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92_HB5906enr
HB5906 Enrolled 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 "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 any individual receiving treatment from
29 an 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 this
5 Act, no person shall open, manage, conduct, offer, maintain,
6 or advertise an end stage renal disease facility without a
7 valid license issued by the Department. All end stage renal
8 disease facilities in existence as of the effective date of
9 this Act shall obtain a valid license to operate within one
10 year after the adoption of rules to implement 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 Health
15 Agency Licensing Act;
16 (2) a hospital licensed under the Hospital Licensing Act
17 or the University of Illinois Hospital Act; and
18 (3) the office of a physician.
19 Section 20. Issuance and renewal of license.
20 (a) An applicant for a license under this Act shall
21 submit an application on forms prescribed by the Department.
22 (b) Each application shall be accompanied by a
23 non-refundable license fee, as established by rule of the
24 Department.
25 (c) Each application shall contain evidence that there
26 is at least one physician responsible for the medical
27 direction of the facility and that each dialysis technician
28 on staff has completed a training program as required by this
29 Act.
30 (d) The Department may grant a temporary initial license
31 to an applicant. A temporary initial license expires on the
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1 earlier of (i) the date the Department issues or denies the
2 license or (ii) the date 6 months after the temporary initial
3 license was issued.
4 (e) The Department shall issue a license if, after
5 application, inspection, and investigation, it finds the
6 applicant meets the requirements of this Act and the
7 standards adopted pursuant to this Act. The Department may
8 include participation as a supplier of end stage renal
9 disease services under Titles XVIII and XIX of the federal
10 Social Security Act as a condition of licensure.
11 (f) The license is renewable annually after submission
12 of (i) the renewal application and fee and (ii) an annual
13 report on a form prescribed by the Department that includes
14 information related to quality of care at the end stage renal
15 disease facility. The report must be in the form and
16 documented by evidence as required by Department rule.
17 Section 25. Minimum staffing. An end stage renal disease
18 facility shall be under the medical direction of a physician
19 experienced in renal disease treatment, as required for
20 licensure under this Act. Additionally, at a minimum, every
21 facility licensed under this Act shall ensure that whenever
22 patients are undergoing dialysis all of the following are
23 met:
24 (1) one currently licensed physician, registered
25 nurse, physician assistant, advanced practice nurse or
26 licensed practical nurse experienced in rendering end
27 stage renal disease care is physically present on the
28 premises to oversee patient care; and
29 (2) adequate staff is present to meet the medical
30 and non-medical needs of each patient, as provided by
31 this Act and the rules adopted pursuant to this Act.
32 Section 30. Minimum standards.
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1 (a) The rules adopted pursuant to this Act shall contain
2 minimum standards to protect the health and safety of a
3 patient of an end stage renal disease facility, including
4 standards for:
5 (1) the qualifications and supervision of the
6 professional staff and other personnel;
7 (2) the equipment used by the facility to insure
8 that it is compatible with the health and safety of the
9 patients;
10 (3) the sanitary and hygienic conditions in the
11 facility;
12 (4) quality assurance for patient care;
13 (5) clinical records maintained by the facility;
14 (6) design and space requirements for the facility
15 to insure safe access by patients and personnel and for
16 ensuring patient privacy;
17 (7) indicators of the quality of care provided by
18 the facility; and
19 (8) water treatment and reuse by the facility.
20 (b) These standards shall be consistent with the
21 requirements for a supplier of end stage renal disease
22 services under Titles XVIII and XIX of the federal Social
23 Security Act.
24 Section 35. Training; minimum requirements. An end stage
25 renal disease facility shall establish and implement a policy
26 to ensure appropriate training and competency of individuals
27 employed as dialysis technicians within the licensed
28 facility. The policy shall, at a minimum, define the acts and
29 practices that are allowed or prohibited for such employees,
30 establish how training will be conducted, and illustrate how
31 initial competency will be established. Proof of initial and
32 annual competency testing shall be maintained in the
33 personnel file of each dialysis technician and shall be made
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1 available to the Department upon request. An individual may
2 not act as a dialysis technician in an end stage renal
3 disease facility unless that individual has been trained and
4 competency tested in accordance with this Act and the rules
5 adopted under this Act. Persons training to act as a
6 dialysis technician must be under the direct supervision of a
7 physician or an appropriately trained nurse.
