Comments

Debra Kukuruga | 11/08/2024

I appreciate the opportunity to provide public feedback concerning the upcoming changes to the governance documents of the OPTN. It is critical that the bylaws governing formation of a nominating committee, and the “special election” for a new OPTN Board of Directors, do not deviate from those established for the "general election". The bylaws need to be developed collaboratively with the transplant community including patients, patient and donor families, living donors, Histocompatibility laboratory professionals, transplant professionals and OPO members. Making decisions based on feedback from the transplant community will enhance the transparency of the OPTN modernization process and allow the transplant community to trust in the partnership with administration of organ transplantation in the U.S., as it once did.

Of specific concern is the recent conversion of the OPTN Board Histocompatibility representative seat from an elected position to a de facto appointment. This Histocompatibility representative seat should reflect the choice of the transplant community through a fair and unbiased election, as it was previously.  Shifting the position back to an elected position would further enhance transparency and partnership with the transplant community.

Thank you for the opportunity to provide feedback on this important topic.

Transplant Families | 11/08/2024

On behalf of Transplant Families, we would like to express our support for the "Revised Bylaws and Management and Membership Policies" proposed by the OPTN. We appreciate the efforts made to modernize and enhance the governance structure of the OPTN. We are also supportive of statements already made by the Children's Hospital Association and SPLIT.

1. We fully support the proposal to maintain a board that is representative of the transplant community. It is crucial to have a diverse board that includes clinicians, hospitals, surgeons, OPOs, and most importantly, patient and donor families. This diversity ensures that all perspectives are considered in decision-making processes. We would not feel comfortable if all stakeholders were not included in making clinical policy decisions for our most vulnerable patients.

2. We strongly advocate for pediatric transplantation to remain a priority. Currently, there is only one required representative for pediatric transplantation out of over forty board members. We recommend increasing this representation to 15%, which would be more reflective of the population and ensure that the unique needs of pediatric patients are adequately addressed.

3. We request an organizational chart of the new contract structure and a more detailed understanding of how these contractors will work together. A diagram illustrating these relationships would be particularly helpful in fostering clarity. So far transparency has NOT been forthcoming in this process.

Lastly, we would like to extend our gratitude to the current OPTN Board of Directors for their dedicated service during this significant and trying period of transition. Your efforts are greatly appreciated, and we look forward to continued collaboration to improve the transplant system for all.

Thank you for considering our comments.
Melissa McQueen
Transplant Families

Anonymous | 11/08/2024

I appreciate the opportunity to provide public feedback concerning the upcoming changes to the governance documents of the OPTN. It is critical that the bylaws governing formation of a nominating committee, and the “special election” for a new OPTN Board of Directors, do not deviate from those established for the "general election". The bylaws need to be developed collaboratively with the transplant community including patients, patient and donor families, living donors, Histocompatibility laboratory professionals, transplant professionals and OPO members. Making decisions based on feedback from the transplant community will enhance the transparency of the OPTN modernization process and allow the transplant community to trust in the partnership with administration of organ transplantation in the U.S., as it once did.

Of specific concern is the recent conversion of the OPTN Board Histocompatibility representative seat from an elected position to a de facto appointment. This Histocompatibility representative seat should reflect the choice of the transplant community through a fair and unbiased election, as it was previously. Shifting the position back to an elected position would further enhance transparency and partnership with the transplant community.

Thank you for the opportunity to provide feedback on this important topic.

The Association for Multicultural Affairs in Transplantation | 11/08/2024

The Association for Multicultural Affairs in Transplantation (AMAT) appreciates the opportunity to contribute feedback on the recent OPTN governance updates. AMAT strongly supports HRSA's efforts to modernize the OPTN governance framework, emphasizing the need for transparency and accountability. Our organization advocates for an inclusive and equitable approach that recognizes the voices of diverse communities impacted by organ donation and transplantation.

As the OPTN considers a new governance structure, AMAT underscores the importance of ensuring the Board of Directors and related committees represent the entire transplant community, including individuals from historically underserved populations, transplant candidates and recipients, donor families, and healthcare professionals. We believe that inclusive representation is essential for developing policies that are responsive to the needs and perspectives of all communities, particularly those affected by disparities in healthcare access and outcomes.

In line with our mission to advance diversity and inclusion within the transplantation system, we urge the OPTN to establish clear mechanisms for community engagement and stakeholder involvement. This will not only strengthen trust but also ensure that policies reflect the diverse voices within our healthcare system.

AMAT looks forward to continued collaboration with HRSA, OPTN, and other stakeholders to foster a system that honors and respects the contributions of all community members.

Thank you for considering our recommendations as part of this significant transition.

UC San Diego Health Center for Transplantation | 11/08/2024

The UCSD Center for Transplantation supports the strategic initiative to establish independent governance for the OPTN Board of Directors. This structural change aims to eliminate potential conflicts of interest and enhance service to the organ donation and transplantation community. However, we wish to address several process concerns regarding the recent governance updates.

