State of Illinois
92nd General Assembly
Legislation

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[ Engrossed ][ House Amendment 001 ]


92_HB3129

 
                                               LRB9204289LBmg

 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
 5    End 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
12    fluid 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  the  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" means a facility  that
22    provides   dialysis   treatment   or   dialysis  training  to
23    individuals with end stage renal disease.
24        "Licensee" means an individual or entity licensed by  the
25    Department to operate an end stage renal disease facility.
26        "Nurse"  means  an individual who is licensed to practice
27    nursing under the Nursing and Advanced Practice Nursing Act.
28        "Patient" means an individual receiving treatment from an
29    end stage renal disease facility.
30        "Person"  means  any   individual,   firm,   partnership,
31    corporation, company, association, or other legal entity.
 
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 1        "Physician"  means  an  individual  who  is  licensed  to
 2    practice  medicine  in  all of its branches under the Medical
 3    Practice Act of 1987.

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

11        Section  15.  Exemptions from licensing requirement.  The
12    following facilities are not required to  be  licensed  under
13    this Act:
14             (1)  a   home  health agency licensed under the Home
15        Health  Agency  Licensing  Act  that  provides   dialysis
16        services in the home under the supervision of a nurse;
17             (2)  a   hospital   licensed   under   the  Hospital
18        Licensing Act or the University of Illinois Hospital Act;
19        and
20             (3)  the office of a physician, unless the office is
21        used primarily as an end stage renal disease facility.

22        Section 20.  Issuance and renewal of license.
23        (a)  An applicant for a  license  under  this  Act  shall
24    submit an application on forms prescribed by the Department.
25        (b)  Each   application   shall   be   accompanied  by  a
26    non-refundable license fee, as established by  the  rules  of
27    the Department.
28        (c)  Each  application  shall contain evidence that there
29    is at least  one  qualified  physician  responsible  for  the
30    medical  direction  of  the  facility  and that each dialysis
31    technician on staff  has  completed  a  training  program  as
 
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 1    required by this Act.
 2        (d)  The Department may grant a temporary initial license
 3    to  an applicant.  A temporary initial license expires on the
 4    earlier of (i) the date the Department issues or  denies  the
 5    license  or  (ii)  the  date  6  months  after  the  date the
 6    temporary initial license was issued.
 7        (e)  The Department  shall  issue  a  license  if,  after
 8    application, inspection, and investigation, it finds that the
 9    applicant   meets  the  requirements  of  this  Act  and  the
10    standards adopted pursuant to this Act.  The  Department  may
11    include  participation  as  a  supplier  of  end  stage renal
12    disease services under Titles XVIII and XIX  of  the  federal
13    Social Security Act as a condition of licensure.
14        (f)  The  license  is renewable annually after submission
15    of (i) the renewal application and fee  and  (ii)  an  annual
16    report  on  a form prescribed by the Department that includes
17    information related to quality of care at the end stage renal
18    disease facility.   The  report  must  be  in  the  form  and
19    documented  by  evidence  as required by the rules adopted by
20    the Department.

21        Section  25.   Minimum  staffing.   An  end  stage  renal
22    disease facility shall be under the medical  direction  of  a
23    qualified  physician  experienced in renal disease treatment,
24    as required for licensure under this Act.  Additionally, at a
25    minimum, every facility licensed under this Act shall  ensure
26    that  whenever  patients  are  undergoing dialysis all of the
27    following are met:
28             (1)  one currently  licensed  physician,  registered
29        nurse,   or   licensed  practical  nurse  experienced  in
30        rendering end stage  renal  disease  care  is  physically
31        present on the premises to oversee patient care;
32             (2)  adequate  staff  is present to meet the medical
33        and non-medical needs of each  patient,  as  provided  by
 
                            -4-                LRB9204289LBmg
 1        this Act and the rules adopted pursuant to this Act, in a
 2        ratio  of  at  least one staff member to every 3 patients
 3        receiving end stage renal disease services  at  the  same
 4        time; and
 5             (3)  if   the  facility  offers  self-care  dialysis
 6        training,  a  qualified  nurse  is  in  charge  of   that
 7        training.