8 Section 40. Inspections.
9 (a) The Department, whenever it deems necessary, may
10 conduct an inspection, survey, or evaluation of an end stage
11 renal disease facility to determine compliance with licensure
12 requirements and standards or a plan of correction submitted
13 as a result of deficiencies cited by the Department.
14 (b) An inspection conducted under this Section shall be
15 unannounced.
16 (c) Upon completion of each inspection, survey, or
17 evaluation, the appropriate Department personnel who
18 conducted the inspection, survey, or evaluation shall submit
19 a copy of their report to the licensee upon exiting the
20 facility, and shall submit the actual report to the
21 appropriate regional office. The report shall identify areas
22 in a facility identified as deficient in compliance with the
23 requirements of this Act or the standards adopted under this
24 Act. The report and any recommendation for action by the
25 Department under this Act shall be sent to the Department's
26 central office together with a plan of correction from the
27 facility. The plan of correction may contain related comments
28 or documentation provided by the licensee that may refute
29 findings in the report, that explain extenuating
30 circumstances that the facility could not reasonably have
31 prevented, or that indicate methods and timetables for
32 correction of deficiencies described in the report. A
33 licensee has 10 days after the date of the inspection,
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1 survey, or evaluation to submit a plan of correction.
2 (d) The Department shall determine whether a facility is
3 in violation of this Section no later than 60 days after
4 completion of each inspection, survey, evaluation, or plan of
5 correction.
6 (e) The Department shall maintain all inspection,
7 survey, or evaluation reports for at least 5 years in a
8 manner accessible to the public.
9 Section 45. Notice of violation. When the Department
10 determines that a facility is in violation of this Act or of
11 any rule promulgated hereunder, a notice of violation shall
12 be served upon the licensee. Each notice of violation shall
13 be prepared in writing and shall specify the nature of the
14 violation and the statutory provision or rule alleged to have
15 been violated. The notice shall inform the licensee of any
16 action the Department may take under the Act, including the
17 requirement of a plan of correction under Section 50, or
18 licensure action under Section 60. The Director or his
19 designee shall also inform the licensee of the right to a
20 hearing under Section 60.
21 Section 50. Plan of correction.
22 (a) Each facility served with a notice of violation
23 under Section 45 of this Act shall file with the Department a
24 written plan of correction, which is subject to approval of
25 the Department, within 10 days after receipt of such notice.
26 The plan of correction shall state with particularity the
27 method by which the facility intends to correct each
28 violation and shall contain a stated date by which each
29 violation shall be corrected.
30 (b) If the Department rejects a plan of correction, it
31 shall send notice of the rejection and the reason for the
32 rejection to the licensee. The facility shall have 10 days
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1 after receipt of the notice of rejection to submit a modified
2 plan. If the modified plan is not timely submitted, or if
3 the modified plan is rejected, the facility shall follow a
4 plan of correction imposed by the Department.
5 (c) If a facility desires to contest any Department
6 action under this Section it shall send a written request for
7 a hearing under Section 60 to the Department within 10 days
8 of receipt of the notice of the contested action. The
9 Department shall commence the hearing as provided in Section
10 60. Whenever possible, all actions of the Department under
11 this Section arising out of a single violation shall be
12 contested and determined at a single hearing. Issues decided
13 as the result of the hearing process may not be reheard at
14 subsequent hearings under this Act, but such determinations
15 may be used as grounds for other administrative action by the
16 Department pursuant to this Act.
17 Section 55. Denial, suspension, revocation, or refusal
18 to renew a license; suspension of a service.
19 (a) When the Director determines that there is or has
20 been a substantial or continued failure to comply with this
21 Act or any rule promulgated hereunder, the Department may
22 issue an order of license denial, suspension, revocation, or
23 refusal to renew a license in accordance with subsection (a)
24 of Section 60 of this Act.
