210 ILCS 62/ End Stage Renal Disease Facility Act. - Illinois Statutes

(210 ILCS 62/1)     Sec. 1. Short title. This Act may be cited as the End Stage Renal Disease Facility Act. (Source: P.A. 92‑794, eff. 7‑1‑03.)

    (210 ILCS 62/5)
    Sec. 5. Definitions. As used in this Act:
    "Committee" means the End Stage Renal Disease Advisory Committee.
    "Department" means the Department of Public Health.
    "Dialysis" means a process by which dissolved substances are removed from a patient's body by diffusion from one fluid compartment to another across a semipermeable membrane.
    "Dialysis technician" means an individual who is not a registered nurse or physician and who provides dialysis care under the supervision of a registered nurse or physician.
    "Director" means the Director of Public Health.
    "End stage renal disease" means that stage of renal impairment that appears irreversible and permanent and that requires a regular course of dialysis or kidney transplantation to maintain life.
    "End stage renal disease facility" or "ESRDF" means a facility that provides dialysis treatment or dialysis training to individuals with end stage renal disease.
    "Licensee" means an individual or entity licensed by the Department to operate an end stage renal disease facility.
    "Nurse" means an individual who is licensed to practice nursing under the Nurse Practice Act.
    "Patient" means any individual receiving treatment from an end stage renal disease facility.
    "Person" means any individual, firm, partnership, corporation, company, association, or other legal entity.
    "Physician" means an individual who is licensed to practice medicine in all of its branches under the Medical Practice Act of 1987.
(Source: P.A. 95‑639, eff. 10‑5‑07.)

(210 ILCS 62/10)     Sec. 10. License required. Except as provided by this Act, no person shall open, manage, conduct, offer, maintain, or advertise an end stage renal disease facility without a valid license issued by the Department.     Each ESRDF, including those that provide only training services, may oversee remote station facilities for home dialysis patients in licensed nursing homes under the ESRDF's license. These remote station facilities are not required to obtain a separate license under this Act, but shall be inspected under Department rules as remote stations of the ESRDF.     Notwithstanding any other provisions of this Section, all end stage renal disease facilities in existence as of the effective date of rules adopted by the Department to implement this Act (the "Implementation Date") may continue to operate but must obtain a valid license to operate within one year after the Implementation Date. (Source: P.A. 92‑794, eff. 7‑1‑03; 93‑766, eff. 7‑20‑04.)

    (210 ILCS 62/15)
    Sec. 15. Exemptions from licensing requirement. The following facilities are not required to be licensed under this Act:
        (1) a home health agency licensed under the Home

Health, Home Services, and Home Nursing Agency Licensing Act;

(2) a hospital licensed under the Hospital Licensing

Act or the University of Illinois Hospital Act; and

(3) the office of a physician. (Source: P.A. 94‑379, eff. 1‑1‑06.)

(210 ILCS 62/20)     Sec. 20. Issuance and renewal of license.     (a) An applicant for a license under this Act shall submit an application on forms prescribed by the Department.     (b) Each application shall be accompanied by a non‑refundable license fee, as established by rule of the Department.     (c) Each application shall contain evidence that there is at least one physician responsible for the medical direction of the facility and that each dialysis technician on staff has completed a training program as required by this Act.     (d) The Department may grant a temporary initial license to an applicant. A temporary initial license expires on the earlier of (i) the date the Department issues or denies the license or (ii) the date 6 months after the temporary initial license was issued. The Department may issue subsequent temporary licenses when necessary.     (e) The Department shall issue a license if, after application, inspection, and investigation, it finds the applicant meets the requirements of this Act and the standards adopted pursuant to this Act. The Department may include participation as a supplier of end stage renal disease services under Titles XVIII and XIX of the federal Social Security Act as a condition of licensure. The Department may consider facilities and remote stations certified under Titles XVIII and XIX of the federal Social Security Act as meeting the licensure requirements under this Section.     (f) The license is renewable annually after submission of (i) the renewal application and fee and (ii) an annual report on a form prescribed by the Department that includes information related to quality of care at the end stage renal disease facility. The report must be in the form and documented by evidence as required by Department rule. (Source: P.A. 92‑794, eff. 7‑1‑03; 93‑766, eff. 7‑20‑04.)

