinator to undertake its duties as specified in § 906 of this title. (81 Del. Laws, c. 257, § 1.) § 905B. State response to notifications of infants with prenatal substance exposure. (a) In implementing the Division’s role in protecting the safety and well-being of infants with prenatal substance exposure, upon receipt of a notification under § 903B of this title, the Division shall do all of the following: (1) Determine if the case requires an investigation or family assessment. (2) Develop a Plan of Safe Care. (3) Provide copies of the Plan of Safe Care to all agencies and providers involved in the care or treatment of the infant with prenatal substance exposure and affected family or caregiver. (4) Implement and monitor the provisions of the Plan of Safe Care. (b) For any case accepted by the Division for investigation or family assessment, the Division may contract for services to comply with §§ 906 and 905B of this title. (c) For cases that are not accepted by the Division for investigation or family assessment, or those cases accepted for family assessment where the report does not involve a multidisciplinary case under § 906(e)(3) of this title, but that still meet the definition of an infant with prenatal substance exposure, the Division shall contract for services to do any of the following: (1) Protect the safety and well-being of the infant with prenatal substance exposure following release from the care of health-care providers while preserving the family unit whenever the safety of the infant is not jeopardized. (2) Develop a Plan of Safe Care. (3) Provide copies of the Plan of Safe Care to all agencies and providers involved in the care or treatment of the infant with prenatal substance exposure and affected family or caregiver. (4) Implement and monitor the provisions of the Plan of Safe Care. (5) Provide a final report to the Division to assist the Division in complying with § 906B of this title. (d) For any case referred for contracted services under this chapter, the contractor shall immediately notify the Division if it determines that an investigation is required or is otherwise appropriate under § 906 of this title. The contracted staff who have conducted the assessment may remain involved in the provision of services to the child and family as appropriate. (e) In implementing the Investigation Coordinator’s role in ensuring the safety and well-being of infants with prenatal substance exposure, the Investigation Coordinator, or the Investigation Coordinator’s staff, shall have electronic access and the authority to track within the Department’s internal information system each notification of an infant with prenatal substance exposure. (81 Del. Laws, c. 257, § 1.) § 906B. Data and reports. (a) The Division shall document all of the following information in its internal information system for all notifications of infants with prenatal substance exposure under this chapter: (1) The number of infants identified as being affected by substance abuse, withdrawal symptoms, or fetal alcohol spectrum disorder. (2) The number of infants for whom a Plan of Safe Care was developed, implemented and monitored. (3) The number of infants for whom referrals were made for appropriate services, including services for the affected family or caregiver. (4) The implementation of such Plans to determine whether and in what manner local entities are providing, in accordance with state requirements, referrals to and delivery of appropriate services for the infant and affected family or caregiver. (b) The Department of Health and Social Services, the Investigation Coordinator and health-care providers shall assist the Division in complying with this section. (c) In addition to any required federal reporting requirements, the Division, with assistance from the Department of Health and Social Services and the Investigation Coordinator, shall provide an annual report to the Child Protection Accountability Commission and Maternal and Child Death Review Commission summarizing the aggregate data gathered on infants with prenatal substance exposure. (d) To protect the privacy of the affected family or caregivers, including the infant named in a report, this chapter is subject to the privacy and confidentiality provisions in §§ 906 and 909 of this title. (81 Del. Laws, c. 257, § 1; 83 Del. Laws, c. 364, § 2.) Page 89 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 10 Hospitals § 1001. “Hospital” defined [For application of this section, see 83 Del. Laws, c. 102, § 2]. (a) As used in this chapter, “hospital” means a health-care organization that has a governing body, an organized medical and professional staff, and inpatient facilities, and provides either medical diagnosis, treatment and care, nursing and related services for ill and injured patients, or rehabilitation services for the rehabilitation of ill, injured or disabled patients 24 hours per day, 7 days per week and primarily engaged in providing inpatient services. (b) Hospitals may be further classified as: (1) General. — Providing diverse patient services, diagnostic and therapeutic, for a variety of medical conditions. A general hospital must provide on-site: a. Diagnostic x-ray services with facilities and staff for a variety of procedures. b. Clinical laboratory services with facilities and with anatomical pathology services regularly and conveniently available available. c. Operating room service with facilities and staff. d. Emergency department with facilities and staff. (2) Long-term care. — Providing inpatient services for patients whose medically-complex conditions require a long hospital stay with an average length of stay of greater than 25 days. (3) Psychiatric. — Providing services for the diagnosis and treatment of patients with psychiatric-related illness. (4) Rehabilitation. — Providing intensive inpatient rehabilitative services for 1 or more conditions requiring rehabilitation. (5) Surgical. — Providing inpatient and outpatient surgical and related services in which the anticipated duration of the patient’s stay will not exceed 72 hours following admission. A surgical hospital must provide all of the following services on-site: a. Diagnostic x-ray services with facilities and staff for a variety of procedures. b. Clinical laboratory services with facilities and anatomical pathology services regularly and conveniently available. c. Operating room service with facilities and staff. d. Basic emergency care. (c) Hospitals classified under paragraphs (b)(2) through (4) of this section shall not be required to comply with the provisions of paragraph (b)(1) of this section, but must, at a minimum, provide on-site basic emergency care services. (16 Del. C. 1953, § 1021; 56 Del. Laws, c. 360; 70 Del. Laws, c. 149, § 87; 70 Del. Laws, c. 186, § 1; 80 Del. Laws, c. 404, § 1; 82 Del. Laws, c. 73, § 1; 83 Del. Laws, c. 102, § 1.) § 1002. Regulations. (a) The Department shall develop, establish and enforce standards governing the construction, maintenance and operation of hospitals to protect and promote the public health and welfare. (b) The Department shall further adopt regulations to ensure that hospital staff have ready access to a locked hospital bathroom in the event of an emergency. (16 Del. C. 1953, § 1027; 56 Del. Laws, c. 360; 70 Del. Laws, c. 149, § 92; 70 Del. Laws, c. 186, § 1; 79 Del. Laws, c. 243, § 1; 82 Del. Laws, c. 73, § 1.) § 1003. License requirement. (a) No person shall construct, establish, conduct or maintain a hospital in this State without a license being issued under this chapter. (b) A license is not transferable from person to person or entity to entity. (c) Separate licenses. (1) Separate licenses are required for hospitals maintained on separate premises, even though both hospitals may be operated under the same management. (2) Separate licenses are not required for separate buildings on the same grounds or adjoining grounds, if the buildings are operated under 1 management. Page 90 Title 16 - Health and Safety (3) All off-site ambulatory care service facilities must be licensed as free-standing facilities if identified as such in § 122(3) of this title. (16 Del. C. 1954, § 1023; 56 Del. Laws, c. 360; 82 Del. Laws, c. 73, § 1.) § 1004. Application for license. An application for license shall be made to the Department upon forms provided by it and shall contain such information as the Department may reasonably require including affirmative evidence of ability to comply with such reasonable standards, rules and regulations as are lawfully prescribed under this chapter. (16 Del. C. 1953, § 1024; 56 Del. Laws, c. 360; 70 Del. Laws, c. 149, § 88; 70 Del. Laws, c. 186, § 1; 82 Del. Laws, c. 73, § 1.) § 1005. Issuance and renewal of license. (a) The Department shall grant an initial license for a period of up to 1 year to a new hospital that completes the application process, submits the nonrefundable application fee of $1,000 plus $2 per licensed inpatient bed and $500 for each emergency department not located on the hospital’s main campus, and demonstrates compliance with the requirements established under this chapter. (b) The Department shall renew annually a hospital’s license, unless suspended or revoked, upon filing by the hospital, payment of an annual licensure fee of $750 plus $2 per licensed inpatient bed and $500 for each emergency department not located on the hospital’s main campus, and demonstration of its continued compliance with the requirements established under this chapter. (c) The Department may grant a provisional license to a hospital which is not in substantial compliance with the requirements established under this chapter. A hospital which has been issued a provisional license shall resubmit the initial application fee for reinspection prior to the issuance of an annual license. (d) The licensure fees collected by the Department pursuant to this section are hereby appropriated to, and shall be retained by, the Department to defray operating expenses associated with this chapter. (16 Del. C. 1953, § 1025; 56 Del. Laws, c. 360; 67 Del. Laws, c. 266, § 5; 70 Del. Laws, c. 149, § 89; 70 Del. Laws, c. 186, § 1; 82 Del. Laws, c. 73, § 1.) § 1006. Denial or revocation of license, hearings and appeal. (a) The Department shall have the authority to deny, suspend, or revoke a license in any case where it finds that there has been a failure to comply with this chapter or the rules and regulations issued under this chapter or the Health-Care Associated Infections Disclosure Act [Chapter 10A of this Title] § 1731A of Title 24 or § 903 of this title. (b) Before a license issued under this chapter is denied, suspended or revoked, notice shall be given in writing to the holder of the license setting forth the particular reasons for such action. Denial, suspension or revocation of a license shall become effective 30 days after the mailing by registered mail or personal service of the notice, unless the applicant or licensee within such 30 day period shall give written notice to the Department requesting a hearing, in which case the notice shall be deemed to be suspended. If a hearing has been requested, the applicant or licensee shall be given an opportunity for a prompt and fair hearing before the Department. At any time at or prior to the hearing, the Department may rescind the notice of denial, suspension or revocation, upon being satisfied that the reasons for such action have been or will be removed. A copy of the decision of the Department setting forth the finding of facts and the particular reasons for the decision shall be sent by registered mail or served personally upon the applicant or licensee. The decision shall become final 30 days after it is so mailed or served unless the applicant or licensee within such 30-day period appeals the decision to the Superior Court. A copy of said notice of appeal must be provided simultaneously to the Department. The Department shall promptly certify and file with the Court a copy of the record and decision, including the transcript of the hearings on which the decision is based. Proceedings thereafter shall be governed by the Rules of the Superior Court of the State. (c) The procedure governing hearings authorized by this section shall be in accordance with rules promulgated by the Department. A full and complete record shall be kept of all proceedings and all testimony. (16 Del. C. 1953, § 1026; 56 Del. Laws, c. 360; 70 Del. Laws, c. 149, §§ 90, 91; 70 Del. Laws, c. 186, § 1; 76 Del. Laws, c. 122, § 2; 77 Del. Laws, c. 320, § 7; 82 Del. Laws, c. 73, § 1.) § 1007. Enforcement. (a) Any person constructing, managing or operating any hospital without a license shall be fined not more than $5,000 for the first offense and not more than $10,000 for each subsequent offense. Each day of a continuing violation shall be considered a separate offense. (b) The Department may impose civil money penalties for the violation of provisions of this chapter or the regulations adopted pursuant to it. (1) A licensee or other person is liable for a civil money penalty of not more than $10,000 per violation for violations which the Department determines pose a serious threat to the health and safety of a patient. Each day a violation continues constitutes a separate violation. (2) In determining the amount of a civil money penalty imposed pursuant to subsection (a) of this section or this subsection, the Department shall consider the following factors: a. The seriousness of the violation, including the nature, circumstances, extent and gravity of the violation and the threat or potential threat to the health or safety of patients; b. The history of violations committed by the person or the person’s affiliate, employee, or controlling person; Page 91 Title 16 - Health and Safety c. The efforts made by the hospital to correct the violation; d. Any misrepresentation made to the Department; and e. Any other matter that affects the health, safety or welfare of a patient. (c) The Department shall have the authority to collect any civil money penalty. Any civil money penalties collected by the Department under this section are hereby appropriated to the Department to carry out the purposes of this section. (1) Payment of any civil penalty by a facility is not an allowable cost for reimbursement under the state Medicaid program or under other state-funded programs. (2) In the event of nonpayment of a civil money penalty the Department may add the amount of the civil penalty to the licensing fee for the hospital. If the licensee refuses to make the payment at the time of the application for renewal of its license its license may not be renewed. (3) In the event of nonpayment of a civil money penalty after all legal appeals have been exhausted, a civil action may be brought by the Secretary in Superior Court for collection of the civil money penalty, including interest, attorney fees and costs. In a civil action to collect the civil money penalty the validity, amount and appropriateness of the civil money penalty shall not be subject to review. (16 Del. C. 1953, § 1027; 56 Del. Laws, c. 360; 70 Del. Laws, c. 149, § 92; 70 Del. Laws, c. 186, § 1; 79 Del. Laws, c. 243, § 1; 82 Del. Laws, c. 73, § 1.) § 1008. Injunction. Notwithstanding the existence or pursuit of any other remedy, the Department may, in the manner provided by law, maintain an action in the name of the State for injunction or other process against any person to restrain or prevent the construction, maintenance or operation of a hospital without a license. (16 Del. C. 1953, § 1036; 56 Del. Laws, c. 360; 70 Del. Laws, c. 149, § 98; 70 Del. Laws, c. 186, § 1; 82 Del. Laws, c. 73, § 1.) § 1009. Construction. (a) All construction, whether new or renovation, must conform to the design and construction standards established by the Department. (1) A “renovation” is: a. The strengthening or upgrading of building elements, materials, equipment, or fixtures that does not result in a reconfiguration of the building spaces within; or b. Any reconfiguration of a space that affects an exit, a corridor, or any component of a means of egress; or c. Work that changes the current designated purpose or occupancy classification of a building space. (2) Cosmetic changes such as repainting or changing carpeting are not considered renovations. (b) When a hospital plans to construct or renovate any buildings or spaces within a building, 2 copies of properly-prepared plans and specifications for the entire project shall be submitted to the Department. (c) An approval, in writing, shall be obtained from the Department before construction or renovation work is begun. (d) Hospitals wishing to construct or renovate must apply to the Department and submit the appropriate fee for approval. The fee structure for plan review shall be as follows: New Construction Square footage 10,000 or less 10,001-20,000 20,001-30,000 30,001-40,000 40,001-50,000 50,001-above Fee $250 $300 $350 $400 $450 $500 Square footage 5,000 or less 5,001-10,000 10,001-15,000 15,001-20,000 20,001-25,000 25,001-30,000 30,001-35,000 35,001-40,000 40,001-above Fee $100 $150 $200 $250 $300 $350 $400 $450 $500 Renovations Page 92 Title 16 - Health and Safety (e) After the hospital has submitted all required documentation, the Department shall review the submission within a timeframe agreed upon by both parties. (f) Hospitals failing to complete the plan review process and receive approval prior to construction or renovation shall be subject to a $5,000 fine for each project. (g) Any licensure fees or fines collected by the Department pursuant to this section are hereby appropriated to, and shall be retained by, the Department to defray operating expenses associated with this chapter. (82 Del. Laws, c. 73, § 1.) § 1010. Inspections and investigations. (a) The Department shall make or cause to be made such inspections and investigations of a hospital as it may deem necessary. (b) The Department shall accept the survey report of an approved accrediting organization, as defined by regulations, in lieu of an annual licensure inspection. (16 Del. C. 1953, § 1029; 56 Del. Laws, c. 360; 70 Del. Laws, c. 149, § 94; 70 Del. Laws, c. 186, § 1; 82 Del. Laws, c. 73, § 1.) § 1011. Compliance. All hospitals must comply with applicable federal, state, county and local laws and regulations. (82 Del. Laws, c. 73, § 1.) § 1012. Reportable events. (a) Hospitals must report all major adverse incidents involving a patient to the Department within 10 calendar days. (1) A major adverse incident is a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient. The Department shall define “major adverse incident” and provide further clarification in regulation. (2) Major adverse incidents must be investigated by the hospital. (3) A summary of the hospital’s investigative findings will be forwarded to the Department within a timeframe agreeable to both parties. (b) Hospitals must notify the Department immediately of any event occurring within the hospital that jeopardizes the health or safety of patients or employees including: (1) An unscheduled interruption for 3 or more hours of physical plant or clinical services impacting the health or safety of patients or employees. (2) A fire, disaster or accident which results in evacuation of patients out of the hospital. (3) An alleged or suspected crime which endangers the life or safety of patients or employees, which is also reportable to the police department, and which results in an immediate on-site investigation by the police. (4) An alleged incident of medication diversion, as defined under § 1131 of this title. (c) Information submitted as a major adverse incident is considered peer review information and not subject to public disclosure except as aggregate data. (16 Del. C. 1953, § 1033; 56 Del. Laws, c. 360; 70 Del. Laws, c. 149, § 96; 70 Del. Laws, c. 186, § 1; 82 Del. Laws, c. 73, § 1; 83 Del. Laws, c. 22, § 11.) § 1013. Designation of hospitals as primary stroke centers. (a) The Secretary of Health and Social Services shall designate as a comprehensive stroke center any acute care hospital within Delaware, or an out-of-state acute care hospital upon request, which has received Advanced Certification for Comprehensive Stroke Centers issued by the Joint Commission or an equivalent certification by another nationally-recognized guidelines-based accrediting organization as determined by the Secretary. (b) The Secretary of Health and Social Services shall designate as a primary stroke center any acute care hospital within Delaware, or an out-of-state acute care hospital upon request, which has received Advanced Certification for Primary Stroke Centers issued by the Joint Commission or an equivalent certification by another nationally-recognized guidelines-based accrediting organization as determined by the Secretary. (c) The Secretary of Health and Social Services shall designate as an acute stroke ready center any acute health-care facility within Delaware, or an out-of-state acute health-care facility upon request, which has received Advanced Certification for Acute Stroke Ready Centers issued by the Joint Commission or an equivalent certification by another nationally-recognized guidelines-based accrediting organization as determined by the Secretary. (d) The Secretary of Health and Social Services shall designate as a thrombectomy-capable stroke center any acute health-care facility within Delaware, or an out-of-state acute health-care facility upon request, which has received Advanced Certification for ThrombectomyCapable Stroke Centers issued by the Joint Commission or an equivalent certification by another nationally-recognized guidelines-based accrediting organization as determined by the Secretary. Page 93 Title 16 - Health and Safety (e) The Secretary of Health and Social Services may establish other distinct categories of stroke center certification if additional categories are established by the Joint Commission or by an equivalent nationally recognized guidelines-based accrediting organization as determined by the Secretary, and may designate any acute health-care facility as such based on certification by the Joint Commission or other nationally-recognized guidelines-based accrediting organization. (f) The Secretary of Health and Social Services shall suspend or revoke a facility’s designation as a comprehensive stroke center, primary stroke center, acute stroke ready center or other categorization if the Joint Commission or equivalent nationally-recognized guidelines-based accrediting organization as determined by the Secretary suspends or revokes a facility’s certification. (76 Del. Laws, c. 299, § 1; 80 Del. Laws, c. 404, § 2; 82 Del. Laws, c. 73, § 1.) § 1014. Hospital visitation policy. (a) Each hospital shall include in its visitation policy a provision allowing each competent adult patient to receive visits from any individual from whom a patient desires to receive visits, subject to restrictions contained in the visitation policy related to a patient’s medical condition, the number of visitors simultaneously permitted in a patient’s room, and the hospital’s visitation hours, as well as protective orders issued by a court. (b) The duties and rights conferred by this section are in addition to, and not in derogation of, duties and rights otherwise conferred by law, including §§ 2508 and 5161 of this title. (c) Nothing in this chapter shall preclude a hospital from restricting visitations due to: (1) Attempts to interfere with patient care; or (2) The presentation of a threat to staff, patients or hospital personnel; or (3) Actions disruptive to hospital operations; or (4) Pandemic or infectious disease outbreak. (d) Except as provided in subsection (c) of this section, nothing in this section shall be read to overrule any decision of the Delaware Department of Correction. (77 Del. Laws, c. 49, § 1; 82 Del. Laws, c. 73, § 1.) § 1015. Confidentiality of proprietary information. Information obtained by the Secretary under this chapter shall be available to the public as provided in Chapter 100 of Title 29, unless the Secretary certifies such information to be proprietary. The Secretary may make such certification where any person shows to the satisfaction of the Secretary that the information, or parts thereof, if made public, would divulge methods, processes or activities entitled to protection as trade secrets or as confidential financial or commercial information. Nothing in this section shall be construed as limiting the disclosure of information by the Secretary to any officer, employee or authorized representative of the state or federal government to effectuate the purposes of this chapter. Furthermore, nothing in this section shall prevent the Secretary from including in the remedial decision record information concerning the cost of the remedy or the manner in which it is performed. Prior to disclosure of information certified by the Secretary to be proprietary to an authorized representative who is not an officer or employee of the state or federal government, the person providing the proprietary information may require the representative to sign an agreement prohibiting disclosure of such information to anyone not authorized by this chapter or the terms of the agreement. Such agreement shall not preclude disclosure by the representative to any state or federal government officer or employee concerned with effecting this chapter. (77 Del. Laws, c. 49, § 1; 82 Del. Laws, c. 73, § 1.) Page 94 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 10A Health-care Associated Infections Disclosure Act § 1001A. Short title. This chapter may be cited as the “Health-care Associated Infections Disclosure Act.” (76 Del. Laws, c. 122, § 1; 78 Del. Laws, c. 351, § 1.) § 1002A. Definitions. For purposes of this chapter: (1) “Advisory Committee” means the Committee established under this chapter. (2) “Correctional facility” means any health-care facility operated at any Department of Correction facility in this State. (3) “Department” means the Department of Health and Social Services. (4) “Dialysis center” means a facility approved to furnish outpatient dialysis services directly to end stage renal disease (ESRD) patients. Outpatient dialysis includes: staff-assisted dialysis (dialysis performed by the staff of the facility) and self-dialysis (dialysis performed with little or no professional assistance by an ESRD patient who has completed an appropriate course of training). ESRD is that stage of renal impairment that appears irreversible and permanent, and requires a regular course of dialysis or kidney transplantation to maintain life. (5) “Freestanding surgical center” means a facility licensed under Chapter 1 of this title. (6) “Health-care associated infection” means a localized or systemic condition: a. That results from adverse reaction to the presence of an infectious agent or agents or its toxin or toxins; and b. That was not present or incubating at the time of admission to the health-care facility. (7) “Health-care facility” means a correctional facility, dialysis center, freestanding surgical center, hospital, long-term care facility, or psychiatric facility. (8) “Hospital” means an acute care health-care facility licensed under Chapter 10 of this title. (9) “Long-term care facility” means a nursing home or intermediate care facility for persons with mental retardation licensed under Chapter 11 of this title. (10) “Psychiatric facility” means a facility that is primarily engaged in providing, by or under the supervision of a doctor of medicine or osteopathy, psychiatric services for the diagnosis and treatment of mentally ill persons. (11) “Public report” means the report provided to the health-care facilities and the public by the Department as set forth in this chapter. (76 Del. Laws, c. 122, § 1; 78 Del. Laws, c. 351, § 1.) § 1003A. Reporting of infections by physicians. In accordance with this chapter, a physician who diagnoses and treats a health-care associated infection related to a clinical procedure, or a licensed practitioner who is permitted by law to diagnose and treat such infection and does so, is required to report the infection back to the health-care facility at which the clinical procedure was performed. The infection control department of the health-care facility will then be required to report to the Department only those infections that meet the accepted National Healthcare Safety Network definitions and are currently required to be reported by law. (78 Del. Laws, c. 351, § 1.) § 1004A. Hospital reports. (a) Individual hospitals shall collect data on health-care associated infection rates related to specific clinical procedures as determined by the Advisory Committee and set forth in regulations promulgated by the Department. Examples may include the following categories: (1) Surgical site infections such as total hip and knee arthroplasty; (2) Central line-related bloodstream infections in an intensive care unit (ICU); (3) Direct health-care provider’s influenza vaccination rates; and (4) Other categories as provided under subsection (c) of this section. (b) (1) Infection control professionals, or a designee, of hospitals shall submit quarterly reports on their health-care associated infection rates to the Department using the accepted Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network (NHSN) definitions. Prevention and control data related to quality measures will be based on nationally recognized and recommended standards that may include those developed by the CDC, Centers for Medicare and Medicaid, and/or the Agency for Healthcare, Research and Quality, to name a few. Data in quarterly reports must cover a period ending not earlier than 45 days prior to submission of the report. Page 95 Title 16 - Health and Safety Quarterly reports shall be made available to each hospital 45 days after submittal to the Department for review by the hospitals. The hospitals shall have 7 days to review the quarterly reports and report any changes to the Department. Following the 7-day review period, such quarterly reports shall be made available to the public at each hospital and through the Department (the “public report”). (2) If the hospital is a division or subsidiary of another entity that owns or operates other hospitals or related organizations, the quarterly report shall be for the specific division or subsidiary and not for the other entity. (c) After June 30, 2010, and upon consultation with the Advisory Committee and other experts in infection, prevention, identification and control, the Department may revise categories of infections set forth in subsection (a) of this section. (76 Del. Laws, c. 122, § 1; 77 Del. Laws, c. 233, §§ 1, 2; 78 Del. Laws, c. 351, § 1.) § 1005A. Department reports. (a) The Department shall annually submit to the legislature a report summarizing the hospital quarterly reports and shall publish the annual report on its website. The first annual report shall be published no later than June 30, 2009. Following the initial report, the Department shall update the public information on a quarterly basis. (b) All reports issued by the Department shall be risk adjusted, or use some other method to account for the differences in patient populations among hospitals. (c) The annual report shall compare health-care associated infection rates to national rates published by the CDC’s NHSN program and collected pursuant to this chapter for each individual hospital in the State. The Department, in consultation with the Advisory Committee, shall make this report as easy to comprehend as possible. The report shall also include an executive summary, written in plain language that shall include but not be limited to a discussion of findings, conclusions and trends concerning the overall state of health-care associated infections in the State, including a comparison to prior years. The report may include policy recommendations, as appropriate. (d) The Department shall publicize the report and its availability as widely as practical to interested parties, including but not limited to hospitals, providers, media organizations, health insurers, health maintenance organizations, purchasers of health insurance, organized labor, consumer or patient advocacy groups and individual consumers. The annual report shall be made available to any person upon request. (e) No hospital report or Department disclosure may contain information identifying a patient, employee or licensed health-care professional in connection with a specific infection incident. (f) The annual report shall provide background information about each hospital which shall include: the hospital’s adult and pediatric populations, bed size, and specialty divisions; whether the hospital provides tertiary care; and whether the hospital is a teaching or a nonteaching institution. This background information shall be included in the public report. (g) The annual report shall include a brief summary report to allow hospitals to comment on performance improvement and changes in patient population and risk factors. The information contained in the summary report shall be considered proprietary information and shall be utilized by the Department but shall not be made available in the public report and shall not be subject to disclosure under the State’s Freedom of Information Act (Chapter 100 of Title 29). (76 Del. Laws, c. 122, § 1; 78 Del. Laws, c. 351, § 1.) § 1006A. Correctional facility reports. (a) Correctional facilities shall collect data on health-care associated infections related to specific clinical procedures resulting from care in the correctional facility, as determined by the Advisory Committee and as set forth in regulations promulgated by the Department. These categories of infection data may differ from that information required from hospitals. (b) Correctional facilities shall report data to the Department in accordance with regulations of the Department. The information from the correctional facilities shall be segregated from the hospital data contained in the reports submitted pursuant to this chapter. (76 Del. Laws, c. 122, § 1; 78 Del. Laws, c. 351, § 1.) § 1007A. Reports by other health-care facilities. Only with the concurrence of the Advisory Committee, and not until such time that the Centers for Medicaid and Medicare or the Centers for Disease Control and Prevention issue final federal regulations requiring such, and after careful evaluation of the economic and public health impact, the Department may through regulation require the reporting of health-care associated infections from health-care facilities other than hospitals and correctional facilities. The procedures for reporting shall be consistent with procedures for reporting by hospitals as specified in this chapter, except as may be necessary to accommodate the unique characteristics and capabilities of the health-care facilities and the capabilities of the National Healthcare Safety Network. (78 Del. Laws, c. 351, § 1.) § 1008A. Advisory Committee. (a) The Secretary of the Department shall appoint an Advisory Committee, which shall include: 1 infection control professional who has responsibility for infection control programs for each hospital or health-care system in Delaware; 4 infection disease physicians with expertise in infection control; 1 representative of the Delaware Health Care Facilities Association; 1 representative of a freestanding Page 96 Title 16 - Health and Safety surgical center; 1 representative of a dialysis center; 1 representative of a psychiatric facility; 1 representative from the State Division of Public Health; and the Public Health Healthcare Associated Infections Specialist responsible for collating and reporting data. The Secretary shall also appoint 8 other members of the Committee including representatives from direct care nursing staff, academic researchers, consumer organizations, health insurers, health maintenance organizations, organized labor and purchasers of health insurance, such as employers. The Advisory Committee shall have the authority to engage personnel with appropriate training and/or certification in infection prevention and control for the purposes of collecting data. (b) The Advisory Committee shall assist the Department in the development of all aspects of the Department’s methodology for collection, analyzing and disclosing the information collected under this chapter, including collection methods, formatting and methods and means for release and dissemination. (c) In developing the methodology for collecting and analyzing the infection rate data, the Department and the Advisory Committee shall adopt the methodologies and system for data collection from the Centers for Disease Control’s National Healthcare Safety Network, or its successor. The data collection and analysis methodology shall be disclosed to the public prior to any public disclosure of healthcare associated infection rates. (d) The Advisory Committee shall assist the Department in the sharing of information and best practices toward the development of activities and policies that: (1) Enhance coordination between health-care facilities throughout the continuum of care for the prevention and control of healthcare associated infections; (2) Promote the prevention and control of health-care associated infections generally; and (3) Encourage the creation of benchmarks against which to measure progress in the prevention and control of health-care associated infections. (78 Del. Laws, c. 351, § 1.) § 1009A. Privacy. It is the express intent of the legislature that a patient’s right of confidentiality shall not be violated in any manner. Patient Social Security numbers and any other information that could be used to identify an individual patient shall not be released notwithstanding any other provision of law. (76 Del. Laws, c. 122, § 1; 78 Del. Laws, c. 351, § 1.) § 1010A. Penalties. A determination that a health-care facility has violated the provisions of this chapter may result in any of the following: (1) Termination of licensure or other sanctions relating to licensure under Chapter 10 of this title; or (2) A civil penalty of up to $500 per day per violation for each day the health-care facility is in violation of this chapter. (76 Del. Laws, c. 122, § 1; 78 Del. Laws, c. 351, § 1.) § 1011A. Regulatory oversight. The Department shall be responsible for ensuring compliance. When the Department licenses a health-care facility according to the provisions of this title, compliance with this chapter shall be a condition of licensure. (76 Del. Laws, c. 122, § 1; 78 Del. Laws, c. 351, § 1.) § 1012A. Hospital Infection Specialist. The Department shall establish and fund a Healthcare Associated Infection Specialist position within the Division of Public Health supporting the functions of this chapter. The Healthcare Associated Infection Specialist must have knowledge of the NHSN system and skills to appropriately analyze health-care acquired infection data. (76 Del. Laws, c. 122, § 1; 78 Del. Laws, c. 351, § 1.) § 1013A. Privilege and confidentiality protections. Notwithstanding any other provision of federal, state or local law, the health-care associated infection data provided pursuant to this chapter is privileged and, with the exception of §§ 1003A, 1004A and 1005A of this title, shall not be: (1) Subject to admission as evidence or other disclosure in any federal, state or local civil, criminal or administrative proceeding, or (2) Subject to use in a disciplinary proceeding against a health-care facility or provider, or (3) Subject to disclosure under Chapter 100 of Title 29. (76 Del. Laws, c. 122, § 1; 78 Del. Laws, c. 351, § 1.) § 1014A. Membership in National Healthcare Safety Network. By December 31, 2007, all hospitals in the State shall join the Centers of Disease Control and Prevention’s National Healthcare Safety Network or its successor. If the Network is not open for enrollment to all hospitals by this date, all hospitals shall join the Network within Page 97 Title 16 - Health and Safety 180 days after the Center of Disease Control and Prevention permits such enrollment. Hospitals shall authorize the Department to have access to hospital-specific data contained in the National Healthcare Safety Network database consistent with the requirements of this chapter. With the concurrence of the Advisory Committee the Department may require other health-care facilities through regulation to join the National Healthcare Safety Network as may be appropriate in accordance with this chapter. (76 Del. Laws, c. 122, § 1; 78 Del. Laws, c. 351, § 1.) Page 98 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 11 Long-Term Care Facilities and Services. (81 Del. Laws, c. 206, § 1.) Subchapter I Licensing By The State § 1101. Purpose and overview. (a) It is the intent of the General Assembly that the primary purpose of the licensing and regulation of long-term care facilities is to ensure that these facilities provide a high quality of care and quality of life to their residents. (b) This chapter and the regulations adopted to implement it establish minimum acceptable levels of care. A violation of a minimum acceptable level of care is prohibited by law. (c) The State shall undertake measures to prevent violations. Prevention shall be promoted through education, particularly regarding any new laws and regulations adopted by the State. (d) The State shall undertake measures to assure that violations of this chapter and the regulations promulgated under this chapter are remedied. To that end, the Department shall do all of the following: (1) Set standards of care. (2) Determine compliance with those standards through inspections, investigations and other compliance measures. (3) Impose sanctions and remedies for noncompliance. (e) (1) The Department shall be responsible for issuing licenses and certifying the compliance of facilities with state laws and regulations. (2) Each facility licensed under this chapter shall, at a minimum, provide quality care in accordance with this chapter and the regulations promulgated thereunder. Components of quality of care and quality of life addressed by this chapter and regulations promulgated thereunder include all of the following: a. Access to care. b. Continuity of care. c. Comprehensiveness of care, including activities. d. Coordination of services. e. Humaneness of treatment and respect for the dignity of each resident. f. Safety of the environment. g. Qualifications of caregivers. (f) This chapter and its regulations are intended for use in state inspections of facilities licensed under this chapter and any investigations and enforcement actions, and are designed to be useful to consumers and providers in assessing the quality of care provided in a facility. (g) The consumer protection goal of ensuring that residents of long-term care facilities receive quality care shall be strived for in the following ways: (1) Monitoring the factors relating to the health, safety, welfare and dignity of each resident. (2) Providing effective remedies and requiring their prompt imposition for noncompliance with licensing standards. (3) Providing the public with information concerning the operation of long-term care facilities in this State. (h) This chapter shall be construed broadly to accomplish the purposes set forth in this section. (71 Del. Laws, c. 488, § 2; 81 Del. Laws, c. 206, § 2.) § 1102. Definitions. As used in this chapter: (1) “Controlling person” means: a. A person who has the ability, acting alone or in concert with others, to directly or indirectly influence, direct, or cause the direction of the management, expenditure of money, or policies of a facility or other person. b. For purposes of this chapter, “controlling person” includes the following: 1. A management company, landlord, or other business entity that operates or contracts with others for the operation of a facility. 2. Any person who is the controlling person of a management company or other business entity that operates a facility or who contracts with another person for the operation of a facility. Page 99 Title 16 - Health and Safety 3. Any other individual who, because of a personal, familial, or other relationship with the owner, manager, landlord, tenant, or provider of a facility, is in a position of actual control or authority with respect to the facility, without regard to whether the individual is formally an owner, manager, director, officer, provider, consultant, contractor, or employee of the facility. c. A controlling person described by paragraph (1)b.3. of this section does not include a person, such as an employee, lender, secured creditor, or landlord, who does not exercise any influence or control, whether formal or actual, over the operation of a facility. d. The Department may adopt regulations to define the ownership interest and other relationships that qualify a person as a controlling person. (2) “Department” means the Department of Health and Social Services. (3) “Division” shall mean the Division of Health Care Quality; (4) a. “Long-term care facility” means a residential facility that provides shelter and food to more than 1 individual who meets all of the following: 1. Because of his or her physical or mental condition, require a level of care and services suitable to his or her needs to contribute to his or her health, comfort, and welfare. 2. Is not related within the second degree of consanguinity to the facility’s controlling person. b. “Long-term care facility” includes all of the following: 1. A nursing facility. — As used in this chapter, “nursing facility” commonly referred to as a “nursing home,” means a residential facility that provides services to residents including resident beds, continuous nursing services, and health and treatment services for individuals who do not currently require continuous hospital care and that provides care in accordance with a physician’s order and requires the supervision of a registered nurse (RN). 2. An assisted living facility. — As used in this chapter, “assisted living facility” means a special combination of housing, supportive services, supervision, personalized assistance, and health care designed to respond to the individual needs of those who need help with activities of daily living or instrumental activities of daily living. Facilities offer living arrangements to medically stable adult individuals who do not require the skilled nursing services of a nursing facility. 3. Intermediate care facility for persons with intellectual disabilities. — As used in this chapter, “intermediate care facility for persons with intellectual disabilities” means a residential facility that provides services to residents with intellectual disabilities including resident beds, continuous nursing services, and health and treatment services for individuals who do not currently require continuous hospital care and that provides care in accordance with a physician’s order and requires the supervision of a registered nurse (RN). 4. A neighborhood home. — As used in this chapter, a “neighborhood home” means a residence for no more than 5 individuals that is fully integrated in the community, not on the grounds of an institution, has shared common living areas, is where the individual chooses to live, and offers 24-hour supports to individuals with intellectual or developmental disabilities. 5. A group home for persons with mental illness. — As used in this chapter, a “group home for persons with mental illness” means a residence that provides 24-hour supports, mental health treatment, rehabilitation, housing for between 3 and 10 adults with a primary diagnosis of psychiatric disabilities, and is fully integrated in the community, not on the grounds of an institution, has shared common living areas, and is where the individual chooses to live. “Group home for persons with mental illness” does not include supervised apartments. 6. A group home for persons with AIDS. — As used in this chapter, a “group home for persons with AIDS” means a residence for 16 or less individuals with AIDS that only admits those individuals with an established diagnosis and disease progression such that the individual requires a routine and frequent combination of physician, professional nursing, and supportive services. 7. A family care home. — As used in this chapter, a “family care home” means a home, including a physical structure and the necessary equipment, that provides beds and personal care services for 2 or 3 residents who cannot live independently and who need or could benefit from a family living situation, and that provides shelter, housekeeping services, food, meals, and personal care for residents. 8. A rest residential facility. — As used in this chapter, a “rest residential facility” means a facility that provides resident beds and personal care services in a homelike environment for adult individuals who are normally able to manage their own activities of daily living. 9. An intensive behavioral support and educational residence. — As used in this chapter, an “intensive behavioral support and educational residence” means a residential facility that provides services to adult individuals with autism, developmental disabilities, or severe mental or emotional disturbances who have specialized behavioral needs. Page 100 Title 16 - Health and Safety (5) “Long-Term Care Residents’ Trust Fund” means a fund maintained by the Department to which civil monetary penalties are to be remitted consistent with the federal Centers for Medicare and Medicaid Services (“CMS”) regulations, 42 C.F.R. § 488.442(g). (6) “Person” means an individual, firm, partnership, corporation, association, joint stock company, limited partnership, limited liability company, or any other legal entity, and includes a legal successor of those entities. (7) “Protection and advocacy agency” means the Community Legal Aid Society, Inc. or successor agency designated the state protection and advocacy system under 42 U.S.C. § 10801 et seq.; 42 U.S.C. § 15001 et seq.; or 29 U.S.C. § 794e. (8) “Resident” means an individual, whether identified as a patient, guest, or other designation, residing and receiving services in a long-term care facility. (9) “State Civil Penalty Trust Fund” means a fund maintained by the Department to which civil money penalties imposed for violations of state statute or regulation are to be remitted. Money deposited into this Trust Fund may not be used for salaries or general operating costs of the Department but must be used for the benefit and protection of long-term care residents to further the purposes set forth in this chapter and Chapter 79 of Title 29. (71 Del. Laws, c. 488, § 2; 71 Del. Laws, c. 489, § 2; 75 Del. Laws, c. 88, § 21(5); 77 Del. Laws, c. 49, § 2; 77 Del. Laws, c. 201, § 1; 77 Del. Laws, c. 309, § 1; 78 Del. Laws, c. 179, § 163; 81 Del. Laws, c. 206, § 3; 81 Del. Laws, c. 209, § 1.) § 1103. License and renewal requirement. (a) A person may not establish, conduct, or maintain any long-term care facility in this State without first obtaining a license from the Department and thereafter renewing this license on an annual basis. Failure to comply with this subsection shall result in the imposition by the Department of a civil penalty not to exceed $10,000 per violation. (b) A nursing facility, assisted living facility, or rest residential facility must operate under the direction of an individual authorized or licensed to perform the functions of a nursing home administrator under Chapter 52 of Title 24. (71 Del. Laws, c. 488, § 2; 76 Del. Laws, c. 89, § 2; 81 Del. Laws, c. 206, § 4.) § 1104. License and renewal application. (a) An application for a license or renewal of a license shall be submitted to the Division on forms provided by the Division and must be accompanied by the applicable license fee. (b) In addition to the general information requested on the application forms, the applicant or license holder must furnish evidence to affirmatively establish the applicant’s or license holder’s ability to comply with all of the following: (1) Minimum standards of medical care or nursing care, as applicable by type of facility. (2) Financial capability. (3) Any other applicable state and federal laws and regulations for that category of facility. (c) The Department shall consider the background and qualifications of the applicant or license holder and it may also consider the background and qualifications of all of the following: (1) Any partner, officer, director, or managing employee of the applicant or license holder. (2) Any person who owns or controls the physical plant in which the facility operates or is to operate. (3) Any controlling person with respect to the facility for which a license or license renewal is requested. (d) In making the evaluation described in subsection (c) of this section, the Department shall require the applicant or license holder to file a sworn affidavit of a satisfactory compliance history and any other information required by the Department to substantiate a satisfactory compliance history relating to each state or other jurisdiction in which the applicant operated a facility any time during the 5year period preceding the date on which the application is made. The Department by regulation shall define what constitutes a satisfactory compliance history. The Department may also require the applicant to file information relating to its financial condition during the 5-year period preceding the date on which the application is made. The Department may also request any of the above-described information about any other person described by subsection (c) of this section. (e) The Department may monitor the financial capability and financial health of licensed long-term care facilities. The Department shall promulgate regulations regarding the financial disclosure requirements for long-term care facilities and documents provided are not public records under the Freedom of Information Act, Chapter 100 of Title 29. (f) (1) The license shall terminate if and when there is a transfer of a long-term care facility to another person or controlling person or the business ceases legal existence or discontinues operation. (2) No license granted by the Department shall be assigned or otherwise transferred to another person or controlling person. (g) The Department shall grant an initial license to any newly established long-term care facility, provided that the requirements of this section are met. The term of such initial license may be no more than 365 days. (h) A license, unless sooner suspended or revoked, may be renewed annually upon filing by the licensee and payment of an annual licensure fee. A provisional license, as authorized by the Department, may be issued when requirements are not met and the annual licensure fee has been submitted. A long-term care facility which has been issued a provisional license shall resubmit the application fee for re-inspection prior to the issuance of an annual license. (71 Del. Laws, c. 488, § 2; 72 Del. Laws, c. 305, § 1; 81 Del. Laws, c. 206, § 5.) Page 101 Title 16 - Health and Safety § 1105. Denial of license or its renewal. (a) The Department may deny a license to any applicant or refuse to renew a license to any license holder if the Department finds that the applicant or license holder or any partner, officer, director, managerial employee or controlling person of the applicant or license holder has done any of the following: (1) Failed to meet the requirements of § 1104 of this title. (2) Operated any long-term care facility without a license or under a revoked or suspended license in any jurisdiction. (3) Knowingly, or with reason to know, made a false statement of a material fact in an application for license or renewal, or any data attached thereto, or in connection with any matter under investigation by the Department, or in any document submitted to the Department, including a plan for the correction of all violations of applicable laws or regulations. (4) Refused to allow representatives or agents of the Department to inspect a portion of the premises of the facility or any residentrelated documents, records, and files required to be maintained by the facility. (5) Interfered with or attempted to impede in any way the work of any authorized representative of the State or protection and advocacy agency or the lawful enforcement of any provision of this chapter. (6) Has a history of noncompliance with federal or state law or regulations in providing long-term care. (b) The due process protections of notice and an opportunity to be heard must be provided to facilities prior to the denial of a license or its nonrenewal. The hearing process must be consistent with the Administrative Procedures Act, Chapter 101 of Title 29. (c) In deciding whether to deny a license or its renewal under this section, the factors to be considered by the Department must include the severity and recurrence of the noncompliance. (71 Del. Laws, c. 488, § 2; 77 Del. Laws, c. 201, § 2; 81 Del. Laws, c. 206, § 6.) § 1106. License fees. (a) (1) The fees for issuance and renewal of licenses pursuant to this chapter for nursing facilities, assisted living facilities, rest residential facilities, and intermediate care facilities for persons with intellectual disabilities may not exceed $150 plus the following: a. $250 for facilities with less than 100 units of capacity or bed space for which a license is sought. b. $400 for facilities with 100 or more units of capacity or bed space. c. A background examination fee for initial applications in an amount set by the Department necessary to defray its expenses in administering its duties under § 1104(c) and (d) of this title, but not to exceed $500. (2) The total fee for all other facilities with 16 or fewer units of capacity or bed space is $50. (b) The license fee required under subsection (a) of this section must be paid with each application for initial license, a renewal license, or an initial license. (c) The State is not required to pay the license fee for any facilities it operates or owns which require licensure under this chapter. (d) All license fees collected by the Department must be remitted to the General Fund. (e) A new application and a fee of $50 must be submitted for changes to a license which occur during the licensure year, including any of the following changes: (1) An approved increase in bed space. (2) An approved decrease in bed space. (3) A facility change of name. (71 Del. Laws, c. 488, § 2; 72 Del. Laws, c. 3, §§ 1, 2; 81 Del. Laws, c. 206, § 7.) § 1107. Inspections and monitoring. (a) The Department shall inspect each long-term care facility on a regular basis to ensure compliance with this chapter and the regulations adopted pursuant to it. (b) The Department shall have the authority to assess additional fees to recover the actual costs and expenses of the Department for any monitoring or inspections needed beyond the standard inspection in those cases in which substantiated violations are found. (c) Any duly authorized employee or agent of the Department may enter and inspect any facility licensed under this chapter without notice at any time. All licensees are required to provide immediate access to Department personnel to conduct inspections. Such inspections may include any of the following: (1) Interviewing residents. (2) Interviewing family members or staff. (3) Reviewing and photocopying any records and documents maintained by the licensee. (4) Inspecting any portion of the physical plant of the facility. (5) Enforcing any provision of this chapter and the regulations pursuant to it, as well as applicable federal law and regulations. (d) Advance notice may not be given to any facility of any inspection conducted under this chapter unless specifically authorized by the Secretary of the Department or the Secretary’s designee or as otherwise required by federal law or regulation. Failure to comply with this subsection results in the imposition by the Department of a civil penalty not to exceed $5,000 per violation. Page 102 Title 16 - Health and Safety (e) At the conclusion of each inspection, the Department shall promptly notify the facility of any violations of this chapter and its regulations as well as of federal law and regulations. It shall provide a comprehensive exit interview at the conclusion of each inspection whereby the facility is made aware of any problems found, including violations of applicable law or regulations. Representatives from the Long-Term Care Ombudsperson’s Office shall be invited to attend each exit interview. (f) [Repealed.] (g) Any person who is a former employee of a long-term care facility is disqualified from participating for 2 years in any manner in any inspection of that facility. (h) Any person who has a relative residing or working in a long-term care facility is disqualified from participating in any manner in any inspection of that facility. (71 Del. Laws, c. 488, § 2; 70 Del. Laws, c. 186, § 1; 74 Del. Laws, c. 59, § 1; 81 Del. Laws, c. 206, § 8.) § 1108. Posting of inspection summary and other information and public meetings. (a) Each facility shall prominently and conspicuously post for display in a public area of the facility that is readily available to residents, employees, and visitors the following: (1) The license issued under this subchapter. (2) A sign prescribed by the Department that specifies complaint procedures and provides the “1-800” hotline number to receive complaints 24 hours a day, 7 days a week. (3) The most recent state survey report prepared by the Department of the most recent inspection report for the facility. (4) A notice, as required by regulation, in the form prescribed by the Department stating that informational materials relating to the compliance history of the facility are available for inspection at a location in the facility specified by the sign and online at a web site specified by the sign. The notice shall also provide the telephone number to reach the Department to obtain the same information concerning the facility. (5) A notice, as required by regulation, that the Division of Professional Regulation can provide information about the facility administrator along with the Division of Professional Regulation telephone number to call for this information. (b) [Repealed.] (c) The compliance history information required to be maintained for public review must be maintained in a well-lighted accessible location. The compliance history material must include all inspection reports produced for that facility during the preceding 3-year period. The information must be updated as each new inspection or other Department report is received by the facility. (d) Following completion of the annual inspection report, the Department shall schedule a meeting, as required under regulations, to take place at the facility to present the findings of the annual report. (1) The Department shall require the facility to notify residents and their families of the meetings required under this subsection. (2) The Department shall provide staff for these meetings and the staff shall be prepared to present the findings of the surveys and to answer questions regarding the surveys and plans of action. (71 Del. Laws, c. 488, § 2; 72 Del. Laws, c. 3, § 3; 77 Del. Laws, c. 401, §§ 1, 2; 81 Del. Laws, c. 206, § 9.) § 1109. Civil penalties. (a) (1) The Department may impose civil money penalties for the violation of provisions of this chapter or the regulations adopted pursuant to it. (2) A licensee or other person is liable for a civil penalty of not less than $1,000 nor more than $10,000 per violation for violations which the Department determines pose a serious threat to the health and safety of a resident. (b) In determining the amount of the penalty to be assessed under subsection (a) of this section, the Department must consider all of the following: (1) The seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation and the hazard or potential hazard created by the violation to the health or safety of a resident or residents. (2) The history of violations committed by the person or the person’s affiliate, employee, or controlling person. (3) The efforts made by the facility to correct the violation. (4) The culpability of the person who committed the violation. (5) A misrepresentation made to the Department or to another person regarding any of the following: a. The quality of services provided by the facility. b. The compliance history of the facility. c. The identity of an owner or controlling person of the facility. (6) Any other matter that affects the health, safety, or welfare of a resident. (c) For all other violations that do not constitute a serious threat to the health and safety of a resident, but do violate this chapter or the regulations adopted pursuant to it, the maximum civil penalty is $5,000 per violation. Violations in this category include any of the following: Page 103 Title 16 - Health and Safety (1) Making a false statement that the person knows or should know is false, about 1 of the following: a. A material fact on an application for issuance or renewal of a license or any document attached to an application. b. A material fact with respect to a matter under investigation by the Department. (2) Refusing to allow a representative of the Department to inspect without notice at any time either of the following: a. Any portion of the premises of a facility. b. Any documents, records, or files required to be maintained by a facility. (3) Wilfully interfering with the work of a representative of the Department or with the enforcement of this chapter. (4) Wilfully interfering with the preservation of evidence of a violation of this chapter or regulation pursuant to it. (d) In determining the amount of the penalty to be assessed under subsection (c) of this section, the Department shall consider the factors in subsection (b) of this section. (e) Each day of a continuing violation constitutes a separate violation. However, a penalty for a health and safety violation may not exceed $2,500 per day beyond the initial day. A penalty for a nonhealth and safety violation may not exceed $1,250 per day beyond the initial day. (71 Del. Laws, c. 488, § 2; 72 Del. Laws, c. 305, § 2; 81 Del. Laws, c. 206, § 10.) § 1110. Waiver of penalty if first time violation(s) corrected [Repealed]. (71 Del. Laws, c. 488, § 2; repealed by 81 Del. Laws, c. 206, § 11, effective Feb. 14, 2018.) § 1111. Overlap of state licensing and federal certification penalties. (a) The Department may not collect a civil monetary penalty for the same deficient practice for which the federal government has levied a civil monetary penalty. (b) In the event that a civil monetary penalty has been collected by the State and the federal government subsequently collects a penalty for the same conditions, the State shall refund the previously collected penalty. (71 Del. Laws, c. 488, § 2; 72 Del. Laws, c. 428, § 1; 81 Del. Laws, c. 206, § 12.) § 1112. Collection of civil penalties. (a) All civil penalties collected under this chapter must be remitted to the Long-Term Care Residents’ Trust Fund if based on a federal regulation, or to the State Civil Penalty Trust Fund, if based on a state statute or regulation. (b) Payment of any civil penalty by a facility is not an allowable cost for reimbursement under the state Medicaid program or under other state-funded programs. (c) If a long-term care facility, after notice and opportunity for hearing, does not pay a properly assessed penalty in accordance with this subchapter, the Department shall deduct the amount of the civil penalty from amounts otherwise due from the State to the long-term care facility and remit that amount to the State Civil Penalty Trust Fund. (d) Alternatively, the Department may add the amount of the civil penalty to the licensing fee for the long-term care facility. If the licensee refuses to make the payment at the time of the application for renewal of its license, its license may not be renewed. (e) The Department may also proceed for the collection of the civil money penalty in an action brought in the name of the Department in any court of competent jurisdiction. (f) In the event of financial hardship, as determined by the Department, the Department may redirect the payment of penalties by the facility to take remedial action to correct the violation or violations. (71 Del. Laws, c. 488, § 2; 74 Del. Laws, c. 194, § 1; 77 Del. Laws, c. 309, §§ 2, 3; 81 Del. Laws, c. 206, § 13.) § 1113. Other remedies for noncompliance. In addition to civil money penalties, the Department may impose any or all of the following remedies for noncompliance with this chapter and the regulations promulgated pursuant to it or for noncompliance with § 1731A of Title 24 or § 903 of this title: (1) Require monitoring at facility expense, according to the terms and conditions, including timeframes, determined necessary by the Department. (2) Suspend the admission or readmission of residents to the long-term care facility under the terms and conditions, including timeframes, determined by the Department. (3) Transfer residents whose care needs are not being met by the licensee. (4) Suspend, revoke, or refuse to renew a license. (5) In cases where the physical health or safety of residents is in imminent risk, issue an emergency order temporarily transferring the management of the facility to another qualified entity under the terms and conditions, including timeframes, determined by the Department. (6) Issue a provisional license for a long-term care facility that is in substantial but not full compliance with applicable laws and regulations. (71 Del. Laws, c. 488, § 2; 72 Del. Laws, c. 305, § 3; 77 Del. Laws, c. 320, § 8; 81 Del. Laws, c. 206, § 14.) Page 104 Title 16 - Health and Safety § 1114. Right to hearing on deficiencies and remedies for noncompliance. The due process protections of notice and opportunity to be heard shall be provided to facilities to appeal survey deficiencies, as well as the imposition of remedies for noncompliance imposed under §§ 1112 and 1113 of this title. The hearing process shall be consistent with the Administrative Procedures Act, Chapter 101 