OPTN BOD - Vendor Questions and Responses (Draft RFP).pdf

OPTN BOARD OF DIRECTORS (BOD) SUPPORT IDIQ DRAFT RFP Pg. 1 of 10

Question Response Will attendees and their companies who participated in today's session and future sessions be provided? HRSA appreciates your question and/or feedback. Please see the Final RFP.

Is the Volume I document to be submitted in Phase I (April, 26) the Prior Experience Summary or the Technical Proposal? I have found some contradictory results between the solicitation draft online versus what was presented today. We would appreciate your confirmation to the nature of the document to be summited in phase I to start preparations while awaiting the final solicitation. Thank you!

The BOD Solicitation does not include phases; all proposal submissions are to be submitted by the stated deadline.

The OPTN Directors were notified that the RFPs for the first phase of HRSA’s OPTN Modernization Initiative had been released. The Executive Committee reviewed the RFPs and met to determine exactly how HRSA seeks to provide support to the OPTN in the future. We expected answers to the questions we have been asking for months, and, unfortunately, we found that the RFPs have left us with even more questions.

Despite months of discussion about change and improvement to the OPTN coming soon, the RFPs for the transition contracts seem at their best, to be a solicitation for ideas and HRSA has proposed to UNOS an extension of the current contract for up to two years. That seems consistent with the fact that the RFPs are not final, but rather they are drafts intended to allow those who may bid more time to learn about the requirements.

This is disappointing because we have been partnering with HRSA to prepare the transplant community to be active and excited participants in this process. The undefined nature of the RFPs dampens this enthusiasm and injects more doubt and uncertainty into our community at time when anxieties are already running high.

We directors are profoundly disappointed that the draft RFPs did not provide more insight into HRSA’s vision for the future of the OPTN. The work of the OPTN is focused on caring for people with end-stage organ failure. These individuals are very ill and at the end of their life without an organ transplant. The healthcare professionals that engage in this work and the patients and donor families who volunteer their expertise take the OPTN’s role in this life-saving mission very seriously. It was our hope that publication of the RFP would be the first step in creating our new future, but what was delivered was a draft RFP offering no specific plan to improve the system. Our future continues to be uncertain and as leaders of this network, it makes supporting our community that much more difficult.

HRSA says that the actions it is proposing are in response to “the community.” We reject this. At this moment, there is no organization other than the OPTN that can speak for the entire community because its members represent all aspects of the community. For this reason, we believe the OPTN’s feedback should be a priority to HRSA. The OPTN Board is a collection of representatives reflecting diverse perspectives elected by the OPTN members. The RFPs describe the OPTN as a “…comprehensive network of transplant professionals and community members.” NOTA provides more specificity, by including in the OPTN all transplant centers, OPOs, histocompatibility labs, individuals with patient and donor experience, and various others. By these definitions, the OPTN is the transplant community. Through the OPTN Board’s day-to-day contact with the community, regional meetings, public comment periods, and more than 700 volunteers working within the OPTN committees, the Board hears the ideas and concerns of the members, and, therefore, the OPTN Board has its finger on the pulse of the OPTN community.

While the issues we identify are a component of contracts to be issued, the contracts only deal with support. The focus of the Executive Committee is on OPTN structure and operations. We believe NOTA and the Final Rule make the OPTN primarily responsible for transplant policy and operations. HRSA’s role is to provide contractors to support the OPTN and not who the transplant community chooses to fulfill Board responsibilities. NOTA was explicitly designed to place oversight of the transplant system in the transplant community. The draft RFPs propose a plan to construct a Board of Directors in a manner that is not compliant with NOTA and envisions support and operations activities that we do not believe are consistent with the needs of the OPTN and, more importantly, the patients it serves.

The following issues require immediate, thoughtful consideration:

HRSA appreciates your question and/or feedback. Please see the Final RFP.

We believe the OPTN needs to be a fully independent non-profit corporation, with the ability to carry out the instructions of the Final Rule, procure directors and officers insurance, obtain and manage a bank account, retain legal counsel, hire and compensate staff. The OPTN Board needs to know HRSA’s plan to establish such a corporation. When will this be forthcoming?

For details on the new independent OPTN Board entity, see HRSA's modernization webpage.

How will the OPTN Board execute oversight of future contracts? For example, tasks reference HRSA and the OPTN approving different communications. How will responsibilities be divided? How will HRSA eliminate barriers between the OPTN Board and execution of its oversight tasks?

The Government is responsible for oversight and coordination of all contracts and contractors. The OPTN Board will provide feedback on contractor performance, OPTN Board needs, and help determine the long and short term priorities of the OPTN.

