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92nd General Assembly

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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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