of Title 29. (71 Del. Laws, c. 488, § 2; 74 Del. Laws, c. 59, § 2.) § 1115. Injunctive relief. In addition to any other remedy provided by law, the Department may bring an action in Chancery Court to enjoin a long-term care facility from engaging in activities that pose a threat to the health or safety of a resident of the long-term care facility. A temporary restraining order may be granted by the court if continued activity by the long-term care facility would create an imminent risk to a resident at the facility. (71 Del. Laws, c. 488, § 2; 81 Del. Laws, c. 206, § 15.) § 1116. Coordination of enforcement actions with the attorney general’s office. (a) The Department and the Attorney General shall work in close cooperation throughout any legal proceeding initiated by the Department to enforce this chapter and the regulations promulgated under it. (b) The Secretary of the Department or the Secretary’s designee must be fully consulted before concluding any settlement agreement to a lawsuit brought under this chapter or any other law relating to the health and safety of residents in long-term care facilities. (71 Del. Laws, c. 488, § 2; 70 Del. Laws, c. 186, § 1; 81 Del. Laws, c. 206, § 16.) § 1117. Retaliation or discrimination against complainant. (a) A licensee or other person may not discriminate or retaliate in any manner against a resident or employee in its facility on the basis that such resident or employee or any other person on behalf of the resident or employee has initiated or participated in any proceeding pursuant to this chapter, including providing information in connection with an inspection or facilitating a protection and advocacy agency investigation. The Department shall impose a civil penalty of not more than $10,000 per violation upon any licensee or other person who violates this subsection. (b) Any attempt to expel a resident of the long-term care facility or any other type of retaliatory or discriminatory treatment of a resident or employee or any other person by whom, or upon whose behalf, a complaint has been submitted to the Department or protection and advocacy agency or who has participated in any proceeding instituted under this chapter within 1 year of the filing of the complaint or the institution of such action, shall raise a rebuttable presumption that such action was taken by the licensee or other person in retaliation for the filing of the complaint or the cooperation with the proceeding. (71 Del. Laws, c. 488, § 2; 77 Del. Laws, c. 201, §§ 3, 4; 81 Del. Laws, c. 206, § 17.) § 1118. Third-Party reimbursement. Consistent with federal law, 42 U.S.C. § 1395i-3 (c)(5), with respect to admissions policy and practices, a long-term care facility must not require a third-party guarantee or payment to the facility as a condition of admission or expedited admission to, or continued stay in the facility. (71 Del. Laws, c. 488, § 2; 81 Del. Laws, c. 206, § 18.) § 1119. Priority placement of publicly assisted persons [Repealed]. (71 Del. Laws, c. 488, § 2; repealed by 81 Del. Laws, c. 206, § 19, effective Feb. 14, 2018.) § 1119A. Confidentiality of resident records. To protect the privacy of residents of a long-term care facility, the Department shall establish guidelines to protect the confidentiality of any records, documents, or files pertaining to such residents. (71 Del. Laws, c. 488, § 2; 81 Del. Laws, c. 206, § 20.) § 1119B. Pediatric nursing services. A facility that provides services to a resident younger than 18 years of age shall ensure all of the following: (1) Nursing services for a resident younger than 18 years of age are provided by staff who have received training and demonstrated competence in the care of children. (2) Consultative pediatric nursing services are available to the staff. (71 Del. Laws, c. 488, § 2; 81 Del. Laws, c. 206, § 21.) § 1119C. Regulations. (a) The Department has the authority to adopt, amend, repeal, or issue regulations to implement this chapter. In addition to regulations by category of facility to be licensed, the Department shall also develop pediatric regulations regarding the care of children in long-term care facilities. Page 105 Title 16 - Health and Safety (b) The Department shall include in its regulations for all facilities licensed under this chapter a requirement of full cooperation with the protection and advocacy agency in fulfilling functions authorized by this chapter. Without limiting the protection and advocacy’s agency’s pursuit of other legal remedies, the Department shall enforce violations of such regulations consistent with §§ 1109 and 1113 of this title. (71 Del. Laws, c. 488, § 2; 77 Del. Laws, c. 201, § 5; 81 Del. Laws, c. 206, § 22.) Subchapter II Rights of Residents. (81 Del. Laws, c. 206, § 23.) § 1121. Resident’s rights. (a) It is the intent of the General Assembly, and the purpose of this section, to promote the interests and well-being of the residents in long-term care facilities. (b) It is declared to be the public policy of this State that the interests of the resident shall be protected by a declaration of a resident’s rights, and by requiring that all facilities treat their residents in accordance with such rights, which shall include the following: (1) Each resident shall have the right to receive considerate, respectful, and appropriate care, treatment and services, in compliance with relevant federal and state law and regulations, recognizing each person’s basic personal and property rights which include dignity and individuality. (2) Each resident and the authorized representative under § 1122 of this title of such resident shall, prior to or at the time of admission, receive a written statement of the services provided by the facility including those required to be offered on an “as needed” basis, and a statement of related charges for services not covered under Medicare or Medicaid, or not covered by the facility’s basic per diem rate. Upon receiving such statement, the resident and the resident’s authorized representative under § 1122 of this title representative shall sign a written receipt which must be retained by the facility in its files. (3) After admission, each facility shall submit to the resident or authorized representative, on a monthly basis, a written, itemized statement detailing, in language comprehensible to the ordinary layperson, the charges and expenses the resident incurred during the previous month. a. The statement shall contain a description of specific services, equipment and supplies received, and expenses incurred for each such item. b. The statement shall include an explanation of any items identified by code or by initials, but shall not include nursing home based physician charges if billed separately. c. The facility shall make reasonable efforts to communicate the contents of the individual written statement to persons who it has reason to believe cannot read the statement. (4) Each resident shall receive from the attending physician or facility physician complete and current information concerning the resident’s diagnosis, treatment, and prognosis in terms and language the resident can reasonably be expected to understand, unless medically inadvisable. (5) Each resident shall participate in the planning of the resident’s medical treatment, including attendance at care plan meetings. (6) Each resident may refuse medication or treatment and must be informed of the medical consequences of all medication and treatment alternatives. (7) Each resident shall give prior informed consent to participation in any experimental research after a complete disclosure of the goals, possible effects on the resident and whether or not the resident can expect any benefits or alleviation of the resident’s condition. a. In any instance of any type of experiment or administration of experimental medicine, there shall be written evidence of compliance with this section, including the signature of the resident or the resident’s authorized representative if the resident has been adjudicated incompetent. b. A copy of signed acknowledgment or informed consent, or both when required, shall be forwarded to each signer and a copy shall be retained by the facility. (8) At the bedside of each resident, the facility shall place and maintain in good order the name, address, and telephone number of the physician responsible for the resident’s care. (9) Each resident shall receive respect and privacy in the resident’s own medical care program. Case discussion, consultation, examination, and treatment shall be confidential, and shall be conducted discreetly. a. At the resident’s discretion, persons not directly involved in the resident’s care may not be permitted to be present during such discussions, consultations, examinations or treatment, except with the consent of the resident. b. Personal and medical records shall be treated confidentially, and shall not be made public without the consent of the resident, except such records as are needed for a resident’s transfer to another health-care institution or as required by law or third-party payment contract. c. No personal or medical records shall be released to any person inside or outside the facility who has no demonstrable need for such records. Page 106 Title 16 - Health and Safety (10) Each resident shall be free from chemical and physical restraints imposed for purposes of discipline and convenience, and not necessary to treat the resident’s medical condition. (11) Each resident shall receive from the administrator or staff of the facility a courteous, timely, and reasonable response to requests, and the facility shall make prompt efforts to resolve grievances. Responses to requests and grievances shall be made in writing upon written request by the resident. (12) Each resident shall be provided with information as to any relationship the facility has with other health-care and related institutions or service providers, including pharmacy and rehabilitation services, to the extent the resident is offered care or services from these related entities. Such information shall be provided in writing upon admission, and thereafter when additional services are offered. (13) Each resident shall receive care that meets professional standards of care. (14) a. Each resident may associate and communicate, including visits and visitation, privately and without restriction with persons and groups of the resident’s own choice, on the resident’s own or their initiative, at any reasonable hour. b. Nothing in 77 Del. Laws, c. 49 precludes a long-term care facility, as defined in § 1102 of this title, from restricting visitations due to attempts to interfere with resident care, the presentation of a threat to staff, and residents, or personnel, or other actions disruptive to the facility’s operations. (15) Each resident may send and shall receive mail promptly and unopened. (16) Each resident shall have access at any reasonable hour to a telephone where the resident may speak privately. (17) Each resident shall have access to writing instruments, stationery, postage, and the Internet. (18) Each resident has the right to manage the resident’s own financial affairs. a. If, by written request signed by the resident, or by the authorized representative of a resident who has been adjudicated incompetent, the facility manages the resident’s financial affairs, it shall have available for inspection a monthly accounting, and shall furnish the resident and the resident’s authorized representative with a quarterly statement of the resident’s account. b. The resident shall have unrestricted access to such account at reasonable hours. (19) If married, a resident shall enjoy privacy in visits by the resident’s spouse, and, if spouses are both residents of the facility, they shall be afforded the opportunity where feasible to share a room, unless medically contraindicated. (20) Each resident has the right of privacy in the resident’s own room, and personnel of the facility shall respect this right by knocking on the door before entering the resident’s room. (21) Each resident has the right, personally, through other persons, or in combination with others to do any the following: a. Exercise the resident’s own rights. b. Present grievances. c. Recommend changes in facility policies or services on behalf of the resident’s self or others. d. Present complaints or petitions to the facility’s staff or administrator, the Department of Health and Social Services, the protection and advocacy agency, or other persons or groups without fear of reprisal, restraint, interference, coercion, or discrimination. (22) A resident may not be required to perform services for the facility. (23) Each resident shall have the right to retain and use the resident’s own personal clothing and possessions where reasonable, and shall have the right to security in the storage and use of such clothing and possessions. (24) The facility must permit each resident to remain in the facility, and not transfer or discharge the resident from the facility, except as provided in § 1127 of this title. (25) Each resident has the right to inspect all records pertaining to the resident, upon oral or written request, within 24 hours of notice to the facility. Each resident has the right to purchase photocopies of such records or any portion of them, at a cost not to exceed the community standard, upon written request and 2 working days’ advance notice to the facility. (26) Each resident shall be fully informed, in language the resident can understand, of the resident’s rights and all rules and regulations governing resident conduct and the resident’s responsibilities during the stay at the facility. (27) Each resident has the right to choose a personal attending physician. (28) Each resident has the right to examine the results of the most recent survey of the facility conducted by federal or state surveyors and any plan of correction in effect with respect to the facility. (29) Each resident has the right to receive information from the protection and advocacy agency and agencies acting as client advocates and be afforded the opportunity to contact those agencies. (30) Each resident shall be free from verbal, physical or mental abuse, cruel and unusual punishment, involuntary seclusion, withholding of monetary allowance, withholding of food, and deprivation of sleep. (31) Each resident shall be free to make choices regarding activities, schedules, health care, and other aspects of the resident’s life that are significant to the resident, as long as such choices are consistent with the resident’s interests, assessments, and plan of care and do not compromise the health or safety of the individual or other residents within the facility. Page 107 Title 16 - Health and Safety (32) Each resident has the right to participate in an ongoing program of activities designed to meet, in accordance with the resident’s individualized assessments and plan of care, the resident’s interests and physical, mental, and psychosocial well-being. (33) Each resident has the right to participate in social, religious, and community activities that do not interfere with the rights of other residents. (34) Each resident shall receive notice before the resident’s room or roommate is changed, except in emergencies. The facility shall endeavor to honor the room or roommate requests of the resident whenever possible. (35) Each resident shall be encouraged to exercise the resident’s own rights as a citizen of this State and the United States of America. (36) Each resident has the right to request and receive information regarding minimum acceptable staffing levels as it relates to the resident’s own care. (37) Each resident has the right to request and receive the names and positions of staff members providing care to the resident. (38) Each resident has the right to request and receive an organizational chart outlining the facility’s chain of command for purposes of making requests and asserting grievances. (39) Each resident has the right to compliance with the resident’s advance health-care directive, power of attorney, Delaware Medical Orders for Scope of Treatment, or similar document in accordance with and subject to Chapter 49 of Title 12 and Chapter 25 of this title. (40) If a resident is adjudicated incompetent, is determined to be incompetent by the resident’s attending physician, or is unable to communicate, the resident’s rights shall devolve to the resident’s authorized representative, as established under any of the following: a. An advance health-care directive. b. A medical durable power of attorney for health-care decisions. c. A court-appointed guardian under Chapters 39 and 39A of Title 12, in accordance with the authority granted by the appointing court. d. A surrogate appointed under Chapter 25 of this title. e. An individual who is otherwise authorized under applicable law to make the health-care decisions being made by execution of the DMOST form on the patient’s behalf under Chapter 25A of this title. (61 Del. Laws, c. 373, § 2; 69 Del. Laws, c. 345, § 5; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 465, § 1; 75 Del. Laws, c. 387, § 1; 77 Del. Laws, c. 49, §§ 3-5; 77 Del. Laws, c. 201, §§ 6, 7; 79 Del. Laws, c. 203, § 1; 79 Del. Laws, c. 204, § 3; 81 Del. Laws, c. 206, § 24.) § 1122. Devolution of rights. Where consistent with the nature of each right in § 1121 of this title, all rights, particularly as they pertain to a resident adjudicated incompetent in accordance with state law, or a resident who is found medically incapable by the resident’s own attending physician, or a resident who is unable to communicate with others, shall devolve to the resident’s authorized representative, as established under any of the following: (1) An advance health-care directive. (2) A medical durable power of attorney for health-care decisions. (3) A court-appointed guardian pursuant to Chapters 39 and 39A of Title 12, in accordance with the authority granted by the appointing court. (4) A surrogate appointed under Chapter 25 of this title. (5) An individual who is otherwise authorized under applicable law to make the health-care decisions being made by execution of the DMOST form on the patient’s behalf under Chapter 25A of this title. (6) A sponsoring agency or representative payee, except where the facility itself is the representative payee, selected under § 205(j) of the Social Security Act (42 U.S.C. § 405(j)). (61 Del. Laws, c. 373, § 2; 70 Del. Laws, c. 186, § 1; 81 Del. Laws, c. 206, § 25.) § 1123. Notice to patient. (a) Section 1121 of this title shall be posted conspicuously in a public place in long-term care facilities. (b) Copies of § 1121 of this title shall be furnished to the resident upon admittance to the facility; all residents currently residing in the facility; and the authorized representative under § 1122 of this title. The long-term care facility shall retain in its files a statement signed by each person listed in this subsection that the person has received a copy of § 1122 of this title. (61 Del. Laws, c. 373, § 2; 81 Del. Laws, c. 206, § 26.) § 1124. Staff training; issuance of regulations. (a) Each facility shall provide appropriate staff training to implement the bill of rights under § 1121 of this title. (b) Rules and regulations implementing this subchapter shall be developed by the Department. (61 Del. Laws, c. 373, § 2; 81 Del. Laws, c. 206, § 27.) Page 108 Title 16 - Health and Safety § 1125. Investigation of grievances. (a) The Department shall independently investigate any grievance concerning long-term care facilities. (b) Upon completion of an investigation, the Department shall report the findings to the complainants and to all other appropriate agencies of the State, county, or municipality as the case may be. If a grievance involves a protection and advocacy agency client, the findings shall be shared with the protection and advocacy agency. (61 Del. Laws, c. 373, § 2; 70 Del. Laws, c. 186, § 1; 77 Del. Laws, c. 201, § 8; 81 Del. Laws, c. 206, § 28.) § 1126. Recording anatomical gift data. (a) All long-term care facilities shall, if possible, ascertain from a resident upon admission whether or not the resident has donated all or part of the resident’s own body as an anatomical gift in a manner permitted by § 2713 of this title and the person, institution, or organization to which such gift has been made. (b) All long-term care facilities, as required by regulation, shall maintain as part of a resident’s permanent record the information required under this section and such other pertinent information about said anatomical gift which will facilitate the carrying out of the resident’s wishes in the event of the resident’s death. (c) Upon the death of a resident who has made an anatomical gift, long-term care facilities shall make every reasonable effort to contact without delay the person, institution, or organization to which such gift has been made. (63 Del. Laws, c. 238, § 2; 70 Del. Laws, c. 186, § 1; 81 Del. Laws, c. 206, § 29.) § 1127. Resident transfer or discharge. (a) The facility must permit each resident to remain in the facility and not transfer or discharge the resident from the long-term care facility unless at least 1 of the following criteria has been met: (1) The transfer or discharge is both necessary for the resident’s welfare and the resident’s needs cannot be met in the facility with reasonable accommodations when assessed with due regard to the scope of the facility’s license. (2) The discharge is appropriate because the resident’s health has improved sufficiently so the resident no longer needs the services provided by the facility. (3) The transfer or discharge is appropriate because the safety of individuals in the facility is endangered by the clinical or behavioral status of the resident. (4) The transfer or discharge is appropriate because the health of other individuals in the facility would otherwise be endangered. (5) The resident has failed, after reasonable and appropriate notice, to pay for, or to have paid by Medicare, Medicaid, or third party, a stay at the facility leading to discharge provided that: a. A resident who becomes eligible for Medicaid after admission to a facility may only be charged allowable charges under Medicaid. b. A resident who has submitted the necessary paperwork for third-party payment may not be discharged if a final decision on the claim has not been issued. (6) The facility ceases to operate. (b) Documentation. — Transfers or discharges under this section must be documented in the resident’s clinical record and must include all of the following: (1) The basis for the transfer or discharge under subsection (a) of this section. (2) In the case of a transfer or discharge under paragraph (a)(1) of this section, all of the following: a. The specific needs that cannot be met in the facility. b. The attempts made to meet those needs. c. The services available at the receiving facility to meet those needs. (3) The certification of the resident’s personal attending physician that transfer or discharge is necessary under paragraph (a)(1) or (a)(2) of this section. (4) A physician certification that transfer or discharge is necessary under paragraph (a)(3) or (a)(4) of this section. (c) Before a long-term care facility transfers or discharges a resident, the facility must issue a written notice of the transfer or discharge to the resident or resident’s authorized representative under § 1122 of this title and, if known, a family member or legal representative of the resident, whose content conforms to subsection (b) of this section. (d) Timing of the notice of transfer or discharge. — (1) Except as permitted under paragraph (d)(3) of this section, a notice of discharge must be issued by the long-term facility at least 30 days before the resident is transferred or discharged. (2) A long-term care facility may not discharge a resident during the pendency of administrative proceedings implementing a resident’s appeal of a discharge. (3) Notice must be issued as soon as practicable before transfer or discharge when 1 of the following standards is met: Page 109 Title 16 - Health and Safety a. An immediate transfer or discharge is required by the resident’s urgent medical needs supported by the certification required under subsection (b) of this section. b. There is a significant and immediate threat to the health or safety of other individuals in the long-term care facility as documented under paragraph (b)(3) or (b)(4) of this section. c. The resident was admitted solely on a respite basis not to exceed 14 days or as an emergency placement by the Department not to exceed 21 days. (e) The written notice described in paragraph (d)(3) of this section must include all of the following in language comprehensible to the ordinary layperson subject to revision to meet known special language considerations of the recipient: (1) A detailed individualized explanation of each reason for the transfer or discharge. (2) The effective date of transfer or discharge. (3) The location to which the resident is transferred or discharged. (4) The time frame and procedure to appeal the action to the State. (5) The name, address, and telephone number of the State Long-Term Care Ombudsperson and Division. (6) The name, address, and telephone number of the protection and advocacy agency for facility residents with developmental disabilities or mental illness. (f) In administrative and judicial proceedings implementing a resident’s appeal of a transfer or discharge, resident rights and protections conferred by applicable federal law must be considered. (g) For any transfer or discharge authorized by subsection (a) of this section, the long-term care facility shall develop a plan with the participation of the resident and resident’s authorized representative under § 1122 of this title, if any, to assist with orientation and the safe and orderly transfer or discharge from the facility. (h) (1) If a resident is transferred out of a long-term care facility to an acute care facility or other specialized treatment facility all of the following apply: a. The long-term care facility must accept the resident back when the resident no longer needs acute or specialized care and there is space available in the facility. b. If no space is available, the resident must be accepted into the next available bed. (2) For purposes of this subsection, “specialized treatment facility” means a health-care setting including, settings licensed or certified pursuant under this chapter or Chapter 22, 50, or 51 of this title. (81 Del. Laws, c. 206, § 30; 70 Del. Laws, c. 186, § 1.) Subchapter III Abuse, Neglect, Mistreatment, Financial Exploitation, or Medication Diversion of Patients or Residents (81 Del. Laws, c. 206, § 31; 83 Del. Laws, c. 22, § 1.) § 1131. Definitions. For purposes of this subchapter: (1) “Abuse” means the infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain, or mental anguish and includes all of the following: a. Physical abuse. — “Physical abuse” means the unnecessary infliction of pain or injury to a patient or resident. “Physical abuse” includes hitting, kicking, punching, slapping, or pulling hair. If any act constituting physical abuse has been proven, the infliction of pain is presumed. b. Sexual abuse. — “Sexual abuse” includes any sexual contact, sexual penetration, or sexual intercourse, as those terms are defined in § 761 of Title 11, with a patient or resident by an employee or volunteer working at a facility. It is not a defense that the sexual contact, sexual penetration, or sexual intercourse was consensual. c. Emotional abuse. — “Emotional abuse” means the use of oral, written, or gestured language that includes disparaging and derogatory terms to patients, residents, their families, or within their hearing distance, regardless of their age, ability to comprehend, or disability. “Emotional abuse” includes the violation of resident rights and privacy through the posting of inappropriate materials on social media. “Emotional abuse” includes all of the following: ridiculing, demeaning, humiliating, or cursing at a patient or resident; punishment or deprivation; or threatening a patient or resident with physical harm. d. [Repealed.] (2), (3) [Repealed.] (4) “Facility” means all of the following: a. Any facility required to be licensed under this chapter. Page 110 Title 16 - Health and Safety b. Any facility operated by or for the State which provides long-term care residential services. c. [Repealed.] d. Any hospital as defined under Chapter 10 of this title. “Hospital” is included in the definition of facility only for the purposes and application of this section and § 1136 of this title. (5) “Financial exploitation” means the illegal or improper use of a patient’s or resident’s resources or financial rights by another person, whether for profit or other advantage. (6) [Repealed.] (7) “High managerial agent” means an officer of a facility or any other agent in a position of comparable authority with respect to the formulation of the policy of the facility or the supervision in a managerial capacity of subordinate employees. (8) “Investigation” means the collection of evidence in response to an allegation of abuse, neglect, mistreatment, financial exploitation, or medication diversion of a patient or resident to determine if that patient or resident has been abused, neglected, mistreated, or financially exploited or has been the victim of medication diversion. The Department shall develop protocols for its investigations which focus on ensuring the safety and well-being of the patient or resident and which satisfy the requirements of this chapter. (9) “Licensed independent practitioner” means a physician or an individual licensed and authorized to write medical orders under Chapter 17 or Chapter 19 of Title 24 and who is providing care for the patient or resident or is overseeing the health care provided to the resident. (10) a. “Medication diversion” means the knowing or intentional interruption, obstruction, or alteration of the delivery or administration of a prescription drug to a patient or resident, if both of the following apply: 1. The prescription drug was prescribed or ordered by a licensed independent practitioner for the patient or resident. 2. The interruption, obstruction, or alteration occurred without the prescription or order of a licensed independent practitioner. b. “Medication diversion” does not mean conduct performed by any of the following: 1. A licensed independent practitioner or licensed health-care professional who acted in good faith within the scope of the individual’s practice or employment. 2. An individual acting in good faith while rendering emergency care at the scene of an emergency or accident. (11) “Mistreatment” means the inappropriate use of medications, isolation, or physical or chemical restraints on or of a patient or resident. (12) “Neglect” means the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness. Neglect includes all of the following: a. Lack of attention to physical needs of the patient or resident including toileting, bathing, meals, and safety. b. Failure to report patient or resident health problems or changes in health problems or changes in health condition to an immediate supervisor or nurse. c. Failure to carry out a prescribed treatment plan for a patient or resident. d. A knowing failure to provide adequate staffing which results in a medical emergency to any patient or resident where there has been a documented history of at least 2 prior cited instances of such inadequate staffing within the past 2 years in violation of minimum maintenance of staffing levels as required by statute or regulations promulgated by the Department, all so as to evidence a wilful pattern of such neglect. (13) “Person” means a human being and, where appropriate, a public or private corporation, an entity, an unincorporated association, a partnership, a government, or governmental instrumentality. (14) [Repealed.] (15) “Prescription drug” means a drug required by federal or state law or regulation to be dispensed only by a prescription, which means a lawful written or verbal order of a practitioner for a drug, including finished dosage forms and active ingredients, subject to § 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 353(b)). (65 Del. Laws, c. 442, § 1; 70 Del. Laws, c. 222, § 3; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 550, § 1; 71 Del. Laws, c. 487, § 1; 72 Del. Laws, c. 120, §§ 1-4; 77 Del. Laws, c. 201, § 9; 78 Del. Laws, c. 30, § 1; 79 Del. Laws, c. 193, § 1; 80 Del. Laws, c. 404, § 1; 81 Del. Laws, c. 206, § 32; 81 Del. Laws, c. 209, §§ 2,14; 83 Del. Laws, c. 22, § 2; 83 Del. Laws, c. 283, § 20.) § 1132. Reporting requirements. (a) (1) Any employee of a facility or person who provides services to a patient or resident on a regular or intermittent basis who has reasonable cause to believe that a patient or resident in a facility has been abused, neglected, mistreated, or financially exploited or has been the victim of medication diversion shall immediately report the abuse, neglect, mistreatment, financial exploitation, or medication diversion to the Department by oral communication. The employee or person providing services to a patient or resident shall file a written report within 48 hours after the employee or person providing services to a patient or resident first gains knowledge of the abuse, neglect, mistreatment, financial exploitation, or medication diversion. Page 111 Title 16 - Health and Safety (2) In addition to the persons required to report abuse, neglect, mistreatment, financial exploitation, or medication diversion under paragraph (a)(1) of this section, any other person, including a patient or resident, may contact the Department to report any complaint concerning the health, safety, and welfare of patients or residents. (3) The Department shall inform a person making a report under paragraph (a)(1) or (a)(2) of this section of the person’s right to obtain information concerning the disposition of the report. The person must receive, if requested, information on the general disposition of the report at the conclusion of the investigation. (4) If the Department does not have jurisdiction over the report, the Department shall so advise the person making the report under paragraph (a)(1) or (a)(2) of this section and shall promptly refer the person to the appropriate agency. (b) Any person required by subsection (a) or (c) of this section to make an oral and a written report who fails to do so is to be fined not more than $1,000 or imprisoned not more than 15 days, or both. (c) In addition to those persons subject to subsection (a) of this section, any other person shall make a report if the person has reasonable cause to believe that a patient or resident has been abused, neglected, mistreated, or financially exploited, or has been the victim of medication diversion. A report under this subsection is confidential and the reporting person cannot be compelled to do either of the following: (1) Notify the facility, care provider, or individual implicated in the event. (2) Provide information regarding the reported abuse, neglect, mistreatment, financial exploitation, or medication diversion to the facility, care provider, or individual implicated in the event. (d) Any person who intentionally makes a false report under this subchapter is guilty of a class A misdemeanor. (e) Any correspondence or other written communication from a patient or resident to the Department, the Attorney General’s office, the protection and advocacy agency, or a law-enforcement agency must, if delivered to or received by a facility, be promptly forwarded, unopened, by the facility to the agency to which it is written. Violation of this subsection is punishable by a civil penalty not to exceed $1,000 per violation. (f) Any correspondence or other written communication from the Department, the Attorney General’s office, the protection and advocacy agency, or a law-enforcement agency to a patient or resident must, if delivered to or received by a facility, be promptly forwarded, unopened, by the facility to the patient or resident. Violation of this subsection is punishable by a civil penalty not to exceed $1,000 per violation. (65 Del. Laws, c. 442, § 1; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 292, § 1; 71 Del. Laws, c. 487, §§ 3, 5, 6; 74 Del. Laws, c. 196, § 1; 77 Del. Laws, c. 201, § 10; 81 Del. Laws, c. 206, § 33; 83 Del. Laws, c. 22, § 3.) § 1133. Contents of reports. The reports required under this subchapter must contain all of the following information: (1) The name and sex of the patient orresident. (2) The name and address of the facility in which the patient or resident resides. (3) The age of the patient or resident, if known. (4) The name and address of the reporter and where the reporter can be contacted. (5) Any information relative to the nature and extent of the abuse, neglect, mistreatment, financial exploitation, or medication diversion and, if known to the reporter, any information relative to prior abuse, neglect, mistreatment, financial exploitation, or medication diversion of the patient or resident. (6) The circumstances under which the reporter became aware of the abuse, neglect, mistreatment, financial exploitation, or medication diversion. (7) What action, if any, was taken to treat or otherwise assist the patient or resident. (8) Any other information which the reporter believes to be relevant in establishing the cause of the abuse, neglect, mistreatment, financial exploitation, or medication diversion. (65 Del. Laws, c. 442, § 1; 70 Del. Laws, c. 186, § 1; 81 Del. Laws, c. 206, § 34; 83 Del. Laws, c. 22, § 4.) § 1134. State response to reports of adult abuse, neglect, mistreatment, financial exploitation, or medication diversion. (a) The Department shall ensure that patients or residents are afforded the same rights and protections as other individuals in the State. (b) [Repealed.] (c) The Department shall establish and maintain a 24-hour statewide toll-free telephone report line operating at all times and capable of receiving reports of alleged abuse, neglect, mistreatment, financial exploitation, and medication diversion. (d) On receipt of an allegation of abuse, neglect, mistreatment, financial exploitation, or medication diversion, the Department shall do all of the following: (1) Receive and maintain reports in a computerized central data base. Page 112 Title 16 - Health and Safety (2) Acknowledge all complaints, when authorized by the person making the report. The acknowledgement shall identify other relevant remedial agencies, including the protection and advocacy agency, Office of the Long-Term Care Ombudsperson, and victim rights resource organizations. (3) Forward complaints to the appropriate Department staff who shall determine, through the use of standard operating procedures developed by the Department, whether an investigation should be initiated to respond to the complaint. The Department shall develop the protocols for making this determination and the protocols must give priority to ensuring the well-being and safety of patients and residents. (4) Begin the investigation within 24 hours of receipt of any report or complaint that alleges any of the following: a. A patient’s or resident’s health or safety is in imminent danger. b. A patient or resident has died due to alleged abuse, neglect, mistreatment, or medication diversion. c. A patient or resident has been hospitalized or received medical treatment due to alleged abuse, neglect, mistreatment, or medication diversion. d. The existence of circumstances that could result in abuse, neglect, mistreatment, or medication diversion and that could place a patient’s or resident’s health or safety in imminent danger. e. A patient or resident has been the victim of financial exploitation or risk thereof and exigent circumstances warrant an immediate response. (5) Except in situations outlined in paragraph (d)(4) of this section, initiate and conclude an investigation within 10 days of receiving a report or complaint unless extenuating facts warrant a longer time to complete the investigation. (6) Contact the appropriate law-enforcement agency immediately on receipt of any complaint requiring an investigation under this section and provide the police with a detailed description of the complaint received. a. The appropriate law-enforcement agency shall conduct its investigation or provide the Department within a reasonable time an explanation detailing the reasons why it is unable to conduct the investigation. b. The Department may defer its own investigation in these circumstances until it receives appropriate guidance from the Attorney General’s Office and the relevant police agency with respect to how to proceed with its investigation thereby assuring a coordinated investigation. c. Notwithstanding any provision of the Delaware Code to the contrary, to the extent the law-enforcement agency with jurisdiction over the case is unable to assist, the Department may request that the Delaware State Police exercise jurisdiction over the case and, upon such request, the Delaware State Police may exercise such jurisdiction. (7) If a case is classified as an investigation under this subchapter, have the authority to secure a medical examination of a longterm care patient or resident on the consent of the patient or resident without the consent of the long-term care facility if the patient or resident has been reported to be a victim of abuse, neglect, or mistreatment, or medication diversion. (8) When a written report of abuse, neglect, mistreatment, financial exploitation, or medication diversion is made by a person required to report under § 1132(a) of this title, the Department shall contact the person who made the report within 48 hours of the receipt of the report in order to ensure that full information has been received and to obtain any additional information, including medical records, which may be pertinent. (9) Conduct an investigation involving all reports which, if true, would constitute a criminal offense, or an attempt to commit a criminal offense, under any of the following provisions of Title 11: §§ 601, 602, 603, 604, 611, 612, 613, 621, 625, 626, 627, 631, 632, 633, 634, 635, 636, 645, 763, 764, 765, 767, 768, 769, 770, 771, 772, 773, 774, 775, 791, 841, 842, 843, 844, 845, 846, 848, 851, 861, 862 and 908. (10) Develop protocols to ensure that it conducts its investigation in coordination with the relevant law-enforcement agency. The primary purpose of the Department’s investigation must be the protection of the patient or resident. (11) Do any of the following when investigating abuse, neglect, mistreatment, financial exploitation, or medication diversion reports: a. Make unannounced visits to the facility, as required, to determine the nature and cause of the alleged abuse, neglect, mistreatment, financial exploitation, or medication diversion. b. Interview available witnesses identified by any source as having personal knowledge relevant to the reported abuse, neglect, mistreatment, financial exploitation, or medication diversion. c. Conduct interviews in private unless the witness expressly requests that the interview not be private. d. Write an investigation report that includes all of the following: 1. The investigator’s personal observations. 2. A review of the medical and all other relevant documents and records. 3. A summary of each witness statement. 4. A statement of the factual basis for the findings for each incident or problem alleged in the complaint. (12)-(16) [Repealed.] Page 113 Title 16 - Health and Safety (17) Before the completion of an investigation, file a petition for the temporary care and protection of the patient or resident if the Department determines that immediate removal is necessary to protect the patient or resident from further abuse, neglect, mistreatment, financial exploitation, or medication diversion. (18) On completing an investigation of a complaint, the Department shall take 1 or more of the following courses of action, as appropriate: a. If representatives of the Department, the Attorney General’s Office, or the appropriate law-enforcement agency are unable to substantiate a complaint that applicable laws or regulations have been violated, the Department, Attorney General’s Office, or appropriate law-enforcement agency shall so advise the complainant and the facility, agency, or individual against which the complaint was made. b. If Department representatives are able to substantiate a complaint that applicable laws or regulations have been violated, the Department shall take appropriate enforcement action. 1. An enforcement action may include instituting actions by the Department for injunctive relief or other relief deemed appropriate. 2. The Attorney General’s Office shall provide legal advice and assist the Department to institute an enforcement action. c. If the Department discovers a violation of federal laws or regulations or rules administered by any other government agency, the Department shall refer the matter directly to the appropriate government agency for an enforcement action. d.-f. [Repealed.] (19) Protect the privacy of the long-term care patient or resident and the patient’s or resident’s family. a. The Department shall establish guidelines concerning the disclosure of information relating to complaints and investigations regarding abuse, neglect, mistreatment, financial exploitation, or medication diversion involving that patient or resident. b. The Department may require persons to make written requests for access to records maintained by the Department. c. Records maintained for investigations conducted under this section are not public records under Chapter 100 of Title 29 and the Department may only release information to persons who have a legitimate public safety need for the information and the information must be used only for the purpose for which it is released under a user agreement with the Department. (e) The protection and advocacy agency may complement the Department’s complaint resolution system through monitoring, investigation, and advocacy on behalf of facility patients or residents. In furtherance of this authority, protection and advocacy agency representatives may engage in all of the following functions: (1) Solicit and receive oral and written reports and complaints of abuse, neglect, mistreatment, financial exploitation, or medication diversion of facility patients or residents. (2) Access a facility. (3) Interview patients, residents, facility staff, and agents. (4) Inspect and copy records pertaining to the patient or resident with valid consent or as otherwise authorized by federal law. (f) The Department may develop protocols with the protection and advocacy agency to facilitate coordination whenever both agencies have initiated an overlapping investigation. (g) The immunities and protections under § 1135 of this title apply to persons offering reports or testimony to initiate or support protection and advocacy agency investigation or advocacy. (h) Appointment of special investigators; powers and duties. — (1) The Secretary of the Department may appoint qualified persons to be special investigators. a. The investigators hold office at the pleasure of the Secretary. b. Any individual appointed under this section must have all of the following qualifications: 1. A minimum of 10 years experience as a police officer, as that term is defined in § 1911(a) of Title 11. 2. Significant investigatory experience while working as a police officer. 3. Be in good standing with the previous or present law-enforcement agency where the individual was or is employed. 4. Other qualifications deemed appropriate by the Secretary. (2) Special investigators appointed under this section may conduct investigations of abuse, neglect, mistreatment, financial exploitation, or medication diversion of patients and residents of facilities and adults who are impaired as defined in § 3902 of Title 31 anywhere in this State as directed by the Department and have the power to make arrests and serve writs anywhere in this State. a. In conducting the investigations, the special investigators have the statewide powers enumerated under § 1911 of Title 11 and other powers as conferred by law on police officers, but the powers are limited to offenses involving abuse, neglect, mistreatment, financial exploitation, or medication diversion of patients and residents of long-term care facilities and adults who are impaired anywhere in this State as directed by the Department. b. To the extent possible, special investigators under this section may consult with the police agency having jurisdiction and the Department before making an arrest and shall do so in all cases after making the arrest. Page 114 Title 16 - Health and Safety (3) The Secretary of the Department shall fix the salary of special investigators within the appropriations made to the Department. (4) Special investigators shall assist in the training of other Department staff. (i) On receipt of any report under paragraph (d)(5) of this section, the law-enforcement agency having jurisdiction shall conduct a full and complete criminal investigation based on their departmental policies and shall assess probable cause and effectuate arrests when appropriate. (1) The Attorney General’s Office or other law-enforcement agency conducting the investigation shall keep the Department informed of the case status and all major decisions under memoranda of understanding between the Department and the Attorney General’s Office and other relevant law-enforcement agencies entered into under subsection (j) of this section. (2) The Attorney General’s Office shall keep the Department well informed of the case status and all major decisions, including the disposition of criminal charges and the specifics of any sentencing order rendered. (j) The Department, the Attorney General’s Office, and other law-enforcement agencies shall develop memoranda of understanding under this subchapter which provide for timely notification, co-investigation, referral of cases, including automatic referral in certain cases, and ongoing coordination in order to keep each other apprised of the status of their respective investigations. The memoranda of understanding may be amended as needed. (k) If the Department suspects or discovers information indicating the commission of violations of standards of professional conduct by facilities licensed under this chapter or by staff employed by such facilities, the Department shall immediately contact the Attorney General’s Office and the relevant professional licensing board. (l) The Department and the Attorney General’s Office shall cooperate with law-enforcement agencies to develop training programs to increase the effectiveness of Department personnel, Attorney General’s Office personnel, and law-enforcement officers in investigating suspected cases of abuse, neglect, mistreatment, financial exploitation, or medication diversion. (m) If a criminal prosecution for abuse, neglect, mistreatment, financial exploitation, or medication diversion is initiated by the Attorney General’s Office based on a report under this subchapter, and incarceration of the individual who is the subject of the report is ordered by the court, the Attorney General’s Office shall keep the Department informed of actions taken by the court which result in the release of the individual if the Attorney General’s Office is represented at the hearing. (n) If a criminal prosecution for abuse, neglect, mistreatment, financial exploitation, or medication diversion is initiated by the Attorney General’s Office against a person employed by or associated with a facility or organization required to be licensed or whose staff are required to be licensed under Delaware law, the Attorney General’s Office shall notify the Department within 48 hours and the Department shall then notify the individual’s employer as follows: (1) When the individual is charged with having committed at least 1 felony offense involving an allegation of abuse, neglect, mistreatment, financial exploitation, or medication diversion. (2) On an adjudication of guilt of the person for any misdemeanor or violation, when the offense involved abuse, neglect, mistreatment, financial exploitation, or medication diversion. (65 Del. Laws, c. 442, § 1; 70 Del. Laws, c. 222, § 4; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 487, § 4; 72 Del. Laws, c. 3, § 4; 74 Del. Laws, c. 212, § 1; 77 Del. Laws, c. 201, §§ 11-14; 77 Del. Laws, c. 318, § 6; 78 Del. Laws, c. 179, § 164; 81 Del. Laws, c. 206, § 35; 81 Del. Laws, c. 209, §§ 3, 14; 83 Del. Laws, c. 22, § 5.) § 1135. Immunities and other protections. (a) A person making any oral or written report under this subchapter is not liable in any civil or criminal action by reason of the report where the report was made in good faith or under the reasonable belief that the abuse, neglect, mistreatment, financial exploitation, or medication diversion has occurred. (b) A facility may not discharge, or in any manner discriminate or retaliate against any person, by any means whatsoever, who in good faith makes or causes to be made, a report under this subchapter, or who testifies or who is about to testify in any proceeding concerning abuse, neglect, mistreatment, financial exploitation, or medication diversion of patients or residents. (c) Any facility which discharges, discriminates, or retaliates against a person because the person reports, testifies, or is about to testify concerning abuse, neglect, mistreatment, financial exploitation, or medication diversion of patients or residents is liable to the person for treble damages, costs, and attorney fees. If a facility discharges, demotes, or retaliates by any other means against a person after the person makes a report, testifies, or is subpoenaed to testify as a result of a report authorized under this subchapter, there is a rebuttable presumption that the facility discharged, demoted, or retaliated against the person as a result of the report or testimony. (d) This section does not apply to any person who has engaged in the abuse, neglect, mistreatment, financial exploitation, or medication diversion of a patient or resident. (65 Del. Laws, c. 442, § 1; 70 Del. Laws, c. 186, § 1; 77 Del. Laws, c. 201, §§ 15, 16; 81 Del. Laws, c. 206, § 36; 83 Del. Laws, c. 22, § 6.) § 1136. Violations. (a) Any person who knowingly or recklessly abuses, mistreats, or neglects a patient or resident is guilty of a class A misdemeanor. Page 115 Title 16 - Health and Safety (1) If the abuse involves sexual contact such person is guilty of a class G felony. (2) If the abuse, mistreatment, or neglect results in serious physical injury, sexual penetration, or sexual intercourse, such person is guilty of a class C felony. (3) If the abuse, mistreatment, or neglect results in death, then the person is guilty of a class A felony. (b) Any person who knowingly causes medication diversion of a patient or resident,is guilty of the following: (1) A class G felony. (2) A class F felony, if committed by a health-care professional. (c) Any person who knowingly commits financial exploitation of a patient’s or resident’s resources is guilty of the following: (1) A class A misdemeanor if the value of the resources is less than $1,000. (2) A class G felony if the value of the resources is $1,000 or more. (d) Any member of the board of directors or a high managerial agent who knows that patients or residents of the facility are being abused, mistreated, neglected, or financially exploited or are the victim of medication diversion and fails to promptly take corrective action is guilty of a class A misdemeanor. (e) Nothing in this section precludes a separate charge, conviction, and sentence for any other crime under this title or this Code. (65 Del. Laws, c. 442, § 1; 72 Del. Laws, c. 120, §§ 5, 6; 78 Del. Laws, c. 30, §§ 2, 3; 79 Del. Laws, c. 193, § 2; 81 Del. Laws, c. 206, § 37; 83 Del. Laws, c. 22, § 7.) § 1137. Suspension or revocation of license for violation by licensed or registered professional. On a finding of abuse, neglect, mistreatment, or medication diversion by a licensed or registered professional, or a licensed or registered professional’s failure to report abuse, neglect, mistreatment, or medication diversion by a licensed or registered professional, the Department or the Attorney General’s Office shall notify the appropriate licensing or registration board. If, after a hearing, a licensed or registered professional is found to have abused, neglected, or mistreated, or committed medication diversion against, a patient or resident or has failed to report abuse, neglect, mistreatment, or medication diversion, the appropriate board shall suspend or revoke the licensed or registered professional’s license. (65 Del. Laws, c. 442, § 1; 83 Del. Laws, c. 22, § 8.) § 1138. Suspension or revocation of license for violation by facility. On a finding that abuse, neglect, mistreatment, financial exploitation, or medication diversion has occurred in a facility, if it is determined that a member of the board of directors or a high managerial agent knew that patients or residents were abused, neglected, mistreated, or financially exploited or the victim of medication diversion and failed to promptly take corrective action, the Department must suspend or revoke the facility’s license. (65 Del. Laws, c. 442, § 1; 81 Del. Laws, c. 206, § 38; 83 Del. Laws, c. 22, § 9.) § 1139. Treatment by spiritual means. Nothing in this subchapter may be construed to mean that a patient or resident is abused, neglected, or mistreated, or is the victim of medication diversion, for the sole reason the patient or resident relies on, or is being furnished with, treatment by spiritual means through prayer alone in accordance with the tenets and practices of a recognized church or religious denomination, nor may anything in this subchapter be construed to authorize or require any medical care or treatment over the implied or express objection of the patient or resident. (65 Del. Laws, c. 442, § 1; 70 Del. Laws, c. 186, § 1; 81 Del. Laws, c. 206, § 39; 83 Del. Laws, c. 22, § 10.) § 1140. Jurisdiction. The Superior Court shall have original and exclusive jurisdiction over violations of this subchapter. (65 Del. Laws, c. 442, § 1.) Subchapter IV Criminal Background Checks; Mandatory Drug Screening; Long-Term Care Facilities; Nursing Home Compliance with Title XIX of the Social Security Act. (81 Del. Laws, c. 206, § 40.) § 1141. Criminal background checks. (a) Purpose. — The purpose of the criminal background check and drug screening requirements of this section and § 1142 of this title is the protection of the safety and well-being of residents of long-term care facilities licensed pursuant to this chapter. These sections shall be construed broadly to accomplish this purpose. Page 116 Title 16 - Health and Safety (b) Definitions. — As used in this subchapter: (1) “Applicant” means any of the following: a. A person seeking employment in a facility. b. A current employee of a facility who seeks a promotion in the facility. c. A self-employed person or a person employed by an agency for work in a facility. d. A current employee of a facility or a person as defined in paragraph (b)(1)c. of this section who the Department has a reasonable basis to suspect has been arrested for a disqualifying crime since becoming employed or commencing work. e. A former employee who consents prior to leaving employment to periodic review of his or her criminal background for a fixed time period. (2) “Background Check Center (BCC)” means the electronic system which combines the data streams from various sources within and outside the State in order to assist an employer in determining the suitability of a person for employment in a long-term care facility. (3) “Criminal history” means a report from the Department regarding its review of the applicant’s entire federal criminal history from the Federal Bureau of Investigation, under Public Law 92-544 as amended (28 U.S.C. § 534), and the applicant’s Delaware record from the State Bureau of Identification. (4) [Repealed.] (5) “Facility” means any facility licensed under subchapter I of this chapter. (6) [Repealed.] (7) “SBI” means the State Bureau of Identification. (c) An employer may not employ an applicant for work in a facility before obtaining a criminal history. The criminal history of any person not employed directly by the facility must be provided to the facility upon the person’s commencement of work. (d) The requirements of subsection (c) of this section may be suspended for 60 days if the employer wishes to employ the applicant on a conditional basis. (1) Before an employer may offer conditional employment, the employer must receive verification that the applicant has been fingerprinted by the SBI for purposes of the criminal history. (2) The Department may not issue a criminal history if the applicant fails to provide information to the Department regarding the status or disposition of an arrest within 45 days from the date of notice from the Department of an open criminal charge. The Department may extend the time limits for good cause shown. (e) An employer may not employ or continue to employ an individual with a conviction deemed disqualifying by the Department’s regulations. (f) Any employer who employs an applicant and fails to secure a criminal history is subject to a civil penalty of not less than $1,000 nor more than $5,000 for each violation. An employer is also subject to this penalty if that employer conditionally employs an applicant before receiving verification that the applicant has been fingerprinted for purposes of the criminal history. (g) The criminal history provided to the employer is strictly confidential. It may be used solely to determine the suitability of an applicant for employment or continued employment in a facility. It must be stored in a manner that maintains its confidentiality. (h) An applicant may not be employed in a facility, other than conditionally under subsection (d) of this section, until the applicant’s employer has secured the applicant’s criminal history. (i) Before an applicant is permitted to be employed in a facility, the applicant must, upon request, do all of the following: (1) Provide accurate information sufficient to secure a criminal history. (2) Execute a full release to enable the employer to secure a criminal history and to update the criminal history while employed. (3) Execute a full release giving the employer permission to provide the criminal history to the facility where the work is to be performed if the employer is other than the facility. (j) An applicant who fails to comply with subsection (i) of this section is subject to a civil penalty of not less than $1,000 nor more than $5,000 for each violation. (k), (l) [Repealed.] (m) The Department shall promulgate regulations regarding all of the following: (1) The criteria it uses to determine unsuitability for employment. (2) The policies and procedures for preparing the criminal history which govern the frequency of criminal record review and updating. (3) The frequency with which fingerprints must be obtained. (4) The information that the Department provides in the criminal history about disqualifying and nondisqualifying criminal convictions. (5) The methods for notifying applicants and employers of the results of the Department’s review, and for providing applicants with the criminal history. Page 117 Title 16 - Health and Safety (6) The administrative review process available to a person desiring to contest adverse information. (7) Other provisions required to achieve the purpose of this section. (71 Del. Laws, c. 466, § 2; 70 Del. Laws, c. 186, § 1; 72 Del. Laws, c. 2, § 1; 74 Del. Laws, c. 195, §§ 1-6; 77 Del. Laws, c. 84, § 205; 78 Del. Laws, c. 303, § 2; 81 Del. Laws, c. 206, § 41.) § 1142. Mandatory drug screening. (a) An employer may not employ an applicant without first obtaining the results of that applicant’s mandatory drug screening. (b) All applicants must submit to mandatory drug screening, as specified by regulations promulgated by the Department. (c) The Department shall promulgate regulations, regarding the pre-employment testing of all applicants, for use of all of the following illegal drugs: (1) Marijuana/cannabis. (2) Cocaine. (3) Opiates. (4) Phencyclidine (“PCP”). (5) Amphetamines. (6) Any other illegal drug specified by the Department under regulations promulgated under this section. (d) An agency, including temporary agencies, must provide the drug screening results it receives regarding an applicant referred to work in a facility to that particular facility so that the facility is better able to make an informed decision whether to accept the referral. (e) The employer must provide confirmation of the drug screen in the manner prescribed by the Department’s regulations. (f) Any employer who fails to comply with the requirements of this section is subject to a civil penalty of not less than $1,000 nor more than $5,000 for each violation. (71 Del. Laws, c. 466, § 2; 72 Del. Laws, c. 2, § 1; 72 Del. Laws, c. 366, § 1; 78 Del. Laws, c. 303, § 2; 81 Del. Laws, c. 206, § 42.) § 1143. Standards of care for nursing homes providing care to Medicaid recipients. (a) Any nursing facility as defined in 42 U.S.C. § 1396r(a) shall comply with all requirements regarding such facilities contained in Title XIX of the Social Security Act [42 U.S.C. § 1396 et seq.] and in any federal regulation issued pursuant thereto. (b) For any violation of subsection (a) of this section, a nursing facility shall be subject to 1 or more of the following remedies: (1) Denial of payment with respect to any recipient under the state Medicaid program admitted to the nursing facility, with notice to the public and the facility as provided for by regulations promulgated by the Department. (2) A civil fine between 2 percent to 100 percent of a facility’s current per diem rate, which shall be collected with interest at the legal rate of interest, for each day in which a facility fails to comply with a requirement constituting a separate violation. Funds collected as a result of imposition of such a penalty shall be applied to the protection of the health or property of residents of the nursing facility found to have been in violation, including payment for the costs of relocation of residents to other facilities, maintenance of operation of a facility pending correction of deficiencies or closure, and reimbursement of residents for personal funds lost. (3) The appointment, pursuant to regulations adopted by the Department, of temporary management to oversee the operation of the facility and to assure the health and safety of the facility’s residents. (4) In the case of an emergency, the closure of the facility, the transfer of residents in that facility or other facilities, or both. (c) In the case of a nursing facility which, on 3 consecutive standard surveys conducted pursuant to the rules or regulations promulgated by the Department, has been found to have provided substandard quality of care or has otherwise failed to comply with the requirement imposed pursuant to subsection (a) or (e) of this section, the Department shall (regardless of what other remedies are provided): (1) Impose the remedy described in paragraph (b)(1) of this section; and (2) Monitor the facility pursuant to regulations promulgated by the Department, until the facility has demonstrated, to the satisfaction of the Department, that the facility is in compliance with the requirements imposed pursuant to subsection (a) or (e) of this section, and that the facility will remain in compliance with such requirements. (d) If a nursing facility has failed to comply with any of the requirements pursuant to subsection (a) or (e) of this section, within 3 months after the date the facility is found to be out of compliance with such requirements, the Department shall impose the remedy described in paragraph (b)(1) of this section for all individuals who are admitted to the facility after such date. (e) The Department may establish and promulgate such rules and regulations governing the administration and operation of this section as may be deemed necessary and which are not inconsistent with the laws of this State. (f) The Secretary of the Department or the Secretary’s designee shall have jurisdiction to hear any matter arising under subsections (a) and (e) of this section and shall have the power to impose any remedy listed under subsections (b), (c), and (d) of this section. Any party who is not satisfied with a decision of the Secretary or the Secretary’s designee may appeal to the Superior Court for the county in which Page 118 Title 16 - Health and Safety the facility is located. Such appeal must be filed within 30 days from the date of the Secretary’s or the Secretary’s designee’s decision and must be on the record made before the Secretary or the Secretary’s designee. (g) This section is intended to be applicable solely to nursing facilities as defined by 42 U.S.C. § 1396r(a) and shall not alter, amend, repeal, restrict or otherwise affect any existing Medicaid appeals procedures established by the Department. (67 Del. Laws, c. 79, § 1; 70 Del. Laws, c. 149, §§ 105, 106; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 466, § 1; 81 Del. Laws, c. 206, § 43.) § 1144. Influenza immunizations. (a) Nursing and assisted living facilities shall annually offer, beginning no later than October 1 and extending through March 1 of a calendar year, onsite vaccinations for influenza vaccine to all employees with direct contact with patients at no cost and contingent upon availability of the vaccine. (b) The facility shall keep on record a signed statement from each employee stating that the employee has been offered vaccination against influenza and has either accepted or declined such vaccination. (c) [Repealed.] (81 Del. Laws, c. 346, § 1; 82 Del. Laws, c. 141, § 18; 83 Del. Laws, c. 306, § 1.) Subchapter V Criminal Background Checks; Drug Testing — Home-Care