State of Illinois
92nd General Assembly
Legislation

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92_HB5906eng

 
HB5906 Engrossed                              LRB9216063LBprA

 1        AN ACT concerning health facilities.

 2        Be  it  enacted  by  the People of the State of Illinois,
 3    represented in the General Assembly:

 4        Section 1. Short title. This Act may be cited as the  End
 5    Stage Renal Disease Facility Act.

 6        Section 5. Definitions. As used in this Act:
 7        "Committee"  means  the  End Stage Renal Disease Advisory
 8    Committee.
 9        "Department" means the Department of Public Health.
10        "Dialysis" means a process by which dissolved  substances
11    are removed from a patient's body by diffusion from one fluid
12    compartment to another across a semipermeable membrane.
13        "Dialysis  technician"  means  an individual who is not a
14    registered nurse or physician and who provides dialysis  care
15    under the supervision of a registered nurse or physician.
16        "Director" means the Director of Public Health.
17        "End  stage  renal  disease"  means  that  stage of renal
18    impairment that appears irreversible and permanent  and  that
19    requires   a   regular   course   of   dialysis   or   kidney
20    transplantation to maintain life.
21        "End  stage  renal  disease  facility" or "ESRDF" means a
22    facility  that  provides  dialysis  treatment   or   dialysis
23    training to individuals with end stage renal disease.
24        "Nurse"  means  an individual who is licensed to practice
25    nursing under the Nursing and Advanced Practice Nursing Act.
26        "Patient" means any individual receiving  treatment  from
27    an end stage renal disease facility.
28        "Person"   means   any   individual,  firm,  partnership,
29    corporation, company, association, or other legal entity.
30        "Physician"  means  an  individual  who  is  licensed  to
31    practice medicine in all of its branches  under  the  Medical
 
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 1    Practice Act of 1987.

 2        Section  10. License required. Except as provided by this
 3    Act, no person shall open, manage, conduct, offer,  maintain,
 4    or  advertise  an  end stage renal disease facility without a
 5    valid license issued by the Department. All end  stage  renal
 6    disease  facilities  in existence as of the effective date of
 7    this Act shall obtain a valid license to operate  within  one
 8    year after the adoption of rules to implement this Act.

 9        Section  15.  Exemptions  from licensing requirement. The
10    following facilities are not required to  be  licensed  under
11    this Act:
12        (1)  a  home health agency licensed under the Home Health
13    Agency Licensing Act;
14        (2)  a hospital licensed under the Hospital Licensing Act
15    or the University of Illinois Hospital Act;  and
16        (3)  the office of a physician.

17        Section 20. Issuance and renewal of license.
18        (a)  An applicant for a  license  under  this  Act  shall
19    submit an application on forms prescribed by the Department.
20        (b)  Each   application   shall   be   accompanied  by  a
21    non-refundable license fee, as established  by  rule  of  the
22    Department.
23        (c)  Each  application  shall contain evidence that there
24    is  at  least  one  physician  responsible  for  the  medical
25    direction of the facility and that each  dialysis  technician
26    on staff has completed a training program as required by this
27    Act.
28        (d)  The Department may grant a temporary initial license
29    to  an  applicant. A temporary initial license expires on the
30    earlier of (i) the date the Department issues or  denies  the
31    license or (ii) the date 6 months after the temporary initial

 
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 1    license was issued.
 2        (e)  The  Department  shall  issue  a  license  if, after
 3    application, inspection,  and  investigation,  it  finds  the
 4    applicant   meets  the  requirements  of  this  Act  and  the
 5    standards adopted pursuant to this Act.  The  Department  may
 6    include  participation  as  a  supplier  of  end  stage renal
 7    disease services under Titles XVIII and XIX  of  the  federal
 8    Social Security Act as a condition of licensure.
 9        (f)  The  license  is renewable annually after submission
10    of (i) the renewal application and fee  and  (ii)  an  annual
11    report  on  a form prescribed by the Department that includes
12    information related to quality of care at the end stage renal
13    disease  facility.  The  report  must  be  in  the  form  and
14    documented by evidence as required by Department rule.

