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92_HB5906ham001
LRB9216063ACdvam01
1 AMENDMENT TO HOUSE BILL 5906
2 AMENDMENT NO. . Amend House Bill 5906 by replacing
3 everything after the enacting clause with the following:
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
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1 training to individuals with end stage renal disease.
2 "Nurse" means an individual who is licensed to practice
3 nursing under the Nursing and Advanced Practice Nursing Act.
4 "Patient" means any individual receiving treatment from
5 an end stage renal disease facility.
6 "Person" means any individual, firm, partnership,
7 corporation, company, association, or other legal entity.
8 "Physician" means an individual who is licensed to
9 practice medicine in all of its branches under the Medical
10 Practice Act of 1987.
11 Section 10. License required. Except as provided by this
12 Act, no person shall open, manage, conduct, offer, maintain,
13 or advertise an end stage renal disease facility without a
14 valid license issued by the Department. All end stage renal
15 disease facilities in existence as of the effective date of
16 this Act shall obtain a valid license to operate within one
17 year after the adoption of rules to implement this Act.
18 Section 15. Exemptions from licensing requirement. The
19 following facilities are not required to be licensed under
20 this Act:
21 (1) a home health agency licensed under the Home Health
22 Agency Licensing Act;
23 (2) a hospital licensed under the Hospital Licensing Act
24 or the University of Illinois Hospital Act; and
25 (3) the office of a physician.
26 Section 20. Issuance and renewal of license.
27 (a) An applicant for a license under this Act shall
28 submit an application on forms prescribed by the Department.
29 (b) Each application shall be accompanied by a
30 non-refundable license fee, as established by rule of the
31 Department.
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1 (c) Each application shall contain evidence that there
2 is at least one physician responsible for the medical
3 direction of the facility and that each dialysis technician
4 on staff has completed a training program as required by this
5 Act.
6 (d) The Department may grant a temporary initial license
7 to an applicant. A temporary initial license expires on the
8 earlier of (i) the date the Department issues or denies the
9 license or (ii) the date 6 months after the temporary initial
10 license was issued.
11 (e) The Department shall issue a license if, after
12 application, inspection, and investigation, it finds the
13 applicant meets the requirements of this Act and the
14 standards adopted pursuant to this Act. The Department may
15 include participation as a supplier of end stage renal
16 disease services under Titles XVIII and XIX of the federal
17 Social Security Act as a condition of licensure.
18 (f) The license is renewable annually after submission
19 of (i) the renewal application and fee and (ii) an annual
20 report on a form prescribed by the Department that includes
21 information related to quality of care at the end stage renal
22 disease facility. The report must be in the form and
23 documented by evidence as required by Department rule.
24 Section 25. Minimum staffing. An end stage renal disease
25 facility shall be under the medical direction of a physician
26 experienced in renal disease treatment, as required for
27 licensure under this Act. Additionally, at a minimum, every
28 facility licensed under this Act shall ensure that whenever
29 patients are undergoing dialysis all of the following are
30 met:
31 (1) one currently licensed physician, registered
32 nurse, or licensed practical nurse experienced in
33 rendering end stage renal disease care is physically
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1 present on the premises to oversee patient care; and
2 (2) adequate staff is present to meet the medical
3 and non-medical needs of each patient, as provided by
4 this Act and the rules adopted pursuant to this Act.
5 Section 30. Minimum standards.
6 (a) The rules adopted pursuant to this Act shall contain
7 minimum standards to protect the health and safety of a
8 patient of an end stage renal disease facility, including
9 standards for:
10 (1) the qualifications and supervision of the
11 professional staff and other personnel;
12 (2) the equipment used by the facility to insure
13 that it is compatible with the health and safety of the
14 patients;
15 (3) the sanitary and hygienic conditions in the
16 facility;
17 (4) quality assurance for patient care;
18 (5) clinical records maintained by the facility;
19 (6) design and space requirements for the facility
20 to insure safe access by patients and personnel and for
21 ensuring patient privacy;
22 (7) indicators of the quality of care provided by
23 the facility; and
24 (8) water treatment and reuse by the facility.
