2005 Illinois Code - Chapter 210 Health Facilities 210 ILCS 62/ End Stage Renal Disease Facility Act.
(210 ILCS 62/1) Sec. 1. Short title. This Act may be cited as the End Stage Renal Disease
Facility Act. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/5) Sec. 5. Definitions. As used in this Act: "Committee" means the End Stage Renal Disease Advisory Committee. "Department" means the Department of Public Health. "Dialysis" means a process by which dissolved substances are removed from a
patient's body by diffusion from one fluid
compartment to another across a semipermeable membrane. "Dialysis technician" means an individual who is not a registered nurse or
physician and who provides dialysis care under
the supervision of a registered nurse or physician. "Director" means the Director of Public Health. "End stage renal disease" means that stage of renal impairment that appears
irreversible and permanent and that requires
a regular course of dialysis or kidney transplantation to maintain life. "End stage renal disease facility" or "ESRDF" means a facility that provides
dialysis treatment or dialysis training to
individuals with end stage renal disease. "Licensee" means an individual or entity licensed by the Department to
operate an end stage renal disease facility. "Nurse" means an individual who is licensed to practice nursing under the
Nursing and Advanced Practice Nursing Act. "Patient" means any individual receiving treatment from an end stage renal
disease facility. "Person" means any individual, firm, partnership, corporation, company,
association, or other legal entity. "Physician" means an individual who is licensed to practice medicine in all
of its branches under the Medical Practice Act of 1987. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/10) Sec. 10. License required. Except as provided by this Act, no person shall
open, manage, conduct, offer, maintain, or
advertise an end stage renal disease facility without a valid license issued by
the Department. Each ESRDF, including those that provide only training services, may oversee remote station facilities for home dialysis patients in licensed nursing homes under the ESRDF's license. These remote station facilities are not required to obtain a separate license under this Act, but shall be inspected under Department rules as remote stations of the ESRDF.
Notwithstanding any other provisions of this Section, all end stage renal disease facilities
in existence as of the effective date of rules adopted by the Department to implement this Act (the "Implementation Date") may continue to operate but must obtain a valid license
to operate within one year after the Implementation Date. (Source: P.A. 92‑794, eff. 7‑1‑03; 93‑766, eff. 7‑20‑04.)
(210 ILCS 62/15) Sec. 15. Exemptions from licensing requirement. The following facilities
are not required to be licensed under this Act: (1) a home health agency licensed under the Home
Health, Home Services, and Home Nursing Agency Licensing Act;
(2) a hospital licensed under the Hospital Licensing
Act or the University of Illinois Hospital Act; and
(3) the office of a physician. (Source: P.A. 94‑379, eff. 1‑1‑06.)
(210 ILCS 62/20) Sec. 20. Issuance and renewal of license. (a) An applicant for a license under this Act shall submit an application on
forms prescribed by the Department. (b) Each application shall be accompanied by a non‑refundable license fee,
as
established by rule of the Department. (c) Each application shall contain evidence that there is at least one
physician responsible for the medical direction of the
facility and that each dialysis technician on staff has completed a training
program as required by this Act. (d) The Department may grant a temporary initial license to an applicant. A
temporary initial license expires on the earlier
of (i) the date the Department issues or denies the license or (ii) the date 6
months after the temporary initial license was issued. The Department may issue subsequent temporary licenses when necessary.
(e) The Department shall issue a license if, after application, inspection,
and
investigation, it finds the applicant meets the
requirements of this Act and the standards adopted pursuant to this Act.
The
Department may include participation as a supplier
of end stage renal disease services under Titles XVIII and XIX of the federal
Social Security Act as a condition of licensure. The Department may consider facilities and remote stations certified under Titles XVIII and XIX of the federal Social Security Act as meeting the licensure requirements under this Section. (f) The license is renewable annually after submission of (i) the renewal
application and fee and (ii) an annual report on a
form prescribed by the Department that includes information related to quality
of care at the end stage renal disease facility. The
report must be in the form and documented by evidence as required by Department
rule. (Source: P.A. 92‑794, eff. 7‑1‑03; 93‑766, eff. 7‑20‑04.)
