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Electronic Code of Federal Regulations

e-CFR data is current as of February 26, 2020

Title 42Chapter IVSubchapter GPart 486Subpart G → §486.322

Title 42: Public Health
Subpart G—Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations

§486.322   Condition: Relationships with hospitals, critical access hospitals, and tissue banks.

(a) Standard: Hospital agreements. An OPO must have a written agreement with 95 percent of the Medicare and Medicaid participating hospitals and critical access hospitals in its service area that have both a ventilator and an operating room and have not been granted a waiver by CMS to work with another OPO. The agreement must describe the responsibilities of both the OPO and hospital or critical access hospital in regard to donation after cardiac death (if the OPO has a protocol for donation after cardiac death) and the requirements for hospitals at §482.45 or §485.643. The agreement must specify the meaning of the terms “timely referral” and “imminent death.”

(b) Standard: Designated requestor training for hospital staff. The OPO must offer to provide designated requestor training on at least an annual basis for hospital and critical access hospital staff.

(c) Standard: Cooperation with tissue banks.

(1) The OPO must have arrangements to cooperate with tissue banks that have agreements with hospitals and critical access hospitals with which the OPO has agreements. The OPO must cooperate in the following activities, as may be appropriate, to ensure that all usable tissues are obtained from potential donors:

(i) Screening and referral of potential tissue donors.

(ii) Obtaining informed consent from families of potential tissue donors.

(iii) Retrieval, processing, preservation, storage, and distribution of tissues.

(iv) Providing designated requestor training.

(2) An OPO is not required to have an arrangement with a tissue bank that is unwilling to have an arrangement with the OPO.

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