Modify Living Donation Policy to Include Living VCA Donors

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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.

Click here to search the OPTN glossary

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

Related Proposals

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.

Comments

Sam Dey | 10/01/2020

Very critical to incorporate.

Region 11 | 10/01/2020

Region 11 vote: 6 strongly support, 6 support, 6 neutral/abstain, 2 oppose, 1 strongly oppose. Comments: One attendee stated that testing all living donors for toxoplasma may be a good approach, although the risk is low. Another attendee asked the committee to consider if living VCA donors should receive priority on the kidney list given to other living donors who subsequently need a kidney transplant.

Region 9 | 10/01/2020

Region 9 vote: 5 strongly support, 6 support, 8 abstain/neutral, 0 oppose, 0 strongly oppose. Comments: A member commented that uterine transplant should be removed from VCA, as the uterus is a separate and unique organ, and the training and clinical pathways are different from VCA.

National Catholic Bioethics Center, et al. | 10/01/2020

Dear Dr. Gonzalez: The National Catholic Bioethics Center, the Catholic Medical Association, the National Association of Catholic Nurses, USA, and the National Catholic Partnership on Disability, wish to respond to the call for comment concerning the Proposal: Modify Living Donor Policy to Include Living VCA Donors, hereafter, Proposal. The National Catholic Bioethics Center is a non-profit research and educational institute committed to applying the moral teachings of the Catholic Church to ethical issues arising in health care and the life sciences, including biomedical research. The NCBC serves numerous health care agencies in their development and analysis of policies and protocols, including protocols for transplantation. The Center has 2100 members throughout the United States and provides consultations to hundreds of institutions and individuals seeking its opinion on these and other matters as they pertain to the appropriate application of Catholic moral teaching to the common good. The Catholic Medical Association is a non-profit national organization comprised of over 2,000 members representing physicians and other health care providers in over 75 medical specialties. The Association helps to educate the medical profession and society at large about issues in medical ethics, including ethics involved in human transplantation impacting the best interest of those entrusted to their care. The Association accomplishes this through its annual conferences, local Guilds, its quarterly award-winning bioethics journal, The Linacre Quarterly, and its other programs, publications, and web communications. The National Association of Catholic Nurses, U.S.A. (NACN-USA) is the national professional organization for Catholic nurses in the United States representing a membership of hundreds of nurses. Nursing plays an integral role in the process of organ donation and transplantation. In that role, nurses advocate for patients, protect the vulnerable, and promote human dignity and, thus, have a great interest in this policy. The National Catholic Partnership on Disability is a non-profit agency that affirms the dignity of every person, working collaboratively to ensure meaningful participation of people with disabilities in all aspects of the life of the Church and society. As an organization that advocates for policies respectful of all persons, especially those with disabilities, the National Catholic Partnership on Disability wishes to express its concern for any government sanctioned program that fosters the creation of a disability, even for the laudable cause of providing organs for transplant, thus, violating society’s obligation to the human person. As we have shared with you in the past, the Catholic Church encourages organ donation as providing a gift of life to those in need. In terms of both living and deceased donors, the same generosity of donors is recognized, if there is respect for true informed consent, donor and recipient safety and wellbeing, and human physical and psychosocial integrity. Therefore, we hope that our comments contained herein will be helpful in securing the public safety that we all are hoping to protect. Overall, we wish to reiterate that, despite the fact that the U.S. Dept. of Health and Human Services had precluded the authority of OPTN/UNOS to prevent living donations of vascularized composite allografts (VCAs), there is the authority of OPTN/UNOS to restrict living donations as rigorously as possible. We urge such an approach. As you know the Secretary of the U.S. Department of Health and Human Services expanded the definition of human organs and added VCA to the covered list of human organs for transplant under the OPTN. The OPTN Final Rule of July 2020 expanded the definition of organ as follows: • Organ means a human kidney, liver, heart, lung, pancreas, intestine (including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract) or vascularized composite allograft (defined in this section). Blood vessels recovered from an organ donor during the recovery of such organ(s) are considered part of an organ with which they are procured for purposes of this part if the vessels. • VCAs are defined to include: Head and neck (including, but not limited to, face including underlying skeleton and muscle, larynx, parathyroid gland, scalp, trachea, or thyroid); Abdominal wall (including, but not limited to, symphysis pubis or other vascularized skeletal elements of the pelvis); Genitourinary organs (including, but not limited to, uterus, internal/external male and female genitalia, or urinary bladder); Upper limb (including, but not limited to, any group of body parts from the upper limb or radial forearm flap); Glands (including, but not limited to adrenal or thymus); Lower limb (including, but not limited to, pelvic structures that are attached to the lower limb and transplanted intact, gluteal region, vascularized bone transfers from the lower extremity, anterior lateral thigh flaps, or toe transfers); Musculoskeletal composite graft segment (including, but not limited to, latissimus dorsi, spine axis, or any other vascularized muscle, bone, nerve, or skin flap); Spleen. This Proposal will provide eligibility for all the aforementioned organs for donation by a living donor. The vastness of such a listing of living donor options is rife for potential abuses of vulnerable populations due to family pressures for donation, necessitating the most stringent informed consent policies and medical evaluation, not reflected in this current Proposal. Recovery hospitals are given great latitude in determining donor eligibility. Furthermore, consent policies cannot justify permitting self- mutilating acts, which will occur with the donation of many of these “organs.” We recognize there is an ethical option for the donation of some organs from a living donor, such as one of paired organs for a proportionate reason. However, a number of examples of VCA donation, e.g., face, limb, and womb, even if paired, clearly create a disability for the living donor with a loss of a function. The Proposal elevates consent above donor wellbeing, thus, ignoring the mandate to “do no harm.” We understand there are two categories of VCA donations: “restorative” transplants, introduced in 1998 following the first hand transplant in France; and non- “restorative” VCA transplants, exemplified by womb transplants, thirty-one of which have been done in the United States since 2016, and nineteen of these were from living donors. Each of these examples, if from living-donors, represents a deliberate irreversible mutilation of