(210 ILCS 62/25) Sec. 25. Minimum staffing. An end stage renal disease facility shall be
under the medical direction of a physician
experienced in renal disease treatment, as required for licensure under this
Act. Additionally, at a minimum, every facility licensed
under this Act shall ensure that whenever patients are undergoing dialysis all
of the following are met: (1) one currently licensed physician, registered
nurse, physician assistant, advanced practice nurse or licensed practical nurse experienced in rendering end stage renal disease care is physically present on the premises to oversee patient care; and
(2) adequate staff is present to meet the medical
and non‑medical needs of each patient, as provided by this Act and the rules adopted pursuant to this Act.
(Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/30) Sec. 30. Minimum standards. (a) The rules adopted pursuant to this Act shall contain minimum standards
to
protect the health and safety of a patient of
an end stage renal disease facility, including standards for: (1) the qualifications and supervision of the
professional staff and other personnel;
(2) the equipment used by the facility to insure
that it is compatible with the health and safety of the patients;
(3) the sanitary and hygienic conditions in the
facility;
(4) quality assurance for patient care; (5) clinical records maintained by the facility; (6) design and space requirements for the facility
to insure safe access by patients and personnel and for ensuring patient privacy;
(7) indicators of the quality of care provided by
the facility; and
(8) water treatment and reuse by the facility. (b) These standards shall be consistent with
the requirements for a supplier
of end stage renal disease services under Titles
XVIII and XIX of the federal Social Security Act. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/35) Sec. 35. Training; minimum requirements. An end stage renal disease
facility
shall establish and implement a policy
to ensure appropriate training and competency of individuals employed as
dialysis technicians within the licensed facility. The
policy shall, at a minimum, define the acts and practices that are allowed or
prohibited for such employees, establish how training
will be conducted, and illustrate how initial competency will be established.
Proof of initial and annual competency testing shall
be maintained in the personnel file of each dialysis technician and shall be
made available to the Department upon request. An
individual may not act as a dialysis technician in an end stage renal disease
facility unless that individual has been trained and
competency tested in accordance with this Act and the rules adopted under this
Act. Persons training to act as a dialysis technician must
be under the direct supervision of a physician or an appropriately trained
nurse. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/40) Sec. 40. Inspections. (a) The Department, whenever it deems necessary, may conduct an inspection,
survey, or evaluation of an end stage renal
disease facility to determine compliance with licensure requirements and
standards or a plan of correction submitted as a result of
deficiencies cited by the Department. (b) An inspection conducted under this Section shall be unannounced. (c) Upon completion of each inspection, survey, or evaluation, the
appropriate
Department personnel who conducted the
inspection, survey, or evaluation shall submit a copy of their report to the
licensee upon exiting the facility, and shall submit the
actual report to the appropriate regional office. The report shall identify
areas in a facility identified as deficient in compliance with
the requirements of this Act or the standards adopted under this Act. The
report and any recommendation for action by the
Department under this Act shall be sent to the Department's central office
together with a plan of correction from the facility. The
plan of correction may contain related comments or documentation provided by
the licensee that may refute findings in the report,
that explain extenuating circumstances that the facility could not reasonably
have prevented, or that indicate methods and timetables
for correction of deficiencies described in the report. A licensee has 10 days
after the date of the inspection, survey, or evaluation
to submit a plan of correction. (d) The Department shall determine whether a facility is in violation of
this
Section no later than 60 days after completion
of each inspection, survey, evaluation, or plan of correction. (e) The Department shall maintain all inspection, survey, or evaluation
reports
for at least 5 years in a manner accessible
to the public. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/45) Sec. 45. Notice of violation. When the Department determines that a
facility is in violation of this Act or of any rule
promulgated hereunder, a notice of violation shall be served upon the licensee.
