Comments

Transplant Families | 10/03/2025

Transplant Families is strongly supportive of this proposal.

Living donors give an immeasurable gift of life, and as a community we have a responsibility to ensure that they are protected, supported, and fully informed not only before donation, but throughout their lives. Collecting more comprehensive and efficient long-term data is an essential step in fulfilling this obligation.

While we recognize that this proposal may increase the data collection burden for transplant centers, the benefits far outweigh the challenges. Long-term data collection has the potential to provide unprecedented insights into the physical, psychosocial, and economic impacts of living donation. 

Living donors have already given so much. We owe it to them to understand what that gift means over the long term, not just for their recipients, but for their own health and well-being. This proposal moves us closer to meeting that ethical responsibility, and we urge its adoption.

Society of Pediatric Liver Transplantation (SPLIT) | 10/01/2025

The Society of Pediatric Liver Transplantation (SPLIT) appreciates the opportunity to comment on the Living Donor Committee’s proposal to Update and Improve Efficiency in Living Donor Data Collection. Voluntary follow up beyond 2 years is an important option to allow for a more robust data regarding long term outcomes that can be presented to potential donors. In addition, identifying reasons why a potential donor does not proceed with donation may help us better understand the barriers to living donation in hopes of increasing the donor pool.

Cedars-Sinai Medical Center | 10/01/2025

Although I see value in the effort to increase our knowledge of the living donor pathway and factors contributing to successful living donation, I have some reservation that the proposed initiatives will create significant burden for transplant programs.

The total amount of data collection - particularly from candidates who do not progress to donation - will divert important resources from candidates continuing through the living donation pathway. Furthermore, this data collection may potentially create an unforeseen barrier for apprehensive living donor candidates who wish to maintain their privacy - especially altruistic donors.

I share the interest in expanding our understanding of living donor motivations to inform best practices in increasing living donation. I would support a streamlining of the total data collection, particularly from candidates who do not ultimately proceed with donation.

NYU Langone Health | 10/01/2025

We recommend that this be modified to allow donors to volunteer to complete the data collection independently from the transplant program.

The transplant program requirement would be, with the expressed written permission of the donor, to submit their name and contact information to UNOS. UNOS can then send a volunteer survey of questions which the donor answers. UNOS can also request information from the transplant center. UNOS will need to create a secure HIPAA compliant portal for this.

In its current written form we believe the following:

• Adverse impact on donors who choose not to donate (may make them feel poorly about their decision/guilt etc.)
• Exacerbate mistrust in the transplant system
• Adverse impact on donor-transplant coordinator relationship
• Added pressure to the donor relationship and brings into question the promise of confidentiality that donors deserve, especially from staff not part of their care team
• Further administrative burden to the clinicians taking time away from progressing donors through evaluation to donation

We believe that donor data collection including that of declined donors is well-intentioned/valuable as this will help inform donor risk assessment/informed consent moving forward as the transplant community broadens acceptable criteria. However, the logistics outlined in the proposal need modification.

DaVita | 10/01/2025

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Region 2 | 10/01/2025

Sentiment: 2 strongly support, 9 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose

Comments: Questions were asked about the need for the OPTN forms if SRTR can already use data linkages, and whether clinic data would be required on the Non-Donation form. If so, clarification was requested on who would be responsible for ordering and reporting such tests. Attendees emphasized that more detailed information is needed to understand the scope and expectations. Concerns were expressed that if data collection is not required, some institutions may stop supporting these activities, even if centers wish to continue them. Additional uncertainty was noted about the SRTR’s role, since it is a private contractor and may not sustain this function long term. Some attendees warned that reducing mandatory follow-up from two years to a voluntary process could risk losing critical outcome data, limiting the ability to monitor donor safety, identify long-term complications, and maintain transparency. Others highlighted that improved long-term data collection could be beneficial, both in extending beyond the current two-year window and in capturing barriers to donation among those who do not proceed. Operational and ethical concerns were also raised. Attendees noted that the process could be burdensome, particularly for individuals who did not proceed to donation, who may feel pressured, disappointed, or reluctant to respond to follow-up requests. They emphasized that centers would need compensation to offset the added regulatory workload. The timing of donor interactions varies across programs, which adds confusion about when and how data should be collected. Attendees also referenced the growing involvement of third-party and commercial organizations in the living donor space, complicating responsibilities and expectations. Finally, there were questions about how SRTR would secure sufficient funding to sustain long-term donor follow-up activities.

Region 1 | 10/01/2025

Sentiment: 3 strongly support, 4 support, 1 neutral/abstain, 3 oppose, 0 strongly oppose

Comments: A member noted that this policy has been in development for two decades without materializing and sees a great opportunity to rely on the SRTR partnership proposed through the Living Donor Collective experience. An attendee asked how the policy will distinguish between healthy nondonors who chose not to proceed and those not accepted for medical or psychological reasons, and raised questions about donors who withdraw before their health status is known. A member opposed the policy as written, citing significant administrative burden and variability in defining the first in person visit, which could lead to missing important data. An attendee recommended follow-up with the donor facility or current care provider if new medical concerns are identified. A member expressed conditional support, requesting clarity on the minimum dataset, SRTR protocols, and privacy protections. An attendee, both an HLA professional and family member to two living kidney donors, stated that donors deserve closer relationships and follow-up with transplant centers beyond two years, rather than only being contacted by a registry. A member voiced concern about administrative burden and confusion over what qualifies as an in-person evaluation. An attendee questioned the purpose of the policy, expressing concern that it may send the wrong message about donor care and raised doubts about how SRTR would collect data on complications such as creatinine levels, testicular pain, or hernias, noting that such a policy might worry donors rather than reassure them.

Luis Mayen | 10/01/2025

As an altruistic living donor, I support the intent of this proposal, specifically addressing the need for improved data collection and long-term follow-up. During my own donation, I came to understand many of the barriers donors face (administrative, logistical, and informational), which were invisible to me until experiencing the process myself. Improved data collection and follow-up may also help ensure donors understand the protections they have if they ever need a transplant themselves, while helping to identify and reduce barriers, making living donation safer and more sustainable for future donors.

American Society of Nephrology | 10/01/2025

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North Shore University Hospital | 10/01/2025

The proposed policy to update living donor data collection has several issues related to potential living donor rights, the protection of extensive PHI and how well the data collection tool matches its goals.

Firstly, the policy does not fully protect the rights of the potential living donors, especially regarding their privacy and informed consent. The policy aims to improve informed decision-making, but the requirement to collect extensive data infringes on the potential donors' privacy (it includes data metrics such as the social security numbers, extensive lab data, extensive family history, their substance use, neurological abnormalities, psychosocial results, etc...). This requirement might make potential donors feel pressured to share personal information without a clear understanding of how it will be used. Additionally, while follow-up contact by the SRTR is described as 'voluntary,' there isn't a clear option for these individuals to opt-out, which could limit their autonomy.

Secondly, there appears to be a mismatch between the policy's goals of understanding long-term outcomes and barriers to donation, and the data collection tool it proposes. The extensive list of required data fields may not effectively capture the specific barriers potential donors face. The policy does not clearly explain how this data will be used to improve donor experiences and outcomes, raising questions about its practical value.

We are surprised that the Policy notice did not acknowledge the Centers for Medicare & Medicaid Services (CMS) reviews/audits of living donors who are ruled out. This is a standard review during their recertification surveys and audits. In these regulatory audits, Living Donor programs are required to review with CMS the reasons donors are excluded and adherence to living donor selection criteria. This audit is done in a confidential manner and with the proper regulatory oversight. This existing regulatory review questions the need for additional data collection requirements, as proposed.