the donor, and in some cases creates a permanent disability. The Proposal states: “Non-restorative VCA, such as uterine transplantation, repairs lost or missing non-essential function (i.e. reproductive) to an otherwise healthy individual.” [Proposal, Background] However, at the same time it creates the same loss in the living donor. The Americans with Disabilities Act defines “disability” to include a significant impairment to reproductive functions. The very foundational principle of organ donation is that there be no harm done to the donor, which is being violated by such donations. The stated need to “improve waitlisted patient, living donor, and transplant recipient outcomes,” does not justify such harm to the donor. [Proposal, Background] Despite the fact that death is less likely after VCA living donation, since the potential for compromise to vital organ function is lower, there is no denying that loss of a uterus or a limb would constitute a serious and irreparable impairment to the donor. In contrast, the procedure for the recipient is only life-enhancing, not life-saving; and, since in virtually all cases, the benefit of living donation to the recipient is merely a shorter waiting time for a deceased donor, this is clearly insufficient to justify such massive harm to the donor. We note that the Proposal considers reproductive organs, including testes and the womb “non-essential.” Granted they are not essential to life, but clearly essential to psycho-social, physical wellbeing of a man or woman, who may later regret this substantial loss. Data support that 28% of American women aged 25 to 45 years of age regret their tubal ligation. A number of women seek reversals. Removal of reproductive organs is not reversable. Thus, the elective removal of such a healthy organ is mutilating to the human person and should not be allowed; and if it is to occur requires the most rigorous informed consent processes. This Proposal does not provide for this basic right of the donor to full informed consent. Presenting as the solitary psychosocial risk for a Genitourinary donor, “Feelings of emotional distress or grief if the transplant recipient does not experience a successful functional, cosmetic, or reproductive outcome,” does not truly inform the donor. [Proposal, Overview of Proposal: Psychological Risks] Documented scientific data on outcomes of such transplants for donor and recipient need to be presented, not just the risks, e.g., the nature of reproductive processes (invitro fertilization), data on death of embryos with such processes, and miscarriages, and womb rejection, and the unknown impact on the unborn child. There needs to be a clear statement that there are no long term studies of the impact of such transplants on the mother or child, or even the donor, who similar to women who have undergone tubal ligations may experience irremediable regret and depression. The lack of exclusion criteria for womb donation is of great concern. There is no minimum age, except one must be an adult, nor history of childbearing required. Because of the impact of infertility on the extended family, emotions run high, placing emotional burdens on fertile relatives who have healthy uteruses. Any signs of donor coercion should prevent the donation. However, the Proposal only excludes living donation (for any organ) if there is a “high suspicion” of donor coercion. [Medical Evaluation Requirements for Living Donors, #14.4 E] The Proposal contains the same criteria for illegal financial exchange between donor and recipient: “high suspicion.” The potential for organ trafficking is significant. Furthermore, living donation of any organ represents a loss, regardless of the functional impact, which the Proposal allows. There needs to be a clear prohibition against any donation that decreases physiologic function. Also, the exclusion criterion of having an “uncontrolled diagnosable psychiatric conditions requiring treatment before donation” is inadequate. This would allow a person who has a history of engaging in self-mutilating behaviors, but is temporarily medicated, to donate a limb, a face, or any other organ, when confronted with a family member’s need. The Proposal defines “genitourinary organs,” as “including, but not limited to, uterus, internal/external male and female genitalia, or urinary bladder.” [Proposal, Overview of Proposal, Informed Consent] As proposed, VCA living donation will allow the creation of an irreversible mutilation of healthy function to the living donor. It also represents potential hazards to recipients and their future offspring from certain provisions it contains. In fact, the unborn child is treated as an expendable commodity due to such risks. Engendering is accomplished by in vitro fertilization, a process that usually results in numerous offspring, with only some deemed suitable for implantation, with the expectation that some implanted may not gestate. This is an unacceptable violation of human dignity. In terms of informed consent these hazards remain completely unaddressed by the Proposal. Thus, while we do not support such donations, to minimize the risk to the living donors, the recipients, society, and the children engendered through such donations, more substantial evidenced-based data needs to be presented related to these aforementioned concerns. The National Catholic Bioethics Center, the Catholic Medical Association, the National Association of Catholic Nurses, USA, and the National Catholic Partnership on Disability are agencies of the largest provider of non-governmental, non-profit health care, education, and social services: The Catholic Church. The Catholic Church encourages organ donation as providing a gift of life to those in need. In terms of both living and deceased donors, the same generosity of donors is recognized, if there is respect for true informed consent, donor and recipient safety and wellbeing, and human physical and psychosocial integrity. Many of those with whom we collaborate are providers or consumers of transplant services. They advocate for true informed consent and the principle to “do no harm.” Allowing living donation of vascularized composite allographs compromises these principles. While there could be envisioned cases in which such a donation serves a proportionate good for the recipient without harming the donor, those specific cases and criteria need to be clearly identified, with very specific exclusion criteria. Informed consent requires that risks to the donor in terms of human functioning, as well as psychosocial wellbeing need to be clearly and specifically identified, and if human functioning or wellbeing is compromised by the donation, the donation should not be allowed. The risks to the donor and recipient, and in the case of the donated womb the risks to the unborn child cannot be allowed, and, if unfortunately they are, must be presented to the donor. Most VCA donations are not essential to human life. Thus, if the donation creates a disability or diminished functioning for the donor it is not proportional. This is clearly the case with womb donations. Informed consent cannot justify a procedure that is mutilating to the human person. Sincerely yours, Dr. Marie T. Hilliard, MS, MS, JCL, PhD, RN Senior Fellow The National Catholic Bioethics Center 6399 Drexel Road Philadelphia, PA 19151 215-877-2660484-270-8002 Dr. Michael Parker, MD President The Catholic Medical Association 550 Pinetown Rd., Suite 205 Fort Washington, PA 19034 484-270-8002 Ellen Gianoli, BSN, MA, RN President National Association of Catholic Nurses, USA P.O. Box 4556 Wheaton, IL 60189 CatholicNurses@nacn-usa.org Marsha Rivas Board Chair Nat. Catholic Partnership on Disability 415 Michigan Avenue, N.E., Suite 95 Washington, D.C. 20017-4501 202-529-2933