The implementation timeline and stakeholder engagement approach warrant careful consideration. The INVEST Board of Directors adopted these changes four months prior to community notification, and the abbreviated public comment period may not fully align with principles of transparency and inclusive decision-making. While these modifications have been characterized as "minor and non-substantive," they encompass multiple governance document revisions that would benefit from clearer delineation, such as the addition of underlining and strikethrough formatting to highlight new and modified language.

Given the significance of these changes, even if in concept only, stakeholders would benefit from extended time to conduct thorough reviews and provide comprehensive feedback. Additionally, the current proposal's scope does not fully address outstanding questions regarding the operational and procedural implications of this governance separation. Greater clarity on these distinctions would facilitate more meaningful community engagement and ensure successful implementation of these important reforms.

Eszter Lazar-Molnar | 11/08/2024

It is critical that the bylaws governing the “special election”, and related nominating committee, for a new OPTN Board of Directors do not deviate from those established for the "general election". The bylaws need to be developed collaboratively with the transplant community including patients, patient and donor families, living donors, Histocompatibility laboratory professionals, transplant professionals and OPO members. Making decisions based on feedback from the transplant community will enhance the transparency of the OPTN modernization process and allow the transplant community to regain the trust it once had in the administration of organ transplantation in the U.S.
Recently the Histocompatibility representative seat on the OPTN Board was changed from an elected position to a de facto appointment. This Histocompatibility representative seat should reflect the choice of the transplant community through a fair and unbiased election, as it was previously. Shifting the OPTN Board Histocompatibility position back to an elected position would further enhance transparency and foster trust from the transplant community.

Society of Pediatric Liver Transplantation (SPLIT) | 11/08/2024

The Society of Pediatric Liver Transplantation (SPLIT) appreciates the opportunity to comment on the proposed Revised Bylaws and Management and Membership Policies. We are increasingly concerned about the clear underrepresentation of pediatric voices throughout the modernization, and hope to utilize this opportunity to secure adequate pediatric representation across all aspects of the OPTN.

• The Bylaws say there must be "at least one pediatric provider on the Board of Directors"- which is vastly insufficient. We recommend that at least 10% of board of directors’ members as stakeholders with specific pediatric expertise; this mirrors the percent of pediatric candidates on the transplant waiting list. Our pediatric patients remain a vulnerable population as highlighted in NOTA, which charges the OPTN to "recognize the differences in health and in organ transplantation issues between children and adults … and adopt criteria, policies, and procedures that address the unique health care needs of children."
• We encourage the Board and Nominating Committee, as well as the new organizations to involved in Board management, to consult directly with the Pediatric Committee in consideration of determining criteria for pediatric expertise adequate to represent this vulnerable population in OPTN leadership.
• The Nominating, Executive or any leadership committee should also be required to have pediatric expertise to ensure that OPTN throughout its sections is equipped to adequately address children’s health care needs
• We ask for more clarity on how HRSA will ensure that Committee work can be efficiently and accurately carried out, that the Board of Directors is able to effectively (and again efficiently) oversee and coordinate work without delays caused by contractors being assigned different tasks
• We have concerns about how the Board will function when it has no direct say over the activities of the contractors. 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. This means that HRSA will have to step up its level of involvement massively under the new structure.
• We strongly recommend that individuals who have previously served on the OPTN board or committees under the previous contractor not be excluded, and be allowed to participate in leadership roles within the new OPTN if they choose to with appropriate assessment, and if necessary mitigation, of any actual or perceived conflicts of interest.

American Society of Nephrology | 11/08/2024

Kindly refer to the attachment.

View attachment from American Society of Nephrology

Anonymous | 11/08/2024

Yet again, HRSA is trying to pull the strings behind the scenes but has missed the point... Yes, everybody agrees that the OPTN can be improved but this proposal doesn't help modernize the OPTN.

1) This is effectively the same structure that UNOS had with the OPTN. There is a private company with their own Board that operates the OPTN. UNOS was created for the sole purpose of bidding on the OPTN contract - just like INVEST.

2) But lets talk about this perceived conflict of interest. I've served on the OPTN Board and committees. I've talked with a lot of my fellow board and committee members. I don't know a single one who signed up for the board or committees whose desire was to help a private company called UNOS. In fact, many of us were surprised when we were informed that serving on the OPTN meant serving on the board of a private corporation - just like this new INVEST structure.

3) Since I have served on the OPTN board, I took a while to read the board minutes from the last year. No where do I see a meeting where the OPTN board adopted these INVEST bylaws as the OPTN bylaws. Which means, THESE ARE NOT OPTN BYLAWS YET. Invest can no more dictate the bylaws of the OPTN than UNOS could dictate the bylaws of the OPTN.

4) I read the comments and I agree with those who are concerned about the special election. The OPTN has bylaws that dictate how elections are held. HRSA does not have the authority to appoint a new Board. Not only would it be incredibly foolish to dismiss all of the expertise on the Board, it would be against NOTA which states, requires "continuity of leadership for the board."