To better meet these goals, a research study using detailed surveys and interviews with potential donors who were ruled out, could be conducted, allowing for the full consent of a potential donor candidate. This approach would focus on their real experiences, challenges, and concerns during the donation process. Collecting qualitative feedback would also provide deeper insights into the barriers to donation, aligning data collection more closely with the policy’s goals of understanding the barriers and outcomes more effectively.

Lastly, adding this data burden is a step backwards in attempting to increase living donation rates and promote efficiency.

We support further efforts to monitor living donor health, post-donation.

Please reconsider this policy proposal and the impact it will truly have.

American Society of Transplant Surgeons | 10/01/2025

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Region 4 | 10/01/2025

Sentiment: 2 strongly support, 7 support, 4 neutral/abstain, 9 oppose, 1 strongly oppose

Comments: During the discussion, one attendee commented that the OPTN Data Advisory Committee declined to endorse the proposed data collection changes, citing excessive data burden, particularly with the Living Donor Non-Donation Form that would require significant manual entry. While the committee supported the overall goal of better understanding barriers to living donation, they raised concerns that the proposal goes beyond what is necessary to address the barriers to donation. They added that the DAC recommended that the Living Donor Committee re-present the proposal after the public comment period. Another attendee raised concerns about autonomy for non-donors, the potential harm in revisiting sensitive decisions, and the questionable clinical or scientific utility of the information. One attendee suggested that efforts to contact non-donors should count toward compliance, even if data are incomplete. Another attendee commented that more data is needed on living donor outcomes, especially considering recent reports of increased mortality from non-donation-related issues such as suicide. Several attendees raised concerns about collecting data from individuals who choose not to donate, noting the sensitive interpersonal issues involved and the limited benefit to those participants. They questioned who ultimately benefits from such data collection, whether the effort would meaningfully advance clinical improvement, and what knowledge gaps still need to be addressed. One attendee recalled that prior attempts at long-term donor follow-up failed due to lack of donor participation and expressed skepticism about expanding data collection to non-donors given the significant manual burden it would place on programs. One attendee recommended separating this proposal into two policies, one addressing data collection from prospective donors (including non-donors) and another focused on long-term donor follow-up. Participants stressed that if long-term data collection is to be successful, the burden on centers must be minimized, with SRTR taking responsibility for much of the follow-up. One attendee suggested a pilot study to evaluate feasibility and benefit before broader implementation. Several attendees emphasized that future efforts should balance the need for more comprehensive data with the realities of program capacity and the ethical considerations of involving individuals who ultimately choose not to donate.

OPTN Membership & Professional Standards Committee | 10/01/2025

The Membership and Professional Standards Committee (MPSC) appreciates the work of the Living Donor Committee in developing this proposal and presenting it to the committee. The committee is supportive of expanding living donor data collection with the aim to improve knowledge about barriers to living donation as well as establish a comparator data set via the living donor non-donation group in order to understand the long-term impact of living donation. 

Several members expressed the importance of education for living donors about these changes. Messaging should affirm that living donors will still be followed, and even if they do not proceed with donation, data will still be collected to understand the reason why. Further, care should be taken to convey that a trusted organization (SRTR) will follow them to collect ongoing data in the future. A member reiterates the need for communication with living donors about the proposed changes and asks whether feedback was obtained from current living donors in relation to this proposal. They further note that the inclusion of the ‘opt-out’ (living donor non-donation form) living donor data is a missing component of the current data collection. The group was reminded that transfer of 2-year follow-up to the SRTR is aligned with their existing living donor data collection efforts. The Chair notes that the current proposal presents a limitation for the monitoring of living donor non-donation form submission, as no true denominator data collection are planned. 

In consideration of the care and safety of living donors, members also expressed concern about the SRTRs plan for management of follow-up data collection which reveals acute medical or psychosocial concerns. Currently, the close relationship programs have with their living donors offers the opportunity for the living donor to receive necessary referrals or follow-up should an issue warranting attention or intervention arise in the course of collecting information for the Living Donor Follow-up Form (LDF). Members ask whether the SRTR has similar protocols in place to ensure referrals when necessary. It is noted that SRTR’s goal is data collection, but they also have Medical Directors who can communicate directly with living donors to offer guidance. Acknowledging the diligence living donor programs currently exercise in pursuit of obtaining the 2-year living donor data, the Chair further questions whether SRTR will pursue the vital status of living donors and non-donors who are unresponsive to contact at the 2 year anniversary. Additionally, if the transplant hospital no longer owns the 2 year LDF data entry, could this unintentionally result in misses of required living donor safety event reporting to the OPTN? 

The MPSC is grateful for the Living Donor Committee’s work on this proposal and appreciates their thoughtful consideration of the committee’s feedback.

Anonymous | 10/01/2025

As a prior living donor coordinator, I can't even fathom trying to gather information on living donors who have now been declined as donors somewhere in the process or told they can no longer donate due to recipient status. Those conversations are already very emotional and tough for both people but then to say "oh and I need to get some additional information on you while I have you on the phone" ... that sounds quite insensitive and hard. I think this policy needs to be completely rethought. I fully support having data surrounding living donation but I do not think this is the correct approach.

OPTN Patient Affairs Committee | 10/01/2025

The Patient Affairs Committee (PAC) broadly supports the goals of this proposal and the need for long-term follow-up and improved data collection on living donors. PAC members know from lived experience that comprehensive data on living donation and living donor outcomes is lacking, and that this creates challenges when speaking to others about living donation or considering it for themselves. Furthermore, lack of data prevents the community from understanding barriers to living donation and hinders our ability to adopt new approaches to increase living donation. If changes to living donor follow up requirements are adopted, PAC emphasizes the need to ensure patients are not disconnected from clinical follow-ups through their transplant programs where they have established care and relationships. PAC supports the proposal for SRTR to contact patients directly, but suggests that more education be provided regarding the SRTR, as most patients are not familiar with this entity.

Rhode Island Hospital | 10/01/2025

Regarding the proposal:
When is a person considered to have had contact with the transplant team? Is it the online referral/first phone call, when ILDA makes first contact, evaluation meeting call or the in-person evaluation? The proposal does not tell us what data they want to be collected. Is it, why did someone contact us, discontinuation of the work-up or why someone was not a candidate?
Project is well intentioned to understand why people do not complete the work up. but it is not clear if we need to differentiate between why they did not donate: Medical? Mental? Practical (no health care, inability to get to appointments, no follow up or support), self-withdrew, or no return phone call to the program? Other reasons for not donating may be another donor may have shown interest or Abo incompatible & did not want KPD?
For donor candidates, there needs to be a consent from SRTR that all donor candidates sign. PHI will be covered whether they donate or not. Patients will need to know up front about the data collection purpose and the research that they are participating in with SRTR.
Also, considering this data may be used to fuel efforts to remove barriers to donation in the future and create a much more aggressive environment, who will oversee ethical scrutiny? In other words, some of us do not want to be a part of the “there is an organ shortage” culture. Wondering if these patients want to be involved with SRTR? And then there is the issue of follow-up. How are we supposed to collect data on someone who does not want to be part of the process? Are we supposed to track them down or document their silence? It is hard to see how that is going to lead to anything useful—or make anyone more likely to donate.

Has the calculation for additional workload been reviewed? Administrative tasks take away time from the RN Coordinator

Fortunately, the SRTR picks up the project after year one for living donors, and it will be up to them to do the analysis. One troubling thing is that this removes the requirement for the second-year follow-up after donation. That is not just to collect data but to make certain donors do well. Less follow-up time with physicians strikes me as a bad idea, especially if we are trying to keep track of physical and mental health. We do not have issues seeing donors for their follow-up appointments, even for up to two years. Following them up for a longer period is recommended. In addition to checking in on the donor’s health, they give us real, firsthand information to share with future donors. Often potential donors meet with past donors, which enhances their experience. Follow-up visits give us the opportunity to talk to donors and have them meet. Many people considering donation ask us how our donors do afterward, and being able to speak from experience — with data and personal stories — makes a significant difference. Cutting back on follow-up might make things a bit easier in some ways, but it is at risk of losing valuable insight and connection with our donors.
The current follow-up requirements (or even improving them) are important for the safety of our donors and the strength of all programs.

