Guidance for VCA Deceased Donor Authorization (Resolution 7) Vascularized Composite Allograft (VCA)Transplantation Committee Sue V. McDiarmid, MD, Chair

Guidance for VCA Deceased Donor Authorization July 3, 2014 VCAs were classified as “covered human organs” under the OPTN Final Rule Prior to that time, VCAs were not considered an organ and fell under the U.S. Food and Drug Administration Individuals enrolling in donor registries likely did not consider VCAs in decision-making On July 3, 2014, VCAs were classified as “covered human organs” under the OPTN Final Rule. New OPTN Policies and Bylaws regarding VCAs were effective at the same time. However, prior to this date, federal regulation and the OPTN Bylaws and Policies did not include VCAs as an “organ”. Covered human organs prior to that time included a kidney, liver, heart, lung, pancreas, or intestine (including the esophagus, stomach, small or large intestine, or any portion of the gastrointestinal tract). These human organs were likely the scope of the general public’s understanding of an organ that may be used in a transplant procedure. Additionally, these organs were likely the scope considered when an individual entered a decision regarding donor authorization in a recognized donor registry, and VCAs were likely not considered in decision-making. The goal of this guidance document is to provide support to Organ Procurement Organizations (OPOs) and other designated requestors, transplant hospitals, staff at local donor hospitals and administrators, as well as the general public.

# 1 – Increase the number of transplants Strategic Plan # 1 – Increase the number of transplants Increase the number of organ donors Provide clear and accurate information on VCA deceased donor authorization Alignment with the OPTN Strategic Plan is noted here to maximize the number of donors and transplants.

Guidance for VCA Deceased Donor Authorization Transparency in donation request Guidance on obtaining explicit and specific authorization for VCA recovery The VCA Committee sought to: Ensure of this transparency in the donation request Require explicit and specific authorization for VCA from deceased donors, whether given by the donor prior to death, or by family as surrogate decision makers after death, and Authorization for VCA donation should not be assumed under the general term “organ” donation.

Guidance for VCA Deceased Donor Authorization VCA Committee collaborated with the following groups: OPO Committee Minority Affairs Committee Transplant Coordinators Committee Patient Affairs Committee Ethics Committee Living Donor Committee Association of Organ Procurement Organizations The guidance document was a collaborative effort by the VCA and Ethics Committees. Review and input was sought by seven other groups identified on the slide. Feedback was very positive and the consensus was the guidance document would be helpful to the transplant community and the public regarding deceased VCA donor authorization.

Overall Project Impact Product Guidance Document Target Population Impact: OPOs, transplants hospitals, designated requesters, staff at donor hospitals, and the public Total IT Implementation Hours 0/10,680 Total Overall Implementation Hours 25/17,885

Resolution 7, page 16 RESOLVED, that the guidance document entitled, “Guidance for VCA Deceased Donor Authorization”, is hereby approved, effective November 13, 2014.