VENDOR QUESTIONS AND RESPONSES FOR DRAFT SOLICITATION OF OPTN BOARD OF DIRECTORS SUPPORT IDIQ

OPTN BOARD OF DIRECTORS (BOD) SUPPORT IDIQ DRAFT RFP Pg. 2 of 10

The OPTN Final Rule stipulates that “An OPTN member shall pay a registration fee to the OPTN for each transplant candidate it places on the waiting list”. Currently 90% of the OPTN budget arises from registration fees. Although the current OPTN contractor is designated by the HHS secretary as the OPTN so that, as a corporate entity doing business as the OPTN, it can receive registration fees and pay the contractor for its work, the PWS is silent on whether the Board Support contractor (or one of the operations transition contractors) will be designated as the OPTN for this purpose. Given that appropriated funds fall far short of the amount needed to fund the OPTN contracts, how does HRSA envision creating or designating a corporate entity as the OPTN that can receive and distribute registration fees to contractors as needed to meet contractual obligations.

For details on the new independent OPTN Board entity, see HRSA's modernization webpage. OPTN activities will continue to be paid for through fees and appropriations.

Vendor payments will be identified/determined through Task orders.

In the operations transition PWS documents, HRSA defines the OPTN as follows: "The OPTN currently includes the Board of Directors, operating committees, policy committees, other standing committees defined in OPTN bylaws, subcommittees, ad hoc committee and groups, OPTN review boards, workgroups, and OPTN regions." This definition does not refer to OPTN members or the public. The Board support PWS refers in multiple places to “OPTN Members” and the OTPN Final Rule implies that only designated transplant programs in OPTN member hospitals can list patients, pay registration fees and receive organs for transplantation. Therefore, the OPTN must be an entity capable of having members consistent with NOTA, the Final Rule and the OPTN Bylaws. And although the Board Support Contractor or one of the operations contractors (if a non-profit) could be designated as the OPTN for the purpose of receiving OPTN fees and distributing registration fees to contractors as needed to meet contractual obligations, neither PWS provides explicit details about how the OPTN will house and support the necessary member functions.

If HRSA is not intending that the OPTN be a not-for-profit membership organization independent of the Board Support or operations transition contractors, which entity will house OPTN members in order that recipient listing and organ allocation can occur compliant with the Final Rule?

HRSA appreciates your question and/or feedback. Please see the Final RFP.

Section G.7, page 13. The RFP states that the “due date for task order proposals will be stated in each RFTOP and determined on a case-by-case basis, depending on the complexity of the requirement.” Does HRSA have any guidance on what the typical turnaround time will be for task order proposals?

Not at this time. HRSA appreciates your question and/or feedback.

To better serve patients' interests, will HRSA agree to move from the special election model to Administration appointments, supported through a public nominations process? (Note: OPTN elections have been dictated by 90%+ industry - transplant centers/OPOs/histo labs in the past. This model is totally inappropriate for a quasi-governmental body with authority over national policymaking)

HRSA appreciates your question and/or feedback. Please see the Final RFP.

for the Board Support, what is the anticipated duration of work and what is the range of anticipated contract amount? HRSA appreciates your question and/or feedback. Please see the Final RFP.

OPTN BOARD OF DIRECTORS (BOD) SUPPORT IDIQ DRAFT RFP Pg. 3 of 10

OPTN Board Independence

The OPTN is the result of NOTA and the Final Rule, and OPTN Bylaws were created under that authority. The Board Support RFP contemplates a special nominating committee structured by the new contractor leading to a special election of a new Board. The resulting effect on then current Board members would be termination of their role as directors prior to the end of the terms set by the Bylaws. It is our understanding that:

•Neither NOTA nor the Final Rule have an explicit mechanism for the Secretary to remove OPTN Board members.

•OPTN Bylaws do not currently allow for special elections; and •OPTN Bylaws do not currently provide for the designation of a special nominating committee or obtaining public input on committee memberships and Board nominations.

In our view, establishing a nominating committee, obtaining public input, and removing current directors prior to the end of their terms as described in the RFP would require the OPTN Board to vote to amend the Bylaws. This would require the Board to vote for a nominating process that it may not believe to be in the best interest of the OPTN, and to vote for its own disbandment. A two-thirds vote of the Board is required by the Bylaws to enact these amendments. Then, the community members of the OPTN would need to approve the Bylaws changes and the early discharge of then current members of the Board of Directors.

Therefore, for HRSA’s plan to proceed as stated, the following questions need to be addressed a priori.

•Will the OPTN Board vote to approve bylaw amendments?

•Will OPTN members vote to approve bylaw amendments?

If the answer to either of these questions is no, we request an explanation of what authority HRSA would use to carry out this proposed plan.

Because the RFP calls for the special election to occur before analysis of current Board structure is to take place, presumably the special election will be to fill seats on the Board as currently structured. If that is true, it seems the sole purpose of a special election and replacement of Board members is to create “independence,” which some observers equate with removing any director who has served as a director of UNOS. It is asserting that Board members are acting in the best interests of UNOS and not the OPTN.