Agencies. (81 Del. Laws, c. 206, § 44.) § 1145. Criminal background checks. (a) Purpose. — The purpose of the criminal background check and drug screening requirements of this section and § 1146 of this title is the protection of the safety and well-being of residents of this State who use the services of home health agencies, hospice agencies, or personal assistance services agencies licensed under this title or who employ a person to provide care in a private residence. These sections must be construed broadly to accomplish this purpose. (b) Definitions. — As used in this subchapter: (1) “Applicant” means any of the following: a. A person seeking employment with an employer. b. A current employee who seeks a promotion from an employer. c. A self-employed person seeking employment in a private residence for the purpose of providing services to protect the health, safety, and well-being of an individual who requires home health-care service as defined in § 122(3)m, § 122(3)o., or § 122(3)x. of this title. d. A current employee of an employer who the Department has a reasonable basis to suspect has been arrested for a disqualifying crime since becoming employed. e. A former employee who consents prior to leaving employment to periodic review of the former employee’s criminal background for a fixed time period. (2) “Authorized representative” means an individual who has the highest priority to act for the patient under law, and who has the authority to make decisions with respect to the patient’s health-care preferences. The patient’s authorized representative can be 1 of the following: a. An individual designated by a patient under an advance health-care directive; an agent under a medical durable power of attorney for health-care decisions. b. A guardian of the person appointed under Chapter 39 or 39A of Title 12, in accordance with the authority granted by the court; a surrogate appointed under Chapter 25 of this title. c. An individual who is otherwise authorized under applicable law to make health-care decisions on the patient’s behalf, if the patient lacks decision-making capacity. (3) “Background Check Center (BCC)” means the electronic system which combines the data streams from various sources within and outside the State in order to assist an employer in determining the suitability of a person for employment in a home-care agency or private residence. (4) “Criminal history” means a report from the Department regarding its review of the applicant’s entire federal criminal history from the Federal Bureau of Investigation, under Public Law 92-544 as amended (28 U.S.C. § 534) and the applicant’s Delaware record from the State Bureau of Identification. (5) “Department” means the Department of Health and Social Services. Page 119 Title 16 - Health and Safety (6) “Employer” means a home-care agency; a management company that contracts to provide services on behalf of a home-care agency; or other business entity, including a temporary employment agency, that contracts to provide services on behalf of a homecare agency. (7) “Home-care agency” means all programs or agencies licensed under § 122(3)m., § 122(3)o., or § 122(3)x. of this title that provide services to individuals in their private residence. (8) “Private residence” means the domicile of the individual in need of care, either personally owned by that individual or considered the place of residence of that individual. (9) “SBI” means the State Bureau of Identification. (c) An employer may not employ an applicant for work in a private residence before obtaining a criminal history. Upon request, the criminal history must be provided to the person for whom the services are to be provided, or to the person’s authorized representative upon the applicant’s commencement of work. (d) A private individual seeking to hire or employ a self-employed individual to provide services in a private residence may secure access to the BCC from the Department. (1) The BCC user fee shall be set by regulation, but may not exceed that charged to an employer. (2) The cost of the criminal background check from SBI or drug screening must be borne by the person making the request. (e) The requirements of subsection (c) of this section may be suspended for 60 days from the date of hire if the employer wishes to employ the applicant on a conditional basis. (1) Before an employer may offer conditional employment, the employer must receive verification that the applicant has been fingerprinted by the SBI for purposes of the criminal history. (2) The Department may not issue a criminal history if the applicant fails to provide information to the Department regarding the status or disposition of an arrest within 45 days from the date of notice from the Department of an open criminal charge. The Department may extend the time limits for good cause shown. (f) An employer, other than a private person, may not employ or continue to employ an individual with a conviction deemed disqualifying by the Department’s regulations. (g) Any employer, other than a private person, who employs an applicant and fails to secure a criminal history is subject to a civil penalty of not less than $1,000 nor more than $5,000 for each violation. An employer is also subject to this penalty if that employer conditionally employs an applicant before receiving verification that the applicant has been fingerprinted for purposes of the criminal history. (h) The criminal history provided to the employer is strictly confidential. It may be used solely to determine the suitability of an applicant for employment or continued employment. (i) No applicant is permitted to be employed by an employer other than conditionally under subsection (e) of this section until the applicant’s employer has secured the applicant’s criminal history. (j) Before an applicant may be employed by an employer, the applicant must, upon request, do any of the following: (1) Provide accurate information sufficient to secure a criminal history. (2) Execute a full release to enable the employer to secure a criminal history and to update the criminal history while employed. (3) Execute a full release giving the employer permission to provide the criminal history to the person for whom the services are to be provided, or to the person’s authorized representative. (k) An applicant who fails to comply with subsection (j) of this section is subject to a civil penalty of not less than $1,000 nor more than $5,000 for each violation. (l), (m) [Repealed.] (n) The Department shall promulgate regulations regarding all of the following: (1) The criteria it uses to determine unsuitability for employment. (2) The policies and procedures for preparing the criminal history which govern the frequency of criminal record review and updating. (3) The frequency with which fingerprints must be obtained. (4) The information that the Department provides in the criminal history about disqualifying and nondisqualifying criminal convictions. (5) The methods for notifying applicants and employers of the results of the Department’s review, and for providing applicants with the criminal history. (6) The administrative review process available to a person desiring to contest adverse information. (7) Other provisions required to achieve the purpose of this section. (73 Del. Laws, c. 10, § 2; 70 Del. Laws, c. 186, § 1; 74 Del. Laws, c. 195, §§ 7-13; 77 Del. Laws, c. 84, § 206; 78 Del. Laws, c. 303, § 3; 81 Del. Laws, c. 206, § 45.) § 1146. Mandatory drug screening. (a) [Repealed.] Page 120 Title 16 - Health and Safety (b) An employer may not employ any applicant without first obtaining the results of that applicant’s mandatory drug screening. (c) All applicants, with the exception of a self-employed individual seeking employment from a private person to provide services in a private residence, must submit to mandatory drug screening, as specified by regulations promulgated by the Department. The requirement for drug screening for self-employed persons seeking employment in a private residence is left to the discretion of the individual in need of care in the private residence. (d) The Department shall promulgate regulations regarding the pre-employment screening of all applicants for use of the following illegal drugs: (1) Marijuana/cannabis. (2) Cocaine. (3) Opiates. (4) Phencyclidine (“PCP”). (5) Amphetamines. (6) Any other illegal drug specified by the Department under regulations promulgated under this section. (e) An employer may not employ an applicant for work in a private residence before getting the results of that applicant’s drug screening. Upon request, the results of the drug screen must be provided upon the applicant’s commencement of work to the person for whom the services are to be provided, or to the person’s authorized representative. (f) The employer must provide confirmation of the drug screen in the manner prescribed by the Department’s regulations. (g) Any employer who fails to comply with the requirements of this section is subject to a civil penalty of not less than $1,000 nor more than $5,000 for each violation. (73 Del. Laws, c. 10, § 2; 78 Del. Laws, c. 303, § 3; 81 Del. Laws, c. 206, § 46.) Subchapter VI Office of the Long-Term Care Ombudsperson § 1150. Creation of Office. There is hereby established within the Department of Health and Social Services, Division of Administration, the Office of the LongTerm Care Ombudsperson as provided by the Older Americans Act Amendments of 1987 (P.L. 100-175). (67 Del. Laws, c. 76, § 1; 69 Del. Laws, c. 345, § 5; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 78, § 140; 78 Del. Laws, c. 118, § 1.) § 1151. Definitions. As used in this subchapter: (1) “Agency” means any private or public agency operating in the State, one of whose purposes is the funding, provision or regulation of health care services. (2) “Long-term care facility” means any facility as defined in § 1102 of this title. (3) “Long-Term Care Ombudsperson” or “Ombudsperson” means the person designated under the Older Americans Act, as amended (42 U.S.C. § 3001 et. seq.) to perform the mandated functions of the Office of the Long-Term Care Ombudsperson in the State, or the Ombudsperson’s designee. (4) “Record” means any medical, social, or financial information pertaining to a resident of a long-term care facility which is maintained by any agency regulated under this chapter or Chapter 10 of this title; provided, however, that “record” does not include criminal investigative files. (67 Del. Laws, c. 76, § 1; 70 Del. Laws, c. 186, § 1; 81 Del. Laws, c. 206, § 47.) § 1152. Purpose and duties. The purpose of the Ombudsperson is to provide a program to advocate for and promote the adequacy of care received and the quality of life experienced by residents of long-term care facilities in Delaware. The Ombudsperson shall have the power to: (1) Investigate and seek to resolve complaints and concerns made by or on behalf of residents of long-term care facilities in the State relating to the actions or inactions of any long-term care facility or agencies which may adversely affect the health, safety, welfare or rights of such residents; (2) Promote the well-being and quality of life of residents of long-term care facilities; (3) Enter into written agreements of understanding, cooperation and collaboration with other government agencies that provide funding, oversight, inspection or operation of long-term care facilities; (4) Establish and carry out program policies and procedures for eliciting, receiving, investigating, verifying, referring and resolving residents’ complaints; Page 121 Title 16 - Health and Safety (5) Receive and investigate complaints of abuse, mistreatment or neglect in accordance with subchapter III of this chapter; (6) Promulgate rules and regulations and adopt policies to implement this subchapter; and (7) Perform other duties as mandated by the Older Americans Act, as amended (42 U.S.C. § 3001 et seq.). (67 Del. Laws, c. 76, § 1; 70 Del. Laws, c. 186, § 1; 81 Del. Laws, c. 206, § 48.) § 1153. Access to facilities and patient records. (a) The Ombudsperson shall have access to any facility or record which is relevant to the performance of the Ombudsperson’s responsibilities under this subchapter, including any record otherwise rendered confidential under Delaware law; provided, however, that the Ombudsperson shall obtain the consent of any resident who is able to consent or any resident’s legal agent or guardian for access to such resident’s records. (b) The Ombudsperson may initiate an investigation of any long-term care facility independent of the receipt of a specific complaint. (c) Any state agency to which the Ombudsperson refers a complaint shall periodically advise the Ombudsperson of the status of the investigation of the complaint and notify the Ombudsperson in a timely manner of the disposition of the complaint. (d) The Ombudsperson shall protect the confidentiality of residents’ records and shall permit access to such records only in accordance with regulations of the Office of the Long-Term Care Ombudsperson. (e) The Ombudsperson shall protect the confidentiality of files maintained by the Ombudsperson and shall permit access to such files only under conditions as the Ombudsperson, in the Ombudsperson’s own sole discretion, deems appropriate. (f) Notwithstanding any other provision of this subchapter, the Ombudsperson shall not disclose the identity of any complainant or resident unless a court orders such disclosure or the complainant or resident consents in writing to the disclosure of the complainant’s or resident’s identity. (67 Del. Laws, c. 76, § 1; 70 Del. Laws, c. 186, § 1.) § 1154. Good faith immunity. (a) Persons and agencies participating in an investigation under this subchapter shall be immune from civil liability arising from their good faith participation in the investigation. (b) No long-term care facility, other entity or person shall engage in retaliation or reprisals against any person or agency due to such person or agency’s participation in an investigation under this subchapter. (67 Del. Laws, c. 76, § 1.) § 1155. Sanctions for interference with Ombudsperson. (a) No person, agency or long-term care facility shall wilfully interfere with the performance of the duties and exercise of the powers of the Ombudsperson provided in this subchapter. (b) Whoever violates this subchapter shall be fined not more than $100 for the first offense and not less than $100 nor more than $1,000 for each subsequent offense. Each violation shall be considered a separate offense. (67 Del. Laws, c. 76, § 1; 70 Del. Laws, c. 186, § 1.) § 1156. Jurisdiction. (a) Justices of the Peace shall have jurisdiction over violations of this subchapter. (b) The Superior Court shall have jurisdiction over appeals of the decisions entered pursuant to subsection (a) of this section. Such appeals shall be on the record. (67 Del. Laws, c. 76, § 1.) Subchapter VII Minimum Staffing Levels for Residential Health Facilities § 1161. Definitions. (a) “Advanced practice nurse” shall mean an individual whose education and certification meet the criteria outlined in Chapter 19 of Title 24, and who is certified in at least 1 of the following specialty areas: (1) Adult nurse practitioner; (2) Gerontological clinical nurse specialist; (3) Gerontological nurse practitioner; (4) Psychiatric/mental health clinical nurse specialist; or (5) Family nurse practitioner. (b) “Department” shall mean the Department of Health and Social Services. Page 122 Title 16 - Health and Safety (c) “Direct care” shall mean an activity performed by a nursing services direct caregiver that is specific to a resident. Direct care activities are as follows: (1) “Hands-on” treatment or care, including, but not limited to, assistance with activities of daily living (e.g., bathing, dressing, eating, range of motion, toileting, transferring and ambulation); medical treatments; and medication administration; (2) Physical and psychosocial assessments; (3) Documentation, if conducted for treatment or care purposes; (4) Care planning; and (5) Communication with a family member or a health-care professional or entity, regarding a specific resident. (d) “Division” shall mean the Division of Health Care Quality. (e) “Nursing services direct caregivers” shall mean certified nursing assistants, licensed practical nurses, registered nurses, advanced practice nurses and nursing supervisors when and only when providing direct care of residential health facility residents. The director of nursing (“DON”), assistant director of nursing (“ADON”), and/or registered nurse assessment coordinator (“RNAC”) may be designated as a nursing services direct caregiver and counted in the direct care hours and minimum staffing ratios when exigent circumstances require that they discontinue their administrative and managerial duties in order to provide direct care. Within 24 hours of the exigent circumstance(s) that require that the DON, ADON and/or RNAC provide direct care, the facility shall notify the Division in writing of this emergency situation and provide documentation of the amount of direct care time that was provided by the DON, ADON and/or RNAC. (f) “Nursing supervisor” shall mean an advanced practice nurse or registered nurse who is assigned to supervise and evaluate nursing services direct caregivers no less than 25 percent of the nursing supervisor’s time per shift. Up to 75 percent of the nursing supervisor’s time per shift may be spent providing direct care. Registered nurses (RN) holding the following positions may provide the supervision required of a nursing supervisor, and the supervision may be counted towards the minimum 25 percent supervision required per shift: (1) Director of nursing (“DON”). (2) Assistant director of nursing (“ADON”). (3) Registered nurse assessment coordinator (“RNAC”). (4) Director of in-service education (RN). (5) Quality improvement coordinator nurse (if an RN). (6) Nursing home administrator (if an RN). An individual serving as a nursing supervisor must be an employee of the facility, thus excluding temporary employment agency personnel from serving in this capacity unless exigent circumstances exist. The term “exigent circumstances” means a short-term emergency or other unavoidable situation, and all reasonable alternatives to the use of a temporary employee as a nursing supervisor have been exhausted. Within 24 hours of the exigent circumstances that require the use of temporary employment agency staffing to fill a nursing supervisor position in a residential health facility, the facility shall notify the Division in writing of the exigent circumstances and the expected duration. For any shift that exceeds the minimum RN/LPN shift ratio mandated by § 1162 of this title, the amount of RN time that exceeds the minimum ratio may be counted towards the minimum 25 percent supervision required for that shift; provided, however, that said RN time was dedicated to supervisory functions. For those facilities that are not required by state or federal regulations to have a registered nurse on duty on each shift, a licensed practical nurse with 3 years long-term care experience may serve as a nursing supervisor, provided that no registered nurse is on duty. There shall be a nursing supervisor on duty and on-site at all times. By June 1, 2002, the Nursing Home Residents Quality Assurance Commission shall issue to the Governor and to the General Assembly a report evaluating the requirement that nursing supervisors spend a minimum of 25 percent of their time on supervisory functions. The purpose of the report is to determine if the required minimum amount of supervision time is appropriate and necessary, and whether it should be adjusted. (g) “Residential health facility” shall mean any facility that provides long-term health-related care and nursing services to individuals who do not require the degree of care and treatment that a hospital is designed to provide. These are those facilities, licensed pursuant to this chapter, that: (1) Provide skilled nursing services to persons who require medical or nursing care; or (2) Provide nursing services above the level of room and board to those who, because of a mental or physical condition, routinely require these services. Also included are units, licensed pursuant to this chapter, of facilities that provide active treatment and health and rehabilitation services to persons with mental retardation or related conditions, in which care is delivered to residents in accordance with medical plans of care. This definition does not include group homes for the mentally ill, mentally retarded or persons with AIDS, rest family care homes, neighborhood homes, rest/residential health facilities, assisted living facilities and intermediate care facilities that, as of March 1, 1999, were solely private pay, provided they remain exclusively intermediate care facilities. (72 Del. Laws, c. 490, § 2; 73 Del. Laws, c. 162, §§ 2-4; 73 Del. Laws, c. 304, § 1; 81 Del. Laws, c. 209, § 4.) § 1162. Nursing staffing. (a) Every residential health facility must at all times provide a staffing level adequate to meet the care needs of each resident, including those residents who have special needs due to dementia or a medical condition, illness or injury. Every residential health facility shall Page 123 Title 16 - Health and Safety post, for each shift, the names and titles of the nursing services direct caregivers assigned to each floor, unit or wing and the nursing supervisor on duty. This information shall be conspicuously displayed in common areas of the facility, in no fewer number than the number of nursing stations. Every residential health facility employee shall wear a nametag prominently displaying his or her full name and title. Personnel hired through temporary agencies shall be required to wear photo identification listing their names and titles. (b) By March 1, 2001, the minimum staffing level for nursing services direct caregivers shall not be less than the staffing level required to provide 3.0 hours of direct care per resident per day, provided that funds have been appropriated for 3.0 hours of direct care per resident for Medicaid eligible reimbursement. Nursing staff, rounded to the nearest whole person, must be distributed in order to meet the following minimum shift ratios: RN/LPN Day Evening Night 1:20 1:25 1:40 CNA (or RN/LPN or NAIT serving as a CNA) 1:9 1:10 1:22 (c) On or before December 1, 2001, a comprehensive report assessing and reviewing the quality of nursing facility care in Delaware shall be completed by the Delaware Nursing Home Residents Quality Assurance Commission and submitted to the Governor and the General Assembly. The purpose of the report is to determine the efficacy of the minimum staffing levels required under this chapter, including, but not limited to, the availability of qualified personnel in the job market to meet the requirement, the cost and availability of nursing home care, and patient outcomes based on scheduled facility surveys, surprise inspections and other reviews conducted by the Division. Based on this information, the Commission will determine if increasing the minimum nurse staffing levels to 3.28 hours of direct care with the corresponding increased required shift ratios is appropriate and necessary. By January 1, 2002, the minimum staffing level for nursing services direct caregivers shall not be less than the staffing level required to provide 3.28 hours of direct care per resident per day, subject to Commission recommendation and provided that funds have been appropriated for 3.28 hours of direct care per resident for Medicaid eligible reimbursement. Nursing staff must be distributed in order to meet the following minimum shift ratios: RN/LPN Day Evening Night 1:15 1:23 1:40 CNA (or RN/LPN or NAIT serving as a CNA) 1:8 1:10 1:20 To the extent a nursing facility meets the minimum nurse staff levels of 3.28 hours of direct care and compliance with the above referenced shift ratios provided in this subsection requires more than 3.28 hours of direct care, the Division may permit a nursing facility to alter the shift ratios above; provided, however, the alternative shift ratios as determined by the Division shall not, on any shift or at any time, fall below the following alternative minimum shift ratios: Day Evening Night RN/LPN 1:20 1:25 1:40 CNA (or other direct care-givers) 1:9 1:10 1:22 If a nursing facility cannot meet the above referenced shift ratios due to building configuration or any other special circumstances, they may apply for a special waiver through the Division, subject to final approval by the Delaware Nursing Home Residents Quality Assurance Commission. All nursing facilities shall conspicuously display the minimum shift ratios governing the nursing facility, along with posting requirements pursuant to subsection (a) of this section. Notwithstanding subsection (g) of this section, the time period for review and compliance with any alternative minimum shift ratios or ratios pursuant to a special waiver under this subsection shall be 1 day. (d) Within 6 months of an appropriation by the General Assembly funding the staffing requirements of subsection (e) of this section, a comprehensive report assessing and reviewing the quality of nursing facility care in Delaware shall be completed by the Delaware Nursing Home Residents Quality Assurance Commission and submitted to the Governor and the General Assembly. The purpose of the report is to determine the efficacy of the minimum staffing levels required under this chapter, including, but not limited to, the availability of qualified personnel in job market to meet the requirement, the cost and availability of nursing home care, and patient outcomes based on scheduled facility surveys, surprise inspections and other reviews conducted by the Division. Based on this information, the Commission Page 124 Title 16 - Health and Safety will determine if increasing the minimum nurse staffing levels to 3.67 hours of direct care with the corresponding increased required shift ratios is appropriate and necessary. (e) By May 1, 2003, the minimum staffing level for nursing services direct caregivers shall not be less than the staffing level required to provide 3.67 hours of direct care per resident per day, subject to Commission recommendation and provided that funds have been appropriated for 3.67 hours of direct care per resident for Medicaid eligible reimbursement. Nursing staff, rounded to the nearest whole person, must be distributed in order to meet the following minimum shift ratios: RN/LPN Day Evening Night 1:15 1:20 1:30 CNA (or RN/LPN or NAIT serving as a CNA) 1:7 1:10 1:15 (f) An individual in a facility-sponsored training program who has completed all but the final 37.5 hours of requisite classroom and clinical training to become a CNA may be counted in the direct care hours and minimum staffing shift ratios under the CNA staffing requirements given in subsections (b), (c) and (e) of this section. The individual shall be referred to as a nursing assistant in training (NAIT). The Division shall conduct a study of the certified nursing assistant training programs in Delaware, both those sponsored by facilities and those sponsored by educational institutions. It shall report its findings to the Nursing Home Quality Residents Assurance Commission (Commission). The factors to be studied include, but are not limited to, the percentage of each training program’s graduates who passed the certified nursing assistant certification test and the number of attempts it took each graduate to become certified, along with the total number of hours, divided by classroom and clinical time, spent in the overall certified nursing assistant training program. The study shall encompass a period of 6 months commencing with the promulgation of the certified nursing assistant regulations. The report shall be issued no later than 2 months after the completion of the study period. Based on the results of its study, the Division shall recommend to the Commission whether a nursing assistant, while in training and prior to certification, should be counted as a CNA in the minimum staffing ratios, and, if so, at what point in the training program. (g) The time period for review and determining compliance with the staffing ratios required under this chapter shall be 1 week. To the extent a residential health facility subject to the required ratios of this chapter desires an alternative shift schedule, they shall notify the Division of such alternative shift schedule prior to implementation; the proposed shift schedule and corresponding staff ratios must meet the minimum hour requirements and must not exceed the patient to staff ratios provided under this chapter for the night shift. Any alternative shift schedule must be clearly posted along with the postings required pursuant to subsection (a) of this section. (h) Notwithstanding the minimum staffing requirements established in this subchapter, to the extent additional staffing is necessary to meet the needs of residents, nursing facilities must provide sufficient nursing staffing. If the Division finds unsatisfactory outcomes in a facility, the Department may impose protocols for staffing adequacy, including but not limited to staffing levels above the minimum required under this subchapter. Outcomes examined shall include those outcomes as enumerated by the United States Health Care Financing Administration Quality Indicators. Evidence of a failure to meet the nursing staffing needs of residents shall be grounds for enforcement action under this chapter. (i) All residential health facilities shall have, in addition to the requirements in subsections (b) through (h) of this section, a full-time director of nursing who is an advanced practice nurse or a registered nurse with 1 year’s work experience as a registered nurse. After July 1, 2001, any newly hired director of nursing shall be an advanced practice nurse or a registered nurse with a B.S. degree in nursing and 2 years’ experience in long-term care or a registered nurse with 3 years of long-term care experience. After July 1, 2001, all newly hired directors of nursing must complete, within 3 months of hire (or as soon as a course is available), a long-term care director of nursing workshop in accordance with regulations promulgated by the Department in consultation with the Commission. (j) All residential health facilities licensed for 100 beds or more shall have, at a minimum, the following supervisory and administrative nursing staff, in addition to the personnel listed in subsections (b) through (i) of this section: a full-time assistant director of nursing who is an advanced practice nurse or a registered nurse and a full-time equivalent director of in-service education who is an advanced practice nurse or a registered nurse. (k) All residential health facilities licensed for fewer than 100 beds shall employ, at a minimum, in addition to the personnel listed in subsections (b) through (i) of this section, a part-time assistant director of nursing who is an advanced practice nurse or a registered nurse and a part-time director of in-service education who is an advanced practice nurse or a registered nurse, in accordance with the following formula: Number of beds ÷ 100 x 40 = hours per week minimum required for an assistant director of nursing and a director of in-service education. A subacute transitional care unit of an acute care hospital with 30 beds or fewer is exempt from the provisions of this subsection provided that other licensed personnel perform the duties of this function. (l) For residential health facilities with 15 beds or fewer, the director of nursing, assistant director of nursing, and/or nursing supervisor, while on duty, may also serve as nursing services direct caregivers as described in subsections (b) through (e) of this section. Page 125 Title 16 - Health and Safety (m) The educational requirements described above shall be met provided that if an insufficient pool of applicants exists, other qualifications may be deemed acceptable in accordance with regulations promulgated by the Department. (72 Del. Laws, c. 490, § 2; 73 Del. Laws, c. 162, §§ 5-13; 73 Del. Laws, c. 258, §§ 1, 3; 81 Del. Laws, c. 209, § 5.) § 1163. Activities staffing. (a) All residential health facilities licensed for 30 beds or more shall have a full-time activities director. Any activities director hired after July 1, 2001, shall be a certified therapeutic recreation specialist, a certified occupational therapy assistant, a certified music therapist, a certified art therapist, a certified drama therapist, a certified dance/movement therapist, a certified activities director, or a registered occupational therapist. (b) All residential health facilities licensed for fewer than 30 beds shall have, at a minimum, a part-time activities director as described in subsection (a) of this section, in accordance with the following formula: Number of beds ÷ 30 x 40 = hours per week minimum required for an activities director. A subacute transitional care unit of an acute care hospital with 30 beds or fewer is exempt from the provisions of this subsection provided that other licensed personnel perform the duties of this function. (72 Del. Laws, c. 490, § 2; 73 Del. Laws, c. 162, §§ 14, 15.) § 1164. Nutrition and dietetics staffing. Every residential health facility must at all times provide nutrition and dietetics staffing adequate to meet the care needs of each resident. The staffing level must, at a minimum, include a full-time food service manager. Any food service manager hired after July 1, 2001, must be a registered dietitian or a certified dietitian/nutritionist, a registered dietetic technician, a certified dietary manager, or must have a Bachelor of Science or associate degree in food service management or related field. The educational requirements shall be met provided that if an insufficient pool of applicants exists, other qualifications may be deemed acceptable in accordance with regulations promulgated by the Department. A sub-acute transitional care unit of an acute care hospital with 30 beds or fewer is exempt from the provisions of this subsection provided that other licensed personnel perform the duties of this function. Any full-time food service manager with a minimum of 3 years’ experience as a full-time food service manager as of July 1, 2001, shall be exempt from the requirements of this subsection. (72 Del. Laws, c. 490, § 2; 73 Del. Laws, c. 162, § 16.) § 1165. Social services staffing. All residential health facilities shall employ a full-time social worker, except that facilities licensed for fewer than 100 beds may designate other personnel to assume the duties associated with that position in accordance with the rules and regulation promulgated and adopted pursuant to this subchapter. (72 Del. Laws, c. 490, § 2.) § 1166. Medicaid reimbursement. (a) The Medicaid reimbursement program shall be adjusted to reflect costs associated with the increased staffing levels described herein. Reimbursement rates for nursing wages will be adjusted to the seventy-fifth percentile under the current wage determination methodology for primary care under the state Medicaid program. (b) The Department shall ensure that 100% of Medicaid funds paid for primary care are expended by the residential health facility for primary care purposes. If, during any annual cost reporting period, a facility expends less than 100% of the primary care reimbursement it receives from Medicaid for primary care, the sum under-spent must be repaid to the Medicaid program. The repayment will be made through a cost settlement process when the provider files its annual cost report. The Department will revise its regulations and Medicaid cost report forms to require a cost settlement for the primary care reimbursement classification. (c) Medicaid reimbursement of providers shall be consistent with the provisions of this chapter regardless of the payment methodology employed by Medicaid or its contractors, including managed care. (72 Del. Laws, c. 490, § 2.) § 1167. Outcomes monitoring. In addition to compliance monitoring, the Division shall use data collected by residential health facilities to monitor quality of care and patient outcomes pursuant to § 1162(h) of this title. The Division shall analyze this data in order to help target licensing surveys and inspections. The Department shall promulgate and adopt regulations that define the outcomes monitoring process. (72 Del. Laws, c. 490, § 2; 73 Del. Laws, c. 162, § 17.) § 1168. Waiver. A residential health facility may seek from the Delaware Nursing Home Residents Quality Assurance Commission a time-limited waiver of the minimum staffing requirements required under § 1162(c) and (e) of this title. Such waiver will only be granted upon a showing of exigent circumstances, including but not limited to documented evidence of the facility’s best efforts to meet the minimum staffing requirements under § 1162(c) and (e) of this title. Any such waiver will be time-limited and will include a plan and a timeline Page 126 Title 16 - Health and Safety for compliance with this chapter. The Commission may seek input from the Department of Labor in terms of issues of labor availability in connection with any waiver request under this section. (72 Del. Laws, c. 490, § 2.) § 1169. Regulations. The Department shall promulgate and adopt rules and regulations to fully and effectively implement the provisions of this subchapter. The regulations will become effective 60 days after adopted by the Department. (72 Del. Laws, c. 490, § 2.) Subchapter VIII Nursing Facility Quality Assessment Fund § 1180. Definitions. As used in this subchapter: (1) [Repealed]. (2) “CMS” means as defined in § 6501 of Title 30. (3) “Managed care company under contract to the Medicaid agency” means an entity as defined in § 6501 of Title 30. (4) “Medicaid” means as defined in § 6501 of Title 30. (5) “Medicaid-enrolled nursing facility” means a nursing facility enrolled in the Medicaid program or enrolled with a managed care company under contract to the Medicaid agency for the purpose of providing nursing facility services to Medicaid eligible residents, but excludes the Delaware Veterans Home and any state, federal, or other public government-owned facilities and any facilities that exclusively serve children. (6) “Medicaid resident day” means as defined in § 6501 of Title 30. (7) “Medicaid share of the quality assessment” means for each nursing facility, the assessment cost applicable to Medicaid residents. (8) “Nursing facility” means as defined in § 6501 of Title 30. (9) “Nursing facility services” means as defined in § 6501 of Title 30. (78 Del. Laws, c. 286, § 2; 81 Del. Laws, c. 206, § 49.) § 1181. Nursing Facility Quality Assessment Fund — Establishment; funding. (a) There shall be established in the State Treasury and in the accounting system of the State a special fund to be known as the Nursing Facility Quality Assessment Fund (the “Fund”). (b) All of the following revenue must be deposited into the Fund: (1) As specified in § 6502(e)(1) of Title 30, 90% of the quality assessment collected. (2) On the last day of each month, the State Treasurer shall credit the Fund with interest on the average balance in the Fund for the preceding month. The interest to be paid to the Fund must be that proportionate share, during such preceding month, of interest to the State as the Fund’s and the State’s average balance is to the total State’s average balance. (78 Del. Laws, c. 286, § 2; 81 Del. Laws, c. 206, § 50.) § 1182. Use of Nursing Facility Quality Assessment Fund; payments. (a) Funds deposited into the Nursing Facility Quality Assessment Fund must be used by the Department exclusively to secure federal matching funds available through the state Medicaid plan and any applicable waivers, and together with the Federal funds must be used exclusively by the Department including any managed care companies under contract to the Medicaid agency to do all of the following: (1) Provide for per diem rate adjustments in accordance with § 1183 of this title to Medicaid enrolled nursing facilities. (2) Reimburse the Medicaid share of the quality assessment in accordance with § 1183 of this title. (3) Reimburse any funds advanced from the Department Medicaid budget appropriation that were used to make the payments referred to under paragraphs (a)(1) and (2) of this section. (b) If the quality assessment imposed by § 6502 of Title 30 and the payments referred to by paragraphs (a)(1) and (2) of this section are repealed, any funds remaining in the Nursing Facility Quality Assessment Fund must: (1) First reimburse the Department if the total of all quality assessment payments received from nursing facilities are equal to or less than the state share of all of the payments referred to by paragraphs (a)(1) and (2) of this section made by the Department including managed care companies under contract to the Medicaid agency to nursing facilities. (2) If the total of all quality assessments received is greater than the state share of the payments issued referred to by paragraphs (a) (1) and (2) of this section, the remaining funds must be distributed back to the nursing facilities generally and proportionately on the same basis as the assessments were collected in the last calendar quarter. (78 Del. Laws, c. 286, § 2; 81 Del. Laws, c. 206, § 51.) Page 127 Title 16 - Health and Safety § 1183. Nursing facility rate adjustments. (a) Medicaid enrolled nursing facilities that are not subject to penalties under § 6503 of Title 30 shall be eligible for per diem rate adjustments referred to by § 1182(a)(1) and (2) of this title. Nursing facilities subject to penalties under § 6503 of Title 30 shall be eligible for per diem rate adjustments only after all penalties and past due quality assessments are paid in full. (b) Effective April 1, 2012, nursing facilities are paid for services rendered to Medicaid patients directly by DHSS as well as by managed care companies under contract to the Medicaid agency. The per diem rate adjustments referred to by § 1182(a)(1) and (2) of this title will be incorporated into the DHSS nursing facility level of reimbursement rate schedules. Unless a facility is subject to penalties as described in subsection (a) of this section, DHSS and the managed care companies will pay no lower than the adjusted per diem rates in these schedules. (c) The rate adjustments referred to by § 1182(a)(1) and (2) of this title shall be a rate paid on a per Medicaid resident day basis. The rate paid will be the same per diem amount for each facility other than the per diem to reimburse the Medicaid share of the assessment. (d) The rate adjustments referred to by § 1182(a)(1) and (2) of this title will be retroactive for dates of service on or after June 1, 2012. Upon CMS notification to DHSS of waiver approval and, if required, state plan amendment approval, the per diem rates in effect as of June 1, 2012, will be increased by the rate adjustments referred to by § 1182(a)(1) and (2) of this title. The retroactive rate adjustments for Medicaid paid claims for service dates between June 1, 2012, and the date of CMS notification of waiver and, if required, plan amendment approval, must be paid within 30 days of CMS approval. (78 Del. Laws, c. 286, § 2.) Subchapter IX Criminal Background Checks; Drug Testing — PPECC § 1190. Criminal background checks. (a) The purpose of the criminal background check and drug screening requirements of this section and § 1191 of this title is the protection of the safety and well-being of residents of this State who use the services of prescribed pediatric extended care centers licensed under this title or who employ a person to provide care in the facility. These sections must be construed broadly to accomplish this purpose. (b) Definitions.— As used in this subchapter: (1) “Applicant” means any of the following: a. An individual seeking employment with an employer. b. A current employee who seeks a promotion from an employer. c. A self-employed individual or contractor seeking employment in a prescribed pediatric extended care center. d. A current employee of an employer who the Department has a reasonable basis to suspect has been arrested for a disqualifying crime since becoming employed. e. A former employee who consents prior to leaving employment to periodic review of his or her criminal background for a fixed time period. (2) “Background Check Center” (“BCC”) means the electronic system which combines the data streams from various sources within and outside the State in order to assist an employer in determining the suitability of an individual for employment in a prescribed pediatric extended care center. (3) “Criminal history” means a report from the Department of Health and Social Services regarding its review of the applicant’s entire federal criminal history from the Federal Bureau of Investigation, under Public Law 92-544 as amended (28 U.S.C. § 534) and the applicant’s Delaware record from the State Bureau of Identification. (4) “Employer” means a prescribed pediatric extended care center. (5) “Prescribed pediatric extended care center” means a facility licensed under § 122(3)q. of Title 16. (6) “SBI” means the State Bureau of Identification. (c) An employer may not employ an applicant for work in a prescribed pediatric extended care center before obtaining a criminal history. The criminal history of any individual not employed directly by the facility must be provided to the facility upon the individual’s commencement of work. (d) The requirements of subsection (c) of this section may be suspended for 60 days from the date of hire if the employer wishes to employ the applicant on a conditional basis. (1) Before an employer may offer conditional employment, the employer must receive verification that the applicant has been fingerprinted by the SBI for purposes of the criminal history. (2) The Department may not issue a criminal history if the applicant fails to provide information to the Department regarding the status or disposition of an arrest within 45 days from the date of notice from the Department of an open criminal charge. The Department may extend the time limits for good cause shown. (e) An employer may not employ or continue to employ an individual with a conviction deemed disqualifying by Department regulations. Page 128 Title 16 - Health and Safety (f) Any employer who employs an applicant and fails to secure a criminal history is subject to a civil penalty of not less than $1,000 nor more than $5,000 for each violation. An employer is also subject to this penalty if that employer conditionally employs an applicant before receiving verification that the applicant has been fingerprinted for purposes of the criminal history. (g) The criminal history provided to the employer is strictly confidential. It may be used solely to determine the suitability of an applicant for employment or continued employment. It must be stored in a manner that maintains its confidentiality. (h) An applicant may not be employed by an employer other than conditionally pursuant to subsection (d) of this section until the applicant’s employer has secured the applicant’s criminal history. (i) Before an applicant is permitted to be employed in a prescribed pediatric extended care center, the applicant must, upon request, do any of the following: (1) Provide accurate information sufficient to secure a criminal history. (2) Execute a full release to enable the employer to secure a criminal history and to update the criminal history while employed. (3) Execute a full release giving the employer permission to provide the criminal history to the facility where the work is to be performed if the employer is other than the facility. (j) An applicant who fails to comply with subsection (i) of this section is subject to a civil penalty of not less than $1,000 nor more than $5,000 for each violation. (k) The Department shall promulgate regulations regarding all of the following: (1) The criteria it uses to determine unsuitability for employment. (2) The policies and procedures for preparing the criminal history which govern the frequency of criminal record review and updating. (3) The frequency with which fingerprints must be obtained. (4) The information that the Department provides in the criminal history about disqualifying and nondisqualifying criminal convictions. (5) The methods for notifying applicants and employers of the results of the Department’s review, and for providing applicants with the criminal history. (6) The administrative review process available to a person desiring to contest adverse information. (7) Other provisions required to achieve the purpose of this section. (81 Del. Laws, c. 206, § 52.) § 1191. Mandatory drug screening. (a) An employer may not employ any applicant without first obtaining the results of that applicant’s mandatory drug screening. (b) All applicants must submit to mandatory drug screening, as specified by regulations promulgated by the Department. (c) The Department shall promulgate regulations regarding the pre-employment screening of all applicants for use of all of the following illegal drugs: (1) Marijuana/cannabis. (2) Cocaine. (3) Opiates. (4) Phencyclidine (“PCP”). (5) Amphetamines. (6) Any other illegal drug specified by the Department, under regulations promulgated under this section. (d) The employer must provide confirmation of the drug screen in the manner prescribed by the Department’s regulations. (e) Any employer who fails to comply with the requirements of this section is subject to a civil penalty of not less than $1,000 nor more than $5,000 for each violation. (81 Del. Laws, c. 206, § 52.) Page 129 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 12 Informed Consent and Confidentiality Subchapter I Genetic Information § 1201. Definitions. As used in this subchapter: (1) “Genetic characteristic” means any inherited gene or chromosome, or alternation thereof, that is scientifically or medically believed to predispose an individual to a disease, disorder or syndrome, or to be associated with a statistically significant increased risk of development of a disease, disorder or syndrome. This includes, but is not limited to, information regarding carrier status, information regarding an increased likelihood of future disease or increased sensitivity to any substance, information derived from laboratory tests that identify mutations in specific genes or chromosomes, requests for genetic services or counseling, tests of gene products and direct analysis of genes or chromosomes. (2) “Genetic information” means information about inherited genes or chromosomes, and of alterations thereof, whether obtained from an individual or family member, that is scientifically or medically believed to predispose an individual to disease, disorder or syndrome or believed to be associated with a statistically significant increased risk of development of a disease, disorder or syndrome. (3) “Genetic test” means a test for determining the presence or absence of an inherited genetic characteristic in an individual, including tests of nucleic acids such as DNA, RNA, and mitochrondrial DNA, chromosomes or proteins in order to identify a predisposing genetic characteristic associated with disease, disorder or syndrome. (4) “Informed consent” a. For the purpose of obtaining genetic information, means the signing of a consent form which includes a description of the genetic test or tests to be performed, its purpose or purposes, potential uses, and limitations and the meaning of its results, and that the individual will receive the results unless the individual directs otherwise; b. For the purpose of retaining genetic information, means the signing of a consent form which includes a description of the genetic information to be retained, its potential uses and limitations; c. For the purpose of disclosing genetic information, means the signing of a consent form which includes a description of the genetic information to be disclosed and to whom or a notice that the information will be available to individuals who have access to Electronic Medical Records (EMR) or to the Delaware Health Information Network (DHIN). d. For the purpose of obtaining insurance, there may be a single signing which shall allow the obtaining, retaining and disclosure of genetic information, which, in addition to the requirements of paragraphs (4)a. and b. of this section, shall: 1. Be written in plain language; 2. Be dated; 3. Name or identify by generic reference the persons authorized to disclose information about the individual; 4. Specify the nature of the information authorized to be disclosed; 5. Name or identify by generic reference the person to whom the individual is authorizing information to be disclosed, or subsequently redisclosed; 6. Describe the purpose for which the information is collected; 7. Specify the length of time such authorization shall remain valid; and, 8. Be signed by: A. The individual; B. Such other person authorized to consent for such individual, if such individual lacks the capacity to consent; or; C. The claimant for the proceeds of an insurance policy. (71 Del. Laws, c. 458, § 2; 78 Del. Laws, c. 277, § 3; 80 Del. Laws, c. 126, § 1.) § 1202. Informed consent required to obtain genetic information. (a) No person shall obtain genetic information about an individual without first obtaining informed consent from the individual. (b) The requirements of this section shall not apply to genetic information obtained: (1) By a state, county, municipal or federal law-enforcement agency for the purposes of establishing the identity of a person in the course of a criminal investigation or prosecution; (2) To determine paternity; Page 130 Title 16 - Health and Safety (3) Pursuant to the DNA analysis and data bank requirements of § 4713 of Title 29; (4) To determine the identity of deceased individuals; (5) For anonymous research where the identity of the subject will not be released; (6) Pursuant to newborn screening requirements established by state or federal law; or (7) As authorized by federal law for the identification of persons. (71 Del. Laws, c. 458, § 2; 78 Del. Laws, c. 277, § 3.) § 1203. Authorization to retain genetic information and samples from which genetic information is derived. (a) No person shall retain an individual’s genetic information without first obtaining informed consent from the individual unless: (1) Retention is necessary for the purposes of a criminal or death investigation or a criminal or juvenile proceeding; (2) Retention is necessary to determine paternity; (3) Retention is authorized by order of a court of competent jurisdiction; (4) Retention is made pursuant to the DNA analysis and data bank requirements of § 4713 of Title 29; (5) Retention of information is for anonymous research where the identity of the subject will not be released; or (6) Retention is pursuant to newborn screening requirements established by state or federal law. (b) The sample of an individual from which genetic information has been obtained shall be destroyed promptly unless: (1) Retention is necessary for the purposes of a criminal or death investigation or a criminal or juvenile proceeding; (2) Retention is authorized by order of a court of competent jurisdiction; or (3) Retention is authorized by the individual; or (4) Retention is for anonymous research where the identity of the subject will not be released. (71 Del. Laws, c. 458, § 2; 78 Del. Laws, c. 277, § 3; 80 Del. Laws, c. 96, § 2.) § 1204. Genetic information access by the subject. An individual promptly upon request, may inspect, request correction of and obtain genetic information from the records of that individual. (71 Del. Laws, c. 458, § 2; 78 Del. Laws, c. 277, § 3.) § 1205. Conditions for disclosure to others of genetic information. (a) Regardless of the manner of receipt or the source of genetic information, including information received from an individual, a person shall not disclose or be compelled, by subpoena or any other means, to disclose the identity of an individual upon whom a genetic test has been performed or to disclose genetic information about the individual in a manner that permits identification of the individual, unless: (1) Disclosure is necessary for the purposes of a criminal or death investigation or a criminal or juvenile proceeding or to protect the interests of an issuer in the detection or prevention of fraud, material misrepresentation or material nondisclosure; (2) Disclosure is necessary to determine paternity; (3) Disclosure is authorized by order of a court of competent jurisdiction; (4) Disclosure is made pursuant to the DNA analysis and data bank requirements of § 4713 of Title 29; (5) Disclosure is authorized by obtaining informed consent of the tested individual describing the information to be disclosed and to whom; (6) Disclosure is for the purpose of furnishing genetic information relating to a decedent for medical diagnosis of blood relatives of the decedent; (7) Disclosure is for the purpose of identifying bodies; (8) Disclosure is pursuant to newborn screening requirements established by state or federal law; (9) Disclosure is authorized by federal law for the identification of persons; or (10) Disclosure is by an insurer to an insurance regulatory authority; (11) Disclosure is authorized in accordance with § 1201(4)c. of this title; or (12) Disclosure is otherwise permitted by law. (b) This section shall apply to any subsequent disclosure by any person after another person has disclosed genetic information or the identity of an individual upon whom a genetic test has been performed. (71 Del. Laws, c. 458, § 2; 78 Del. Laws, c. 277, § 3; 80 Del. Laws, c. 126, § 1.) § 1206. Subchapter applicability. This subchapter applies only to genetic information or samples that can be identified as belonging to an individual or family. This subchapter does not apply to any law, contract or other arrangement that determines a person’s rights to compensation relating to substances or information derived from a sample of an individual from which genetic information has been obtained. (71 Del. Laws, c. 458, § 2; 78 Del. Laws, c. 277, § 3.) Page 131 Title 16 - Health and Safety § 1207. Parental rights. This subchapter does not alter any right of parents or guardians to order medical and/or genetic tests of their children. (71 Del. Laws, c. 458, § 2; 78 Del. Laws, c. 277, § 3.) § 1208. Violations, penalties for unlawful disclosure of genetic information, jurisdiction. (a) Any person who wilfully retains an individual’s genetic information or retains an individual’s sample in violation of this subchapter shall be punished by a fine of not less than $1,000 nor more than $10,000. (b) Any person who wilfully obtains or discloses genetic information in violation of this subchapter shall be punished by a fine not less than $5,000 nor more than $50,000. (c) Any person who wilfully discloses an individual’s genetic information in violation of this subchapter, shall be liable to the individual for all actual damages, including damages for economic, bodily or emotional harm which is proximately caused by the disclosure. (d) The Superior Court shall have jurisdiction over all violations of this subchapter. (71 Del. Laws, c. 458, § 2; 78 Del. Laws, c. 277, § 3.) Subchapter II Confidentiality of Personal Health Information § 1210. Definitions. As used in this subchapter: (1) “Expunge” or “expunged” means to permanently destroy, delete or make nonidentifiable. (2) “Informed consent” means a written authorization for the disclosure of protected health information on a form substantially similar to one promulgated by the Department of Health and Social Services which is signed in writing or electronically by the individual who is the subject of the information. This authorization shall be dated and shall specify to whom the disclosure is authorized, the general purpose for such disclosure, and the time period in which the authorization for the disclosure is effective. (3) “Legitimate public health purpose” means a population-based activity or individual effort primarily aimed at the prevention of injury, disease, or premature mortality or the promotion of health in the community, including all of the following: a. Assessing the health needs of the community through public health surveillance and epidemiological research. b. Developing public health policy. c. Responding to public health needs and emergencies. d. Review by the Maternal and Child Death Review Commission or the Child Protection Accountability Commission. e. Requests for hospital records by the Division of Health Care Quality pursuant to § 1212 of this title. f. Review by the Drug Overdose Fatality Review Commission. (4) “Protected health information” means any information, whether oral, written, electronic, visual, pictorial, physical or any other form, that relates to an individual’s past, present or future physical or mental health status, condition, treatment, service, products purchased, or provision of care and that reveals the identity of the individual whose healthcare is the subject of the information, or about which there is a reasonable basis to believe such information could be utilized (either alone or with other information that is or should reasonably be known to be available to predictable recipients of such information) to reveal the identity of that individual. (5) “Research” means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (73 Del. Laws, c. 355, § 12; 75 Del. Laws, c. 361, § 4; 75 Del. Laws, c. 387, § 3; 77 Del. Laws, c. 307, § 1; 78 Del. Laws, c. 277, § 3; 80 Del. Laws, c. 187, § 10; 81 Del. Laws, c. 94, § 1; 81 Del. Laws, c. 209, § 6; 83 Del. Laws, c. 364, § 2.) § 1211. Use of protected health information. (a) Protected health information collected by the Department of Health and Social Services or its agencies, the Maternal and Child Death Review Commission, the Child Protection Accountability Commission, and the Drug Overdose Fatality Review Commission shall be used solely for legitimate public health purposes. (b) Nonidentifiable health information shall be used by the Department of Health and Social Services and its agencies whenever possible consistent with the accomplishment of legitimate public health purposes. (c) Any use of protected health information permitted by this subchapter shall be limited to the minimum amount of information which the official using the information reasonably believes is necessary to accomplish the legitimate public health purpose. (d) Protected health information shall not be used by the State for commercial purposes. (e) Protected health information whose use no longer furthers the legitimate public health purpose for which it was acquired shall be expunged. (73 Del. Laws, c. 355, § 12; 75 Del. Laws, c. 361, § 5; 78 Del. Laws, c. 277, § 3; 80 Del. Laws, c. 187, § 11; 81 Del. Laws, c. 94, § 1; 83 Del. Laws, c. 364, § 2.) Page 132 Title 16 - Health and Safety § 1212. Disclosure of protected health information. (a) General privacy protection. — Protected health information is not public information as defined at § 10002 of Title 29 and may not be disclosed without the informed consent of the individual (or the individual’s lawful representative) who is the subject of the information except as expressly provided by statute. Whenever disclosure of protected health information is made pursuant to this subchapter, such disclosure shall be accompanied by a statement concerning the Department of Health and Social Services’ disclosure policy. (b) Scope of disclosure. — Protected health information shall be disclosed with the informed consent of the individual who is the subject of the information to any person and for any purpose for which the disclosure is authorized pursuant to informed consent. (c) Nonidentifiable information. — Any disclosure of protected health information permitted by this subchapter shall be disclosed in a nonidentifiable form whenever possible, consistent with the accomplishment of legitimate public health purposes, except when the disclosure is authorized through the informed consent of the person who is the subject of the information. Any disclosures of protected health information permitted by this subchapter shall also be limited to the minimum amount of information which the person making the disclosure reasonably believes is necessary to accomplish the purpose of the disclosure, except when the disclosure is authorized through the informed consent of the individual who is the subject of the information. (d) Disclosure without informed consent. — Protected health information may be disclosed without the informed consent of the individual who is the subject of the information where any of the following disclosures are made: (1) Directly to the individual. (2) To appropriate federal agencies or authorities as permitted by federal or state law and for law-enforcement purposes in accordance with 45 C.F.R. Parts 160, 162, and 164. (3) To health-care personnel to the extent necessary in an emergency to protect the health or life of the person who is the subject of the information from serious, imminent harm. (4) To the public safety authority during a public health emergency in accord with the uses described in § 1211 of this title. (5) In the course of any judicial or administrative proceeding in accordance with 45 C.F.R. Parts 160, 162, and 164, or pursuant to a court order to avert a clear danger to the individual or the public health. (6) To the Maternal and Child Death Review Commission or to the Child Protection Accountability Commission. (7) To the Division of Health Care Quality in cases where the Division is engaged in an investigation or survey involving the care or treatment of an individual at a facility licensed by the Division, and the individual has been admitted to a hospital from the facility or discharged from a hospital to the facility. The Division of Health Care Quality is an entity charged with helping to safeguard the health and safety of patients. It shall be recognized as a “public health authority” and as a “health oversight agency,” and it shall be recognized in the performance of its functions as a peer review organization or auditor or evaluator with respect to such aspects of health-care delivery systems or providers. (8) Pursuant to § 2005 of this title. (9) For research, regardless of the source of funding of the research, provided that the researcher provides documentation that an alteration to or waiver, in whole or in part, of the individual authorization required by subsection (a) of this section for use or disclosure of protected health information has been approved by the applicable privacy board in accordance with HIPAA regulations. Said approval shall not be granted until the Board has determined all of the following: a. The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements: 1. An adequate plan to protect the identifiers from improper use and disclosure; 2. An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and 3. Adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of protected health information would be permitted by this subpart; b. The research could not practicably be conducted without the waiver or alteration; and c. The research could not practicably be conducted without access to and use of the protected health information. (10) For patient treatment and care coordination, defined as the provision, coordination, or management of health-care and related services by 1 or more health-care providers, including the coordination or management of health care by a health-care provider with a third party; consultation between health-care providers relating to a patient; or the referral of a patient for health care from 1 healthcare provider to another. (11) To a health plan, health-care clearinghouse, business associate, or health-care provider, as each is defined by 45 C.F.R. Part 160, to use only in accordance with federal law for transactions that transmit information between 2 parties to carry out financial or administrative activities related to health care, health-care operations, and health insurance, as set forth in 45 C.F.R Parts 160, 162, and 164. (12) To the Drug Overdose Fatality Review Commission. Page 133 Title 16 - Health and Safety (13) To the Prescription Monitoring Program. (14) To the Fatal Incident Review Team of the Domestic Violence Coordinating Council. The Fatal Incident Review Team of the Domestic Violence Coordinating Council is an entity charged with investigating and reviewing the facts and circumstances of all deaths and near deaths as a result of domestic violence. It shall be recognized as a “public health authority” and as a “health oversight agency,” and it shall be recognized in the performance of its functions as a peer review organization or auditor or evaluator with respect to any aspect of health-care delivery systems or providers. (15) As permitted by federal law, including regulations. (e) Deceased individuals. — Nothing in this subchapter shall prohibit the disclosure of protected health information: (1) In a certificate of death, autopsy report or related documents prepared under applicable laws or regulations; (2) For the purposes of identifying a deceased individual; (3) For the purposes of determining a deceased individual’s manner of death by a medical examiner; or (4) To provide necessary information about a deceased individual who is a donor or prospective donor of an anatomical gift. (f) Informed consent by others. — When an individual who is the subject of protected health information is not competent or is otherwise legally unable to give informed consent for the disclosure of protected health information, informed consent may be given by the individual’s parents, legal guardians or other persons lawfully authorized to make health-care decisions for the individual. (g) Secondary disclosures. — No person to whom protected health information has been disclosed pursuant to this subchapter shall disclose the information to another person except as authorized by this