5) And why would the country want to dismiss all of the expertise on the OPTN Board? These are some of the best physicians, ethicists, patient reps, etc. in the country chosen by their peers. Isn't that who we want to make these critical decisions? Would we rather have bureaucrats making these decisions? Many of the things that the community and the public complain about are decisions made by HRSA.
- The OPTN has an outdated data collection system. Correct. Who decided that the OPTN had to send every change to data collection through OMB? HRSA. Who decided that the OPTN could only change the data system a couple times a year? HRSA.
- The OPTN has not exercised enough oversight over OPOs. Who told the OPTN that they didn't have any authority over OPOs? HRSA until the public starting screaming then HRSA changed their interpretation.
- The OPTN doesn't collaborate enough with the community. Who told the OPTN that they couldn't survey members for their input? HRSA. Who hasn't approved the OPTN budget in years? HRSA.
- The OPTN changed the geographic distribution of organs. Guess who told the OPTN that they had to do that? HRSA.

So tell me, do we really want bureaucrats at HRSA making the decisions about who gets an organ transplant? Who benefits from that construct? The United States has the most advanced transplant system in the world and our peers around the world are asking why we're risking it all to make these changes. I'm wondering the same thing.

Donor Network West | 11/08/2024

DNW applauds the Health Resources and Services Administration’s (HRSA) efforts to better serve the interests of patients and donor families through OPTN Modernization. An independent OPTN board aligns with the goals of the Securing the U.S. Organ Procurement and Transplantation Network Act of 2023, which aims to improve accountability and patient-focused governance and eliminating conflicts of interest within the Board is fundamental to advancing transparency, trust, and effective collaboration across all stakeholders in the donation and transplantation system. Moreover, by separating Management and Membership Policies from the bylaws, the OPTN creates a pathway for future membership requirements to be modified without having to change Bylaws.

We submit three recommendations for consideration:
Family/Patient-Centered Language: As these language changes are incorporated, it remains crucial to consider their impact on organ donor families and candidates awaiting transplantation. We encourage the OPTN to incorporate language that underscores its commitment to transparency and compassionate support for donor families.

Subject Matter Expertise:
Integrating voices from the broader transplant community - including patients, donor families, living donors, transplant professionals, and affiliated advocates - is essential to the development of informed, equitable, and responsive policies within the OPTN framework. Their direct involvement through structured and ongoing engagement will enhance the quality, relevance, and ethical integrity of these guidelines. We strongly recommend that OPTN formalize mechanisms to ensure comprehensive and regular consultation with the transplant community, thereby fostering transparency and inclusivity in the policy development process. This inclusive approach not only aligns with best practices in policy formulation but also strengthens the legitimacy and adaptability of the resulting regulations.

Building Trust: We strongly recommend implementing regular updates and feedback sessions with the transplant community, patients, and healthcare providers to strengthen community confidence and transparency.

Maintaining Transparency: While separating boards is a positive step, we must consider implementing ongoing reviews and policies to prevent potential conflicts as new members join the OPTN board. Clear disclosures, recusals, and oversight guidelines are essential to maintaining impartiality.

Thank you for considering these recommendations as we continue to enhance OPTN governance and begin to refocus on addressing the needs of transplant patients and donor families.

Association of Organ Procurement Organizations (AOPO) | 11/08/2024

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View attachment from Association of Organ Procurement Organizations (AOPO)

Anonymous | 11/08/2024

I appreciate the opportunity to provide public feedback concerning the upcoming changes to the governance documents of the OPTN. It is critical that the bylaws governing formation of a nominating committee, and the “special election” for a new OPTN Board of Directors, do not deviate from those established for the "general election". The bylaws need to be developed collaboratively with the transplant community including patients, patient and donor families, living donors, Histocompatibility laboratory professionals, transplant professionals and OPO members. Making decisions based on feedback from the transplant community will enhance the transparency of the OPTN modernization process and allow the transplant community to trust in the partnership with administration of organ transplantation in the U.S., as it once did.
Of specific concern is the recent conversion of the OPTN Board Histocompatibility representative seat from an elected position to a de facto appointment. This Histocompatibility representative seat should reflect the choice of the transplant community through a fair and unbiased election, as it was previously. Shifting the position back to an elected position would further enhance transparency and partnership with the transplant community.
Thank you for the opportunity to provide feedback on this important topic.

Anonymous | 11/08/2024

I appreciate the opportunity to provide public feedback concerning the upcoming changes to the governance documents of the OPTN. It is critical that the bylaws governing formation of a nominating committee, and the “special election” for a new OPTN Board of Directors, do not deviate from those established for the "general election". The bylaws need to be developed collaboratively with the transplant community including patients, patient and donor families, living donors, Histocompatibility laboratory professionals, transplant professionals and OPO members. Making decisions based on feedback from the transplant community will enhance the transparency of the OPTN modernization process and allow the transplant community to trust in the partnership with administration of organ transplantation in the U.S., as it once did.

Of specific concern is the recent conversion of the OPTN Board Histocompatibility representative seat from an elected position to a de facto appointment. This Histocompatibility representative seat should reflect the choice of the transplant community through a fair and unbiased election, as it was previously. Shifting the position back to an elected position would further enhance transparency and partnership with the transplant community.

