At a glance
What is current policy and why change it?
The Organ Procurement and Transplantation Network (OPTN) has policies that are meant to keep living donors and recipients of living donor organ transplants safe. These policies do not apply to living uterus or other living vascularized composite allograft (VCA) donors. The number of living uterus donors is increasing and the proposed change will make sure that these donors and their recipients will be protected by the same policies as other living donors.
Modify Living Donor Policy to Include Living VCA Donors
Heather Hunt, Chair of the OPTN Living Donor Committee, reviews the Modify Living Donor Policy to Include Living VCA Donors policy proposal.
Terms you need to know
- Living donor: A living individual from whom at least one organ is recovered for transplantation.
- 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.
- Independent Living Donor Advocate (ILDA): A person available to assist potential living donors in the living donation process.
What’s the proposal?
- Update policy to include all living donors, including uterus and other VCA donors
- Require transplant programs to get information from patients about their social and psychological well being
- Make sure that all potential living donors receive education about being a living donor, including the risks
- Require transplant programs to do specified medical exams and tests of anyone who wants to be a living donor
- Require an independent living donor advocate
- Add new, VCA-specific requirements
- Medical tests important for the safety of the VCA donors and recipients of the donated organs
- Education that will help people who want to be a VCA donor make an informed choice
What’s the anticipated impact of this change?
- What it’s expected to do
- Require transplant programs to complete certain steps for everyone who wants to be a living uterus or other VCA donor to make sure donation and transplant is as safe as possible
- Require all patients who want to be living donors to undergo a series of interviews, exams, and testing
- Require transplant programs to do additional education and medical tests for people who want to be living uterus or other VCA donors
- What it won’t do
- This will not change what is already required of people who want to be a living kidney, liver, pancreas, lung or intestine donor
Themes to consider
- Education and medical testing needed to keep living donors and recipients safe
- Education that will help someone make the decision to be a living donor
|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: Public Comment
Sponsoring Committee: Living Donor Committee
Strategic Goal: Promote living donor and transplant recipient safety
Region 4 | 08/26/2020
Region 4 vote: 6 Strongly Support, 9 Support, 8 Neutral/Abstain, 2 Oppose, 0 Strongly Oppose Region 4 supported this proposal and had no comments.
Christopher Yanakos | 08/27/2020
The consideration of the unique challenges in VCA, specifically uterus transplant. I am in favor of more transparency to patients of potential risks including psychological risk. I also strongly support increased mandatory testing for all living donor transplants to improve the consistency of care between transplant centers. this also improves accountability. the language and proposal are easy to understand and robust.
Region 5 | 08/28/2020
Region 5 vote: 3 Strongly Support, 23 Support, 4 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. Region 5 supported this proposal and had the following comment: • Current OPTN living donor policy do not apply to living uterus donors or other VCA donors. These types of transplants are increasing, and as such, makes it necessary to change current policy to accommodate such transplants. It is imperative such living donors and recipients be protected as other living donors and recipients by the same policy.
OPTN Ad Hoc Disease Transmission Advisory Committee | 09/04/2020
The DTAC is overall supportive of this policy change meant to keep living donors and recipients of living donor organ transplants safe. The Committee supports amending the policy to specify timing for certain additional transmissible disease screening for uterus donors. Testing for chlamydia, gonorrhea, trichomoniasis, and fungal should occur at both evaluation and procurement in order to ensure greater safety against unexpected transmission. DTAC does believe that toxoplasma testing should be included for all living donors. Toxoplasma can remain latent in any tissues or organs, and DTAC has found proven/probable transmissions in non-cardiac recipients. This is the second most common donor-derived parasitic infection in the DTAC 10-year review.
Adam Frank | 09/09/2020
This proposal provides valuable structure to protect living VCA donors. It is well reasoned and well presented. However, what of the case of a living VCA donor who goes on to develop renal failure and thus needs a kidney transplant? Current deceased donor kidney allocation policy would place this candidate in the prior living donor group and thus ahead of the standard candidate. I question the correctness of this.