25 (b) When the Director determines that a facility has
26 failed to demonstrate the capacity to safely provide one or
27 more of its services to patients, the Department may issue an
28 order of service suspension in accordance with subsection (a)
29 of Section 60 of this Act.
30 Section 60. Notice of administrative actions; hearing
31 procedures.
32 (a) Notice of all administrative actions taken under this
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1 Act shall be effected by registered mail, certified mail, or
2 personal service and shall set forth the particular reasons
3 for the proposed action and provide the applicant or licensee
4 with an opportunity to request a hearing. If a hearing
5 request is not received within 10 days after receipt of the
6 notice of administrative action, the right to a hearing is
7 waived.
8 (b) The procedure governing hearings authorized by this
9 Section shall be in accordance with rules promulgated by the
10 Department consistent with this Act. A hearing shall be
11 conducted by the Director or by an individual designated in
12 writing by the Director as administrative law judge. A full
13 and complete record shall be kept of all proceedings,
14 including notice of hearing, complaint, and all other
15 documents in the nature of pleadings, written motions filed
16 in the proceedings, and the report and orders of the Director
17 and administrative law judge. All testimony shall be
18 reported but need not be transcribed unless the decision is
19 appealed pursuant to Section 70 of this Act. Any interested
20 party may obtain a copy or copies of the transcript on
21 payment of the cost of preparing such copy or copies.
22 (c) The Director or administrative law judge shall, upon
23 his own motion or on the written request of any party to the
24 proceeding, issue subpoenas requiring the attendance and
25 testimony of witnesses and subpoenas duces tecum requiring
26 the production of books, papers, records or memoranda. The
27 fees of witnesses for attendance and travel shall be the same
28 as the fees of witnesses before any circuit court of this
29 State. Such fees shall be paid when the witness is excused
30 from further attendance. When the witness is subpoenaed at
31 the instance of the Director or administrative law judge,
32 such fees shall be paid in the same manner as other expenses
33 of the Department. When the witness is subpoenaed at the
34 instance of any other party to a proceeding, the Department
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1 may require that the cost of service of the subpoena or
2 subpoena duces tecum and the fee of the witness be borne by
3 the party at whose instance the witness is summoned. In such
4 case, the Department, in its discretion, may require a
5 deposit to cover the cost of such service and witness fees.
6 A subpoena or subpoena duces tecum issued under this Section
7 shall be served in the same manner as a subpoena issued by a
8 court.
9 (d) Any circuit court of this State, upon the
10 application of the Director or the application of any other
11 party to the proceeding, may, in its discretion, compel the
12 attendance of witnesses, the production of books, papers,
13 records or memoranda, and the giving of testimony before the
14 Director or administrative law judge conducting an
15 investigation or holding a hearing authorized by this Act, by
16 an attachment for contempt, or otherwise, in the same manner
17 as production of evidence may be compelled before the court.
18 (e) The Director or administrative law judge, or any
19 party in a hearing before the Department, may compel the
20 attendance of witnesses and the production of books, papers,
21 records, or memoranda.
22 (f) The Director or administrative law judge shall make
23 findings of fact in such hearing and the Director shall
24 render his decision within 60 days after the termination or
25 waiving of the hearing unless he or she requires additional
26 time for a proper disposition of the matter. When a
27 administrative law judge has conducted the hearing, the
28 Director shall review the record and findings of fact before
29 rendering a decision. A copy of the findings of fact and
30 decision of the Director shall be served upon the applicant
31 or licensee in person, by registered mail or by certified
32 mail in the same manner as the service of the notice of
33 hearing. The decision denying, suspending, or revoking a
34 license shall become final 35 days after it is mailed or
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1 served, unless the applicant or licensee, within the 35-day
2 period, petitions for review pursuant to Section 70 of this
3 Act.
4 Section 65. Receiving and investigating complaints. The
5 Department shall establish by rule a procedure for receiving
6 and investigating complaints regarding any ESRDF, consistent
7 with federal complaint procedures.
