Organ Donation Organization Architecture: Recommendations From an International Consensus Forum.

This report contains recommendations from 1 of 7 domains of the International Donation and Transplantation Legislative and Policy Forum (the Forum). The purpose is to provide expert guidance on the structure and function of Organ and Tissue Donation and Transplantation (OTDT) systems. The intended audience is OTDT stakeholders working to establish or improve existing systems. Methods: The Forum was initiated by Transplant Québec and co-hosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. This domain group included administrative, clinical, and academic experts in OTDT systems and 3 patient, family, and donor partners. We identified topic areas and recommendations through consensus, using the nominal group technique. Selected topics were informed by narrative literature reviews and vetted by the Forum's scientific committee. We presented these recommendations publicly, with delegate feedback being incorporated into the final report. Results: This report has 33 recommendations grouped into 10 topic areas. Topic areas include the need for public and professional education, processes to assure timely referral of patients who are potential donors, and processes to ensure that standards are properly enforced. Conclusions: The recommendations encompass the multiple roles organ donation organizations play in the donation and transplantation process. We recognize the diversity of local conditions but believe that they could be adapted and applied by organ donation organizations across the world to accomplish their fundamental objectives of assuring that everyone who desires to become an organ donor is given that opportunity in a safe, equitable, and transparent manner.

Deceased Donor Organ Transplantation Performed in the United States for Noncitizens and Nonresidents.

Since 2012, the Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) has required transplant centers to record the citizenship residency status of patients undergoing transplantation in the United States. This policy replaced the 5% threshold of the non-US citizen/nonresidents (NC/NR) undergoing organ transplantation that could result in an audit of transplant center activity. Since April 1, 2015, the country of residence for the NC/NR on the waitlist has also been recorded. We analyzed the frequency of NC/NR deceased donor organ transplants and waitlist registrations at all US transplant centers by data provided by UNOS for that purpose to the UNOS Ad Hoc International Relations Committee. During the period of 2013 to 2016, 1176 deceased donor transplants (of all organs) were performed in non-US citizen/non-US resident (NC/NR) candidates (0.54% of the total number of transplants). We focused on high-volume NC/NR transplant centers that performed more than 5% of the deceased donor kidney or liver transplants in NC/NR or whose waitlist registrants exceeded 5% NC/NR. This report was prepared to fulfill the transparency policy of UNOS to assure a public trust in the distribution of organs. When viewed with a public awareness of deceased donor organ shortages, it suggests the need for a more comprehensive understanding of current NC/NR activity in the United States. Patterns of organ specific NC/NR registrations and transplantations at high-volume centers should prompt a review of transplant center practices to determine whether the deceased donor and center resources may be compromised for their US patients.

Honoring patients' organ donation decisions when family conflict is present: Experience from a single organ procurement organization.

BACKGROUND: Donor designation refers to the laws and processes for documentation of an individual's wishes regarding organ donation should that person become eligible for donation at death. All 50 states have laws supporting donor designation. Donor-family conflict arises when a designated donor's family attempts to rescind the donor's authorization to donate. Little guidance exists in the current literature to address these situations. METHODS: Hospital public relations offices and organ procurement organization (OPO) records were queried to assess the incidence of legal action and adverse media coverage. Public legal records were searched for civil actions involving the hospitals at which these conflicts occurred. RESULTS: Fourteen cases of donor-family conflict were identified. Organ procurement proceeded in 9 (64%) of 14. A total of 38 organs were transplanted from these 9 donors. For those nine cases, median follow-up time was 57 months (interquartile range, 52-77 months; range, 38-114 months). The identified reasons for conflict include a belief by the family that they were given a choice in the decision about whether to proceed with donation; misunderstanding and lack of acceptance of the brain death diagnosis; disagreement among family members; concerns about timing/length of the donation process and desire to withdraw ventilator support; next-of-kin anger over cause of death when cause of death was suicide; and challenges to the validity of donor document and stated donor intent. No adverse news items were reported, and no lawsuits were filed in cases of donor-family conflict where organ donation proceeded. In addition, we found no mention of lawsuits brought against hospitals for failure to proceed with organ donation when donor was designated and eligible. CONCLUSION: The 2006 Anatomical Gift Act compels hospitals and OPOs to pursue donation regardless of family wishes in cases of brain death in designated donors. When a donor's family attempts to rescind the donor's authorization, the donor's wishes, not the families, should be honored. Fears of legal action and adverse media coverage are unfounded. Clinicians, OPO staff, and hospital administrators should strive to understand state donor designation law and create a plan for managing this conflict should it arise. LEVEL OF EVIDENCE: Therapeutic/care management study, level V.

The nondirected live-kidney donor: ethical considerations and practice guidelines: A National Conference Report.

BACKGROUND: The success of kidney transplantation from a genetically unrelated living spouse or friend has influenced transplant physicians to consider the requests of individuals wishing to volunteer to be a kidney donor who have no intended recipient specified. Representatives of the transplant community gathered in Boston, MA, on May 31, 2001, to deliberate on the experience of live kidney donation from such volunteers, currently termed nondirected donors (NDD). OBJECTIVE OF CONFERENCE PARTICIPANTS: The objective of the conference was to recommend ethical and practice guidelines for health care professionals considering the transplantation of a kidney from a live NDD. CONFERENCE PARTICIPANTS: This conference was convened under the sponsorship of The National Kidney Foundation, with representation from The American Society of Transplantation and The American Society of Transplant Surgeons, The American Society of Nephrology, The United Resource Networks, The United Network for Organ Sharing, The Association of Organ Procurement Organizations, The National Institutes of Health, and The Division of Transplantation of the Health Resources and Services Administration (see Appendix). CONFERENCE REPORT: The suggested content of screening interviews, which provide information regarding the donation process, elicits pertinent medical and psychosocial history, and assesses NDD motivation are presented in this report. Approaches to identifying the center that would evaluate the suitability of the NDD, to performing the kidney recovery, and to selecting the NDD recipient are also proposed. Other ethical issues such as the use of prisoners as an NDD, compensation for the NDD, media involvement, and communication between the NDD and recipient are discussed. CONCLUSION: The willingness of health care professionals to consider NDD volunteers is driven by the compelling need to provide organs for an ever-expanding list of patients awaiting a kidney transplant. However, the psychological impact and emotional reward of donation has yet to be determined for NDD who may not have any relationship to the recipient or knowledge of the recipient's outcome. Transplant centers that accept NDD should document an informed consent process that details donor risks, assures donor safety, and determines that the goals and expectations of the NDD and the recipient can be realized.