Comments

Region 10 | 03/19/2025

Sentiment: 1 strongly support, 9 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. An attendee noted that the guidance document is well-constructed and could serve as a nice template for program policy development for these donor candidates.

OPTN Minority Affairs Committee | 03/19/2025

The OPTN Minority Affairs Committee (MAC) appreciates the opportunity to comment on the Ad Hoc International Relation Committee's (AHIRC) Guidance document, Barriers Related to the Evaluation and Follow-up of International Living Donors. Overall, the MAC supports the proposed guidance and agrees with providing the transplant community guidance and standardization with these recommendations, as most transplant programs do not work with international living donors frequently. The MAC especially appreciates AHIRC's ongoing efforts to understand how the community currently defines "non-citizen resident" and "non- resident". The MAC raised the concern that the recommendation for international living donors to conduct as much of the preliminary donor evaluation as possible in their home country could be challenging if laboratory standards or benchmarks differ from those of the United States but agrees with AHIRC that this can be assessed on a case-by-case basis. The MAC also suggested AHIRC might provide the community with any existing translation tools, such as those that could read electronic medical records in other languages. Finally, the MAC also voiced concern regarding potential barriers to obtaining a visa in the current political climate, which would negatively impact potential living donors from specific regions more significantly.

Region 6 | 03/19/2025

Sentiment: 2 strongly support, 9 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee commented that concerns remain regarding the lack of guidance and potential changes to OPTN policy, as key barriers to international living donation persist. They also raised issues related to feasibility and safety, including challenges with interpreters and language barriers, costs associated with donation and follow-up care, and ensuring proper post-donation tracking. Additional concerns included the logistics of travel, the financial burden on donors, and how to effectively monitor long-term outcomes. They commented that without clear policies and solutions for these challenges, uncertainty about the safety and viability of international living donors continues.

Region 9 | 03/18/2025

Sentiment:  1 strongly support, 6 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose 

Region 11 | 03/18/2025

Sentiment: 5 strongly support, 14 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: Region 11 supports this proposal. No comments were provided.

Alpha-1 Foundation | 03/18/2025

Public Comment Submission on OPTN Winter 2025 Proposals

The Alpha-1 Foundation appreciates the opportunity to provide feedback on the Organ Procurement and Transplantation Network (OPTN) Winter 2025 public comment proposals. As an organization dedicated to advocating for patients with Alpha-1 Antitrypsin Deficiency (Alpha-1), we represent individuals who frequently require lung and liver transplants due to progressive chronic obstructive pulmonary disease (COPD), emphysema, and liver cirrhosis.

The Alpha-1 Foundation strongly supports efforts to improve the transparency, efficiency, and fairness of the organ allocation system. We appreciate the opportunity to provide input on these critical issues and look forward to continued collaboration with OPTN to ensure the best possible outcomes for Alpha-1 patients.

Policy Proposals

Barriers Related to the Evaluation and Follow-Up of International Living Donors (Ad Hoc International Relations Committee) Alpha-1 patients rarely have living donors for lung transplantation, but living donor liver transplantation (LDLT) is a potential option. We support efforts to improve access to and follow-up care for international living donors, ensuring that:

•Regulatory barriers do not prevent LDLT from being a viable option for Alpha-1 patients with severe liver disease.

•Donor follow-up is prioritized, particularly for international donors whose post-donation care may be inconsistent.

Region 8 | 03/18/2025

Sentiment: 1 strongly support, 8 support, 4 neutral/abstain, 1 oppose, 0 strongly oppose 

Comments: The region appreciated the guidance and recommended the committee consider a different approach regarding follow-up for international donors. Specifically they recommended the committee look into an approach that decreases the compliance percentage requirements for this population.

American Society of Nephrology | 03/18/2025

Please see attachment.

View attachment from American Society of Nephrology

OPTN Transplant Coordinators Committee | 03/17/2025

The OPTN Transplant Coordinators Committee appreciates the opportunity to comment on the OPTN Ad-Hoc International Relations Committee’s proposal Barriers Related to the Evaluation and Follow Up of International Living Donors.

