Comments

Kelley Hitchman | 11/06/2024

I respectfully suggest that bylaws governing the nominating committee and the "special election" process mirror those established for the "general election". This is essential to ensure fairness and consistency in these important processes. These bylaws should be developed in collaboration with the transplant community (patients, patient and donor families, living donors, Histocompatibility laboratorians, transplant professionals and OPO members) and NOT solely appointed by government officials. Allowing the transplant community to play a central role in founding these processes will enhance transparency, promote trust, foster partnership and best reflect the diverse, and important, perspectives within the organ transplant community. I appreciate the opportunity to give public feedback on this vital matter.

American Society of Transplantation | 11/06/2024

The American Society of Transplantation supports the OPTN bylaws changes included in the proposal, “Revised Bylaws and Management and Membership Policies” released during a special public comment period, recognizing these changes are a necessary step in support of OPTN modernization initiatives. This OPTN bylaws proposal also highlights the need to update the current OPTN Charter so it is aligned with recent revisions to the National Organ Transplant Act (NOTA) and the goals of OPTN modernization efforts.

Keith Plummer | 11/05/2024

I believe breaking up the by-laws from the qualifications is small step but a giant step in the right direction. Being a waitlist member for close to five years, I feel that there needs to be someone on the board that has been through the effects of a lost organ due to delivery issues. I have since been transplanted but will never forget the feeling of a loss when you are told, "not today"

Anonymous | 11/04/2024

Yes, the OPTN needed to adopt new bylaws when the OPTN designation moved from UNOS to INVEST. But I am appalled that HRSA worked with a new contractor and the INVEST Board to develop and adopt these bylaws and policies MONTHS ago and the public is just now seeing these. How is that due process, transparency, collaboration, and all of the other things that HRSA promised in the OPTN Modernization Initiative?!

The proposal states, "As part of the OPTN Modernization Initiative, HRSA has indicated its intent to hold a special election for the Board but has not announced the timing of the special election." HRSA has indicated that HRSA (not the OPTN or the transplant community) will change the process of the nominations and Board elections for the special election but has not provided any details for how this will be done fairly, without conflict, or collaboratively with the transplant community. What is HRSA's legal authority here? I urge the current OPTN Board of Directors to amend these Bylaws to include appropriate safeguards for special and regular elections.

Also, in response to the comment that stated, "The proposal strengthens conflict of interest guidelines." I believe the conflict of interest content that the user mentions is actually from an earlier proposal to establish a Code of Conduct and Whistleblower protection. (https://optn.transplant.hrsa.gov/policies-bylaws/public-comment/establish-code-of-conduct-and-whistleblower-protection-bylaws/).

George Bayliss | 11/04/2024

Transplantation in the US is undergoing major changes, following critical hearings by the Senate and Congress and demands to increase organ recovery and transplantation and reduce waste of organs. The premise of the reorganization is that it will improve transplantation for patients and families. Critics cite conflict of interest as the reason to distance the OPTN from UNOS and create a separate board of directors for the network. HRSA created a separate entity INVEST to act as the newly independent board of directors for the OPTN. Under the circumstances there seems to be no choice about accepting the separation of INVEST’s bylaws and OPTN polices since Delaware corporate law dictates that.

This bureaucratic change does not show how the creation of the new entity will improve transplantation for patients and families, other than to make the OPTN board independent of UNOS and remove perceived conflicts of interest between the OPTN and the contractor. Under the new structure, the OPTN has no authority over the new contractors. Its board (INVEST) will hold weekly meetings with the contractors and HRSA and monthly meetings with HRSA alone.

The proposed document describing the creation of INVEST needs to show in specific terms how this reorganization will improve transplantation. It must specify that the “patients and families” to which it refers are organ recipients, organ donors and their families. It must describe how these changes will “better serve” those patients and families by improving the network's ability to recover more organs and transplant them, allocate them more equitably and efficiently, and honor the gift of donors and their families by using as many of the organs recovered as possible.