subchapter. This section shall not apply to: (1) The individual who is the subject of the information; (2) The individual’s parents, legal guardians or other persons lawfully authorized to make healthcare decisions for the individual where the individual who is the subject of the information is unable to give legal consent pursuant to subsection (f) of this section; or (3) Any person who is specifically required by federal or state law to disclose the information. (h) Upon written request of an individual to a medical laboratory for a copy of the results of a laboratory examination of that individual, the medical laboratory shall provide a copy of those results that are sought to that individual. The medical laboratory may require a reasonable copying fee for copying and transmitting the records. (i) The Maternal and Child Death Review Commission and the Child Protection Accountability Commission are charged with helping to safeguard the health and safety of children. Each shall be recognized as a “health oversight agency,” and as a “public health authority,” and each shall be recognized in the performance of its functions as a peer review organization or auditor or evaluator with respect to any aspect of health-care delivery systems or providers. (73 Del. Laws, c. 355, § 12; 75 Del. Laws, c. 329, § 1; 75 Del. Laws, c. 361, §§ 6, 7; 75 Del. Laws, c. 387, § 4; 76 Del. Laws, c. 292, § 3; 77 Del. Laws, c. 307, §§ 2-4; 77 Del. Laws, c. 392, §§ 1-4; 78 Del. Laws, c. 277, § 3; 80 Del. Laws, c. 187, § 12; 81 Del. Laws, c. 94, § 1; 81 Del. Laws, c. 209, § 7; 81 Del. Laws, c. 429, § 1; 82 Del. Laws, c. 243, § 36; 83 Del. Laws, c. 321, § 2; 83 Del. Laws, c. 364, § 2.) § 1213. Regulations. The Department of Health and Social Services shall enforce this subchapter and shall from time to time promulgate any additional forms and regulations that are necessary for this purpose. (76 Del. Laws, c. 292, § 4; 78 Del. Laws, c. 277, § 3.) Subchapter III Medical Examinations (82 Del. Laws, c. 211, § 1.) § 1220. Definitions. As used in this subchapter: (1) “Health-care practitioner” means as defined in § 701 of this title. (2) “Health-care professional” means as defined in § 701 of this title. (3) “Informed consent” means the signing of a consent form by the patient or a person authorized to make health care decision on behalf of the patient that satisfies all of the following conditions: a. Is written in plain language. b. Is dated. c. Includes a description of the procedure to be performed. d. States if there will be a student or resident that will perform or be present at the patient’s examination. (82 Del. Laws, c. 211, § 1.) Page 134 Title 16 - Health and Safety § 1221. Pelvic, rectal, or prostate examinations. (a) A health-care practitioner or a health-care professional may not knowingly perform or supervise the performance of a pelvic, rectal, or prostate examination on a patient who is anesthetized or unconscious unless one of the following applies: (1) The patient or the person authorized to make health care decisions for the patient has given informed consent to the examination. (2) The examination is necessary for diagnostic or treatment purposes. (3) An emergency exists and it and it is impracticable to obtain consent and the examination is necessary for diagnostic or treatment purposes. (4) A court of competent jurisdiction orders the performance of the examination for the collection of evidence and such order must be issued in compliance with all of the following provisions: a. The court must find that there is a compelling need for such examination, which cannot be accommodated by other means. In assessing compelling need, the court shall weigh the need for the examination and the disclosure of the results against the privacy interest of the individual to be examined. b. Pleadings pertaining to the ordering of the examination shall substitute a pseudonym for the true name of the subject of the examination. The true name shall be communicated confidentially to the court and kept under seal of the court. (b) A health-care practitioner or health-care professional shall notify the patient as soon as reasonably practical that an examination was performed pursuant to § 1221(a)(3) and (4) of this title. (c) Any health-care practitioner or health-care professional who violates § 1221(a) of this title is subject to discipline by the appropriate professional licensing board. (82 Del. Laws, c. 211, § 1.) Page 135 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 12A Notification of Emergency Medical Providers of Persons with Communicable Diseases § 1201A. Definitions. As used in this chapter: (1) “Communicable disease” means human immunodeficiency virus, (HIV, the virus that causes AIDS), and hepatitis B. (2) “Division” means Division of Public Health, Department of Health and Social Services. (3) “Emergency medical care provider” means a fire fighter, law enforcement officer, paramedic, emergency medical technician, correctional officer, ambulance attendant or other person who serves as an employee or volunteer of an ambulance service and/or provides prehospital emergency medical services. (4) “Receiving medical facility” means a hospital or similar facility that receives a patient attended by an emergency medical care provider for the purposes of continued medical care. (5) “Universal precautions” means those precautions, including the appropriate use of hand washing, protective barriers, and care in the use and disposal of needles and other sharp instruments that minimize the risk of transmission of communicable diseases between patients and health-care providers. (68 Del. Laws, c. 415, § 1; 69 Del. Laws, c. 108, §§ 1, 2.) § 1202A. Report of exposed emergency medical provider. (a) An emergency medical care provider may request notification concerning exposure to a communicable disease under this section if the exposure is of a manner known to transmit a communicable disease. (b) Each employer of an emergency medical care provider, and every organization which supervises volunteer emergency medical care providers, shall designate an officer who shall receive requests for notification from emergency medical care providers; collect facts relating to the circumstances under which the emergency medical provider may have been exposed to a communicable disease; distribute the forms as specified by subsection (c) of this section to receiving medical facilities; report to the emergency medical care provider findings provided by the receiving medical facility; and assist the emergency care provider to take medically appropriate action when necessary. The designated officer shall delegate these duties as may be necessary to ensure compliance with this chapter. (c) If an emergency medical care provider desires to be notified under this chapter, the officer designated pursuant to subsection (b) of this section shall notify the receiving medical facility within 24 hours after the patient is admitted to or treated by the facility, utilizing a form that is prescribed or approved by the Division of Public Health. (68 Del. Laws, c. 415, § 1; 69 Del. Laws, c. 108, § 3; 70 Del. Laws, c. 147, § 7; 70 Del. Laws, c. 186, § 1.) § 1203A. Notification by a receiving medical facility. (a) Each receiving medical facility shall designate an officer or individual who shall receive completed forms as specified by § 1202A(c) of this title, and who shall insure compliance with the requirements of this section. (b) If, within 30 days after a patient is admitted or treated, a receiving medical care facility determines whether or not the emergency medical care provider has been exposed to a communicable disease, the receiving medical facility shall so notify the officer designated pursuant to § 1202A(b) of this title as soon as possible, but in no case more than 48 hours after that determination. The receiving medical facility shall base this determination upon information provided in the request for notification made pursuant to § 1202A(c) of this title and patient records or a finding at the facility. (c) If, after expiration of the 30-day period, the receiving medical facility cannot determine whether or not the emergency medical care provider has been exposed to a communicable disease, the receiving medical facility shall notify the officer designated pursuant to § 1202A(b) of this title as soon as possible, but not more than 48 hours after expiration of the 30-day period. (d) If a request for notification has been made pursuant to § 1202A(c) of this title, the receiving medical facility shall provide to the Division a copy of the form which shall include information about whether or not the patient is infected with a communicable disease; and if exposure to the patient is considered by the receiving medical facility to be in a manner known to transmit that communicable disease. The Division shall settle any disputes regarding whether or not an emergency medical care provider has or has not been exposed to a communicable disease. (68 Del. Laws, c. 415, § 1; 69 Del. Laws, c. 108, § 4.) § 1204A. Universal precautions. In recognition of the importance of universal precautions to the control of communicable diseases from a patient to an emergency medical care provider, education and training with respect to universal precautions shall be a mandatory component of any required Page 136 Title 16 - Health and Safety training and any required continuing education for all emergency medical care providers who have patient contact. Training requirements for this purpose shall be established by the Division of Public Health. (68 Del. Laws, c. 415, § 1; 70 Del. Laws, c. 147, § 8; 70 Del. Laws, c. 186, § 1.) § 1205A. Rules and regulations. (a) The Division of Public Health shall make such rules and regulations as may in its judgment be necessary to carry out the provisions of this section, and may make additions of other communicable diseases which shall be subject to this chapter. (b) The Division of Public Health may issue regulations necessary to ensure compliance with this chapter relating to patients who are transferred between institutions, or who may die during or shortly after being transferred. The Division of Public Health shall require emergency medical care facilities to notify the officer designated pursuant to § 1202A(b) of this title when an emergency care provider has been exposed to a communicable disease identified by the Division of Public Health to be transmitted through the air, even if a request for notification has not been made pursuant to § 1202A(c) of this title. (68 Del. Laws, c. 415, § 1; 69 Del. Laws, c. 108, § 5; 70 Del. Laws, c. 147, §§ 9, 10; 70 Del. Laws, c. 186, § 1.) § 1206A. Confidentiality of HIV test results. A person who has knowledge of the identity of any person upon whom an HIV related test is performed, or the results of such test, in accordance with this chapter, shall maintain the confidentiality of that information pursuant to § 717 of this title. (68 Del. Laws, c. 415, § 1; 78 Del. Laws, c. 277, §§ 2, 3.) § 1207A. Confidentiality. All information contained in requests for notification and in the notification itself shall be confidential and used solely for the purposes of complying with this chapter. However, any person or agency, including but not limited to a receiving medical care facility or officer designated pursuant to § 1202A(b) of this title, acting in good faith to provide notification in accordance with this chapter, shall not be liable in any cause of action related to the breach of patient confidentiality. (68 Del. Laws, c. 415, § 1; 69 Del. Laws, c. 108, § 6.) § 1208A. Failure to provide notice. A receiving medical care facility or officer designated pursuant to § 1202A(b) of this title, acting in good faith to provide notification in accordance with this chapter, shall not be liable in any cause of action for failure to give the required notice if the emergency medical care provider fails to properly initiate the notification procedures pursuant to § 1202A of this title. (68 Del. Laws, c. 415, § 1; 69 Del. Laws, c. 108, § 7.) § 1209A. Minors. This chapter shall apply in the same manner and to the same extent to any emergency medical care provider who is a minor and above the age of 15, as if such minor were 21 years or older. (69 Del. Laws, c. 108, § 8.) Page 137 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 13 Pollution of Streams § 1301. Pollution of streams supplying drinking water; nuisance; penalty; abatement; jurisdiction. (a) No person shall cast, put, place, discharge in or permit or suffer to be cast, put, placed, discharged in or to escape into any running stream of water within the limits of this State, from which stream the inhabitants of any borough, town or city within this State are supplied wholly or in part with water for and as drink or beverage, any dye-stuffs, drugs, chemicals or other substance or matter of any kind whatsoever whereby the water so supplied as and for a drink or beverage is made and becomes noxious to the health or disagreeable to the senses of smell or taste. (b) Whoever violates subsection (a) of this section shall be fined not less than $1,000 nor more than $5,000. (c) The Superior Court shall have exclusive jurisdiction of offenses under this section. (d) In addition to the fine imposed under subsection (b) of this section, the Court shall issue an order for the abatement of the nuisance within 20 days after conviction. Any police officer authorized to make arrests in the jurisdiction in which the conviction takes place shall, under such order, unless the nuisance was abated before the expiration of the time allowed for its abatement, abate the same, and to this end shall enter on the premises from which the nuisance proceeded and arrest, stop and put an end to the business from the carrying on of which or in the process of which the nuisance was created and carried on. (12 Del. Laws, c. 405, §§ 1, 2; Code 1915, §§ 764, 765; Code 1935, §§ 770, 771; 16 Del. C. 1953, § 1301; 78 Del. Laws, c. 266, § 18.) § 1302. Maintenance of privy, hogpen or slaughterhouse near stream supplying drinking water; nuisance; abatement; penalty; jurisdiction. (a) No person shall put or place, or permit to be put, placed or used, any privy, hogpen or slaughterhouse over or so near that the excrement or offal therefrom shall escape or run into any stream of running water within the limits of this State from which the inhabitants of any town, borough or city are wholly or in part furnished with water as a drink or beverage. (b) Whoever violates subsection (a) of this section shall be fined $100. The Court shall order the nuisance to be abated immediately. (c) The Superior Court shall have exclusive jurisdiction of offenses under this section. (12 Del. Laws, c. 405, § 3; Code 1915, § 766; Code 1935, § 772; 16 Del. C. 1953, § 1302.) Page 138 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 14 Water and/or Sewer Authorities § 1401. Definitions. As used in this chapter: (1) “Authority” means a body politic and corporate created pursuant to this chapter or, if such body politic and corporate shall be abolished, the board, body or commission succeeding to the principal functions thereof or to which the powers given by this chapter to such body politic and corporate shall be given by law. (2) “Board” means the governing body of an authority. (3) “Bonds” means and includes notes, bonds and other evidences of indebtedness or obligations which each authority is authorized to issue pursuant to § 1408 of this title. (4) “Cost” as applied to a water system or a sewerage system includes the purchase price of any such system or the cost of acquiring all of the capital stock of the corporation owning such system and the amount to be paid to discharge all of its obligations in order to vest title to the system or any part thereof in the authority, the cost of improvements, the cost of all lands, properties, rights, easements, franchises and permits acquired, the cost of all machinery and equipment, financing charges, interest prior to and during construction and for 1 year after completion of construction, cost of engineering and legal services, plans, specifications, surveys, estimates of cost and of revenues, other expenses necessary or incident to the determining of the feasibility or practicability of any such acquisition, improvement or construction, administrative expenses and such other expenses as may be necessary or incident to the financing herein authorized, to the acquisition, improvement, construction of a water system or a sewerage system and the placing of the same in operation by the authority prior to the issuance of revenue bonds under this chapter for engineering studies and for estimates of cost and of revenues and for other technical or professional services which may be utilized in the acquisition, improvement or construction of such system, may be regarded as a part of the cost of such system. (5) “Federal agency” means and includes the United States of America, any department or bureau thereof, and any agency or instrumentality of the United States of America heretofore established or which may be established or created hereafter. (6) “Governing body” as applied to any municipality means the body or board authorized by law to enact ordinances or adopt resolutions for the particular municipality. (7) “Improvements” means such construction, erection, repairs, replacements, additions, extensions and betterments of and to a water system or a sewerage system as are deemed necessary by the authority to place or to maintain such system in proper condition for the safe, efficient and economic operation thereof or to meet requirements for service in areas which may be served by the authority and in which no existing service is being rendered. (8) “Municipality” means any county, city, town, village, sanitary district or other political subdivision of this State. (9) “Project” means any water system, sewer system and any combination or part or parts thereof owned, constructed or operated by an authority under this chapter. (10) “Sewage” means the water carried wastes created in and carried or to be carried away from residences, hotels, schools, hospitals, industrial establishments, commercial establishments or any other private or public building together with such household and industrial wastes as may be present. (11) “Sewerage system” means and includes all plants, systems, facilities or properties used or useful or having the present capacity for future use in connection with the collection, carrying away, treating, neutralizing, stabilizing or disposal of sewage, industrial wastes or other wastes, and any integral part thereof, including sewage treatment plants, disposal fields, lagoons, pumping stations, drainage ditches, surface water intercepting ditches, outfall sewers, trunk sewers, intercepting sewers, lateral sewers, force mains, pipes, pipelines, conduits, equipment, appurtenances and all properties, rights, easements and franchises relating thereto and deemed necessary or convenient by the authority for the operation thereof. (12) “Water system” means and includes all plants, systems, facilities or properties used or useful or having the present capacity for future use in connection with the supply or distribution of water, and any integral part thereof, including water supply systems, water distribution systems, reservoirs, dams, wells, intakes, mains, laterals, pumping stations, standpipes, filtration plants, purification plants, hydrants, meters, valves and equipment, appurtenances and all properties, rights, easements and franchises relating thereto and deemed necessary or convenient by the authority for the operation thereof. (16 Del. C. 1953, § 1401; 49 Del. Laws, c. 417.) § 1402. General referendum; creation of authority; certificate and recording; certification of information to Secretary of State. (a) (1) After a favorable majority referendum vote at a special election in the municipality or in each of the municipalities creating an authority, which referendum election shall be held on the same date in each of such municipalities, the governing body of a municipality Page 139 Title 16 - Health and Safety or the governing bodies of 2 or more municipalities may by ordinances or resolutions signify their intention to create an authority to acquire, construct, reconstruct, extend, repair, improve, maintain and operate a project under an appropriate name and title, containing the word “authority,” which shall be a public body politic and corporate. (2) Notice of the holding of such referendum election shall be authorized by resolution of the governing body of each municipality and published once a week for at least 3 consecutive weeks in at least 1 newspaper circulating in the municipality. Such notice shall set out in summary form the purpose, the date and place of holding the referendum election and the hours the polls will be open. (3) At said referendum election every resident and nonresident taxable of the municipality of the age of 21 years or upwards who has, by the time of voting, paid all municipal taxes theretofore assessed to the taxable resident or nonresident and/or assessed against the property the taxable resident or nonresident owns at the time of the referendum election shall be entitled to vote and shall have 1 vote for each dollar, or fractional part of a dollar, of taxes paid by the taxable resident or nonresident according to the last municipal assessment and tax payment records preceding the referendum election. The judge of the election shall note on the outside of each ballot, before the judge deposits the ballot in the ballot box, the number of votes to which each voter is entitled, in accordance with municipal assessment and tax payment records. (4) In cases of jointly owned property the votes of the owners of shares therein shall be in accordance with their respective shares or, if all owners appear at the polls and so consent, all of the votes may be cast by the owner of any share, except that the spouse first present at the polls may cast all the votes in reference to property held by husband and wife as tenants by the entirety. Life tenants shall have the entire vote as to the property so held and holders of remainder interest only shall have no vote by reason thereof. (5) The clerk of each municipality shall provide sufficient ballots which shall have printed thereon “For” and “Against.” The election shall be conducted in conformity with the provisions governing general elections as provided in Chapter 49 of Title 15. (b) Each such ordinance or resolution shall include articles of incorporation which shall set forth: (1) The name of the “authority;” (2) A statement that such authority is formed under this chapter; (3) The name of the incorporating municipality or municipalities; (4) The names, addresses and terms of office of the first members of the board of said authority and, if the governing body of the municipality determines that its members shall constitute the board of said authority, a statement to that effect; (5) The purpose or purposes for which the authority is to be created or is created. (c) The articles of incorporation shall be executed by each incorporating municipality by its proper officers and shall be filed with the Secretary of State, who shall receive the same and endorse thereon the date and time of such receipt. If the Secretary of State finds that the articles of incorporation conform to law, the Secretary of State shall forthwith endorse the Secretary of State’s own approval thereon and issue a certificate of approval to which shall be attached a copy of the approved articles. Upon the issuance of such certificate of approval by the Secretary of State, the corporate existence of said authority shall begin and thereupon such authority shall be conclusively deemed to have been lawfully and properly created and established and authorized to exercise its powers under this chapter. Promptly thereafter the Secretary of State shall record said articles of incorporation, together with the endorsements thereon, in a book to be kept for that purpose. (d) When the authority has been organized and its officers elected, the secretary shall certify to the Secretary of State the names and addresses of its officers as well as the principal office of the authority. Any change in the location of the principal office shall likewise be certified to the Secretary of State within 10 days after such change. (16 Del. C. 1953, § 1402; 49 Del. Laws, c. 417; 53 Del. Laws, c. 327; 70 Del. Laws, c. 186, § 1.) § 1403. Amendment of articles of incorporation. Every authority of this State may, from time to time and in the manner hereinafter provided, amend its articles of incorporation and thereby accomplish any 1 or more of the following: The adoption of a new name, changes in, additions to and diminutions of its powers and purposes, provided that such amendment shall contain only such provisions as it would be lawful or proper to insert in articles of incorporation made at the time of such amendment. (16 Del. C. 1953, § 1403; 49 Del. Laws, c. 417.) § 1404. Withdrawal or joinder of municipalities; procedure. (a) Whenever an authority has been incorporated by 2 or more municipalities, any 1 or more of such municipalities may withdraw therefrom and any municipality not having joined in the original incorporation may join in the authority, but no municipality shall be permitted to withdraw from any authority after an obligation has been incurred by the authority. (b) Any municipality wishing to withdraw from or to become a member of an existing authority shall signify its desire by resolution or ordinance after an enabling referendum. If the authority shall by resolution express its consent to such withdrawal or joining, articles of withdrawal or articles of joinder, as the case may be, shall be executed by the proper officers of the withdrawing or incoming municipality and shall be joined by the proper officers of the governing body of the authority and, in the case of a municipality seeking to become a member of the authority, also by the proper officers of each of the municipalities that are then members of the authority, pursuant to resolutions or ordinances by the governing bodies of such municipalities. In the case of a certificate of joinder, the certificate shall set forth all of the information required in the case of original incorporation insofar as it applies to the incoming municipality including the name Page 140 Title 16 - Health and Safety and address and term of office of the first member of the board of the authority from the incoming municipality. Articles of withdrawal and articles of joinder shall be filed with the Secretary of State, who shall receive the same and endorse thereon the date and time of such receipt. If the Secretary of State finds that the articles of withdrawal or articles of joinder, as the case may be, conform to law, the Secretary of State shall forthwith endorse the Secretary of State’s own approval thereon and issue a certificate of approval to which shall be attached a copy of the approved articles. Upon the issuance of such certificate of approval by the Secretary of State, said articles of withdrawal or articles of joinder, as the case may be, shall become effective and be in full force and effect, and such articles shall be conclusively deemed to have been lawfully and properly adopted. Promptly after the issuance of a certificate of approval the Secretary of State shall record the articles of withdrawal or articles of joinder, as the case may be, together with the endorsements thereon, in the book kept by it for the purpose of recording articles of incorporation. (16 Del. C. 1953, § 1404; 49 Del. Laws, c. 417; 70 Del. Laws, c. 186, § 1.) § 1405. Exercise of powers by governing body; composition; quorum; personnel; salaries; records. (a) The powers of each authority shall be exercised by a governing body (herein called the “board”) composed as follows: (1) If the authority is incorporated by 1 municipality, the board shall be composed of the members of the governing body of the municipality creating the authority or shall be composed of 5 citizens of such municipality, as the governing body of such municipality shall determine. If the governing body of the municipality creating the authority determines that the said board shall be composed of the members of said governing body, the terms of office of the members of said board shall coincide with their terms of office as members of the governing body and any member of said governing body shall automatically be a member of said board and shall cease to be a member of said board upon ceasing to be a member of said governing body. If the governing body of the municipality creating an authority shall determine that the board shall consist of 5 citizens, the governing body of such municipality shall appoint the members of the board, whose terms of office shall commence on the date of appointment and 1 of whom shall serve for 1 year, 1 for 2 years, 1 for 3 years, 1 for 4 years and 1 for 5 years from the January 1st next succeeding the date of incorporation, and thereafter the said governing body shall, at a meeting held not later than 1 month prior to January 1 in each year in which a vacancy occurs, appoint as a member of the board a citizen of the municipality for which the authority is created for a term of 5 years to succeed the member whose term expires on the January 1st next succeeding. (2) If the authority is incorporated by 2 or more municipalities, the board shall consist of a number of members at least equal to the number of municipalities incorporating the authority, but in no event less than 5. When 1 or more additional municipalities join an existing authority, each of such joining municipalities shall have 1 member on the board. The first of such members shall be appointed immediately upon the admission of the municipality into the authority for a full term of years equal to that fixed for the other members of the board. The members of the board shall be appointed, their terms staggered and vacancies filled, and where the number of municipalities joining is less than 5, shall be apportioned in such manner as the articles of incorporation shall provide. No member shall be appointed for a term longer than 5 years. (b) Members of the board who are not members of the governing body of the municipality or municipalities composing the authority shall hold office until their successors have been appointed, and may succeed themselves, and shall receive such salaries as may be determined by the governing body or bodies of the municipality or municipalities, but none of such salaries shall be increased or diminished by such governing body or bodies during the term for which the member receiving the same shall have been appointed. Members of the board who are members of the governing body of a municipality shall serve as board members without pay. If a vacancy shall occur by reason of the death, disqualification, resignation or removal of an appointed member, the governing body of the municipality shall appoint a successor to fill the member’s unexpired term. In joint authorities such vacancies shall be filled by the governing body of the municipality in the representation of which the vacancy occurs. Whenever any municipality shall withdraw from a joint authority the term of any member or members appointed from such municipality shall immediately terminate. (c) A majority of the members shall constitute a quorum of the board for the purpose of organizing the authority and conducting the business thereof and for all other purposes, and all action may be taken by vote of a majority of the members present, unless in any case the bylaws shall require a larger number. The board shall have full authority to manage the properties and business of the authority and to prescribe, amend and repeal bylaws, rules and regulations governing the manner in which the business of the authority may be conducted, and the powers granted to it may be exercised and embodied. The board shall fix and determine the number of officers, agents and employees of the authority and their respective powers, duties and compensation and may appoint to such office or offices any members of the board with such powers, duties and compensation as the board may deem proper. (d) Every such officer appointed shall be adequately bonded. (e) Each authority shall keep a complete and true record of its receipts, expenses and expenditures and shall employ a certified or licensed public accountant to audit its books and accounts. Each authority shall always keep available and open to public inspection during business hours, at its principal office, a detailed audit and financial statement of its accounts. Each authority shall file annually with the governing body or governing bodies of the municipality or municipalities composing the authority a certified copy of such detailed audit and financial statement. The governing body of the municipality composing an authority, or in the case of an authority composed of 2 or more municipalities the governing body of each such municipality, may at any time in person or by its duly authorized agent or agents audit and examine the books and records of such authority; provided, however, that such audit or examination shall be without cost to said authority. Page 141 Title 16 - Health and Safety (f) Notwithstanding anything in Title 8 or anything in the certificate of incorporation of an authority to the contrary notwithstanding, a member of the Board may be removed at any time and without cause by act of the governing body of the municipality responsible for appointing that Board member. (16 Del. C. 1953, § 1405; 49 Del. Laws, c. 417; 70 Del. Laws, c. 186, § 1; 79 Del. Laws, c. 132, § 1.) § 1406. Character of authorities with reference to public health and welfare; projects; general powers. (a) Each authority created hereunder shall be deemed to be an instrumentality exercising public and essential governmental functions to provide for the public health and welfare and shall be for the purpose of acquiring, holding, constructing, reconstructing, repairing, improving, maintaining and operating, owning or leasing, either in the capacity of lessor or lessee, a project or projects within or partly within and partly without 1 or more of the municipality or municipalities by action of whose governing body or governing bodies the authority was created. (b) Every authority is granted and shall have and may exercise all powers necessary or convenient for the carrying out the aforesaid purposes including, but without limiting the generality of the foregoing, the following rights and powers: (1) To have perpetual existence; (2) To adopt bylaws for the regulation of its affairs and the conduct of its business; (3) To adopt an official seal and alter the same at pleasure; (4) To maintain an office at such place or places as it may designate; (5) To appoint officers, agents, employees and servants, to prescribe their duties and to fix their compensation; (6) To sue and be sued; (7) To acquire, purchase, hold, lease as lessee and use any franchise, property, real, personal or mixed, tangible or intangible, or any interest therein necessary or desirable for carrying out the purposes of the authority and to sell, lease as lessor, transfer or dispose of any property or interest therein at any time acquired by it; (8) To acquire by gift, purchase or the exercise of the right of eminent domain lands or rights in land or water rights in connection therewith; provided, however, that no property or any interest therein owned by any county, city, town or other political subdivision of the State shall be acquired by the exercise of the power of eminent domain without the consent of the governing body of such county, city, town or political subdivision; (9) To issue revenue bonds of the authority, payable solely from revenues, for the purpose of paying all or a part of the cost of any 1 or more projects, and to secure the payment of such bonds or any part thereof by pledge or deed of trust of all or any part of its revenues, and to make such agreements with the purchasers or holders of such bonds or with others in connection with any such bonds, whether issued or to be issued, as the authority may deem advisable, and in general, to provide for the security for said bonds and the rights of the holders thereof; (10) To combine any water system and any sewerage system as a single system for the purpose of operation and financing; (11) To fix, alter, charge and collect rates, fees and charges for the use of or for the services furnished by its systems and each of them for the purpose of providing for the payment of the expenses of the authority, the construction, reconstruction, extension, repair, improvement, maintenance and operation of its facilities and properties, the payment of the principal of and interest on its bonds, and to fulfill the terms and provisions of any agreements made with the purchasers or holders of any of its bonds or with the municipality or municipalities incorporating or the municipalities which are members of said authority or with any municipality served or to be served by said authority; said rates, fees and charges to be at reasonable and uniform rates to be determined exclusively by the authority. Any person questioning the reasonableness or uniformity of any rate, fee or charge fixed by an authority may bring suit against the authority; (12) To enter into contracts with the federal government, the State, or any agency or instrumentality thereof, or with any municipality, private corporation, copartnership, association or individual providing for or relating to the furnishing of services and facilities of any project of the authority or in connection with the services and facilities rendered by any water system or sewerage system owned or controlled by the federal government or the State, any agency or instrumentality thereof, and any municipality, private corporation, copartnership, association or individual; (13) To contract with any municipality, county, corporation, individual or any public authority of this or any adjoining state, on such terms as the said authority shall deem proper, for the construction and operation of any project which is partly in this State and partly in such adjoining state; (14) To make and enter into all contracts or agreements, as the authority may determine, which are necessary or incidental to the performance of its duties and to the execution of the powers granted by this chapter, including contracts with any federal agency or with any municipality, on such terms and conditions as the authority may approve, relating to (i) the use by such agency or by such municipality or the inhabitants thereof of any project acquired or constructed by the authority under this subsection or the services therefrom or the facilities thereof, or (ii) the use by the authority of the services or facilities of any water system or sewerage system owned or operated other than by the authority. Any such contract shall be subject to such provisions, limitations or conditions as may be contained in the resolution of the authority authorizing revenue bonds of the authority or the provisions of any trust agreement securing such bonds. Any such contract may provide for the collecting of fees, rates or charges for the services and facilities rendered to a municipality or to the inhabitants thereof by such municipality or by its agents or by the agents of the authority, and for the enforcement Page 142 Title 16 - Health and Safety of delinquent charges for such services and facilities. The provisions of any such contract and of any ordinance or resolution of the governing body of a municipality enacted pursuant thereto shall be irrepealable so long as any of the revenue bonds issued under the authority of this chapter shall be outstanding and unpaid, and the provisions of any such contract and of any ordinance or resolution enacted pursuant thereto shall be and be deemed to be for the benefit of such bondholders. The aggregate of any fees, rates or charges which shall be required to be collected pursuant to any such contract or any ordinance or resolution enacted thereunder shall be sufficient to pay all obligations which may be assumed by the other contracting party; (15) To enter upon, use, occupy and dig up any street, road, highway or private or public lands necessary to be entered upon, used or occupied in connection with the acquisition, construction or improvement, maintenance or operation of a project, subject, however, to such reasonable local police regulation as may be established by the governing body of any municipality having jurisdiction in the particular respect; (16) To receive and accept from any federal agency grants for or in aid of the construction, acquisition or operation of any project, and to receive and accept aid or contributions from any source of either money, property, labor or other things of value to be held, used and applied only for the purposes for which such grants and contributions may be made; (17) To charge a reasonable tapping fee whenever the owner of any property connects such property with a water or sewer system operated by the authority, which fee shall be in addition to any rental or use charges assessed by the authority; (18) In the event of any annexation by a municipality not a member of the authority of lands, areas or territory served by the authority, to continue to do business, exercise its jurisdiction over its properties and facilities in and upon or over such lands, areas or territory as long as any bonds or indebtedness remain outstanding or unpaid, or any contracts or other obligations remain in force. (16 Del. C. 1953, § 1406; 49 Del. Laws, c. 417; 53 Del. Laws, c. 327.) § 1407. Limits of powers. None of the powers granted by this chapter shall be exercised in the construction, improvement, maintenance, extension or operation of any project or projects which in whole or in part shall duplicate or compete with existing utilities, public or private, serving substantially the same purposes. The municipality or municipalities organizing such an authority may, in the resolution or ordinance signifying their intention so to do, or from time to time by subsequent resolution or ordinance, specify the project or projects to be undertaken by the said authority, and no other projects shall be undertaken by the said authority than those so specified. If the municipality or municipalities organizing an authority fail to specify the project or projects to be undertaken, then the authority shall be deemed to have all the powers granted by this chapter. No municipality which shall have created an authority under this chapter shall thereafter create any other authority serving the whole or any part of the same area. No municipality which shall have joined with any other municipality or municipalities in the creation of any authority under this chapter shall thereafter create or join in the creation of any other authority unless such other municipality or municipalities shall consent thereto by ordinance or resolution after a general referendum. (16 Del. C. 1953, § 1407; 49 Del. Laws, c. 417.) § 1408. Issuance of revenue bonds — Interest; maturity; use of proceeds; interim receipts or temporary bonds. (a) (1) Each authority created under this chapter may provide by resolution of its board, at 1 time or from time to time, for the issuance of revenue bonds of the authority for the purpose of paying the whole or any part of the cost of any project. (2) The principal of and the interest on such bonds shall be payable solely from the funds herein provided for such payment. The bonds of each issue shall be dated, shall bear interest at such rate or rates, shall mature at such time or times not exceeding 40 years from their date or dates, as may be determined by the authority, and may be made redeemable before maturity, at the option of the authority, at such price or prices and under such terms and conditions as may be fixed by the authority prior to the issuance of the bonds. (3) The authority shall determine the form of the bonds, including any interest coupons to be attached thereto, and the manner of execution of the bonds, and shall fix the denomination or denominations of the bonds and the place or places of payment of principal and interest, which may be at any bank or trust company. (4) In case any officer, whose signature or a facsimile of whose signature shall appear on any bonds or coupons, shall cease to be such officer before the delivery of such bonds, such signature or such facsimile shall nevertheless be valid and sufficient for all purposes the same as if the officer had remained in office until such delivery. (5) All revenue bonds issued under this chapter shall have and are declared to have, as between successive holders, all the qualities and incidents of negotiable instruments under the negotiable instruments laws of the State. The bonds may be issued in coupon or in registered form, or both, as the authority may determine, and provision may be made for the registration of any coupon bonds as to principal alone and also as to both principal and interest and for the reconversion into coupon bonds of any bonds registered as to both principal and interest. (6) The issuance of such bonds shall not be subject to any limitations or conditions contained in any other law and the authority may sell such bonds in such manner, either at public or at private sale, and for such price as it may determine to be in the best interests of the authority and the municipality to be served thereby. Page 143 Title 16 - Health and Safety (b) (1) The proceeds of such bonds shall be used solely for the payment of the cost of the project or projects on account of which such bonds are issued and shall be disbursed in such manner and under such restrictions, if any, as the authority may provide in the authorizing resolution or in the trust agreement hereafter mentioned securing the same. (2) If the proceeds of such bonds, by error of estimates or otherwise, shall be less than such cost, additional bonds may in like manner be issued to provide the amount of such deficit, and, unless otherwise provided in the authorizing resolution or in the trust agreement securing the same, shall be deemed to be of the same issue and shall be entitled to payment from the same fund without preference or priority of the bonds first issued for the same purpose. (3) If the proceeds of the bonds of any issue shall exceed the amount required for the purpose for which such bonds shall have been issued, the surplus shall be deposited to the credit of the reserve account or sinking fund for such bonds. (c) (1) Prior to the preparation of definitive bonds, the authority may, under like restrictions, issue interim receipts or temporary bonds, with or without coupons, exchangeable for definitive bonds when such bonds have been executed and are available for delivery. (2) The authority may also provide for the replacement of any bonds which shall become mutilated, destroyed or lost. (d) Bonds may be issued under this chapter without obtaining the approval or consent of any department, division, commission, board, bureau or agency of the State and without any other proceeding or the happening of any other condition or thing than those proceedings, conditions or things which are specifically required by this chapter. (e) The resolution providing for the issuance of revenue bonds of the authority and any trust agreement securing such bonds may contain such limitations upon the issuance of additional revenue bonds as the authority may deem proper, and such additional revenue bonds shall be issued under such restrictions and limitations as may be prescribed by such resolution or trust agreement. (16 Del. C. 1953, § 1408; 49 Del. Laws, c. 417; 70 Del. Laws, c. 186, § 1; 72 Del. Laws, c. 328, §§ 1, 2.) § 1409. Issuance of revenue bonds — Faith and credit of State or political subdivisions as unaffected. Revenue bonds issued under this chapter shall not be deemed to constitute a pledge of the faith and credit of the State or of any political subdivision thereof. All such bonds shall contain a statement on their face substantially to the effect that neither the faith and credit of the State nor the faith and credit of any county, city, town or other subdivision of the State are pledged to the payment of the principal of or the interest on such bonds. The issuance of revenue bonds under this chapter shall not directly or indirectly or contingently obligate the State or any county, city, town or other subdivision of the State to levy any taxes whatever therefor or to make any appropriation for their payment except from the funds pledged under this chapter. (16 Del. C. 1953, § 1409; 49 Del. Laws, c. 417.) § 1410. Exemption of projects from taxes. No authority shall be required to pay any taxes or assessments upon any project acquired, constructed or operated by it under this chapter or upon the income therefrom, and the bonds issued under this chapter, their transfer and the income therefrom (including any profit made on the sale thereof) shall at all times be free from taxation by the State or any of its political subdivisions or by any town or incorporated municipality or any other public agency within the State. (16 Del. C. 1953, § 1410; 49 Del. Laws, c. 417.) § 1411. Fixed charges in connection with projects; regulation of sewage; water meter readings. (a) The rates, fees and charges of each authority in connection with each project shall be so fixed and revised as to provide funds, with other funds available for such purposes, sufficient at all times: (1) To pay the cost of maintaining, repairing and operating the project on account of which the authority shall have issued revenue bonds as authorized by this chapter including reserves for such purposes and for replacement and depreciation and necessary extensions; (2) To pay the principal of and interest on the revenue bonds as the same shall become due and payable and to create reserves and provide a margin of safety for such purposes; and (3) To fulfill the terms and provisions of any agreements made with the purchasers or holders of any of its bonds or with the municipality or municipalities incorporating or the municipalities which are members of said authority or with any municipality served or to be served by said authority. (b) Any authority may fix rates, fees and charges for the services and facilities of its water system sufficient to pay all or any part of the cost of maintaining, repairing and operating its sewerage system and all or any part of the principal of and interest on revenue bonds issued on account of such sewerage system, and to pledge any surplus revenues of its water system, subject to prior pledges thereof, for such purpose or purposes. (1) Rates, fees and charges for the services of a sewerage system may be based or computed either upon the quantity of water used or upon the amount of the water bill or upon the number and size of sewer connections or upon the number and kind of plumbing fixtures in use in the premises connected with the sewerage system or upon the number or average number of persons residing or working in or otherwise connected with such premises or upon the type or character of such premises or upon any other factor affecting the use of the facilities furnished or upon any combination of the foregoing factors. Page 144 Title 16 - Health and Safety (2) Charges for sewerage services to premises obtaining all or a part of their water supply from sources other than public water system may be determined by gauging or metering or in any other manner approved by the authority. (3) All other rates, fees and charges of the authority shall be based or computed upon such factor or factors as the authority shall deem reasonable and proper. (c) In cases where the character of the sewage or waste from any manufacturing, commercial or industrial plant, building or premises is such that it imposes an unreasonable burden upon any sewerage system, an additional charge may be made therefor, or the authority may, if it deems advisable, compel such manufacturing, commercial or industrial plant, building or premises to treat such sewage or waste in such manner as shall be specified by the authority before discharging such sewage or waste into any sewage system owned, operated or maintained by such authority. (d) Every municipality composing an authority operating a sewerage system shall, at the request of such authority, supply such authority, on or before the fifteenth day of the month following the month during which water bills are issued by such municipality, with a list of all water meter readings forming the basis of such bills and/or a statement of the amount of such bills so that such data may be used by such authority in calculating or computing its rates, fees and charges for sewer services to such water consumer. (16 Del. C. 1953, § 1411; 49 Del. Laws, c. 417.) § 1412. Trust agreements to secure bonds; pledges and assignments; contents of authorizing resolutions; depositaries for bond sales proceeds. (a) In the discretion of the authority, any revenue bonds issued under this chapter may be secured by a trust agreement by and between the authority and a corporate trustee, which may be any trust company or bank having the powers of a trust company. (b) (1) The resolution authorizing the issuance of the bonds or the trust agreement may pledge or assign the revenues to be received from the operation of the project or projects on account of which the bonds are issued and, in the case of bonds issued to finance a sewerage system, may pledge or assign as security for such bonds the revenues to be received from its water system to the extent authorized by § 1411 of this title, but shall not convey or mortgage any project or any part thereof, and may contain such provisions for protecting and enforcing the rights and remedies of the bondholders as may be reasonable and proper and not in violation of law, including covenants setting forth the duties of the authority in relation to the acquisitions, construction, improvement, maintenance, operation, repair and insurance of the project or projects on account of which such bonds are issued, and provisions for the custody, safeguarding and application of all moneys and for the employment of consulting engineers in connection with such construction, reconstruction or operation. (2) Such resolution or trust agreement may set forth the rights and remedies of the bondholders and of the trustees in the case of a trust agreement and may restrict the individual right of action by bondholders as is customary in trust agreements or trust indentures securing bonds or debentures of corporations. (3) In addition to the foregoing, such resolution or trust agreement may contain such other provisions as the authority may deem reasonable and proper for the security of the bondholders. (c) Except as is in this chapter otherwise provided, the authority may provide for the payment of the proceeds of the sale of the bonds and its revenues to such officer, board or depositary as it may designate for the custody thereof and for the method of disbursement thereof, with such safeguards and restrictions as it may determine. (d) All expenses incurred in carrying out such resolution or trust agreement may be treated as a part of the cost of operation of the project or projects. (16 Del. C. 1953, § 1412; 49 Del. Laws, c. 417.) § 1413. Connection with sewerage system by abutting property owners; conditions. Upon the acquisition or construction of any sewerage system under this chapter, the owner of each lot or parcel of land which abuts upon a street or other public way containing a sanitary sewer which is a part of or which is served or may be served by such sewerage system and upon which lot or parcel of land a building shall have been constructed for residential, commercial or industrial use, shall, if so required by the rules and regulations or a resolution of the authority, connect such building with such sanitary sewer and shall cease to use any other method for the disposal of sewage, sewage waste or other polluting matter; provided, however, that the owner of such lot or parcel of land having a method for the disposal of sewage, sewage waste or other polluting matter constructed and operated in accordance with standards prescribed or approved by the Secretary of the Department of Natural Resources and Environmental Control shall not be required to make such connection. All such connections shall be made in accordance with rules and regulations which shall be adopted from time to time by the authority, which rules and regulations may provide for a charge for making any such connection in such reasonable amount as the authority may fix and establish. (16 Del. C. 1953, § 1413; 49 Del. Laws, c. 417; 55 Del. Laws, c. 442, § 10; 59 Del. Laws, c. 212, § 1.) § 1414. Provisions permitted for inclusion in resolutions or trust agreements providing for bonds. (a) Any resolution or trust agreement providing for the issuance of revenue bonds under this chapter may include any or all of the following provisions and may require the authority to adopt such resolutions or to take such other lawful action as shall be necessary to effectuate such provisions, and the authority may adopt such resolutions and take such other action: Page 145 Title 16 - Health and Safety (1) That the authority may require the owner, tenant or occupant of each lot or parcel of land who is obligated to pay rates, fees or charges for the use of or for the services furnished by any project acquired, constructed or operated by the authority under this chapter to make a reasonable deposit with the authority in advance to insure the payment of such rates, fees or charges and to be subject to application to the payment thereof if and when delinquent; (2) That if any rates, fees or charges for the use of or for the services furnished by any project acquired, constructed or operated by the authority under this chapter shall not be paid within 30 days after the same shall become due and payable, the authority may at the expiration of such 30-day period disconnect the premises from the water and/or sewer system or otherwise suspend services and the authority may proceed to recover the amount of any such delinquent rates, fees or charges with interest, in a civil action or by foreclosure of the lien therefor; (3) That, if any rates, fees or charges for the use and services of any sewerage system acquired, constructed or operated by the authority under this chapter shall not be paid within 30 days after the same shall become due and payable, the owner, tenant or occupant of such premises shall cease to dispose of sewage or industrial wastes originating from or on such premises by discharge thereof directly or indirectly into the sewerage system until such rates, fees or charges with interest shall be paid; that, if such owner, tenant or occupant shall not cease such disposal at the expiration of such 30-day period, any political subdivision, district, private corporation, board, body or person supplying water to or selling water for use on such premises shall cease supplying water to or selling water for use on such premises within 5 days after the receipt of notice of such delinquency from the authority; and that, if such political subdivision, district, private corporation, board, body or person shall not, at the expiration of such 5-day period, cease supplying water to or selling water for use on such premises, the authority may shut off the supply of water to such premises. (b) There shall be lien upon real estate for the amount of any fees, rents or other charges, including tapping fees, by an authority to the owner or lessee or occupant of such real estate for the use and services for any project of the authority by or in connection with such real estate from and after the time when such fees, rents or charges are due and payable, and for the interest which may accrue thereon. Such lien shall be superior to the interest of any owner, lessee or occupant of such real estate. (c) Such lien shall not bind or affect a subsequent bona fide purchaser of such real estate for valuable consideration without actual notice of such lien, until and except from the time that the amount of such fees, rents and charges are entered in a register or registers furnished for such purpose by and at the expense of the authority and kept in the office where deeds may be recorded in the municipality wherein the real estate or a part thereof is located. The clerk in whose office deeds may be recorded shall keep and preserve and hold available for public inspection any such register which may be delivered to the clerk by the authority and cause entries to be made and indexed therein from time to time upon certification by the authority for which the clerk shall be entitled to a fee of 5 cents per entry to be paid by the authority and added to the amount of the lien. (d) Such lien on any real estate may be discharged by the payment to the authority of the total amount of such lien and the interest which may accrue to the date of such payment and the authority shall deliver a certificate thereof to the person paying the same, and upon presentation thereof, the clerk having the record of such lien shall mark the entry of such lien satisfied without further fee. (16 Del. C. 1953, § 1414; 49 Del. Laws, c. 417; 70 Del. Laws, c. 186, § 1.) § 1415. Moneys received as trust funds; fiscal agents to act as trustees. All moneys received pursuant to the authority of this chapter, whether as proceeds from the sale of bonds or as revenues, shall be deemed to be trust funds to be held and applied solely as provided in this chapter. The resolution or trust agreement providing for the issuance of revenue bonds of the authority shall provide that any officer to whom or any bank, trust company or other fiscal agent to which such moneys shall be paid shall act as trustees of such moneys and shall hold and apply the same for the purposes hereof, subject to such regulations as such resolution or trust agreement may provide. (16 Del. C. 1953, § 1415; 49 Del. Laws, c. 417.) § 1416. Rights of bondholders and trustees. Any holder of revenue bonds issued by an authority under this chapter or any of the coupons appertaining thereto and the trustee under any trust agreement, except to the extent the rights herein given may be restricted by the resolution or trust agreement providing for the issuance of such bonds, may either at law or in equity, by suit, mandamus or other proceeding protect and enforce any and all rights under the laws of this State or granted hereunder or under such resolution or trust agreement, and may enforce and compel the performance of all duties required by this chapter or by such resolution or trust agreement to be performed by the authority or by an officer thereof, including the fixing, charging and collecting of rates, fees and charges for the use of or for the services furnished by any project. (16 Del. C. 1953, § 1416; 49 Del. Laws, c. 417.) § 1417. Revenue refunding bonds; single issues of revenue bonds; applicability thereto of other provisions of this chapter. Each authority created hereunder may provide by resolution for the issuance of revenue refunding bonds of the authority for the purpose of refunding any revenue bonds outstanding and issued under this chapter. Each such authority may further provide by resolution for the issuance of a single issue of revenue bonds of the authority for the combined purposes of: (1) Paying the cost of any project, or the improvement, extension, addition or reconstruction thereof; and Page 146 Title 16 - Health and Safety (2) Refunding revenue bonds of the authority which shall theretofore have been issued under this chapter and shall then be outstanding and which shall then have matured or be subject to redemption or can be acquired for retirement. The issuance of such bonds, the maturities and other details thereof, the rights and remedies of the holders thereof, and the rights, powers, privileges, duties and obligations of the authority with respect to the same, shall be governed by the foregoing provisions of this chapter insofar as the same may be applicable. (16 Del. C. 1953, § 1417; 49 Del. Laws, c. 417.) § 1418. Accreditation of bonds for investment purposes. Bonds issued under this chapter are made securities in which all public officers and public agencies of the State and its political subdivisions, and all bonds, trust companies, savings and loan associations, investment companies and others carrying on a banking business, all insurance companies and insurance associations and others carrying on an insurance business, all administrators, executors, guardians, trustees and other fiduciaries and other persons may legally and properly invest funds, including capital in their control or belonging to them. Such bonds are made securities which may properly and legally be deposited with and received by any state or municipal officer or any agency or political subdivision of the State for any purpose for which the deposit of bonds or other obligations of the State is now or may hereafter be authorized by law. (16 Del. C. 1953, § 1418; 49 Del. Laws, c. 417.) § 1419. Transfer of interest by municipalities; use of certain lands; powers of municipalities. (a) Notwithstanding any contrary provision of law, any municipality may transfer jurisdiction over, lease, lend, grant, sell or convey to any authority upon the request of such authority, with or without consideration, any facilities or any right or interest therein or any property appertaining thereto or any real property or estate, right or interest therein for use by such authority in connection with the construction, reconstruction, extension, repair, improvement, maintenance or operation of 1 or more projects upon such terms and conditions as the governing body of such municipality shall determine to be for the best interest of such municipality. The State consents to the use of all lands below high watermark owned or controlled by it and to the use of any land between the right-of-way limits of any state highway which are necessary or desirable in connection with the construction, reconstruction, extension, repair, improvement, maintenance or operation of any project; provided, however, that the use of any portion between the right-of-way limits of a state highway shall be subject to the approval of the State Highway Department. (b) Each municipality may: (1) Contract with any authority created hereunder for the collection, treatment or disposal of sewage; (2) Contract with any authority created hereunder for shutting off the supply of water furnished by any water system owned or operated by such municipality or under its jurisdiction or control to any premises connected with any sewerage system of the authority in the event that the owner, tenant or occupant of such premises shall fail to pay any rates, fees or charges for the use of or for the services furnished by such sewerage system within the time or times specified in such contract; (3) Contract with any authority with respect to any and all matters and things concerning which such authority is authorized to contract with such municipality under this chapter; (4) Loan to any newly created authority money for the purpose of providing funds to pay the organization and preliminary expenses of such authority on condition that such moneys shall be repaid out of the proceeds of the first issue of such authority. (16 Del. C. 1953, § 1419; 49 Del. Laws, c. 417.) § 1420. Transfer of projects to municipalities; conditions; termination of authorities. When any authority shall have paid or provided for the payment of the principal of and the interest on all bonds secured by a pledge of any of the revenues of a project, it may (subject to any agreements concerning the operation or disposition of such project) grant and convey such project to the municipality or municipalities composing the authority. When any authority shall have paid or made provisions for the payment of the principal of and the interest on all bonds issued by it and settled all other claims against it, it may terminate its existence. A certificate, requesting the termination of the existence of the authority, signed by the proper officers of the authority and stating that the principal of and the interest on all bonds issued by it have been paid or that provisions for such payment have been made and that all claims against the authority have been settled shall be filed with the Secretary of State. If the certificate is approved by the municipality or municipalities composing the authority by ordinance or resolution, the Secretary of State shall note the termination of existence on the records of the Secretary of State and issue its certificate of approval to the board and thereupon the authority shall cease to exist. (16 Del. C. 1953, § 1420; 49 Del. Laws, c. 417.) § 1420A. Incorporation of project within other governmental system; assumption of debt. No project acquired or constructed by an authority pursuant to this chapter may be incorporated within any other governmental system except upon the assumption without surcharge to the authority or its customers by the governing body of that government of full responsibility for payments of any outstanding revenue bonds issued by the authority to finance the acquisition or construction of the project. (63 Del. Laws, c. 23, § 1.) Page 147 Title 16 - Health and Safety § 1421. Scope and construction of chapter. This chapter shall constitute full and complete authority, without regard to any other law for the doing of the acts and things herein authorized, and shall be liberally construed to effect the purposes hereof; provided, however, that nothing herein contained shall be taken as restricting any control which the Department of Health and Social Services, State Highway Department and the Water Pollution