8 Section 70. Judicial review. Whenever the Department
9 refuses to grant or decides to revoke or suspend a license to
10 open, conduct, or maintain an ESRDF, the applicant or
11 licensee may have such decision judicially reviewed. The
12 provisions of the Administrative Review Law and the rules
13 adopted pursuant thereto shall apply to and govern all
14 proceedings for the judicial review of final administrative
15 decisions of the Department hereunder. The term
16 "administrative decisions" is defined as in Section 3-101 of
17 the Code of Civil Procedure.
18 Section 75. Fines. Any person opening, conducting, or
19 maintaining an ESRDF without a license issued pursuant to
20 this Act shall be guilty of a business offense punishable by
21 a fine of $5,000 and each day's violation shall constitute a
22 separate offense. Any person opening, conducting, or
23 maintaining an ESRDF who violates any other provision of this
24 Act shall be guilty of a business offense punishable by a
25 fine of not more than $5,000.
26 The Department shall adopt rules for determining the
27 fines for violations.
28 Section 80. Injunctions. The operation or maintenance
29 of an ESRDF in violation of this Act or of the rules adopted
30 by the Department is declared a public nuisance inimical to
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1 the public welfare. The Director of the Department, in the
2 name of the People of the State, through the Attorney General
3 or the State's Attorney of the county in which the violation
4 occurs, may, in addition to other remedies herein provided,
5 bring action for an injunction to restrain such violation or
6 to enjoin the future operation or maintenance of any such
7 ESRDF.
8 Section 85. Department access to and reproduction of
9 documents. The Department shall have access to and may
10 reproduce or photocopy at its cost any books, records, and
11 other documents maintained by the facility to the extent
12 necessary to carry out the purposes of this Act and the rules
13 adopted under this Act. The Department shall not divulge or
14 disclose the identity of any patient or other information
15 prohibited from disclosure by the laws of this State.
16 Section 90. Refusal to allow inspections. Any licensee,
17 applicant for a license, or person operating what may be an
18 end stage renal disease facility shall be deemed to have
19 given consent to any authorized officer, employee, or agent
20 of the Department to enter and inspect the facility in
21 accordance with this Act. Refusal to permit such entry or
22 inspection shall constitute grounds for denial, nonrenewal,
23 or revocation of a license.
24 Section 95. Probationary license. If the applicant has
25 not been previously licensed or if the facility is not in
26 operation at the time application is made, the Department
27 shall issue a probationary license. A probationary license
28 shall be valid for 120 days unless sooner suspended or
29 revoked under this Act. Within 30 days prior to the
30 termination of a probationary license, the Department shall
31 fully and completely inspect the facility and, if the
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1 facility meets the applicable requirements for licensure,
2 shall issue a license under this Act. If the Department finds
3 that the facility does not meet the requirements for
4 licensure but has made substantial progress toward meeting
5 those requirements, the license may be renewed once for a
6 period not to exceed 120 days from the expiration date of the
7 initial probationary license.
8 Section 100. Change of ownership.
9 (a) Whenever ownership of a facility is transferred from
10 the person named on the license to any other person, the
11 transferee must obtain a new probationary license. The
12 transferee shall notify the Department of the transfer and
13 apply for a new license at least 30 days prior to final
14 transfer.
15 (b) The transferor shall notify the Department at least
16 30 days prior to final transfer. The transferor shall remain
17 responsible for the operation of the facility until such time
18 as a license is issued to the transferee.
19 (c) The license granted to the transferee shall be
20 subject to any plan of correction submitted by the previous
21 owner and approved by the Department and any conditions
22 contained in a conditional license issued to the previous
23 owner. If there are outstanding violations and no approved
24 plan of correction has been implemented, the Department may
25 issue a conditional license and plan of correction as
26 provided in this Act.
27 (d) The transferor shall remain liable for all penalties
28 assessed against the facility that are imposed for violations
29 occurring prior to transfer of ownership.
