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91_HB4693eng HB4693 Engrossed LRB9113012ACtm 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 5 End Stage Renal Disease Facility Act. 6 Section 5. Definitions. As used in this Act: 7 "Committee" means the End Stage Renal Disease Advisory 8 Committee. 9 "Department" means the Department of Public Health. 10 "Dialysis" means a process by which dissolved substances 11 are removed from a patient's body by diffusion from one 12 fluid compartment to another across a semipermeable membrane. 13 "Dialysis technician" means an individual who is not a 14 registered nurse or physician and who provides dialysis care 15 under the supervision of a registered nurse or physician. 16 "Director" means the Director of Public Health. 17 "End stage renal disease" means 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" means a facility that 22 provides dialysis treatment or dialysis training to 23 individuals with end stage renal disease. 24 "Licensee" means the 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. HB4693 Engrossed -2- LRB9113012ACtm 1 "Physician" means an individual who is licensed to 2 practice medicine in all of its branches under the Medical 3 Practice Act of 1987. 4 Section 10. License required. Except as provided by 5 this Act, no person shall open, manage, conduct, offer, 6 maintain, or advertise an end stage renal disease facility 7 without a valid license issued by the Department. All end 8 stage renal disease facilities in existence as of the 9 effective date of this Act shall obtain a valid license to 10 operate within one year after the effective date of this Act. 11 Section 15. Exemptions from licensing requirement. The 12 following facilities are not required to be licensed under 13 this Act: 14 (1) a home health agency licensed under the Home 15 Health Agency Licensing Act that provides dialysis 16 services in the home under the supervision of a nurse; 17 (2) a hospital licensed under the Hospital 18 Licensing Act or the University of Illinois Hospital Act; 19 and 20 (3) the office of a physician, unless the office is 21 used primarily as an end stage renal disease facility. 22 Section 20. Issuance and renewal of license. 23 (a) An applicant for a license under this Act shall 24 submit an application on forms prescribed by the Department. 25 (b) Each application shall be accompanied by a 26 non-refundable license fee, as established by rule of the 27 Department. 28 (c) Each application shall contain evidence that there 29 is at least one qualified physician responsible for the 30 medical direction of the facility and that each dialysis 31 technician on staff has completed a training program as HB4693 Engrossed -3- LRB9113012ACtm 1 required by this Act. 2 (d) The Department may grant a temporary initial license 3 to an applicant. A temporary initial license expires on the 4 earlier of (i) the date the Department issues or denies the 5 license or (ii) the date 6 months after the date the 6 temporary initial license was issued. 7 (e) The Department shall issue a license if, after 8 application, inspection, and investigation, it finds the 9 applicant meets the requirements of this Act and the 10 standards adopted pursuant to this Act. The Department may 11 include participation as a supplier of end stage renal 12 disease services under Titles XVIII and XIX of the federal 13 Social Security Act as a condition of licensure. 14 (f) The license is renewable annually after submission 15 of (i) the renewal application and fee and (ii) an annual 16 report on a form prescribed by the Department that includes 17 information related to quality of care at the end stage renal 18 disease facility. The report must be in the form and 19 documented by evidence as required by Department rule. 20 Section 25. Minimum staffing. An end stage renal 21 disease facility shall be under the medical direction of a 22 qualified physician experienced in renal disease treatment, 23 as required for licensure under this Act. Additionally, at a 24 minimum, every facility licensed under this Act shall ensure 25 that whenever patients are undergoing dialysis all of the 26 following are met: 27 (1) one currently licensed physician, registered 28 nurse or licensed practical nurse experienced in 29 rendering end stage renal disease care is physically 30 present on the premises to oversee patient care; 31 (2) adequate staff is present to meet the medical 32 and non-medical needs of each patient, as provided by 33 this Act and the rules adopted pursuant to this Act, in a HB4693 Engrossed -4- LRB9113012ACtm 1 ratio of at least one staff member to every 3 patients 2 receiving end stage renal disease services at the same 3 time; and 4 (3) if the facility offers self-care dialysis 5 training, a qualified nurse is in charge of that 6 training. 7 Section 30. Minimum standards. 8 (a) The rules adopted pursuant to this Act shall contain 9 minimum standards to protect the health and safety of a 10 patient of an end stage renal disease facility, including 11 standards for: 12 (1) the qualifications and supervision of the 13 professional staff and other personnel; 14 (2) the equipment used by the facility to insure 15 that it is compatible with the health and safety of the 16 patients; 17 (3) the sanitary and hygienic conditions in the 18 facility; 19 (4) quality assurance for patient care; 20 (5) clinical records maintained by the facility; 21 (6) design and space requirements for the facility 22 to insure safe access by patients and personnel and for 23 ensuring patient privacy; 24 (7) indicators of the quality of care provided by 25 the facility; and 26 (8) water treatment and reuse by the facility. 