 8        Section 30.  Minimum standards.
 9        (a)  The rules adopted pursuant to this Act shall contain
10    minimum  standards  to  protect  the  health  and safety of a
11    patient of an end stage  renal  disease  facility,  including
12    standards for:
13             (1)  the   qualifications  and  supervision  of  the
14        professional staff and other personnel;
15             (2)  the equipment used by the  facility  to  insure
16        that  it  is compatible with the health and safety of the
17        patients;
18             (3)  the sanitary and  hygienic  conditions  in  the
19        facility;
20             (4)  quality assurance for patient care;
21             (5)  clinical records maintained by the facility;
22             (6)  design  and space requirements for the facility
23        to insure safe access by patients and  personnel  and  to
24        insure patient privacy;
25             (7)  indicators  of  the quality of care provided by
26        the facility; and
27             (8)  water treatment and reuse by the facility.
28        (b)  The standards described in item  (8)  of  subsection
29    (a)  of  this Section shall apply only (i) to a facility that
30    initiates the provision of end stage renal  disease  services
31    on or after January 1, 2003 or (ii) to the area of a facility
32    affected  by  design  and  space modifications or renovations
33    completed after  January 1, 2004.
 
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 1        Section 35.   Training;  minimum  requirements.   An  end
 2    stage  renal disease facility shall establish and implement a
 3    policy to  ensure  appropriate  training  and  competency  of
 4    individuals  employed  as  dialysis  technicians  within  the
 5    licensed  facility.   The  policy shall, at a minimum, define
 6    the acts and practices that are  allowed  or  prohibited  for
 7    such employees, establish how training will be conducted, and
 8    illustrate how initial competency will be established.  Proof
 9    of  initial and annual competency testing shall be maintained
10    in the personnel file of each  employee  and  shall  be  made
11    available  to the Department upon request.  An individual may
12    not act as a  dialysis  technician  in  an  end  stage  renal
13    disease  facility unless that individual has been trained and
14    competency tested in accordance with this Act and  the  rules
15    adopted  thereunder.   Persons  training  to  act as dialysis
16    technicians  must  be  under  the  direct  supervision  of  a
17    physician or an appropriately trained nurse.

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

18        Section 45.  Civil penalties.
19        (a)  The  license  of  a facility that is in violation of
20    this Act or any rule adopted thereunder may be subject to the
21    penalties or fines levied by the Department as  specified  in
22    this Section.
23        (b)  A  Class  I  violation  is  one  that the Department
24    determines presents an imminent danger to the patients of the
25    facility or a substantial probability that death  or  serious
26    physical  harm  could result therefrom.  A physical condition
27    or one or more practices, means, methods,  or  operations  in
28    use  in  a  facility  may  constitute  such a violation.  The
29    condition or practice constituting a Class I violation  shall
30    be  abated or eliminated immediately unless a fixed period of
31    time, as  stipulated  by  the  Department,  is  required  for
32    correction.    Each   day   such  a  violation  exists  after
33    expiration of the  stipulated  time  shall  be  considered  a
 
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 1    subsequent  violation.   The  civil  penalty  for  a  Class I
 2    violation is as follows:
 3             (1)  $1,500 for a first violation within a 24  month
 4        period;
 5             (2)  $3,000 for a second violation within a 24 month
 6        period;
 7             (3)  $5,000  for a third violation within a 24 month
 8        period; and
 9             (4)  $10,000 for a fourth  or  subsequent  violation
10        within a 24 month period.
11        (c)  A  Class  II  violation  is  one that the Department
12    determines has a direct  or  immediate  relationship  to  the
13    health,  safety,  or security of the facility's patients, but
14    is not a Class I violation.  The  citation  for  a  Class  II
15    violation  shall  specify the time within which the violation
16    is required to be  corrected.   Each  day  such  a  violation
17    exists  after  the  expiration of the specified time shall be
18    considered a subsequent violation.  The civil penalty  for  a
19    Class II violation is as follows:
20             (1)  $250  for  a  first violation within a 24 month
21        period;
22             (2)  $500 for a second violation within a  24  month
23        period;
24             (3)  $1,000  for a third violation within a 24 month
25        period;
26             (4)  $2,500 for a fourth violation within a 24 month
27        period; and
28             (5)  $5,000 for  a  fifth  or  subsequent  violation
29        within a 24 month period.
30        (d)  A  Class III violation is one that is not classified
31    as serious by the Department or  that  is  against  the  best
32    practices  as interpreted by the Department.  The citation of
33    a Class III violation shall specify a time within  which  the
34    violation  is  required  to  be  corrected.  Each  day such a
 
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 1    violation exists after the expiration of the  specified  time
 2    shall  be considered a subsequent violation.  A civil penalty
 3    shall not be assessed for a first violation within a 24 month
 4    period.  The civil penalty for a Class III  violation  is  as
 5    follows:
 6             (1)  $200  for  a second violation within a 24 month
 7        period;
 8             (2)  $500 for a third violation within  a  24  month
 9        period;
10             (3)  $750  for  a fourth violation within a 24 month
11        period; and
12             (4)  $1,000 for  a  fifth  or  subsequent  violation
13        within a 24 month period.
14        (e)  For  purposes of assessing fines under this Section,
15    a repeat violation is a violation that has been cited  during
16    one  inspection  of  a facility for which an accepted plan of
17    correction was not complied with.  A new citation  is  not  a
18    repeat  violation  unless  the  licensee is not substantially
19    addressing the issue routinely throughout the facility.

