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

2. 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.

3. # 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.

4. 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.

5. 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.

6. 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

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