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Public Act 92-0794
HB5906 Enrolled LRB9216063LBprA
AN ACT concerning health facilities.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 1. Short title. This Act may be cited as the End
Stage Renal Disease Facility Act.
Section 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.
Section 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. All end stage renal
disease facilities in existence as of the effective date of
this Act shall obtain a valid license to operate within one
year after the adoption of rules to implement this Act.
Section 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
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.
Section 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.
(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.
(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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 135. The State Finance Act is amended by adding
Section 5.570 as follows:
(30 ILCS 105/5.570 new)
Sec. 5.570. The End Stage Renal Disease Facility
Licensing Fund.
Section 999. Effective date. This Act takes effect July
1, 2003.
Passed in the General Assembly May 15, 2002.
Approved August 09, 2002.
Effective July 01, 2003.
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