20        Section 50.  Department access  to  and  reproduction  of
21    documents.   The  Department  shall  have  access  to and may
22    reproduce or photocopy at its cost any  books,  records,  and
23    other  documents  maintained  by  the  facility to the extent
24    necessary to carry out the purposes of this Act and the rules
25    promulgated under this Act.  The Department shall not divulge
26    or disclose the identity of any patient or other  information
27    prohibited from disclosure by the laws of this State.

28        Section 55.  Refusal to allow inspections.  Any licensee,
29    applicant  for  a license, or person operating what may be an
30    end stage renal disease facility  shall  be  deemed  to  have
31    given  consent  to any authorized officer, employee, or agent
32    of the Department  to  enter  and  inspect  the  facility  in
 
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 1    accordance  with  this  Act.  Refusal to permit such entry or
 2    inspection shall constitute grounds for  denial,  nonrenewal,
 3    or revocation of a license.

 4        Section   60.    Denial,  suspension,  or  revocation  of
 5    license.
 6        (a)  The  Department  may  deny,  suspend,  or  revoke  a
 7    license for a  violation  of  this  Act  or  a  rule  adopted
 8    pursuant to this Act.
 9        (b)  The  denial,  suspension, or revocation of a license
10    by the  Department  and  the  appeal  from  that  action  are
11    governed by the Illinois Administrative Procedure Act.
12        (c)  Immediately   upon   the   denial,   suspension,  or
13    revocation of a license,  the  Department  shall  notify  the
14    applicant  or  licensee  in  writing.   Notice of the denial,
15    suspension, or revocation shall include a  statement  of  the
16    violations  of  the Act or rules on which the denial is based
17    and notice  of  the  opportunity  for  a  hearing  under  the
18    Illinois  Administrative  Procedure  Act.   If  the applicant
19    desires to contest the Department's action, a written request
20    for a hearing shall be provided to the Department  within  10
21    days after receipt of the Department's notice.

22        Section  65.  Probationary license.  If the applicant has
23    not been previously licensed or if the  facility  is  not  in
24    operation  at  the  time  application is made, the Department
25    shall issue a probationary license.  A  probationary  license
26    shall  be  valid  for  120  days  unless  sooner suspended or
27    revoked  under  this  Act.   Within  30  days  prior  to  the
28    termination of a probationary license, the  Department  shall
29    fully  and  completely  inspect  the  facility  and,  if  the
30    facility  meets  the  applicable  requirements for licensure,
31    shall issue a license under  this  Act.   If  the  Department
32    finds  that  the  facility does not meet the requirements for
 
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 1    licensure but has made substantial  progress  toward  meeting
 2    those  requirements,  the  license  may be renewed once for a
 3    period not to exceed 120 days from the expiration date of the
 4    initial probationary license.

 5        Section 70.  Change of ownership.
 6        (a)  Whenever ownership of a facility is transferred from
 7    the person named in the license  to  any  other  person,  the
 8    transferee  must  obtain  a  new  probationary  license.  The
 9    transferee  shall  notify  the Department of the transfer and
10    apply for a new license at  least  30  days  prior  to  final
11    transfer.
12        (b)  The  transferor shall notify the Department at least
13    30 days prior to final transfer.  The transferor shall remain
14    responsible for the operation of the facility until such time
15    as a license is issued to the transferee.
16        (c)  The license  granted  to  the  transferee  shall  be
17    subject  to  any plan of correction submitted by the previous
18    owner and approved  by  the  Department  and  any  conditions
19    contained  in  a  conditional  license issued to the previous
20    owner.  If there are outstanding violations and  no  approved
21    plan  of  correction has been implemented, the Department may
22    issue  a  conditional  license  and  plan  of  correction  as
23    provided in this Act.
24        (d)  The transferor shall remain liable for all penalties
25    assessed against the facility that are imposed for violations
26    occurring prior to transfer of ownership.

27        Section  75.  Access  to  information.    The   following
28    information  is  subject  to  disclosure to the public by the
29    Department:
30             (1)  records of license  inspections,  surveys,  and
31        evaluations of facilities; and
32             (2)  complaints and complaint investigation reports,
 
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 1        except that a complaint or complaint investigation report
 2        shall  not  be  disclosed  to  a  person  other  than the
 3        complainant or complainant's representative before it  is
 4        disclosed  to  a facility and except that a complainant's
 5        or patient's name shall not be disclosed.

