Conditions for Coverage for End-stage Renal Disease Facilities

Basis and scope.

This provision identifies the statutory authority and scope for the conditions of coverage for End-Stage Renal Disease (ESRD) facilities.

Definitions.

As used in this part—

Condition: Care at home.

A dialysis facility that is certified to provide services to home patients must ensure through its interdisciplinary team, that home dialysis services are at least equivalent to those provided to in-facility patients and meet all applica...

Condition: Quality assessment and performance improvement.

The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team.

Condition: Special purpose renal dialysis facilities.

A special purpose renal dialysis facility is approved to furnish dialysis on a short-term basis at special locations.

Condition: Laboratory services.

The dialysis facility must provide, or make available, laboratory services (other than tissue pathology and histocompatibility) to meet the needs of the patient.

Condition: Personnel qualifications.

All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed.

Condition: Responsibilities of the medical director.

The dialysis facility must have a medical director who meets the qualifications of § 494.140(a) to be responsible for the delivery of patient care and outcomes in the facility.

[Reserved]

This section is reserved and contains no regulatory requirements.

Condition: Medical records.

The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of dialysis services and...

Condition: Governance.

The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility.

Condition: Compliance with Federal, State, and local laws and regulations.

The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements.

Condition: Infection control.

The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.

Condition: Water and dialysate quality.

The facility must be able to demonstrate the following:

Condition: Reuse of hemodialyzers and bloodlines.

This provision outlines the requirements for the safe reuse of hemodialyzers and bloodlines, including reprocessing guidelines, monitoring, and reporting of adverse outcomes.

Condition: Physical environment.

The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.

Condition of participation: Emergency preparedness.

The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements.

Condition: Patients' rights.

The dialysis facility must inform patients (or their representatives) of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights.

Condition: Patient assessment.

The facility's interdisciplinary team consists of, at a minimum, the patient or the patient's designee (if the patient chooses), a registered nurse, a physician treating the patient for kidney failure, a social worker, and a dietitian.

Condition: Patient plan of care.

The interdisciplinary team as defined at § 494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient's needs, as identified by the comprehensive as...