25 (b) These standards shall be consistent with the
26 requirements for a supplier of end stage renal disease
27 services under Titles XVIII and XIX of the federal Social
28 Security Act.
29 Section 35. Training; minimum requirements. An end stage
30 renal disease facility shall establish and implement a policy
31 to ensure appropriate training and competency of individuals
32 employed as dialysis technicians within the licensed
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1 facility. The policy shall, at a minimum, define the acts and
2 practices that are allowed or prohibited for such employees,
3 establish how training will be conducted, and illustrate how
4 initial competency will be established. Proof of initial and
5 annual competency testing shall be maintained in the
6 personnel file of each dialysis technician and shall be made
7 available to the Department upon request. An individual may
8 not act as a dialysis technician in an end stage renal
9 disease facility unless that individual has been trained and
10 competency tested in accordance with this Act and the rules
11 adopted under this Act. Persons training to act as a
12 dialysis technician must be under the direct supervision of a
13 physician or an appropriately trained nurse.
14 Section 40. Inspections.
15 (a) The Department, whenever it deems necessary, may
16 conduct an inspection, survey, or evaluation of an end stage
17 renal disease facility to determine compliance with licensure
18 requirements and standards or a plan of correction submitted
19 as a result of deficiencies cited by the Department.
20 (b) An inspection conducted under this Section shall be
21 unannounced.
22 (c) Upon completion of each inspection, survey, or
23 evaluation, the appropriate Department personnel who
24 conducted the inspection, survey, or evaluation shall submit
25 a copy of their report to the licensee upon exiting the
26 facility, and shall submit the actual report to the
27 appropriate regional office. The report shall identify areas
28 in a facility identified as deficient in compliance with the
29 requirements of this Act or the standards adopted under this
30 Act. The report and any recommendation for action by the
31 Department under this Act shall be sent to the Department's
32 central office together with a plan of correction from the
33 facility. The plan of correction may contain related comments
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1 or documentation provided by the licensee that may refute
2 findings in the report, that explain extenuating
3 circumstances that the facility could not reasonably have
4 prevented, or that indicate methods and timetables for
5 correction of deficiencies described in the report. A
6 licensee has 10 days after the date of the inspection,
7 survey, or evaluation to submit a plan of correction.
8 (d) The Department shall determine whether a facility is
9 in violation of this Section no later than 60 days after
10 completion of each inspection, survey, evaluation, or plan of
11 correction.
12 (e) The Department shall maintain all inspection,
13 survey, or evaluation reports for at least 5 years in a
14 manner accessible to the public.
15 Section 45. Notice of violation. When the Department
16 determines that a facility is in violation of this Act or of
17 any rule promulgated hereunder, a notice of violation shall
18 be served upon the licensee. Each notice of violation shall
19 be prepared in writing and shall specify the nature of the
20 violation and the statutory provision or rule alleged to have
21 been violated. The notice shall inform the licensee of any
22 action the Department may take under the Act, including the
23 requirement of a plan of correction under Section 50, or
24 licensure action under Section 60. The Director or his
25 designee shall also inform the licensee of the right to a
26 hearing under Section 60.
27 Section 50. Plan of correction.
28 (a) Each facility served with a notice of violation
29 under Section 45 of this Act shall file with the Department a
30 written plan of correction, which is subject to approval of
31 the Department, within 10 days after receipt of such notice.
32 The plan of correction shall state with particularity the
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1 method by which the facility intends to correct each
2 violation and shall contain a stated date by which each
3 violation shall be corrected.
4 (b) If the Department rejects a plan of correction, it
5 shall send notice of the rejection and the reason for the
6 rejection to the licensee. The facility shall have 10 days
7 after receipt of the notice of rejection to submit a modified
8 plan. If the modified plan is not timely submitted, or if
9 the modified plan is rejected, the facility shall follow a
10 plan of correction imposed by the Department.
11 (c) If a facility desires to contest any Department
12 action under this Section it shall send a written request for
13 a hearing under Section 60 to the Department within 10 days
14 of receipt of the notice of the contested action. The
15 Department shall commence the hearing as provided in Section
16 60. Whenever possible, all actions of the Department under
17 this Section arising out of a single violation shall be
18 contested and determined at a single hearing. Issues decided
19 as the result of the hearing process may not be reheard at
20 subsequent hearings under this Act, but such determinations
21 may be used as grounds for other administrative action by the
22 Department pursuant to this Act.
23 Section 55. Denial, suspension, revocation, or refusal
24 to renew a license; suspension of a service.