 6        Section 80.  Information available for public inspection.
 7        (a)  A facility shall post in plain view  of  the  public
 8    (i)  its current license, (ii) a description, provided by the
 9    Department, of complaint procedures  established  under  this
10    Act,  and  (iii) the name, address, and telephone number of a
11    person authorized by the Department to receive 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;
16             (2)  a complete copy of every inspection  report  of
17        the facility received from the Department during the past
18        5 years;
19             (3)  a   copy  of  every  order  pertaining  to  the
20        facility issued by the Department or a court  during  the
21        past 5 years;
22             (4)  a  description  of the services provided by the
23        facility and the rates charged for those services;
24             (5)  a copy of the statement of  ownership  required
25        by this Act;
26             (6)  a  record  of personnel employed or retained by
27        the facility who are licensed, certified,  or  registered
28        by the Department of Professional Regulation; and
29             (7)  a  complete  copy of the most recent inspection
30        report of the facility received from the Department.

31        Section 85.  End Stage Renal Disease Advisory Committee.
32        (a)  The  Director  shall  appoint  an  End  Stage  Renal
 
                            -12-               LRB9204289LBmg
 1    Disease Advisory Committee to advise  and  consult  with  the
 2    Director  in  the  administration of this Act.  The Committee
 3    shall be composed of the following members:
 4             (1)  3 members who represent end stage renal disease
 5        facilities, one of whom  shall  represent  not-for-profit
 6        facilities,   one  of  whom  shall  represent  for-profit
 7        facilities,   and   one   of   whom    shall    represent
 8        institution-based facilities;
 9             (2)  2   members  who  are  physicians  licensed  to
10        practice medicine in all its  branches;
11             (3)  one   member   who   is    a    board-certified
12        nephrologist;
13             (4)  one member who represents licensed hospitals;
14             (5)  one  member  who  is  a registered professional
15        nurse with experience treating  end stage renal disease;
16             (6)  3 members of the general public, one of whom is
17        currently receiving dialysis.
18        The recommendations of professional organizations may  be
19    considered  in  selecting  individuals for appointment to the
20    End Stage Renal Disease Advisory Committee.
21        (b)  Each member shall be  appointed  for  a  term  of  3
22    years,  except  that  of  the  original  members,  3 shall be
23    appointed for a term of one year, 4 shall be appointed for  a
24    term  of  2  years,  and 4 shall be appointed for a term of 3
25    years.  The term of office of each of the original appointees
26    shall commence on July 1, 2002.  A member appointed to fill a
27    vacancy occurring prior to the expiration  of  the  term  for
28    which his or her predecessor was appointed shall be appointed
29    for the remainder of that term.
30        (c)  The  Committee  shall  meet  as  frequently  as  the
31    Director  deems  necessary.  Committee members, while serving
32    on business  of  the  Committee,  shall  receive  actual  and
33    necessary  travel  and  subsistence expenses while so serving
34    away from their places of residence.
 
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 1        Section 90.  Adoption of  rules.   The  Department  shall
 2    adopt rules to implement this Act, including requirements for
 3    physical  plant  standards  and  for  the  issuance, renewal,
 4    denial, suspension, and revocation of a license to operate an
 5    end stage renal disease facility.

 6        Section 95.  Fees.   The  Department  may  establish  and
 7    collect  fees  in  amounts reasonable and necessary to defray
 8    the cost of administering this Act.  In  setting  fees  under
 9    this  Act,  the  Department shall consider setting a range of
10    license and renewal fees based  on  the  number  of  dialysis
11    stations at the end stage renal disease facility, the patient
12    census,  and  the  average  costs  involved  in surveying the
13    facility.

14        Section 100. Deposit of fees  and  penalties.   Fees  and
15    penalties  collected  under  this Act shall be deposited into
16    the End Stage Renal Disease Facility Licensing Fund, which is
17    hereby created as a  special  fund  in  the  State  treasury.
18    Moneys  in the Fund may be used, subject to appropriation, by
19    the Department for the administration of this Act.

20        Section 105.  The State Finance Act is amended by  adding
21    Section 5.545 as follows:

22        (30 ILCS 105/5.545 new)
23        Sec.   5.545.   The  End  Stage  Renal  Disease  Facility
24    Licensing Fund.

25        Section 999.   Effective  date.  This  Act  takes  effect
26    January 1, 2002.

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