2015 Delaware Code
Title 16 - Health and Safety
CHAPTER 8C. SCREENING OF NEWBORN INFANTS FOR METABOLIC, HEMATOLOGIC, ENDOCRINOLOGIC, IMMUNOLOGIC, AND CERTAIN STRUCTURAL DISORDERS
§ 805C Parental options.

(a) All newborns in Delaware shall have a satisfactory blood specimen taken prior to 72 hours of age and shall been 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 population-based studies in which all identifying information is removed; the blood spots may be used within the Division of Public Health for quality assurance or performance improvement activities including pilot studies when a new disorder is being considered for addition to the panel, or may be used by Division of Public Health for any other purpose authorized by law.

80 Del. Laws, c. 96, § 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 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.

(b) No person to whom the results of an 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.;