Thank you for the opportunity to provide feedback on this important topic.

Anonymous | 11/08/2024

The current Board of Directors bylaws and management and membership policies are the exact same, however, there are five pediatric representatives currently sitting on the Board. I urge HRSA to ensure that this number stays the same or increases. To guarantee that the needs of children are included in the OPTN modernization process, more than one pediatric specialist must be involved on the Board of Directors. These advocates understand the needs of pediatric patients and the policies that will support them.

The specific needs of pediatric transplant candidates vary by organ and across age groups from infancy to adolescence. Further, caregivers of children in need of transplant face unique challenges accessing transplant with variable access around the country. In the United States, children under the age of 18 make up approximately 22% of the population. If only one of the potential 34 members is a pediatric specialist, this is approximately 3% of the board, which would create substantial under-representation of the pediatric population. There would be further misrepresentation if the INVEST Board of Directors had a full 42 individuals, with only one pediatric specialist.

I have specific concerns about the lack of pediatric representation if the new bylaws do not require increased pediatric patient advocates. Lack of pediatric representation does not support achieving equity for children in the transplant community since there are differing definitions of optimal access and outcomes for children with end-stage organ failure. The majority of children will need multiple transplants over their lifetime. As such, the classification of “high-quality” organs for children differs from adults. Transplant equity for children is not solely about reducing wait times; it involves children receiving organs that will last as well as receiving these organs expeditiously.

Anonymous | 11/08/2024

As a patient deeply affected by the organ donation and transplantation system, I have closely followed the recent OPTN Modernization Initiative led by HRSA, which marks a critical step toward establishing a more transparent, efficient, and equitable system. Although I praise our previously successful organ procurement and transplantation system, this reform is much-needed to address long-standing inefficiencies, improve patient outcomes, and reduce conflicts of interest that have hindered progress in the past. However, resistance has emerged, notably from those who previously benefited from the old system, including certain figures associated with Science in Donation & Transplant (SID&T), spearheaded by Tenaya Wallace. I am not part of “Organize” or any whistleblowing patient group; however, I firmly believe that the experiences of even a few patients matter significantly. Accusing patients of creating distrust in the system simply for sharing their lived experiences, experiences that may reflect poorly on the old system, is shameful and potentially harmful to those patients and their families. Silencing patients is not good behavior and certainly not patient advocacy or advancing patient-centric outcomes.

As both a patient and a family member of a recipient, I find it confusing and troubling that SID&T are presenting themselves as scientific authorities of organ transplantation and therefore manipulating the public, creating distrust in our community and actively working to undermine the progress of this difficult but critical task of modernizing our transplantation system. Their arguments potentially misuse data reports to push a self-serving bias and lack the rigorous, peer-reviewed evidence they claim to support, potentially misleading the general public and the families directly impacted by our transplant system. Reputable entities such as the National Institutes of Health (NIH), American Medical Association (AMA), American Association for the Advancement of Science (AAAS), American Society of Transplantation (AST), the American Society of Transplant Surgeons (ASTS), the Scientific Registry of Transplant Recipients (SRTR), and the United Network for Organ Sharing (UNOS) are better suited to position themselves as scientific experts of organ transplantation and therefore, provide the community with evidence-based information, ensuring that public discourse is informed by credible and transparent sources rather than opinion or self-interest.

As someone directly impacted by these issues, I am a strong supporter of HRSA’s efforts to modernize the OPTN, recognizing its potential to reduce conflicts of interest, enhance operational efficiency, and improve patient trust. The separation of OPTN governance from HRSA contractors is essential in mitigating these conflicts and ensuring unbiased oversight. I am grateful for the opportunity for public comment and commend HRSA’s leadership on the strides taken so far. It would further benefit the public and the transplant community if current members of the INVEST board were more transparent and accountable regarding their contributions and any criticisms associated with INVEST’s formation. HRSA did not exclude them from the process; they have been involved. A deeper dive will show that the same group of leaders that have been easily rotating for years in our highest profile and influential roles are still involved. I very much value our current longstanding members leadership yet the assertions from certain leaders that they are “unaware” of most modernization details, despite documented involvement in meetings, suggest a need for clearer accountability within the leadership structure. I agree with the commentary that self reflecting on our fears and filtering for status anxiety, fear of obsolescence, and transparency aversion, will allow each of us to navigate HRSA’s modernization journey collaboratively, drawing on the strengths of both legacy knowledge and fresh ideas.

To further strengthen modernization efforts, I recommend that HRSA reassess the legal status of OPTN, specifically the implications of its non-profit designation. Ensuring legal compliance while maintaining a structure that promotes transparency is essential for the organization’s future operations. In addition, engaging the transplant community proactively before implementing significant changes will foster inclusivity and confidence in the process. Providing clear timelines and outlining the roles and responsibilities of contractors will improve operational transparency. Public participation in Board member elections is also vital, and I suggest that criteria and processes for Board selection be clearly communicated and accessible.

