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92_SB1066
LRB9205488ACcd
1 AN ACT creating the End Stage Renal Disease Facility Act.
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
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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, 2001. 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
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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 5.545 as follows:
19 (30 ILCS 105/5.545 new)
20 Sec. 5.545. The End Stage Renal Disease Facility
21 Licensing Fund.
22 Section 999. Effective date. This Act takes effect upon
23 becoming law.