Commission are empowered to exercise over or within any authority. The foregoing sections of this chapter shall be deemed to provide an additional and alternative method for the doing of the things authorized thereby and shall be regarded as supplemental and additional to powers conferred by other laws and shall not be regarded as in derogation of any powers not existing. (16 Del. C. 1953, § 1421; 49 Del. Laws, c. 417; 70 Del. Laws, c. 149, § 107.) Page 148 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 15 Cesspools, Privy Wells, Drainage Systems and Water Supply Systems § 1501. Regulating construction of drainage systems and water supply systems. (a) The Department of Health and Social Services may regulate and prescribe the manner in which all cesspools, privy wells and other drainage systems shall be constructed within the limits of all incorporated towns and at any place within 1 mile from the water supply thereof. The Department of Health and Social Services may adopt regulations to insure that water supply systems are constructed or altered in a manner that preserves the quality of water supplied to the public. (b) As used in this chapter, “water supply system” means all plants, systems, facilities or properties used or useful, or having the present capacity for future use, in connection with the supply or distribution of water, and any integral part thereof, including water distribution systems, mains, laterals, pumping stations, standpipes, filtration plants, purification plants, hydrants, meters, valves and equipment, appurtenances and all properties, rights, easements and franchises relating thereto and deemed necessary or convenient by the authority for the operation thereof. Except as otherwise provided in this chapter, the term “water supply system” shall not mean a dam, reservoir, surface water intake, waterway obstruction or well. (33 Del. Laws, c. 56, § 2; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 66, § 1; 34 Del. Laws, c. 69, § 1; Code 1935, § 859; 16 Del. C. 1953, § 1501; 64 Del. Laws, c. 479, § 2; 70 Del. Laws, c. 149, § 108.) § 1502. Changing existing drainage systems. The Department of Health and Social Services may order and direct any changes in the construction of any cesspool or privy well or other drainage already constructed and used on any property in any incorporated town or within 1 mile of the water supply of the town which it deems necessary for the protection of the health of the inhabitants of the town or for the protection of the water supply thereof. (33 Del. Laws, c. 56, § 3; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 66, § 1; 34 Del. Laws, c. 69, § 1; Code 1935, § 860; 16 Del. C. 1953, § 1502; 70 Del. Laws, c. 149, § 109.) § 1503. Construction changes in drainage systems. The Department of Health and Social Services may order and direct that the owner of any property on which there is a cesspool or privy well and all other drainage already in use in any incorporated town or within 1 mile from the water supply of the town shall so change and construct the same out of brick and cement or concrete in such manner as to prevent the contents thereof from oozing through or passing into the soil around the cesspool or privy well or from overflowing over the top thereof. (33 Del. Laws, c. 56, § 4; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 66, § 1; 34 Del. Laws, c. 69, § 1; Code 1935, § 861; 16 Del. C. 1953, § 1503; 70 Del. Laws, c. 149, § 110.) § 1504. Prohibiting surface drainage. The Department of Health and Social Services may prohibit the owner or tenant of any property within any incorporated town or within 1 mile from the water supply thereof from discharging any sewerage or drainage from any house or building on or over the surface of the ground adjoining the same whenever it determines that the same is detrimental to the health of the inhabitants of the town or those living within 1 mile from the water supply thereof. (33 Del. Laws, c. 56, § 5; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 66, § 1; 34 Del. Laws, c. 69, § 1; Code 1935, § 862; 16 Del. C. 1953, § 1504; 70 Del. Laws, c. 149, § 111.) § 1505. Cleaning of cesspools and privy wells. The Department of Health and Social Services may order and direct the owner or tenant of any property within any incorporated town or within 1 mile from the water supply thereof on which there is a cesspool or privy well to clean the same in such manner as it directs whenever it deems the cleaning thereof to be necessary. Whoever neglects or refuses to comply with the order within 30 days from the time notice of the order is served shall be subject to the fines and penalties provided in § 1507 of this title for the violation of this chapter. (33 Del. Laws, c. 56, § 6; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 66, § 1; 34 Del. Laws, c. 69, § 1; Code 1935, § 863; 16 Del. C. 1953, § 1505; 70 Del. Laws, c. 149, § 112.) § 1506. Plans for construction or alteration of a water supply system. All plans for the construction or alteration of a water supply system shall be submitted to the Division of Public Health of the Department of Health and Social Services for approval before the construction or alteration of said water supply system begins. Notwithstanding the exclusions in § 1501(b) of this title, the Division of Public Health may review and inspect the construction of wells, dams, reservoirs, surface water intakes and waterway obstructions for health aspects, including but not limited to such features as venting, grouting, integrity Page 149 Title 16 - Health and Safety of well seals and protection from contamination. Any negative health aspects observed by the Division of Public Health during such review or inspection shall be referred to the Department of Natural Resources and Environmental Control for investigation, resolution or enforcement action. In addition, and pursuant to § 7931 of this title, a dug well or any type of private water supply that is located where there is access to a public water supply shall not be permitted unless the private water supply is approved in writing by the Department of Health and Social Services. (34 Del. Laws, c. 66, § 1; 34 Del. Laws, c. 69, § 1; Code 1935, § 864; 16 Del. C. 1953, § 1506; 55 Del. Laws, c. 442, § 9; 56 Del. Laws, c. 372, § 2; 57 Del. Laws, c. 739, §§ 219, 220; 64 Del. Laws, c. 479, § 3; 70 Del. Laws, c. 149, § 113.) § 1507. Penalties; jurisdiction. (a) Whoever violates this chapter or any order or regulation of the Department of Health and Social Services or any laws of this State conferring powers upon boards of health or refuses or omits to obey such order and regulation within the time prescribed for the performance thereof, or obstructs or interferes with the execution of such order or regulation, shall, for the first offense, be fined not less than $10 and not more than $100 and for any subsequent offense not less than $25 nor more than $200. (b) Prosecutions under this section may be brought before the alderperson of the incorporated town in which the violation occurs. (33 Del. Laws, c. 56, § 7; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 66, § 1; 34 Del. Laws, c. 69, § 1; Code 1935, § 865; 16 Del. C. 1953, § 1507; 70 Del. Laws, c. 149, § 114; 70 Del. Laws, c. 186, § 1.) Page 150 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 16 Litter Control Law § 1601. Short title. This chapter shall be known and may be cited as the “Delaware Litter Control Law.” (60 Del. Laws, c. 613, § 1.) § 1602. Declaration of intent. It is the intention of this chapter to end littering on public or private property, including bodies of water, as a threat to the health and safety of the citizens, fish, birds, and other animals of this State. It is also the intent of the General Assembly to single out for enhanced penalties those who dump a substantial quantity of litter in violation of this chapter. (60 Del. Laws, c. 613, § 1; 82 Del. Laws, c. 167, § 1; 83 Del. Laws, c. 180, § 1.) § 1603. Definitions. As used in this chapter: (1) “Balloon” means a bag made from rubber, latex, polychloroprene, nylon, mylar, or other material which is or can be filled with air, water, or a gas, including helium, hydrogen, nitrous oxide, or oxygen. (2) “Dumping” means the deposit of litter in a substantial quantity on public or private property. (3) “LIEF” means the Littering Investigation and Enforcement Fund. (4) “Litter” includes all rubbish, waste material, refuse, cans, bottles, garbage, trash, debris, dead animals, 1 to 4 balloons released at 1 time, or other discarded materials of every kind and description. (5) “Mass release of balloons” means the intentional release of 5 or more balloons at 1 time. (6) “Public or private property” includes the right-of-way of any road or highway; any body of water or watercourse, or the shores or beaches thereof; any park, playground, building, refuge, or conservation or recreation area; and any residential or farm properties, timberlands, or forests. (7) “Substantial quantity” means a gross, uncompressed volume of litter equal to or greater than 32 gallons or 4.28 cubic feet, which is the capacity of a standard garbage can. (60 Del. Laws, c. 613, § 1; 82 Del. Laws, c. 167, § 2; 83 Del. Laws, c. 180, § 2.) § 1604. Unlawful activities. (a) Littering. — It is unlawful for a person to deposit, throw, release, or leave, or cause or permit the depositing, placing, throwing, or leaving of litter on public or private property of this State, unless either of the following 2 conditions is met: (1) The property is designated by the State or by any of its agencies or political subdivisions for the management of litter, and the person is authorized by the proper public authority to use the property for that purpose. (2) Both of the following apply: a. The litter is placed in a litter receptacle or container installed on or at the property. b. The person is the owner or tenant in lawful possession of the property or has first obtained consent of the owner or tenant in lawful possession, or the act is done under the personal direction of the owner or tenant, all in a manner consistent with the public welfare. (b) Dumping. — It is unlawful for a person to dump litter in substantial quantities on public or private property, except under paragraphs (a)(1) through (a)(2) of this section. (c) Mass release of balloons. — It is unlawful for a person to intentionally release, or intentionally cause or permit the release of, 5 or more balloons on private or public property of this State. (d) This section does not apply to any of the following: (1) A balloon that is released for scientific or meteorological purposes, on behalf of a governmental agency, or under a governmental contract. (2) A hot air balloon that is recovered after launching. (3) A balloon that is released and remains indoors. (4) A balloon that, for recreational purposes, is filled with water and recovered after recreation. Page 151 Title 16 - Health and Safety (5) A balloon that is unintentionally or negligently released. (60 Del. Laws, c. 613, § 1; 82 Del. Laws, c. 167, § 3; 83 Del. Laws, c. 180, § 3.) § 1605. Penalties; jurisdiction; voluntary assessment form [For application of this section, see 83 Del. Laws, c. 283, § 50]. (a) (1) A person found guilty of littering under § 1604(a) of this title must be punished by a fine of not less than $50 and up to 8 hours of community service for a first offense, and $75 and up to 25 hours of community service for a second offense within 2 years of the first offense. This paragraph does not apply to the intentional release of 1 to 4 balloons. The penalty for intentionally releasing 1 to 4 balloons is provided in paragraph (a)(3)a. of this section. (2) A person found guilty of dumping under § 1604(b) of this title must be punished by a fine of not less than $500 and not less than 8 hours of community service for a first offense, and a fine of not less than $1,000 and not less than 16 hours of community service for a second offense within 2 years of the first offense. Each instance of dumping constitutes a separate offense under this chapter. (3) Balloons. a. A person who is found in violation of § 1604(a) of this title by releasing 1 to 4 balloons must do the following: 1. For a first violation, pay a civil penalty of not less than $25. 2. For a second or subsequent violation within 2 years of a first violation, pay a civil penalty of not less than $75 and complete up to 8 hours of community service. b. A person who is found in violation of § 1604(c) of this title through the mass release of balloons must do the following: 1. For a first violation, pay a civil penalty of not less than $250 and complete up to 8 hours of community service. 2. For a second or subsequent violation, pay a civil penalty of not less than $350 and complete up to 25 hours of community service. (4) An additional mandatory penalty of $500 must be imposed, in addition to the fine, for every first or subsequent offense, or an additional mandatory civil penalty of $500 must be imposed in addition to the civil penalty for every first or subsequent violation, if the offense or violation occurred in any of the following locations: a. On or along a Delaware byway, as defined in § 101 of Title 17. b. A State park, forestry area, or fish and wildlife area. c. A federal wildlife refuge. d. Land within the State that is administered by the United States Department of Interior, National Park Service. (5) In addition to the penalties listed in paragraphs (a)(1) through (a)(4) of this section, the Court may require a person found guilty of violating this chapter to do 1 or both of the following: a. Pick up and remove from any public street, highway, public or private right-of-way, public beach, stream, bank, or public park all litter deposited or dumped on the property by anyone before the date of execution of sentence. b. Pay as restitution an amount determined by the Court to the Littering Investigation and Enforcement Fund. The State shall maintain the LIEF as a subaccount of the Special Law Enforcement Assistance Fund established under subchapter II of Chapter 41 of Title 11. Disbursement of LIEF funds must be authorized under the procedures established under § 4113 of Title 11, for the purpose of investigation, enforcement, and remediation of unlawful littering or dumping. (b) The Justice of the Peace Court has jurisdiction over a violation of this chapter. (c) The Court shall make public the names of persons convicted of violating this chapter. (d) (1) A peace officer of this State who charges a person with littering or mass release of balloons under § 1604 of this title may, in addition to issuing a summons for the offense or violation, provide the offender with a voluntary assessment form which, when properly executed by the officer and the offender, allows the offender to dispose of the charge without the necessity of personally appearing in the Court to which the summons is returnable. (2) a. Payments made under paragraphs (a)(1) through (a)(4) of this section must be remitted to and received by the Court to which the summons is returnable within 10 days from the date of arrest or, for the release of 1 to 4 balloons or mass release of balloons, the date of the violation, excluding Saturday and Sunday. b. Restitution made to the LIEF under paragraph (a)(5)b. of this section must be remitted to and received by the Court ordering restitution within 10 days from the date of the order for restitution, excluding Saturday and Sunday. (3) The fine imposed under this subsection must be the minimum fine as provided for in subsection (a) of this section, plus other costs as may be assessed by law. (4) “Voluntary assessment form”, as used in this section, means the written agreement or document signed by the violator in which the violator agrees to pay by mail the fine for the offense described in the agreement or document together with costs and penalty assessment. (60 Del. Laws, c. 613, § 1; 62 Del. Laws, c. 387, §§ 1, 2; 70 Del. Laws, c. 186, § 1; 76 Del. Laws, c. 325, § 1; 77 Del. Laws, c. 350, § 3; 82 Del. Laws, c. 167, § 4; 83 Del. Laws, c. 180, § 4; 83 Del. Laws, c. 283, § 50.) Page 152 Title 16 - Health and Safety § 1606. Prima facie evidence. (a) (1) The throwing, depositing, dropping, releasing, or dumping of litter from a motor vehicle, boat, airplane, or other conveyance in violation of this chapter is prima facie evidence that the operator of the conveyance violated chapter. (2) If, under paragraph (a)(1) of this section, a motor vehicle is used and the identity of the operator is not discernable, there is a rebuttable presumption that the registered owner of the motor vehicle caused or contributed to the violation. (b) A license to operate a conveyance listed in paragraph (a)(1) of this section may be suspended for a period not to exceed 30 days together with, or in lieu of, other penalties for littering under this chapter or another law of this State. But, if littering or dumping from a conveyance listed in subsection (a) of this section is a first offense, the license may not be suspended and the sanctions provided in § 1605 of this title apply. (60 Del. Laws, c. 613, § 1; 82 Del. Laws, c. 167, § 5; 83 Del. Laws, c. 180, § 5.) § 1607. Receptacles to be provided. (a) A public authority or agency having supervision of a property of this State shall do all of the following: (1) Establish and maintain receptacles for the deposit of litter at appropriate locations if a property is frequented by the public. (2) Post signs directing the public to the receptacles and serving notice of this chapter. (3) Otherwise publicize the availability of litter receptacles and the requirements of this chapter. (b) A public authority or agency may designate a park or recreation area as a carry-in and carry-out facility by posting or otherwise providing a notice to visitors, in which case the public authority or agency is not required to provide receptacles under subsection (a) of this section. (60 Del. Laws, c. 613, § 1; 82 Del. Laws, c. 167, § 6.) § 1608. Enforcement. All law-enforcement agencies of the State, including enforcement personnel of the Department of Natural Resources and Environmental Control, shall enforce this chapter. (61 Del. Laws, c. 241, § 1; 82 Del. Laws, c. 167, § 7.) § 1609. Notice. A retail or wholesale establishment that sells balloons must prominently display the following notice at the location in the establishment where balloons are sold or where payment is made: “The intentional release of balloons into the air is a violation of Delaware law and is subject to penalties. 16 Del. Code Ch. 16.” (83 Del. Laws, c. 180, § 6.) Page 153 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 17 Refuse and Garbage § 1701. Bringing garbage or household refuse into State; permit and bond. No person shall bring into the State from any place without the State, garbage or household refuse for the purpose of feeding it to hogs or for any other purpose, unless there has first been obtained from the Department of Health and Social Services a permit naming the area within which such garbage or household refuse shall be disposed of, and unless there has been deposited with the Department of Health and Social Services a bond for the sum of $500 which shall be forfeitable if the disposal of such garbage is not provided for in such a manner as meets the requirements of the Department of Health and Social Services. (38 Del. Laws, c. 46, § 1; Code 1935, § 890; 16 Del. C. 1953, § 1701; 70 Del. Laws, c. 149, §§ 115, 116.) § 1702. Prohibited areas for garbage disposal; revocation of permit. The Department of Health and Social Services may at any time determine the limits of areas within which garbage under no circumstances shall be disposed of or deposited and shall at any time revoke any permit given if the disposal of any garbage is conducted in such a way as to constitute a nuisance or a menace to the public health. (38 Del. Laws, c. 46, § 2; Code 1935, § 890; 16 Del. C. 1953, § 1702; 70 Del. Laws, c. 149, § 117.) § 1703. Nuisance. The bringing in of garbage from any place without the State without a permit, the depositing of garbage in any area not named by the Department of Health and Social Services as an area suitable for the disposal of such garbage, and the disposal of any garbage in an unsanitary manner shall be deemed a nuisance under § 310 of this title and subject to the penalties provided in § 317 of this title. (38 Del. Laws, c. 46, § 3; Code 1935, § 890; 16 Del. C. 1953, § 1703; 70 Del. Laws, c. 149, § 118.) § 1704. Dumping refuse or other material upon property; penalty. (a) No person, by agent or otherwise, shall cast, throw, fell or deposit or in any manner cause to be felled or deposited on or upon any public or private real property anywhere in this State, without first obtaining the consent of the legal owner or custodian of such property or premises first obtained for that purpose in the case of private property or from the legal authority having control, management or administration thereof in the case of such public property, any refuse, debris, waste, dirt, trash, brush, tree or part thereof, offal or any other material, matter or substance of any kind whatsoever. No such refuse, etc., shall be dumped or deposited within 50 feet of any highway, whether or not the consent required has been obtained, except where any authorized dumping is to fill a low place to a level not higher than the adjacent roadway shoulder and a sign has been erected designating such place for dumping. (b) Whoever violates subsection (a) of this section shall be fined not less than $15 nor more than $100. (20 Del. Laws, c. 123; Code 1915, § 3488; Code 1935, § 3963; 47 Del. Laws, c. 127, § 1; 16 Del. C. 1953, § 1704.) § 1705. Refuse from fowl and poultry dressing — Dumping. No person shall dump or otherwise deposit any blood, garbage, carrion, offal, filth or other refuse derived or resulting from the dressing of fowl and poultry of all kinds in an obnoxious or noisome state upon any land or in any stream or other body of water within this State. (43 Del. Laws, c. 94, § 1; 16 Del. C. 1953, § 1705.) § 1706. Refuse from fowl and poultry dressing — Treatment. (a) The Department of Natural Resources and Environmental Control, by rules and regulations, shall prescribe the methods and means of treating any blood, garbage, carrion, offal, filth or other refuse from the dressing of fowl and poultry so as to remove the noisome or obnoxious nature thereof. (b) Whoever dumps or otherwise deposits any blood, garbage, carrion, offal, filth or other refuse from the dressing of fowl and poultry upon any land or in any stream or other body of water within this State without first having treated the same in accordance with the rules and regulations prescribed by the Department of Natural Resources and Environmental Control, pursuant to the authority contained in subsection (a) of this section, shall be fined not less than $10 nor more than $50, with cost of suit, or imprisoned until the same be paid or until discharged by law. (c) Any person convicted of violating this section, who shall not immediately remove the blood, garbage, carrion, offal, filth or other refuse from the dressing of fowl and poultry from the place where the same has been by that person dumped or otherwise deposited, is guilty of a separate and distinct offense for each day thereafter that the same has not been removed from the place where it has been so dumped or deposited by that person. (43 Del. Laws, c. 94, § 2; 16 Del. C. 1953, § 1706; 55 Del. Laws, c. 442, § 10; 57 Del. Laws, c. 739, § 221; 70 Del. Laws, c. 186, § 1.) Page 154 Title 16 - Health and Safety § 1707. Burning of refuse and garbage in certain residential areas; penalty. (a) In any residential area consisting of homes on lots of 1 acre or less no outdoor fire shall be fueled by any material other than wood, wood by-products, limited to paper, leaves, twigs, clippings and grass cuttings and coke for barbecues. (b) Any violation of this section shall be punishable by a fine not to exceed $25. (16 Del. C. 1953, § 1707; 54 Del. Laws, c. 320.) § 1708. Storage of refuse and garbage in multi-family buildings; penalty. (a) Multi-family houses and apartment complexes shall provide adequate storage areas outside the principal structure of such multifamily houses and apartment complexes for the temporary storage of trash and garbage and shall provide covered metal containers in such areas for the temporary storage of refuse classed as garbage. (b) Any person who violates this section shall upon the first conviction thereof be fined $10 and upon each subsequent conviction thereof shall be fined not less than $25 nor more than $500 or shall be imprisoned not more than 90 days, or both. (16 Del. C. 1953, § 1708; 56 Del. Laws, c. 150.) § 1709. Trash containers on highways; penalty. (a) (1) A person, by agent or otherwise, may not cause a trash container having a capacity of 2 cubic yards or greater to be placed on a highway, unless the container has all of the following: a. A strip of red and white, high-intensity, reflective conspicuity adhesive tape that is no less than 4 inches wide and wrapped fully around the midpoint of the container. The midpoint of the container is between the bottom of the container and the opening at the top. b. The name and phone number of the owner of the container, or the owner’s agent, in font that is no less than 3 inches high. (2) For purposes of this section, “highway” means a way or place open to the use of the public as a matter of right for purposes of vehicular travel and includes the entire width between the boundary lines of the way or place, including parking spaces, berms, and shoulders. “Highway” does not mean a road or driveway on grounds owned by private persons, colleges, universities, or other private institutions. (b) (1) An owner of a container that refuses, fails, or neglects to comply with this section is subject to a civil penalty in an amount that is not less than $50 or more than $500. (2) Any law-enforcement officer, as defined under § 9702 of this title, may enforce this section. (3) Justice of the Peace Court has jurisdiction over violations of this section. (74 Del. Laws, c. 286, § 1; 83 Del. Laws, c. 172, § 1.) Page 155 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 18 Solid Waste: Management, Storage, Collection and Disposal § 1801. Definitions. As used in this chapter: (1) “Collection and disposal systems” mean systems for the storage, collection, transportation, transfer, processing, reclamation, reduction and disposal of solid wastes. (2) “Federal aid or grant” means any and all federal grants-in-aid, regardless of source, which supplement the aid provided by the State in this chapter, and which are applied to the planning of solid waste collection and disposal systems by qualified agencies. (3) “Qualified agency” means the Levy Court or county council of the counties. (4) “Planning of solid waste collection and disposal systems” means engineering or planning services to survey, plan, develop and supervise the establishment or construction of comprehensive solid waste collection and disposal systems. (5) “Solid waste” means that material that is made up of residential, domestic, institutional, commercial, agricultural, industrial and street or highway refuse. It includes garbage, rubbish, ashes, street refuse, dead animals, abandoned automobiles, demolition rubble and sewage sludge. (16 Del. C. 1953, § 1801; 57 Del. Laws, c. 623, § 1.) § 1802. Establishment of county plans. Each of the 3 counties shall prepare and administer a comprehensive and detailed plan for a system for the collection, storage and disposal of all solid wastes which are produced or are disposed of within the boundaries of the respective counties. Provided, however, that if a county does not indicate its willingness within 60 days from June 30, 1970, to submit a plan as provided in this section, the Division of Public Health of the Department of Health and Social Services shall conduct its own study and prepare plans as to that county. Such plans shall: (1) Consider domestic, industrial, demolition, commercial and agricultural wastes; (2) Provide for the control of the wastes from point of origin to the place or places of disposal; (3) Include a method or methods of adequately financing the comprehensive plan; (4) Establish an organization for the administration and enforcement of the comprehensive plan; (5) Be completed and submitted to the Division of Public Health of the Department of Health and Social Services by April 1, 1971. (16 Del. C. 1953, § 1802; 57 Del. Laws, c. 623, § 1; 70 Del. Laws, c. 150, § 5.) § 1803. Amount of aid; limitation. A qualified agency proceeding with the planning of solid waste collection and disposal systems and applying for aid under this chapter shall receive state aid funds appropriated pursuant to the purposes and provisions of this chapter in an amount not to exceed 75% of the cost of the planning of the solid waste collection and disposal system. If federal funds are received, the sum of state and federal grantsin-aid shall not exceed 75% of the cost of the planning of the solid waste collection and disposal system. (16 Del. C. 1953, § 1803; 57 Del. Laws, c. 623, § 1.) § 1804. Allocation of funds. The Division of Public Health of the Department of Health and Social Services is hereby empowered to administer this chapter and allocate and disburse funds to qualified agencies which make proper application for such funds. Application forms shall be furnished by the Division, and the Division Director, with the approval of the Secretary of the Department, may set rules and regulations to govern the applications and aid the payment process. (16 Del. C. 1953, § 1804; 57 Del. Laws, c. 623, § 1; 70 Del. Laws, c. 150, § 6.) Page 156 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 19 Mosquito Control § 1901. Department of Natural Resources and Environmental Control — Supervision. The duties, powers and functions of the former Mosquito Control Commission of the State and the State Highway Department shall be under the supervision and control of the Department of Natural Resources and Environmental Control, which Department may perform all the duties, powers and functions formerly vested in the Mosquito Control Commission and the State Highway Department. (Code 1935, c. 182; 45 Del. Laws, c. 27, § 1; 16 Del. C. 1953, § 1901; 57 Del. Laws, c. 739, §§ 228-230.) § 1902. Department of Natural Resources and Environmental Control — Powers and duties. (a) The Department of Natural Resources and Environmental Control, hereinafter referred to as the Department, may: (1) Take all necessary and proper steps and measures for the eradication of mosquitoes, including but not limited to source reduction methods that alter or eliminate the habitats of immature mosquitoes, biological controls such as native fish stocking, and the application of insecticides by air or ground to control immature or adult mosquitoes, all done in order to effect nuisance relief, to protect public health, and to help avoid adverse impacts to local economies from severe mosquito infestations; and (2) Treat as nuisances all stagnant pools of water or other breeding places of mosquitoes to help protect the public’s well being and health; and (3) Purchase all needed equipment, supplies and materials, and employ such labor and services as may be proper or necessary in the furtherance of the objects of this chapter of this title and fix the compensation and prescribe the duties of all employees, agents and servants; and (4) Enter upon land, whether privately-owned or not, for the purpose of determining the breeding places of immature mosquitoes or occurrence of adult mosquitoes, and treat with proper means all such breeding places or adult mosquito populations wherever situated, doing no unnecessary damage; and (5) Generally do any and all things necessary or incident to the powers granted and to carry out the objects specified in this chapter of this title. This may include at the Secretary’s discretion the promulgation of rules and regulations to help effectuate the purposes of this subchapter of this chapter of this title. (b) Control measures taken for the eradication of mosquitoes shall, to the extent practicable, not be injurious to pets, livestock or wildlife. The Department shall perform and exercise the authority and powers granted under this chapter of this title within the limitations of any appropriation made under any appropriation act of the General Assembly for mosquito control purposes. (Code 1935, c. 182; 45 Del. Laws, c. 309, § 1; 46 Del. Laws, c. 309, § 1; 16 Del. C. 1953, § 1902; 76 Del. Laws, c. 151, § 1.) § 1903. Declaration of nuisance. Any accumulation of water in which mosquitoes are breeding or are likely to breed is declared to be a nuisance. (Code 1935, c. 182; 45 Del. Laws, c. 271, § 3; 46 Del. Laws, c. 309, § 2; 16 Del. C. 1953, § 1903.) § 1904. Source reduction practices for mosquito control; notice of entry, claims, damages and payments. (a) Source reduction practices for mosquito control involving physical, topographical, or hydrological alterations of wetlands or other aquatic habitats, such as but not limited to the installation of shallow ponds or small ditches to harbor or allow access for mosquito-eating fishes, or the construction of shallow ponds or small ditches or the placement of fill to eliminate or usurp mosquito-rearing sites, must be done in an environmentally-compatible manner and to the extent practicable shall limit adverse impacts to flora and fauna and shall only be undertaken after all required federal and state permits have been obtained. A property owner must be informed at least 30 days in advance in writing, of any intention to perform such source reduction work. Any property owner objecting to the proposed source reduction work, or who is aggrieved or who claims injury or damages due to the execution of any source reduction work of the Department on said property, may file a protest with the Department setting forth the grievance or claim. The Department shall thereupon and within 30 days after the filing of such protest or claim set a time, place and location for a public hearing thereof. If the protest involves a property owner asserting that the proposed source reduction work is not necessary or is otherwise improper, such work shall not commence or proceed until the protest has been denied by the Secretary after the public hearing. In all such cases the decision of the Department as to the necessity and appropriateness of such source reduction work shall be final. Any damage claimed by any party on account of source reduction work of the Department upon that party’s property may be judicially determined. The amount of any damage that may be awarded such party shall be paid by the Department. (b) This section shall not apply to the application of mosquito control insecticides which are subject to other federal and state laws and regulations governing their legal applications, and are also subject to the Department’s administrative policies and procedures for making Page 157 Title 16 - Health and Safety such applications. This section shall also not apply to the use of biological controls such as the stocking of native fish that consume immature mosquitoes, which is a practice subject to the Department’s administrative policies and procedures. (Code 1935, c. 182; 45 Del Laws, c. 271, § 4; 46 Del. Laws, c. 309, § 2; 16 Del. C. 1953, § 1904; 57 Del. Laws, c. 739, § 232; 70 Del. Laws, c. 186, § 1; 76 Del. Laws, c. 151, § 2.) § 1905. Obstructions and interferences. Whoever obstructs or interferes with the entry of the Department or its employees upon land or who obstructs or interferes with, molests or damages any of the work performed by it is guilty of a misdemeanor. (Code 1935, c. 182; 45 Del. Laws, c. 271, § 5; 46 Del. Laws, c. 309, § 2; 16 Del. C. 1953, § 1905; 57 Del. Laws, c. 739, § 233.) Page 158 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 20 Uniform Health Data § 2001. Purpose. It is the purpose of this chapter to establish a health information data base that will assist the health care system to advance the general well-being of the population by better directing and improving the availability of health-care services. It is the policy of this State to foster appropriate and efficient use of health-care resources by requiring information necessary for evaluating utilization patterns and costs to the community and the State for health-care services. This information shall be available to health-care purchasers, health-care insurers, health-care providers, health-care planners and the general public without compromise of patient confidentiality. Such information will improve decision making with regard to access, identified needs, patterns of health-care delivery, charges and use of health-care services. (67 Del. Laws, c. 143, § 1; 69 Del. Laws, c. 347, § 1.) § 2002. Definitions. The following words, terms and phrases, when used in this chapter, shall have meaning ascribed to them in this section, except where the context indicates a different meaning: (1) “Delaware uniform claims and billing data set” shall mean that data approved for use by the State Uniform Billing Committee. (2) “Hospital” shall mean any nonfederal facility licensed as such pursuant to Chapter l0 of this title. (3) “Individual” shall mean a singular human being. (4) “Nursing home” shall mean any and all rest residential, assisted living facility, skilled care or intermediate nursing facility licensed pursuant to Chapter 11 of this title. (5) “Person” shall mean an individual, trust or estate, a partnership, a corporation (including associations, joint stock companies and insurance companies), or a state or political subdivision or instrumentality (including a municipal corporation) of a state. (6) “Raw data” shall mean any information collected pursuant to this chapter which has not been approved for release by the state agency. (7) “State agency” shall mean the Division of Public Health within the Department of Health and Social Services. The Division of Public Health shall serve as the designated statistical agency under Public Law 95-623 for data analysis and statistical research related to the National Center for Health Statistics activities and for the designation of Health Manpower Shortage Areas (HMSAs) and Medically Underserved Areas (MUAs) by the U.S. Department of Health and Social Services. (8) “Third-party payers” shall mean any person authorized to transact health insurance or to engage in the business of a health service corporation in this State. (67 Del. Laws, c. 143, § 1; 69 Del. Laws, c. 347, § 1; 70 Del. Laws, c. 149, § 119; 74 Del. Laws, c. 161, § 1; 76 Del. Laws, c. 194, § 1.) § 2003. Duties and authority of state agency. (a) The state agency shall compile, correlate, analyze and develop data which it collects pursuant to this chapter. The state agency shall prepare and distribute or make available reports to health-care purchasers, health-care insurers, health-care providers and the general public. The data shall be collected in the most efficient and cost-effective manner. Data collected shall be limited to that contained in the Delaware uniform claims and billing data set (UB-82 or successor form). (b) The state agency shall periodically compile and disseminate reports on the data collected such as, but not limited to: charge levels, age-specific utilization patterns, morbidity patterns, patient origin and trends in health-care charges. Prior to release or dissemination of any compilations, the state agency shall provide a specified time period for hospitals and nursing homes to review the information they have submitted and to submit corrections. The state agency shall incorporate any valid corrections prior to release. Hospitals and nursing homes shall have the right to provide independent data interpretation which shall be disseminated along with the report. (c) The state agency shall adopt such policies and procedures as necessary to carry out this chapter. (d) The state agency shall establish the Hospital Discharge Technical Advisory Committee to study issues such as the collection, compilation, dissemination and confidentiality of data with regard to hospital discharge data reporting. The Committee shall be comprised of 9 members. These members shall include hospital and nursing home representatives from the Delaware Healthcare Association and the Delaware Health Care Facilities Association. The members shall be appointed by the Secretary of the Department of Health and Social Services. Members shall serve a 3-year term and are eligible for reappointment. The state agency may establish other committees as deemed appropriate. (e) The state agency shall issue annual reports to the General Assembly outlining actions and accomplishments as well as recommendations for changes needed to further the purpose of this chapter. Page 159 Title 16 - Health and Safety (f) The state agency may study and issue reports on special medical needs, demographic characteristics, access to health care services and need for financing of health-care services for the entire population or various population subgroups. (g) The state agency may also study and issue reports on health status issues such as: (1) The incidence of medical and surgical procedures; (2) Mortality rates for specified diagnoses and treatments; (3) Rates of infection for specified diagnoses and treatments; (4) Morbidity rates for specified diagnoses and treatments; (5) Readmission rates for specified diagnoses and treatments; and (6) Rate of incidence for selected diagnoses and procedures. (67 Del. Laws, c. 143, § 1; 69 Del. Laws, c. 347, § 1; 77 Del. Laws, c. 57, § 1.) § 2004. Reporting requirements. (a) The Delaware uniform claims and billing data set (UB-82 or successor form) shall be completed for all hospital inpatient discharges and shall be submitted by all hospitals to the state agency according to a schedule established pursuant to subsection (d) of this section. All third-party payers shall be required to accept this uniform claims and billing form. The state agency shall recognize the capabilities of each hospital in specifying the medium or mediums to be used in submitting data (hard copy, data tape or other appropriate electronic media). (b) The Delaware uniform claims and billing data set (UB-82 or successor form) shall be completed for all nursing home inpatient discharges beginning not sooner than June 30, 1995, and shall be submitted by all nursing homes to the state agency according to a schedule established pursuant to subsection (d) of this section. All third-party payers shall be required to accept the Delaware uniform claims and billing form. Prior to this time, nursing homes shall continue to submit data in a medium and format as agreed to by the state agency and the Delaware Health Care Facilities Association. (c) The state agency shall assure that any report of data specific to hospitals or nursing homes presents data that are reliable, valid and informative. Such data shall reflect, as appropriate, factors including, but not limited to, the number of patients, patient severity at admission, age of patients, the actual versus expected number of deaths, average length of stay and case mix. The report shall explain each of these adjustments. The report also shall include information necessary to adequately represent the operations of the individual hospital or nursing home such as whether or not physician charges are included in the hospital charges, whether or not the hospital maintains medical education programs and the hospital’s payer mix. The state agency shall consult with the Association of Delaware Hospitals and the Delaware Health Care Facilities Association in identifying the various adjustment factors and information to be included. (d) The state agency shall establish schedules for the timely submission of data and information collected pursuant to this section. The state agency may grant waivers from such schedules for good cause shown. (67 Del. Laws, c. 143, § 1; 69 Del. Laws, c. 347, § 1.) § 2005. Cancer incidence data. (a) Notwithstanding any provisions in this title to the contrary, the agency shall make available as public records cancer incidence by census tract and by type of cancer. Such released data shall be assigned consensus tract geography from the most recent decennial census. If release of such information by census tract will explicitly or implicitly identify any individual, the agency may combine data among contiguous census tracts, but only insofar as is necessary to protect patient confidentiality. (b) The agency shall create a detailed map of each county in Delaware that graphically illustrates the overall incidence of cancer in each census track. The census tracks will be identified on the maps and shall be color-coded to designate the degree of cancer incidence in each track. These maps shall be created within 90 days of the agency receiving the cancer incidence data. (c) The agency shall post the maps created under subsection (b) of this section above on their website in a format that can be easily accessed and read by the public. (76 Del. Laws, c. 292, § 2.) § 2006. Confidentiality and access to data. (a) The collection, compilation, data analysis and dissemination of reports and studies shall be done in a manner that protects the privacy of any individual about whom information is given. The state agency shall consider confidential any information that explicitly or implicitly identifies an individual. Raw data shall not be available for public inspection nor is it a public record within the meaning of the Delaware Freedom of Information Act [§ 10001 et seq. of Title 29]. (b) All compilations prepared and authorized by the state agency for release and dissemination shall be public records and efforts will be made to assure their accessibility. (67 Del. Laws, c. 143, § 1; 69 Del. Laws, c. 347, § 1; 76 Del. Laws, c. 292, § 1.) § 2007. Sanctions. (a) A hospital or nursing home which wilfully violates this chapter shall be reported to the Department of Health and Social Services which may take such action as deemed appropriate to enforce compliance. No action shall be taken by the Department of Health and Social Services without first providing an opportunity to the hospital or nursing home for a fair hearing. Page 160 Title 16 - Health and Safety (b) A hospital or nursing home which is aggrieved by any action taken by the Department of Health and Social Services pursuant to this section may, within 30 days of being notified of such action, appeal to the Superior Court. (67 Del. Laws, c. 143, § 1; 69 Del. Laws, c. 347, § 1; 70 Del. Laws, c. 149, §§ 120, 121; 76 Del. Laws, c. 292, § 1.) § 2008. Immunity. No person shall be subject to, and all persons shall be immune from, any claim, suit, liability, damages or any other recourse, civil or criminal, arising from any act or proceeding, decision or determination undertaken or performed, or recommendation made while discharging any duty or authority under this chapter, so long as such person acted in good faith, without malice, and within the scope of the person’s duty or authority under this chapter or any other provisions of the Delaware law, federal law or regulations or duly adopted rules and regulations providing for the administration of this chapter, good faith being presumed until proven otherwise, with malice required to be shown by the complainant. (67 Del. Laws, c. 143, § 1; 69 Del. Laws, c. 347, § 1; 70 Del. Laws, c. 186, § 1; 76 Del. Laws, c. 292, § 1.) § 2009. Data from other providers. The Delaware Health Care Commission or its successor agency shall complete an analysis of the merits and feasibility of collecting data from providers other than hospitals and nursing homes. Other providers to be considered shall include, but not be limited to, physicians, freestanding surgical centers, freestanding birthing centers and freestanding emergency centers licensed in the State. The results of such analysis along with proposed enabling legislation, as appropriate, shall be submitted to the Governor and the General Assembly by December 31, 1995. (69 Del. Laws, c. 347, § 1.) Page 161 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 21 Mattresses, Pillows and Bedding § 2101. Definitions. As used in this chapter, unless the context requires a different meaning: (1) “Bedding” shall mean any mattress, mattress pad, mattress protector pad, box spring, upholstered spring, upholstered bed, davenport, upholstered sofa bed, quilted pad, comforter, bolster, cushion, pillow, featherbed, sleeping bag or any other bag, case or cover made of leather, textile or other material which is stuffed or filled in whole or in part with concealed material, which is intended for use by any human being for sleeping or reclining purposes. (2) “Comfortable” means any cover, quilt or quilted article made of cotton or other textile material and stuffed or filled with fiber, cotton, wool, hair, jute, feathers, feather down, kapok or other soft material. (3) “Mattress” means any quilted pad, mattress, mattress pad, mattress protector, bunk, quilt or box spring stuffed or filled with excelsior, straw, hay, grass, cornhusks, moss, fiber, cotton, wool, hair, jute, kapok or other soft material, to be used on a couch or other bed for sleeping purposes. (4) “New” means any material or article which has not been previously manufactured or used for any purpose. (5) “Pillows,” “bolster,” or “featherbed,” mean any bag, case or covering made of cotton or other textile material, and stuffed or filled with excelsior, straw, hay, grass, cornhusks, moss, fiber, cotton, wool, hair, jute, feathers, feather down, kapok or other soft material to be used on a bed or other article for sleeping purposes. (6) “Secondhand” means any material or article of which prior use has been made. (7) “Shoddy” means any material which has been spun into yarn, knit or woven into fabric and subsequently cut up, torn up, broken up or ground up. (Code 1915, § 824A; 36 Del. Laws, c. 102; Code 1935, § 874; 16 Del. C. 1953, § 2101; 60 Del. Laws, c. 356, § 1.) § 2102. Sterilization and disinfection of materials — Required. No person shall employ or use in the making or renovating of any mattress, pillow, bolster, featherbed or comfortable: (1) Any material known as “shoddy” or any fabric or material from which shoddy is constructed; (2) Any secondhand material; (3) Any new or secondhand feathers, unless such shoddy, secondhand material or new or secondhand feathers have been sterilized and disinfected by a reasonable process approved by the Department of Health and Social Services. (Code 1915, § 824B; 36 Del. Laws, c. 102; Code 1935, § 875; 16 Del. C. 1953, § 2102; 70 Del. Laws, c. 149, § 122.) § 2103. Sterilization and disinfection of materials — Permit. (a) Any person engaged in the making, remaking or renovating of any mattress, pillow, bolster or comfortable in which secondhand material is used, or in the making of any new or secondhand feather or down filled article or engaged in sterilizing and disinfecting any material, feathers or article coming under this chapter, shall submit to the Department of Health and Social Services for approval a reasonable and effective process, together with duplicate plans of apparatus or auxiliary devices, for the sterilization and disinfection of secondhand material, feathers and secondhand articles enumerated in this section. (b) Upon the approval of the process for sterilization and disinfection, a numbered permit for its use shall be issued to the applicant by the Department of Health and Social Services. Such permit shall expire 1 year from date of approval and issue. Every person to whom a permit has been issued shall keep such permit conspicuously posted in the person’s office or place of business. Refusal to display such permit in accordance with this chapter shall be sufficient reason to revoke and forfeit the permit. (c) For all permits issued as required by this chapter (not including, however, by the term “permits” the “tags” otherwise referred to in this chapter) there shall at time of issue thereof be paid by the applicant to the Department of Health and Social Services a fee of $50. (d) Nothing in this section shall prevent any person engaged in the making, remaking, renovating or sale of any article described in this section, which requires sterilizing and disinfecting under this section, from having such sterilizing and disinfecting performed by any person to whom a permit for such purposes has been issued, provided the number of the permit shall appear in the statement on the tag attached to the article. (Code 1915, § 824C; 36 Del. Laws, c. 102; Code 1935, § 876; 16 Del. C. 1953, § 2103; 70 Del. Laws, c. 149, §§ 123, 124; 70 Del. Laws, c. 186, § 1.) § 2104. Inspection of premises. All places where any mattress, pillow, bolster, featherbed or comfortable is made, remade or renovated, or where materials for articles named in this section are prepared, or establishment where the articles are offered for sale or are in possession of any person with intent Page 162 Title 16 - Health and Safety to sell, deliver or consign them, or establishment where sterilizing and disinfecting are performed, shall be subject to inspection by the Department of Health and Social Services to ascertain whether the materials and the finished articles enumerated in this section conform to the requirements of this chapter. (Code 1915, § 824D; 36 Del. Laws, c. 102; Code 1935, § 877; 16 Del. C. 1953, § 2104; 70 Del. Laws, c. 149, § 125.) § 2105. Selling or leasing used mattresses; sterilization and disinfection. No person shall sell, lease, offer to sell or lease, or deliver or consign in sale or lease, or have in the person’s possession with intent to sell, lease, deliver or consign in sale or lease: (1) Any mattress, pillow, bolster, featherbed or comfortable made, remade or renovated in violation of this chapter; (2) Any secondhand mattress, pillow, bolster, featherbed or comfortable, unless since last used it has been thoroughly sterilized and disinfected by a reasonable process approved by the Department of Health and Social Services. (Code 1915, § 824E; 36 Del. Laws, c. 102; Code 1935, § 878; 16 Del. C. 1953, § 2105; 70 Del. Laws, c. 149, § 126; 70 Del. Laws, c. 186, § 1.) § 2106. Tagging; regulations and prohibitions. (a) Each and every mattress or article covered by this chapter, other than a feather or down filled pillow, bolster, bed or comforter, shall bear securely attached thereto and visible on the outside covering a tag of cloth or other substantial material upon which shall be plainly and indelibly stamped or printed in English: (1) A statement showing the kind of materials used in filling the mattress or article and whether the materials used in filling are wholly new or secondhand or partly secondhand; (2) The word “secondhand” upon any article of which prior use has been made; (3) The number of the permit issued for sterilizing and disinfecting; and (4) The registry number used in applying and enforcing the tagging and inspection provisions of this chapter. (b) Each and every pillow or other article covered by this chapter in which feathers or down are used shall bear securely attached thereto and visible on the outside covering a substantial cloth tag upon which shall be plainly and indelibly stamped or printed in English: (1) A statement that the feathers or down have been sterilized and disinfected in accordance with this chapter; (2) The number of the permit issued for sterilizing and disinfecting the feathers or down; (3) The word “secondhand” upon a feather or down filled article of which prior use has been made; and (4) The registry number used in applying and enforcing the tagging and inspection provisions of this chapter. (c) No additional information shall be contained in the statements. The statement of materials used in filling must be in plain type not less than one-eighth inch in height. The tag required by this chapter to be attached to any article covered by this chapter shall be not less than 6 square inches in size. (d) The word “felt,” or words of like import if any other than garnetted materials are used in filling, or the words “curled hair,” or words of like import if other than curled hair is used in filling, shall not be used exclusively in the statement concerning any mattress, pillow, bolster or comfortable. (e) No person shall make any false, untrue or misleading statement, term or designation on the tag or remove, deface, alter or in any manner attempt to remove, deface or alter the tag required by this chapter or cause to be removed, defaced or altered any statement on a tag placed upon any article included in this chapter. (Code 1915, § 824F; 36 Del. Laws, c. 102; Code 1935, § 879; 16 Del. C. 1953, § 2106; 49 Del. Laws, c. 269, §§ 1, 2; 60 Del. Laws, c. 356, §§ 2-6.) § 2107. Registration and issuance of registry numbers. The Department of Health and Social Services shall, upon application to it by any person entitled thereto, register each applicant, issue a permit and assign a registry number by which number applicants shall thereafter be identified in applying and enforcing the tagging and inspection of this chapter. (Code 1915, § 824G; 36 Del. Laws, c. 102; Code 1935, § 880; 16 Del. C. 1953, § 2107; 50 Del. Laws, c. 251, § 1; 60 Del. Laws, c. 356, § 7; 70 Del. Laws, c. 149, § 127.) § 2108. Registration and permit fee. The initial annual permit fee and subsequent annual renewal fee under this chapter for manufacturers of bedding products within the State or manufacturers of such products who ship said products into this State shall be as follows: Bedding manufacturer................................................................................................................. $50 (Code 1915, § 824H; 36 Del. Laws, c. 102; Code 1935, § 881; 16 Del. C. 1953, § 2108; 49 Del. Laws, c. 269, § 3; 60 Del. Laws, c. 356, § 8.) Page 163 Title 16 - Health and Safety § 2109. Renewal of permit. Permits shall remain effective only during a calendar year beginning January 1, and ending December 31, or any remaining portion of a calendar year beginning on the date the permit is issued. Applications for renewal of the permit must be made within the 60-day period preceding expiration of the permit currently held by the applicant. The fee for renewal of a manufacturer’s permit shall be $50. (Code 1915, § 824I; 36 Del. Laws, c. 102; Code 1935, § 882; 16 Del. C. 1953, § 2109; 60 Del. Laws, c. 356, § 9.) § 2110. Disposition of fees. All fees collected under this chapter shall be paid to the Department of Health and Social Services and when so paid shall be turned over by the Department of Health and Social Services to the State Treasurer and credited to the General Fund of the State. (Code 1915, § 824J; 36 Del. Laws, c. 102; 37 Del. Laws, c. 59, § 1; Code 1935, § 883; 16 Del. C. 1953, § 2110; 70 Del. Laws, c. 149, §§ 128, 129.) § 2111. Inspection of products and plants of nonresidents. (a) It is the intent of this chapter to prevent both the manufacture and the sale within this State of any of the articles enumerated in § 2105 of this title, except in conformity to and in compliance with this chapter. Inasmuch, however, as some of the articles so enumerated may be made or the material used in the manufacture or renovation thereof may be processed outside of the limits of this State, it is expressly provided that where the person so manufacturing any such article or processing any such material shall have or operate a plant outside of the limits of this State the Department of Health and Social Services may, in its discretion, in lieu of a physical inspection of the plant of such nonresident person, satisfy itself by examination of the product made or possessed by such nonresident or by such other means as the Department of Health and Social Services Board deems adequate, of the propriety of issuing to such nonresident the permit required by this chapter or of renewing or keeping in force a permit so issued. (b) In the event that at any time the Department of Health and Social Services deems it necessary to make physical inspection of any plant or factory of the nonresident, it may require the payment by such nonresident of such sum as may cover the reasonable traveling charges entailed by such physical inspection and refuse to issue, or revoke or suspend, any permit until or unless such charges are so paid. (Code 1915, § 824K; 36 Del. Laws, c. 102; Code 1935, § 884; 16 Del. C. 1953, § 2111; 70 Del. Laws, c. 149, §§ 130, 131; 70 Del. Laws, c. 186, § 1.) § 2112. Enforcement; rules and regulations; provisions subject to Chapter 23 of Title 11. (a) The Department of Health and Social Services, through its officers and employees, is charged with the administration and enforcement of this chapter and may take for evidence, at any trial involving violation of this chapter, any article made or offered for sale in violation of this chapter. The Department of Health and Social Services shall make and enforce reasonable rules and regulations for the enforcement of this chapter. (b) This section is subject to Chapter 23 of Title 11. If there is any conflict or inconsistency between this section and such chapter, the latter shall prevail. (Code 1915, § 824L; 36 Del. Laws, c. 102; Code 1935, § 885; 16 Del. C. 1953, § 2112; 70 Del. Laws, c. 149, §§ 132, 133.) § 2113. Penalties; appeals. (a) Whoever violates this chapter or the rules and regulations adopted thereunder shall be fined for each offense not less than $10 nor more than $50. In default of the payment of such fine the violator shall be imprisoned for not less than 10 days for each separate offense. The total term of imprisonment at any 1 time for additional offenses shall not exceed 10 months. (b) Each mattress, mattress pad, mattress protector pad, box spring, upholstered spring, upholstered bed, davenport, upholstered sofa bed, quilted pad, comforter, bolster, cushion, pillow, featherbed or sleeping bag made or remade, or renovated, sold, offered for sale, delivered or consigned contrary to this chapter shall constitute a separate offense. (c) Any person convicted of an offense under this section, before a justice of the peace, may appeal the judgment of conviction to the Court of Common Pleas of the county. (Code 1915, § 824M; 36 Del. Laws, c. 102; 37 Del. Laws, c. 59, § 2; Code 1935, § 886; 16 Del. C. 1953, § 2113; 60 Del. Laws, c. 356, §§ 10, 11; 69 Del. Laws, c. 423; 70 Del. Laws, c. 186, § 1.) § 2114. Revocation of permit. The Department of Health and Social Services may revoke any permit issued under this chapter if the person to whom the permit was issued has violated this chapter or the rules or regulations established thereunder. (Code 1915, § 824N; 36 Del. Laws, c. 102; 37 Del. Laws, c. 59, § 2; Code 1935, § 886; 70 Del. Laws, c. 149, § 134.) Page 164 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 22 Substance Abuse Treatment Act § 2201. Declaration of policy. Substance abuse is one of the greatest challenges facing our State, schools, workplaces and families because it has destructive influences that pervade all facets of our society. Accordingly, it is the policy of this State to provide treatment to those who abuse substances such as alcohol, drugs or inhalants. Therefore, this chapter is designed to enable those engaged in substance abuse to receive appropriate care and treatment. Although voluntary treatment is preferred, this chapter also provides a mechanism for involuntary treatment in suitable cases. (73 Del. Laws, c. 358, § 2.) § 2202. Establishment of Office. There is hereby established an Office of Substance Abuse Services within the Department of Health and Social Services Division of Alcoholism, Drug Abuse and Mental Health. The establishment of the Office is not intended to contravene any authority for alcohol and drug treatment services vested in the Department of Services for Children, Youth and Their Families pursuant to Chapter 90 of Title 29. (73 Del. Laws, c. 358, § 2.) § 2203. Definitions. For the purposes of this chapter, definitions of the following terms and phrases shall be as follows: (1) “Administrator” means the individual or individuals who have been appointed by the entity that operates a licensed treatment facility to manage its affairs and who will be its agent for service of process or orders of a court. (2) “Court,” unless otherwise identified, means the Superior Court of the State, except where the person in need of treatment is under the age of 18 years. If the person in need of treatment is under the age of 18 and it is appropriate, “court” may then mean the Family Court of the State. (3) “Department” means the Department of Health and Social Services unless the usage indicates otherwise. (4) “Designated transport personnel” means those personnel designated by the Secretary of the Department of Health and Social Services, in the case of adults, or the Secretary of the Department of Services for Children, Youth and Their Families, in the case of minors under the age of 18 years, to transport persons in need of treatment. (5) “Division” means the Department of Health and Social Services, Division of Alcoholism, Drug Abuse and Mental Health, or Division of Prevention and Behavioral Health Services as indicated by the usage. (6) “Facility” or “treatment facility” means an entity, other than a licensed hospital, that provides care, lodging or treatment to persons in need of treatment. A “residential treatment facility” provides 24-hour, live-in treatment to persons in need of treatment. A treatment facility may have 1 or more “treatment programs” which are distinct therapeutic service components that may also address different age populations. “Facility” does not include the outpatient practice offices of licensed independent practitioners, including, but not limited to, physicians, psychologists, social workers and counselors. (7) “Office” means the Office of Substance Abuse Services within the Department of Health and Social Services. (8) “Patient” means a person in need of treatment who is the subject of a petition for involuntary treatment or anyone engaged in substance abuse who is requesting voluntary treatment, or as permitted under this chapter, those individuals for whom treatment has been consented to by a parent, relative caregiver, legal guardian or legal custodian. (9) “Patient representative” means an individual or entity authorized to act on the patient’s behalf by operation of law or express appointment by the patient. (10) “Peace officer” means any public officer authorized by law to make arrests in a criminal case. (11) “Person in need of treatment” means an individual who engages in substance abuse as previously defined in this section to the extent that: a. Such use causes the person to pose an imminent risk of injury to self or others without treatment; or b. Otherwise substantially interferes with the individual’s ability to provide self-care in an age-appropriate manner, as evidenced by a significant impairment of functioning in hydration, nutrition, self-protection or self-control, thereby posing a grave and immediate risk of serious harm to the individual’s health and well-being. (12) “Person who is incompetent” means a person who has been adjudged incompetent by an appropriate state court. (13) “Physician” means an individual licensed to practice medicine in this State; or a physician employed by the Delaware Psychiatric Center, registered within the Medical Council of Delaware, and certified by the Division as being qualified in the diagnosis and treatment of substance abuse; or any physician employed by the United States government within the State in the capacity of psychiatrist and certified by the Division as qualified in the diagnosis and treatment of substance abuse. Page 165 Title 16 - Health and Safety (14) “Secretary” means the Secretary of the Department of Health and Social Services, unless the usage indicates otherwise. (15) “Staff,” means individuals with specific training in drug and alcohol assessment or treatment who are licensed by the State as independent practitioners in the fields of nursing, social work, medicine, psychology, or counseling; or individuals otherwise certified as drug and alcohol counselors in a manner acceptable to the State; or individuals otherwise permitted to practice as set out above. (16) “Substance abuse” means the chronic, habitual, regular or recurrent use of alcohol, inhalants or controlled substances as identified in Chapter 47 of this title. (17) “Substance evaluation team” is staff in the substance abuse and mental health field charged with assisting other agencies in determination of the appropriate treatment modalities for patients referred. (18) “Treatment” means clinical and related services rendered to a person who abuses alcohol, drugs or inhalants. (19) “Treatment team” means staff members who collectively provide clinical services to a person in need of treatment. (20) “Working day” means all days other than Saturdays, Sundays and legal state and federal holidays. (73 Del. Laws, c. 358, § 2; 77 Del. Laws, c. 327, § 210(a); 78 Del. Laws, c. 179, § 165.) § 2204. Powers of the Office. The Office of Substance Abuse Services, as a component of the Department of Health and Social Services, may, subject to the express provisions of other sections of this chapter: (1) Plan for, establish, amend and revise standards for treatment programs when necessary or desirable; (2) Make contracts necessary or incidental to the performance of its duties and the execution of its powers; (3) Solicit and accept for use any money, real property or personal property made by will or otherwise and any grant of money, services or property from the federal government, the State or any political subdivision thereof or any private source, and do all things necessary to cooperate with the federal government or any of its agencies in making an application for any grants; (4) Administer or supervise the administration of the provisions relating to persons in need of treatment of any state plan submitted for federal