The OPTN/UNOS Board of Directors, at its meeting November 12-13, approved policies to ensure thorough and consistent processes are used in the medical evaluation and informed consent process for living organ donors. The policies specifically address living donation for kidney transplantation as well as segmental liver, lung, intestine and/or pancreas transplantation.
“These policies will support the needs and interests of people who choose to help a relative, a friend, or even a complete stranger through living donation,” said Carl Berg, M.D., OPTN/UNOS president. “They standardize certain medical tests, evaluation criteria and informed consent processes at all transplant hospitals. The individual transplant team will still decide whether living donation is appropriate for a given potential donor. In many cases, the transplant program will perform additional tests and take additional steps to help them make that decision.”
Similar policies have been in effect since February 2013 for living donor kidney transplantation, which is the most common form of living organ donation. The policies newly approved by the Board address commonalities for living donation of kidney, liver, lung, intestine and pancreas, while specifying additional criteria most appropriate to each organ type.
In other action, the Board approved a series of policy revisions and new policies to help minimize the risk of transmitting blood-borne infectious disease through transplantation. The policies conform to guidance issued in June 2013 by the Public Health Service to reduce the transmission risk of diseases including HIV and hepatitis. The new and updated requirements apply to both deceased and living donors and address a variety of topics including:
- laboratory testing of potential donors and recipients, including new requirements related to nucleic acid testing (NAT)
- collection, storage, tracking and reporting of donor and recipient specimens
- informed consent of potential recipients
- donor risk assessment and screening
The Board also endorsed four guidance documents addressing various donation and transplantation topics. The guidance documents are not policies subject to specific monitoring or enforcement. They are intended either to establish fundamental principles that may be used to develop or interpret policy, or to provide resource information to donation and transplantation professionals to aid in their decision-making. The documents include:
- donor screening guidance for seasonal and geographically endemic infectious diseases
- general principles for allocation of organs to pediatric candidates
- guidance for the allocation of heart/lung combinations
- guidance to develop protocols for authorization to donate vascularized composite allografts (VCA), such as the face or limb
United Network for Organ Sharing (UNOS) serves as the Organ Procurement and Transplantation Network (OPTN) by contract with the U.S. Department of Health and Human Services, Health Resources and Services Administration, Division of Transplantation. The OPTN brings together medical professionals, transplant recipients and donor families to develop national organ transplantation policy.