Sec. 10.30.04.02. Dialyzer Reuse Standards

A. Patient Information.

(1) The freestanding dialysis facility shall:

(a) Provide information to the patient or, if appropriate, the patient's health care decision maker concerning the center's reuse of dialysis supplies, including hemodialyzers and tubing and their suitability for reuse; and

(b) Obtain the patient's or, if appropriate, the patient's health care decision maker's informed consent regarding the reuse of dialysis supplies.

(2) The signed informed consent form shall be maintained in the patient's medical record.

B. Standards. If the freestanding dialysis facility reuses dialysis supplies, the medical director shall:

(1) Develop a dialysis reuse policy in accordance with 42 CFR §494.50, which is incorporated by reference; and

(2) Ensure compliance with the policy.