Missing from the discussion about creating new administrative oversight is how these changes will help transplant centers increase organ viability, so patients receive the benefit of organs last longer than the survival models predict. For example: How will the reorganization help resolve the biological and ethical questions around thoracic normothermic regional perfusion; how will it help develop newer reperfusion and preservation mechanisms; how will it help reduce or eliminate reperfusion ischemia injury; will it help provide for better aftercare of kidney transplant recipients with dense delayed graft function?

Administratively, how will these changes affect implementation of continuous distribution of kidneys and help make allocation more equitable? Will they help get marginal organs rapidly to centers willing to accept them and reduce cold ischemic time?

One hopes that INVEST will be able to press for changes in the network that improve organ recovery, allocation and transplantation and encourage research to improve organ longevity for the benefit of transplant recipients, organ donors and their families

Anonymous | 11/04/2024

When UNOS is replaced with a different contractor, there should be a reasonable overlap period. When we turned over the Panama Canal in 1979 to the Panamanian Government, the US engineering professionals spent 20 years training their Panamanian counterparts. However, in this specific instance the overlap period should be much shorter, but long enough so that the public and transplant programs don't suffer.

Anonymous | 11/04/2024

The decision to implement these bylaws prior to public comment highlights a critical disconnect with the community. It’s unclear how these can be in effect before being fully vetted, raising questions about transparency and stakeholder input. Furthermore, these changes place an operational burden on organizations to realign procedures without providing any tangible benefit to patient outcomes. The existence of two separate sets of OPTN policies is entirely unnecessary and does not add value.

The lack of clarity on how the public accesses these bylaws only adds to this disconnect. Additionally, the unresolved issue of managing conflicts among contractors competing for the same contracts is problematic. Expecting these contractors to support one another when they’re vying for future task orders is unrealistic and risks fostering competition over cooperation, which could ultimately hinder cohesive, patient-centered outcomes.

Anonymous | 11/04/2024

After reviewing the proposal, we remain concerned with the lack of transparency and ability to provide feedback prior to changes being implemented. We feel it is critical for Transplant Centers, OPOs, patients, and other members of the transplant community to voice their concerns/opinions prior to any major changes. We feel that the previous system encouraged experienced clinicians to come together and create new policy/changes. We share the concerns of many other transplant community members when it comes to the lack of experienced transplant professionals on the new board and their ability to create effective policies. Breaking up the bylaws into 2 documents is likely to create confusion and does not appear to be necessary, as there already several regulatory documents that must be reviewed frequently by transplant centers and OPOs.

Anonymous | 11/01/2024

I am a patient and I have mixed views on these recent changes.

I have been privileged to have heard HRSA speak several times about their modernization of OPTN. However the one question I have asked several times and was never answered is who is the new contractor and is UNOS also getting a renewed contract to work along side this new contractor?

To me this is a very important part of this transition and as a patient and a volunteer I have been worried about how these changes WILL affect those waiting for a transplant.

I also do not entirely understand, because I do not feel it has been explained well in layman’s terms, what the role of the independent Board actually is. In addition, I do not feel that a board which is made up of people who have no connection or understanding of transplant policy or allocation should be on this new board.

Additionally, I do not believe that HRSA has kept the public abreast of parts of this modernization plan and instead has kept important information from the volunteers and the public, making decisions long before a public comment period was opened. HRSA has failed miserably in the area of transparency.

Lastly I’m an troubled by the possibility of HRSA making decisions that can affect patients if the independent board of directors do not have the ability to govern the new contractor(s) chosen by HRSA, without any input from the transplant community.

It feels to me like all of a sudden patients complained about lack of transparency and now HRSA woke up and has decided they need to be more involved. It’s as if they were not doing their job before patients started to grumble. And now they are scrambling to make it right. I know OPTN is a government agency but I do not like the idea of OPTN being governed through the political lens.

Anonymous | 11/01/2024

How can we, as a community committed to saving lives, ensure that HRSA’s modernization efforts benefit from both the wisdom of experience and the dynamism of fresh perspectives?