funding pursuant to federal health, welfare or treatment legislation; (5) Coordinate its activities with the Department of Services for Children, Youth and Their Families, and cooperate with alcohol and drug treatment programs in this and other states, and make contracts and other joint or cooperative arrangements with state, local or private agencies in this and other states to provide services to persons in need of treatment; (6) Keep records and engage in the gathering of relevant statistics; (7) Do other acts and things necessary to execute the authority expressly granted to it; and (8) Acquire, hold or dispose of real property or any interest therein, and construct, lease or otherwise provide treatment facilities for persons in need of treatment. (73 Del. Laws, c. 358, § 2.) § 2205. Duties of Office. The Office of Substance Abuse Services, as a component of the Department of Health and Social Services, shall: (1) Cooperate with the Department of Safety and Homeland Security and the Department of Correction to assist in developing and establishing programs to provide services for persons in need of treatment within the criminal justice system; (2) Cooperate with the Department of Education, law-enforcement officials, and other public and private agencies to assist with the development and dissemination of substance abuse prevention materials for use at all levels of school education; (3) Work in partnership with the Department of Services for Children, Youth and Their Families in establishing, licensing and evaluating programs for the prevention and treatment of substance abuse among children and youth; (4) Organize and foster training programs for all persons engaged in providing services to persons in need of treatment; (5) In coordination with the Department of Services for Children, Youth and Their Families, specify uniform methods for keeping statistical information by public and private agencies, organizations and individuals; and collect and annually provide relevant statistical information, including at a minimum the number of persons treated, the most commonly used substances, age of the treatment population, nature of treatment, frequency of admission and readmission, and frequency and duration of treatment; (6) Advise the Governor in the preparation of a comprehensive plan for providing services to persons in need of treatment and its inclusion into a state comprehensive health plan; the plan should consider diagnosis, treatment, rehabilitation and education in the areas of substance abuse and dependence and should be revised over time as deemed necessary. In matter related to minors, advisement will be done in coordination with the Department of Services for Children, Youth and Their Families; (7) Encourage hospitals and other health facilities to admit persons in need of treatment if the required treatment is within their scope of practice; (8) Encourage all health and disability insurance programs to include substance abuse as a covered illness; (9) Promote, develop, establish, coordinate and conduct through the Department or any approved agency, public or private, unified programs for education, prevention, diagnosis, research, treatment, aftercare, community referral and rehabilitation in the field of substance abuse and dependency, and to implement and administer such programs; Page 166 Title 16 - Health and Safety (10) Promulgate rules and regulations with the approval of the Secretary for the implementation of the authority and responsibilities within this chapter and employ persons responsible for implementing the purposes of this chapter, except insofar as such authority is granted to the Department of Services for Children, Youth and Their Families in Chapter 90 of Title 29; (11) In coordination with the Department of Services for Children, Youth and Their Families, establish guidelines and provide for the systematic and comprehensive evaluation of the effectiveness of various programs licensed by the Office; (12) Establish a substance evaluation team to assist all other agencies in determination of the appropriate treatment modalities for patients referred. (73 Del. Laws, c. 358, § 2; 74 Del. Laws, c. 110, § 138.) § 2206. Residential and nonresidential facilities. The Office of Substance Abuse Services, as a component of the Department of Health and Social Services Division of Alcoholism, Drug Abuse and Mental Health, shall, subject to the express provisions of other sections under this chapter: (1) Have the authority to license all facilities to be used exclusively or partially for the treatment of persons in need of treatment upon application and under this chapter. These facilities may be operated as residential or nonresidential facilities. The Department of Services for Children, Youth and Their Families will be consulted prior to adoption of regulations and standards applicable to facilities serving minors. (2) Establish procedures whereby persons who are in need of treatment may seek admission to these programs on a voluntary basis and provide a system to accept appropriate referrals from all components of the criminal justice system and provide assistance where necessary for security for such referrals. (3) Have the authority to contract with other governmental or private agencies for additional diagnostic and treatment facilities or programs. The Office is encouraged to establish these programs on a regional basis with emphasis on prevention and preventive education and broad community involvement. (4) Except as authorized in § 2211 of this title, provide that no person who voluntarily enters a facility for persons in need of treatment shall be retained in such facilities or programs against the person’s will. Such voluntary admission shall not be used as evidence in any criminal prosecution. (5) Initiate and maintain programs which will include: a. Prevention of substance abuse; b. Residential treatment; c. Nonresidential treatment; and d. Follow-up treatment. (73 Del. Laws, c. 358, § 2.) § 2207. Standards for public and private treatment facilities. (a) In cooperation with the Department of Services for Children, Youth and Their Families, the Office shall establish standards for treatment facilities that must be met for a treatment facility to be licensed as a public or private treatment facility. (b) In coordination with the Department of Services for Children, Youth and Their Families, the Office periodically shall inspect licensed public and private treatment facilities at least every 2 years. (c) The Office shall maintain a list of licensed public and private treatment facilities. (d) Each licensed public and private treatment facility shall file with the Office, on request, data, statistics, schedules and information the Office reasonably requires. A licensed public or private treatment facility that without good cause fails to furnish any data, statistics, schedules or information as requested or files fraudulent returns thereof may be removed from the list of licensed treatment facilities, as its license will be either revoked or suspended. (e) The Office may at times enter and inspect and examine the records and operations of any licensed public or private treatment facility to determine compliance with this chapter. (f) No action will be taken under this section by the Office without consultation with the Department for Children, Youth and Their Families regarding the operation of treatment facilities for minors. (73 Del. Laws, c. 358, § 2.) § 2208. Licensing of treatment facility; regulations. (a) The Secretary, upon recommendation from the Division, shall approve the licensure of entities applying to be substance abuse treatment facilities and may designate certain facilities for treatment of individuals on an involuntary basis. Additionally, the Secretary may restrict, condition, limit and/or set the term of the license of a treatment facility as may be reasonable or prudent. In the case of treatment facilities for minors, the Secretary of the Department of Services for Children, Youth and Their Families, or the Secretary’s designee, may designate certain facilities for the treatment of minors on a voluntary or involuntary basis. Page 167 Title 16 - Health and Safety (b) The Secretary is authorized to promulgate regulations for licensing and develop standards for the proper operation of treatment facilities and conduct of any hearing that may be required so as to implement this chapter. The Secretary may refuse to renew, revoke, suspend, limit or restrict the license of a facility where the facility has been given 30 days’ notice of adverse action and an opportunity for a hearing. The Secretary shall not promulgate any such regulations or standards for facilities engaged in the treatment of minors without consulting the Department of Services for Children, Youth and Their Families. The Secretary may also delegate the authority to promulgate regulations and develop standards to the Department of Services for Children, Youth and Their Families. (c) The Secretary or his or her designee shall conduct licensing or other hearings in accord with applicable sections of Chapters 100 and 101 of Title 29. (d) The Secretary’s final decision on the licensing or sanctioning of a treatment facility or applicant may be judicially reviewed in accord with subchapter V of Chapter 101 of Title 29. (73 Del. Laws, c. 358, § 2; 70 Del. Laws, c. 186, § 1.) § 2209. Violation of licensing requirement; injunction. (a) Any organization that maintains, manages or operates, or aids or abets another in maintaining, managing or operating, a facility knowingly without a valid license or outside of a facility’s proper designation is guilty of a class A misdemeanor and subject to the penalties as set out in Chapter 42 of Title 11. (b) In addition to any other remedy, the Secretary, through the Attorney General, may commence proceedings in the Chancery Court of the State to enjoin any violation of this chapter and may, in the case of a wilful and wanton violation, be awarded the costs of prosecution, including a reasonable amount for attorney fees, if the Secretary prevails. (73 Del. Laws, c. 358, § 2.) § 2210. Voluntary treatment for substance abuse. (a) A person in need of treatment or anyone engaging in substance abuse may request voluntary treatment from a licensed treatment facility. If the applicant is a person who is incompetent or a minor under 14 years of age, a parent, legal custodian, relative caregiver or legal guardian shall make the request for voluntary treatment and give written consent for treatment. (b) If a minor is 14 years of age or over, then either the minor, or a parent, legal custodian, relative caregiver or legal guardian may give written consent to a treatment facility for voluntary treatment for nonresidential treatment. In the case of residential treatment, consent to treatment shall be given only by a parent, custodian, relative caregiver or legal guardian. Consent so given by a minor 14 years of age or over shall, notwithstanding the minor’s minority, be valid and fully effective for all purposes regardless of whether such minor’s substance abuse is subsequently medically confirmed and shall be binding upon such minor, the minor’s parents, custodian, relative caregiver and legal guardian as effectively as if the minor were of full legal age at the time of giving such written consent. Consent so given shall not be subject to later denial or disclaimer, and the consent of no other person or court shall be necessary for the treatment rendered such minor. (c) Subject to regulations adopted by the Secretary, or in the case of a treatment program for minors, the Secretary of the Department of Services for Children, Youth and Their Families, an administrator of a treatment facility may determine who shall be admitted for treatment. If a person is refused admission to a facility, the Division, subject to the rules adopted by the Secretary, shall refer the person to another facility for treatment if available and appropriate. (d) If a voluntary patient requests or attempts to leave a treatment facility against the advice of the treatment team and administrator of the facility, the facility may initiate involuntary treatment procedures as provided for under this chapter. If the patient is a minor or is incompetent, the request for discharge against advice shall be made by a parent, custodian, relative caregiver, legal guardian or other appropriate legal representative, and the provisions of this subsection shall apply as if the patient had made the request. (73 Del. Laws, c. 358, § 2; 78 Del. Laws, c. 179, § 166.) § 2211. Involuntary treatment. (a) A person in need of treatment shall be involuntarily admitted to a licensed residential treatment facility or outpatient treatment program upon a written request for involuntary treatment that provides a factual basis for the request by anyone with knowledge that an individual may be a person in need of treatment and the written certification by a physician that the individual is a person in need of treatment as provided for in this chapter. The request for involuntary treatment shall concisely provide the observations, circumstances and knowledge of the requestor regarding the requestor’s belief that a particular individual is in need of treatment. The request shall also contain the written certificate of a physician stating that the physician has reviewed the request and examined the patient and concluded that in the physician’s medical opinion the particular individual is a person in need of treatment and is either incapable of or unwilling to consent to treatment. If the individual is incapable of consenting to treatment, the certificate shall state with particularity the physician’s findings regarding why the individual is incapable of providing voluntary informed consent to treatment. The refusal to undergo treatment does not in itself constitute evidence of lack of judgment as to the need for treatment. (b) Any peace officer or designated transport personnel may lawfully transport an individual whom they reasonably believe is a person in need of treatment without the consent of said individual, to or from a hospital, physician’s office or licensed treatment facility for the purpose of carrying out this section. Page 168 Title 16 - Health and Safety (c) Upon admission of the person in need of treatment, the facility shall evaluate and treat the individual as medically necessary and appropriate for a period not to exceed 2 working days. (d) The State Treasurer shall pay sheriffs and deputy sheriffs for service as peace officers under this section at the rate of the state’s mileage reimbursement amount for each mile necessarily traveled and a custody fee of $25 for the first peace officer and $15 for each additional peace officer, and shall pay medical doctors for services under this section $15 for each case, unless the medical doctor is reimbursed under another public or private plan. (e) The administrator in charge of a licensed treatment facility shall refuse an application if the request for treatment or physician’s certificate fails to meet the requirements of this section. (73 Del. Laws, c. 358, § 2; 70 Del. Laws, c. 186, § 1.) § 2212. Commitment; judicial proceedings. (a) Not more than 2 working days after the date a patient is admitted to a licensed treatment facility or program under a request for involuntary treatment, the administrator of the treatment facility, through the Attorney General, shall file a petition for involuntary commitment to a licensed treatment facility, supported by affidavit with the Court, unless the patient is discharged or admitted on a voluntary basis. The petition shall state that the administrator, as petitioner, based upon an evaluation by a physician, reasonably and in good faith believes that the involuntary patient (who shall be named as respondent) is a person in need of treatment who should be continued as a patient at the facility pursuant to this chapter until the patient is determined no longer to be in need of treatment at the treatment facility or program. The petition shall also state that the involuntary patient has been advised of the patient’s procedural and substantive rights under this chapter. A copy of supporting certificates by an examining physician shall be attached to the petition. (b) Upon the filing of a petition, the facility may continue to treat the patient as medically necessary and appropriate on an involuntary basis pending a judicial hearing on the petition. (c) The petition shall indicate the facility’s reasonable belief, based upon investigation, as to whether the involuntary patient is able to afford counsel and an independent expert witness. (73 Del. Laws, c. 358, § 2.) § 2213. Limitation on involuntary treatment. Subject to Chapters 50 and 51 of this title, no person shall be involuntarily admitted or committed to or confined as a patient at a residential treatment facility, and such facilities, other than general hospitals, shall not admit or confine as an involuntary patient any person, unless: (1) Such person is determined to be a person in need of treatment in accordance with the procedures of this chapter; and (2) Said treatment facility has been specifically designated as an appropriate facility for the treatment of involuntary adult patients by the Secretary of Health and Social Services and by the Department of Services for Children, Youth and Their Families for the treatment of involuntary minor patients. (73 Del. Laws, c. 358, § 2.) § 2214. Hearing on petition; notice; decision; review. Upon the filing of the petition the court shall promptly: (1) Schedule a hearing to determine based on clear and convincing evidence whether the patient is a person in need of treatment and that cause exists for the involuntary treatment of the patient, and if unable to afford counsel, to appoint counsel to represent the involuntary patient. Such hearing shall be held as soon as practicable, but no later than 8 working days from the filing of the petition. (2) Direct that notice of the hearing and copies of pleadings be supplied to the involuntary patient and the patient’s counsel. In the case of a minor, copies of the pleading will be supplied to the patient’s parents or legal guardian. (3) Enter such other orders as may be appropriate, including an order authorizing the continued involuntary treatment of the patient until further order of the court. (4) If the court determines after a hearing that the patient is not a person in need of treatment or that such patient does not need involuntary treatment, the patient shall be discharged in accord with the court’s order. If the court determines that the patient is a person in need of treatment who is unwilling to accept or incapable of accepting voluntary treatment, it may order continued treatment for an additional period not to exceed 30 days. Thereafter, the court shall schedule an additional hearing within 30 days to review the need for continued involuntary treatment unless the court is informed the patient is under voluntary treatment or has been appropriately discharged from treatment. If continued involuntary treatment is warranted beyond the 30 days, the court shall hold hearings to determine the necessity for continued involuntary treatment at intervals of not more than 6 months. A patient involuntarily receiving treatment, if represented by counsel, may waive, orally or in writing, any hearing under this section. The waiver must be submitted in writing to the court or be orally presented in open court. (5) The court for good cause may order that judicial proceedings under this chapter take place in the Superior Court or Family Court in a county other than the county in which the action was initiated. (73 Del. Laws, c. 358, § 2.) Page 169 Title 16 - Health and Safety § 2215. Procedural rights of involuntary patients. An individual whom the staff of a facility has determined to be a person in need of treatment will be provided: (1) Notice (including a written statement) of the factual grounds upon which the proposed treatment is predicated and the reasons for the necessity of involuntary treatment and confinement. (2) Judicial review and determination of: a. Whether the involuntary patient’s confinement is based upon sufficient cause; b. Whether the involuntary patient is a person in need of treatment; and c. Whether a less restrictive placement such as nonresidential treatment is more appropriate. Such hearings shall be without jury and not open to the public and shall be preceded by adequate notice to the involuntary patient, and the involuntary patient shall be entitled to be present at all such hearings. (3) Representation by counsel at all judicial proceedings, such counsel to be court-appointed if the involuntary patient cannot afford to retain counsel; (4) Examination by an independent, licensed professional in the area of substance abuse and treatment and to have such persons testify as a witness on the patient’s behalf, such witness to be court-appointed if the involuntary patient cannot afford to retain such witness. (5) Reasonable discovery, the opportunity to summon and cross-examine witnesses, to present evidence on the person’s own behalf and to all other procedural rights afforded litigants in civil causes. The privilege against self-incrimination shall be applicable to all proceedings under this chapter and the patient’s testimony, if any, shall not otherwise be admissible in any criminal proceedings against the patient. (6) To have a full record made of the proceedings, including findings adequate for review. All records and pleadings shall remain confidential unless the court for good cause orders otherwise. (73 Del. Laws, c. 358, § 2.) § 2216. Discharge by the facility. Notwithstanding the pendency of the action or any order previously entered by the court, if at any time after the petition is filed the staff of the facility determines that the involuntary patient is no longer in need of involuntary treatment, the facility may so certify in writing and discharge the patient, and shall promptly notify the court of its discharge, and the court may dismiss the action. (73 Del. Laws, c. 358, § 2.) § 2217. Changing to voluntary status. An involuntary patient is entitled to change that patient’s own status to that of a voluntary patient if a member of the staff of the facility certifies that: (1) The patient is reasonably capable of understanding the nature of the decision to change status; and (2) Such a change is in the patient’s best interest. If such a change in status is challenged within 2 days by the patient’s next of kin or legal representative, the court will schedule a hearing to finally determine the matter. (73 Del. Laws, c. 358, § 2; 70 Del. Laws, c. 186, § 1.) § 2218. Enlargement of time. Notwithstanding the above provisions of this chapter, except for the time to appeal, the court may enlarge the time for performance for a reasonable period upon a showing of good cause. (73 Del. Laws, c. 358, § 2.) § 2219. Appeal; rules of procedure. (a) Any party to the proceedings may appeal an order of discharge or involuntary treatment to the Supreme Court within 30 days of the entry of such order. The appeal shall not operate as a stay of the order of disposition unless the court or the Supreme Court so directs. (b) The Superior Court and the Family Court may adopt such rules of procedure as may be required to implement the procedural requirements of this chapter. (73 Del. Laws, c. 358, § 2.) § 2220. Patient’s rights. It is the intent of the General Assembly and the purpose of this section to promote the interests and well-being of residential and nonresidential patients of treatment facilities. It is declared to be the public policy of this State that the interests of the patient shall be protected by a declaration of a patient’s rights and by requiring that all facilities treat their patients in accordance with such rights, which, unless otherwise provided by state or federal law, shall include but not be limited to the following: (1) Every patient shall have the right to receive considerate, respectful and appropriate care, treatment and services in compliance with relevant federal and state law and regulations, recognizing each person’s basic personal and property rights, which include dignity and individuality. Page 170 Title 16 - Health and Safety (2) Each patient or patient’s representative of such patient or resident shall, prior to or at the time of admission, receive a written statement of the services provided by the facility, including those required to be offered on an “as needed” basis, and a statement of related charges for services not covered under Medicare or Medicaid or not covered by the facility’s basic per diem rate. Upon receiving such statement, the patient and the patient’s representative shall sign a written receipt which must be retained by the facility in its files. (3) After admission, the facility shall submit to the patient and the patient’s representative, on a timely basis not to exceed 3 calendar months, a written, itemized statement detailing in language comprehensible to the ordinary lay person the charges and expenses the patient incurred during the treatment period. The statement shall contain a description of specific services, equipment and supplies received and expenses incurred for each such item. The statement shall include an explanation of any items identified by code or by initials. The facility shall make reasonable efforts to communicate the contents of the individual written statement to persons who it has reason to believe cannot read the statement. (4) Each patient or patient’s representative shall receive from the attending or resident physician or staff of the facility complete and current information concerning the patient’s diagnosis, treatment and prognosis in terms and language the patient can reasonably be expected to understand. The patient or patient’s representative shall participate in the planning of the patient’s medical treatment, including attendance at treatment plan meetings, shall be informed of the medical consequences of all medication and treatment alternatives, and shall give prior written informed consent to participation in any experimental research after a complete disclosure of the goals, possible effects on the patient, and whether or not the patient can expect any benefits or alleviation of the patient’s condition. (5) The facility shall provide the name, address and telephone number of the primary staff person or physician responsible for the patient’s care. (6) Each patient shall receive respect and privacy in the patient’s own medical care program. Case discussion, consultation, examination and treatment shall be confidential and shall be conducted discreetly. In the patient’s discretion, persons not directly involved in the patient’s care shall not be permitted to be present during such discussions, consultations, examinations or treatment except with the consent of the patient. Personal and medical records shall be treated confidentially and shall not be made public without the consent of the patient, except such records as are needed for a patient’s transfer to another health care institution or as required by law or third party payment contract. No personal or medical records shall be released to any person inside or outside the facility who has no demonstrable need for such records. (7) Every patient shall be free from chemical and physical restraints imposed for purposes of discipline and convenience and not necessary to treat the patient’s medical condition. (8) Every patient or patient’s representative shall receive from the administrator or staff of the facility a courteous, timely and reasonable response to requests, and the facility shall make prompt efforts to resolve grievances. Responses to requests and grievances shall be made in writing upon written request by the patient. (9) Every patient or patient’s representative shall be provided with information as to any relationship the facility has with other health-care and related institutions and/or service providers, including, but not limited to, pharmacy and rehabilitation services, to the extent the patient is offered care and/or services from these related entities. Such information shall be provided in writing upon admission and thereafter when additional services are offered. (10) Every patient shall receive reasonable continuity of care. (11) Every patient may send and shall receive mail promptly, and shall have access at any reasonable hour to a telephone where the patient may speak privately, and shall have access to writing instruments, stationary and postage. (12) Each patient has the right to manage personal financial affairs. (13) Every patient has the right, personally or through other persons or in combination with others, to exercise patient rights; to present grievances; to recommend changes in facility policies or services on behalf of the patient or others; to present complaints or petitions to the facility’s staff or administrator, to the Division of Alcoholism, Drug Abuse and Mental Health, and, if the patient is a minor under the age of 18, to the Department of Services for Children, Youth and Their Families, or to other persons or groups without fear of reprisal, restraint, interference, coercion or discrimination. (14) A patient shall not be required to perform services for the facility. (15) Every patient shall have the right to inspect all records pertaining to that patient’s own self, upon oral or written request. If a patient requests records to assist with preparation of any court hearing under this chapter, such records will be supplied on an expeditious basis. (16) All patients shall be fully informed, in language they can understand, of their rights and all rules and regulations governing patient conduct and their responsibilities during the stay at the facility. Every patient shall be directed to a prominent place within the facility where a listing of the patient’s rights are posted. The facility shall guarantee that a current list of patient’s rights are always posted in a highly visible and accessible place. (17) Every patient shall have the right to receive information from agencies acting as client advocates and be afforded the opportunity to contact those agencies without reprisal. (18) Every patient shall be free from verbal, physical or mental abuse, cruel and unusual punishment, involuntary seclusion, withholding of monetary allowance, withholding of food and deprivation of sleep. Page 171 Title 16 - Health and Safety (19) Every patient has the right to participate in an ongoing program of activities designed to meet, in accordance with personal assessments and plan of care, the patient’s interests and physical, mental and psychosocial well-being. (20) Every patient shall have the right to participate in social, religious and community activities that do not interfere with the patient’s treatment plan or the rights of other patients or residents. (21) Every patient shall have the right to request and receive the names and positions of staff members providing care to the patient. (22) Every patient shall have the right to request and receive an organizational chart outlining the facility’s chain of command for purposes of making requests and asserting grievances. (23) Where a patient is a minor under the age of 18 years and the patient did not consent to treatment under this chapter, the patient’s rights shall devolve to a parent, legal custodian, relative caregiver or legal guardian, as appropriate. (24) A patient’s care and treatment shall be provided in a setting and under conditions which restrict the patient’s personal liberty only to the extent required by the patient’s treatment needs, applicable law, and judicial orders. (25) The rights described in this section are in addition to, and not in derogation of, any other constitutional, statutory, or regulatory rights. (73 Del. Laws, c. 358, § 2.) § 2221. Devolution of rights. Where consistent with the nature of each right in § 2220 of this title and unless otherwise provided by state or federal law, all of such rights, particularly as they pertain to a person adjudicated incompetent in accordance with state law, or a patient who is found physically or mentally incapable by the patient’s own attending physician, or a patient who is unable to communicate with others, or a minor under the age of 18 years who does not consent to treatment under this chapter, shall devolve to the patient’s next of kin, legal guardian, legal custodian, relative caregiver, parents, representative, sponsoring agency or representative payee (except where the facility itself is the representative payee) selected pursuant to § 205(j) of the Social Security Act [42 U.S.C. § 405(j)]. (73 Del. Laws, c. 358, § 2.) § 2222. Immunity, limitation of liability. Any peace officer, emergency medical technician, firefighter, ambulance attendant, physician, employee of the Division, administrator or staff of a treatment facility, or other person acting under their supervision or assisting them, as well as the entities that may employ or direct the foregoing, acting or omitting to act within this chapter shall not be subject to any civil claim or civil legal proceeding of any nature, in law or equity, for damages of any nature or for any harm resulting from any act or proceeding, decision or determination undertaken, performed or recommended unless such harm was intentionally or recklessly caused by the misconduct of the foregoing individuals. (73 Del. Laws, c. 358, § 2.) § 2223. Unwarranted confinement in a substance abuse treatment facility or denial of rights; penalties. (a) Any person that willingly causes or conspires with or assists another to cause: (1) The unwarranted involuntary confinement of any individual in a substance abuse treatment facility under this chapter; or (2) The denial to any individual of any of the rights accorded to said individual under this chapter; Shall be punished by a fine not exceeding $500 or imprisonment not exceeding 1 year, or both. (b) The Superior Court shall have jurisdiction of offenses under this section. (73 Del. Laws, c. 358, § 2.) § 2224. Reporting requirements. (a) Any employee of a facility or anyone who provides services to a patient of a facility on a regular or intermittent basis who has reasonable cause to believe that a patient or resident in a facility has been abused, mistreated, neglected or financially exploited shall immediately report such abuse, mistreatment, neglect or financial exploitation to the Department by oral and written communication. The written report shall be filed by the employee or service provider within 48 hours after the employee or service provider first gains knowledge of the abuse, mistreatment, neglect or financial exploitation. (b) Any person required by subsection (a) of this section to make an oral and a written report who fails to do so shall be liable for a civil penalty not to exceed $1,000 per violation. (c) In addition to those persons subject to subsection (a) of this section, any other person may make such a report if such person has reasonable cause to believe that a patient or resident of a facility has been abused, mistreated, neglected or financially exploited. (d) Any individual who intentionally makes a false report under this subchapter shall be guilty of a class A misdemeanor. (e) Any correspondence or other written communication from a patient to the Department, the Attorney General’s office and/or a lawenforcement agency shall, if delivered to or received by a facility, be promptly forwarded, unopened, by the facility or service provider Page 172 Title 16 - Health and Safety to the agency to which it is written. Any correspondence or other written communication from the Department, the Attorney General’s office and/or a law enforcement agency to a patient shall, if delivered to or received by the facility or other service provider, be promptly forwarded, unopened, by the facility or other service provider to such patient. Failure to comply with this section shall result in a civil penalty not to exceed $1,000 per violation. (73 Del. Laws, c. 358, § 2.) § 2225. Coverage of persons for substance abuse treatment. (81 Del. Laws, c. 28, § 2; expired under 81 Del. Laws, c. 28, § 5.) § 2226. Distribution of fentanyl testing strips; immunity. (a) The purpose of this section is to expand the harm reduction strategies available in Delaware to address the epidemic level of drug overdose deaths through the distribution of fentanyl testing strips. Fentanyl is a potent opioid that is increasingly being mixed into illicitly sold drugs, often without the buyer’s knowledge. In 2018, fentanyl was involved in 72% of overdose deaths in Delaware. The distribution of fentanyl testing strips provides an opportunity to prevent potential overdose deaths. (b) For purposes of this section, “person” means 1 of the following that provides aid to drug users without the expectation of monetary or other compensation from the individual aided: (1) A lay individual. (2) A nonprofit organization. (c) This section does not apply to any of the following: (1) A manufacturer or distributor of fentanyl testing strips. (2) A pharmacy. (3) A hospital. (4) A medical clinic. (5) A for profit organization. (6) A credentialed individual. (d) A person may distribute functional fentanyl testing strips to determine the presence of fentanyl or fentanyl-related substances. (e) A person who provides functional fentanyl testing strips to an individual to determine the presence of fentanyl or fentanyl-related substances under this section must do so in good faith and with reasonable care. (f) A person who provides functional fentanyl testing strips to an individual to determine the presence of fentanyl or fentanyl-related substances is not subject to civil damages in excess of the limits of any applicable insurance coverage, unless it is established that the person caused injuries or death wilfully, wantonly, or recklessly or by gross negligence. (g) Nothing in this section is intended to waive the State’s sovereign immunity or the privileges and immunities under Chapter 40 of Title 10. (83 Del. Laws, c. 21, § 1.) §§ 2227-2232. [Reserved.] Page 173 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 23 Caustic Alkali, Acids or Corrosive Substances § 2301. Definitions. As used in this chapter, unless the context requires a different meaning: (1) “Dangerous caustic or corrosive substance” means each and all of the acids, alkalis and substances named below: a. Hydrochloric acid and any preparation containing free or chemically unneutralized hydrochloric acid (HCl) in a concentration of 10 percent or more; b. Sulphuric acid and any preparation containing free or chemically unneutralized sulphuric acid (H2SO4) in a concentration of 10 percent or more; c. Nitric acid or any preparation containing free or chemically unneutralized nitric acid (HNO3) in a concentration of 5 percent or more; d. Carbolic acid (C6H5OH), otherwise known as phenol, and any preparation containing carbolic acid in a concentration of 5 percent or more; e. Oxalic acid and any preparation containing free or chemically unneutralized oxalic acid (H2C2O4) in a concentration of 10 percent or more; f. Any salt of oxalic acid and any preparation containing any such salt in a concentration of 10 percent or more; g. Acetic acid or any preparation containing free or chemically unneutralized acetic acid (C2H4O2) in a concentration of 20 percent or more; h. Hypochlorous acid, either free or combined, and any preparation containing the same in a concentration so as to yield 10 percent or more by weight of available chlorine excluding calx chlorinata, bleaching powder and chloride of lime; i. Potassium hydroxide and any preparation containing free or chemically unneutralized potassium hydroxide (KOH), including caustic potash and Vienna paste, in a concentration of 10 percent or more; j. Sodium hydroxide and any preparation containing free or chemically unneutralized sodium hydroxide (NaOH), including caustic soda and lye, in a concentration of 10 percent or more; k. Silver nitrate, sometimes known as lunar caustic, and any preparation containing silver nitrate (AgNO3) in a concentration of 5 percent or more; and l. Ammonia water and any preparation yielding free or chemically uncombined ammonia (NH3), including ammonium hydroxide and “hartshorn,” in a concentration of 5 percent or more. (2) “Misbranded parcel, package or container” means a retail parcel, package or container of any dangerous caustic or corrosive substance for household use not bearing a conspicuous, easily legible label or sticker containing: a. The name of the article; b. The name and place of business of the manufacturer, packer, seller or distributor; c. The word “POISON” running parallel with the main body of reading matter on the label or sticker, on a clear, plain background of a distinctly contrasting color, in uncondensed gothic capital letters, the letters to be not less than 24 point size, unless there is on the label or sticker no other type so large, in which event the type shall be not smaller than the largest type on the label or sticker; and d. Directions for treatment in case of accidental personal injury by the dangerous caustic or corrosive substance. (35 Del. Laws, c. 54, § 1; Code 1935, § 853; 16 Del. C. 1953, § 2301.) § 2302. Selling in misbranded parcel. No person shall sell, barter or exchange, or receive, hold, pack, display, or offer for sale, barter or exchange, in this State, any dangerous caustic or corrosive substance in a misbranded parcel, package or container, the parcel, package or container being designed for household use. Household products for cleaning and washing purposes, subject to this chapter and labeled in accordance therewith, may be sold, offered for sale, held for sale and distributed in this State by any dealer, wholesale or retail. (35 Del. Laws, c. 54, § 2; Code 1935, § 854; 16 Del. C. 1953, § 2302.) § 2303. Approval and registration of brands and labels. (a) The Department of Health and Social Services may approve and register such brands and labels intended for use under this chapter as may be submitted to it for that purpose and as may in its judgment conform to the requirements of this chapter. (b) In any prosecution under this chapter the fact that any brand or label involved in the prosecution has not been submitted to the Department of Health and Social Services for approval, or, if submitted, has not been approved by it, shall be immaterial. (35 Del. Laws, c. 54, § 4; Code 1935, § 856; 16 Del. C. 1953, § 2303; 70 Del. Laws, c. 149, §§ 135, 136.) Page 174 Title 16 - Health and Safety § 2304. Penalties. Whoever violates this chapter shall be fined not more than $200 or imprisoned not more than 90 days, or both. (35 Del. Laws, c. 54, § 3; Code 1935, § 855; 16 Del. C. 1953, § 2304.) Page 175 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 24 Hazardous Chemical Information § 2401. Short title. This chapter shall be known and may be cited as the “Hazardous Chemical Information Act.” (64 Del. Laws, c. 344, § 1.) § 2402. Declaration of purpose. The General Assembly finds that the health and safety of persons living and working in Delaware may be improved by providing access to information regarding hazardous chemicals to which they may be exposed either during their normal employment activities or during emergency situations. The General Assembly also finds that many employers in the State have already established suitable information programs for their employees and that such programs will be required of all manufacturing employers by November, 1985, under the federal Occupational Safety and Health Administration’s hazard communication standard. It is therefore, the intent and purpose of this chapter to provide accessibility to information regarding hazardous chemicals to employees who may be exposed to such chemicals in nonmanufacturing employer workplaces as well as to emergency service organizations whose members may be exposed to such chemical hazards during emergency situations. (64 Del. Laws, c. 344, § 1.) § 2403. Definitions. (a) “Chemical manufacturer” shall mean an employer in Standard Industrial Classification (SIC) Codes 20 through 39 with a workplace where chemicals are produced for use or distribution. (b) “Chemical name” shall mean the scientific designation of a chemical in accordance with the nomenclature system developed by the International Union of Pure and Applied Chemistry (IUPAC) or the Chemical Abstracts Service (CAS) rules of nomenclature or a name which will clearly identify the chemical for the purpose of conducting a hazard evaluation. (c) “Common name” shall mean any designation or identification such as code name, code number, trade name, brand name or generic name used to identify a chemical other than by its chemical name. (d) “Designated representative” shall mean the individual or organization to whom an employee gives written authorization to exercise such employee’s rights under this chapter. A recognized or certified collective bargaining agent shall be treated automatically as a designated representative without regard to written employee authorization. (e) “Distributor” shall mean any business, other than a chemical manufacturer or importer, which supplies hazardous chemicals to other distributors or to purchasers. (f) “Employee” shall mean any person who may be exposed to hazardous chemicals in that person’s workplace under normal operating conditions or foreseeable emergencies. Office workers, grounds maintenance, security and nonresident management personnel are not included unless their job performances routinely involve potential exposure to hazardous chemicals. For the purposes of this chapter, “employee” includes persons working for the State and its political subdivisions, as well as members of volunteer emergency service organizations. (g) “Expose or exposure” means that an employee is subjected to a hazardous chemical in the course of employment through any route of entry (inhalation, ingestion, skin contract or absorption, etc.) and includes potential (e.g., accidental or possible) exposure. (h) “Hazardous chemical” shall mean any element, chemical compound or mixture of elements and/or compounds which is a physical hazard or health hazard as defined by the OSHA standard in 29 C.F.R. § 1910.1200(c) or a hazardous substance as defined by the OSHA standard in 29 C.F.R. § 1910.1200(d)(3). (i) “Label” shall mean any written, printed or graphic material displayed on or affixed to containers of hazardous chemicals. (j) “Manufacturing employer” shall mean an employer with a workplace classified in SIC Codes 20 through 39 who manufactures or uses a hazardous chemical. (k) “Material safety data sheet (MSDS)” shall mean a document containing chemical hazard and safe handling information, provided that, after November 25, 1985, MSDS shall mean a document prepared in accordance with the requirements of the OSHA standard for such document. (l) “Nonmanufacturing employer” or “employer” shall mean an employer with a workplace in a SIC Code, other than 20 through 39, the State, its political subdivisions, and all volunteer emergency service organizations. (m) “OSHA standard” shall mean the hazard communication standard issued by the Occupation Safety and Health Administration in 48 Federal Register 53280 et seq. (November 25, 1983), to be codified under Title 29 of the Code of Federal Regulations (C.F.R.) Part 1910.1200. Page 176 Title 16 - Health and Safety (n) “Secretary” shall mean the Secretary of the Department of Health and Social Services. (o) “Work area” shall mean a room or defined space in a workplace where hazardous chemicals are produced or used, and where employees are present. (p) “Workplace” shall mean an establishment at 1 geographical location containing 1 or more work areas. (q) “Workplace chemical list” shall mean the list of hazardous chemicals developed pursuant to § 2406 of this title or subsection (e) (i) of the OSHA standard [29 C.F.R. 1910.1200(e)(i)]. (64 Del. Laws, c. 344, § 1; 70 Del. Laws, c. 186, § 1.) § 2404. Relationship to OSHA standard. (a) Manufacturing employers and distributors that are regulated by and complying with the OSHA standard shall be exempt from this chapter except for §§ 2406(d), 2406(e), 2407(a), 2407(d), 2409 and 2415 of this title. Manufacturing employers and distributors shall be included under this chapter until the OSHA standard goes into effect. (b) Nonmanufacturing employers that adopt and comply with the OSHA standard may be certified by the Secretary as in compliance with this chapter except for §§ 2406(d), 2406(e), 2407(a), 2407(d), 2409 and 2415 of this title. (64 Del. Laws, c. 344, § 1.) § 2405. Notice to employees. Employers shall post adequate notice, at locations where notices are normally posted, informing employees about their rights under this chapter. In the absence of a notice prepared by the Secretary pursuant to § 2413 of this title, an employer notice shall be posted. (64 Del. Laws, c. 344, § 1.) § 2406. Workplace chemical list. (a) Employers shall compile and maintain a workplace chemical list which shall contain the following information for each hazardous chemical normally used or stored in the workplace in excess of 55 gallons or 500 lbs.: (1) The chemical name or the common name used on the MSDS and/or container label; and (2) The work area in which the hazardous chemical is normally stored or used. (b) The workplace chemical list shall be updated as necessary but not less than annually. (c) The workplace chemical list may be prepared for the workplace as a whole or for each work area, provided that the list is readily available to employees and their representatives. New or newly assigned employees shall be made aware of the workplace chemical list before working with or in a work area containing hazardous chemicals. (d) The workplace chemical list shall be provided to the Secretary upon request. (e) The workplace chemical list shall be maintained by the employer for 30 years. Complete records shall be sent to the Secretary if the business ceases to operate within the State. (64 Del. Laws, c. 344, § 1.) § 2407. Material safety data sheets. (a) Chemical manufacturers and distributors shall provide manufacturing and nonmanufacturing purchasers of hazardous chemicals in Delaware appropriate MSDSs for the hazardous chemicals purchased. (b) Employers shall maintain the most current MSDS received from manufacturers or distributors for each hazardous chemical purchased. If an MSDS has not been provided by the manufacturer or distributor for chemicals on the workplace chemical list at the time the chemicals are received at the workplace, the employer shall request one in writing from the manufacturer or distributor in a timely manner. (c) Material safety data sheets shall be readily available, upon request, for review by employees or designated representatives. (d) A copy of an MSDS shall be provided to the Secretary, upon request. (64 Del. Laws, c. 344, § 1.) § 2408. Hazardous chemical labels. (a) Existing labels on incoming containers of hazardous chemicals shall not be removed or defaced. (b) Employees shall not be required to work with a hazardous chemical from an unlabeled container except for a portable container intended for the immediate use of the employee who performs the transfer. (64 Del. Laws, c. 344, § 1.) § 2409. Emergency information. (a) Employers or manufacturing employers who normally store a hazardous chemical in excess of 55 gallons or 500 lbs. shall provide the fire chief of the fire department having jurisdiction over the workplace, in writing, the name(s) and telephone number(s) of knowledgeable representative(s) of the employer or manufacturing employer who can be contacted for further information or in case of an emergency. Page 177 Title 16 - Health and Safety (b) Each employer or manufacturing employer shall provide a copy of the workplace chemical list to the fire chief, upon request. The employer shall notify the fire chief of any significant changes that occur in the workplace chemical list. (c) The fire chief or the fire chief’s representative, upon request, shall be permitted on site inspections of the chemicals on the workplace chemical list for the sole purpose of preplanning fire department activities in the case of an emergency. (d) Employers or manufacturing employers shall provide the fire chief, upon request, a copy of the MSDS for any chemical on the workplace chemical list. (e) The fire chief shall, upon request, make the workplace chemical list and MSDSs available to members of the fire company having jurisdiction over the workplace and to personnel responsible for preplanning emergency police or fire activities but shall not otherwise distribute the information without approval of the employer. (64 Del. Laws, c. 344, § 1; 70 Del. Laws, c. 186, § 1.) § 2410. Employee education programs. (a) Every employer shall provide, at least annually, an education and training program for employees using or handling hazardous chemicals. Additional instruction shall be provided whenever the potential for exposure to hazardous chemicals is altered or whenever new and significant information is received by the employer concerning the hazards of a chemical. New or newly assigned employees shall be provided training before working with or in a work area containing hazardous chemicals. (b) The program shall include, as appropriate, information on interpreting labels and material safety data sheets and the relationship between these 2 methods of hazards communication, the location, acute and chronic effects, safe handling, protective equipment to be used and first aid treatment with respect to the hazardous chemicals used by the employees, and general safety instructions on the handling, cleanup procedures and disposal of hazardous chemicals. Employers shall keep a record of the dates of training sessions given to employees. (c) The Secretary, pursuant to § 2412 of this title, shall develop and maintain an education and training assistance program to aid those employers who, because of size or other practical considerations, are unable to develop such programs by themselves. Such a program shall be made available to such an employer upon request. (64 Del. Laws, c. 344, § 1.) § 2411. Construction of chapter. The provision of information to an employee shall not in any way affect the liability of an employer with regard to the health and safety of an employee or other persons exposed to hazardous chemicals, nor shall it affect the employer’s responsibility to take any action to prevent the occurrence of occupational disease as required under any other provision of law. The provision of information to an employee shall not affect any other duty or responsibility of a manufacturer, producer or formulator to warn ultimate users of a hazardous chemical under any other provision of law. (64 Del. Laws, c. 344, § 1.) § 2412. Powers of Secretary. The Secretary may, in the manner provided by law, promulgate rules, regulations and administrative procedures reasonably necessary to carry out the purposes of this chapter. (64 Del. Laws, c. 344, § 1.) § 2413. Complaints; investigations; penalties. (a) Complaints received in writing from employees or their designated representative, relating to alleged violations of this chapter by nonmanufacturing employers, shall be investigated in a timely manner by the Secretary or the Secretary’s designated representative. Complaints from employees or their designated representatives relating to alleged violations by manufacturing employers shall be referred to the federal Occupational Safety and Health Administration by the Secretary. (b) Officers or duly designated representatives of the Secretary, upon presentation of appropriate credentials and written notice or warrant to the employer, shall have the right of entry into any workplace at reasonable times to inspect and investigate complaints within reasonable limits and in a reasonable manner. (c) Employers found to be in violation of this chapter shall be given 14 days to comply. Employers not complying within 14 days following written notification of a violation shall be subject to civil penalties of not more than $500 per violation. (64 Del. Laws, c. 344, § 1; 70 Del. Laws, c. 186, § 1.) § 2414. Outreach program. (a) The Secretary shall develop and provide each employer with a suitable form of notice providing employees with information regarding their rights under this chapter. (b) As part of the outreach program, the Secretary shall develop an education and training program to assist employers pursuant to § 2410 of this title. Page 178 Title 16 - Health and Safety (c) As part of the outreach program, the Secretary may develop and distribute a supply of informational leaflets on employer duties, employee rights, the outreach program and/or the effects of hazardous chemicals. (d) The Secretary may contract with the University of Delaware or other public or private organizations to develop and implement such an outreach program. (e) The Secretary shall establish and publicize the availability of an information office to answer inquiries from employees, employers or the public in Delaware concerning the effects of hazardous chemicals. (64 Del. Laws, c. 344, § 1.) § 2415. Employee rights. (a) Employees that may be exposed to hazardous chemicals shall be informed of such exposure and shall have access to the workplace chemical list and material safety data sheets for the hazardous chemicals. In addition, employees shall receive training on the hazards of the chemicals and on measures they can take to protect themselves from those hazards and shall be provided appropriate personal protective equipment. These rights are guaranteed on the effective date of these subsections providing the information or action. (b) No employer shall discharge, or cause to be discharged, or otherwise discipline or in any manner discriminate against an employee because the employee has filed a complaint, assisted an inspector of the Department who may make or is making an inspection under § 2413 of this title, or has instituted or caused to be instituted any proceeding under or related to this chapter or has testified or is about to testify in any such proceeding or because of the exercise of any rights afforded pursuant to this chapter on behalf of the employee or on behalf of others, nor shall pay, position, seniority or other benefits be lost for exercise of any right provided by this chapter. (c) Any waiver by an employee of the benefits or requirements of this chapter shall be against public policy and be null and void. Any employer’s request or requirement that an employee waive any rights under this chapter as a condition of employment shall constitute a violation. (64 Del. Laws, c. 344, § 1.) § 2416. Protection of trade secrets. (a) An employer who believes that all or any part of the information required under §§ 2406, 2409(b) or 2409(d) of this title is a trade secret may withhold the information provided that: (1) Material safety data sheets are available to employees in the area where they work; (2) Hazard information on the trade secret chemicals is provided to the fire chief; (3) All relevant information is provided to a physician diagnosing and treating an employee exposed to the chemical, pursuant to requirements stated in the OSHA standard set forth in 29 C.F.R. Part 1910.1200(i)(2); and (4) The employer can substantiate the trade secret claim. (b) The Secretary, upon the Secretary’s own initiative, or upon request of an employee, an employee’s representative or a fire chief, may request any or all of the data substantiating the trade secret claim to determine whether the claim made pursuant to subsection (a) of this section is valid. The Secretary shall protect from disclosure any or all information coming into the Secretary’s possession when such information is marked by the employer as confidential and shall return all information so marked to the employer at the conclusion of the Secretary’s determination. (c) The employer shall have 30 days after notification by the Secretary that a trade secret claim is not valid to request an administrative hearing on the determination. Any such hearing shall be held in a manner similar to that provided for in the Administrative Procedures Act [Chapter 101 of Title 29] for hearings in contested cases. (64 Del. Laws, c. 344, § 1; 70 Del. Laws, c. 186, § 1.) § 2417. Exemptions. Notwithstanding any language to the contrary, this chapter shall not apply to chemicals in the following: (1) Any article which is formed to a specific shape or design during manufacture, which has end use function(s) dependent in whole or in part upon its shape or design during end use, and which does not release or otherwise result in exposure to a hazardous chemical under normal conditions of use; (2) Products intended for personal consumption by employees in the workplace; (3) Retail food sale establishments and all other retail trade establishments, exclusive of processing and repair areas; (4) A workplace where a hazardous chemical is received in a sealed package and is subsequently sold or transferred in that package if the seal remains intact while the chemical is in the workplace and if the chemical does not remain in the workplace more than 5 working days, except for the provisions of § 2409(a) and § 2410 of this title. (5) Any food, food additive, color additive, drug or cosmetic as such terms are defined in the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) or distilled spirits, wines or malt beverages as such terms are defined in the Federal Alcohol Administration Act (27 U.S.C. § 201 et seq.). Page 179 Title 16 - Health and Safety (6) A laboratory under the direct supervision or guideline of a technically qualified individual provided that: a. Labels on containers of incoming chemicals shall not be removed or defaced; b. MSDSs received shall be maintained and made accessible to employees and students; c. Sections 2409 and 2410 of this title are met; and d. The laboratory is not used primarily to produce hazardous chemicals in bulk for commercial purposes. (7) The workplace of an agriculture employer or employer group if the Secretary of the Department of Agriculture certifies to the Secretary that the chemicals are covered by other federal or state laws and regulations. (64 Del. Laws, c. 344, § 1.) Page 180 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 25 Health-Care Decisions § 2501. Definitions. (a) “Advance health-care directive” shall mean an individual instruction or a power of attorney for health care, or both. (b) “Agent” shall mean an individual designated in a power of attorney for health care to make a health-care decision for the individual granting the power. (c) “Artificial nutrition and hydration” means supplying food and water through a conduit, such as a tube or intravenous line where the recipient is not required to chew or swallow voluntarily, including, but not limited to, nasogastric tubes, gastrostomies, jejunostomies and intravenous infusions. Artificial nutrition and hydration does not include assisted feeding, such as spoon or bottle feeding. (d) “Capacity” shall mean an individual’s ability to understand the significant benefits, risks and alternatives to proposed health care and to make and communicate a health-care decision. (e) “Declarant” shall mean a person who executes an advance health-care directive. (f) “Guardian” shall mean a judicially appointed guardian or conservator having authority to make health-care decisions for an individual. (g) “Health care” shall mean any care, treatment, service or procedure to maintain, diagnose or otherwise affect an individual’s physical or mental condition. (h) “Health-care decision” shall mean a decision made by an individual or the individual’s agent, surrogate or guardian regarding the individual’s health care, including: (1) Selection and discharge of health-care providers and institutions; (2) Acceptance or refusal of diagnostic tests, surgical procedures, programs of medication and orders not to resuscitate; (3) Directions to provide, withhold or withdraw artificial nutrition and hydration and all other forms of health care; and (4) Execution of a DMOST form pursuant to Chapter 25A of this title. (i) “Health-care institution” means an institution, facility or agency licensed, certified or otherwise authorized or permitted by law to provide health care in the ordinary course of business. (j) “Health-care provider” means an individual licensed, certified or otherwise authorized or permitted by law to provide health care in the ordinary course of business or practice of a profession. (k) “Individual instruction” means an individual’s direction concerning a health-care decision for the individual. (l) “Life-sustaining procedure” means: (1) Any medical procedure, treatment or intervention that: a. Utilizes mechanical or other artificial means to sustain, restore, or supplant a spontaneous vital function; and b. Is of such a nature as to afford a patient no reasonable expectation of recovery from a terminal condition or permanent unconsciousness. (2) Procedures which can include, but are not limited to, assisted ventilation, renal dialysis, surgical procedures, blood transfusions and the administration of drugs, antibiotics and artificial nutrition and hydration. (m) “Medically ineffective treatment” means that, to a reasonable degree of medical certainty, a medical procedure will not: (1) Prevent or reduce the deterioration of the health of an individual; or (2) Prevent the impending death of an individual. (n) “Person” means an individual, corporation, statutory trust, business trust, estate, trust, partnership, association, joint venture, government, governmental subdivision, agency or instrumentality or any other legal or commercial entity. (o) “Physician” means an individual authorized to practice medicine under Chapter 17 of Title 24. (p) “Power of attorney for health care” means the designation of an agent to make health-care decisions for the individual granting the power. (q) “Primary physician” or “attending physician” shall mean a physician designated by an individual or the individual’s agent, surrogate or guardian to have primary responsibility for the individual’s health care or, in the absence of a designation or if the designated physician is not reasonably available, a physician who undertakes the responsibility. (r) “Qualifying condition” means the existence of 1 or more of the following conditions in the patient, certified in writing in the patient’s medical record by the attending physician and by at least 1 other physician who, when the condition in question is “permanently unconscious” shall be a board-certified neurologist and/or neurosurgeon: Page 181 Title 16 - Health and Safety (1) “Permanently unconscious” or “permanent unconsciousness” means a medical condition that has existed for at least 4 weeks and that has been diagnosed in accordance with currently accepted medical standards and with reasonable medical certainty as total and irreversible loss of consciousness and capacity for interaction with the environment. The term includes, without limitation, a persistent vegetative state or irreversible coma. (2) “Terminal condition” means any disease, illness or condition sustained by any human being for which there is no reasonable medical expectation of recovery and which, as a medical probability, will result in the death of such human being regardless of the use or discontinuance of medical treatment implemented for the purpose of sustaining life or the life processes. (3) “Serious illness or frailty” means a condition based on which the health-care practitioner would not be surprised if the patient died within the next year. (s) “Reasonably available” shall mean readily able to be contacted without undue effort and willing and able to act in a timely manner considering the urgency of the patient’s health-care needs. (t) “Supervising health-care provider” shall mean the primary physician, or if there is no primary physician or the primary physician is not reasonably available, the health-care provider who has undertaken primary responsibility for an individual’s health care. (u) “Surrogate” means an adult individual or individuals who: (1) Have capacity; (2) Are reasonably available; (3) Are willing to make health-care decisions, including decisions to initiate, refuse to initiate, continue or discontinue the use of a life-sustaining procedure on behalf of a patient who lacks capacity; and (4) Are identified by the attending physician in accordance with this chapter as the person or persons who are to make those decisions in accordance with this chapter. (70 Del. Laws, c. 392, § 2; 73 Del. Laws, c. 329, § 57; 80 Del. Laws, c. 18, §§ 2, 4.) § 2502. Right of self-determination. An individual, legally adult, who is mentally competent, has the right to refuse medical or surgical treatment if such refusal is not contrary to existing public health laws. (70 Del. Laws, c. 392, § 2.) § 2503. Advance health-care directives. (a) Subject to the limitations of this chapter, an adult who is mentally competent may: (1) Give an individual instruction. The instruction may be limited to take effect only if a specified condition arises; and/or (2) Execute a power of attorney for health care, which may authorize the agent to make any health-care decision the principal could have made while having capacity. (b) (1) An advance health-care directive must be: a. In writing; b. Signed by the declarant or by another person in the declarant’s presence and at the declarant’s expressed direction; c. Dated; d. Signed in the presence of 2 or more adult witnesses neither of whom: 1. Is related to the declarant by blood, marriage or adoption; 2. Is entitled to any portion of the estate of the declarant under any will or trust of the declarant or codicil thereto then existing nor, at the time of the executing of the power of attorney for health-care, is entitled thereto by operation of law