27 (b) The standards described in item (8) of subsection 28 (a) shall apply only (i) to a facility that initiates the 29 provision of end stage renal disease services on or after 30 January 1, 2001 or (ii) to the area of a facility affected by 31 design and space modifications or renovations completed after 32 January 1, 2002. HB4693 Engrossed -5- LRB9113012ACtm 1 Section 35. Training; minimum requirements. An end 2 stage renal disease facility shall establish and implement a 3 policy to ensure appropriate training and competency of 4 individuals employed as dialysis technicians within the 5 licensed facility. The policy shall, at a minimum, define 6 the acts and practices that are allowed or prohibited for 7 such employees, establish how training will be conducted, and 8 illustrate how initial competency will be established. Proof 9 of initial and annual competency testing shall be maintained 10 in the personnel file of each employee and shall be made 11 available to the Department upon request. An individual may 12 not act as a dialysis technician in an end stage renal 13 disease facility unless that individual has been trained and 14 competency tested in accordance with this Act and the rules 15 adopted thereunder. Persons training to act as a dialysis 16 technician must be under the direct supervision of a 17 physician or an appropriately trained nurse. 18 Section 40. Inspections. 19 (a) The Department, whenever it deems necessary, may 20 conduct an inspection, survey, or evaluation of an end stage 21 renal disease facility to determine compliance with licensure 22 requirements and standards or a plan of correction submitted 23 as a result of deficiencies cited by the Department. 24 (b) An inspection conducted under this Section shall be 25 unannounced. 26 (c) Areas in a facility identified as deficient in 27 compliance with the requirements of this Act or the standards 28 adopted under it shall be presented to the facility. 29 (d) Upon completion of each inspection, survey, or 30 evaluation, the appropriate Department personnel who 31 conducted the inspection, survey, or evaluation shall submit 32 a copy of their report to the licensee upon exiting the 33 facility, and shall submit the actual report to the HB4693 Engrossed -6- LRB9113012ACtm 1 appropriate regional office. The report and any 2 recommendation for action by the Department under this Act 3 shall be sent to the Department's central office together 4 with a plan of correction from the facility. The plan of 5 correction may contain related comments or documentation 6 provided by the licensee that may refute findings in the 7 report, that explain extenuating circumstances that the 8 facility could not reasonably have prevented, or that 9 indicate methods and timetables for correction of 10 deficiencies described in the report. A licensee has 10 days 11 to submit a plan of correction. 12 (e) Violations shall be determined under this Section no 13 later than 60 days after completion of each inspection, 14 survey, evaluation, or plan of correction. 15 (f) The Department shall maintain all inspection, 16 survey, or evaluation reports for at least 5 years in a 17 manner accessible to the public. 18 Section 45. Civil penalties. 19 (a) The license of a facility that is in violation of 20 this Act or any rule adopted thereunder may be subject to the 21 penalties or fines levied by the Department as specified in 22 this Section. 23 (b) A Class I violation is one that the Department 24 determines presents an imminent danger to the patients of the 25 facility or a substantial probability that death or serious 26 physical harm could result therefrom. A physical condition 27 or one or more practices, means, methods, or operations in 28 use in a facility may constitute such a violation. The 29 condition or practice constituting a Class I violation shall 30 be abated or eliminated immediately unless a fixed period of 31 time, as stipulated by the Department, is required for 32 correction. Each day such a violation exists after 33 expiration of the stipulated time shall be considered a HB4693 Engrossed -7- LRB9113012ACtm 1 subsequent violation. The civil penalty for a Class I 2 violation is as follows: 3 (1) $1,500 for a first violation within a 24 month 4 period; 5 (2) $3,000 for a second violation within a 24 month 6 period; 7 (3) $5,000 for a third violation within a 24 month 8 period; and 9 (4) $10,000 for a fourth or subsequent violation 10 within a 24 month period. 