Each notice of violation shall be prepared in writing
and shall specify the nature of the violation and the statutory provision or
rule alleged to have been violated. The notice shall
inform the licensee of any action the Department may take under the Act,
including the requirement of a plan of correction under
Section 50, or licensure action under Section 60. The Director or his designee
shall also inform the licensee of the right to a hearing
under Section 60. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/50) Sec. 50. Plan of correction. (a) Each facility served with a notice of violation under Section 45 of this
Act shall file with the Department a written plan
of correction, which is subject to approval of the Department, within 10 days
after receipt of such notice. The plan of correction
shall state with particularity the method by which the facility intends to
correct each violation and shall contain a stated date by
which each violation shall be corrected. (b) If the Department rejects a plan of correction, it shall send notice of
the
rejection and the reason for the rejection to the
licensee. The facility shall have 10 days after receipt of the notice of
rejection to submit a modified plan. If the modified plan is
not timely submitted, or if the modified plan is rejected, the facility shall
follow a plan of correction imposed by the Department. (c) If a facility desires to contest any Department action under this
Section
it shall send a written request for a hearing under
Section 60 to the Department within 10 days of receipt of the notice of the
contested action. The Department shall commence the
hearing as provided in Section 60. Whenever possible, all actions of the
Department under this Section arising out of a single
violation shall be contested and determined at a single hearing. Issues
decided as the result of the hearing process may not be
reheard at subsequent hearings under this Act, but such determinations may be
used as grounds for other administrative action by
the Department pursuant to this Act. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/55) Sec. 55. Denial, suspension, revocation, or refusal to renew a license;
suspension of a service. (a) When the Director determines that there is or has been a substantial or
continued failure to comply with this Act or any
rule promulgated hereunder, the Department may issue an order of license
denial, suspension, revocation, or refusal to renew a
license in accordance with subsection (a) of Section 60 of this Act. (b) When the Director determines that a facility has failed to demonstrate
the
capacity to safely provide one or more of its
services to patients, the Department may issue an order of service suspension
in accordance with subsection (a) of Section 60 of
this Act. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/60) Sec. 60. Notice of administrative actions; hearing procedures. (a) Notice of all administrative actions taken under this Act shall be
effected
by registered mail, certified mail, or personal
service and shall set forth the particular reasons for the proposed action and
provide the applicant or licensee with an opportunity
to request a hearing. If a hearing request is not received within 10 days
after receipt of the notice of administrative action, the right
to a hearing is waived. (b) The procedure governing hearings authorized by this Section shall be in
accordance with rules promulgated by the
Department consistent with this Act. A hearing shall be conducted by the
Director or by an individual designated in writing by
the Director as administrative law judge. A full and complete record shall be
kept of
all proceedings, including notice of hearing, complaint,
and all other documents in the nature of pleadings, written motions filed in
the proceedings, and the report and orders of the
Director and administrative law judge. All testimony shall be reported but
need not be
transcribed unless the decision is appealed pursuant
to Section 70 of this Act. Any interested party may obtain a copy or copies of
the transcript on payment of the cost of preparing
such copy or copies. (c) The Director or administrative law judge shall, upon his own motion or
on the
written request of any party to the proceeding, issue
subpoenas requiring the attendance and testimony of witnesses and subpoenas
duces tecum requiring the production of books,
papers, records or memoranda. The fees of witnesses for attendance and travel
shall be the same as the fees of witnesses before
any circuit court of this State. Such fees shall be paid when the witness is
excused from further attendance. When the witness is
subpoenaed at the instance of the Director or administrative law judge, such
fees shall
be paid in the same manner as other expenses of the
Department. When the witness is subpoenaed at the instance of any other party
to a proceeding, the Department may require that
the cost of service of the subpoena or subpoena duces tecum and the fee of the
witness be borne by the party at whose instance the
witness is summoned. In such case, the Department, in its discretion, may
require a deposit to cover the cost of such service and
witness fees. A subpoena or subpoena duces tecum issued under this Section
shall be served in the same manner as a subpoena
issued by a court. (d) Any circuit court of this State, upon the application of the Director or
the application of any other party to the
proceeding, may, in its discretion, compel the attendance of witnesses, the
production of books, papers, records or memoranda, and
the giving of testimony before the Director or administrative law judge
conducting an
investigation or holding a hearing authorized by this
Act, by an attachment for contempt, or otherwise, in the same manner as
production of evidence may be compelled before the court. (e) The Director or administrative law judge, or any party in a
hearing before the Department, may compel the attendance of witnesses and the
production of books, papers, records, or
memoranda. (f) The Director or administrative law judge shall make findings of fact in
such
hearing
and the Director shall render his decision
within 60 days after the termination or waiving of the hearing unless he or she
requires additional time for a proper disposition of