The Committee offers the following feedback for consideration:

•The Transplant Coordinators Committee asks for further guidance regarding cultural competency of language translation.

•The Transplant Coordinators Committee asks for further guidance navigating foreign healthcare systems, especially insurance or lack thereof.

•The Transplant Coordinators Committee asks for further guidance regarding appropriateness of international directed living donation in circumstances where the donor and candidate do not know each other.

Region 1 | 03/17/2025

Sentiment:  5 strongly support, 2 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose 

Comments: This was not discussed during the meeting, but attendees were able to submit comments. The document effectively highlights key challenges and offers practical strategies to enhance donor safety and ethical oversight. Additional challenges include visa and immigration hurdles, with a suggestion to streamline guidance on visa processes, and psychosocial support, as donors may experience stress related to travel, separation, and cultural differences. Recommended additional strategies include fostering international partnerships with hospitals in donor home countries for improved evaluation and follow-up, as well as using remote ILDA and SW assessments, such as virtual interviews, to assess voluntariness and identify potential stressors before travel. 

Region 2 | 03/14/2025

Sentiment: 2 strongly support, 12 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose 

Comments: This was not discussed during the meeting, but attendees were able to submit comments with their sentiment.  An attendee noted their support for the guidance document. 

American Society of Transplantation | 03/13/2025

The American Society of Transplantation (AST) is generally supportive of what is outlined in the proposed guidance document, “Barriers Related to the Evaluation and Follow-Up of International Living Donors.” This is a complex topic which will continue to evolve with the changing political environment, e.g., visa restrictions that could complicate travel for donation and follow-up care. While the proposed guidance document is comprehensive, more robust guidance on critical aspects of the screening process, such as language barriers, cultural cues, coercion, and informed consent comprehension would be beneficial.

The proposed guidance accurately outlines specific challenges during the evaluation and follow-up of international living donors and provides a valuable resource for living donor programs in the United States. In addition to the strategies already included, it is essential that transplant hospitals develop toolkits and policies to support the initiative and educate their staff. Transplant hospitals should be encouraged to perform the donor evaluation without the presence or participation of the potential recipient or the recipient’s representatives, affiliates, or employees. Certified medical interpreters are critically important, and the living donor’s interpreter should be different from the recipient’s interpreter in the spirit of separating the donor and recipient care teams. Transplant hospitals should also develop cultural sensitivity around cultural norms when assessing donating motivation.

The AST also suggests that the proposed guidance document address informing international living donors that current OPTN allocation policy creates additional prioritization for previous living donors; however, this prioritization is specific to the United States’ current organ allocation system and does not necessarily extend globally. Should the international living donor need a transplant in the future, it is important that they consider the potential challenges to return to the United States for their care to realize this benefit.

The AST agrees that transplant centers should strive to develop a robust plan for follow-up before donation by partnering with local physicians; however, the recommendations to consider transporting donors back to United States for complication arising from donation may not be practical.

This document provides a thoughtful approach to evaluation and follow-up of international living donors. Due to the variability of resources available at each transplant hospital, the AST would caution against future efforts to transition this guidance document to OPTN policy. The AST does believe that some minimal required criteria to create a baseline standard for screening protocols and follow-up of international donors is prudent to support ethical and medically sound evaluations and follow-up across all centers.

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/13/2025

This proposal is not pertinent to ASHI or its members.

Michael Lollo | 03/12/2025

With my extensive experience with living donors, the primary barrier is getting the potential international donors a visa to come to the US, and how to reimburse them for travel expenses. We have tried to contact the USDS to create a pathway for potential donors that will allow pre-approved donors to help loved ones here in the US, but have gotten no real answers.

Anonymous | 03/12/2025

I agree with this change

Amir H | 03/11/2025

I agree with this change

Region 4 | 03/11/2025

Sentiment: 6 strongly support, 6 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: Region 4 supported this guidance document commenting that the document is a valuable resource for facilitating the evaluation of international donors, emphasizing the importance of visa procedures, preventing coercion or exploitation, and ensuring post-donation follow-up is established beforehand. They added that inclusion of suggested best practices in this area is a positive step forward. One attendee commented that the OPTN must place greater focus on living donors and living donation, as increasing living donation is essential to addressing the national transplant need.