Additionally, increasing pediatric representation on the Board and in key committees is crucial to addressing the unique needs of this patient population. Finally, updating the standards and certifications required for histocompatibility laboratory membership is necessary to ensure the highest quality of care and consistency across facilities, directly impacting transplant outcomes.
I deeply appreciate the commitment shown by HRSA and OPTN to improve transparency, efficiency, and equity within our transplant system. These reforms are essential to building a system that meets the highest standards for all patients in need. I believe that a more transparent and accountable organ transplant system, fortified by HRSA’s reforms and public oversight, will ultimately serve patients, families, and the broader community more effectively and equitably. Thank you.

Anonymous | 11/08/2024

Thank you for the opportunity to provide public feedback concerning the upcoming changes to the governance documents of the OPTN. It is critical that the bylaws governing formation of a nominating committee, and the “special election” for a new OPTN Board of Directors, do not deviate from those established for the "general election". The bylaws need to be developed collaboratively with the transplant community including patients, patient and donor families, living donors, Histocompatibility laboratory professionals, transplant professionals and OPO members. Making decisions based on feedback from the transplant community will enhance the transparency of the OPTN modernization process and allow the transplant community to trust in the partnership with administration of organ transplantation in the U.S., as it once did.
Of specific concern is the recent conversion of the OPTN Board Histocompatibility representative seat from an elected position to a de facto appointment. This Histocompatibility representative seat should reflect the choice of the transplant community through a fair and unbiased election, as it was previously. Shifting the position back to an elected position would further enhance transparency and partnership with the transplant community.
Thank you for the opportunity to provide feedback on this important topic.

Elaine Reed | 11/08/2024

I appreciate the opportunity to provide public feedback concerning the upcoming changes to the governance documents of the OPTN. It is critical that the bylaws governing formation of a nominating committee, and the “special election” for a new OPTN Board of Directors, do not deviate from those established for the "general election". The bylaws need to be developed collaboratively with the transplant community including patients, patient and donor families, living donors, Histocompatibility laboratory professionals, transplant professionals and OPO members. Making decisions based on feedback from the transplant community will enhance the transparency of the OPTN modernization process and allow the transplant community to trust in the partnership with administration of organ transplantation in the U.S., as it once did.

Of specific concern is the recent conversion of the OPTN Board Histocompatibility representative seat from an elected position to a de facto appointment. This Histocompatibility representative seat should reflect the choice of the transplant community through a fair and unbiased election, as it was previously. Shifting the position back to an elected position would further enhance transparency and partnership with the transplant community.

Thank you for the opportunity to provide feedback on this important topic.

Brett Loehmann | 11/08/2024

I appreciate the opportunity to provide public feedback concerning the upcoming changes to the governance documents of the OPTN. It is critical that the bylaws governing formation of a nominating committee, and the “special election” for a new OPTN Board of Directors, do not deviate from those established for the "general election". The bylaws need to be developed collaboratively with the transplant community including patients, patient and donor families, living donors, Histocompatibility laboratory professionals, transplant professionals and OPO members. Making decisions based on feedback from the transplant community will enhance the transparency of the OPTN modernization process and allow the transplant community to trust in the partnership with administration of organ transplantation in the U.S., as it once did.
Of specific concern is the recent conversion of the OPTN Board Histocompatibility representative seat from an elected position to a de facto appointment. This Histocompatibility representative seat should reflect the choice of the transplant community through a fair and unbiased election, as it was previously. Shifting the position back to an elected position would further enhance transparency and partnership with the transplant community.
Thank you for the opportunity to provide feedback on this important topic.

Anonymous | 11/08/2024

I support the Revised Bylaws and Management and Membership Policies as proposed by OPTN. While the revisions are necessary to achieve the recently stated goals of the Modernization Initiative, however they are not sufficient.

The additions of language, movement to new documents, creation of a 501c3 and other steps for the Bylaws is largely an administrative action that may allow OPTN to improve its performance for patients. Most importantly theses steps are wholly insufficient to achieve that improvement.

Following these administrative steps, significant changes in the culture, operations, measurements, goals and consequences of failures to meet goals are required. As noted by OPTN, "This proposal does not change existing OPTN Policies, sometimes referred to as organ allocation policies." A significant change in OPTN policies is required. If significant and meaningful changes in the OPTN policies and operations fail to occur, patients will ultimately continue to suffer the consequences.

Changes in policies and procedures must also be implemented within HRSA

Boston Childrens Hospital | 11/08/2024

On behalf of the nation’s children’s hospitals and the patients and families we serve, thank you for the opportunity to comment on the revised OPTN bylaws and management and membership policies. We appreciate your efforts to modernize the OPTN and urge you to ensure adequate pediatric representation on the INVEST Board of Directors.