15        Section 25. Minimum staffing. An end stage renal  disease
16    facility  shall be under the medical direction of a physician
17    experienced in  renal  disease  treatment,  as  required  for
18    licensure  under  this Act. Additionally, at a minimum, every
19    facility licensed under this Act shall ensure  that  whenever
20    patients  are  undergoing  dialysis  all of the following are
21    met:
22             (1)  one currently  licensed  physician,  registered
23        nurse,   or   licensed  practical  nurse  experienced  in
24        rendering end stage  renal  disease  care  is  physically
25        present on the premises to oversee patient care; and
26             (2)  adequate  staff  is present to meet the medical
27        and non-medical needs of each  patient,  as  provided  by
28        this Act and the rules adopted pursuant to this Act.

29        Section 30. Minimum standards.
30        (a)  The rules adopted pursuant to this Act shall contain
31    minimum  standards  to  protect  the  health  and safety of a
32    patient of an end stage  renal  disease  facility,  including
 
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 1    standards for:
 2             (1)  the   qualifications  and  supervision  of  the
 3        professional staff and other personnel;
 4             (2)  the equipment used by the  facility  to  insure
 5        that  it  is compatible with the health and safety of the
 6        patients;
 7             (3)  the sanitary and  hygienic  conditions  in  the
 8        facility;
 9             (4)  quality assurance for patient care;
10             (5)  clinical records maintained by the facility;
11             (6)  design  and space requirements for the facility
12        to insure safe access by patients and personnel  and  for
13        ensuring patient privacy;
14             (7)  indicators  of  the quality of care provided by
15        the facility; and
16             (8)  water treatment and reuse by the facility.
17        (b)  These  standards  shall  be  consistent   with   the
18    requirements  for  a  supplier  of  end  stage  renal disease
19    services under Titles XVIII and XIX  of  the  federal  Social
20    Security Act.

21        Section  35. Training; minimum requirements. An end stage
22    renal disease facility shall establish and implement a policy
23    to ensure appropriate training and competency of  individuals
24    employed   as   dialysis   technicians  within  the  licensed
25    facility. The policy shall, at a minimum, define the acts and
26    practices that are allowed or prohibited for such  employees,
27    establish  how training will be conducted, and illustrate how
28    initial competency will be established. Proof of initial  and
29    annual   competency   testing  shall  be  maintained  in  the
30    personnel file of each dialysis technician and shall be  made
31    available  to  the Department upon request. An individual may
32    not act as a  dialysis  technician  in  an  end  stage  renal
33    disease  facility unless that individual has been trained and
 
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 1    competency tested in accordance with this Act and  the  rules
 2    adopted  under  this  Act.   Persons  training  to  act  as a
 3    dialysis technician must be under the direct supervision of a
 4    physician or an appropriately trained nurse.

 5        Section 40. Inspections.
 6        (a)  The Department, whenever  it  deems  necessary,  may
 7    conduct  an inspection, survey, or evaluation of an end stage
 8    renal disease facility to determine compliance with licensure
 9    requirements and standards or a plan of correction  submitted
10    as a result of deficiencies cited by the Department.
11        (b)  An  inspection conducted under this Section shall be
12    unannounced.
13        (c)  Upon  completion  of  each  inspection,  survey,  or
14    evaluation,  the   appropriate   Department   personnel   who
15    conducted  the inspection, survey, or evaluation shall submit
16    a copy of their report  to  the  licensee  upon  exiting  the
17    facility,   and   shall  submit  the  actual  report  to  the
18    appropriate regional office. The report shall identify  areas
19    in  a facility identified as deficient in compliance with the
20    requirements of this Act or the standards adopted under  this
21    Act.   The  report  and  any recommendation for action by the
22    Department under this Act shall be sent to  the  Department's
23    central  office  together  with a plan of correction from the
24    facility. The plan of correction may contain related comments
25    or documentation provided by the  licensee  that  may  refute
26    findings    in   the   report,   that   explain   extenuating
27    circumstances that the facility  could  not  reasonably  have
28    prevented,  or  that  indicate  methods  and  timetables  for
29    correction   of  deficiencies  described  in  the  report.  A
30    licensee has 10  days  after  the  date  of  the  inspection,
31    survey, or evaluation to submit a plan of correction.
32        (d)  The Department shall determine whether a facility is
33    in  violation  of  this  Section  no later than 60 days after
 
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 1    completion of each inspection, survey, evaluation, or plan of
 2    correction.
 3        (e)  The  Department  shall  maintain   all   inspection,
 4    survey,  or  evaluation  reports  for  at  least 5 years in a
 5    manner accessible to the public.

