(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.)
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(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.)
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(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.)
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(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
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Health, Home Services, and Home Nursing
Agency Licensing Act;
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(2)
a hospital licensed under the Hospital Licensing
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Act or the University of Illinois Hospital Act; and
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(3)
the office of a physician.
(Source: P.A. 94-379, eff. 1-1-06.)
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(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.)
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(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
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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
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(2)
adequate staff is present to meet the medical
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and non-medical needs of each
patient, as provided by this Act and the
rules adopted pursuant to this Act.
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(Source: P.A. 92-794, eff. 7-1-03.)
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(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
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professional staff and other personnel;
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(2)
the equipment used by the facility to insure
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that it is compatible with the health
and safety of the patients;
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(3)
the sanitary and hygienic conditions in the
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(4)
quality assurance for patient care;
(5)
clinical records maintained by the facility;
(6)
design and space requirements for the facility
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to insure safe access by patients
and personnel and for ensuring patient privacy;
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(7)
indicators of the quality of care provided by
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(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.)
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(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.)
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(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.)
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(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.)
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(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.)
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(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.)
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(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.)
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(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.)
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(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.)
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(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.)
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(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.)
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(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.)
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(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.)
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(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.)
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(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.)
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(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
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evaluations of facilities; and
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(2)
complaints and complaint investigation reports,
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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.
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(Source: P.A. 92-794, eff. 7-1-03.)
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(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
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issued by the Department or a court
during the past 5 years;
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(2)
a complete copy of every inspection report of
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the facility received from the Department
during the past 5 years;
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(3)
a description of the services provided by the
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facility and the rates charged for
those services;
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(4)
a copy of the statement of ownership required by
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(5)
a complete copy of the most recent inspection
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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.
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(Source: P.A. 92-794, eff. 7-1-03.)
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(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
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