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Modify Data Collection on Living VCA Donors

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What is current policy and why change it?

The Organ Procurement and Transplantation Network (OPTN) requires transplant hospitals to submit information about living organ donors through a living donor registration form and a living donor follow-up form to promote living donor and transplant recipient safety. This is not required for living Vascularized Composite Allograft (VCA) donors, including uterus donors. Because living donor uterus transplants are increasing, and other types of living VCA donation may begin, it is important to collect this information.

Modify Data Collection on VCA Living Donors

Dr. Bohdan Pomahac, Chair of the Vascularized Composite Allograft Transplantation Committee, reviews the policy proposal to Modify Data Collection on VCA Living Donors.

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. For example, face and hand transplants are two of the most well-known types of VCA transplants.
  • Living donor: A living individual from whom at least one organ is recovered for transplant.

Click here to search the OPTN glossary

What’s the proposal?

  • Require specific information after living VCA donation is complete on the living donor registration form
    • Includes related health information about the donor, details about the surgery, and complications around the time of surgery
  • Require specific information at six months, one year, and two years after the living VCA donation on the living donor follow-up form
    • Includes complications after surgery
  • Updates policy to reflect that data related to living VCA donation will be collected in the OPTN computer system, UNet

What’s the anticipated impact of this change?

  • What it’s expected to do
    • Collect data for all living donors
    • Assess patient safety for VCA donors and recipients
    • Make sure that living VCA donors have regular checkups after donation
    • Require same forms that are used for all other living donors
  • What it won’t do
    • Change information that is currently required for living organ donors other than VCA

Themes to consider

  • Safety of living VCA donors
  • Safety of recipients of living VCA donor organs

Related Proposals

This proposal is related to two other proposals that have been released for public comment this cycle. These three proposals are summarized below.

Related proposalDescription
Modify Living Donation Policy to Include Living VCA Donors

Sponsor: Living Donor Committee
  • New policy requirements for living VCA donors
Modify Data Collection on VCA Living Donors

Sponsor: VCA Transplantation Committee
  • New data collection for living VCA donors
  • Data collection will be managed in UNet
Programming VCA Allocation in UNet

Sponsor: VCA Transplantation Committee
  • Updates policy to reflect that VCA from deceased donors will be managed in UNet

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.

Overview

Status: Board Approved

Sponsoring Committee: Vascularized Composite Allograft (VCA) Transplantation

Strategic Goal: Promote living donor and transplant recipient safety

Contact:

Tina Rhoades; Kristine Althaus

Documentation

Briefing Paper

Policy Notice

Comments

Data Advisory Committee | 10/02/2020

The Data Advisory Committee (DAC) thanks the OPTN Vascularized Composite Allograft Transplantation Committee for their efforts in developing this public comment proposal, Modify Data Collection on Living Vascularized Composite Allograft (VCA) Donors. DAC supports this proposal. Public Comment Sentiment Vote: Strongly Support- 64% (7), Support – 27% (3), Neutral/Abstain – 9% (1), Oppose – 0% (0), Strongly Oppose 0% (0)

Sam Dey | 10/01/2020

Absolutely!!

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, Modify Data Collection on Living Vascularized Composite Allograft (VCA) Donors. DAC supports this proposal. Public Comment Sentiment Vote: Strongly Support- 64% (7), Support – 27% (3), Neutral/Abstain – 9% (1), Oppose – 0% (0), Strongly Oppose 0% (0)

Region 11 | 10/01/2020

Region 11 vote: 2 strongly support, 8 support, 10 neutral/abstain, 0 oppose, 1 strongly oppose. Comments: One attendee recommended that the committee should address gender sentiments for VCA transplant donors. They added that gender dysphoria or gender identity issues are not captured in the follow-up data collection and should be a separate area of data collection regarding changes in gender self-identification.

Region 9 | 10/01/2020

OPTN Vascularized Composite Allograft Transplantation Committee: Modify Data Collection on Living VCA Donors Region 9 vote: 3 strongly support, 8 support, 5 abstain/neutral, 0 oppose, 0 strongly oppose Comments: One member expressed that uterus transplants are organs, not VCA, and since the goal of a uterus transplant is a live birth, instead of saving a life, it could lead to creation of a whole new category.

Association of Organ Procurement Organizations | 10/01/2020

The Association of Organ Procurement Organizations (AOPO) supports aligning VCA living donor data collection with the current requirements to submit data on other living donors. OPTN data collection and ability to assess patient safety for all living donors are necessary components in maintaining public trust in our donation and transplantation system.