 6        Section 45.  Notice of violation.   When  the  Department
 7    determines  that a facility is in violation of this Act or of
 8    any rule promulgated hereunder, a notice of  violation  shall
 9    be  served upon the licensee.  Each notice of violation shall
10    be prepared in writing and shall specify the  nature  of  the
11    violation and the statutory provision or rule alleged to have
12    been  violated.   The notice shall inform the licensee of any
13    action the Department may take under the Act,  including  the
14    requirement  of  a  plan  of  correction under Section 50, or
15    licensure action under  Section  60.   The  Director  or  his
16    designee  shall  also  inform  the licensee of the right to a
17    hearing under Section 60.

18        Section 50.  Plan of correction.
19        (a)  Each facility served  with  a  notice  of  violation
20    under Section 45 of this Act shall file with the Department a
21    written  plan  of correction, which is subject to approval of
22    the Department, within 10 days after receipt of such  notice.
23    The  plan  of  correction  shall state with particularity the
24    method  by  which  the  facility  intends  to  correct   each
25    violation  and  shall  contain  a  stated  date by which each
26    violation shall be corrected.
27        (b)  If the Department rejects a plan of  correction,  it
28    shall  send  notice  of  the rejection and the reason for the
29    rejection to the licensee.  The facility shall have  10  days
30    after receipt of the notice of rejection to submit a modified
31    plan.   If  the  modified plan is not timely submitted, or if
32    the modified plan is rejected, the facility  shall  follow  a
 
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 1    plan of correction imposed by the Department.
 2        (c)  If  a  facility  desires  to  contest any Department
 3    action under this Section it shall send a written request for
 4    a hearing under Section 60 to the Department within  10  days
 5    of  receipt  of  the  notice  of  the  contested action.  The
 6    Department shall commence the hearing as provided in  Section
 7    60.   Whenever  possible, all actions of the Department under
 8    this Section arising out  of  a  single  violation  shall  be
 9    contested and determined at a single hearing.  Issues decided
10    as  the  result  of the hearing process may not be reheard at
11    subsequent hearings under this Act, but  such  determinations
12    may be used as grounds for other administrative action by the
13    Department pursuant to this Act.

14        Section  55.   Denial, suspension, revocation, or refusal
15    to renew a license; suspension of a service.
16        (a)  When the Director determines that there  is  or  has
17    been  a  substantial or continued failure to comply with this
18    Act or any rule promulgated  hereunder,  the  Department  may
19    issue  an order of license denial, suspension, revocation, or
20    refusal to renew a license in accordance with subsection  (a)
21    of Section 60 of this Act.
22        (b)  When  the  Director  determines  that a facility has
23    failed to demonstrate the capacity to safely provide  one  or
24    more of its services to patients, the Department may issue an
25    order of service suspension in accordance with subsection (a)
26    of Section 60 of this Act.

27        Section  60.  Notice  of  administrative actions; hearing
28    procedures.
29        (a) Notice of all administrative actions taken under this
30    Act shall be effected by registered mail, certified mail,  or
31    personal  service  and shall set forth the particular reasons
32    for the  proposed  action  and  provide  the  application  or
 