25 (a) When the Director determines that there is or has
26 been a substantial or continued failure to comply with this
27 Act or any rule promulgated hereunder, the Department may
28 issue an order of license denial, suspension, revocation, or
29 refusal to renew a license in accordance with subsection (a)
30 of Section 60 of this Act.
31 (b) When the Director determines that a facility has
32 failed to demonstrate the capacity to safely provide one or
33 more of its services to patients, the Department may issue an
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1 order of service suspension in accordance with subsection (a)
2 of Section 60 of this Act.
3 Section 60. Notice of administrative actions; hearing
4 procedures.
5 (a) Notice of all administrative actions taken under this
6 Act shall be effected by registered mail, certified mail, or
7 personal service and shall set forth the particular reasons
8 for the proposed action and provide the application or
9 licensee with an opportunity to request a hearing. If a
10 hearing request is not received within 10 days after receipt
11 of the notice of administrative action, the right to a
12 hearing is waived.
13 (b) The procedure governing hearings authorized by this
14 Section shall be in accordance with rules promulgated by the
15 Department consistent with this Act. A hearing shall be
16 conducted by the Director or by an individual designated in
17 writing by the Director as hearing officer. A full and
18 complete record shall be kept of all proceedings, including
19 notice of hearing, complaint, and all other documents in the
20 nature of pleadings, written motions filed in the
21 proceedings, and the report and orders of the Director and
22 hearing officer. All testimony shall be reported but need
23 not be transcribed unless the decision is appealed pursuant
24 to Section 70 of this Act. Any interested party may obtain a
25 copy or copies of the transcript on payment of the cost of
26 preparing such copy or copies.
27 (c) The Director or hearing officer shall, upon his own
28 motion or on the written request of any party to the
29 proceeding, issue subpoenas requiring the attendance and
30 testimony of witnesses and subpoenas duces tecum requiring
31 the production of books, papers, records or memoranda. The
32 fees of witnesses for attendance and travel shall be the same
33 as the fees of witnesses before any circuit court of this
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1 State. Such fees shall be paid when the witness is excused
2 from further attendance. When the witness is subpoenaed at
3 the instance of the Director or hearing officer, such fees
4 shall be paid in the same manner as other expenses of the
5 Department. When the witness is subpoenaed at the instance
6 of any other party to a proceeding, the Department may
7 require that the cost of service of the subpoena or subpoena
8 duces tecum and the fee of the witness be borne by the party
9 at whose instance the witness is summoned. In such case, the
10 Department, in its discretion, may require a deposit to cover
11 the cost of such service and witness fees. A subpoena or
12 subpoena duces tecum issued under this Section shall be
13 served in the same manner as a subpoena issued by a court.
14 (d) Any circuit court of this State, upon the
15 application of the Director or the application of any other
16 party to the proceeding, may, in its discretion, compel the
17 attendance of witnesses, the production of books, papers,
18 records or memoranda, and the giving of testimony before the
19 Director or hearing officer conducting an investigation or
20 holding a hearing authorized by this Act, by an attachment
21 for contempt, or otherwise, in the same manner as production
22 of evidence may be compelled before the court.
23 (e) The Director or hearing officer, or any party in a
24 hearing before the Department, may cause the deposition of
25 witnesses within the State to be taken in the manner
26 prescribed by law for depositions in civil actions in courts
27 of this State, and may compel the attendance of witnesses and
28 the production of books, papers, records, or memoranda.
29 (f) The Director or Hearing Officer shall make findings
30 of fact in such hearing and the Director shall render his
31 decision within 60 days after the termination or waiving of
32 the hearing unless he or she requires additional time for a
33 proper disposition of the matter. When a hearing officer has
34 conducted the hearing, the Director shall review the record
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1 and findings of fact before rendering a decision. A copy of
2 the findings of fact and decision of the Director shall be
3 served upon the applicant or licensee in person, by
4 registered mail or by certified mail in the same manner as
5 the service of the notice of hearing. The decision denying,
6 suspending, or revoking a license shall become final 35 days
7 after it is mailed or served, unless the applicant or
8 licensee, within the 35-day period, petitions for review
9 pursuant to Section 70 of this Act.
