Federal Regulations

Since the Organ Procurement and Transplantation Network (OPTN) was established in 1984, OPOs and hospitals all over the country have worked together to increase the availability of organs and tissues.

While OPOs span both the professional sphere and the general public, they depend heavily on their partner hospitals to help recover as many transplantable organs as possible. The expectation that hospitals and OPOs work together is established in federal and state laws as well as in Health and Human Services (HHS) rules and regulations.
Federal regulations require that all imminent and actual deaths are referred to an OPO representative to allow for the opportunity for donation.  It is the OPO’s responsibility to evaluate the viability of organs and tissues for transplantation on a case-by-case basis.


Federal Regulations and Organizations

Organ Procurement and Transplantation Network (OPTN)

In 1984, the National Organ Transplant Act (NOTA) established the OPTN as a nationally integrated system for organ donation.

The OPTN is a public-private partnership that enables professionals involved in the donation and transplantation system to interact and coordinate organ sharing 24 hours a day. By facilitating communication across a large geographic area, the OPTN seeks to improve effectiveness, efficiency, and equity in organ sharing nationwide and, consequently, increase the supply of donated organs. The OPTN operates the national database of all patients in the U.S. waiting for a transplant. In addition, the OPTN develops policies and procedures for organ recovery and allocation, and evaluates OPOs and transplant centers for compliance.

The contract for operation of the OPTN was awarded in 1986 [3] to a Richmond-based private, not-for-profit organization called the United Network for Organ Sharing (UNOS) [4]. In 1999, as a move towards a "fast, reliable system to match organs to patient," UNOS started using an internet-based system called UNet to connect transplant hospitals and OPOs [5]. UNet allows transplant hospitals to list patients on the transplant waiting list, and complete and submit OPTN data forms, status justification forms and access reports in a real-time, secure, and a confidential environment. OPOs use UNet to add donors and run donor-recipient matching lists. Donated organs are also offered to transplant centers through UNet.


Centers for Medicare & Medicaid Services (CMS) Conditions of Participation for hospitals require that all providers who accept Medicare and Medicaid financing cooperate and work together to maximize organ and tissue donation by identifying and referring all patients who are at risk of imminent death to the OPO (42 CFR 482.5). Failure to comply with CMS Conditions of Participation places providers at risk of being unable to bill Medicare or Medicaid for services.


The CMS Conditions for Coverage for OPOs (42 CFR Parts 413, 441, 486 & 498,) establish quality standards and specify reporting requirements for OPOs to the OPTN. Specifically, under § 486.328, an OPO must provide individually-identifiable, hospital-specific organ donation and transplantation data and other information to the Organ Procurement and Transplantation Network, the Scientific Registry of Transplant Beneficiaries, and DHHS, as requested by the Secretary. The data may include, but are not limited to, the number of hospital deaths, results of death record reviews, number and timeliness of referral calls from hospitals, number of eligible deaths, data related to non-recovery of organs, data about consents for donation, number of eligible donors, number of organs recovered (by type of organ), and number of organs transplanted (by type of organ).

An OPO must provide hospital-specific organ donation data annually to transplant hospitals with which it has agreements. Data reported by the OPO to OPTN must be reported within 30 days after the end of the month in which a death occurred.

The FDA regulates the use of tissue in transplantation. This includes corneas, tendons, bone, skin and other tissues. FDA rules stipulate the criteria for selecting donors, the handling and processing and transportation of tissue, storage and transfer to tissue banks so that it can be available for future patients.

The FDA regulates human cells, tissues or cellular or tissue-based products intended for implantation, transplantation, infusion or transfer into a human recipient as HCT/Ps. The FDA established regulations for HCT/Ps to prevent the introduction, transmission, and spread of communicable diseases. Further, the FDA issues guidance to assist in complying with the requirements for donor-eligibility determinations based on donor screening and testing for relevant communicable disease agents and diseases. Specifically, under § 1271.50, a donor-eligibility determination is a conclusion that a donor is either eligible or ineligible to donate cells or tissues to be used in an HCT/P, based on results of donor screening and testing.

Organ donation and transplantation proceeds in the context of a strong institutional framework regulated by the federal government.