Donor Network West | 09/30/2025

Donor Network West, serving Northern California and Nevada, and recognized as a Circle of Excellence OPO, supports the proposal to update and improve efficiency in living donor data collection. Streamlined, accurate data collection is essential for monitoring donor outcomes, advancing research, and strengthening public trust in the safety of living donation. We commend the Committee for prioritizing improvements in this area and encourage ongoing collaboration with living donor representatives to ensure that data systems are both comprehensive and user-friendly.

NATCO | 09/30/2025

NATCO thanks the Living Donor Committee for their work on this proposal and for their continued support in efforts to better understand access to, and barriers surrounding, living donation.
We recognize and appreciate that the new data collection form is limited to living donor candidates who have had an in-person evaluation. The increased administrative burden on transplant centers is of concern, however.
Regarding the proposal to make the two-year TIEDI follow-up form voluntary, we acknowledge and support the intent to reduce data collection burden. That said, we note that this time point captures valuable clinical information, and we believe many transplant centers will desire to continue collecting this data due to their ongoing relationships with living donors; potentially diminishing the intended reduction in burden. Additionally, as the SRTR does not have an established relationship with donors, long-term response rates may decline without the involvement of the transplant centers, as donors may feel less inclined to participate.
Nevertheless, we appreciate the SRTR's commitment to continuing data collection and the availability of healthcare providers as a resource for donors who may need support.
In summary, NATCO believes this proposal contains important steps toward improving our understanding of living donation, and we offer our overall support for its implementation.

UNC Center for Transplant Care | 09/30/2025

We strongly oppose this proposal due to the significant increase in workload on the transplant center with no clear clinical benefit. The resulting burden on the transplant centers' already limited resources would be in addition to the massive data collection that will be mandated in 2026 by HRSA for referral and evaluation data. Time that living donor coordinators would spend reporting data would detract from time spent providing direct patient care and outreach/education about living donation.

The Association for Multicultural Affairs in Transplantation | 09/30/2025

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American Society of Transplantation | 09/30/2025

The American Society of Transplantation (AST) offers the following comments in response to the proposal, “Update and Improve Efficiency in Living Donor Data Collection.” The AST strongly supports the broader goal of long-term living donor data collection and safety considerations but has concerns with the approach outlined in this proposal and does not believe it will satisfactorily address this goal.

The current proposal seeks to remove the two-year follow-up while retaining the one-year follow-up of living donors by the recovery hospital. The AST believes that this measure could unintentionally affect the relationship between donors and their providers as it might be perceived by some stakeholders as diluted responsibility. Transplant centers have close relationships with the donors, and it is this trust that leads to better adherence and outcomes. Complications from living donation like hypertension, end stage renal disease, steatotic liver disease, or cirrhosis are long term adverse events which need long term medical follow-up by transplant centers. As such, although yearly questionnaires administered by the Scientific Registry of Transplant Recipients (SRTR) will be helpful in expanding our understanding of living donors’ long-term outcomes, they are not an adequate substitute. Resource constraints and burdens associated with data collection are well understood, and a registry by SRTR may relieve some of those burdens; however, the cost may be high attrition rates, leaving the data uninterpretable. Accordingly, the AST suggests keeping the two-year follow-up as a responsibility of transplant centers. The AST encourages efforts and resource allocation for integration of electronic health records to facilitate automatic data transmission. The AST also believes that a means to improve donor outcomes is emphasizing a focus and strengthening of the relationships between living donors and the transplant centers.

The living donor non-donation form is extensive and provides means to document the evaluation and outcome of the potential living donor; however, the form does not present a clear pathway to better understand and address barriers to donation. The AST recommends limiting this form’s focus to demographics and reasons for not proceeding with donation. All protected health information should be removed to eliminate any concerns about personal information saved in a centralized repository and possible breaches. Obtaining information to complete the living donor non-donation form could also be strengthened with a clear informed consent process for these individuals. The AST suggests that the policy requires the first appointment with the transplant hospital to initiate the living donor evaluation process must include education about data collection requirements, their importance, and an informed consent process that makes it clear that participation in the data collection process is voluntary.

Additionally, the AST is also concerned that potential living donors who withdraw from the process may decline continued contact from the transplant center and be hesitant to share information regarding their decision. While unintended, the potential donor may perceive this follow-up contact as undue pressure. Instead of transplant hospitals collecting this information after a decision that the individual will not be a living donor, an alternative would be to gather this information directly from these individuals through a web-based portal or USPS mail. These concerns about the living donor non-donation form are amplified by the added burden that it will place on living donor teams at these transplant hospitals considering the required training, resources, and staff time allocation that will be necessary to comply with requirements.

UW Health, Transplant Center | 09/30/2025

On behalf of WIUW, we appreciate the opportunity to provide comment on the proposed requirements related to living donor evaluation data collection.
While we fully support efforts to better understand living donor outcomes and decision-making, we do not support this proposal as written for several key reasons:
1. Excessive Administrative Burden
The requirement to complete forms for all living donor candidates evaluated, including those who decline to proceed with donation, creates a disproportionate administrative burden. For some hard-to-match patients, this could result in programs completing as many as five or more forms per recipient candidate—with little clear value added to patient safety or system learning.
2. Violation of Donor Privacy and Autonomy
Living donors reserve the right to be protected anonymously. Collecting and storing data on individuals who ultimately choose not to proceed with donation risks infringing on their autonomy and privacy. We feel strongly this is a fundamental rights issue and an inappropriate expansion of reporting requirements.
3. Misalignment with Intended Research Goals
While we would welcome opportunities to participate in well-designed research to explore why donor candidates decline or are ruled out, this proposal is not structured to achieve that aim. Instead, it imposes reporting obligations without a clear evidence-based plan for how such data will be used to inform or improve practice.
4. Recommendation for Pilot Approach
At a minimum, we urge HRSA to consider implementing this as a pilot project rather than a permanent mandate. A phased approach would allow for evaluation of feasibility, data utility, donor perspectives, and program burden before national rollout.
Conclusion
We respectfully urge HRSA to reconsider this proposal in its current form. We encourage broader engagement of transplant programs, living donor advocates, and research experts to co-design a more balanced, ethically sound, and operationally feasible approach.
We will also be encouraging other programs to provide feedback, as this proposal has wide-ranging implications for donor rights, program resources, and ultimately patient access to transplantation.

Massachusetts General Hospital Living Donor Program | 09/30/2025

1) Oppose - 2 Year Follow up to be passed on to SRTR - We anticipate donors would be far less likely to respond to SRTR at 2 yr mark as opposed to their own living donor team. We enjoy having 2-year follow-up to assess for complications in particular mental health. Donors are less likely to call in to report mental health struggles as opposed medical/surgical concerns. We would propose voluntary collection of data to SRTR starting at 5 years with option of life long monitoring every 5 years.

2) Strongly Oppose - Collection of data on potential donors - Many reasons that people to not move forward with donation are non-modifiable (dependents that rely on their care, unable to take time off work, just don't want to assume the risk or undergo surgery). Also, a reasonable majority of people who opt out of donation or are considered "lost for follow up" are not going to take the time to provide the information requested. Trying to track all these responses from potential donors would add a significant amount of workload to the Living Donor Team.

Baylor St. Luke's Medical Center | 09/30/2025

We strongly oppose the plan to require data collection and submission for each living donor candidate who does not proceed to donation. This represents an additional workload for our coordinators, and may discourage some candidates who do not wish to have their data submitted and/or maintained.