10 Section 65. Receiving and investigating complaints. The
11 Department shall establish by rule a procedure for receiving
12 and investigating complaints regarding any ESRDF, consistent
13 with federal complaint procedures.
14 Section 70. Judicial review. Whenever the Department
15 refuses to grant or decides to revoke or suspend a license to
16 open, conduct, or maintain an ESRDF, the applicant or
17 licensee may have such decision judicially reviewed. The
18 provisions of the Administrative Review Law and the rules
19 adopted pursuant thereto shall apply to and govern all
20 proceedings for the judicial review of final administrative
21 decisions of the Department hereunder. The term
22 "administrative decisions" is defined as in Section 3-101 of
23 the Code of Civil Procedure.
24 Section 75. Fines. Any person opening, conducting, or
25 maintaining an ESRDF without a license issued pursuant to
26 this Act shall be guilty of a business offense punishable by
27 a fine of $5,000 and each day's violation shall constitute a
28 separate offense. Any person opening, conducting, or
29 maintaining an ESRDF who violates any other provision of this
30 Act shall be guilty of a business offense punishable by a
31 fine of not more than $5,000.
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1 Section 80. Injunctions. The operation or maintenance
2 of an ESRDF in violation of this Act or of the rules adopted
3 by the Department is declared a public nuisance inimical to
4 the public welfare. The Director of the Department, in the
5 name of the People of the State, through the Attorney General
6 or the State's Attorney of the county in which the violation
7 occurs, may, in addition to other remedies herein provided,
8 bring action for an injunction to restrain such violation or
9 to enjoin the future operation or maintenance of any such
10 ESRDF.
11 Section 85. Department access to and reproduction of
12 documents. The Department shall have access to and may
13 reproduce or photocopy at its cost any books, records, and
14 other documents maintained by the facility to the extent
15 necessary to carry out the purposes of this Act and the rules
16 adopted under this Act. The Department shall not divulge or
17 disclose the identity of any patient or other information
18 prohibited from disclosure by the laws of this State.
19 Section 90. Refusal to allow inspections. Any licensee,
20 applicant for a license, or person operating what may be an
21 end stage renal disease facility shall be deemed to have
22 given consent to any authorized officer, employee, or agent
23 of the Department to enter and inspect the facility in
24 accordance with this Act. Refusal to permit such entry or
25 inspection shall constitute grounds for denial, nonrenewal,
26 or revocation of a license.
27 Section 95. Probationary license. If the applicant has
28 not been previously licensed or if the facility is not in
29 operation at the time application is made, the Department
30 shall issue a probationary license. A probationary license
31 shall be valid for 120 days unless sooner suspended or
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1 revoked under this Act. Within 30 days prior to the
2 termination of a probationary license, the Department shall
3 fully and completely inspect the facility and, if the
4 facility meets the applicable requirements for licensure,
5 shall issue a license under this Act. If the Department finds
6 that the facility does not meet the requirements for
7 licensure but has made substantial progress toward meeting
8 those requirements, the license may be renewed once for a
9 period not to exceed 120 days from the expiration date of the
10 initial probationary license.
11 Section 100. Change of ownership.
12 (a) Whenever ownership of a facility is transferred from
13 the person named on the license to any other person, the
14 transferee must obtain a new probationary license. The
15 transferee shall notify the Department of the transfer and
16 apply for a new license at least 30 days prior to final
17 transfer.
18 (b) The transferor shall notify the Department at least
19 30 days prior to final transfer. The transferor shall remain
20 responsible for the operation of the facility until such time
21 as a license is issued to the transferee.
22 (c) The license granted to the transferee shall be
23 subject to any plan of correction submitted by the previous
24 owner and approved by the Department and any conditions
25 contained in a conditional license issued to the previous
26 owner. If there are outstanding violations and no approved
27 plan of correction has been implemented, the Department may
28 issue a conditional license and plan of correction as
29 provided in this Act.
30 (d) The transferor shall remain liable for all penalties
31 assessed against the facility that are imposed for violations
32 occurring prior to transfer of ownership.