HRSA’s initiatives to modernize the organ transplantation system represent an essential shift toward greater transparency, accountability, and equity. Significant change, however, naturally brings about various reactions, and some criticisms may stem from underlying concerns like status anxiety, fear of obsolescence, and transparency aversion. Recognizing and reflecting on these dynamics can strengthen HRSA’s path forward, helping all involved to build a governance model that is adaptable, inclusive, and truly representative of our diverse community. For longstanding leaders within transplantation governance, modernization may introduce concerns about shifts in influence or visibility. Adjustments in governance can feel like challenges to established roles, creating understandable concerns about maintaining one’s place in the field. Striking a balance by valuing the experience of these leaders while embracing new perspectives enables HRSA’s modernization to benefit from both continuity and innovation, fostering a culture of growth. HRSA’s push for a more adaptive and forward-thinking system may also raise concerns among those deeply invested in traditional structures about being “phased out.” For some, these changes can feel like an encroachment on long-held roles and responsibilities. Developing roles like advisors or emeritus members could allow experienced voices to continue contributing meaningfully as the system transitions to new approaches. Some criticisms around HRSA’s transparency initiatives may stem from discomfort with increased openness. For those accustomed to a more closed governance style, the shift toward public access to decision-making, community feedback, and policy metrics can feel unsettling. Yet, embracing transparency as a fundamental value supports inclusivity and reinforces public trust, showing that decisions are both ethical and fair. Encouraging such self-reflection allows each of us to navigate HRSA’s modernization journey collaboratively, drawing on the strengths of both legacy knowledge and fresh ideas. By fostering this spirit of openness, HRSA can create a governance model that reflects the evolving needs of patients, donors, and the entire transplantation community.

Anonymous | 11/01/2024

As a patient, I'm deeply concerned about this process. While I support improving the nation's transplant system, I do not believe this process has been transparent. I'm also saddened and worried that transplant has been infiltrated by politics. I understand HRSA is moving toward appointing board members. HRSA's role is oversight. What has made the OPTN so successful over the years, is that it's the transplant community electing board members with knowledge and expertise to make policy. We patients have also had a voice as we experience the real life implications of policy. While not perfect, this process leaves politics out and allows for true medical experts and patients to make decisions in the best interest of patients. I've undergone surgery. I've risked my health to donate my kidney. The last thing I want to see is bureaucrats making medical policy. That's NOT oversight. That can lead to dangerous outcomes, and I fear we risk going backwards. We have transplanted more people year-over-year, including during a pandemic. The US has the best system in the world. I'd much rather see modernization efforts undertaken to streamline policymaking so policy is approved more quickly, incentivizing transplant centers to be more innovative to push the science forward--again to transplant more patients. What we have seen from HRSA for several years now is few answers, lots of "No" to things like the approving an OPTN budget that the Board and community approved that would fund progress, and attempting to censor the results of research at conferences. I truly hope these supposed improvements and modernization don't result in fewer people getting transplanted.

Trysha Galloway | 11/01/2024

I commend HRSA, OPTN, and the Executive Committee for this significant step toward modernizing OPTN’s governance through the establishment of INVEST. The proposal effectively separates governance from operational contractors, improving transparency and oversight in a manner that holds particular significance for living donors, a group whose contributions are essential yet complex in terms of medical, ethical, and support needs.

By establishing the Independent Network of Volunteers for Equitable and Safe Transplants (INVEST) as an autonomous governing body, HRSA is taking a strong step toward mitigating conflicts of interest within OPTN. For living donors, this independence is pivotal; it assures donors that policy decisions are made impartially, focusing on patient and donor welfare without undue influence from operational contractors. Additionally, the increased transparency and streamlined governance structure signal to living donors that their needs and contributions will be managed within an unbiased framework.

Dividing governance documents into Bylaws and Management and Membership Policies introduces flexibility and clarity, which are beneficial for living donor policy development. This structural division allows for more adaptable Management Policies that can respond dynamically to the evolving needs of living donors. For instance, the Management and Membership Policies could be periodically reviewed and updated to include new protocols in donor follow-up care, addressing any emerging post-donation health issues. By keeping these policies separate from the foundational bylaws, OPTN ensures that living donor-related policies remain both responsive and relevant.