Anonymous | 09/30/2025

While we fully support initiatives aimed at improving efficiency in data collection and monitoring living donor outcomes, we respectfully oppose the proposal requiring recovery hospitals to collect information on potential living donors who did not proceed with donation.

Our concerns are as follows:

Burden on Recovery Hospitals

Recovery hospitals already operate under significant regulatory and administrative requirements. Adding the responsibility to track and report information on individuals who never became donors places additional strain on staff and resources without direct benefit to the donor pool.

Data Quality and Reliability Issues

Information on individuals who did not proceed with donation is often incomplete, highly variable, and difficult to standardize. This increases the likelihood of inaccurate or inconsistent reporting, which may compromise rather than improve the integrity of the national data set.

Privacy and Ethical Concerns

Collecting and maintaining records on individuals who voluntarily chose not to proceed could raise privacy concerns and discourage others from considering donation. Respecting a potential donor’s decision to discontinue the process is essential to maintaining trust in the living donor program.

Limited Impact on Efficiency

The stated goal of the proposal is to improve efficiency; however, the collection of additional, non-clinical data may have minimal impact on systemwide outcomes. Instead, it risks creating inefficiencies by diverting resources away from supporting active donors and recipients.

Montefiore Medical Center | 09/30/2025

We appreciate the OPTN Living Donor Committee’s ongoing efforts to improve donor outcomes and enhance data collection. However, we oppose this proposal in its current form for the following reasons:

1. Administrative and Staffing Burden- Implementing the proposed Living Donor Non-Donation (LDND) Form would significantly increase workload for transplant centers. As noted by multiple programs, centers are already preparing for additional requirements in 2026 with the HRSA pre-waitlist referral and evaluation forms. Adding another layer of reporting creates unnecessary duplication and diverts staff time from direct patient care and donor support.

2. Limited Utility of Non-Donation Data- Collecting detailed data on individuals who never proceed to donation does not meaningfully improve understanding of long-term donor outcomes. While reasons for non-donation may be of academic interest, this information can be captured more appropriately through aggregate or research-based approaches, not through mandatory center-level reporting.

3. Focus Should Be on Actual Donors- We support efforts to improve long-term living donor follow-up but believe focus should remain on actual donors, not potential donors who never proceed. Centers already struggle to maintain donor engagement beyond the first year, and expanding scope to non-donors dilutes attention and resources from those who have already made a life-altering commitment.

Global Liver Institute | 09/30/2025

Global Liver Institute supports the goal of updating and increasing living donor data collection. Many people are hesitant due to the lack of information, but transplant centers do not have the capacity to follow donors forever. Done right, this improvement will save lives by enhancing donor safety, advancing research, and ensuring optimal outcomes for recipients.

However, we caution that changes must not inadvertently burden living donors or transplant centers, particularly those in under-resourced regions. For example, during the implementation of the 2020 liver allocation policy, patients in states like Alabama, Louisiana, and Kansas experienced declines in access to transplantation due to unintended consequences of policy changes. Such disparities highlight the need for careful consideration of regional capacities and resources when implementing new data collection requirements – such as extended reporting on non-donors.

Responsible reporting is critical. Data must be collected with context and nuance, capturing not only outcomes but also the circumstances behind them, so that the information supports learning and improvement rather than penalizing centers, donors, or patients. Maintaining trust in living donation and organ availability depends on ensuring that reporting requirements are fair, transparent, and do not create barriers for potential donors or recipients.

Finally, we urge OPTN to track compliance as long-term data collection moves from transplant centers to the SRTR. With any transfer of process, there is attrition and may be an impact on compliance. Donors tend to want to be involved in reporting, but it will be important to ensure that people are not lost in the transition.

We urge OPTN to monitor the impact of these changes closely, ensuring that all transplant centers, regardless of location, have the resources and support to comply without compromising donor care or patient access. Safeguards should be in place to adjust policies if disparities emerge, ensuring that all patients and donors are treated equitably.

Mayo Clinic | 09/30/2025

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Region 9 | 09/30/2025

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

Comments: A member stated that collection of a potential living donor’s social security number should be delayed until they are an approved donor. An attendee raised concern about donors opting out due to fear or pressure who would be uncomfortable with an individual they didn’t know reaching out with questions and suggested adding an opt-out button to the form to allow upfront discussions with the patient. A member noted a unique issue in New York state where they are required to help donors craft a medical reason for not proceeding and asked whether responses should align with the donor’s rights. An attendee requested revision of the proposal’s details and opposed it in its current written form. A member emphasized that EMR programming for the new donor decision forms should occur prior to implementation to reduce burden on transplant centers. An attendee stressed the need for EMR infrastructure to support form submission and reduce administrative burden. A member supported collecting data to identify barriers to donation but opposed placing long-term data collection responsibilities on transplant centers for non-donors, stating that limited OPTN resources should not be used to track the general community’s health.

Henry Ford Hospital | 09/30/2025

The new proposal adds signficantly to more data collection burden on living donor potentials. Potential donors who do not materialize is a significant number and collecting this data does not advance the efficiency of our processes. It does appear as a nice-to-have data set, but in the context of ever increasing reports and metrics, this proposal is not advancing the process or have direct positive impact on living donation. Easing the regulatory burden is a primary objective to be an efficient system. This proposal neither advances efficiency of the process, nor ease burden on transplant center. Strongly oppose the apporach taken with this proposal.

Lorrinda Gray-Davis | 09/29/2025

As a patient who will need a kidney transplant in the future, I strongly support this proposal to expand long-term living donor data collection. The current system creates an impossible ethical situation for both potential donors and recipients.

When I eventually need to approach family members or friends about living donation, I will be asking them to make a life-altering, permanent decision based on incomplete information. Telling someone "we only have 2 years of data on what to expect after donation" is not sufficient for truly informed consent. This same data limitation affects transplant recipients. I faced uncertainty about my own long-term outcomes beyond 5 years post-transplant.

The comments from actual living donors clearly demonstrate their desire to contribute long-term data specifically to help future donors and recipients make better informed decisions. Many donors expressed frustration that they lacked comprehensive outcome data when making their donation decision, and they want to ensure future donors have better information.

While I understand concerns about administrative burden and implementation challenges, we cannot continue asking people to make permanent decisions based on temporary data. The current system is ethically problematic: we're requesting life-changing sacrifices from donors while providing them with systematically incomplete information about long-term risks and outcomes.

Comprehensive, long-term data collection is not just academically interesting, it's ethically necessary for truly informed consent on both sides of the transplant process. Both donors and recipients deserve access to complete outcome data to make the best decisions for their lives and health.

I urge support for this proposal as a critical step toward providing the comprehensive information that donors and recipients need and deserve.

Vickie Connell | 09/29/2025

•Reasons a non-donor did not donate, should remain protected. I can understand “the why” for this data, but ultimately the reason(s) should remain the discretion of the potential donor to disclose, for research purposes. The proposed data collection would not really produce the effects on long-term outcomes in living donors. If the Transplant Centers must begin this documentation, then it should be in a batch fashion. This will continue to keep the integrity of the Transplant Center’s promise to any potential donor that their private, personal information will remain protected.

•If you want long-term affects and risks to health, after living donor donation, then the focus should be on a different cohort group. Let SRTR do living donor follow-ups, but on donors that are already at least 3+ years out. Allow Transplant Centers to continue following their donors, as they are doing now at 6m, 1yr and 2yr anniversary’s.
Turning it over to SRTR after 1 year, as voluntary is not going to allow for consistent data collection information. There could be a considerable loss of good/needed data at the 2 year mark. There could also be financial implications on the donor, to complete the follow-ups. These follow-ups, no matter who is gathering the data, should also remain mandatory to at least 5 yrs, then become voluntary. At the 3 yr mark, if SRTR takes over, are they going to financially assist the donors with completing any lab work? Most Transplant Centers are doing this?
If donor’s know in advance, as a requirement after donation, the SRTR will be contacting them starting at their 3yr anniversary, to assist with long-term affects/risks data collection, the donors may be more apt to follow through, for the success of future donors and programs.