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1 Section 105. Access to information. The following
2 information is subject to disclosure to the public by the
3 Department:
4 (1) records of license inspections, surveys, and
5 evaluations of facilities; and
6 (2) complaints and complaint investigation reports,
7 except that a complaint or complaint investigation report
8 shall not be disclosed to a person other than the
9 complainant or complainant's representative before it is
10 disclosed to a facility and except that a complainant's
11 or patient's name shall not be disclosed. This
12 information shall not disclose the name of any health
13 care professionals or employees at the facility.
14 Section 110. Information available for public inspection.
15 (a) A facility shall post in plain view of the public
16 (i) its current license, (ii) a description of complaint
17 procedures established under this Act provided by the
18 Department, and (iii) the name, address, and telephone number
19 of a person authorized by the Department to receive
20 complaints.
21 (b) A facility shall make the following information or
22 documents available upon request for public inspection:
23 (1) a copy of any order pertaining to the facility
24 issued by the Department or a court during the past 5
25 years;
26 (2) a complete copy of every inspection report of
27 the facility received from the Department during the past
28 5 years;
29 (3) a description of the services provided by the
30 facility and the rates charged for those services;
31 (4) a copy of the statement of ownership required
32 by this Act; and
33 (5) a complete copy of the most recent inspection
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1 report of the facility received from the Department. This
2 information shall not disclose the name of any health
3 care professionals or employees at the facility.
4 Section 115. End Stage Renal Disease Advisory Committee.
5 (a) The Director shall appoint an End Stage Renal
6 Disease Advisory Committee to advise and consult with the
7 Director in the administration of this Act. The Committee
8 shall be composed of the following members:
9 (1) 2 members who represent end stage renal disease
10 facilities;
11 (2) 2 members who are physicians licensed to
12 practice medicine in all its branches;
13 (3) one member who is a board-certified
14 nephrologist;
15 (4) one member who represents licensed hospitals;
16 (5) one member who is a registered professional
17 nurse with experience treating end stage renal disease;
18 (6) one member of the general public who is
19 currently receiving dialysis. The recommendations of
20 professional organizations may be considered in selecting
21 individuals for appointment to the End Stage Renal
22 Disease Advisory Committee.
23 (b) Each member shall be appointed for a term of 3
24 years, except that of the original members, 4 shall be
25 appointed for a term of 2 years, and 4 shall be appointed for
26 a term of 3 years. The term of office of each of the original
27 appointees shall commence on July 1, 2003. A member appointed
28 to fill a vacancy occurring prior to the expiration of the
29 term for which his or her predecessor was appointed shall be
30 appointed for the remainder of that term.
31 (c) The Committee shall meet as frequently as the
32 Director deems necessary. Committee members, while conducting
33 the business of the Committee, shall receive actual and
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1 necessary travel and subsistence expenses when conducting
2 such business away from their places of residence.
3 Section 120. Adoption of rules. The Department shall
4 adopt rules to implement this Act, including requirements for
5 physical plant standards and for the issuance, renewal,
6 denial, suspension, and revocation of a license to operate an
7 end stage renal disease facility. These rules shall be
8 consistent with the requirements for end stage renal disease
9 services under Title XVIII and XIX of the federal Social
10 Security Act.
11 Section 125. Fees. The Department may establish and
12 collect fees in amounts reasonable and necessary to defray
13 the cost of administering this Act. In setting fees under
14 this Act, the Department shall consider setting a range of
15 license and renewal fees based on the number of dialysis
16 stations at the end stage renal disease facility, the patient
17 census, and the average costs involved in surveying the
18 facility.
19 Section 130. Deposit of fees and penalties. Fees and
20 penalties collected under this Act shall be deposited into
21 the End Stage Renal Disease Facility Licensing Fund, which is
22 hereby created as a special fund in the State treasury.
23 Moneys in the Fund may be used, subject to appropriation, by
24 the Department for the administration of this Act.
25 Section 135. The State Finance Act is amended by adding
26 Section 5.570 as follows:
27 (30 ILCS 105/5.570 new)
28 Sec. 5.570. The End Stage Renal Disease Facility
29 Licensing Fund.
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1 Section 999. Effective date. This Act takes effect upon
2 becoming law.".