(210 ILCS 62/25)     Sec. 25. Minimum staffing. An end stage renal disease facility shall be under the medical direction of a physician experienced in renal disease treatment, as required for licensure under this Act. Additionally, at a minimum, every facility licensed under this Act shall ensure that whenever patients are undergoing dialysis all of the following are met:         (1) one currently licensed physician, registered

nurse, physician assistant, advanced practice nurse or licensed practical nurse experienced in rendering end stage renal disease care is physically present on the premises to oversee patient care; and

(2) adequate staff is present to meet the medical

and non‑medical needs of each patient, as provided by this Act and the rules adopted pursuant to this Act.

(Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/30)     Sec. 30. Minimum standards.     (a) The rules adopted pursuant to this Act shall contain minimum standards to protect the health and safety of a patient of an end stage renal disease facility, including standards for:         (1) the qualifications and supervision of the

professional staff and other personnel;

(2) the equipment used by the facility to insure

that it is compatible with the health and safety of the patients;

(3) the sanitary and hygienic conditions in the

facility;

(4) quality assurance for patient care;         (5) clinical records maintained by the facility;         (6) design and space requirements for the facility

to insure safe access by patients and personnel and for ensuring patient privacy;

(7) indicators of the quality of care provided by

the facility; and

(8) water treatment and reuse by the facility.     (b) These standards shall be consistent with the requirements for a supplier of end stage renal disease services under Titles XVIII and XIX of the federal Social Security Act. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/35)     Sec. 35. Training; minimum requirements. An end stage renal disease facility shall establish and implement a policy to ensure appropriate training and competency of individuals employed as dialysis technicians within the licensed facility. The policy shall, at a minimum, define the acts and practices that are allowed or prohibited for such employees, establish how training will be conducted, and illustrate how initial competency will be established. Proof of initial and annual competency testing shall be maintained in the personnel file of each dialysis technician and shall be made available to the Department upon request. An individual may not act as a dialysis technician in an end stage renal disease facility unless that individual has been trained and competency tested in accordance with this Act and the rules adopted under this Act. Persons training to act as a dialysis technician must be under the direct supervision of a physician or an appropriately trained nurse. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/40)     Sec. 40. Inspections.     (a) The Department, whenever it deems necessary, may conduct an inspection, survey, or evaluation of an end stage renal disease facility to determine compliance with licensure requirements and standards or a plan of correction submitted as a result of deficiencies cited by the Department.     (b) An inspection conducted under this Section shall be unannounced.     (c) Upon completion of each inspection, survey, or evaluation, the appropriate Department personnel who conducted the inspection, survey, or evaluation shall submit a copy of their report to the licensee upon exiting the facility, and shall submit the actual report to the appropriate regional office. The report shall identify areas in a facility identified as deficient in compliance with the requirements of this Act or the standards adopted under this Act. The report and any recommendation for action by the Department under this Act shall be sent to the Department's central office together with a plan of correction from the facility. The plan of correction may contain related comments or documentation provided by the licensee that may refute findings in the report, that explain extenuating circumstances that the facility could not reasonably have prevented, or that indicate methods and timetables for correction of deficiencies described in the report. A licensee has 10 days after the date of the inspection, survey, or evaluation to submit a plan of correction.     (d) The Department shall determine whether a facility is in violation of this Section no later than 60 days after completion of each inspection, survey, evaluation, or plan of correction.     (e) The Department shall maintain all inspection, survey, or evaluation reports for at least 5 years in a manner accessible to the public. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/45)     Sec. 45. Notice of violation. When the Department determines that a facility is in violation of this Act or of any rule promulgated hereunder, a notice of violation shall be served upon the licensee. Each notice of violation shall be prepared in writing and shall specify the nature of the violation and the statutory provision or rule alleged to have been violated. The notice shall inform the licensee of any action the Department may take under the Act, including the requirement of a plan of correction under Section 50, or licensure action under Section 60. The Director or his designee shall also inform the licensee of the right to a hearing under Section 60. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/50)     Sec. 50. Plan of correction.     (a) Each facility served with a notice of violation under Section 45 of this Act shall file with the Department a written plan of correction, which is subject to approval of the Department, within 10 days after receipt of such notice. The plan of correction shall state with particularity the method by which the facility intends to correct each violation and shall contain a stated date by which each violation shall be corrected.     (b) If the Department rejects a plan of correction, it shall send notice of the rejection and the reason for the rejection to the licensee. The facility shall have 10 days after receipt of the notice of rejection to submit a modified plan. If the modified plan is not timely submitted, or if the modified plan is rejected, the facility shall follow a plan of correction imposed by the Department.     (c) If a facility desires to contest any Department action under this Section it shall send a written request for a hearing under Section 60 to the Department within 10 days of receipt of the notice of the contested action. The Department shall commence the hearing as provided in Section 60. Whenever possible, all actions of the Department under this Section arising out of a single violation shall be contested and determined at a single hearing. Issues decided as the result of the hearing process may not be reheard at subsequent hearings under this Act, but such determinations may be used as grounds for other administrative action by the Department pursuant to this Act. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/55)     Sec. 55. Denial, suspension, revocation, or refusal to renew a license; suspension of a service.     (a) When the Director determines that there is or has been a substantial or continued failure to comply with this Act or any rule promulgated hereunder, the Department may issue an order of license denial, suspension, revocation, or refusal to renew a license in accordance with subsection (a) of Section 60 of this Act.     (b) When the Director determines that a facility has failed to demonstrate the capacity to safely provide one or more of its services to patients, the Department may issue an order of service suspension in accordance with subsection (a) of Section 60 of this Act. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/60)     Sec. 60. Notice of administrative actions; hearing procedures.     (a) Notice of all administrative actions taken under this Act shall be effected by registered mail, certified mail, or personal service and shall set forth the particular reasons for the proposed action and provide the applicant or licensee with an opportunity to request a hearing. If a hearing request is not received within 10 days after receipt of the notice of administrative action, the right to a hearing is waived.     (b) The procedure governing hearings authorized by this Section shall be in accordance with rules promulgated by the Department consistent with this Act. A hearing shall be conducted by the Director or by an individual designated in writing by the Director as administrative law judge. A full and complete record shall be kept of all proceedings, including notice of hearing, complaint, and all other documents in the nature of pleadings, written motions filed in the proceedings, and the report and orders of the Director and administrative law judge. All testimony shall be reported but need not be transcribed unless the decision is appealed pursuant to Section 70 of this Act. Any interested party may obtain a copy or copies of the transcript on payment of the cost of preparing such copy or copies.     (c) The Director or administrative law judge shall, upon his own motion or on the written request of any party to the proceeding, issue subpoenas requiring the attendance and testimony of witnesses and subpoenas duces tecum requiring the production of books, papers, records or memoranda. The fees of witnesses for attendance and travel shall be the same as the fees of witnesses before any circuit court of this State. Such fees shall be paid when the witness is excused from further attendance. When the witness is subpoenaed at the instance of the Director or administrative law judge, such fees shall be paid in the same manner as other expenses of the Department. When the witness is subpoenaed at the instance of any other party to a proceeding, the Department may require that the cost of service of the subpoena or subpoena duces tecum and the fee of the witness be borne by the party at whose instance the witness is summoned. In such case, the Department, in its discretion, may require a deposit to cover the cost of such service and witness fees. A subpoena or subpoena duces tecum issued under this Section shall be served in the same manner as a subpoena issued by a court.     (d) Any circuit court of this State, upon the application of the Director or the application of any other party to the proceeding, may, in its discretion, compel the attendance of witnesses, the production of books, papers, records or memoranda, and the giving of testimony before the Director or administrative law judge conducting an investigation or holding a hearing authorized by this Act, by an attachment for contempt, or otherwise, in the same manner as production of evidence may be compelled before the court.     (e) The Director or administrative law judge, or any party in a hearing before the Department, may compel the attendance of witnesses and the production of books, papers, records, or memoranda.     (f) The Director or administrative law judge shall make findings of fact in such hearing and the Director shall render his decision within 60 days after the termination or waiving of the hearing unless he or she requires additional time for a proper disposition of the matter. When a administrative law judge has conducted the hearing, the Director shall review the record and findings of fact before rendering a decision. A copy of the findings of fact and decision of the Director shall be served upon the applicant or licensee in person, by registered mail or by certified mail in the same manner as the service of the notice of hearing. The decision denying, suspending, or revoking a license shall become final 35 days after it is mailed or served, unless the applicant or licensee, within the 35‑day period, petitions for review pursuant to Section 70 of this Act. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/65)     Sec. 65. Receiving and investigating complaints. The Department shall establish by rule a procedure for receiving and investigating complaints regarding any ESRDF, consistent with federal complaint procedures. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/70)     Sec. 70. Judicial review. Whenever the Department refuses to grant or decides to revoke or suspend a license to open, conduct, or maintain an ESRDF, the applicant or licensee may have such decision judicially reviewed. The provisions of the Administrative Review Law and the rules adopted pursuant thereto shall apply to and govern all proceedings for the judicial review of final administrative decisions of the Department hereunder. The term "administrative decisions" is defined as in Section 3‑101 of the Code of Civil Procedure. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/75)     Sec. 75. Fines. Any person opening, conducting, or maintaining an ESRDF without a license issued pursuant to this Act shall be guilty of a business offense punishable by a fine of $5,000 and each day's violation shall constitute a separate offense. Any person opening, conducting, or maintaining an ESRDF who violates any other provision of this Act shall be guilty of a business offense punishable by a fine of not more than $5,000.     The Department shall adopt rules for determining the fines for violations. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/80)     Sec. 80. Injunctions. The operation or maintenance of an ESRDF in violation of this Act or of the rules adopted by the Department is declared a public nuisance inimical to the public welfare. The Director of the Department, in the name of the People of the State, through the Attorney General or the State's Attorney of the county in which the violation occurs, may, in addition to other remedies herein provided, bring action for an injunction to restrain such violation or to enjoin the future operation or maintenance of any such ESRDF. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/85)     Sec. 85. Department access to and reproduction of documents. The Department shall have access to and may reproduce or photocopy at its cost any books, records, and other documents maintained by the facility to the extent necessary to carry out the purposes of this Act and the rules adopted under this Act. The Department shall not divulge or disclose the identity of any patient or other information prohibited from disclosure by the laws of this State. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/90)     Sec. 90. Refusal to allow inspections. Any licensee, applicant for a license, or person operating what may be an end stage renal disease facility shall be deemed to have given consent to any authorized officer, employee, or agent of the Department to enter and inspect the facility in accordance with this Act. Refusal to permit such entry or inspection shall constitute grounds for denial, nonrenewal, or revocation of a license. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/95)     Sec. 95. Probationary license. If the applicant has not been previously licensed or if the facility is not in operation at the time application is made, the Department shall issue a probationary license. A probationary license shall be valid for 120 days unless sooner suspended or revoked under this Act. Within 30 days prior to the termination of a probationary license, the Department shall fully and completely inspect the facility and, if the facility meets the applicable requirements for licensure, shall issue a license under this Act. If the Department finds that the facility does not meet the requirements for licensure but has made substantial progress toward meeting those requirements, the license may be renewed once for a period not to exceed 120 days from the expiration date of the initial probationary license. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/100)     Sec. 100. Change of ownership.     (a) Whenever ownership of a facility is transferred from the person named on the license to any other person, the transferee must obtain a new probationary license. The transferee shall notify the Department of the transfer and apply for a new license at least 30 days prior to final transfer.     (b) The transferor shall notify the Department at least 30 days prior to final transfer. The transferor shall remain responsible for the operation of the facility until such time as a license is issued to the transferee.     (c) The license granted to the transferee shall be subject to any plan of correction submitted by the previous owner and approved by the Department and any conditions contained in a conditional license issued to the previous owner. If there are outstanding violations and no approved plan of correction has been implemented, the Department may issue a conditional license and plan of correction as provided in this Act.     (d) The transferor shall remain liable for all penalties assessed against the facility that are imposed for violations occurring prior to transfer of ownership. (Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/105)     Sec. 105. Access to information. The following information is subject to disclosure to the public by the Department:         (1) records of license inspections, surveys, and

evaluations of facilities; and

(2) complaints and complaint investigation reports,

except that a complaint or complaint investigation report shall not be disclosed to a person other than the complainant or complainant's representative before it is disclosed to a facility and except that a complainant's or patient's name shall not be disclosed. This information shall not disclose the name of any health care professionals or employees at the facility.

(Source: P.A. 92‑794, eff. 7‑1‑03.)

(210 ILCS 62/110)     Sec. 110. Information available for public inspection.     (a) A facility shall post in plain view of the public (i) its current license, (ii) a description of complaint procedures established under this Act provided by the Department, and (iii) the name, address, and telephone number of a person authorized by the Department to receive complaints.     (b) A facility shall make the following information or documents available upon request for public inspection:         (1) a copy of any order pertaining to the facility

issued by the Department or a court during the past 5 years;

(2) a complete copy of every inspection report of

the facility received from the Department during the past 5 years;

(3) a description of the services provided by the

facility and the rates charged for those services;

(4) a copy of the statement of ownership required by

this Act; and

(5) a complete copy of the most recent inspection

report of the facility received from the Department. This information shall not disclose the name of any health care professionals or employees at the facility.

(Source: P.A. 92‑794, eff. 7‑1‑03.)

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