Rebecca Baranoff | 09/29/2025

Support

Allegheny General Hospital | 09/29/2025

On behalf of Allegheny General Transplant Center, we appreciate the opportunity to provide feedback on this proposal. We do not support this proposal in its current form. Implementing the Living Donor Non-Donation Form would significantly increase the burden on transplant centers, compounding the administrative demands already anticipated in 2026 with the implementation of the new HRSA pre-waitlist transplant referral and evaluation forms. Transplant centers can track the reason why donors choose not to proceed with donation on their own within their EHR. This information should be HIPPA protected. We suggest shifting the focus of long-term follow-up tracking from deceased donor transplant recipients (TRFs) to living donor recipients.

Jessica King | 09/29/2025

I appreciate OPTN’s efforts to strengthen data collection and ensure that the experiences and outcomes of living donors are better understood. However, I have several concerns about the proposed changes:

Financial burden on donors: Requiring donors to complete their two-year follow-up labs under the new structure could create a significant financial burden, particularly for those without health insurance. This may discourage donors from completing their follow-up obligations and could create inequities among donors based on socioeconomic status.

Missed opportunities for donor education: If transplant providers are no longer reviewing donor labs after the one-year mark, there is a real risk that abnormal results will go unnoticed. This removes a valuable opportunity to provide donors with timely education and reassurance about their health after donation.

Support for SRTR long-term tracking: I do support the transition of long-term follow-up to the SRTR once donors have completed their two-year follow-up with the transplant center. This balance ensures both thorough clinical oversight in the early years and consistent long-term data collection nationally.

Burden of declination data collection: Requiring transplant centers to complete paperwork for individuals who chose not to donate will increase administrative burden without clear benefit. In addition, this process could unintentionally create psychological harm, as individuals who decline may feel guilt or shame when formally documented as “non-donors.”

In summary, I strongly encourage OPTN to reconsider how donor follow-up and declination data collection are structured. Protecting living donors means reducing unnecessary burdens, safeguarding their emotional well-being, and ensuring they have continued access to education and support after donation.

Respectfully submitted,
Jessica King, BSN, RN

Anonymous | 09/29/2025

Great initiative if SRTR can go back and try to collect data on patients who already donated say 15-20 years ago and seed if we can any meaningful data

Overall why people don't donate after expressing interest is going to be key to help mitigate some of misconceptions.

John Hodges | 09/26/2025

Glad to have you championing this! I do hopewe can also follow up on the 200,000 +/- extant living donors. Categorize this data differently, and consider validation with transplant centers. Thank you!

American Society for Histocompatibility and Immunogenetics (ASHI) | 09/26/2025

This proposal is not pertinent to ASHI or its members.

VA Pittsburgh Healthcare System | 09/26/2025

My worry, by eliminating the 2-year follow-up requirement will encourage insurance companies to have a reason not to pay for any follow-up testing. OPTN policy on 2-year follow-up supports health insurance payment. I understand that current studies show similar follow-up results moving to the SRTR based follow-up, however, that testing doesn't include whether or not insurance pays for testing.
The OPTN just sent a memo today about the increase in suicides from living donors post donation. I think that's reason along to re-consider this proposal. VA systems allow for follow up for any complications for living donors in this 2-year period. that would eliminate that incentive for individuals who want to donate. In the private sector, many live donors do not have health insurance. if there is a complication, what is to be done if the insurance company refuses to cover treatment related to any complications (including mental health) by removing this policy? I have concerns.

OPTN Minority Affairs Committee | 09/26/2025

The OPTN Minority Affairs Committee thanks the Living Donor Committee for their work on this proposal. The Committee supports efforts to better understand barriers to and access to living donation. In discussing the proposed Living Donor Non-Donation (LDND) Form, members commended the inclusion of socioeconomic variables, noting the value of the added detail and the potential for more meaningful analysis.

The Committee raised concerns about reducing the OPTN’s living donor follow-up requirement from two years to one year, with subsequent follow-up shifting to voluntary reporting to the SRTR. Members noted that often living donors transition their care to primary care providers after the second year, and removing the two-year requirement might result in loss of access to care for patients and the loss of important follow-up data.

Family Lifestyle Solutions LLC | 09/26/2025

Getting the feedback that is needed as a imperative to help the program be successful. I am thankful for the oversight commission for closing those institutions that do not do what they’re supposed to do. Thank you for the opportunity to give feedback.

OPTN Liver & Intestinal Organ Transplantation Committee | 09/25/2025

The OPTN Liver & Intestinal Organ Transplantation Committee thanks the OPTN Living Donor Committee for their efforts on their proposal, Update and Improve Efficiency in Living Donor Data Collection. The Committee commends the Living Donor Committee for addressing the critical gap in long-term living donor data and for their thoughtful approach to improving the efficiency, accuracy, and scope of data collection.

The Committee supports this proposal. The Committee appreciates the introduction of the Living Donor Non-donation Form and supports the removal of the mandatory two-year OPTN follow-up in favor of voluntary annual follow-up by SRTR. The Committee expresses no concerns regarding SRTR contacting individuals directly. The Committee notes that ongoing reporting of adverse events within two years remains important and supports continued encouragement for centers to follow up with living donors.

The Committee encourages the Living Donor Committee to ensure that the data elements collected are focused and essential, to facilitate OMB approval and minimize administrative burden on centers.

Vanderbilt University Medical Center | 09/25/2025

On behalf of Vanderbilt Transplant Center, we appreciate the opportunity to provide feedback on this proposal. We do not support this proposal in its current form. Implementing the Living Donor Non-Donation Form would significantly increase the burden on transplant centers, compounding the administrative demands already anticipated in 2026 with the implementation of the new HRSA pre-waitlist transplant referral and evaluation forms. We also do not believe the proposed new data collection would produce a meaningful comparator group for analyzing long-term outcomes in living donors. Finally, we have concerns about donor consent and privacy as well as data integrity – individuals who choose not to donate may not want their information retained indefinitely in the OPTN database.

UCLA Kidney Transplant | 09/24/2025

Living donors frequently contact our program if they have any health issues that might be related to kidney donation. Many of our donors have changes in contact information and may not answer phone calls or respond to email.

Unless there is a clear research objective that is funded, this additional regulatory requirement will detract from our ability to get new patient ready for transplant. Give the current fiscal restraint, we are not able to hire additional staff to comply with this new proposed requirement.

American Nephrology Nurses Association (ANNA) | 09/24/2025

ANNA agrees. We support the ongoing requirements for collection of long term data to help support living donor outcomes. We believe this information is necessary for informed decision making and safety. Implementation of the transition to SRTR’s responsibility for long term data collection may be difficult; one year required post donation follow-up for transplant centers is already challenging for the transplant center to manage in terms of staff time and effort to contact the donor and follow up to ensure the testing was completed. As far as requiring data on potential living donors who do not donate, we understand the rationale, however, this could also be onerous to manage and would likely require extra time and staff. This would likely require additional resources for the transplant center to be implemented.  