the matter. When a administrative law judge has conducted the hearing, the
Director
shall review the record and findings of fact before
rendering a decision. A copy of the findings of fact and decision of the
Director shall be served upon the applicant or licensee in
person, by registered mail or by certified mail in the same manner as the
service of the notice of hearing. The decision denying,
suspending, or revoking a license shall become final 35 days after it is mailed
or served, unless the applicant or licensee, within
the 35‑day period, petitions for review pursuant to Section 70 of this Act. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/65) Sec. 65. Receiving and investigating complaints. The Department shall
establish by rule a procedure for receiving and
investigating complaints regarding any ESRDF, consistent with federal complaint
procedures. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/70) Sec. 70. Judicial review. Whenever the Department refuses to grant or
decides to revoke or suspend a license to open,
conduct, or maintain an ESRDF, the applicant or licensee may have such decision
judicially reviewed. The provisions of the
Administrative Review Law and the rules adopted pursuant thereto shall apply to
and govern all proceedings for the judicial review
of final administrative decisions of the Department hereunder. The term
"administrative decisions" is defined as in Section 3‑101
of the Code of Civil Procedure. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/75) Sec. 75. Fines. Any person opening, conducting, or maintaining an ESRDF
without a license issued pursuant to this
Act shall be guilty of a business offense punishable by a fine of $5,000 and
each day's violation shall constitute a separate offense.
Any person opening, conducting, or maintaining an ESRDF who violates any other
provision of this Act shall be guilty of a
business offense punishable by a fine of not more than $5,000. The Department shall adopt rules for determining the fines for violations. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/80) Sec. 80. Injunctions. The operation or maintenance of an ESRDF in
violation of this Act or of the rules adopted by the
Department is declared a public nuisance inimical to the public welfare. The
Director of the Department, in the name of the People
of the State, through the Attorney General or the State's Attorney of the
county in which the violation occurs, may, in addition to
other remedies herein provided, bring action for an injunction to restrain such
violation or to enjoin the future operation or
maintenance of any such ESRDF. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/85) Sec. 85. Department access to and reproduction of documents. The
Department
shall have access to and may reproduce
or photocopy at its cost any books, records, and other documents maintained by
the facility to the extent necessary to carry out the
purposes of this Act and the rules adopted under this Act. The Department shall
not divulge or disclose the identity of any patient
or other information prohibited from disclosure by the laws of this State. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/90) Sec. 90. Refusal to allow inspections. Any licensee, applicant for a
license, or person operating what may be an end stage
renal disease facility shall be deemed to have given consent to any authorized
officer, employee, or agent of the Department to enter
and inspect the facility in accordance with this Act. Refusal to permit such
entry or inspection shall constitute grounds for denial,
nonrenewal, or revocation of a license. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/95) Sec. 95. Probationary license. If the applicant has not been previously
licensed or if the facility is not in operation at the
time application is made, the Department shall issue a probationary license. A
probationary license shall be valid for 120 days
unless sooner suspended or revoked under this Act. Within 30 days prior to the
termination of a probationary license, the
Department shall fully and completely inspect the facility and, if the facility
meets the applicable requirements for licensure, shall
issue a license under this Act. If the Department finds that the facility does
not meet the requirements for licensure but has made
substantial progress toward meeting those requirements, the license may be
renewed once for a period not to exceed 120 days from
the expiration date of the initial probationary license. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/100) Sec. 100. Change of ownership. (a) Whenever ownership of a facility is transferred from the person named on
the license to any other person, the transferee
must obtain a new probationary license. The transferee shall notify the
Department of the transfer and apply for a new license at
least 30 days prior to final transfer. (b) The transferor shall notify the Department at least 30 days prior to
final
transfer. The transferor shall remain responsible
for the operation of the facility until such time as a license is issued to the
transferee. (c) The license granted to the transferee shall be subject to any plan of
correction submitted by the previous owner and
approved by the Department and any conditions contained in a conditional
license issued to the previous owner. If there are
outstanding violations and no approved plan of correction has been implemented,
the Department may issue a conditional license
and plan of correction as provided in this Act. (d) The transferor shall remain liable for all penalties assessed against
the facility that are imposed for violations occurring
prior to transfer of ownership. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/105) Sec. 105. Access to information. The following information is subject to
disclosure to the public by the Department: (1) records of license inspections, surveys, and
evaluations of facilities; and
(2) complaints and complaint investigation reports,
except that a complaint or complaint investigation report shall not be disclosed to a person other than the complainant or complainant's representative before it is disclosed to a facility and except that a complainant's or patient's name shall not be disclosed. This information shall not disclose the name of any health care professionals or employees at the facility.
(Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/110) Sec. 110. Information available for public inspection. (a) A facility shall post in plain view of the public (i) its current
license,
(ii) a description of complaint procedures
established under this Act provided by the Department, and (iii) the name,
address, and telephone number of a person authorized
by the Department to receive complaints. (b) A facility shall make the following information or documents available
upon
request for public inspection: (1) a copy of any order pertaining to the facility
issued by the Department or a court during the past 5 years;
(2) a complete copy of every inspection report of
the facility received from the Department during the past 5 years;
(3) a description of the services provided by the
facility and the rates charged for those services;
(4) a copy of the statement of ownership required by
this Act; and
(5) a complete copy of the most recent inspection
report of the facility received from the Department. This information shall not disclose the name of any health care professionals or employees at the facility.
(Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/115) Sec. 115. End Stage Renal Disease Advisory Committee. (a) The Director shall appoint an End Stage Renal Disease Advisory Committee
to
advise and consult with the Director in
the administration of this Act. The Committee shall be composed of the
following members: (1) 2 members who represent end stage renal disease
facilities;
(2) 2 members who are physicians licensed to
practice medicine in all its branches;
(3) one member who is a board‑certified nephrologist; (4) one member who represents licensed hospitals; (5) one member who is a registered professional
nurse with experience treating end stage renal disease;
(6) one member of the general public who is
currently receiving dialysis. The recommendations of professional organizations may be considered in selecting individuals for appointment to the End Stage Renal Disease Advisory Committee.
(b) Each member shall be appointed for a term of 3 years, except that of the
original members, 4 shall be appointed for a
term of 2 years, and 4 shall be appointed for a term of 3 years. The term of
office of each of the original appointees shall commence
on July 1, 2003. A member appointed to fill a vacancy occurring prior to the
expiration of the term for which his or her predecessor
was appointed shall be appointed for the remainder of that term. (c) The Committee shall meet as frequently as the Director deems necessary.
Committee members, while conducting the
business of the Committee, shall receive actual and necessary travel and
subsistence expenses when conducting such business away
from their places of residence. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/120) Sec. 120. Adoption of rules. The Department shall adopt rules to implement
this Act, including requirements for physical
plant standards and for the issuance, renewal, denial, suspension, and
revocation of a license to operate an end stage renal disease
facility. These rules shall be consistent with the requirements for end stage
renal disease services under Title XVIII and XIX of
the federal Social Security Act. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/125) Sec. 125. Fees. The Department may establish and collect fees in amounts
reasonable and necessary to defray the cost
of administering this Act. In setting fees under this Act, the Department shall
consider setting a range of license and renewal fees
based on the number of dialysis stations at the end stage renal disease
facility, the patient census, and the average costs involved
in surveying the facility. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/130) Sec. 130. Deposit of fees and penalties. Fees and penalties collected
under
this Act shall be deposited into the End Stage
Renal Disease Facility Licensing Fund, which is hereby created as a special
fund in the State treasury. Moneys in the Fund may
be used, subject to appropriation, by the Department for the administration of
this Act. (Source: P.A. 92‑794, eff. 7‑1‑03.)
(210 ILCS 62/135) Sec. 135. (Amendatory provisions; text omitted). (Source: P.A. 92‑794, eff. 7‑1‑03; text omitted.)
(210 ILCS 62/999) Sec. 999. Effective date. This Act takes effect July 1, 2003. (Source: P.A. 92‑794, eff. 7‑1‑03.)
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