The more than 200 children’s hospitals that comprise the Children’s Hospital Association (CHA) are dedicated to the health and well-being of our nation’s children. Children’s hospitals provide vital care to pediatric transplant patients. There are key differences in organ transplantation between children and adults. For example, there is a scarcity of pediatric donors. There are often size and anatomical challenges for pediatric transplant candidates, and since children often need more than one organ during their lifetime, there is a critical need for a focus on donor quality over operational efficiency. The many unique considerations for optimizing pediatric transplantation access and outcomes speak to the need for pediatric representation on the INVEST Board of Directors. CHA has previously expressed concerns with the OPTN Modernization Initiative started by HRSA as it separates the OPTN Board of Directors from the OPTN contractor. New contractors may not be familiar with the challenges pediatric patients face with organ procurement and transplantation, making it even more critical that there is increased pediatric representation on the INVEST Board of Directors. We need to ensure there can be alignment between contractors so that children are not overlooked or disadvantaged in the process.

Increased Inclusion of Pediatric Patient Advocates

It is critical for HRSA to include adequate pediatric transplant representation on the INVEST Board of Directors and the larger committees. While we appreciate that the revised bylaws and management and membership policies require that the At-Large Directors must include at least one pediatric specialist, we urge HRSA to increase this number. The current Board of Directors bylaws and management and membership policies are the exact same, however, there are five pediatric representatives currently sitting on the Board. We urge HRSA to ensure that this number stays the same or increases. To guarantee that the needs of children are included in the OPTN modernization process, more than one pediatric specialist must be involved on the Board of Directors. These advocates understand the needs of pediatric patients and the policies that will support them. The specific needs of pediatric transplant candidates vary by organ and across age groups from infancy to adolescence. Further, caregivers of children in need of transplant face unique challenges accessing transplant with variable access around the country. In the United States, children under the age of 18 make up approximately 22% of the population. If only one of the potential 34 members is a pediatric specialist, this is approximately 3% of the board, which would create substantial under-representation of the pediatric population. There would be further misrepresentation if the INVEST Board of Directors had a full 42 individuals, with only one pediatric specialist. We have specific concerns about the lack of pediatric representation, if the new bylaws do not require increased pediatric patient advocates. Lack of pediatric representation does not support achieving equity for children in the transplant community since there are differing definitions of optimal access and outcomes for children with end-stage organ failure. The majority of children will need multiple transplants over their lifetime. As such, the classification of “high-quality” organs for children differs from adults. Transplant equity for children is not solely about reducing wait times; it involves children receiving organs that will last as well as receiving these organs expeditiously. Lastly, there is a lack of resources and staffing shortages within the pediatric transplant community. The pediatric workforce, including those who dedicate their time and expertise to transplantation, is in crisis and access to pediatric transplant varies across the nation, with some families having to travel far distances to obtain access to life-saving organ transplantation for their children. The board must consider the increased challenges children, and their families face in obtaining life-saving transplants. As the OPTN and the INVEST Board of Directors move forward, the best way to ensure that children’s voices are heard is to secure broad pediatric representation in the Board’s composition.

CHA asks HRSA to ensure that there is adequate pediatric representation during the OPTN Modernization process by:

• Requiring the minimum number of pediatric specialists on the Board of Directors be increased to at least 3 pediatric specialists and at least 5 total members who are knowledgeable about pediatric transplantation.
• Require that at least one pediatric representative be included on the Nominating Committee.
• Require that at least one pediatric representative be included on the Executive Committee.
• Require that at least one pediatric representative be included on each of the Permanent Standing Committees.

We thank you for the opportunity to provide comments and look forward to continuing to work with you to improve children’s health care. Please contact Natalie Torentinos at Natalie.Torentinos@childrenshospitals.org or (202) 753-5372 for more information.

Anonymous | 11/08/2024

CHA asks HRSA to ensure that there is adequate pediatric representation during the OPTN Modernization process by:

• Requiring the minimum number of pediatric specialists on the Board of Directors be increased to at least 3 pediatric specialists and at least 5 total members who are knowledgeable about pediatric transplantation.
• Require that at least one pediatric representative be included on the Nominating Committee.
• Require that at least one pediatric representative be included on the Executive Committee.
• Require that at least one pediatric representative be included on each of the Permanent Standing Committees.

We thank you for the opportunity to provide comments and look forward to continuing to work with you to improve children’s health care.

Kevin Daly | 11/08/2024

Pediatric specialists have been recognized as an increasingly important part of the OPTN with the designation of pediatric specific program requirements.  As we move towards data informed decision making, it is all too easy to prioritize optimization of the adult transplant system since it affects more people and more data is available to inform decision making.  However, it is precisely because of that fact that there need to be knowledgeable advocates for pediatric transplantation who will support efforts to improve access and outcomes for children and young adults with end stage organ failure.

I support the comments put forth by the Children's Hospital Association about increasing representation of pediatric specialist and pediatric representatives at the level of the UNOS Board of Directors. I continue to find that when pediatric specialists are not in the room for key decisions, the potential implications for those decisions on pediatric patients and families are often missed. It is vitally important that there is pediatric representation at all levels of decision making within the OPTN. As a result, I advocate for the following changes:

· Requiring the minimum number of pediatric specialists on the Board of Directors be increased to at least 3 pediatric specialists and at least 5 total members who are knowledgeable about pediatric transplantation.