then existing; 3. Has, at the time of the execution of the advance health care directive, a present or inchoate claim against any portion of the estate of the declarant; 4. Has a direct financial responsibility for the declarant’s medical care; or 5. Has a controlling interest in or is an operator or an employee of a health-care institution at which the declarant is a patient or resident. (2) Each witness to the advance health-care directive shall state in writing that he or she is not prohibited under this section from being a witness. (c) An advance health-care directive shall become effective only upon a determination that the declarant lacks capacity, and when the advance health-care directive is to be applied to the providing, withholding or withdrawal of a life-sustaining procedure, the advance health-care directive shall become effective only upon a determination that the declarant lacks capacity and has a qualifying condition. (d) An advance health-care directive ceases to be effective upon a determination that the declarant has recovered capacity. (e) A determination that an individual lacks or has recovered capacity that affects an individual instruction or the authority of an agent must be made by the primary physician or other physician(s) as specified in a written health-care directive; however, a power of attorney Page 182 Title 16 - Health and Safety for health care may include a provision accommodating an individual’s religious or moral beliefs. That provision may designate a person other than a physician to certify in a notarized document that the individual lacks or has recovered capacity. (f) An agent shall make a health-care decision to treat, withdraw or withhold treatment on behalf of the patient after consultation with the attending physician or with the person other than a physician designated pursuant to subsection (e) of this section, and in accordance with the principal’s individual instructions, if any, and other wishes to the extent known to the agent. If the patient’s instructions or wishes are not known or clearly applicable, the agent’s decision shall conform as closely as possible to what the patient would have done or intended under the circumstances. To the extent that the agent knows or is able to determine, the agent’s decision is to take into account, including, but not limited to, the following factors if applicable: (1) The patient’s personal, philosophical, religious and ethical values; (2) The patient’s likelihood of regaining decision making capacity; (3) The patient’s likelihood of death; (4) The treatment’s burdens on and benefits to the patient; and (5) Reliable oral or written statements previously made by the patient, including, but not limited to, statements made to family members, friends, health-care providers or religious leaders. If the agent is unable to determine what the patient would have done or intended under the circumstances, the agent’s decision shall be made in the best interest of the patient. To the extent the agent knows and is able to determine, the agent’s decision is to take into account, including, but not limited to, the factors, if applicable, stated in this subsection. (g) A health-care decision made by an agent for a principal is effective without judicial approval. (h) Unless related to the principal by blood, marriage or adoption, an agent may not have a controlling interest in or be an operator or employee of a residential long-term health-care institution at which the principal is receiving care. (i) A written advance health-care directive may include the individual’s nomination of a guardian of the person. (j) A life-sustaining procedure may not be withheld or withdrawn from a patient known to be pregnant, so long as it is probable that the fetus will develop to be viable outside the uterus with the continued application of a life-sustaining procedure. (70 Del. Laws, c. 392, § 3.) § 2504. Revocation of advance health-care directive. (a) An individual who is mentally competent may revoke all or part of an advance health-care directive: (1) By a signed writing; or (2) In any manner that communicates an intent to revoke done in the presence of 2 competent persons, 1 of whom is a health-care provider. (b) Any revocation that is not in writing shall be memorialized in writing and signed and dated by both witnesses. This record shall be made a part of the medical record. (c) Any person, including, but not limited to, a health-care provider, agent or guardian, who is informed of a revocation shall immediately communicate the fact of the revocation to the supervising health-care provider and to any health-care institution at which the patient is receiving care. (d) A decree of annulment, divorce, dissolution of marriage or a filing of a petition for divorce revokes a previous designation of a spouse as an agent unless otherwise specified in the decree or in a power of attorney for health care. (e) An advance health-care directive that conflicts with an earlier advance health-care directive revokes the earlier directive to the extent of the conflict. (f) The initiation of emergency treatment shall be presumed to represent a suspension of an advance health-care directive while receiving such emergency treatment. (70 Del. Laws, c. 392, § 3.) § 2505. Optional form. The following form may, but need not, be used to create an advance health-care directive. The other sections of this chapter govern the effect of this or any other writing used to create an advance health-care directive. An individual may complete or modify all or any part of the following form: ADVANCE HEALTH-CARE DIRECTIVE EXPLANATION You have the right to give instructions about your own health care. You also have the right to name someone else to make healthcare decisions for you. This form lets you do either or both of these things. It also lets you express your wishes regarding anatomical gifts and the designation of your primary physician. If you use this form, you may complete or modify all or any part of it. You are free to use a different form. Page 183 Title 16 - Health and Safety Part 1 of this form is a power of attorney for health care. Part 1 lets you name another individual as agent to make health-care decisions for you if you become incapable of making your own decisions. You may also name an alternate agent to act for you if your first choice is not willing, able or reasonably available to make decisions for you. Unless related to you, an agent may not have a controlling interest in or be an operator or employee of a residential long-term health-care institution at which you are receiving care. If you do not have a qualifying condition (terminal illness/injury or permanent unconsciousness), your agent may make all health-care decisions for you except for decisions providing, withholding or withdrawing of a life-sustaining procedure. Unless you limit the agent’s authority, your agent will have the right to: (a) Consent or refuse consent to any care, treatment, service or procedure to maintain, diagnose or otherwise affect a physical or mental condition unless it’s a life-sustaining procedure or otherwise required by law. (b) Select or discharge health-care providers and health-care institutions; If you have a qualifying condition, your agent may make all health-care decisions for you, including, but not limited to: (c) The decisions listed in (a) and (b). (d) Consent or refuse consent to life-sustaining procedures, such as, but not limited to, cardiopulmonary resuscitation and orders not to resuscitate. (e) Direct the providing, withholding or withdrawal of artificial nutrition and hydration and all other forms of health care. Part 2 of this form lets you give specific instructions about any aspect of your health care. Choices are provided for you to express your wishes regarding the provision, withholding or withdrawal of treatment to keep you alive, including the provision of artificial nutrition and hydration as well as the provision of pain relief. Space is also provided for you to add to the choices you have made or for you to write out any additional instructions for other than end of life decisions. Part 3 of this form lets you express an intention to donate your bodily organs and tissues following your death. Part 4 of this form lets you designate a physician to have primary responsibility for your health care. After completing this form, sign and date the form at the end. It is required that 2 other individuals sign as witnesses. Give a copy of the signed and completed form to your physician, to any other health-care providers you may have, to any health-care institution at which you are receiving care and to any health-care agents you have named. You should talk to the person you have named as agent to make sure that the person understands your wishes and is willing to take the responsibility. You have the right to revoke this advance health-care directive or replace this form at any time. PART 1: POWER OF ATTORNEY FOR HEALTH CARE (1) DESIGNATION OF AGENT: I designate the following individual as my agent to make health-care decisions for me: (name of individual you choose as agent) (address) (city) (state) (zip code) (home phone) (work phone) OPTIONAL: If I revoke my agent’s authority or if my agent is not willing, able, or reasonably available to make a health-care decision for me, I designate as my first alternate agent: (name of individual you choose as first alternate agent) (address) (city) (state) (zip code) (home phone) (work phone) OPTIONAL: If I revoke the authority of my agent and first alternate agent or if neither is willing, able, or reasonably available to make a health-care decision for me, I designate as my second alternate agent: (name of individual you choose as second alternate agent) (address) (city) (state) (zip code) (home phone) (work phone) (2) AGENT’S AUTHORITY: If I am not in a qualifying condition my agent is authorized to make all health-care decisions for me, except decisions about life-sustaining procedures and as I state here; and if I am in a qualifying condition, my agent is authorized to make all health-care decisions for me, except as I state here: Page 184 Title 16 - Health and Safety (Add additional sheets if necessary.) (3) WHEN AGENT’S AUTHORITY BECOMES EFFECTIVE: My agent’s authority becomes effective when my primary physician determines I lack the capacity to make my own health-care decisions. As to decisions concerning the providing, withholding and withdrawal of life-sustaining procedures my agent’s authority becomes effective when my primary physician determines I lack the capacity to make my own health-care decisions and my primary physician and another physician determine I am in a terminal condition or permanently unconscious. (4) AGENT’S OBLIGATION: My agent shall make health-care decisions for me in accordance with this power of attorney for health care, any instructions I give in Part 2 of this form, and my other wishes to the extent known to my agent. To the extent my wishes are unknown, my agent shall make health-care decisions for me in accordance with what my agent determines to be in my best interest. In determining my best interest, my agent shall consider my personal values to the extent known to my agent. (5) NOMINATION OF GUARDIAN: If a guardian of my person needs to be appointed for me by a court, (please check one): [ ] I nominate the agent(s) whom I named in this form in the order designated to act as guardian. [ ] I nominate the following to be guardian in the order designated: [ ] I do not nominate anyone to be guardian. PART 2: INSTRUCTIONS FOR HEALTH CARE If you are satisfied to allow your agent to determine what is best for you in making end-of-life decisions, you need not fill out this part of the form. If you do fill out this part of the form, you may strike any wording you do not want. (6) END-OF-LIFE DECISIONS: If I am in a qualifying condition, I direct that my health-care providers and others involved in my care provide, withhold, or withdraw treatment in accordance with the choice I have marked below: Choice Not To Prolong Life I do not want my life to be prolonged if: (please check all that apply) (i) I have a terminal condition (an incurable condition caused by injury, disease, or illness which, to a reasonable degree of medical certainty, makes death imminent and from which, despite the application of life-sustaining procedures, there can be no recovery) and regarding artificial nutrition and hydration, I make the following specific directions: I want used I do not want used Artificial nutrition through a conduit Hydration through a conduit (ii) I become permanently unconscious (a medical condition that has been diagnosed in accordance with currently accepted medical standards that has lasted at least 4 weeks and with reasonable medical certainty as total and irreversible loss of consciousness and capacity for interaction with the environment. The term includes, without limitation, a persistent vegetative state or irreversible coma) and regarding artificial nutrition and hydration, I make the following specific directions: I want used I do not want used Artificial nutrition through a conduit Hydration through a conduit Choice To Prolong Life I want my life to be prolonged as long as possible within the limits of generally accepted health-care standards. RELIEF FROM PAIN: Except as I state in the following space, I direct treatment for alleviation of pain or discomfort be provided at all times, even if it hastens my death: (7) OTHER MEDICAL INSTRUCTIONS: (If you do not agree with any of the optional choices above and wish to write your own, or if you wish to add to the instructions you have given above, you may do so here.) I direct that: (Add additional sheets if necessary.) PART 3: ANATOMICAL GIFTS AT DEATH (OPTIONAL) Page 185 Title 16 - Health and Safety (8) I am mentally competent and 18 years or more of age. I hereby make this anatomical gift to take effect upon my death. The marks in the appropriate squares and words filled into the blanks below indicate my desires. I give: [ ] my body; [ ] any needed organs or parts; [ ] the following organs or parts; To the following person or institutions [ ] the physician in attendance at my death; [ ] the hospital in which I die; [ ] the following named physician, hospital, storage bank or other medical institution; [ ] the following individual for treatment; for the following purposes: [ ] any purpose authorized by law; [ ] transplantation; [ ] therapy; [ ] research; [ ] medical education. PART 4: PRIMARY PHYSICIAN (OPTIONAL) (9) I designate the following physician as my primary physician: (name of physician) (address) (city) (state) (zip code) (phone) OPTIONAL: If the physician I have designated above is not willing, able or reasonably available to act as my primary physician, I designate the following physician as my primary physician: (name of physician) (address) (city) (state) (zip code) (phone) Primary Physician shall mean a physician designated by an individual or the individual’s agent or guardian, to have primary responsibility for the individual’s health care or, in the absence of a designation or if the designated physician is not reasonably available, a physician who undertakes the responsibility. (10) EFFECT OF COPY: A copy of this form has the same effect as the original. (11) SIGNATURE: Sign and date the form here: I understand the purpose and effect of this document. (date) (sign your name) (address) (print your name) (city) (state) (zip code) (12) SIGNATURES OF WITNESSES: Statement Of Witnesses SIGNED AND DECLARED by the above-named declarant as and for the declarant’s written declaration under 16 Del. C. §§ 2502 and 2503, in our presence, who in the declarant’s presence, at the declarant’s request, and in the presence of each other, have hereunto subscribed our names as witnesses, and state:A. That the Declarant is mentally competent.B. That neither of them:1. Is related to the declarant by blood, marriage or adoption;2. Is entitled to any portion of the estate of the declarant under any will of the declarant or codicil thereto then existing nor, at the time of the executing of the advance health-care directive, is so entitled by operation of law then existing;3. Has, at the time of the execution of the advance health-care directive, a present or inchoate claim against any portion of the estate of the declarant;4. Has a direct financial responsibility for the declarant’s medical care;5. Has a controlling interest in or is an operator or an employee of a residential long-term health-care institution in which the declarant is a resident; or6. Is under eighteen years of age.C. That if the declarant is a resident of a sanitarium, rest home, nursing home, boarding home or related institution, one of the witnesses, , is at the time of the execution of the advance health-care directive, a patient advocate or ombudsman designated by the Department of Health and Social Services. First witness Second Witness (print name) (print name) (address) (city, state, zip code) (address) (city, state, zip code) (signature of witness) (date) (signature of witness) (date) Page 186 Title 16 - Health and Safety I am not prohibited by § 2503 of I am not prohibited by § 2503 of Title 16 of the Delaware Code Title 16 of the Delaware Code from being a witness. from being a witness. (70 Del. Laws, c. 392, § 3; 70 Del. Laws, c. 186, § 1; 79 Del. Laws, c. 204, § 1.) § 2506. Decisions by guardian. A guardian shall comply with the instructions of the adult person with a disability and may not revoke the person’s advance health-care directive unless the appointing court expressly so authorizes. Nothing in this chapter shall limit the jurisdiction of the Court of Chancery over the person and property of a person with a disability. (70 Del. Laws, c. 392, § 3; 79 Del. Laws, c. 371, § 13.) § 2507. Surrogates. (a) A surrogate may make a health-care decision to treat, withdraw or withhold treatment for an adult patient if the patient has been determined by the attending physician to lack capacity and there is no agent or guardian, or if the directive does not address the specific issue. This determination shall be confirmed in writing in the patient’s medical record by the attending physician. Without this determination and confirmation, the patient is presumed to have capacity and may give or revoke an advance health-care directive or disqualify a surrogate. (b) (1) A mentally competent patient may designate any individual to act as a surrogate by personally informing the supervising healthcare provider in the presence of a witness. The designated surrogate may not act as a witness. The designation of the surrogate shall be confirmed in writing in the patient’s medical record by the supervising health-care provider and signed by the witness. (2) In the absence of a designation or if the designee is not reasonably available, any member of the following classes of the patient’s family who is reasonably available, in the descending order of priority, may act, when permitted by this section, as a surrogate and shall be recognized as such by the supervising health-care provider: a. The spouse, unless a petition for divorce has been filed; b. An adult child; c. A parent; d. An adult sibling; e. An adult grandchild; f. An adult niece or nephew; g. An adult aunt or uncle. Individuals specified in this subsection are disqualified from acting as a surrogate if the patient has filed a petition for a Protection From Abuse order against the individual or if the individual is the subject of a civil or criminal order prohibiting contact with the patient. (3) If an adult patient is in an acute care setting or is a client of the Department of Health and Social Services and none of the individuals eligible to act as a surrogate under subsection (b) of this section is reasonably available, an adult, other than a paid caregiver, who has exhibited special care and concern for the patient, who is familiar with the patient’s personal values and who is reasonably available may make health-care decisions to treat, withdraw or withhold treatment on behalf of the patient. Such person shall provide an affidavit to the health-care facility or to the attending or treating physician which includes statements that he or she is: a. A close friend of the patient; b. Is willing and able to become involved in the patient’s health care; and c. Has maintained such regular contact with the patient as to be familiar with the patient’s activities, health, personal values and morals. The affidavit must also recite facts and circumstances that demonstrate such person’s familiarity with the patient. End of life decisions involving the withdrawal or withholding of treatment must meet the requirements of this chapter. (4) Nothing in this section shall be interpreted as limiting the Court of Chancery’s authority to appoint a guardian of a person to act as a surrogate under the Court’s rules and procedures. (5) A supervising health-care provider may require an individual claiming the right to act as a surrogate for a patient to provide a written declaration under the penalty of perjury stating facts and circumstances sufficient to establish the claimed authority. (6) A mentally competent patient may at any time disqualify a member of the patient’s family from acting as the patient’s surrogate by a signed writing or by personally informing the health-care provider of the disqualification. (7) A surrogate may make a decision to provide, withhold or withdraw a life-sustaining procedure if the patient has a qualifying condition documented in writing with its nature and cause, if known, in the patient’s medical record by the attending physician. (8) A surrogate’s decision on behalf of the patient to treat, withdraw or withhold treatment shall be made according to the following paragraphs and otherwise meet the requirements of this chapter: a. Decisions shall be made in consultation with the attending physician. Page 187 Title 16 - Health and Safety b. 1. The surrogate shall make a health-care decision to treat, withdraw or withhold treatment in accordance with the patient’s individual instructions, if any, and other wishes to the extent known by the surrogate. 2. If the patient’s instructions or wishes are not known or clearly applicable, the surrogate’s decision shall conform as closely as possible to what the patient would have done or intended under the circumstances. To the extent the surrogate knows or is able to determine, the surrogate’s decision is to take into account, including, but not limited to, the following factors if applicable: A. The patient’s personal, philosophical, religious and ethical values; B. The patient’s likelihood of regaining decision making capacity; C. The patient’s likelihood of death; D. The treatment’s burdens on and benefits to the patient; E. Reliable oral or written statements previously made by the patient, including, but not limited to, statements made to family members, friends, health care providers or religious leaders. 3. If the surrogate is unable to determine what the patient would have done or intended under the circumstances, the surrogate’s decision shall be made in the best interest of the patient. To the extent the surrogate knows and is able to determine, the surrogate’s decision is to take into account, including, but not limited to, the factors, if applicable, stated in paragraph (b)(8)b.2. of this section. (9) In the event an individual specified in paragraph (b)(2) of this section claims that the individual has not been recognized or consulted as a surrogate or if persons with equal decision making priority under paragraph (b)(2) of this section cannot agree who shall be a surrogate or disagree about a health-care decision, and a patient who lacks capacity is receiving care in a health-care institution, the attending physician or an individual specified in paragraph (b)(2) of this section may refer the case to an appropriate committee of the health-care institution for a recommendation in compliance with this chapter, and the attending physician may act in accordance with the recommendation of the committee or transfer the patient in accordance with the provisions of § 2508(g) of this title. A physician who acts in accordance with the recommendation of the committee is not subject to civil or criminal liability or to discipline for unprofessional conduct for any claim based on lack of consent or authorization for the action. (70 Del. Laws, c. 392, § 3; 70 Del. Laws, c. 186, § 1; 74 Del. Laws, c. 328, §§ 1-3; 79 Del. Laws, c. 28, § 1.) § 2508. Obligations of health-care provider. (a) Before implementing a health-care decision made for a patient, a supervising health-care provider, if possible, shall promptly communicate to the patient the decision made and the identity of the person making the decision. The decision of an agent or surrogate does not apply if the patient objects to the decision to remove life-sustaining treatment, providing that the objection is (1) by a signed writing or (2) in any manner that communicates in the presence of 2 competent persons, 1 of whom is a physician. (b) A supervising health-care provider who knows of the existence of an advance health-care directive or a revocation of an advance health-care directive shall promptly record its existence in the patient’s health-care record and, if it is in writing, shall request a copy and, if it is not in writing, shall request a copy of the witness statement, and shall arrange for its maintenance in the health-care record. (c) A primary physician who makes or is informed of a determination that a patient lacks or has recovered capacity or that another condition exists which affects an individual instruction or the authority of an agent, surrogate or guardian, shall promptly record the determination in the patient’s health-care record and communicate the determination to the patient, if possible, and to any person then authorized to make health-care decisions for the patient. (d) Except as provided in subsections (e) and (f) of this section, a health-care provider or institution providing care to a patient shall: (1) Comply with an individual instruction of the patient and with a reasonable interpretation of that instruction made by a person then authorized to make health-care decisions for the patient; and (2) In the absence of an individual instruction, comply with a health-care decision for the patient made by a person then authorized to make health-care decisions for the patient to the extent the agent or surrogate is permitted by this chapter. (e) A health-care provider may decline to comply with an individual instruction or health-care decision for reasons of conscience. A health-care institution may decline to comply with an individual instruction or health-care decision if the instruction or decision is contrary to a written policy of the institution which is based on reasons of conscience and if the policy was communicated to the patient or to a person then authorized to make health-care decisions for the patient. (f) A health-care provider or institution may decline to comply with an individual instruction or health-care decision that requires medically ineffective treatment or health care contrary to generally accepted health-care standards applicable to the health-care provider or institution. (g) A health-care provider or institution that declines to comply with an individual instruction or health-care decision shall: (1) Promptly so inform the patient, if possible, and any person then authorized to make health-care decisions for the patient; (2) Provide continuing care, including continuing life-sustaining care, to the patient until a transfer can be effected; and (3) Not impede the transfer of the patient to another health-care provider or institution identified by the patient, the patient’s agent or the patient’s surrogate. (70 Del. Laws, c. 392, § 3; 70 Del. Laws, c. 186, § 1.) Page 188 Title 16 - Health and Safety § 2509. Health-care information. (a) Unless otherwise specified in an advance health-care directive, a person then authorized to make health-care decisions for a patient has the same rights as the patient to request, receive, examine, copy and consent to the disclosure of medical or any other health-care information. (b) Unless otherwise specified in an advance health-care directive or court order, an agent appointed by a valid advance health-care directive under this chapter, a surrogate determined and confirmed under § 2507 of this title or a guardian of the person of a minor or adult appointed pursuant to a court order shall be authorized as a “personal representative” with full authority and standing thereof as provided in the Health Insurance Portability and Accountability Act of 1996 [P.L. 104-191], its regulations and the standards issued by the Secretary of the United States Department of Health and Social Services. (70 Del. Laws, c. 392, § 3; 76 Del. Laws, c. 307, § 1.) § 2510. Immunities. (a) A health-care provider or institution acting in good faith and in accordance with generally accepted health-care standards applicable to the health-care provider or institution is not subject to civil or criminal liability or to discipline for unprofessional conduct for: (1) Complying with a health-care decision of a person apparently having authority to make a health-care decision for a patient, including a decision to withhold or withdraw health care; (2) Declining to comply with a health-care decision of a person based on a belief that the person then lacked authority; (3) Complying with an advance health-care directive and assuming that the directive was valid when made and has not been revoked or terminated; (4) Providing life-sustaining treatment in an emergency situation when the existence of a health-care directive is unknown; or (5) Declining to comply with a health-care decision or advance health-care directive because the instruction is contrary to the conscience or good faith medical judgment of the health-care provider or the written policies of the institution. (b) An individual acting as agent or surrogate under this chapter is not subject to civil or criminal liability or to discipline for unprofessional conduct for health-care decisions made in good faith. (70 Del. Laws, c. 392, § 3.) § 2511. Safeguards. (a) Anyone who has good reason to believe that the withdrawal or withholding of health care in a particular case: (1) Is contrary to the most recent expressed wishes of a declarant; (2) Is being proposed pursuant to an advance health-care directive that has been falsified, forged or coerced; or (3) Is being considered without the benefit of a revocation which has been unlawfully concealed, destroyed, altered or cancelled; may petition the Court of Chancery for appointment of a guardian for such declarant. (b) The Department of Health and Social Services and the Public Guardian shall have oversight over any advance health-care directive executed by a resident of a long-term care facility, as defined in § 1102 of this title. Such advance health-care directive shall have no force nor effect if the declarant is a resident of a long-term care facility, as defined in § 1102 of this title, at the time the advance healthcare directive is executed unless 1 of the witnesses is a person designated as a patient advocate or ombudsperson by the Department of Health and Social Services. The patient advocate or ombudsperson must have the qualifications required of other witnesses under this chapter except as provided in § 2508 of this title. (63 Del. Laws, c. 386, § 1; 64 Del. Laws, c. 204, § 8; 69 Del. Laws, c. 345, § 5; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 392, §§ 3, 4; 79 Del. Laws, c. 204, § 2; 81 Del. Laws, c. 207, § 3.) § 2512. Assumptions and presumptions. (a) Neither the execution of an advance health-care directive under this chapter nor the fact that health care is withheld from a patient in accordance therewith shall, for any purpose, constitute a suicide. (b) The making of an advance health-care directive pursuant to this chapter shall not restrict, inhibit nor impair in any manner the sale, procurement or issuance of any policy of life insurance, nor shall it be deemed or presumed to modify the terms of an existing policy of life insurance. No policy of life insurance shall be legally impaired or invalidated in any manner by the withholding or withdrawal of health care from an insured patient, notwithstanding any term of the policy to the contrary. (c) No physician, health facility or other health-care provider, nor any health-care service plan, insurer issuing disability insurance, self-insured employee welfare benefit plan or nonprofit hospital service plan, shall require any person to execute an advance health-care directive as a condition to being insured, or for receiving health-care services, nor shall the signing of an advance health-care directive be a bar, except as provided in § 2508 of this title. (d) [Repealed.] (63 Del. Laws, c. 386, § 1; 64 Del. Laws, c. 204, § 7; 70 Del. Laws, c. 392, §§ 3, 5.) Page 189 Title 16 - Health and Safety § 2513. Penalties. (a) Whoever threatens directly or indirectly, coerces or intimidates any person to execute a declaration directing the withholding or withdrawal of maintenance medical treatment shall be guilty of a misdemeanor and upon conviction shall be fined not less than $500 nor more than $1,000, be imprisoned not less than 30 days nor more than 90 days, or both. (b) Whoever knowingly conceals, destroys, falsifies or forges a document with intent to create the false impression that another person has directed that maintenance medical treatment be utilized for the prolongation of that person’s life is guilty of a class C felony. (c) The Superior Court shall have jurisdiction over all offenses under this chapter. (63 Del. Laws, c. 386, § 1; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 392, §§ 3, 6.) § 2514. Capacity. (a) This chapter does not affect the right of an individual to make health-care decisions while having capacity to do so. (b) An individual is presumed to have capacity to make a health-care decision and to give or revoke an advance health-care directive. (70 Del. Laws, c. 392, § 7.) § 2515. Accommodation. Notwithstanding this chapter, an individual who elects to have treatment by spiritual means in lieu of medical or surgical treatment shall not be compelled to submit to medical or surgical treatment. (70 Del. Laws, c. 392, § 7.) § 2516. Effect of copy. A copy of an advance health-care directive or revocation of an advance health-care directive, has the same effect as the original. (70 Del. Laws, c. 392, § 7.) § 2517. Recognition of advance directives executed in other states. An advance directive or similar health-care declaration validly executed under the laws of another state in compliance with the laws of that state or of this State is valid for purposes of and subject to the limitations of this chapter. (70 Del. Laws, c. 392, § 7.) § 2518. Effect on prior declarations and directives. Nothing in this chapter shall be construed to modify or affect the terms of any declaration, appointment of agent or durable power of attorney validly executed prior to June 26, 1996, which grants the authority for medical treatment or directs the withholding or withdrawal of medical treatment, except that a prior declaration shall not be interpreted to allow the withdrawal or withholding of artificial nutrition or hydration unless that desire is specifically stated in that directive. If withdrawal or withholding of artificial nutrition or hydration is not specifically addressed in a prior declaration, a health-care provider shall comply with a decision regarding withdrawal or withholding of artificial nutrition or hydration for the patient made by a person then authorized to make health-care decisions for the patient to the extent the agent or surrogate is permitted by this chapter. Nothing in this chapter shall be construed to limit the use of any previous living will forms conforming to law or any other form which meets the requirements of this chapter. (70 Del. Laws, c. 392, § 7; 71 Del. Laws, c. 419, § 1.) § 2519. Health-care institutions and guardianships for nonacute patients. (a) A health-care institution must, as early as 3 but no later than 5 business days of determining that a patient no longer requires acute care in the health-care institution, provide a written notice to the patient, the patient’s surrogate, and, if the patient does not have a surrogate, to any member of the patient’s family who is reasonably available, in the descending order of priority set forth in § 2507 of this title, that the health-care institution has concluded that the nonacute patient would benefit from the appointment of a guardian, who shall be fully authorized with powers necessary to transfer the patient from acute care to less restrictive nonacute care, and that a petition for the appointment of a guardian should be filed within 10 business days of the date of the notice. (b) If the process of appointing a guardian for the nonacute patient has not been initiated within the period set forth in the notice required under subsection (a) of this section, the institution shall provide a second written notice to the patient, the patient’s surrogate, and if the patient does not have a surrogate, to any member of the patient’s family who is reasonably available, in the descending order of priority set forth in § 2507 of this title, that the petition for the appointment of a guardian must be filed within 10 business days of the date of the second notice, or the institution will initiate the process of appointing a guardian. (c) If the process of appointing a guardian for the nonacute patient has not been initiated within the time set forth in the second notice required under subsection (b) of this section, or if a guardian who is fully authorized with powers necessary to transfer the patient from acute care to less restrictive nonacute care has not been appointed within 30 days from the date of the filing of a petition for appointment of a guardian, the health-care institution may initiate the process of appointing a guardian. (82 Del. Laws, c. 270, § 1.) Page 190 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 25A Delaware Medical Orders for Scope of Treatment Act § 2501A. Short title. This chapter shall be known and may be cited as the “Delaware Medical Orders for Scope of Treatment Act” (“DMOST Act”). (80 Del. Laws, c. 18, § 1.) § 2502A. Statement of purpose. (a) An adult individual who has decision-making capacity has the right to refuse medical or surgical treatment in order to allow natural death if such refusal is not contrary to existing public health laws. (b) An adult individual with decision-making capacity has the right to plan ahead for health-care decisions through an advance healthcare directive pursuant to Chapter 25 of this title, or through a DMOST form pursuant to this chapter or both, and to have the wishes expressed in those documents respected, subject to certain limitations, in order to ensure that the right to control decisions about one’s own health care is not lost if a patient loses decision-making capacity and is not able to participate actively in making his or her own decisions, either temporarily or permanently. (c) An advance health-care directive is recommended for every adult whether or not the individual anticipates a period of incapacity. (d) The DMOST form is separate from and is not an advance health-care directive. It expresses an individual’s wishes regarding scope of treatment through medical orders. The DMOST form does not require an advance health-care directive. (e) Data reveal that many individuals may reside or be situated in multiple locations such as home, acute care, and post-acute care settings near the end of life. Changes in such settings require that an easily understood, standardized, portable document be available to communicate the individual’s care preferences. A DMOST form provides such a document. (80 Del. Laws, c. 18, § 1; 70 Del. Laws, c. 186, § 1.) § 2503A. Definitions. (a) “Advance health-care directive” means an advance health-care directive under Chapter 25 of this title, a durable power of attorney for health-care decisions, or any individual instruction or power of attorney for health care valid in the state where such document was executed or where the individual executing such document was a resident at the time that such document was executed that appoints an agent. Said document must have been executed by the individual authorizing the appointed agent to make decisions about the individual’s health care when such individual no longer has decision-making capacity. (b) “Decision-making capacity” means a patient’s ability to understand and appreciate the nature and consequences of a particular health-care decision, including the benefits and risks of that decision and alternatives to any proposed health care, and to reach an informed health-care decision. (c) “Delaware Medical Orders for Scope of Treatment” (DMOST) means a clinical process to facilitate communication between healthcare professionals and patients living with serious illness or frailty whose health-care practitioner would not be surprised if they died within the next year or, if the patient lacks decision-making capacity, the patient’s authorized representative. The process encourages shared, informed medical decision-making. The result is a DMOST form, which contains portable medical orders that respect the patient’s goals for care in regard to the use of CPR and other medical interventions. The DMOST form is applicable across health-care settings, is reviewable, and is revocable. (d) “Department” means the Department of Health and Social Services. (e) “DMOST form” means a standardized document created or approved by the Department that is uniquely identifiable and has a uniform format or color, which: (1) Is used on a voluntary basis by patients living with serious illness or frailty whose health-care practitioner would not be surprised if they died within the next year; (2) Is not an advance health-care directive; (3) Is not valid unless it meets the requirements for a completed DMOST form as set forth in this chapter; (4) Is intended to provide direction to emergency care personnel regarding the use of emergency care and to health-care providers regarding the use of life-sustaining treatment by indicating the patient’s preference concerning the scope of treatment, the use of specified interventions, and the intensity of treatment for each intervention; (5) Is intended to accompany the patient, and to be honored by all personnel attending the patient, across the full range of possible health-care settings, including but not limited to the patient’s home, a health-care institution, at the scene of a medical emergency, or during transport; Page 191 Title 16 - Health and Safety (6) May be reviewed or voided at any time by a patient with decision-making capacity or, if the patient lacks decision-making capacity, the patient’s representative in accordance with the provisions of § 2511A of this title; and (7) Must be signed by a health-care practitioner. (f) “Emergency-care provider” means an emergency medical technician, paramedic, or first responder authorized under Chapter 97 of this title. (g) “Health-care institution” means an institution, facility, or agency licensed, certified or otherwise authorized or permitted by law to provide health care in the ordinary course of business. (h) “Health-care practitioner” means a physician or an individual licensed and authorized to write medical orders under Title 24 who is providing care for the patient or overseeing the health care provided to a patient and has completed all training required by the Department for individuals participating in the completion of a DMOST form. Over time, a patient’s health-care practitioner may change. (i) “Health-care provider” means an individual licensed, certified, or otherwise authorized or permitted by law to provide health care in the ordinary course of business or practice of a profession. A health-care practitioner is also a health-care provider. (j) “Life-sustaining treatment” includes any medical intervention, including procedures, administration of medication, or use of a medical device, that maintains life by sustaining, restoring, or supplanting a vital function. It does not include care provided for the purpose of keeping a patient comfortable. (k) “Patient” means the individual who is under the care of the health-care practitioner or health-care provider. (l) “Patient’s authorized representative” or “authorized representative” means the individual signing a DMOST form on behalf of a patient without decision-making capacity, who has the highest priority to act for the patient under law, and who has the authority to make decisions with respect to the patient’s health-care preferences being made on the DMOST form such individual is executing on behalf of the patient. The health-care practitioner shall determine the individual who is the patient’s authorized representative by referencing the documentation giving such individual the required authority under law. The regulations implementing this chapter shall explain the priority set by law regarding who can act as an authorized representative. Based on the documentation provided by such individual as evidence of his or her authority, the patient’s authorized representative could be an individual designated by a patient under an advance health-care directive, an agent under a medical durable power of attorney for health-care decisions, a guardian of the person appointed pursuant to Chapters 39 and 39A of Title 12, in accordance with the authority granted by the appointing court, a surrogate appointed under Chapter 25 of this title, or an individual who is otherwise authorized under applicable law to make the health-care decisions being made by execution of the DMOST form on the patient’s behalf, if the patient lacks decision-making capacity. (m) “Physician” means an individual authorized to practice medicine under subchapter III, Chapter 17 of Title 24. (n) “Scope of treatment” means those medical interventions, procedures, medications, and treatments that a patient, in consultation with a health-care practitioner, has determined are appropriate, necessary and desired by and for the patient and that a patient has determined to refuse or to allow. Scope of treatment always respects the patient and includes the provision of comfort measures. A patient may decline life-sustaining treatment. (80 Del. Laws, c. 18, § 1; 70 Del. Laws, c. 186, § 1.) § 2504A. Duty of patient’s authorized representative. (a) At such time as a patient lacks decision-making capacity, the patient’s authorized representative shall make a health-care decision to treat, withdraw, or withhold treatment in accordance with the patient’s individual instructions as expressed in an advance health-care directive or DMOST form, if any, and other wishes to the extent known, or, if a guardian appointed pursuant to Chapters 39 and 39A of Title 12, in accordance with the authority granted by the appointing court. The patient’s authorized representative shall have the power to make any health-care decision authorized under this chapter unless limited by the order of a court of competent jurisdiction or limited in the document provided by the authorized representative as evidence of his or her authority. (b) If the patient’s instructions or wishes are not known or clearly applicable, the authorized representative’s decision shall conform as closely as possible to what the patient would have done or intended under the circumstances. To the extent the authorized representative knows or is able to determine, the authorized representative’s decision shall take into account the following nonexclusive list of factors, if applicable: (1) The patient’s personal, philosophical, religious, and ethical values. (2) The patient’s likelihood of regaining decision-making capacity. (3) The patient’s likelihood of death. (4) The treatment’s burdens on and benefits to the patient. (5) Reliable oral or written statements previously made by the patient, including, but not limited to, statements made to family members, friends, health-care providers, or religious leaders. (c) The decision of an authorized representative regarding whether life-sustaining procedures should be provided, withheld, or withdrawn shall not be based on a patient’s status either as an individual with a preexisting long-term mental or physical disability, or as an individual who is economically disadvantaged. (80 Del. Laws, c. 18, § 1; 70 Del. Laws, c. 186, § 1.) Page 192 Title 16 - Health and Safety § 2505A. Powers and duties of Department of Health and Social Services. (a) The Secretary of the Department of Health and Social Services shall be authorized to promulgate regulations and develop protocols to fulfill the following responsibilities: (1) Promulgation of a DMOST form and development of the process for completion, modification, and revocation of the DMOST form including training requirements. (2) Promotion of awareness among health-care practitioners, health-care providers, emergency-care providers, and the general public in this State about the option to complete a DMOST form. (3) Training of emergency-care providers about the use and application of a DMOST form. (4) Development of additional requirements for the completion of a DMOST form that may be applicable in the case of a patient with mental illness or a developmental disability in consultation with organizations that represent individuals with mental illness and development disabilities, respectively. (5) Ongoing evaluation of the design and use of DMOST forms through the use of such data as the Department determines reasonably necessary for that purpose. (b) The Secretary of the Department of Health and Social Services shall be authorized to seek the imposition of civil monetary penalties under this chapter. (80 Del. Laws, c. 18, § 1.) § 2506A. Powers and duties of the Department of State. The Secretary of State is authorized to promulgate regulations and develop protocols for the education of all health-care providers under its licensing or certification jurisdiction. (80 Del. Laws, c. 18, § 1.) § 2507A. Delaware Health Information Network. The Delaware Health Information Network (DHIN) is authorized to create an electronic registry to maintain and store executed DMOST forms and make them available to emergency-care providers, health-care providers and health-care institutions. (80 Del. Laws, c. 18, § 1.) § 2508A. Obligation to treat. A health-care practitioner, health-care provider, health-care institution, or emergency-care provider shall treat a patient who has a completed DMOST form in accordance with the directions and options indicated in such DMOST form, except as otherwise provided in this chapter. (80 Del. Laws, c. 18, § 1.) § 2509A. Mandatory elements of DMOST forms. A DMOST form shall be deemed to be completed and therefore valid for the purposes of this chapter if it: (1) Contains information indicating a patient’s health-care preferences; (2) Has been voluntarily signed by a patient or by another individual subscribing the patient’s name in the patient’s presence and at the patient’s express direction, or, if the patient does not have decision-making capacity, by the patient’s authorized representative; (3) Contains a statement that the DMOST form is being signed after discussion with the patient, or the patient’s authorized representative; (4) Includes the signature of the patient’s health-care practitioner and the date of the health-care practitioner’s signature; (5) If the DMOST form is not signed by the heath-care practitioner in the presence of the patient, the DMOST form will be signed by the individual in whose presence the patient or the patient’s authorized representative signed the DMOST form; (6) The DMOST form shall include a statement that the patient or, if the patient does not have decision-making capacity, the patient’s authorized representative, has been provided with a plain language statement explaining the DMOST form and the consequences of executing the DMOST form, including whether or not the DMOST form may be changed if the patient lacks decision-making capacity; and (7) Meets any other requirements established by regulations to implement or administer this chapter. (80 Del. Laws, c. 18, § 1.) § 2510A. Recognition of medical orders from other states. A document executed in another state, which meets the requirements of this chapter for a DMOST form or the requirements of the state where such document was executed or the state where the patient was a resident at the time the document was executed, shall be deemed to be valid for the purposes of this chapter to the same extent as a DMOST form valid under this chapter. (80 Del. Laws, c. 18, § 1.) Page 193 Title 16 - Health and Safety § 2511A. Modification or revocation of DMOST forms. (a) A patient with decision-making capacity, may, at any time, void his or her completed DMOST form or otherwise request alternative treatment to the treatment that was ordered on the DMOST form. (b) If the orders in a patient’s completed DMOST form regarding the use of any intervention specified therein conflict with the patient’s more recent oral or written directive to the patient’s health-care practitioner, the health-care practitioner shall honor the more recent directive from the patient in accordance with the provisions of subsection (d) of this section. (c) The patient’s authorized representative may, at any time after the patient loses decision-making capacity and after consultation with the patient’s health-care practitioner, request the health-care practitioner to modify or void the completed DMOST form, or otherwise request alternative treatment to the treatment that was ordered on the DMOST form, as the patient’s authorized representative deems necessary to reflect the patient’s health status or goals of care, unless the patient expressly limits the authorized representative’s authority to modify or void the completed DMOST form. The DMOST form shall provide the patient with the option to authorize or not to authorize the patient’s authorized representative to void or modify the patient’s completed DMOST form if the patient who has a completed DMOST form loses decision-making capacity. If the patient indicates on the DMOST form that the authorized representative is not authorized to void or modify the patient’s completed DMOST form, the patient’s authorized representative may not do so. (d) A DMOST form may only be modified in consultation with the patient’s health-care practitioner in accordance with the provisions of the applicable regulations. (80 Del. Laws, c. 18, § 1; 70 Del. Laws, c. 186, § 1.) § 2512A. Resolution of conflicts. (a) In the event of a disagreement between the patient’s authorized representative and the patient’s health-care practitioner concerning the patient’s decision-making capacity or the appropriate interpretation and application of the terms of a completed DMOST form regarding the patient’s course of treatment, the parties: (1) May seek to resolve the disagreement by means of procedures and practices established by the health-care institution, including, but not limited to, consultation with an institutional ethics committee, or with an individual designated by the health-care institution for this purpose; or (2) May seek resolution by a court of competent jurisdiction. (b) A health-care provider involved in the patient’s care or an administrator of a health-care institution may seek to resolve a disagreement concerning the appropriate interpretation and application of the terms of a completed DMOST form to the patient’s course of treatment in the same manner as set forth in subsection (a) of this section. (80 Del. Laws, c. 18, § 1.) § 2513A. Conflicting directives. (a) The patient’s scope of treatment shall be governed by the latest directive available. (b) If the treatment directives of a later advance health-care directive conflict with the patient’s directives on a DMOST form, a healthcare practitioner shall be informed so that the DMOST form can be modified or voided in order to reflect that patient’s later directive. (c) If there is a conflict between the patient’s expressed oral or written directives, the DMOST form, or the decisions of the patient’s authorized representative, the patient’s last expressed oral or written directives shall be followed and, if necessary, a new DMOST form shall be prepared and executed. (80 Del. Laws, c. 18, § 1.) § 2514A. Safeguards. Any individual or entity may petition the Court of Chancery for appointment of a guardian of the person of a patient if that individual or entity has good reason to believe that the withdrawal or withholding of health care in a particular case: (1) Is contrary to the most recent expressed wishes of a patient; (2) Is predicated on an incorrect assessment of the patient’s decision-making capacity; (3) Is being proposed pursuant to a DMOST form that has been falsified, forged, or coerced; (4) Is being considered without knowledge of a revocation of a completed DMOST form which has been unlawfully concealed, destroyed, altered, or cancelled; or (5) Is based on a patient’s status either as an individual with a preexisting long-term mental or physical disability, or as an individual who is economically disadvantaged. (80 Del. Laws, c. 18, § 1.) § 2515A. Immunity. A health-care institution, health-care practitioner, or health-care provider acting in good faith and in accordance with generally accepted health-care standards applicable to the health-care institution, health-care practitioner, or health-care provider is not subject to civil or criminal liability or to discipline for unprofessional conduct for: Page 194 Title 16 - Health and Safety (1) Complying with a DMOST form signed by a health-care practitioner apparently having authority to make a DMOST for a patient, including a decision to withhold or withdraw health care; (2) Declining to comply with a DMOST form based on a belief that the health-care practitioner then lacked authority to sign a DMOST; (3) Complying with a DMOST form and assuming that the DMOST form was valid when made and has not been modified or voided; (4) Providing life-sustaining treatment in an emergency situation when the existence of a DMOST form is unknown; or (5) Declining to comply with a DMOST form because the DMOST form is contrary to the conscience or good faith medical judgment of the health-care practitioner or the written policies of the health-care institution. (80 Del. Laws, c. 18, § 1.) § 2516A. Assumptions and presumptions. (a) Neither the execution of a DMOST form under this chapter nor the fact that health care is withheld or withdrawn from a patient in accordance therewith shall, for any purpose, constitute a suicide. (b) The completion of a DMOST form pursuant to this chapter shall not be deemed or presumed to modify the terms of an existing insurance policy. No policy of insurance shall be legally impaired or invalidated in any manner by the withholding or withdrawal of health care from an insured patient, notwithstanding any term of the policy to the contrary. (c) No health-care institution, health-care provider, health-care service plan, insurer issuing disability insurance, self-insured employee welfare benefit plan, nonprofit hospital service plan, or any other type of direct or indirect provider of health-care benefits or services, shall require any individual to execute a DMOST form as a condition to being insured, to receiving care, or to being admitted to a healthcare institution in order to receiving health-care services. (80 Del. Laws, c. 18, § 1.) § 2517A. Penalties. (a) A health-care provider who fails to act in accordance with the requirements of this chapter is subject to discipline for professional misconduct. (b) A health-care institution that intentionally fails to act in accordance with the requirements of this chapter shall be liable for a civil penalty of not more than $1,000 for each offense. For the purposes of this subsection, each violation shall constitute a separate offense. (c) An emergency-care provider subject to regulation by the Department who intentionally fails to act in accordance with the requirements of this chapter is subject to such disciplinary measures as the Secretary of Department deems necessary and consistent with the Department’s statutory authority. (d) An individual who intentionally or knowingly commits any of the following acts is guilty of a class G felony: (1) Concealing, canceling, defacing, obliterating, or withholding personal knowledge of a completed DMOST form or a modification or revocation thereof, without the patient’s consent, or if the patient lacks decision-making capacity, without the consent of the patient’s authorized representative; (2) Falsifying or forging a completed DMOST form or a modification or revocation thereof; or (3) Coercing or fraudulently inducing the completion of a DMOST form or a modification or revocation thereof by a patient or, if a patient lacks decision-making capacity, by a patient’s authorized representative. (e) Any organization that is a health-care provider, health-care institution, or “person” as defined in § 102(11) of Title 18 who intentionally or knowingly requires or prohibits the completion of a DMOST form or a modification or revocation thereof as a condition of coverage under any policy of health or life insurance, or an annuity, or a public benefits program, or as a condition of the provision of health care is guilty of a class A misdemeanor for each and every act or violation, and may be subject to suspension or revocation of such person’s authority to do business in Delaware. (f) The provisions of this section shall not be construed to repeal any sanctions applicable under any other law. (g) The Superior Court shall have jurisdiction over all civil monetary penalties and offenses under this chapter. (80 Del. Laws, c. 18, § 1.) § 2518A. Capacity. (a) An adult individual is presumed to have capacity to make a health-care decision and to execute, modify or void a DMOST form. (b) A determination that a patient lacks decision-making capacity must be made by a physician, and if a patient’s authorized representative is executing the DMOST form such determination by a physician shall be required. (80 Del. Laws, c. 18, § 1.) § 2519A. Severability. The provisions of this chapter are severable, and if any word, phrase, clause, sentence, section, or provision of this chapter is for any reason held to be unconstitutional, the decision of the court shall not affect or impair any of the remaining provisions of this chapter. Page 195 Title 16 - Health and Safety It is hereby declared as the legislative intent that this chapter would have been adopted had such unconstitutional word, phrase, clause, sentence, section or provision thereof not been included herein. (80 Del. Laws, c. 18, § 1.) § 2520A. Effect of copy. A copy of a DMOST form or revocation of a DMOST form has the same effect as the original. (80 Del. Laws, c. 18, § 1.) Page 196 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 26 Childhood Lead Poisoning Prevention Act § 2601. Short title; definitions. (a) This act shall be known and may be cited as the Childhood Lead Poisoning Prevention Act. (b) For purposes of this chapter: (1) “Elevated blood lead level” means any blood lead level determined by regulations established by the Division of Public Health to be detrimental to the health, behavioral development, or cognitive potential of a child. (2) “Screening” means a capillary blood lead test, including where a drop of blood is taken from a finger or heel of the foot. (3) “Testing” means a venous blood lead test where blood is drawn from a vein. (69 Del. Laws, c. 310, § 1; 83 Del. Laws, c. 75, § 1.) § 2602. Physicians and health-care facilities to screen children. (a) Every health-care provider who is the primary health-care provider for a child shall order lead poisoning screening of the child, under regulations adopted by the Division of Public Health, at or around 12 and 24 months of age. (b) [Repealed.] (c) (1) If screening under subsection (a) of this section determines that a child has an elevated blood lead level, the health-care provider shall order testing under regulations adopted by the Division of Public Health. (2) A health-care provider is encouraged to use the health-care provider’s clinical judgement to determine when testing should be used in lieu of screening under subsection (a) of this section. (d) All laboratories and health-care providers involved in blood lead level analysis, including screening and testing, shall participate in a universal reporting system as established by the Division of Public Health. (e) Nothing in this section may be construed to require any child to undergo screening or testing if the child’s parent or guardian objects on the grounds that the screening or testing conflicts with the parent’s or guardian’s religious beliefs. (f) [Repealed.] (69 Del. Laws, c. 310, § 1; 70 Del. Laws, c. 186, § 1; 77 Del. Laws, c. 402, §§ 1, 3; 83 Del. Laws, c. 75, § 2.) § 2603. Screening prior to child care or school enrollment. (a) For every child who has reached the age of 12 months, child care facilities and public and private nursery schools, preschools, and kindergartens shall require proof of screening for lead poisoning for admission or continued enrollment. (b) Except in the case of enrollment in kindergarten, the screening under subsection (a) of this section may be done within 60 calendar days of the date of enrollment. (c) A child’s parent or guardian must provide 1 of the following: (1) A statement from the child’s primary health-care provider that the child has received a screening for lead poisoning. (2) A certificate signed by the parent or guardian stating that the screening is contrary to the parent’s or guardian’s religious beliefs. (69 Del. Laws, c. 310, § 1; 74 Del. Laws, c. 76, § 1; 83 Del. Laws, c. 75, § 3.) § 2604. Reimbursement by third-party payers. Blood lead testing, screening, screening-related services, and diagnostic evaluations as required by § 2602 of this title are reimbursable under health insurance contracts and group and blanket health insurance under §§ 3337 and 3554 of Title 18, respectively. (69 Del. Laws, c. 310, § 1; 83 Del. Laws, c. 75, § 4.) § 2605. Childhood Lead Poisoning Advisory Committee. (a) The Childhood Lead Poisoning Prevention Advisory Committee is established to advise on the implementation of this chapter and to make any necessary recommendations for the implementation of this chapter or improvements of the processes to be followed by the agencies responsible for the implementation of this chapter. (b) The Committee shall annually prepare and distribute a report to the General Assembly regarding this chapter, the intervention activities, studies of incidence, the State Blood Lead Screening Program, and monitoring and implementation of regulations promulgated under this chapter. (c) The Committee consists of the following: Page 197 Title 16 - Health and Safety (1) The Secretary of the Department of Education. (2) The Secretary of the Department of Health and Social Services. (3) The Secretary of the Department of Services for Children, Youth & their Families. (4) The Director of the Delaware State Housing Authority. (5) The President of the Delaware Association of School Administrators. (6) The President of the Delaware Association of Realtors. (7) A Delaware pediatric provider, appointed by the Governor. (8) Two members, appointed by the Governor, each from a different county. (d) A member serving by virtue of position may appoint a designee to serve in the member’s stead and at the member’s pleasure. (e) The Committee shall elect a Chair and a Vice Chair from among the Committee’s members. (f) The Committee may form advisory subcommittees, which may include individuals who are not members of the Committee, to assist the Committee in its duties. (g) The Department of Health and Social Services shall provide staff support for the Committee. (73 Del. Laws, c. 46, § 2; 70 Del. Laws, c. 186, § 1; 82 Del. Laws, c. 17, § 1; 83 Del. Laws, c. 27, § 1.) § 2606. Annual report. The Division of Public Health shall annually, on or before January 1, provide a report on elevated blood lead levels to the General Assembly by delivering a copy of the report to the Secretary of the Senate, Chief Clerk of the House of Representatives, and the Director and Librarian of the Division of Research. (83 Del. Laws, c. 75, § 5.) Page 198 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 26A Hearing Aid Loan Bank Program § 2601A. Short title. The short title of this chapter shall be known and may be cited as the “Hearing Aid Loan Bank Re-Authorization Act.” (74 Del. Laws, c. 109, § 1; 76 Del. Laws, c. 129, § 1.) § 2602A. Definitions. The following definitions shall be applicable to this chapter: (1) “Director” means the Director of the Division of Public Health, Department of Health and Social Services. (2) “Division” means the Division of Public Health, Department of Health and Social Services. (3) “Eligible child” means a child who: a. Is a resident of the State; b. Is identified by a licensed audiologist as having a hearing impairment; c. Has no immediate access to a hearing aid; and d. Is under the age of 18 years. (4) “Licensed audiologist” means an individual who is licensed to practice audiology under Chapter 37 of Title 24. (5) “Loan bank” means the hearing aid loan bank. (6) “Program” means the Hearing Aid Loan Bank Program. (7) “Program manager” means the program manager of the Hearing Aid Loan Bank Program. (74 Del. Laws, c. 109, § 1; 76 Del. Laws, c. 129, § 1; 76 Del. Laws, c. 408, § 1.) § 2603A. Hearing Aid Loan Bank Program. (a) A Hearing Aid Loan Bank Program is re-established in the Division. (b) The program hereby re-established is for the purpose of lending hearing aids on a temporary basis to parents and legal guardians of eligible