Region 5 | 09/24/2025

Sentiment: 5 strongly support, 12 support, 4 neutral/abstain, 5 oppose, 0 strongly oppose

Comments: An attendee commented that implementing this will be a burden on both transplant centers and living donors. While compiling data could be beneficial, they worried this would make potential donors feel more obligated rather than free-willing. Another attendee commented that more data should be collected, since most of the existing data focuses primarily on recipients. An attendee commented that they support adding a Living Donor Non-Donation Form but do not support removing the 2-year follow-up form. They emphasized that the volume of living donors is small compared to other required submissions, so the data burden is not high enough to justify removing another form. They added that follow-up should be increased rather than decreased and believed SRTR’s response rate would be minimal compared to what transplant centers can collect. One attendee commented that it is important for us to learn why some potential donors may not want to proceed and questioned what the overall response would be from these candidates. Another attendee commented that the ever-growing data burden is already challenging for centers, and this proposal appears to add to that burden with limited utility. They support collecting data on living donors, but not individuals who did not donate. An attendee commented that they support the proposal for SRTR to be responsible for completing the long-term living donor follow-up forms, but they had significant concerns about the increased volume of forms required for people who do not become donors. They felt these two items should have been voted on separately. Another attendee commented that while they support efforts to collect better and more accurate data, they were concerned that cold calls from SRTR may not be answered by donors or potential donors. An attendee commented that they support the concept of both longer data collection on non-donors and longer-term follow-up of donors but found the proposal problematic. They felt it requires much more clarity on what is meant by “in person meetings” or “met with the transplant team,” since not all donors meet in person during evaluation. Using themselves as an example, they said they only met the team in person three days before surgery. They suggested clarifying whether this refers to after evaluation and decision-making. They also questioned how donors will be motivated to provide follow-up data to SRTR, noting that most donors have no idea what SRTR, OPTN, or UNOS are their only interactions are with the transplant center. One attendee questioned how this data collection will help understand the long-term risk for donors. 

Region 10 | 09/24/2025

Sentiment: 1 strongly support, 8 support, 5 neutral/abstain, 2 oppose, 2 strongly oppose

Comments: Attendees agreed on the importance of collecting long-term data on living donors, both to improve counseling for future potential donors and to ensure the donor perspective remains a central focus in transplantation. However, there were concerns about how this would be operationalized and the administrative burden it may impose on transplant programs. One recurring point of confusion was the definition of an “in-person” visit. Attendees asked whether this would include orientations, lab draws, or meetings with healthcare providers, noting that the policy as written seemed unclear. Questions were also raised about how the SRTR would collect follow-up data after one year, particularly since many donors do not have primary care providers. Concerns were expressed about the feasibility of collecting reliable, voluntary follow-up data and whether responses would be sporadic. Some noted that SRTR has already begun reaching out to donors several years post-donation, and programs questioned how this process would be scaled and standardized. Others emphasized that details about SRTR’s methods are not fully worked out but that ongoing discussions are exploring new approaches. The proposal to collect data on individuals who do not proceed with donation—whether because they were declined or chose not to donate—was flagged as a significant administrative challenge. Programs worried about having to follow up with patients who did not move forward, many of whom are unresponsive, and felt this would add considerable workload. Several suggested that if non-donor data is needed, it should be collected in aggregate form rather than on an individual basis. Some attendees questioned whether SRTR is the right entity to manage long-term donor follow-up, particularly in cases where living donors lack established healthcare providers. Others felt strongly that collecting both donor and non-donor data is essential, with the latter serving as a control group. Operational questions included how recovery hospitals would be notified if donors chose to participate in voluntary follow-up, whether those hospitals would have access to the responses, and how donor hospitals would integrate that information.

OPTN Transplant Coordinators Committee | 09/23/2025

The Transplant Coordinator Committee thanks the Living Donor Committee for their work on the Update and Improve Efficiency in Living Donor Data Collection proposal. Members are supportive of this proposal, especially regarding moving the two-year follow-up requirement to SRTR. Members said eliminating difficulties with donor contact for programs, particularly in remote areas, will alleviate burden. Members suggested adding language or education for programs to explain SRTR’s public health authority on collecting living donor & nondonor data.

University of Arkansas for Medical Sciences | 09/23/2025

We appreciate the opportunity to comment on the OPTN proposal to Update and Improve Efficiency in Living Donor Data Collection. We fully support OPTN’s efforts to enhance the quality and efficiency of living donor data collection and commend the consideration given to reducing the staffing burden by shifting data collection responsibilities to the SRTR. However, we have concerns regarding the proposed requirement for transplant programs to submit new data on potential living donors who met in person with the transplant team but ultimately did not proceed with donation. For smaller living donor programs with few living donor coordinators or data analysts, this requirement would represent a significant additional data collection burden. Furthermore, we believe that potential donors who choose not to proceed—whether for personal or medical reasons—may find annual follow-up contacts to be intrusive or emotionally difficult. Even with a voluntary process, these individuals may feel obligated to participate in follow-up, which could inadvertently create undue pressure.

Region 6 | 09/19/2025

Sentiment: 1 strongly support, 4 support, 3 neutral/abstain, 1 oppose, 0 strongly oppose

Comments: Attendees discussed questions and concerns regarding living donor data collection and follow-up. Several attendees expressed concern that the 90-day non-donation form window would create additional burden for transplant programs and could discourage potential living donors, particularly those from at-risk groups, due to uncertainty about how their data might be used. One attendee recommended that SRTR follow up with the donors rather than transplant centers. Some attendees commented that requiring an in-person meeting as a threshold to submit data collection or follow-up could result in missing many living donor candidates who ultimately do not donate, especially since some centers conduct much of their evaluation process virtually. Another attendee commented that we need a true comparison group. They explained that people who consider living donation are typically healthier than the general population; tracking their long-term outcomes lets us compare them with actual donors in a meaningful way and interpret differences as donation-related versus baseline health. They added that it will help the community to understand where people encounter barriers, clinical, psychosocial, or practical, so they can target support and improve access and equity across the process. They emphasized that this comparator approach strengthens risk counseling and policy design by anchoring donor outcomes to a similar, healthy reference group while illuminating points in the pathway where candidates disengage.

Amy Devin | 09/17/2025

I just reached my 2-year mark after donating my kidney in August 2023. My after-care has been disappointing, and I want more data on the long-term health of donors like me. As it is, my best source of information is Facebook donor groups. That's ridiculous. I've been part of an amazing science-based procedure, yet there's no science to support me now.

OPTN Histocompatibility Committee | 09/15/2025

The Histocompatibility Committee thanks the Living Donor Committee for their work on this proposal. The Committee is supportive of efforts to improve data collection for living donors and non-donors. They also agree with the decision to make data collection voluntary for non-donors after the one-year mark, with respect for non-donors who may not wish to participate in long-term follow-up.

Region 7 | 09/12/2025

Sentiment: 2 strongly support, 8 support, 5 neutral/abstain, 2 oppose, 0 strongly oppose

Comments: Attendees discussed questions and concerns regarding living donor data collection and follow-up. Several asked for clarification on what constitutes the “first in-person visit,” whether it begins with initial blood draws for ABO compatibility or after a donor is determined compatible and begins the formal evaluation process. Some supported standardization of follow-up and data collection but requested clarity on whether participation in the living donor collective would be mandatory, whether programs would have access to reports, and whether donors could opt out of future contact. Concerns were raised about the use of non-donor registration forms, noting that follow-up with individuals not approved as donors may not be well received. Attendees emphasized that in-person requirements should apply only after formal evaluation begins, following education, donor advocate meetings, and informed consent. While most agreed that collecting living donor data is important, they highlighted the administrative burden on transplant centers, the variation in how donors present and are evaluated, and differences across programs in how multiple potential donors are managed. There was a recommendation for prioritizing long-term outcomes of actual donors over expanded non-donor data collection.

