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Medicare Conditions of Participation
Coverage for End-Stage Renal Disease Facilities

8. ) Coverage for End-Stage Renal Disease Facilities

        a.) General Provisions

A dialysis facility and its staff must operate and furnish services in compliance with federal and state laws pertaining to licensure and other relevant health and safety requirements.178

        b.) Patient Safety

A dialysis facility must provide a sanitary environment to minimize the transmission of infectious diseases. 179 The facility must report incidences of communicable diseases as required by federal or state regulations.

A dialysis facility must be designed to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.180 This regulation provides standards for the dialysis facility’s building, patient care environment, emergency preparedness of staff, and fire safety.

        c.) Patient Care

A dialysis facility must inform patients or their representatives of their rights and responsibilities when they begin their treatment.181 The facility must also display a copy of a list of patient’s rights in the facility.

A dialysis facility’s interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs.182 The comprehensive assessment must be used to develop the patient’s treatment plan and expectations for care.

A dialysis facility must develop an effective, data-driven quality assessment and performance improvement program with participation by the interdisciplinary team.183 The facility must maintain and demonstrate evidence of its quality and performance improvement program for review by CMS.

        d.) Administration

All dialysis staff must meet applicable licensure requirements and personnel qualifications.184 A dialysis facility must have a medical director who is responsible for the delivery of patient care and outcomes in the facility.185 The medical director must focus on quality assessment and performance improvement program and staff education and performance.

A dialysis facility must maintain records on all patients including home patients.186 The facility must protect patient records, complete records in a prompt manner, keep information in a centeralized place, and retain patient records for 6 years from the date of the patient’s discharge, transfer, or death. 



  • 178. 42 C.F.R. § 494.20
  • 179. 42 C.F.R. § 494.30
  • 180. 42 C.F.R. § 494.60
  • 181. 42 C.F.R. § 494.70
  • 182. 42 C.F.R. §§ 494.80; 494.90
  • 183. 42 C.F.R. § 494.110
  • 184. 42 C.F.R. § 494.140
  • 185. 42 C.F.R. § 494.150
  • 186. 42 C.F.R. § 494.170