The proposal strengthens conflict of interest guidelines, ensuring Board members are not affiliated with entities that could present conflicts in donor policy development and implementation. This provision directly supports living donors by ensuring that policies, such as eligibility and long-term care, are shaped without conflicting commercial or institutional interests. Additionally, robust compliance mechanisms help protect living donors, who may otherwise be vulnerable to biases or conflicts impacting the care and support they receive.

The addition of structured public comment periods under INVEST governance is another promising step. By allowing stakeholders to share insights and concerns about donor policies, living donors have a direct platform for input, ensuring their voices are part of OPTN’s decision-making process. This transparency in feedback collection is crucial in ensuring that policies related to living donors, such as follow-up care standards or ethical considerations, are informed by those with firsthand experience.

The proposal’s inclusion of post-implementation monitoring further aligns with living donors’ interests. Ensuring policies are actively monitored after implementation means that donor policies can be adjusted as outcomes are observed. For example, metrics related to living donor health outcomes, satisfaction, and compliance with follow-up care could be used to assess the success of policies, making room for continuous improvement in donor care standards. This process can provide living donors with reassurance that OPTN is committed to evidence-based policy refinement.

Thank you for the opportunity to engage with this transformative proposal. By establishing INVEST and modernizing OPTN’s governance, HRSA and OPTN demonstrate a profound commitment to transparency, integrity, and the welfare of all those impacted by organ transplantation. :)

Anonymous | 11/01/2024

I commend HRSA, OPTN, and the Executive Committee for this significant step toward modernizing OPTN’s governance through the establishment of INVEST. The proposal effectively separates governance from operational contractors, improving transparency and oversight in a manner that holds particular significance for living donors, a group whose contributions are essential yet complex in terms of medical, ethical, and support needs.

By establishing the Independent Network of Volunteers for Equitable and Safe Transplants (INVEST) as an autonomous governing body, HRSA is taking a strong step toward mitigating conflicts of interest within OPTN. For living donors, this independence is pivotal; it assures donors that policy decisions are made impartially, focusing on patient and donor welfare without undue influence from operational contractors. Additionally, the increased transparency and streamlined governance structure signal to living donors that their needs and contributions will be managed within an unbiased framework.

Dividing governance documents into Bylaws and Management and Membership Policies introduces flexibility and clarity, which are beneficial for living donor policy development. This structural division allows for more adaptable Management Policies that can respond dynamically to the evolving needs of living donors. For instance, the Management and Membership Policies could be periodically reviewed and updated to include new protocols in donor follow-up care, addressing any emerging post-donation health issues. By keeping these policies separate from the foundational bylaws, OPTN ensures that living donor-related policies remain both responsive and relevant.

The proposal strengthens conflict of interest guidelines, ensuring Board members are not affiliated with entities that could present conflicts in donor policy development and implementation. This provision directly supports living donors by ensuring that policies, such as eligibility and long-term care, are shaped without conflicting commercial or institutional interests. Additionally, robust compliance mechanisms help protect living donors, who may otherwise be vulnerable to biases or conflicts impacting the care and support they receive.

The addition of structured public comment periods under INVEST governance is another promising step. By allowing stakeholders to share insights and concerns about donor policies, living donors have a direct platform for input, ensuring their voices are part of OPTN’s decision-making process. This transparency in feedback collection is crucial in ensuring that policies related to living donors, such as follow-up care standards or ethical considerations, are informed by those with firsthand experience.

The proposal’s inclusion of post-implementation monitoring further aligns with living donors’ interests. Ensuring policies are actively monitored after implementation means that donor policies can be adjusted as outcomes are observed. For example, metrics related to living donor health outcomes, satisfaction, and compliance with follow-up care could be used to assess the success of policies, making room for continuous improvement in donor care standards. This process can provide living donors with reassurance that OPTN is committed to evidence-based policy refinement.