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 1    licensee  with  an  opportunity  to  request a hearing.  If a
 2    hearing request is not received within 10 days after  receipt
 3    of  the  notice  of  administrative  action,  the  right to a
 4    hearing is waived.
 5        (b)  The procedure governing hearings authorized by  this
 6    Section  shall be in accordance with rules promulgated by the
 7    Department consistent with this  Act.   A  hearing  shall  be
 8    conducted  by  the Director or by an individual designated in
 9    writing by the Director  as  hearing  officer.   A  full  and
10    complete  record  shall be kept of all proceedings, including
11    notice of hearing, complaint, and all other documents in  the
12    nature   of   pleadings,   written   motions   filed  in  the
13    proceedings, and the report and orders of  the  Director  and
14    hearing  officer.   All  testimony shall be reported but need
15    not be transcribed unless the decision is  appealed  pursuant
16    to Section 70 of this Act.  Any interested party may obtain a
17    copy  or  copies  of the transcript on payment of the cost of
18    preparing such copy or copies.
19        (c)  The Director or hearing officer shall, upon his  own
20    motion  or  on  the  written  request  of  any  party  to the
21    proceeding, issue  subpoenas  requiring  the  attendance  and
22    testimony  of  witnesses  and subpoenas duces tecum requiring
23    the production of books, papers, records or  memoranda.   The
24    fees of witnesses for attendance and travel shall be the same
25    as  the  fees  of  witnesses before any circuit court of this
26    State.  Such fees shall be paid when the witness  is  excused
27    from  further  attendance.  When the witness is subpoenaed at
28    the instance of the Director or hearing  officer,  such  fees
29    shall  be  paid  in  the same manner as other expenses of the
30    Department.  When the witness is subpoenaed at  the  instance
31    of  any  other  party  to  a  proceeding,  the Department may
32    require that the cost of service of the subpoena or  subpoena
33    duces  tecum and the fee of the witness be borne by the party
34    at whose instance the witness is summoned.  In such case, the
 
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 1    Department, in its discretion, may require a deposit to cover
 2    the cost of such service and witness  fees.   A  subpoena  or
 3    subpoena  duces  tecum  issued  under  this  Section shall be
 4    served in the same manner as a subpoena issued by a court.
 5        (d)  Any  circuit  court  of   this   State,   upon   the
 6    application  of  the Director or the application of any other
 7    party to the proceeding, may, in its discretion,  compel  the
 8    attendance  of  witnesses,  the  production of books, papers,
 9    records or memoranda, and the giving of testimony before  the
10    Director  or  hearing  officer conducting an investigation or
11    holding a hearing authorized by this Act,  by  an  attachment
12    for  contempt, or otherwise, in the same manner as production
13    of evidence may be compelled before the court.
14        (e)  The Director or hearing officer, or any party  in  a
15    hearing  before  the  Department, may cause the deposition of
16    witnesses  within  the  State  to  be  taken  in  the  manner
17    prescribed by law for depositions in civil actions in  courts
18    of this State, and may compel the attendance of witnesses and
19    the production of books, papers, records, or memoranda.
20        (f)  The  Director or Hearing Officer shall make findings
21    of fact in such hearing and the  Director  shall  render  his
22    decision  within  60 days after the termination or waiving of
23    the hearing unless he or she requires additional time  for  a
24    proper disposition of the matter.  When a hearing officer has
25    conducted  the  hearing, the Director shall review the record
26    and findings of fact before rendering a decision.  A copy  of
27    the  findings  of  fact and decision of the Director shall be
28    served  upon  the  applicant  or  licensee  in   person,   by
29    registered  mail  or  by certified mail in the same manner as
30    the service of the notice of hearing.  The decision  denying,
31    suspending,  or revoking a license shall become final 35 days
32    after it  is  mailed  or  served,  unless  the  applicant  or
33    licensee,  within  the  35-day  period,  petitions for review
34    pursuant to Section 70 of this Act.
 
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 1        Section 65.  Receiving and investigating complaints.  The
 2    Department shall establish by rule a procedure for  receiving
 3    and  investigating complaints regarding any ESRDF, consistent
 4    with federal complaint procedures.

 5        Section 70.  Judicial review.   Whenever  the  Department
 6    refuses to grant or decides to revoke or suspend a license to
 7    open,  conduct,  or  maintain  an  ESRDF,  the  applicant  or
 8    licensee  may  have  such  decision judicially reviewed.  The
 9    provisions of the Administrative Review  Law  and  the  rules
10    adopted  pursuant  thereto  shall  apply  to  and  govern all
11    proceedings for the judicial review of  final  administrative
12    decisions    of   the   Department   hereunder.    The   term
13    "administrative decisions" is defined as in Section 3-101  of
14    the Code of Civil Procedure.

15        Section  75.  Fines.   Any person opening, conducting, or
16    maintaining an ESRDF without a  license  issued  pursuant  to
17    this  Act shall be guilty of a business offense punishable by
18    a fine of $5,000 and each day's violation shall constitute  a
19    separate   offense.    Any  person  opening,  conducting,  or
20    maintaining an ESRDF who violates any other provision of this
21    Act shall be guilty of a business  offense  punishable  by  a
22    fine of not more than $5,000.