children in order to ensure that such children have maximum auditory exposure during critical years of language development and learning. (74 Del. Laws, c. 109, § 1; 76 Del. Laws, c. 129, § 1.) § 2604A. Administration. (a) The program shall be administered by a program manager hired under the merit system. (b) The Newborn Hearing Screening Program manager shall be the Hearing Aid Loan Bank Program manager, who shall be responsible for the Hearing Aid Loan Program. (c) The program manager must contract with licensed audiologists for the implementation and administration of Hearing Aid Loan Bank sites. (d) The program manager shall provide and maintain: (1) A pool of hearing aids in the loan bank to lend to a parent or legal guardian of an eligible child; (2) Testing and programming equipment or contracts for testing and programming for hearing aids in the loan bank; and (3) Supplies for repair and reconditioning or contracts for supplies and services for repair and reconditioning of hearing aids in the loan bank. (74 Del. Laws, c. 109, § 1; 76 Del. Laws, c. 129, § 1.) § 2605A. Hearing aids: procedures, loans. (a) The program manager shall lend a suitable hearing aid to a parent or legal guardian of an eligible child upon receipt of: (1) A prescription from a licensed audiologist; and (2) Any documents required by the program manager to prove that the child is an eligible child. (b) The loan period shall be for not more than 6 months except that the program manager may extend the original loan period for additional 6-month periods if, prior to each extension, the program manager determines that: (1) The child does not have immediate access to another hearing aid under Medicaid, the State Children’s Health Program, or private health insurance; Page 199 Title 16 - Health and Safety (2) The child’s parent or legal guardian currently does not have the financial means to obtain immediate access to another hearing aid; and (3) The child’s parent or legal guardian is making reasonable efforts to obtain access to another hearing aid. (c) A parent or legal guardian who borrows a hearing aid for an eligible child shall: (1) Be the custodian of the hearing aid; (2) Return the hearing aid immediately to the loan bank upon the expiration of the loan period or receipt of a suitable permanent hearing aid, whichever occurs first; (3) Be responsible for the proper care and use of the hearing aid; (4) Be responsible for any damage to or loss of the hearing aid; and (5) Sign a written agreement provided by the program manager that states the term and conditions of the loan. (d) The program manager shall ensure that the eligible child’s licensed audiologist instructs the parent or legal guardian about the proper care and use of a hearing aid provided under the program. (74 Del. Laws, c. 109, § 1; 76 Del. Laws, c. 129, § 1; 76 Del. Laws, c. 408, § 2.) § 2606A. Regulations. The Division of Public Health shall adopt regulations to implement the provisions of this chapter, including regulations that: (1) For the purpose of implementing § 2605A(a) of this title, identify the types of documents that the program manager may require a parent or legal guardian to submit to prove that a child is an eligible child; and (2) For the purpose of implementing § 2605A(b) of this title, establish factors that the program manager shall consider when evaluating whether a parent or legal guardian: a. Has the financial means to obtain immediate access to another hearing aid; or b. Is making reasonable efforts to obtain immediate access to another hearing aid. (74 Del. Laws, c. 109, § 1; 76 Del. Laws, c. 129, § 1.) § 2607A. Reports. (a) Beginning in the year 2008, and no later than January 15 of each year thereafter, the Director of Public Health shall submit an annual report to the Governor and the General Assembly regarding the implementation of this chapter. (b) The annual report shall include the following information: (1) The number and ages of children who received hearing aids through the loan program that year; (2) The number of children who received hearing aids through the loan program that year and subsequently received hearing aids through Medicaid, the State’s Children’s Health Program, or private insurance; (3) The length of each original loan; (4) The number of times that each original loan was extended and the length of each extension; (5) The number of times that hearing aids were not properly returned to the loan bank; and (6) Any other information that the Director believes is relevant to evaluating the costs and benefits of the program. (74 Del. Laws, c. 109, § 1; 76 Del. Laws, c. 129, § 1.) Page 200 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 27 Anatomical Gifts and Studies Subchapter I Anatomical Studies § 2701. Registration of approved institutions and persons. Any nonprofit hospital, accredited university or research institution and teachers, students, research workers and technicians in this State conducting anatomical studies accredited by a nationally recognized accrediting body approved by the Board of Medical Licensure and Discipline desiring to obtain dead bodies for the purpose of anatomical studies shall register with the Board of Medical Licensure and Discipline on such forms as may be prescribed by the Board and for the purpose of this subchapter such a registered hospital, university or research institution shall be known as an approved institution, and any registered teacher, student, research worker or technician shall be known as an approved person, and the Board of Medical Licensure and Discipline shall have the right to refuse registration of such hospital, accredited university or research institution or such persons. (24 Del. C. 1953, § 1771; 54 Del. Laws, c. 281; 63 Del. Laws, c. 4, § 1; 65 Del. Laws, c. 487, § 2; 77 Del. Laws, c. 319, § 1.) § 2702. Duties of public officers. Every public officer of this State or of any agency, county or political subdivision thereof, who shall have or receive custody or control of the body of any decedent, other than a dead body on which an autopsy has been performed pursuant to § 4707 of Title 29, and which body is not claimed within a reasonable time by a surviving spouse or relative of the decedent but not less than 120 hours following the death of the decedent, and which body will require burial at the expense of the State or of any agency, county or political subdivision thereof, shall forthwith notify the Medical Council of the existence and location of the dead body and of any identification thereof. (24 Del. C. 1953, § 1772; 54 Del. Laws, c. 281; 65 Del. Laws, c. 487, § 2.) § 2703. Designation of recipient approved institution. (a) The Medical Council shall promptly, upon receipt of notice of the existence, location and identification of a dead body pursuant to § 2702 of this title, designate 1 of the approved institutions to receive such body for use, including dissection, in connection with anatomical studies conducted by approved persons and shall notify the approved institutions of its designation and shall notify the officer having custody of the body thereof, and the officer shall promptly deliver the body to the approved institution so designated upon payment by the hospital or research institution of the cost of embalming said body and any necessary transportation and storage costs involved. (b) Each approved institution to which a dead body has been assigned for anatomical studies shall maintain said body in an embalmed condition, shall at all times ensure its proper and safe custody in an approved place of dissection, shall permit only approved persons to have access to such a body and shall identify all parts dissected free from the body with the same serial number assigned to the body by the Medical Council. (24 Del. C. 1953, § 1773; 54 Del. Laws, c. 281; 65 Del. Laws, c. 487, § 2.) § 2704. Disposition of remains. Any approved institution which shall have received a dead body pursuant to this subchapter shall, upon completion of the study thereof, deliver the body as then constituted to the coroner of the county in which such approved institution shall be situate for burial or cremation, and such approved institution shall pay the expenses of such burial or cremation and of the preparation of such body therefor, at the rates provided by law or which are usual and customary in such cases, provided that with the approval of the Inspector of Anatomy mentioned in § 2706 of this title, such an approved institution may retain certain portions of said body for special research or teaching purposes. (24 Del. C. 1953, § 1774; 54 Del. Laws, c. 281; 65 Del. Laws, c. 487, § 2.) § 2705. Powers and duties of Medical Council. The Medical Council shall in the performance of its duties pursuant to this subchapter: (1) Establish such reasonable regulations as may be necessary; (2) Maintain complete records; (3) Maintain a registry of approved institutions and persons pursuant to § 2701 of this title; (4) Allocate unclaimed dead bodies to each of the approved institutions according to the number of approved persons and the character of anatomical studies conducted at such approved institutions. (24 Del. C. 1953, § 1775; 54 Del. Laws, c. 281; 65 Del. Laws, c. 487, § 2.) Page 201 Title 16 - Health and Safety § 2706. Appointment of an Inspector of Anatomy. The Attorney General, in consultation with the Medical Council, shall, on such conditions as the Attorney General may deem fit, appoint as an Inspector of Anatomy, a medical practitioner or a person with a special training or experience in medicolegal matters, and the duties of such Inspector shall be to: (i) Enter and inspect periodically any or all approved institutions where dissection of dead bodies may be in progress and examine any body or record or thing relating to the use of such dead bodies; (ii) report to the Medical Council and the Attorney General any unsatisfactory condition relating to the custody, use or disposal of dead bodies at such institutions or any other place where they may be located; (iii) investigate the alleged misconduct of any authorized or unauthorized person who has access to dead bodies; and, for the purpose of this subchapter, any person who obstructs the Inspector of Anatomy in the performance of the Inspector’s duties shall be punishable by a fine not exceeding $100. (24 Del. C. 1953, § 1776; 54 Del. Laws, c. 281; 65 Del. Laws, c. 487, § 2; 70 Del. Laws, c. 186, § 1.) § 2707. Postmortem examination only by physicians; liability; consent. (a) No postmortem examination of the body of a deceased person shall be conducted by any person other than a duly licensed doctor of medicine or osteopathy. Written or telegraphic consent for a doctor of medicine or osteopathy to conduct a postmortem examination of the body of the deceased person shall be deemed sufficient when given by whichever 1 of the following assumes custody of the body for the purpose of burial: Father, mother, husband, wife, child, guardian, next of kin or, in absence of any of the foregoing, a person who assumes the duty of legal disposal of the body. If 2 or more such persons assume custody of the body, consent of 1 of them who is legally considered as the next of kin shall be deemed sufficient. (b) The licensed physician conducting the postmortem examination shall not be liable in damages for any action taken in making such postmortem examination. (24 Del. C. 1953, § 1777; 56 Del. Laws, c. 429, § 2; 65 Del. Laws, c. 487, § 2.) Subchapter II Uniform Anatomical Gift Act § 2710. Definitions. As used in this subchapter: (1) “Adult” means an individual who is at least 18 years of age. (2) “Advance health-care directive” means a directive under § 2503 of this title. (3) “Agent” means an individual authorized to make health-care decisions on another’s behalf by a power of attorney or an individual expressly authorized to make an anatomical gift on another’s behalf by any other record signed by the individual giving the authorization. (4) “Anatomical gift” means a donation of all or part of a human body to take effect after the donor’s death for the purpose of transplantation, therapy, research, or education. (5) “Decedent” means a deceased individual and includes a stillborn infant or fetus. (6) “Department” means the Delaware Department of Health and Social Services. (7) “Designated requestor” means a hospital employee completing a course offered by the OPO on how to approach potential donor families and request organ and tissue donation. (8) “Document of gift” means a donor card or other record used to make, amend, or revoke an anatomical gift. The term includes a statement or symbol on a driver’s license or identification card or in a donor registry. (9) “Donate Life Delaware Registry” means that subset of persons in the Department of Transportation’s driver’s license and photo identification card database or any expanded or successor database who have elected to include the donor designation on their record. (10) “Donee” means a person authorized to receive an anatomical gift. (11) “Donor” means an individual who makes a gift of all or part of the individual’s body. (12) “Donor registry” means a database which contains records of anatomical gifts. The term includes the Donate Life Delaware Registry. (13) “Eye bank” means a person that is licensed, accredited or regulated under federal or state law to engage in the recovery, screening, testing, processing, storage or distribution of human eyes or portions of human eyes. (14) “Fund” means the Organ and Tissue Donor Awareness Trust Fund. (15) “Hospital” means a hospital licensed, accredited or approved under the laws of any state and includes a hospital operated by the United States government, a state or a subdivision thereof, although not required to be licensed under state laws. (16) “Know” means to have actual knowledge. (17) “Medical examiner” means the Chief Medical Examiner, a Deputy Medical Examiner, an Assistant Medical Examiner, or their designee. Page 202 Title 16 - Health and Safety (18) “Minor” means an individual who is under 18 years of age. (19) “OPO” means the federally certified organ procurement organization for the State. (20) “Part” includes organs, tissues, eyes, bones, arteries, blood, other fluids and other portions of a human body, and “part” includes “parts.” (21) “Person” means an individual, corporation, government or governmental subdivision or agency, statutory trust, business trust, estate, trust, partnership or association or any other legal entity. (22) “Person authorized or obligated to dispose of a decedent’s body” means any of the following without regard to order or priority: a. A medical examiner having jurisdiction over the decedent’s body. b. A warden or director of a correctional facility where the decedent was incarcerated. c. An individual who is otherwise authorized or obligated to dispose of a decedent’s body. d. An official of an entity that is otherwise authorized or obligated to dispose of a decedent’s body. (23) “Physician” or “surgeon” means a physician or surgeon licensed or authorized to practice under the laws of any state. (24) “Prospective donor” means a person who is dead or whose death is imminent and has been determined by the OPO to have a part that could be medically suitable for transplantation, therapy, research, or education. (25) “Reasonably available” means able to be contacted by the OPO, eye bank or tissue bank through the exercise of reasonable due diligence and willing and able to act in a timely manner consistent with existing medical criteria necessary to make an anatomical gift. (26) “Recipient” means an individual into whose body a decedent’s part has been or is intended to be transplanted. (27) “Record” means information that is inscribed on a tangible medium or that is stored in an electronic or other medium and is retrievable in perceivable form. (28) “Recovery specialist” means a medical professional licensed by this or another state or technician trained in accordance with federal standards pursuant to 42 U.S.C. § 274(b) and nationally accredited standards for human body part removal. (29) “State” includes a state, district, commonwealth, territory, insular possession and any other area subject to the legislative authority of the United States of America. (30) “Tissue bank” means a person that is licensed, accredited, or regulated under federal or state law to engage in the recovery, screening, testing, processing, storage, or distribution of tissue. (24 Del. C. 1953, § 1780; 57 Del. Laws, c. 445, § 2; 65 Del. Laws, c. 487, § 3; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 453, § 2; 73 Del. Laws, c. 329, § 58; 80 Del. Laws, c. 182, § 1.) § 2711. Persons who may execute an anatomical gift. (a) Any individual of sound mind and 18 years of age or more or an agent of such an individual, or an individual not of such age who has parental consent may give all or any part of the individual’s body for any purposes specified in § 2712 of this title, the gift to take effect upon the donor’s death. However, a married minor may make such a donation without parental consent. (b) “Parental consent” as used in this section shall be defined as the recorded permission by any of the following persons in order of priority stated below when persons of prior classes are no longer living or no longer have contractual capacity and when there is no notice to a donee of an objection, written or otherwise, by a person of the same class: (1) Either parent; (2) A legal guardian; (3) Any individual having legal custody. (c) Any of the following persons, who are reasonably available, in order of priority stated, when persons in prior classes are not available at the time of death and in the absence of known objections by the decedent or by a member of the same or a prior class, may give all or any part of the decedent’s body for any purpose specified in § 2712 of this title: (1) An agent of the decedent; (2) The spouse of the decedent (unless a petition for divorce has been filed); (3) An adult child of the decedent; (4) A parent of the decedent; (5) An adult sibling of the decedent; (6) An adult grandchild of the decedent; (7) An adult niece or nephew of the decedent; (8) An adult aunt or uncle of the decedent; (9) Any other person related to the decedent by blood, marriage or adoption or an adult who exhibited special care and concern for the decedent; (10) A guardian of the person of the decedent at the time of death; (11) Any other person authorized or obligated to dispose of the decedent’s body; Page 203 Title 16 - Health and Safety (12) A hospital administrator or their designee of the institution at which the decedent was a patient at the time of death. (d) If the donee knows of an objection by the decedent or that a gift authorized by a member of a class is opposed by 50 percent or more of the reasonably available members of the same class or by a member of a prior class, the donee shall not accept the gift. The persons authorized by subsection (c) of this section may make the gift after death or immediately before death. A gift made by a person authorized pursuant to subsection (c) of this section may be amended or revoked by that person subject to § 2715(d) of this title. (e) A gift of all or part of a body authorizes any examination necessary to assure medical acceptability of the gift for the purposes intended. (f) The rights of the donee created by the gift are paramount to the rights of others except as provided by § 2716(f) of this title. (g) A donor’s gift of all or any part of the individual’s body, as indicated pursuant to this chapter, including, but not limited to, a designation on a driver’s license or identification card, donor card, advance health-care directive, will or other document of gift, may not be revoked by the next-of-kin or other persons identified in subsection (c) of this section, nor shall the consent of any such person at the time of the donor’s death or immediately thereafter be necessary to render the gift valid and effective. (h) The absence of a document of gift, in and of itself, shall not create any presumption regarding the person’s wishes regarding anatomical donation. (24 Del. C. 1953, § 1781; 57 Del. Laws, c. 445, § 2; 64 Del. Laws, c. 16, §§ 1-3; 65 Del. Laws, c. 487, § 3; 70 Del. Laws, c. 186, § 1; 73 Del. Laws, c. 1, § 1; 80 Del. Laws, c. 182, § 1.) § 2712. Persons who may become donees, and purposes for which anatomical gifts may be made. (a) An anatomical gift may be made to any of the following persons named in the document of gift: (1) If for research or education, then to a hospital; accredited medical school, dental school, college or university; the organ procurement organization; or other appropriate person as permitted by law. (2) Subject to subsection (b) of this section, an individual designated by the person making the anatomical gift if the individual is the recipient of the part. (3) An eye bank or tissue bank. (4) An organ procurement organization. (b) If an anatomical gift to an individual under paragraph (a)(2) of this section cannot be transplanted into the individual, the part passes in accordance with subsection (c) of this section in the absence of a known objection by the person making the anatomical gift. (c) An anatomical gift of an organ for transplantation or therapy, other than an anatomical gift under paragraph (a)(2) of this section, passes to the organ procurement organization. (d) If the intended purpose or recipient of an anatomical gift is not known the following shall apply: (1) If the part is an eye, the gift passes to the appropriate eye bank. (2) If the part is tissue, the gift passes to the appropriate tissue bank. (3) If the part is an organ, the gift passes to the appropriate organ procurement organization as custodian of the organ. (e) If a document of gift provides for multiple purposes without indicating priority, and transplantation and therapy is one of the purposes, then transplantation and therapy shall be the priority, and the gift, if suitable, shall pass to the appropriate organ procurement organization. If the gift cannot be used for transplantation or therapy, the gift may then be used for any of the other permitted purposes. (f) If an anatomical gift is made in a document of gift that does not name a person described in subsection (a) of this section and does not identify the purpose of the gift, the gift may be used only for transplantation or therapy, and the gift passes in accordance with subsection (d) of this section. (24 Del. C. 1953, § 1782; 57 Del. Laws, c. 445, § 2; 65 Del. Laws, c. 487, § 3; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 453, § 3; 80 Del. Laws, c. 182, § 1.) § 2713. Manner of executing anatomical gifts. (a) A gift of all or part of the body under § 2711(a) of this title may be made by will. The gift becomes effective upon the death of the testator without waiting for probate. If the will is not probated, or if it is declared invalid for testamentary purposes, the gift, to the extent that it has been acted upon in good faith, is nevertheless valid and effective. (b) A gift of all or part of the body under § 2711(a) of this title may also be made by a document other than a will, including authorizing a statement or symbol indicating that the donor has made an anatomical gift to be recorded in a donor registry or on the donor’s driver’s license or identification card, or a card or other record signed by the donor. If the donor or other person making a gift is physically unable to sign a record, the record may be signed for the donor at the donor’s direction and in the donor’s presence and in the presence of 2 witnesses who must sign the document in the donor’s presence. Delivery of the document of gift during the donor’s lifetime is not necessary to make the gift valid. Revocation, suspension, expiration or cancellation under Title 21 of a driver’s license or identification card upon which an anatomical gift is indicated does not invalidate the gift. (c) The gift may be made to a specified donee or without specifying a donee. A physician who becomes a donee under this subsection shall not participate in the procedures for removing or transplanting a part. Page 204 Title 16 - Health and Safety (d) Any gift by a person designated in § 2711(c) of this title shall be made by a document signed by the person or made by the person’s telegraphic, recorded, telephonic or other recorded message. (e) A person who so directs the manner in which the person’s body or any part of the person’s body shall be disposed of shall receive no remuneration or other thing of value for such disposition. (f) A document of gift is valid if executed in accordance with: (1) This chapter; (2) The law of the state or country where it was executed; or (3) The law of the state or country where, at the time of execution of the document of gift, the person making the anatomical gift: a. Is domiciled; b. Has a place of residence; or c. Is a citizen. (g) If a document of gift is valid under this section, the law of Delaware governs interpretation of the document. (h) A person may rely on a document of gift or amendment of an anatomical gift as being valid unless that person knows that it was not validly executed or was revoked. (24 Del. C. 1953, § 1783; 57 Del. Laws, c. 445, § 2; 59 Del. Laws, c. 330, § 1; 65 Del. Laws, c. 487, § 3; 67 Del. Laws, c. 360, § 1; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 453, § 4; 80 Del. Laws, c. 182, § 1.) § 2714. Delivery of document of gift. If the gift is made by the donor to a specified donee, the will, card or other document of gift, or an executed copy thereof, may be delivered to the donee to expedite the appropriate procedures immediately after death, but delivery is not necessary to the validity of the gift. The will, card or other document of gift, or an executed copy thereof, may be deposited in any hospital, bank or storage facility or registry office that accepts them for safekeeping or for facilitation of procedures after death. On request of any interested party upon or after the donor’s death, the person in possession shall produce the document for examination. (24 Del. C. 1953, § 1784; 57 Del. Laws, c. 445, § 2; 65 Del. Laws, c. 487, § 3; 80 Del. Laws, c. 182, § 1.) § 2715. Amendment or revocation of the gift. (a) If the will, card or other document or executed copy thereof has been delivered to a specified donee, the donor may amend or revoke the gift by: (1) The execution and delivery to the donee of a signed statement; (2) An oral statement made in the presence of 2 persons and communicated to the donee; (3) A statement during a terminal illness or injury addressed to an attending physician and communicated to the donee; or (4) A signed card or document found on the person or in the person’s effects. (b) Any document of gift which has not been delivered to the donee may be revoked by the donor in the manner set in subsection (a) of this section or by destruction, cancellation or mutilation of the document and all executed copies thereof. (c) Any gift made by a will may also be amended or revoked in the manner provided for amendment or revocation of wills or as provided in subsection (a) of this section. (d) Unless a revocation of a gift under this section includes an objection or refusal to make a gift of a part, it shall not prohibit a person listed in § 2711(c) of this title from authorizing such a gift. (24 Del. C. 1953, § 1785; 57 Del. Laws, c. 445, § 2; 65 Del. Laws, c. 487, § 3; 70 Del. Laws, c. 186, § 1; 80 Del. Laws, c. 182, § 1.) § 2716. Rights and duties at death. (a) The donee may accept or reject the gift. If the donee accepts a gift of the entire body, the donee may, subject to the terms of the gift, authorize embalming and the use of the body in funeral services. If the gift is of a part of the body, the donee, upon the death of the donor and prior to embalming, shall cause the part to be removed without unnecessary mutilation. After removal of the part, custody of the remainder of the body vests in the surviving spouse, next of kin or other persons under obligation to dispose of the body. The heir of any donor, at the time the disposition of the body takes place, may submit a request in writing to the donee that the body be returned to the heir at such time as the donee either refuses the disposition of the entire body or the parts thereof or determines that the donee no longer has use of the remains. (b) A surgeon, physician, funeral director, recovery specialist or eye bank technician who is authorized to remove any part in accordance with this subchapter is also authorized to draw or secure a blood sample from the donor, in order to screen the tissue received for medical purposes. (c) The time of death shall be determined by a physician who attends the donor at the donor’s death or, if none, the physician who certifies the death. This physician shall not participate in the procedures for removing or transplanting a part. Page 205 Title 16 - Health and Safety (d) A person who acts in good faith in accord with the terms of this subchapter or under the anatomical gift laws of another state (or a foreign country) is not liable for damages in any civil action or subject to prosecution in any criminal proceeding for that act. (e) Where no other provision for the same exists, a body, or the remains thereof, after it is no longer needed for the purpose indicated by the donor, may be buried at public expense on order of the Medical Council of Delaware, but in no case shall the expense of the burial exceed $100. (f) This subchapter is subject to the laws of this State prescribing powers and duties with respect to autopsies. The OPO is authorized to obtain a copy of an autopsy report in a timely fashion upon request and payment of reasonable copying fees. (24 Del. C. 1953, § 1786; 57 Del. Laws, c. 445, § 2; 65 Del. Laws, c. 335, §§ 1, 2; 65 Del. Laws, c. 487, § 3; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 453, § 5; 80 Del. Laws, c. 182, § 1.) § 2717. Uniformity of interpretation. This subchapter shall be so construed as to effectuate its general purpose to make uniform the law of those states which enact it. (24 Del. C. 1953, § 1787; 57 Del. Laws, c. 445, § 2; 65 Del. Laws, c. 487, § 3; 80 Del. Laws, c. 182, § 1.) § 2718. Short title. This subchapter may be cited as the “Uniform Anatomical Gift Act.” (24 Del. C. 1953, § 1788; 57 Del. Laws, c. 445, § 2; 65 Del. Laws, c. 487, § 3; 80 Del. Laws, c. 182, § 1.) § 2719. Forms [Repealed]. (24 Del. C. 1953, § 1789; 57 Del. Laws, c. 445, § 2; 64 Del. Laws, c. 16, § 4; 65 Del. Laws, c. 487, § 3; repealed by 80 Del. Laws, c. 182, § 1, effective Oct. 3, 2015.) § 2720. [Reserved]. § 2721. Requests for anatomical gifts. (a) (1) At or near the time of death of any patient in a hospital, the attending physician or hospital designee shall make contact with the OPO in order to determine the suitability for organ, tissue and eye donation for any purpose specified under this chapter. This contact and the disposition shall be noted in the patient’s medical record. (2) a. If the OPO determines that additional medical history or information is required to determine suitability for the donation, the OPO may seek additional health information on the potential anatomical donor from the Delaware Health Information Network (DHIN). b. If the OPO has entered into an agreement with the DHIN for access to clinical data in DHIN’s possession, DHIN shall provide the OPO with timely access to medical information on the potential anatomical donor. (b) Protocol for referral of potential anatomical donors to OPO. (1) The person designated by the hospital to contact the OPO shall have the following information available: a. Patient’s name and identifier number; b. Patient’s age; c. Anticipated cause of death; d. Past medical history; and e. Other pertinent medical information. (2) a. If the OPO determines that donation is not appropriate based on established medical criteria, this shall be noted by hospital personnel in the patient’s record and no further action shall be necessary. b. If the OPO determines that donation may be appropriate, the OPO shall make a reasonable search of the records of the Donate Life Delaware Registry or the applicable state donor registry that it knows exists for the geographic area in which the individual resided or resides in order to ascertain whether the individual has made an anatomical gift. c. If the referred patient has a document of gift, including registration with the Donate Life Delaware Registry, the OPO representative or the designated requestor shall attempt to notify a person listed in § 2711(c) of this title of the gift. d. If no document of gift is known to the OPO representative or the designated requestor, 1 of these 2 individuals shall ask the persons listed in § 2711(c) of this title whether the decedent had a validly executed document of gift. If there is no evidence of an anatomical gift by the decedent, the OPO representative or the designated requestor shall notify a person listed in § 2711(c) of this title of the option to donate organs and tissues. The request for donation shall be made by the OPO representative, or the designated requester in consultation with the attending physician or the hospital designee. (3) The person in charge of the hospital or that person’s designated representative shall indicate in the medical record of the decedent: a. Whether or not a document of gift is known to exist or whether a gift was made; and b. The name of the person granting or refusing the gift and that person’s relationship to the decedent. (4) If the OPO determines, based upon a medical record review, that a hospitalized individual who is dead or whose death is imminent may be a prospective donor, the hospital shall, if requested by the OPO, conduct a blood or tissue test or minimally invasive examination, Page 206 Title 16 - Health and Safety which is reasonably necessary to evaluate the medical suitability of a part that is or may be the subject of an anatomical gift. Specific consent to testing or examination under this paragraph (b)(4) is not required. The results of tests and examinations under this paragraph (b)(4) shall be used or disclosed only: a. To evaluate medical suitability for donation and to facilitate the donation process; and b. As required or permitted by law. (5) The attending physician, in collaboration with the OPO, shall ensure that, prior to the withdrawal or withholding of any measures which are necessary to maintain the medical suitability of a part that is or may be the subject of an anatomical gift, the OPO has either: a. Had the opportunity to advise the applicable persons set forth in § 2711(c) of this title of the option to make an anatomical gift; or b. Ascertained that the individual expressed a known objection. (6) Each hospital in the State shall develop and implement a protocol for referring potential anatomical donors as provided in this section. The protocol shall require that, at or near the time of the death of any patient, the hospital shall contact by telephone the OPO to determine suitability for anatomical donation of the potential donor. The protocol shall encourage discretion and sensitivity to family circumstances and beliefs in all discussions regarding donations of organs, tissue or eyes. a. Limitation. — If the hospital staff advises the OPO that the hospital staff has actual knowledge that the decedent did not wish to be an anatomical donor, the gift of all or any part of the decedent’s body shall not be requested. b. Medical record reviews. — Death medical record reviews must be performed annually in each acute care general hospital for the sole purpose of determining anatomical donor potential at the hospital. The hospital may perform the medical record review or may designate the OPO to conduct the review. If the hospital chooses to conduct its own review, it must do so in accordance with clinical specifications and guidelines established by the OPO. If the hospital conducts the review, the OPO must provide the necessary training to hospital personnel conducting the review. The hospital must report the results of the review to the OPO no later than 45 days following the completion of the review. If the hospital designates the OPO to conduct the review, the OPO shall provide the hospital with written assurance that the OPO shall maintain the confidentiality of patient identifying information. c. After a donor’s death, a person to whom an anatomical gift may pass under § 2712 of this title may conduct a test or examination which is reasonably necessary to evaluate the medical suitability of the body or part for its intended purpose. d. Any examination conducted under this section may include an examination and copying of records necessary to determine the medical suitability of the part. This subsection includes medical, dental and other health-related records. e. A hospital shall enter into agreements or affiliations with the OPO for coordination of procurement and use of anatomical gifts. (7) A physician or technician may remove a donated part from the body of a donor that the physician or technician is qualified to remove. (8) A revocation of a gift made under this chapter is effective only if the applicable organ procurement organization, tissue bank, eye bank, or transplant hospital knows of and can reasonably communicate the revocation to the involved physicians or technicians before an incision has been made to remove a part from the donor’s body or before invasive procedures have begun to prepare the recipient. (c) A person, including a medical examiner, that seeks to facilitate the making of an anatomical gift for the purposes of transplantation or therapy from a decedent who was not a hospital patient at the time of death shall notify the OPO at or around the time of the person’s death in order to allow the OPO to evaluate the potential donation and, if applicable, coordinate the donation process. (d) The OPO may, upon request and payment of associated fees, obtain certified copies of death records of a donor from the Delaware Department of Health and Social Services, Office of Vital Statistics. (65 Del. Laws, c. 487, § 4; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 453, § 7; 80 Del. Laws, c. 182, § 1; 83 Del. Laws, c. 139, § 1.) § 2722. Confidentiality requirement. (a) General rule. — Except as provided in subsection (b) of this section, no procurement organization may divulge any individually identifiable information acquired in the course of performing its responsibilities under this chapter except for the purpose of facilitating organ, eye or tissue donation and transplantation or as otherwise required under applicable laws. (b) Donors and recipients. — The identity of the donor and of the recipient may not be communicated unless expressly authorized by: (1) The recipient; (2) If the donor is alive, the donor; and (3) If the donor is deceased, the next-of-kin of the donor. (80 Del. Laws, c. 182, § 1.) § 2723. Donate Life Delaware Registry. (a) The database maintained by the Department of Transportation to record donor designations shall be known as the “Donate Life Delaware Registry.” The Registry shall include only affirmative donation decisions. Registration by a donor in the Registry shall constitute sufficient authorization to donate organs and tissues for transplantation and therapy. Page 207 Title 16 - Health and Safety (b) The Department of Transportation shall provide access by residents of the State to an internet-based interface that promotes organ and tissue donation and enables residents 18 years of age or older who apply for, hold, or seek to renew a Delaware driver’s license or identification card or otherwise have a record in the database to register as donors and have their decisions integrated into the Donate Life Delaware Registry. The form and content of the interface shall be maintained in collaboration with the OPO. (c) By October 3, 2016, the Department of Transportation shall establish a system which allows individuals who apply for, hold, or seek to renew a Delaware driver’s license or identification card, or otherwise have a record in the database to add their donor designation to the Donate Life Delaware Registry by submitting a form to the Department at no cost to the registrant. The Department of Transportation may also provide the opportunity to individuals who do not otherwise have a record in the database to add a record and the donor designation to the Donate Life Delaware Registry. (d) Donor designation information entered into the Donate Life Delaware Registry shall supersede prior conflicting information: (1) Provided to the Donate Life Delaware Registry; (2) On the individual’s physical driver’s license or identification card; (3) On an advance health-care directive; (4) Submitted under § 2711 of this title; or (5) Submitted under any other statutory provision. (e) An information technology system adopted by the Department of Transportation or its successor after October 3, 2015, shall continue to accommodate the inclusion of donor designation information into the database and the ongoing operation of the Donate Life Delaware Registry. (80 Del. Laws, c. 182, § 1.) § 2724. Organ donation designation on driver’s license or identification card. Beginning as soon as practicable but no later than July 1, 1998, the Delaware Division of Motor Vehicles shall modify the driver’s license and identification card application process and renewal system to obtain information regarding an individual’s consent to anatomical donation, including a process to allow persons under age 18 to register as donors with parental consent as defined in § 2711(b) of this title. The following question shall be asked: Do you wish to have the organ donor designation printed on your driver’s license? Only an affirmative response of an individual shall be noted on the front of the driver’s license or identification card with the word “Organ Donor” or a symbol indicating the donor designation and recorded in the Donate Life Delaware Registry. The Department shall record and store all donor designations in the Donate Life Delaware Registry, regardless of whether a driver’s license or identification card is issued. The OPO shall be given access to the foregoing donor information 24 hours a day through the Division of Motor Vehicles computer database. Notwithstanding the Driver’s Privacy Protection Act, § 305 of Title 21, the Division of Motor Vehicles is authorized to provide the OPO with the foregoing donor information. The OPO shall not be assessed a fee or other charges for such access. The donor designation on the driver’s license or identification card or inclusion in the Donate Life Delaware Registry shall be deemed sufficient to satisfy all requirements for consent to organ and tissue donation. (71 Del. Laws, c. 453, § 8; 80 Del. Laws, c. 182, § 1.) § 2725. Collaboration between departments and organ procurement organizations. (a) The Department of Transportation, in consultation with the OPO, shall establish an annual education program for employees of the Department of Transportation. The program shall focus on: (1) Benefits associated with organ and tissue donations; (2) Scope and operation of the State’s donor program; and (3) How the employees can: a. Effectively inform the public about the donor program; and b. Best assist those wishing to designate as donors, including use of the Donate Life Delaware Registry. (b) State agencies are encouraged to collaborate with the OPO on initiatives designed to enhance awareness of organ and tissue donation and may collaborate with the OPO in applying for federal, state or private grants. (80 Del. Laws, c. 182, § 1.) § 2726. Liability. A person who acts in good faith in accord with the terms of this subchapter is not liable for damages in any civil action or subject to prosecution in any criminal proceeding for that act. (65 Del. Laws, c. 487, § 4; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 453, § 9; 80 Del. Laws, c. 182, § 1.) § 2727. Facilitation of anatomical gift from decedent whose death is under investigation. (a) The OPO shall in all cases collaborate with the medical examiner to ensure the preservation of forensic evidence and collection of photographs and specimens. A medical examiner shall, upon request, release to the OPO the name, contact information and available Page 208 Title 16 - Health and Safety medical and social history of a decedent whose death is under investigation. If the decedent’s body or part is medically suitable for transplantation, therapy, research or education, the medical examiner shall release postmortem examination results to the OPO. The OPO may make a subsequent disclosure of the postmortem examination results or other information received from the medical examiner to support the purposes of the donation. (b) Notwithstanding any provision of this chapter or any other law to the contrary, if the medical examiner has notice, by an advance health-care directive, will, card or other document or as otherwise provided in this chapter, that a deceased person whose death is under investigation is a donor, the medical examiner shall perform an examination, autopsy or analysis of tissues or organs only in a manner and within a time period compatible with the preservation of the tissues or organs for the purpose of transplantation. (c) If the examination, autopsy or analysis has not been undertaken under subsection (b) of this section, all of the following apply to cases involving a prospective organ donor: (1) A physician or technician authorized to remove an anatomical gift from a donor may remove the donated part from the body of a donor whose death is under investigation for acceptance by a person authorized to become a donee subject to paragraph (c)(2) of this section. (2) The medical examiner shall be invited to be present during organ recovery if, in the judgment of the medical examiner, those organs may be involved in the cause of death. While in attendance, if the medical examiner determines that the organs are involved in the cause of death, the medical examiner may request a biopsy of those organs or deny removal of the anatomical gift. The medical examiner shall explain in writing the reasons for determining that those organs may be involved in the cause of death and the basis for denying removal of the anatomical gift and shall include the written explanation in the records maintained by the medical examiner. (3) The OPO shall pay the reasonable costs for the professional services of the medical examiner associated with attending the recovery under paragraph (c)(2) of this section above. (d) The physician or technician recovering a part from a donor under this section shall file upon request of the medical examiner, a report detailing the condition of the part of the body that is the anatomical gift. If appropriate, the report shall include a biopsy or medically approved sample from the anatomical gift. (71 Del. Laws, c. 453, § 10; 80 Del. Laws, c. 182, § 1.) § 2728. Organ and Tissue Donor Awareness Trust Fund contributions. The Delaware Department of Finance shall provide a space on the face of the state individual income tax return for the 1998 tax year and each year thereafter whereby an individual may voluntarily designate a contribution of any amount desired to the Fund. The amount so designated by an individual on the state income tax return form shall be deducted from the tax refund to which the individual is entitled or added to the individual’s payment and shall not constitute a charge against the income tax revenues due the State. (71 Del. Laws, c. 453, § 10; 73 Del. Laws, c. 179, § 3; 80 Del. Laws, c. 182, § 1.) § 2729. Organ and Tissue Donation Awareness Trust Fund. (a) There is hereby created a special fund in the State Treasury to be known as the Organ and Tissue Donor Awareness Trust Fund. (b) Moneys deposited into the Fund and interest which accrues from those funds are hereby appropriated to the Organ and Tissue Donor Awareness Board as a continuing appropriation, to be distributed by the board in the manner provided in and for the purposes delineated in § 2730 of this title. Funds in the Organ and Tissue Donor Awareness Fund shall not lapse. (71 Del. Laws, c. 453, § 10; 73 Del. Laws, c. 179, § 4; 80 Del. Laws, c. 182, § 1.) § 2730. Organ and Tissue Donor Awareness Board. (a) There is hereby established an Organ and Tissue Donor Awareness Board comprised of 9 members to be appointed by the Governor. The members of the Board shall include a representative of the federally certified organ procurement organization serving Delaware, a representative of an eye bank located in Delaware, a transplant recipient, a donor family member, a physician having special interest in the area of transplantation, a current officer, employee or board member of a Delaware acute care general hospital, 1 representative each from the Department of Health and Social Services, the Department of Education and the Division of Motor Vehicles. Members of the Board shall serve for 3-year terms and may be appointed to successive terms by the Governor. Members of the Board shall serve without compensation, but shall be reimbursed for all reasonable and necessary travel and other expenses incurred in the performance of their duties under this section. (b) The Board shall have the power and its duty shall be: (1) To develop donor awareness programs in Delaware, including but not limited to a promotional campaign to encourage Delaware residents to register as donors through the State’s driver’s license program; educational programs in secondary schools; and an education and awareness campaign for Delaware state employees; (2) From moneys in the Organ and Tissue Donor Awareness Trust Fund or otherwise made available to the Board, to award grants or make and enter into contracts with any person, association, partnership or corporation for the development, design and implementation of donor awareness programs in Delaware. Page 209 Title 16 - Health and Safety (3) To appoint officers, agents, employees and servants, and to prescribe their duties and fix their compensation; provided, that the Board shall have the authority to obtain staff support, office space, equipment and supplies from any state department, with or without compensation; (4) To make and execute contracts and other instruments necessary or convenient for the conduct of its business and the exercise of the authority of the Board; (5) To apply for and accept appropriations, grants, loans and other assistance from, and to enter into contracts, agreements or other transactions with the federal government, the state government, political subdivisions, persons, associations, partnerships or corporations for the development, design and implementation of donor awareness programs in Delaware; (6) To do all acts and things necessary to carry out the powers granted to it by this act. (71 Del. Laws, c. 453, § 10; 80 Del. Laws, c. 182, § 1.) § 2731. Relation to Electronic Signatures in Global and National Commerce Act. This chapter modifies, limits and supersedes the Electronic Signatures in Global and National Commerce Act (Public Law 106-229, 15 U.S.C. § 7001 et seq.) but does not modify, limit or supersede § 101(c) [15 U.S.C. § 7001(c)] of the Electronic Signatures in Global and National Commerce Act or authorize electronic delivery of any of the notices described in § 103(b) [15 U.S.C. § 7003(b)] of the Electronic Signatures in Global and National Commerce Act. (80 Del. Laws, c. 182, § 1.) Subchapter III Nondiscrimination in Access to Organ Transplantation § 2741. Legislative intent. The General Assembly finds that: (1) A mental or physical disability does not diminish a person’s right to health care; (2) The “Americans with Disabilities Act of 1990” [42 U.S.C. § 12101 et seq.] prohibits discrimination against persons with disabilities, yet many individuals with disabilities still experience discrimination in accessing critical health-care services; (3) Individuals with mental and physical disabilities are at risk of being denied life-saving organ transplants based on assumptions that their lives are less worthy, that they are incapable of complying with post-transplant medical regimens, or that they lack adequate support systems to ensure such compliance; (4) Although organ transplant centers must consider medical and psychosocial criteria when determining if a patient is suitable to receive an organ transplant, transplant centers that participate in Medicare, Medicaid, and other federal funding programs are required to use patient selection criteria that result in a fair and nondiscriminatory distribution of organs; and (5) Delaware residents in need of organ transplants are entitled to assurances that they will not encounter discrimination on the basis of a disability. (81 Del. Laws, c. 169, § 1.) § 2742. Definitions. For purposes of this subchapter: (1) “Anatomical gift” means a donation of all or part of a human body to take effect after the donor’s death for the purpose of transplantation or transfusion. (2) “Auxiliary aids and services” includes any or all of the following: a. Qualified interpreters or other effective methods of making aurally delivered materials available to individuals with hearing impairments. b. Qualified readers, taped texts, or other effective methods of making visually delivered materials available to individuals with visual impairments. c. Provision of information in a format that is accessible for individuals with cognitive, neurological, developmental, and/or intellectual disabilities. d. Provision of supported decision-making services. e. Acquisition or modification of equipment or devices. f. Services and actions similar to those described in paragraphs (2)a. through (2)e. of this section. (3) “Covered entity” means: a. Any licensed provider of health-care services, including licensed health-care practitioners, hospitals, nursing facilities, laboratories, intermediate care facilities, psychiatric residential treatment facilities, institutions for individuals with intellectual or developmental disabilities, and prison health centers; or Page 210 Title 16 - Health and Safety b. Any entity responsible for matching anatomical gift donors to potential recipients. (4) “Disability” shall have the same meaning set forth in the Americans with Disabilities Act Americans with Disabilities Act of 1990 (ADA), as amended by the ADA Amendments Act of 2008, at 42 U.S.C. § 12102. (5) “Organ transplant” means the transplantation or transfusion of a part of a human body into the body of another for the purpose of treating or curing a medical condition. (6) “Qualified individual” means an individual who, with or without the support networks available to them, provision of auxiliary aids and services, and/or reasonable modifications to policies or practices, meets the essential eligibility requirements for the receipt of an anatomical gift. (7) The phrase “reasonable modifications to policies or practices” includes: a. Communication with individuals responsible for supporting an individual with post-surgical and post-transplantation care, including medication. b. Consideration of support networks available to the individual, including family, friends, and home and community-based services, including home and community-based services funded through Medicaid, Medicare, another health plan in which the individual is enrolled, or any program or source of funding available to the individual, in determining whether the individual is able to comply with post-transplant medical requirements. (8) The term “supported decisionmaking” includes use of a support person to assist an individual in making medical decisions, communicate information to the individual, or ascertain an individual’s wishes, including: a. Inclusion of the individual’s attorney-in-fact, health-care proxy, or any person of the individual’s choice in communications about the individual’s medical care; b. Permitting the individual access to a person of their choice for the purposes of supporting that individual in communicating, processing information, or making medical decisions; c. Provision of auxiliary aids and services to facilitate the individual’s ability to communicate and process health-related information, including use of assistive communication technology; d. Provision of information to persons designated by the individual, consistent with the provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. § 1301 et seq., and other applicable laws and regulations governing disclosure of health information; e. Provision of health information in a format that is readily understandable by the individual; f. If the individual has a court-appointed guardian or other individual responsible for making medical decisions on behalf of the individual, any measures to ensure that the individual is included in decisions involving his or her own health care and that medical decisions are in accordance with the individual’s own expressed interests. (81 Del. Laws, c. 169, § 1; 70 Del. Laws, c. 186, § 1.) § 2743. Discrimination prohibited. (a) A covered entity shall not, solely on the basis of a qualified individual’s mental or physical disability: (1) Deem an individual ineligible to receive an anatomical gift or organ transplant; (2) Deny medical and related services related to organ transplantation, including evaluation, surgery, counseling, post-operative treatment and services; (3) Refuse to refer the individual to a transplant center or other related specialist for the purpose of evaluation or receipt of an organ transplant; (4) Refuse to place an individual on an organ transplant waiting list, or placement of the individual at a lower-priority position on the list than the position at which he or she would have been placed if not for his or her disability; or (5) Decline insurance coverage for any procedure associated with the receipt of the anatomical gift, including post-transplantation care; (b) Notwithstanding subsection (a) of this section, a covered entity may take an individual’s disability into account when making treatment and/or coverage recommendations or decisions, solely to the extent that the physical or mental disability has been found by a physician or surgeon, following an individualized evaluation of the potential recipient, to be medically significant to the provision of the organ transplant. The provisions of this section shall not be deemed to require referrals or recommendations for, or the performance of, medically inappropriate organ transplants. (c) If an individual has the necessary support system to assist the individual in complying with post-transplant medical requirements, an individual’s inability to independently comply with those requirements shall not be deemed to be medically significant for the purposes of subsection (b) of this section. (d) A covered entity shall make reasonable modifications in policies, practices, or procedures, when such modifications are necessary to make services such as transplantation-related counseling, information, coverage, or treatment available to qualified individuals with disabilities, unless the entity can demonstrate that making such modifications would fundamentally alter the nature of such services; Page 211 Title 16 - Health and Safety (e) A covered entity shall take such steps as may be necessary to ensure that no qualified individual with a disability is denied services such as transplantation-related counseling, information, coverage, or treatment because of the absence of auxiliary aids and services, unless the entity can demonstrate that taking such steps would fundamentally alter the nature of the services being offered or would result in an undue burden; (f) A covered entity shall otherwise comply with the requirements of Titles II and III of the Americans with Disabilities Act [42 U.S.C. § 12141 et seq. and 42 U.S.C. § 12181 et seq.] and ADA Amendments Act of 2008 [P.L. 110-325]. (g) The provisions of this section shall apply to each part of the organ transplant process. (81 Del. Laws, c. 169, § 1; 70 Del. Laws, c. 186, § 1.) § 2744. Remedies. (a) Any person subjected to discrimination in violation of this subchapter or who has reasonable grounds for believing that such person is about to be subjected to discrimination in violation of this subchapter may bring an action in the Court of Chancery for injunctive or other equitable relief. (b) The Court shall accord priority on its calendar and expeditiously proceed with an action brought under this section. (c) Nothing in this section is intended to limit or replace available remedies under the Americans with Disabilities Act [42 U.S.C. § 12101 et seq.] or any other applicable law. (81 Del. Laws, c. 169, § 1.) Page 212 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 28 Sperm Bank and Tissue Bank Registry § 2801. Establishment of registry; testing of donors; penalties. (a) The Department of Health and Social Services shall establish a registry of all sperm banks and tissue banks operating in this State. All sperm banks and tissue banks operating in this State shall register with the Department of Health and Social Services by May 1 of each year. Any person, hospital, clinic, corporation, partnership or other legal entity which operates a sperm bank or tissue bank in this State and fails to register with the Department of Health and Social Services pursuant to this section shall be subject to a fine of $5,000. (b) All donors of semen for purposes of artificial insemination, or donors of corneas, bones, organs or other human tissue for the purpose of injecting, transfusing or transplanting any of them in the human body, shall be tested for evidence of exposure to human immunodeficiency virus (HIV) and any other identified causative agent of Acquired Immunodeficiency Syndrome (AIDS) at the time of or after the donation, but prior to the semen, corneas, bones, organs or other human tissue being made available for such use. However, when in the opinion of the attending physician the life of a recipient of a bone, organ or other human tissue donation would be jeopardized by delays caused by testing for evidence for exposure to HIV and any other causative agent of AIDS, testing shall not be required prior to the life-saving measures. (c) No person may intentionally, knowingly, recklessly or negligently use the semen, corneas, bones, organs or other human tissue of a donor unless the requirements of subsection (b) of this section have been met. No person may knowingly, recklessly or intentionally use the semen, corneas, bones, organs or other human tissue of a donor who has tested positive for exposure to HIV or any other identified causative agent of AIDS, except that this subsection shall not apply to the recovery and use of organs or other anatomical gifts as authorized under federal law for research and/or transplant from a donor who has tested positive for exposure to HIV where the intended recipients have also tested positive for exposure to HIV. Violation of this subsection shall be a class E felony. (d) For the purposes of this section, “tissue bank” means any facility or program that is involved in procuring, furnishing, donating, processing or distributing corneas, bones, organs or other human tissue for the purpose of injecting, transfusing or transplanting any of them in the human body. (66 Del. Laws, c. 335, § 1; 70 Del. Laws, c. 147, §§ 11, 12; 81 Del. Laws, c. 12, § 1.) Page 213 Title 16 - Health and Safety Part II Regulatory Provisions Concerning Public Health Chapter 29 Clean Indoor Air Act § 2901. Legislative intent. The General Assembly finds that it is in the best interest of the people of this State to protect nonsmokers from involuntary exposure to environmental tobacco smoke and emissions produced by electronic smoking devices in most indoor areas open to the public, public meetings, food service establishments and places of employment. The General Assembly recognizes that a balance should be struck between the health concerns of nonconsumers of tobacco products and the need to minimize unwarranted governmental intrusion into and regulation of private spheres of conduct and choice with respect to the use or nonuse of tobacco products in certain designated public areas and in private places. Therefore, the General Assembly declares that the purpose of this act is to preserve and improve the health, comfort and environment of the people of this State by limiting exposure to tobacco smoke and emissions produced by electronic smoking devices. (69 Del. Laws, c. 287, § 1; 80 Del. Laws, c. 81, § 1.) § 2902. Definitions. The following words, terms and phrases, when used in this chapter, shall have the meaning ascribed to them in this section, except where the context clearly indicates a different meaning: (1) “Auditorium” means the part of a public building where an audience sits and any corridors, hallways or lobbies adjacent thereto. (2) “Bar” means any indoor area open to the public operated primarily for the sale and service of alcoholic beverages for on-premises consumption and where the service of food is secondary to the consumption of such beverages. An establishment which has been licensed by the Delaware Alcoholic Beverage Control Commission as a “taproom or tavern” as that term is defined in Title 4 shall be considered a “bar” for purposes of the application of the provisions of this chapter. (3) “Electronic smoking device” means any product containing or delivering nicotine or any other similar substance intended for human consumption that can be used by a person to simulate smoking through inhalation of vapor or aerosol from the product. The term includes any such device, whether manufactured, distributed, marketed, or sold as an e-cigarette, e-cigar, e-pipe, e-hookah, or vape pen, or under any other product name or descriptor. (4) “Employer” means any person, partnership, association, corporation or nonprofit entity that employs 1 or more persons, including the legislative, executive and judicial branches of state government; any county, city, town, village or any other political subdivision of the State, public improvement or special district, public authority, commission, agency or public benefit corporation; or any other separate corporate instrumentality or unit of state or local government. (5) “Environmental tobacco smoke” (ETS) or “secondhand smoke” is the complex mixture formed from the escaping smoke of a burning tobacco product (termed as “sidestream smoke”) and smoke exhaled by the smoker. Exposure to ETS is also frequently referred to as “passive smoking” or “involuntary smoking.” (6) “Food service establishment” means any indoor area open to the public or portion thereof in which the principal business is the sale of food for on-premises consumption including, but not limited to, restaurants, cafeterias, coffee shops, diners, sandwich shops or short order cafes. A food service establishment shall not include the bar area of such establishment. An establishment which has been licensed by the Delaware Alcoholic Beverage Control Commission as a “restaurant” as that term is defined in Title 4 shall be considered a “food service establishment” for purposes of the application of the provisions of this chapter. (7) “Indoor area open to the public” means any indoor area or portion thereof generally accessible to the public. (8) “Place of employment” means any indoor area or portion thereof under the control of an employer in which employees of the employer perform services but that is not generally accessible to the public. (9) “Public building” means any building owned or operated by the State, including the legislative, executive and judicial branches of state government; any county, city, town, village or any other political subdivision of the State, public improvement or special district, public authority, commission, agency or public benefit corporation; or any other separate corporate instrumentality or unit of state or local government. (10) “Public meeting” means all meetings open to the public pursuant to the laws of Delaware and its political subdivisions. (11) “Smoke-free work area” means an indoor area in a place of employment where no smoking occurs. (12) “Smoking” means: a. The burning of a lighted cigarette, cigar, pipe or any other matter or substance that contains tobacco; or b. The use of an electronic smoking device which creates an aerosol or vapor, in any manner or in any form. (13) “Tobacco business” means a sole proprietorship, corporation, partnership or other enterprise engaged primarily in the sale, manufacture or promotion of tobacco, tobacco products and accessories either at wholesale or retail, and in which the sale, manufacture or promotion of other products is merely incidental. Page 214 Title 16 - Health and Safety (14) “Vapor establishment” means a business that: a. Generates at least 80% of its revenue from the sale of electronic smoking devices and substances for use within electronic smoking devices; and b. Does not share indoor common space with other businesses unless there are doors from the vapor establishment to the indoor common space that remain closed other than for ingress and egress. (15) “Work area” means an area in a place of employment where 1 or more employees are routinely assigned and perform services for their employer. (69 Del. Laws, c. 287, § 1; 73 Del. Laws, c. 275, §§ 1-6; 80 Del. Laws, c. 81, § 2.) § 2903. Smoking restrictions. Except as is provided in § 2904 of this title, and in order to reduce the levels of exposure to environmental tobacco smoke and emissions produced by electronic smoking devices, smoking shall not be permitted and no person shall smoke in any indoor enclosed area to which the general public is invited or in which the general public is permitted, including, but not limited to: (1) Public meetings; (2) Elevators; (3) Government owned and/or operated means of mass transportation including buses, vans, trains, taxicabs and limousines; (4) Grocery stores; (5) Gymnasiums; (6) Jury waiting and deliberation rooms; (7) Courtrooms; (8) Child day care facilities; (9) Health-care facilities including hospitals, hea