A. Patient Information.
(1) The kidney dialysis center 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 home dialysis; 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 kidney dialysis center reuses dialysis supplies, the medical director shall:
(1) Develop a dialysis reuse policy in accordance with 42 CFR §§405.2139(a), 405.2140(a)(5), (b), and (c), and 405.2150, which are incorporated by reference; and
(2) Ensure compliance with the policy.