11 (c) A Class II violation is one that the Department 12 determines has a direct or immediate relationship to the 13 health, safety, or security of the facility's patients, but 14 is not a Class I violation. The citation for a Class II 15 violation shall specify the time within which the violation 16 is required to be corrected. Each day such a violation 17 exists after the expiration of the specified time shall be 18 considered a subsequent violation. The civil penalty for a 19 Class II violation is as follows: 20 (1) $250 for a first violation within a 24 month 21 period; 22 (2) $500 for a second violation within a 24 month 23 period; 24 (3) $1,000 for a third violation within a 24 month 25 period; 26 (4) $2,500 for a fourth violation within a 24 month 27 period; and 28 (5) $5,000 for a fifth or subsequent violation 29 within a 24 month period. 30 (d) A Class III violation is one that is not classified 31 as serious by the Department or that is against the best 32 practices as interpreted by the Department. The citation of 33 a Class III violation shall specify a time within which the 34 violation is required to be corrected. Each day such a HB4693 Engrossed -8- LRB9113012ACtm 1 violation exists after the expiration of the specified time 2 shall be considered a subsequent violation. A civil penalty 3 shall not be assessed for a first violation within a 24 month 4 period. The civil penalty for a Class III violation is as 5 follows: 6 (1) $200 for a second violation within a 24 month 7 period; 8 (2) $500 for a third violation within a 24 month 9 period; 10 (3) $750 for a fourth violation within a 24 month 11 period; and 12 (4) $1,000 for a fifth or subsequent violation 13 within a 24 month period. 14 (e) For purposes of assessing fines under this Section, 15 a repeat violation is a violation that has been cited during 16 one inspection of a facility for which an accepted plan of 17 correction was not complied with. A new citation is not a 18 repeat violation unless the licensee is not substantially 19 addressing the issue routinely throughout the facility. 20 Section 50. Department access to and reproduction of 21 documents. The Department shall have access to and may 22 reproduce or photocopy at its cost any books, records, and 23 other documents maintained by the facility to the extent 24 necessary to carry out the purposes of this Act and the rules 25 promulgated under this Act. The Department shall not divulge 26 or disclose the identity of any patient or other information 27 prohibited from disclosure by the laws of this State. 28 Section 55. Refusal to allow inspections. Any licensee, 29 applicant for a license, or person operating what may be an 30 end stage renal disease facility shall be deemed to have 31 given consent to any authorized officer, employee, or agent 32 of the Department to enter and inspect the facility in HB4693 Engrossed -9- LRB9113012ACtm 1 accordance with this Act. Refusal to permit such entry or 2 inspection shall constitute grounds for denial, nonrenewal, 3 or revocation of a license. 4 Section 60. Denial, suspension, or revocation of 5 license. 6 (a) The Department may deny, suspend, or revoke a 7 license for a violation of this Act or a rule adopted 8 pursuant to this Act. 9 (b) The denial, suspension, or revocation of a license 10 by the Department and the appeal from that action are 11 governed by the Illinois Administrative Procedure Act. 12 (c) Immediately upon the denial, suspension, or 13 revocation of a license, the Department shall notify the 14 applicant or licensee in writing. Notice of the denial, 15 suspension, or revocation shall include a statement of the 16 violations of the Act or rules on which the denial is based 17 and notice of the opportunity for a hearing under the 18 Illinois Administrative Procedure Act. If the applicant 19 desires to contest the Department's action, a written request 20 for a hearing shall be provided to the Department within 10 21 days after receipt of the Department's notice. 22 Section 65. Probationary license. If the applicant has 23 not been previously licensed or if the facility is not in 24 operation at the time application is made, the Department 25 shall issue a probationary license. A probationary license 26 shall be valid for 120 days unless sooner suspended or 27 revoked under this Act. Within 30 days prior to the 28 termination of a probationary license, the Department shall 29 fully and completely inspect the facility and, if the 30 facility meets the applicable requirements for licensure, 31 shall issue a license under this Act. If the Department 32 finds that the facility does not meet the requirements for HB4693 Engrossed -10- LRB9113012ACtm 1 licensure but has made substantial progress toward meeting 2 those requirements, the license may be renewed once for a 3 period not to exceed 120 days from the expiration date of the 4 initial probationary license. 5 Section 70. Change of ownership. 6 (a) Whenever ownership of a facility is transferred from 7 the person named in the license to any other person, the 8 transferee must obtain a new probationary license. The 9 transferee shall notify the Department of the transfer and 10 apply for a new license at least 30 days prior to final 11 transfer. 12 (b) The transferor shall notify the Department at least 13 30 days prior to final transfer. The transferor shall remain 14 responsible for the operation of the facility until such time 15 as a license is issued to the transferee. 