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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. HB5906 Enrolled -2- LRB9216063LBprA 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 HB5906 Enrolled -3- LRB9216063LBprA 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. HB5906 Enrolled -4- LRB9216063LBprA 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 HB5906 Enrolled -5- LRB9216063LBprA 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, HB5906 Enrolled -6- LRB9216063LBprA 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 HB5906 Enrolled -7- LRB9216063LBprA 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 HB5906 Enrolled -8- LRB9216063LBprA 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 HB5906 Enrolled -9- LRB9216063LBprA 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 HB5906 Enrolled -10- LRB9216063LBprA 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 HB5906 Enrolled -11- LRB9216063LBprA 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 HB5906 Enrolled -12- LRB9216063LBprA 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: HB5906 Enrolled -13- LRB9216063LBprA 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. HB5906 Enrolled -14- LRB9216063LBprA 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 HB5906 Enrolled -15- LRB9216063LBprA 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.