23        Section  80.  Injunctions.   The operation or maintenance
24    of an ESRDF in violation of this Act or of the rules  adopted
25    by  the  Department is declared a public nuisance inimical to
26    the public welfare.  The Director of the Department,  in  the
27    name of the People of the State, through the Attorney General
28    or  the State's Attorney of the county in which the violation
29    occurs, may, in addition to other remedies  herein  provided,
30    bring  action for an injunction to restrain such violation or
31    to enjoin the future operation or  maintenance  of  any  such
 
HB5906 Engrossed            -11-              LRB9216063LBprA
 1    ESRDF.

 2        Section  85.  Department  access  to  and reproduction of
 3    documents. The  Department  shall  have  access  to  and  may
 4    reproduce  or  photocopy  at its cost any books, records, and
 5    other documents maintained by  the  facility  to  the  extent
 6    necessary to carry out the purposes of this Act and the rules
 7    adopted  under  this Act. The Department shall not divulge or
 8    disclose the identity of any  patient  or  other  information
 9    prohibited from disclosure by the laws of this State.

10        Section  90.  Refusal to allow inspections. Any licensee,
11    applicant for a license, or person operating what may  be  an
12    end  stage  renal  disease  facility  shall be deemed to have
13    given consent to any authorized officer, employee,  or  agent
14    of  the  Department  to  enter  and  inspect  the facility in
15    accordance with this Act. Refusal to  permit  such  entry  or
16    inspection  shall  constitute grounds for denial, nonrenewal,
17    or revocation of a license.

18        Section 95.  Probationary license. If the  applicant  has
19    not  been  previously  licensed  or if the facility is not in
20    operation at the time application  is  made,  the  Department
21    shall  issue  a  probationary license. A probationary license
22    shall be valid  for  120  days  unless  sooner  suspended  or
23    revoked   under  this  Act.  Within  30  days  prior  to  the
24    termination of a probationary license, the  Department  shall
25    fully  and  completely  inspect  the  facility  and,  if  the
26    facility  meets  the  applicable  requirements for licensure,
27    shall issue a license under this Act. If the Department finds
28    that  the  facility  does  not  meet  the  requirements   for
29    licensure  but  has  made substantial progress toward meeting
30    those requirements, the license may be  renewed  once  for  a
31    period not to exceed 120 days from the expiration date of the
 
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 1    initial probationary license.

 2        Section 100. Change of ownership.
 3        (a)  Whenever ownership of a facility is transferred from
 4    the  person  named  on  the  license to any other person, the
 5    transferee  must  obtain  a  new  probationary  license.  The
 6    transferee shall notify the Department of  the  transfer  and
 7    apply  for  a  new  license  at  least 30 days prior to final
 8    transfer.
 9        (b)  The transferor shall notify the Department at  least
10    30  days prior to final transfer. The transferor shall remain
11    responsible for the operation of the facility until such time
12    as a license is issued to the transferee.
13        (c)  The license  granted  to  the  transferee  shall  be
14    subject  to  any plan of correction submitted by the previous
15    owner and approved  by  the  Department  and  any  conditions
16    contained  in  a  conditional  license issued to the previous
17    owner. If there are outstanding violations  and  no  approved
18    plan  of  correction has been implemented, the Department may
19    issue  a  conditional  license  and  plan  of  correction  as
20    provided in this Act.
21        (d)  The transferor shall remain liable for all penalties
22    assessed against the facility that are imposed for violations
23    occurring prior to transfer of ownership.

24        Section  105.  Access  to  information.   The   following
25    information  is  subject  to  disclosure to the public by the
26    Department:
27             (1)  records of license  inspections,  surveys,  and
28        evaluations of facilities; and
29             (2)  complaints and complaint investigation reports,
30        except that a complaint or complaint investigation report
31        shall  not  be  disclosed  to  a  person  other  than the
32        complainant or complainant's representative before it  is
 
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 1        disclosed  to  a facility and except that a complainant's
 2        or  patient's  name  shall   not   be   disclosed.   This
 3        information  shall  not  disclose  the name of any health
 4        care professionals or employees at the facility.