16 (c) The license granted to the transferee shall be 17 subject to any plan of correction submitted by the previous 18 owner and approved by the Department and any conditions 19 contained in a conditional license issued to the previous 20 owner. If there are outstanding violations and no approved 21 plan of correction has been implemented, the Department may 22 issue a conditional license and plan of correction as 23 provided in this Act. 24 (d) The transferor shall remain liable for all penalties 25 assessed against the facility that are imposed for violations 26 occurring prior to transfer of ownership. 27 Section 75. Access to information. The following 28 information is subject to disclosure to the public by the 29 Department: 30 (1) records of license inspections, surveys, and 31 evaluations of facilities; and 32 (2) complaints and complaint investigation reports, HB4693 Engrossed -11- LRB9113012ACtm 1 except that a complaint or complaint investigation report 2 shall not be disclosed to a person other than the 3 complainant or complainant's representative before it is 4 disclosed to a facility and except that a complainant's 5 or patient's name shall not be disclosed. 6 Section 80. Information available for public inspection. 7 (a) A facility shall post in plain view of the public 8 (i) its current license, (ii) a description, provided by the 9 Department, of complaint procedures established under this 10 Act, and (iii) the name, address, and telephone number of a 11 person authorized by the Department to receive complaints. 12 (b) A facility shall make the following information or 13 documents available upon request for public inspection: 14 (1) a copy of any order pertaining to the facility 15 issued by the Department or a court; 16 (2) a complete copy of every inspection report of 17 the facility received from the Department during the past 18 5 years; 19 (3) a copy of every order pertaining to the 20 facility issued by the Department or a court during the 21 past 5 years; 22 (4) a description of the services provided by the 23 facility and the rates charged for those services; 24 (5) a copy of the statement of ownership required 25 by this Act; 26 (6) a record of personnel employed or retained by 27 the facility who are licensed, certified, or registered 28 by the Department of Professional Regulation; and 29 (7) a complete copy of the most recent inspection 30 report of the facility received from the Department. 31 Section 85. End Stage Renal Disease Advisory Committee. 32 (a) The Director shall appoint an End Stage Renal HB4693 Engrossed -12- LRB9113012ACtm 1 Disease Advisory Committee to advise and consult with the 2 Director in the administration of this Act. The Committee 3 shall be composed of the following members: 4 (1) 3 members who represent end stage renal disease 5 facilities, one of whom shall represent not-for-profit 6 facilities, one of whom shall represent for-profit 7 facilities, and one of whom shall represent 8 institution-based facilities; 9 (2) 2 members who are physicians licensed to 10 practice medicine in all its branches; 11 (3) one member who is a board-certified 12 nephrologist; 13 (4) one member who represents licensed hospitals; 14 (5) one member who is a registered professional 15 nurse with experience treating end stage renal disease; 16 (6) 3 members of the general public, one of whom is 17 currently receiving dialysis. 18 The recommendations of professional organizations may be 19 considered in selecting individuals for appointment to the 20 End Stage Renal Disease Advisory Committee. 21 (b) Each member shall be appointed for a term of 3 22 years, except that of the original members, 3 shall be 23 appointed for a term of one year, 4 shall be appointed for a 24 term of 2 years, and 4 shall be appointed for a term of 3 25 years. The term of office of each of the original appointees 26 shall commence on July 1, 2000. A member appointed to fill a 27 vacancy occurring prior to the expiration of the term for 28 which his or her predecessor was appointed shall be appointed 29 for the remainder of that term. 30 (c) The Committee shall meet as frequently as the 31 Director deems necessary. Committee members, while serving 32 on business of the Committee, shall receive actual and 33 necessary travel and subsistence expenses while so serving 34 away from their places of residence. HB4693 Engrossed -13- LRB9113012ACtm 1 Section 90. Adoption of rules. The Department shall 2 adopt rules to implement this Act, including requirements for 3 physical plant standards and for the issuance, renewal, 4 denial, suspension, and revocation of a license to operate an 5 end stage renal disease facility. 6 Section 95. Fees. The Department may establish and 7 collect fees in amounts reasonable and necessary to defray 8 the cost of administering this Act. In setting fees under 9 this Act, the Department shall consider setting a range of 10 license and renewal fees based on the number of dialysis 11 stations at the end stage renal disease facility, the patient 12 census, and the average costs involved in surveying the 13 facility. 14 Section 100. Deposit of fees and penalties. Fees and 15 penalties collected under this Act shall be deposited into 16 the End Stage Renal Disease Facility Licensing Fund, which is 17 hereby created as a special fund in the State treasury. 18 Moneys in the Fund may be used, subject to appropriation, by 19 the Department for the administration of this Act. 20 Section 999. Effective date. This Act takes effect upon 21 becoming law.