· Require that at least one pediatric representative be included on the Nominating Committee.

· Require that at least one pediatric representative be included on the Executive Committee.

· Require that at least one pediatric representative be included on each of the Permanent Standing Committees.

Anonymous | 11/07/2024

I appreciate the efforts to modernize the OPTN and urge you to ensure adequate pediatric representation on the INVEST Board of Directors. However, I am concerned about several issues, most notably the lack of focus and representation for pediatric recipients.

There are key differences in organ transplantation between children and adults. For example, there is a scarcity of pediatric donors. There are often size and anatomical challenges for pediatric transplant candidates, and since children often need more than one organ during their lifetime, there is a critical need for a focus on donor quality over operational efficiency. The many unique considerations for optimizing pediatric transplantation access and outcomes speak to the need for pediatric representation on the INVEST Board of Directors. New contractors may not be familiar with the challenges pediatric patients face with organ procurement and transplantation, making it even more critical that there is increased pediatric representation on the INVEST Board of Directors.

The current proposal that the At-Large Directors must include at least one pediatric specialist are wholly inadequate and unjust to pediatric patients. We urge HRSA to increase this number. The current Board of Directors bylaws and management and membership policies are the exact same, however, there are 5 pediatric representatives currently sitting on the Board. We urge HRSA to ensure that this number stays the same or increases. To guarantee that the needs of children are included in the OPTN modernization process, more than 1 pediatric specialist must be involved on the Board of Directors. These advocates understand the needs of pediatric patients and the policies that will support them. The specific needs of pediatric transplant candidates vary by organ and across age groups from infancy to adolescence. Further, caregivers of children in need of transplant face unique challenges accessing transplant with variable access around the country. In the United States, children under the age of 18 make up approximately 22% of the population. If only 1 of the potential 34 members is a pediatric specialist, this is approximately 3% of the board, which would create substantial under-representation of the pediatric population. There would be further misrepresentation if the INVEST Board of Directors had a full 42 individuals, with only 1 pediatric specialist.

The new bylaws must require increased pediatric patient advocates. Lack of pediatric representation does not support achieving equity for children in the transplant community since there are differing definitions of optimal access and outcomes for children with end-stage organ failure. The majority of children will need multiple transplants over their lifetime. As such, the classification of “high-quality” organs for children differs from adults. Transplant equity for children is not solely about reducing wait times; it involves children receiving organs that will last as well as receiving these organs expeditiously.

The board must consider the increased challenges children and their families face in obtaining life-saving transplants. As the OPTN and the INVEST Board of Directors move forward, the best way to ensure that children’s voices are heard is to secure broad pediatric representation in the Board’s composition.

I absolutely agree with the CHA requests to ensure adequate pediatric representation during the OPTN Modernization process by:

• Requiring the minimum number of pediatric specialists on the Board of Directors be increased to at least 3 pediatric specialists and at least 5 total members who are knowledgeable about pediatric transplantation.
• Require that at least one pediatric representative be included on the Nominating Committee.
• Require that at least one pediatric representative be included on the Executive Committee.
• Require that at least one pediatric representative be included on each of the Permanent Standing Committees.

Paul Grimm | 11/07/2024

The reason the American Academy of Pediatrics exists goes back to the history of the AMA. A specific episode that led to the breach between the AMA and the American Academy of Pediatrics was when the AMA was asked to weigh in on legislation that would eliminate child forced labor. The AMA was going to oppose this legislation because they felt child forced labor was important to maintain the family farm. The pediatric advocates at the time were so disgusted that they left the AMA en masse to form their own organization.

Inappropriate undervaluing of pediatric services has continued for the last hundred years. Today, this inequity continues in pediatric reimbursement structures. Adult specialists and subspecialist providers in general are reimbursed at substantially higher rates than pediatric providers for equivalent services. This undervaluation of pediatric care has far-reaching consequences. For example, for several years, the American Armed Forces have been unable to achieve their enlistment targets, primarily because more than half of the young people screened do not meet health standards. This is directly due to the inadequate pediatric labor force and underprioritization of pediatric health care, leading to a far-reaching crisis.

Inclusion of a single pediatric representative in a board with more than 40 representatives continues this legacy of pediatric neglect and must stop. I support the view of the Children's Hospital Association.

Luis G. Hidalgo | 11/07/2024

It is critical that the bylaws governing the nominating committee and the “special election” for a new OPTN Board of Directors do not deviate from those established for the "general election". The bylaws need to be developed collaboratively with the transplant community including patients, patient and donor families, living donors, Histocompatibility laboratory professionals, transplant professionals and OPO members. Not dictated by newly identified entities under the control of HRSA who have not had the time to familiarize themselves about the complexities of organ transplantation. Making decisions based on feedback from the transplant community will enhance the transparency of the OPTN modernization process, and allow the transplant community to regain the trust it once had in the administration of organ transplantation in the U.S.
An easy step where transparency can be regained is in the reversal of the recent conversion of the OPTN Board Histocompatibility representative seat to a de facto appointment. The Histocompatibility representative seat should reflect the choice of the transplant community through fair and unbiased election as it was previously.
Thank you for the opportunity to provide feedback on this most important topic to the transplant community.

