At a glance
What is current policy and why change it?
The Organ Procurement and Transplant Network (OPTN) officially designated Vascular Composite Allografts (VCA) as organs in 2014. The OPTN has allocated and collected data on VCA transplants separately from all other organs, which are managed in the OPTN computer system, UNetSM. The OPTN is adding VCA transplants to UNet so all organs will be managed and allocated in one system. These changes will update policies by adding VCA allocation and data reporting in UNet.
Programming VCA Allocation in UNet
Dr. Sandra Amaral, Chair of the OPTN Vascularized Composite Allograft Committee, reviews the Programming VCA Allocation in UNet policy proposal.
Terms you need to know
- Vascularized Composite Allograft (VCA): Transplant of multiple structures, which may include connective tissue, skin, bone, muscles, blood vessels, and nerves. Face and hand transplants are two of the most well-known types of VCA transplants.
- Organ Procurement Organization (OPO): An organization designated by the Centers for Medicare and Medicaid Services (CMS) and responsible for the procurement of organs for transplantation and the promotion of organ donation. OPOs serve as the vital link between the donor and recipient and are responsible for the identification of donors, and the retrieval, preservation and transportation of organs for transplantation. They are also involved in data follow-up regarding deceased organ donors. As a resource to the community, OPOs engage in public education the critical need for organ donation.
- UNet: A centralized computer network that links transplant hospitals, OPOs, and histocompatibility labs on one secure web-based transplant platform. Transplant professionals use UNet to list patients for transplant, match patients with available donor organs, and submit required OPTN data.
What’s the proposal?
- Update policy to reflect that all organs will be managed and allocated in one system
- Eliminate the manual process currently used for VCA transplants
- Align VCA organs with all other organs
What’s the anticipated impact of this change?
- What it’s expected to do
- Eliminate separate system used to manage and allocate VCA transplants
- Require Organ Procurement Organizations (OPO), laboratories, and transplant hospitals to use UNet for VCA allocation
- Provide improved data reporting
- Provide a more organized method for identifying VCA organ candidates
- Reduce paperwork for OPOs and transplant hospitals
- What it won’t do
- It will not impact how candidates for VCA organs are prioritized on the match run to receive a potential transplant
Themes to consider
- Data reporting
- System efficiency
This proposal is related to two other proposals that have been released for public comment this cycle. These three proposals are summarized below.
|Modify Living Donation Policy to Include Living VCA Donors
Sponsor: Living Donor Committee
|Modify Data Collection on VCA Living Donors
Sponsor: VCA Transplantation Committee
|Programming VCA Allocation in UNet
Sponsor: VCA Transplantation Committee
Another proposal sponsored by the VCA Transplantation Committee, Update to VCA Transplant Outcomes Data Collection, was approved by the Board of Directors in June 2020 and modifies data collection for VCA transplant recipients. Updates to VCA transplant program membership requirements and the list of covered body parts pertaining to VCA were previously approved by the OPTN Board and are also pending implementation. A summary of these changes is available in a combined policy notice.
All of these proposals will be implemented together with a target completion date of June 2022 for the full body of work.
Status: Board Approved
Sponsoring Committee: Vascularized Composite Allograft Transplantation Committee
Strategic Goal: Promote the efficient management of the OPTN
Region 4 | 08/26/2020
Region 4 vote: 5 Strongly Support, 7 Support, 11 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose This proposal was on the non-discussion agenda for the regional meeting.
Region 5 | 08/28/2020
Region 5 vote: 1 Strongly Support; 22 Support; 7 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No comments
Region 7 | 09/10/2020
Region 7 vote: 4 Strongly Support, 7 Support, 3 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose No Comments
Region 3 | 09/15/2020
OPTN Vascularized Composite Allograft Transplantation Committee: Programming VCA Allocation in UNet Region 3 vote: 2 Strongly Support, 15 Support, 6 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose This proposal was on the non-discussion agenda for the regional meeting.
Region 8 | 09/22/2020
Region 8 vote: 3 strongly support, 10 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose
American Society of Transplantation | 09/24/2020
The American Society of Transplantation supports programming for the allocation VCAs and data collection regarding candidates and recipients. We believe this is the most transparent method for allocation and data collection. We do suggest flexibility regarding rule out criteria or limitations around organ offers by the listing transplant program due to the fact that VCAs remain part of an IRB with its own limitations.
Region 1 | 09/24/2020
Region 1 vote: 4 Strongly Support, 3 Support, 4 Neutral/Abstain, 1 Oppose, 0 Strongly Oppose Comments: No comments
Region 2 | 09/25/2020
Region 2 vote: 7 Strongly Support, 11 Support, 11 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Comments: No comments
AMERICAN SOCIETY FOR HISTOCOMPATIBILITY AND IMMUNOGENETICS | 09/28/2020
The American Society for Histocompatibility (ASHI) and it's National Clinical Affairs Committee (NCAC) are in favor of the UNOS policy proposal to manage VCA allocation with UNET. It will be advantageous for Histocompatibility Laboratories to use the same system for VCA candidate testing as they do for solid organ transplant candidates.
Region 6 | 09/29/2020
Region 6 vote: 6 strongly support; 26 support; 8 neutral/abstain; 0 oppose; 0 strongly oppose. Comments: None
Region 10 | 09/29/2020
Region 10 vote: 3 Strongly Support; 11 Support; 10 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. Comments: No comments
American Society of Transplant Surgeons | 09/29/2020
The American Society of Transplant Surgeons (ASTS) supports this proposal as written. We agree with the proposal in having Transplant hospitals use UNet; noting most who donate and qualify for Vascularized Composite Allograft (VCA) are also multiorgan donors. It is also beneficial to have a unified system that includes registration of all potential recipients and donors for VCA allocation.
Organ Procurement Organization (OPO) Committee | 09/29/2020
The OPO Committee supports the effort to integrate VCA allocation into the system like other organs. One member inquired if additional screening criteria will be developed in the future.
NATCO | 09/30/2020
NATCO supports adding VCA transplants to UNet so that all organs will be managed and allocated in one system.
Association of Organ Procurement Organizations | 10/01/2020
The Association of Organ Procurement Organizations (AOPO) strongly supports programming VCA allocation in UNet. The current manual VCA allocation process requires an OPO to print out a list of potential VCA transplant candidates, contact VCA transplant centers by mechanisms outside of the UNet system, manually document allocation and refusals on the printed out candidate list, and manually return the transplant candidate list to UNOS. It is important that VCA allocation be aligned with the web-based allocation of all other organs and that the inefficiencies of the current manual allocation procedure be eliminated.
Carolina Donor Services | 10/01/2020
Carolina Donor Services strongly supports programming VCA allocation in UNet. The current manual VCA allocation process, managed outside of the electronic notification system that is used for all organs, is inefficient and cumbersome. Allocation will be greatly enhanced with the proposed change.
Region 9 | 10/01/2020
OPTN Vascularized Composite Allograft Transplantation Committee: Programming VCA Allocation in UNet Region 9 vote: 3 strongly support, 9 support, 4 abstain/neutral, 0 oppose, 0 strongly oppose Comments: None
Region 11 | 10/01/2020
Region 11 vote: 3 strongly support, 7 support, 10 neutral/abstain, 0 oppose, 0 strongly oppose
OPTN Data Advisory Committee (DAC) | 10/01/2020
The Data Advisory Committee (DAC) thanks the OPTN Vascularized Composite Allograft Transplantation Committee for their efforts in developing this public comment proposal, Programming Vascularized Composite Allograft (VCA) Allocation in UNet. DAC supports this proposal.
Sam Dey | 10/01/2020
Much needed for the future.