Conditions for Participation

Hospitals Conditions of Participation for Organ Donation

In 1998 the Health Care Financing Administration, now Centers for Medicare and Medicaid Services, published a rule that imposed several requirements a hospital must meet that are designed to increase organ donation. Every hospital that receives Medicare or Medicaid funding must follow these conditions.

FEDERAL REGULATORY SUMMARY

Department of Health and Human Services

42 CFR Part 482

Medicare and Medicaid Programs; Hospital Conditions of Participation; Identification of Potential Organ, Tissue, and Eye Donors and Transplant Hospitals'' Provision of Transplant-Related Data

Agency: Centers for Medicare and Medicaid Services

Effective Date: August 21, 1998

• hospitals must have agreements with a designated OPO and notify, in a timely manner, the OPO (or a designated third party) of all individuals whose death is imminent or who have died in the hospital
• the OPO determines the medical suitability of the donors for donation
• hospitals must have an agreement with at least one tissue bank and eye bank and to cooperate in the retrieval, processing, preservation and storage and distribution of tissue and eyes to assure that all usable tissues and eyes are obtained from potential donors.
• hospitals must ensure, in collaboration with the OPO, that the family of each potential donor is informed of their options to donate organs and tissues
• the individual designated by the hospital to initiate the request to the family must be a "designated requester" or a representative from the OPO
• a "designated requester" is an individual who has completed a course offered or approved by the OPO (and designed in conjunction with the tissue and eye bank community) in the methodology for approaching potential donor families and requesting donation.
• hospitals must encourage discretion and sensitivity with respect to the families of potential donors
• hospitals must work collaboratively with the OPO, tissue and eye bank in educating staff on donation issues, reviewing death records, and maintaining potential donors during the testing and placement processes
• hospitals with transplant programs must be a member of the OPTN and abide by its rules
• "rules of the OPTN" are defined as those rules provided in regulation by the Secretary in accordance with section 372 of the Public Health Service Act (NOTA)
• "organ" is defined as a human kidney, liver, heart, lung or pancreas
• hospitals with transplant programs must provide organ transplant-specific data as requested by the OPTN, the Scientific Registry, the OPO''s and provide such data directly to the Department of Health and Human Services when requested by the Secretary.