Region 8 | 09/12/2025

Sentiment: 1 strongly support, 12 support, 5 neutral/abstain, 1 oppose, 0 strongly oppose

Comments: An attendee questioned whether the SRTR should be explicitly identified as the responsible party, noting that while SRTR is contracted through HRSA under NOTA, the contract could change, and tasks would transfer with it. There was agreement that the data could provide valuable insight into living donation, but transplant centers emphasized the administrative burden it would place on staff. There was a suggestion for extending the reporting timeframe from 90 days to one year, while other attendees supported maintaining a 90-day turnaround if tied either to the date of transplant center denial or the donor’s decision to withdraw. Concerns were raised about the length and complexity of the proposed non-donor form, with requests to streamline it before implementation. Attendees also questioned the definition of “non-donation,” whether it applied to donors who declined, were declined, or who remained in paired exchange beyond 90 days. There was concern that nuanced reasons for declining donors might not be adequately captured. Additional questions were raised about what specific demographic, clinical, and decision-making data would be collected, and how data from non-donors would be used to inform understanding of barriers to living donation and long-term donor outcomes. Attendees noted financial barriers for donors, including complications with insurance coverage, evaluation costs, and lack of financial protection for complications after donation. There was support for shifting long-term follow-up responsibility after one year to SRTR along with SRTR contacting donors directly. While the burden of data collection remained a central concern, some noted that improved understanding of barriers could ultimately encourage more living donors.

Region 11 | 09/11/2025

Sentiment: 2 strongly support, 12 support, 4 neutral/abstain, 7 oppose, 0 strongly oppose

Comments: A member expressed concern that their center receives a lot of potential living donors, who do not end up moving forward in the process for a variety of reasons, and this proposal could potentially add burden to transplant programs or disrupt workflow. An attendee noted that the two year follow up conducted by transplant programs helps them learn and that removing this requirement might negatively impact future donors because programs may not continue to follow them. A member stated they do not favor additional forms but understand the rationale and suggested implementing the process for a specific time period followed by reevaluation. An attendee emphasized that two-year follow-up is essential for donor health and noted this change would place additional demands on coordinators and divert nursing time from other responsibilities. A member expressed concern about using the first in-person appointment as the start of data collection, recommending instead the first appointment with the pre-transplant team due to remote evaluations. An attendee acknowledged the value of comprehensive data collection but raised several concerns: operational burden from expanded data collection, uncertainty about center-specific versus national reporting, variability in testing practices, and unclear cost responsibility. A member recommended that the 90-day living donor form submission for those who do not proceed should be based on the evaluation closure date, not the first clinic visit. An attendee supported making the second-year follow-up voluntary and conducted by SRTR, but did not support collecting data on donors who decide not to donate, citing privacy concerns and limited actionable value. A member supported the initiative but noted the increased data collection burden for evaluations that do not proceed and emphasized that long-term follow-up response rates may be lower if conducted by an unfamiliar organization.

Michael Murphy | 09/10/2025

Thank you for moving the 2023 proposal forward by clarifying the process and providing specifics on the types of data to be collected. I am a living kidney donor and long-time living donor advocate so I am responding from that perspective. Here is my input to the topics specifically requested by the Committee.

* Feedback on the decision to remove the two-year follow-up (page 18).

My feeling is donors generally would be indifferent as to who collects follow-up data – the transplant center or SRTR – as long as the data are collected. Therefore, I believe donors would support removal of the two-year follow up requirement for the transplant centers because SRTR will pick it up from there (and beyond).

However, there are two consequences that could alter my assessment. First is if the transplant center uses the removal as a signal to cut off support of the donor at the 12-month mark. Donors value their relationships with the transplant teams as a resource to answer questions during recovery and to hold the centers accountable for care and potential complications over the longer term. The Committee does encourage centers to maintain a relationship beyond the first 12 months, but stronger responsibility and accountability may be needed in practice.

Second is concern that funding of the donor’s follow-up visits will disappear after the 12-month visit. A 2022 study (Lentine, Sarabu, et al.) revealed 89% of transplant centers cover the cost of a donor’s follow-up visits in a manner that does not involve charges to the donor or donor’s insurance. (Unfortunately, 11% actually charge the donor!) Thus, the majority of donors would look for assurances that the cost of follow-up visits would still be covered if SRTR were to take over data collection in year two. The latest version of the proposal does not state how the cost of follow up in year two (and beyond) would be covered. Protecting donors from the cost of these visits supports the goal of donor financial neutrality and, perhaps most importantly for the success of this project, encourages ongoing participation by donors in these annual visits. If SRTR does not have a way to cover the cost of the visit at the 24-month mark, the removal represents a financial setback for most donors.

Therefore, it is difficult to endorse the change from the donor perspective until the Committee clarifies that this change will not adversely affect continuity of the donor’s relationship with the transplant center or coverage of follow-up visit costs.

* Feedback on the purpose and utility of the proposed data collection as a justification for the effort involved (page 20).

For the Data Advisory Committee’s (DAC) consideration, here are ways I would expect long-term living donor data to be used: improve donor selection criteria and risk assessment to yield better transplant outcomes and improve donor safety; evaluate transplant center performance including identifying high performers (to establish best practices) and other centers that would benefit from quality improvement; understand why potential living donors do not donate so action can be taken to remove modifiable barriers and increase the size of the donor pool; identify medical, psychosocial, and financial issues that emerge only after the long run; provide surgeons and their teams with details on pre-, peri-, and post-operative experience that can improve surgical processes and post-surgery care; protect transplant centers with informed consent statements backed by accurate and defensive data on donor experiences, including long-term outcomes; reveal gaps in living donor protections (medical issues, psychosocial issues, insurability, financial neutrality, etc.) that could guide interventions as a way to encourage donation as well as simply do the right thing for donors; determine whether alternative policies and procedures are warranted based on type of donor (related/unrelated, directed/nondirected, paired, etc.) and type of donated organ (kidney, liver); provide OPTN with information to improve policies (informed consent content, donor exclusion criteria, donor discharge instructions, follow-up procedures, etc.); inform living donors and their primary care physicians (PCP) of issues to monitor based on long-term experience; support peer-reviewed medical research that compares the long-term experiences of living donors with an appropriate health-matched comparator group; identify inequities in experiences based on age, location, race, ethnicity, gender, etc.; provide accountability and transparency to the interested parties of living donation – donors, potential donors, their families, medical professionals, mental health professionals, financial professionals, the U.S. Congress, state legislatures, OPTN/UNOS, the media, and the public – through regular reporting of donor experiences; monitor living donor safety on an ongoing “real time” (annual) basis that could initiate immediate interventions; and provide an example of world class living donor care.

The other issue baked into the DAC’s hesitancy is whether data can actually be collected from donors and non-donors. Concerns about donor and non-donor participation are valid but manageable. OPTN has shown that policy changes (Policy 18.5) can address lackluster participation rates by clarifying accountability and sharing best practices. The Living Donor Collective has also shown it can be effective in collecting data from donors over many years. Also, benchmarking other living donor registries could reveal useful policies and practices for encouraging and maintaining participation. Frankly, even if participation rates are less than desired, something is better than nothing.

* Considerations for the Community (page 27).

3. Are there any concerns related to barriers to donation or long-term outcomes not addressed among members of the living donor community? The only open issue I see is how the process would work for the growing number of people who are “double donors” – those who have donated both a kidney and liver. How will they be accounted for in the registry and are there any special issues that should be tracked for them long term?

4. Do you endorse removal of the current two-year required OPTN follow-up data collection and submission for living donors, to be changed to a voluntary annual follow-up administered by the SRTR (centers are still encouraged to follow up with patients, but no data submission would be required)? See my previous comments from the donor perspective on this topic.

Do you endorse the SRTR contacting the patient directly? Yes, and if possible, also getting contact information for the donor’s PCP so the PCP can be included in the annual outreach.

5. Are there any educational considerations that you believe would be helpful for living donors to understand these potential changes? Yes. One possibility is to include language in “informed consent” that describes the registry and the expectation (or desire) that the donor will participate annually for life. A second possibility is to create a letter or brochure that goes to the donor at the time of discharge from the hospital that describes the process in detail – the timing of follow-up visits, data to be collected, how it will be collected, how costs are covered, how to stay in contact, etc. The material could also include a letter to be shared by the donor with the donor’s PCP that describes the PCP’s potential involvement in the long-term data collection. Finally, there’s the opportunity to benchmark existing donor registries to learn how they communicate at the initiation of participation and on an ongoing basis.