Ethics Committee | 09/30/2020

The OPTN Ethics Committee thanks the VCA Committee for presenting its proposal. The Committee expresses its concerns about the collection of induced abortion data, if clinically insignificant, due to unconscious biases relating to persons who have undergone induced abortions. The Committee wants to ensure potential donors receive information about why the data are being collected and whether or not it affects their eligibility to donate. The use of the term abortion when referring to a miscarriage should be reconsidered. Questions about abortions and miscarriages have the potential to cause secondary trauma and stigma to the potential donor and if deemed unnecessary, should be considered for removal. The Committee also suggests collecting new onset psychological symptoms for all living VCA donors, not just living uterus donors. The results of the Ethics Committee sentiment vote are 5 Strongly Support; 6 Support; 0 Neutral/Abstain; 0 Oppose; and 0 Strongly Oppose.

American Society of Transplant Surgeons | 09/29/2020

The American Society of Transplant Surgeons (ASTS) supports this proposal as written with the statement that uterus transplantation should be removed from VCA since a uterus is a solid organ.

Region 10 | 09/29/2020

Region 10 vote: 3 Strongly Support; 12 Support; 9 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. Comments: No comments

Region 6 | 09/29/2020

Region 6 vote: 7 strongly support; 25 support; 8 neutral/abstain; 0 oppose; 0 strongly oppose. Comments: None

Region 2 | 09/25/2020

Region 2 vote: 5 Strongly Support, 14 Support, 11 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Comments: No comments

Region 1 | 09/24/2020

Region 1 vote: 4 Strongly Support, 5 Support, 2 Neutral/Abstain, 1 Oppose, 0 Strongly Oppose Comments: No Comments

American Society of Transplantation | 09/24/2020

The American Society of Transplantation supports this proposal in concept. We appreciate this work to bring VCA living donations in line with requirements for all other living donors, including the collaboration of the UNOS VCA, Living Donor and Ethics Committees. We recognize the policy language for required data collection for living VCA donors as an important advance over the current voluntary data submission process for living VCA donors. This data collection will be important for the ongoing monitoring of VCA living donors. We see no reason for it to be any different than any other living donor. Also, because the LD VCA case numbers are small, this should not add burden to the Transplant Center’s Data and Quality team. We offer the following comments for the committee’s consideration: • For VCA living donor data collection requirements, consider adding intraoperative complications including anesthetic complications under surgical information for all VCA donors (as currently collected for living lung donors). • Likewise consider adding post-operative complications during the initial hospitalization under Post-operative information for all VCA donors (as currently collected for living lung donors). • We would favor the collection of “new onset psychological symptoms” for all VCA donors, not limited to uterus donors only. Non-uterine VCA donors are uncommon, so this will not pose a large data collection burden but may be relevant to understanding outcomes as practice evolves. The data collection would also align with disclosure in the informed consent policy that there may be potential psychosocial risks of living VCA donation. Accordingly, over time, this may help centers provide more quantitative information in their risk disclosure. • We suggest the following additions for data collection regarding infectious disease • Syphilis screening for uterus donor • Treatment history for sexually transmitted infections of uterus donor, in particular Gonorrhea/Chlamydia (due to the possibility of drug resistance) • We suggest that specific data points may be more beneficial with granular detail, such as: Equivocal results should be an option for certain screening serologies (e.g. Toxoplasma IgG and HSV1/2 IgG ) and The source of the sample for Gonorrhea/Chlamydia NAAT should be specified

Region 8 | 09/22/2020

Region 8 vote: 4 strongly support, 9 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

Living Donor Committee | 09/21/2020

The OPTN Living Donor Committee thanks the OPTN VCA Committee for inviting feedback on the Modify Data Collection on Living VCA Donors public comment proposal. The Committee strongly supports the proposal and appreciates the VCA Committee’s efforts to align data collection requirements with the establishment of VCA in living donor policy. The Committee recommends ensuring the data elements being added are clear and not redundant of other data fields already existing on the LDF. The Committee indicated the following sentiments for the proposal: 4 Strongly Support, 6 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose.

Region 3 | 09/15/2020

OPTN Vascularized Composite Allograft Transplantation Committee: Modify Data Collection on Living VCA Donors Region 3 vote: 1 Strongly Support, 13 Support, 11 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose This proposal was on the non-discussion agenda for the regional meeting.

Region 7 | 09/10/2020

Region 7 vote: 3 Strongly Support, 8 Support, 3 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose No Comments

OPTN Transplant Coordinators Committee | 09/02/2020

The Transplant Coordinators Committee is in support of this proposal. The TCC feels that in the setting of increasing volumes of living VCA donation, this proposal would potentially improve the OPTNs ability to monitor patient safety. The committee felt that post donation monitoring is critical to monitor the long term safety of these transplants as well as to help monitor donor characteristics that are linked to poorer recipient outcomes. Given the additional data that would be reported, the committee sought clarification regarding the timing of consent for living VCA donors. VOTE: 3 Strongly support, 5 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Region 5 | 08/28/2020

Region 5 vote: 3 Strongly Support; 23 Support; 4 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No comments

Region 4 | 08/26/2020

Region 4 vote: 4 Strongly Support, 9 Support, 9 Neutral/Abstain, 1 Oppose, 0 Strongly Oppose This proposal was on the non-discussion agenda for the regional meeting.