Region 7 | 09/10/2020
Region 7 vote: 4 Strongly Support, 11 Support, 2 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Region 7 supported the proposal and had the following comments: • Two attendees stated they do not support adding toxoplasma to policy for other living donors unless there is data to support
Anonymous | 09/15/2020
This should be limited to uterine donors at this time. Rare other cases (testicular, for example) can be accomplished through their own institution's IRB, Ethics and hospital staffs. This is an overreach by UNOS and may have unintended consequences.
Region 3 | 09/15/2020
Region 3 vote: 2 Strongly Support; 18 Support; 6 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose: No comments during discussion. Comments submitted online during meeting: In support of inclusion of VCA living donors to same OPTN living donor processes and requirements as with other OPTN living donor programs.
OPTN Vascularized Composite Allograft Transplantation Committee | 09/18/2020
Vote: 5 Strongly Support, 7 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose The Vascularized Composite Allograft (VCA) Transplantation Committee supports this proposal. Members suggested that it might be more appropriate for the informed consent requirements for living genitourinary VCA organ donors to apply specifically to living uterus donors, since there are several serious ethical considerations that should be taken into account prior to the point of informed consent for living donation of any other genitourinary organs. Members said that VCA transplant programs in the U.S. are not close to performing living donation of genitourinary organs other than uterus, and noted that testicular donation raises another level of ethical concerns related to donor DNA and genetic transmission of disease. A member suggested that sharing previous transplant program outcomes should be included in the informed consent process.
Region 8 | 09/22/2020
Region 8 vote: 3 strongly support, 12 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose Comments: One member stated that testing all living donors for toxoplasma maybe a good approach, although the risk is low.
American Society of Transplantation | 09/24/2020
The American Society of Transplantation supports this proposal. 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. The process and guidelines for living donor education, evaluation, and consent should be universal. • We support the policy language for informed consent and medical evaluation. • We additionally recommend in the “potential surgical risks” portion of the informed consent: • That centers are required to provide to the potential donor their center level VCA donors and recipient transplant outcomes given this from of transplantation is still considered experimental • That, for uterus donation, centers discuss the potential for not only short term but also long-term consequences of the surgical risk of urinary tract injury or dysfunction • In the “potential financial impact” of the informed consent, we recommend that the proposal require centers to disclosure that VCA uterine donation is still considered experimental and complications of the procedure may not be covered by the health insurance. Therefore, programs should be required to convey to the potential donor that there are degrees of financial risk involved for the donor • Regarding the request for feedback, “Should toxoplasma be a required test for all living donors?,” we agree with the recommendations of the 2017 KDIGO living kidney donor guideline that testing should be guided by risk factors for possible exposure and recommend against universal testing for all living donors.
Region 1 | 09/24/2020
Region 1 vote: 4 Strongly Support, 6 Support, 0 Neutral/Abstain, 2 Oppose, 0 Strongly Oppose Comments: Region 1 supports this proposal.
Region 2 | 09/25/2020
Region 2 vote: 3 Strongly Support, 17 Support, 8 Neutral/Abstain, 3 Oppose, 1 Strongly Oppose Comments: • An attendee noted that given the limited use of living VCA donors the requirements in the proposal should be recommendations instead of policy. • Another attendee agreed that these should not be policy. They support live donor safety, including toxoplasmosis testing, but believe these recommendations should instead be added to the published VCA live donor guidance document. • One attendee disagreed with the previous comments and supports the requirement for testing all living VCA donors for toxoplasmosis. If the testing is required of all deceased donors, the same should be true for living donors.
Society for Transplant Social Workers | 09/26/2020
The Society for Transplant Social Workers supports the OPTN’s proposal to align policy for living vascularized composite allograft (VCA) donors with policies covering other living donors. This proposal appears to have donors’ best interests in mind. We believe all living donors should have a comprehensive workup to ensure they are supported, educated and evaluated by a multidisciplinary team. We support standardized requirements related to informed consent about risks and benefits of living donation. Inclusion of the independent living donor advocate (ILDA) role would enhance protection and fairness for the living VCA donor. While the proposed requirements may increase the cost and length of the evaluation, they do not seem onerous. Programs need to be accountable for the safety of their living VCA donors.