Cassandra Smith-Fields | 11/07/2024

I support the comments provided by the Children's Hospital Association and provide this additional feedback:
- A single director with pediatric expertise is insufficient due to the unique needs of the pediatric population as outlined in the CHA comments. Also, the individual in the role should currently be employed and active in pediatric transplant.
-"An officer’s term may not be extended more than two consecutive times." - I do not support this language. One extension is understandable, two is not. This causes the board to become insular and does not provide ongoing appointments by the community.
- The nominating committee, executive committee and permanent standing committees should have pediatric representatives - these can serve dual purposes, but should be actively working in a pediatric program
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American Society of Transplant Surgeons | 11/07/2024

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Children's Hospital Association | 11/07/2024

On behalf of the nation’s children’s hospitals and the patients and families we serve, thank you for the opportunity to comment on the revised OPTN bylaws and management and membership policies. We appreciate your efforts to modernize the OPTN and urge you to ensure adequate pediatric representation on the INVEST Board of Directors.

The more than 200 children’s hospitals that comprise the Children’s Hospital Association (CHA) are dedicated to the health and well-being of our nation’s children. Children’s hospitals provide vital care to pediatric transplant patients. There are key differences in organ transplantation between children and adults. For example, there is a scarcity of pediatric donors. There are often size and anatomical challenges for pediatric transplant candidates, and since children often need more than one organ during their lifetime, there is a critical need for a focus on donor quality over operational efficiency. The many unique considerations for optimizing pediatric transplantation access and outcomes speak to the need for pediatric representation on the INVEST Board of Directors. CHA has previously expressed concerns with the OPTN Modernization Initiative started by HRSA as it separates the OPTN Board of Directors from the OPTN contractor. New contractors may not be familiar with the challenges pediatric patients face with organ procurement and transplantation, making it even more critical that there is increased pediatric representation on the INVEST Board of Directors. We need to ensure there can be alignment between contractors so that children are not overlooked or disadvantaged in the process.

Increased Inclusion of Pediatric Patient Advocates

It is critical for HRSA to include adequate pediatric transplant representation on the INVEST Board of Directors and the larger committees. While we appreciate that the revised bylaws and management and membership policies require that the At-Large Directors must include at least one pediatric specialist, we urge HRSA to increase this number. The current Board of Directors bylaws and management and membership policies are the exact same, however, there are five pediatric representatives currently sitting on the Board. We urge HRSA to ensure that this number stays the same or increases. To guarantee that the needs of children are included in the OPTN modernization process, more than one pediatric specialist must be involved on the Board of Directors. These advocates understand the needs of pediatric patients and the policies that will support them. The specific needs of pediatric transplant candidates vary by organ and across age groups from infancy to adolescence. Further, caregivers of children in need of transplant face unique challenges accessing transplant with variable access around the country. In the United States, children under the age of 18 make up approximately 22% of the population. If only one of the potential 34 members is a pediatric specialist, this is approximately 3% of the board, which would create substantial under-representation of the pediatric population. There would be further misrepresentation if the INVEST Board of Directors had a full 42 individuals, with only one pediatric specialist. We have specific concerns about the lack of pediatric representation, if the new bylaws do not require increased pediatric patient advocates. Lack of pediatric representation does not support achieving equity for children in the transplant community since there are differing definitions of optimal access and outcomes for children with end-stage organ failure. The majority of children will need multiple transplants over their lifetime. As such, the classification of “high-quality” organs for children differs from adults. Transplant equity for children is not solely about reducing wait times; it involves children receiving organs that will last as well as receiving these organs expeditiously. Lastly, there is a lack of resources and staffing shortages within the pediatric transplant community. The pediatric workforce, including those who dedicate their time and expertise to transplantation, is in crisis and access to pediatric transplant varies across the nation, with some families having to travel far distances to obtain access to life-saving organ transplantation for their children. The board must consider the increased challenges children, and their families face in obtaining life-saving transplants. As the OPTN and the INVEST Board of Directors move forward, the best way to ensure that children’s voices are heard is to secure broad pediatric representation in the Board’s composition.

CHA asks HRSA to ensure that there is adequate pediatric representation during the OPTN Modernization process by:

• Requiring the minimum number of pediatric specialists on the Board of Directors be increased to at least 3 pediatric specialists and at least 5 total members who are knowledgeable about pediatric transplantation.
• Require that at least one pediatric representative be included on the Nominating Committee.
• Require that at least one pediatric representative be included on the Executive Committee.
• Require that at least one pediatric representative be included on each of the Permanent Standing Committees.

We thank you for the opportunity to provide comments and look forward to continuing to work with you to improve children’s health care. Please contact Natalie Torentinos at Natalie.Torentinos@childrenshospitals.org or (202) 753-5372 for more information.

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)