American Nephrology Nurses Association (ANNA) | 03/10/2025

Attachment

View attachment from American Nephrology Nurses Association (ANNA)

OPTN Living Donor Committee | 03/06/2025

The OPTN Living Donor Committee thanks the OPTN Ad Hoc International Relations Committee (AHIRC) for their work to create guidance to share practices for evaluation and follow up of international living donors. The Committee appreciates that the project members thoroughly considered all possible issues and barriers faced by international donors. It will be helpful for transplant centers to have guidance to consider challenges for international living donors in advance of an appointment. Additionally, the majority of international living donors are noncitizens, but residents living in the United States, which outnumber noncitizen, nonresident potential donors. While transplant centers may not want to directly incentivize potential international donors by assisting with acquisition of visas, a best practice could be to provide education on how to acquire a visa or additionally providing a letter of intent for the potential living donor. The Committee is interested to know how many international potential living donors complete the donation process, and how this might impact transplant coordinator workload. It was suggested that centers might consider designating a specialized team to facilitate the process for international living donors, with the intention of making this process easier and increasing the number of international donors.

Region 7 | 03/04/2025

Sentiment:  0 strongly support, 5 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose 

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. The region was generally supportive of this guidance document. One attendee stating: “Strongly support the proposal to support international donation but to prevent exploitation.” 

Region 3 | 03/03/2025

Sentiment: 0 strongly support, 9 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: None

Region 5 | 02/28/2025

Sentiment:  6 strongly support, 18 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose 

Comments: No comments 

Nancy Marlin | 01/27/2025

The guidance document recommends using a trained medical interpreter, not someone sponsored by the potential donor's organization, for exactly the reasons stated in the 1/21/2025 anonymous comment.

Anonymous | 01/22/2025

Generally, there should be no barriers however psychosocial evaluation and ILDA check-in should be first step if medically appropriate ensuring donors understands process, under no coercion or offer of any compensation, etc.

Understanding about the logistics, supports both in their home state and in US close to center, financial planning with cost and travel, readiness for this, are they prepared for out-of-pocket cost and expenses including healthcare, accessibility of healthcare in home country and feasibility of this especially post-donation, able to adhere and comply with follow-up requirements.

Anonymous | 01/21/2025

In my previous positions, as well as my current position, I have almost 18 years' experience in living donor follow up. I have completed hundreds of UNOS TIEDI forms and collected thousands of data points.

In my experience, international donors, specifically from middle eastern countries are not vetted properly, and often due to the recipient's connection to an Embassy, Military, and/or wealth in their home country, potentially unethical practices including coercion, monetary payment and offers of Asylum are swept under the rug, i.e. don't ask, don't tell. Most often, these donors are "Long time friends of the family". It's like a script. They do not speak English, and are unable to speak confidentially, as they are attended by their own sponsored "interpreter", not an impartial, hospital interpreting service.

Once the organ has been donated, the only contact for the donor is thru the Embassy, or the recipient, who responds invariably, if at all, with " He's fine, doing well, I see him all the time". I have not been able to contact a donor directly for follow up, and if labs are received, they are also thru the recipient and their Medical Center Who knows if the results are actually from the donor. On one specific occasion, when searching the Medical Record for contact information, I found our young, 20-somethin "Kuwaiti" donor, as identified in his records, had a Syrian Passport. This threw up red flags everywhere, especially with regard to our inability to ever speak to these donors for follow up, even when calling with an interpreter. The Embassy also played "Gatekeeper". We did have an "International Liaison" officer; however, I considered him a facilitator who tried to be helpful to a point--seemingly aware yet unwilling to question current practices.

This situation has the appearance of impropriety, bordering on illegal in my opinion, but no one has ever been open to discussing this issue. I'm hopeful that some new policies and investigation can make these diplomatic agreements more uniform and transparent. Thanks for asking!