30 Section 105. Access to information. The following
31 information is subject to disclosure to the public by the
32 Department:
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1 (1) records of license inspections, surveys, and
2 evaluations of facilities; and
3 (2) complaints and complaint investigation reports,
4 except that a complaint or complaint investigation report
5 shall not be disclosed to a person other than the
6 complainant or complainant's representative before it is
7 disclosed to a facility and except that a complainant's
8 or patient's name shall not be disclosed. This
9 information shall not disclose the name of any health
10 care professionals or employees at the facility.
11 Section 110. Information available for public inspection.
12 (a) A facility shall post in plain view of the public
13 (i) its current license, (ii) a description of complaint
14 procedures established under this Act provided by the
15 Department, and (iii) the name, address, and telephone number
16 of a person authorized by the Department to receive
17 complaints.
18 (b) A facility shall make the following information or
19 documents available upon request for public inspection:
20 (1) a copy of any order pertaining to the facility
21 issued by the Department or a court during the past 5
22 years;
23 (2) a complete copy of every inspection report of
24 the facility received from the Department during the past
25 5 years;
26 (3) a description of the services provided by the
27 facility and the rates charged for those services;
28 (4) a copy of the statement of ownership required
29 by this Act; and
30 (5) a complete copy of the most recent inspection
31 report of the facility received from the Department. This
32 information shall not disclose the name of any health
33 care professionals or employees at the facility.
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1 Section 115. End Stage Renal Disease Advisory Committee.
2 (a) The Director shall appoint an End Stage Renal
3 Disease Advisory Committee to advise and consult with the
4 Director in the administration of this Act. The Committee
5 shall be composed of the following members:
6 (1) 2 members who represent end stage renal disease
7 facilities;
8 (2) 2 members who are physicians licensed to
9 practice medicine in all its branches;
10 (3) one member who is a board-certified
11 nephrologist;
12 (4) one member who represents licensed hospitals;
13 (5) one member who is a registered professional
14 nurse with experience treating end stage renal disease;
15 (6) one member of the general public who is
16 currently receiving dialysis. The recommendations of
17 professional organizations may be considered in selecting
18 individuals for appointment to the End Stage Renal
19 Disease Advisory Committee.
20 (b) Each member shall be appointed for a term of 3
21 years, except that of the original members, 4 shall be
22 appointed for a term of 2 years, and 4 shall be appointed for
23 a term of 3 years. The term of office of each of the original
24 appointees shall commence on July 1, 2003. A member appointed
25 to fill a vacancy occurring prior to the expiration of the
26 term for which his or her predecessor was appointed shall be
27 appointed for the remainder of that term.
28 (c) The Committee shall meet as frequently as the
29 Director deems necessary. Committee members, while conducting
30 the business of the Committee, shall receive actual and
31 necessary travel and subsistence expenses when conducting
32 such business away from their places of residence.
33 Section 120. Adoption of rules. The Department shall
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1 adopt rules to implement this Act, including requirements for
2 physical plant standards and for the issuance, renewal,
3 denial, suspension, and revocation of a license to operate an
4 end stage renal disease facility. These rules shall be
5 consistent with the requirements for end stage renal disease
6 services under Title XVIII and XIX of the federal Social
7 Security Act.
8 Section 125. Fees. The Department may establish and
9 collect fees in amounts reasonable and necessary to defray
10 the cost of administering this Act. In setting fees under
11 this Act, the Department shall consider setting a range of
12 license and renewal fees based on the number of dialysis
13 stations at the end stage renal disease facility, the patient
14 census, and the average costs involved in surveying the
15 facility.
16 Section 130. Deposit of fees and penalties. Fees and
17 penalties collected under this Act shall be deposited into
18 the End Stage Renal Disease Facility Licensing Fund, which is
19 hereby created as a special fund in the State treasury.
20 Moneys in the Fund may be used, subject to appropriation, by
21 the Department for the administration of this Act.
22 Section 135. The State Finance Act is amended by adding
23 Section 5.570 as follows:
24 (30 ILCS 105/5.570 new)
25 Sec. 5.570. The End Stage Renal Disease Facility
26 Licensing Fund.
27 Section 999. Effective date. This Act takes effect July
28 1, 2003.
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