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Revised Bylaws and Management and Membership Policies

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Background

The OPTN Board of Directors became independent after HRSA changed the OPTN contract to remove the requirement that the OPTN Contractor’s Board of Directors serve as the OPTN Board of Directors, and the OPTN Board of Directors subsequently approved corresponding changes in the OPTN Bylaws in March 2024.

The Board of Directors of a new corporation, INVEST (The Independent Network of Volunteers for Equitable and Safe Transplants, Inc.) is now designated by HRSA to be the OPTN Board of Directors. To support this structural change, the governance documents of the OPTN have been updated with the prior OPTN Bylaws split into two distinct documents: (1) Bylaws and (2) Management and Membership Policies. The Bylaws focus on the governance structure and roles. The Management and Membership Policies cover the operational details of the OPTN. The pre-existing policies related to the safe and equitable allocation of organs will remain its own document.

These changes have already been adopted on an interim basis. The purpose of this public comment period is to inform the community about these developments, foster transparency regarding HRSA’s modernization efforts and provide an opportunity for feedback.

Anticipated impact

  • What it's expected to do
    • Create OPTN Bylaws that focus exclusively on the structure and operation of the OPTN Board of Directors
    • Add language to the OPTN Bylaws including definitions, indemnification requirements, officer terms, and other previously approved changes
    • Move operational and administrative aspects of the OPTN to a new document, Management and Membership Policies
  • What it won't do
    • This proposal does not change existing OPTN Policies, sometimes referred to as organ allocation policies
    • There are no expected impacts, positive or negative, on any particular patient

Terms to know

  • Board of Directors: a group of people elected to oversee and guide a company, nonprofit, or government agency
  • Bylaws: a set of rules or law established by an organization or community so as to regulate itself, as allowed or provided for by some higher authority
  • Indemnification: security against legal liability for one's actions

Click here to search the OPTN glossary

Read the full proposal (PDF)

Provide feedback

eye iconComments

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)