Thank you for the opportunity to engage with this transformative proposal. By establishing INVEST and modernizing OPTN’s governance, HRSA and OPTN demonstrate a profound commitment to transparency, integrity, and the welfare of all those impacted by organ transplantation.

Anonymous | 11/01/2024

Why am I responding anonymously? I am concerned about potential retaliation from HRSA. While the OPTN has a code of conduct that protects individuals from retaliation from the OPTN, it does not extend to HRSA, which has significant influence over OPTN decisions. HRSA has indicated a desire to have MORE control over the selection of OPTN volunteers, leaders, and policies. I fear that my comments could provoke HRSA and jeopardize my ability to participate in future policy discussions.

Concerns about the Proposal:

Timing: The changes outlined in the proposal took effect in June, but the public was not invited to comment until October. Why was there a four-month delay in seeking public input? Furthermore, why was there no public comment period before the Board adopted these bylaws?

Private INVEST Meeting: While INVEST, as a private corporation, is entitled to hold private meetings, it is troubling that all discussions regarding these bylaws occurred in private meetings between HRSA, INVEST, and a new private contractor. The public was not consulted on whether the bylaws should be divided into multiple documents. Now, we learn that these bylaws and policies have been in effect for months, and HRSA delayed their release. One of the goals of the OPTN Modernization was to enhance transparency and collaboration. This process appears to contradict those goals, raising concerns about HRSA’s future operations.

Designation Contract: Finally, the proposal frequently mentions a designation contract. However, this document has not been made available to the public. What does it contain, and why has HRSA not disclosed it?

Officer Terms and Special Election: Since the proposal mentions the forthcoming special election, how will the transplant community be involved in nominating and selecting the new Board? Who will decide the process for the special election? Will patients get a vote? Will there be geographic representation or organ specific representation? How will we ensure there is no gap in knowledge or there is a knowledge transfer so that innovation doesn't stall? Again, HRSA mentions a significant step but doesn't provide details to the community.

Again and again through the OPTN Modernization Initiative, the community has asked HRSA for more details and HRSA continues to provide vague or no answers. This proposal is another example of HRSA not being transparent or collaborative with the community and I fear for what this means for patients moving forward.

Anonymous | 11/01/2024

The modernization of donation and transplant is long overdue. However, the way HRSA is attempting to do this does not promote trust in their efforts or actions. Independent oversight of the OPTN is essential to ensuring equity, fairness and safety. You undermine your goals when you operate in secrecy and do not clearly relay what is happening or going to happen. As a patient I am gravely concerned about how HRSA has chosen to move forward and am rapidly losing faith in their ability to change transplantation without negatively impacting the system as a whole. It may not be perfect, but it was/is functioning and HRSA seems to be jeopardizing it. It looks as if the OPTN board (INVEST) is losing much of its authority or ability to manage donation and transplant services to HRSA and contractors who have no specific experience in this arena.

Jake Kleinmahon | 11/01/2024

Thank you for undertaking this large task of developing INVEST and revising the bylaws and policies. As a pediatric provider and medical director, it often feels that pediatrics is not given the consideration that is needed for this unique population of patients. I think that a minimum of one pediatric representative on the board is an insufficient voice to ensure that the board is making decisions with this vulnerable population in mind. I propose that this requirement is raised to a minimum of 15% of the makeup of the board in order to have enough diversity of thought for the pediatric patient population. Thank you for the work that you do and have done and consideration of our small, but very important patient population.