Region 3 | 09/10/2025

Sentiment: 2 strongly support, 6 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose

Comments: One attendee commented that it is vital to understand the long-term effects of living donation beyond 2 years. They went on to comment that transplant centers have tried to obtain the required follow up from living donors with no real impact. They recommend removing the two-year living donor follow-up requirement from the OPTN and transfer voluntary follow-up to the SRTR, which will follow the living donor and potential living donors long-term and hopefully increase data collection. Another attendee recommended that the committee consider allowing centers to batch report the non-donation data semi-annually to lessen the burden.

Glenna Frey | 09/10/2025

As a nephrology nurse, a family with kidney disease, and a nondirected living kidney donor in 2017, I know firsthand the importance of long-term donor follow-up. There is currently very little research on living donors beyond the required 2 years, which does a disservice to both potential donors and the patients who depend on them. Updating and improving the efficiency of living donor data collection is critical to protecting donor health, advancing research, and ensuring the best outcomes for recipients. I strongly support this proposal.

Jennifer Roberts | 09/08/2025

Living donors take on serious risk to help others. We deserve a system that tracks outcomes, learns from them, and gives us the knowledge we need to make one of the biggest decisions of our lives.

I know now that I didn’t have enough information about long-term outcomes when I donated my right kidney to a stranger in 2015 and the left lobe of my liver to another stranger in 2023. More than two years after my liver donation, I am experiencing ongoing health issues related to the surgery, yet there is no mechanism to track, assess, share, or learn from my experience so that others can benefit from it. That failure of follow-up is a systemic failure of duty—leaving donors on their own and future donor candidates in the dark.

I support the OPTN proposal to update and improve efficiency in living donor data collection. Shifting longer-term follow-up to SRTR and expanding data collection to include donor candidates are essential steps. This will reduce burden on centers, improve consistency nationwide, and—most importantly—begin to close this systemic gap and give future donors and donor candidates a more clear picture of the realities of living donation.

Lainie Ross | 09/08/2025

1. To collect the post-donation data, the donor needs to trust the organization. They are more likely to trust the institution where the surgery was done than the SRTR; also we know that living kidney donor health problems may not begin for 8 or more years. Limiting inperson examination/evaluation and data collection by the center to one year is going backwards (we originally collected for zero years, then 1 year and then 2 years)

2. 2 years is too short, but we should not decrease it. we need a system to collect data for life, but this should go hand-in-hand with examination and evaluation. we know that 20% of living donors do not have health insurance. just getting their data (without providing appropriate medical care) is using them purely as a means. They are also our patients.

3. Collecting data on nondonors should be anonymized (or at least deidentified). and they MUST have the right to refuse to have the data collected. a

4. As proposed we would be collecting a lot of PHI on non-donors which may not be desired by the nondonor. Especially since this will be done without (or prior) to getting informed consent. and so this may result in fewer living donors.

5. If I am overruled, and such data are collected, it MUST be done with a full consent process --that is a full consent process even before the discussion (which may impede living donation). it is not enough to do consent in a piece-meal approach--oh we are just getting you social security number to start a file, because this does not explain the whole process (and the value of using them for research as control non-donor to compare to donors). So in the consent process, it must be explained that we will use this data for research purposes.

Mythreyi Govindarajan | 09/05/2025

This policy change is a thoughtful and necessary evolution in the field of transplantation. By expanding the scope of data collection and centralizing long-term oversight under SRTR, it lays the groundwork for improved donor care, better-informed policies, and stronger outcomes. With careful implementation and a focus on donor rights, this policy could significantly enhance the living donation experience.

Betsy Snow | 09/05/2025

I am a living non-directed kidney donor 2018 and I strongly support collecting living kidney donor data past 2 years. The current requirement for 2 years of follow up is failing because many donors feel that the transplant centers aren’t interested in a donors issues after their donation. When donors call with issues they are not getting call backs so when the hospitals reach out for required data donors don’t respond. Until hospitals become more responsive collecting good data will be difficult. Obviously - some hospitals are better than others but this has been a recurring theme in the donors I have mentored since my donation. Without good comprehensive data it is hard to dispel all the myths around living kidney donation.

Aubrey Sepko | 09/04/2025

As a living kidney donor, I can confidently say that this information is vital. When I donated in 2011, the data shared with me was incredibly minimal. Little was (and still is) known about the long term risks and any complications. Donors should be able to make informed decisions about their bodies and any risks involved. If someone is willing to donate part of their body to help someone in need, the least we can do is provide them with data during the evaluation process to determine if this is a decision that they are comfortable with.

Anonymous | 09/04/2025

It is high time the OPTN focus on living donation. The OPTN puts so much energy into trying to make more marginal quality deceased donor organs work for the abundance of patients waiting for their life-saving organ transplant. The OPTN should put just as much, if not more, energy, time and resources into getting the best quality organs for the patients in need of transplantation (living donor organs). The living donors that the transplant system asks this of deserve lifetime follow up and scientifically and medically sound, controlled, data. The vast need for transplantation will not be met with deceased donation alone and living donation rates will remain stagnant (as they have for decades) unless the community can provide better data to help donor candidates inform their decisions to donate. Thank you to the committee for pushing this project forward and to the community for considering how much it is worth the effort and cost.

Trysha Galloway | 09/03/2025

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View attachment from Trysha Galloway

Colleen Maher | 09/03/2025

As a living donor, I feel it is vital to have a database with long term followup data on donors. I believe it would help undecided potential donors make an informed decision. I would have liked to know data >2 years out at time of my donation, and even now am relying on social media to connect with other donors to hear their stats. I would like to see this data centralized and accessible.

Anonymous | 09/03/2025

Many potential donors and their family members ask about long term data on living donation. We educate donors, but sometimes donors to back out from lack of long-term data. It is important data for transplant professionals to have as well when caring for this group of patients.

Anonymous | 09/02/2025

The data collection on living donors should include current and retrospective data from living donors. There are many of us who are decades post transplant and there is much to be learned from including us in studies.

Anonymous | 08/31/2025

Strongly support. I was a living donor candidate who passed all of the screening and ultimately opted out of donation owing to the lack of long term data available. I did not feel the “informed consent” was truly informed and that gave me too much pause to feel fully at ease with moving forward. This would be a start to changing much of that.

Kristen Hovey | 08/30/2025

I donated 66% of my liver to a stranger in Texas. I live in Iowa. I flew down there for the transplant and got to meet him the day before. They followed up with me for two years but that only included sending them my blood work. The only way I knew my liver had fully regenerated is because I got tested a year later to donate one of my kidneys. It would be nice if a living donor could be followed for at least a minimum of five years.

Anonymous | 08/30/2025

I think this would be great! Many people wonder about what life looks like beyond 2 years.

Jullie Hoggan | 08/28/2025

Potential donors, and those educating them, should have access to as much data as possible about living donation so I support this data collection.

Anonymous | 08/28/2025

We need standardadized data collection for DCD donors such as GCS, reflexes, ability to breathe on their own, CPAP trial and etc to help guide us on which donors will expire and who wont

Terri Milton | 08/27/2025

There needs to be standardization and effective communication. So yes. I agree.

Nancy Marlin | 08/27/2025

When I was searching for a living kidney donor, not surprisingly potential candidates asked me about the long-term effects of living donation. I shared the available research, but with the limitations that the studies were often of limited duration, single-center or lacked an appropriate control group. This important data collection project will, in the long-term, answer such questions as well as provide valuable information about barriers to living donation.

Anonymous | 08/27/2025

Support

Anonymous | 08/27/2025

Strongly Support

Susan Rackley | 08/27/2025

Living donors and their data need to be available to anyone who needs it.