 5        Section 110. Information available for public inspection.
 6        (a)  A facility shall post in plain view  of  the  public
 7    (i)  its  current  license,  (ii)  a description of complaint
 8    procedures  established  under  this  Act  provided  by   the
 9    Department, and (iii) the name, address, and telephone number
10    of   a   person  authorized  by  the  Department  to  receive
11    complaints.
12        (b)  A facility shall make the following  information  or
13    documents available upon request for public inspection:
14             (1)  a  copy of any order pertaining to the facility
15        issued by the Department or a court  during  the  past  5
16        years;
17             (2)  a  complete  copy of every inspection report of
18        the facility received from the Department during the past
19        5 years;
20             (3)  a description of the services provided  by  the
21        facility and the rates charged for those services;
22             (4)  a  copy  of the statement of ownership required
23        by this Act; and
24             (5)  a complete copy of the most  recent  inspection
25        report of the facility received from the Department. This
26        information  shall  not  disclose  the name of any health
27        care professionals or employees at the facility.

28        Section 115. End Stage Renal Disease Advisory Committee.
29        (a)  The  Director  shall  appoint  an  End  Stage  Renal
30    Disease Advisory Committee to advise  and  consult  with  the
31    Director  in  the  administration  of this Act. The Committee
32    shall be composed of the following members:
 
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 1             (1)  2 members who represent end stage renal disease
 2        facilities;
 3             (2)  2  members  who  are  physicians  licensed   to
 4        practice medicine in all its branches;
 5             (3)  one    member    who   is   a   board-certified
 6        nephrologist;
 7             (4)  one member who represents licensed hospitals;
 8             (5)  one member who  is  a  registered  professional
 9        nurse with experience treating end stage renal disease;
10             (6)  one   member  of  the  general  public  who  is
11        currently  receiving  dialysis.  The  recommendations  of
12        professional organizations may be considered in selecting
13        individuals  for  appointment  to  the  End  Stage  Renal
14        Disease Advisory Committee.
15        (b)  Each member shall be  appointed  for  a  term  of  3
16    years,  except  that  of  the  original  members,  4 shall be
17    appointed for a term of 2 years, and 4 shall be appointed for
18    a term of 3 years. The term of office of each of the original
19    appointees shall commence on July 1, 2003. A member appointed
20    to fill a vacancy occurring prior to the  expiration  of  the
21    term  for which his or her predecessor was appointed shall be
22    appointed for the remainder of that term.
23        (c)  The  Committee  shall  meet  as  frequently  as  the
24    Director deems necessary. Committee members, while conducting
25    the business of  the  Committee,  shall  receive  actual  and
26    necessary  travel  and  subsistence  expenses when conducting
27    such business away from their places of residence.

28        Section 120. Adoption  of  rules.  The  Department  shall
29    adopt rules to implement this Act, including requirements for
30    physical  plant  standards  and  for  the  issuance, renewal,
31    denial, suspension, and revocation of a license to operate an
32    end stage renal  disease  facility.   These  rules  shall  be
33    consistent  with the requirements for end stage renal disease
 
HB5906 Engrossed            -15-              LRB9216063LBprA
 1    services under Title XVIII and  XIX  of  the  federal  Social
 2    Security Act.

 3        Section  125.  Fees.  The  Department  may  establish and
 4    collect fees in amounts reasonable and  necessary  to  defray
 5    the  cost  of  administering  this Act. In setting fees under
 6    this Act, the Department shall consider setting  a  range  of
 7    license  and  renewal  fees  based  on the number of dialysis
 8    stations at the end stage renal disease facility, the patient
 9    census, and the  average  costs  involved  in  surveying  the
10    facility.

11        Section  130.  Deposit  of  fees  and penalties. Fees and
12    penalties collected under this Act shall  be  deposited  into
13    the End Stage Renal Disease Facility Licensing Fund, which is
14    hereby  created  as  a  special  fund  in the State treasury.
15    Moneys in the Fund may be used, subject to appropriation,  by
16    the Department for the administration of this Act.

17        Section  135.  The State Finance Act is amended by adding
18    Section 5.570 as follows:

19        (30 ILCS 105/5.570 new)
20        Sec.  5.570.   The  End  Stage  Renal  Disease   Facility
21    Licensing Fund.

22        Section  999.  Effective date. This Act takes effect upon
23    becoming law.

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