Anonymous | 10/31/2024

The current proposal from HRSA is deeply flawed, and it is astounding that such a document could come from an organization responsible for overseeing the OPTN. (And let's not kid ourselves, this project clearly came from HRSA not OPTN volunteers or UNOS staff.) Here are my key concerns:
• Inexperienced Contractor Involvement: HRSA's decision to hire a new contractor with no experience in OPTN laws or regulations to rewrite the OPTN bylaws is both reckless and irresponsible. This contractor has demonstrated a lack of understanding of the OPTN and the community's reliance on these governance documents. Their continued involvement in future OPTN work would be highly detrimental.
• Lack of Transparency: Despite HRSA's repeated claims that transparency and collaboration are cornerstones of the OPTN modernization act, this proposal embodies the opposite. HRSA's decision to hire a contractor without public solicitation raises serious concerns about future contractor or award processes. Furthermore, HRSA undertook this project with the new contractor without notifying or including the community. The designation contract with INVEST (which is what makes the INVEST bylaws operate as the OPTN bylaws) is not publicly accessible, prompting questions about other potentially undisclosed decisions and directives by HRSA. This is a clear departure from the promised transparency and collaboration.
• Unnecessary Bylaw Splitting: The decision to split the bylaws is completely unnecessary. For example, this action has resulted in two sets of OPTN policies and two OPTN Policy 1s, which will undoubtedly cause confusion. This move appears to lack any valid justification and serves only to complicate the governance structure.
• Quality Concerns: The presence of multiple typos and incorrect cross-references within the proposal is unacceptable. It is concerning that HRSA and the Board have already adopted this document despite these glaring errors. This calls into question the quality of work we can expect from HRSA and their new contracting partners in the future.

Simon Horslen | 10/31/2024

1. I have concerns about how the Board will function when it has no direct say over the activities of the contractors - which will mean HRSA will have to step up its level of involvement massively. Essentially, because the contractors sit outside of the OPTN, if the Board or the OPTN as a whole is concerned about a contractors activities or lack thereof, or there are concerns of conflicts between contractors affecting patients or the functioning of the OPTN, the only recourse is for the Board to talk to HRSA and hope that HRSA addresses the issues promptly and effectively to the benefit of the patients.
2. The Byelaws say there must be "at least one pediatric provider on the Board of Directors" - this seems insufficient representation for children to me!
3. There is no requirement for a pediatric provider to be on the Nomination or Executive committee, and I think there should be.
4. The whole process lacks transparency, with information drip fed in small portions so it is not possible to get an overall sense of how the new system is expected to function and who will be able to actively participate in decision making.

John Schmitz | 10/30/2024

This response is relevant to the histocompatibility laboratory membership section of the OPTN revised bylaws.

Please clarify why in Appendix C.1.2 the 2013 ASHI standards are referenced. I suggest this be reworded to "...the most recent version of the ASHI standards."

In the director qualifications on page 55, American Board of Medical Laboratory Immunology certification is appropriately included. This board is no longer certifying individuals although it offers maintenance of certification. The American Society for Clinical Pathology now offers a CMS/CLIA recognized certification exam for Immunologists that serves as a replacement of the ABMLI certification. The ASCP certification (Diplomat in Medical Laboratory Immunology) should be included in this list of acceptable board certifications.

In the portfolio requirements, also on page 55: for a new director that is ASHI certified, can that individual use the portfolio documentation submitted for ASHI review in lieu of preparing and submitting additional case studies to the OPTN for approval? Alternatively, the OPTN should consider relying on ASHI certification of new directors as fulfilling the portfolio requirement.

American Society for Histocompatibility and Immunogenetics (ASHI) | 10/30/2024

The American Society of Histocompatibility & Immunogenetics welcomes the opportunity for OPTN Bylaws public comment. ASHI represents the only professional accreditation organization and community in the US that is solely dedicated to the practices of transplantation immunology, histocompatibility and immunogenetics. ASHI opposes the recent conversion of the OPTN Board Histocompatibility representative seat to a de facto appointment. ASHI strongly supports bylaws amendment to appoint the OPTN Board Histocompatibility representative through fair and unbiased election by OPTN membership vote. The OPTN community should be given opportunity to select the most qualified candidate amongst a slate of appropriate experts in Histocompatibility. De facto appointment reduces community involvement, as well as opportunities for qualified individuals to lend their expertise in this important role. At a time when the OPTN's reputation has been tarnished by the lack of transparency, a bylaw change back to an open election for the OPTN Board Histocompatibility representative is an easy way to demonstrate the OPTN's openness to ensure that OPTN Board membership reflects the will of the OPTN community.

View attachment from American Society for Histocompatibility and Immunogenetics (ASHI)