Association of Organ Procurement Organizations | 10/01/2020

The Association of Organ Procurement Organizations (AOPO) supports the recommendation to add living VCA donors to the Living Donor Policy. AOPO defers to the expertise of the Living Donor Committee and agrees that required education and medical testing are essential for living donor and recipient safety.

Ethics Committee | 09/30/2020

The OPTN Ethics Committee thanks the Living Donor Committee for presenting its proposal. The Committee supports including VCA donors in Living Donor policy to ensure they undergo a consent process similar to other living donors. The results of the Ethics Committee sentiment vote are 6 Strongly Support; 6 Support; 0 Neutral/Abstain; 0 Oppose; and 0 Strongly Oppose.

Patient Affairs Committee | 09/29/2020

5 Strongly Support; 5 Support; 1 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. The Patient Affairs Committee (PAC) appreciates the opportunity to provide feedback on this proposal. Overall, the PAC supports this policy change. Some members suggested that it be expanded to include other living VCA donors, such as potential living donor testicular transplants. A member raised the question about the evolving nature of this specialty, which presents special considerations. For example, in the case of a living donor testicular transplant, what are the specific legal responsibilities for paternity since the donated testicle will continue to produce donor sperm? There were also comments about whether the proposal should include other fertility related risks based on gender, such as “decreased fertility” for males and “physical disfigurement” for females. Members emphasized their concern for patient’s sense of identity. The members wondered whether language regarding psychosocial risks related to surgical risk should be expounded. For example, psychosocial risks related to physical disfigurement. Members agreed with the requirement for toxoplasma testing for all VCA living donors. The committee suggested the proposal include an education plan for implementation. Additionally, members advocated for a broader involvement of living donors during the proposal development.

American Society of Transplant Surgeons | 09/29/2020

The American Society of Transplant Surgeons (ASTS) supports the proposal’s intent to streamline requirements and policies for living organ donation across all organs. We agree with: 1) the specific requirements in the proposed language with the exception that uterine transplantation should be separated out from Vascularized Composite Allograft (VCA) as it is a solid organ, 2) the definition and description of risk in Table 1 including the definition of financial risk, 3) uterine specific evaluations and tests required in Table 2, and 4) that Toxoplasma should be included in living donor evaluations for uterine transplant only.

Anonymous | 09/29/2020

Region 10 vote: 4 Strongly Support; 13 Support; 8 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. Comments: • An attendee asked that the committee consider whether a living VCA donor should acquire prioritization points if they ever need to be listed for an organ transplant in the future.

Anonymous | 09/29/2020

Region 6 vote: 6 strongly support; 31 support; 5 neutral/abstain; 1 oppose; 0 strongly oppose. Comments: No comments.

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.

Anonymous | 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.

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.

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.

Anonymous | 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.

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 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.

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 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.

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.

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.

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.

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 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.