We remind you that awarding the OPTN contract to UNOS, HRSA accepted that that the UNOS Board member would serve as the OPTN Board. In our experience, Board members are overwhelmingly motivated to serve out of a desire to serve the OPTN and to positively impact transplant policy for the benefit of patients. Any interest in serving on the UNOS Board comes only with a desire to serve the OPTN not the contractor. HRSA has played a role in creating this conflict and has been relying on us to steer the transplant community and HRSA in a new direction. This conflict was not created by any OPTN director. We are concerned that by taking the significant step of discharging the entire OPTN Board at once, all institutional memory of this highly complex system will be lost. The OPTN will have a president and other officers who have not previously served on the Board and have no understanding of its workings or why current policies are in place. We are concerned that a wedge will be created between HRSA and the OPTN community. In our opinion, that outcome would be disastrous for everyone but most importantly the patients we serve.

HRSA appreciates your question and/or feedback. Please see the Final RFP.

Who employs and pays the Executive Director and any associated staff? Will they be employed directly by the OPTN Board of Directors, or will they be employed by the contractor who holds the Board Support contract? Is the role of Executive Director a full-time job/devoted function? The OPTN Board appoints the Executive Director (per the Final Rule).

The Government is responsible for oversight and coordination of all contracts and contractors. The Board Support contract includes the services necessary to support the work of the OPTN Board, including the services of the Executive Director. The Executive Director is estimated to be a full-time job.

What formalized mechanism will be created to allow the OPTN Board to provide HRSA with feedback on contractor performance? The Government is responsible for oversight and coordination of all contracts and contractors. The OPTN Board will provide feedback on contractor performance, OPTN Board needs, and help determine the long and short term priorities of the OPTN.

Section G.8, page 13. The RFP states that Task Orders may be issued by email or other electronic methods. Will HRSA also have a forecast for anticipated task order proposals?

Not at this time.

In light of recent reporting of federal investigations into potential criminal activity by OPTN members, will HRSA agree to open up the board support contract to law firms who can both establish the OPTN as an independent 501c3 in compliance with the OPTN final rule, and ensure that the OPTN board is fulfilling its fiduciary responsibilities?

No. HRSA does not plan to change eligibility requirements.

Please see Final RFP.

OPTN BOARD OF DIRECTORS (BOD) SUPPORT IDIQ DRAFT RFP Pg. 4 of 10

Can a vendor be sub-contractor on two different contract proposals? Yes. A vendor can be a sub-contractor on multiple Board Support IDIQ proposals. Please note that it will not be possible to be a subcontractor under both the OPTN Operations IDIQ and Board Support IDIQ.

Board Restructure

We do acknowledge it may be appropriate to restructure the board composition, and we are open to those discussions. Many within the OPTN, including many current and former Board members, have discussed the difficulties of managing OPTN business with such a large Board. There is discussion amongst the OPTN Board of Directors as to whether the patient and donor community is adequately represented and what changes are needed to remedy this. Additionally, there may be better ways to assure diversity of views than by regional representation. These and many other questions are appropriate and should be asked. It is necessary to point out that the current Board and those that proceeded it, were constructed in accordance with requirements in NOTA and the Final Rule. The current Board of Directors fully supports change designed to improve the OPTN. However, any change must be well thought out, protect the well-being of patients the OPTN serves, and designed to ensure that the mission of the OPTN is carried out in a responsible manner. Therefore, the following questions need to be answered:

•Is it better for board replacement to occur before or after a full review of composition and process?

•Why would a special election take place before this work has been completed? Task Orders should be issued in sequence so these workstreams are not simultaneous processes.

For details on the new independent OPTN Board entity, see HRSA's Modernization website.

HRSA has stated that they are committed to providing insurance for volunteers. What is the status of this? How will volunteers be protected? Can HRSA provide assurances that routinely used Directors & Officers (D&O) insurance is sufficient to safeguard OPTN Board members? We do not believe this is sufficient for the OPTN, please explain your rationale.

For details on the new independent OPTN Board entity, see HRSA's Modernization website. Provision of insurance for the OPTN Board is within the scope of the Board Support

IDIQ.

What is HRSA’s short-term transition plan for the OPTN after March 29? Is there funding for this transition plan? Will new awards be made while a potential extension/bridge contract with the current contractor is in place?

For details on the new independent OPTN Board entity, see HRSA's Modernization website. The Board Support and OPTN Operations IDIQS will be awarded while an extension of the current contract is in place.

Section L.5.2, page 41. Are non-profit offerors permitted to team with for-profit organizations for this IDIQ (including small businesses)? Non-profit, prime offerors can subcontract with for-profit organizations, including small businesses, under this IDIQ.

In keeping with federal ethics policies that bar people who have worked for the government from engaging with that part of the government for a period of time (1 year, 2 years, or for life, depending on the seniority and the matter), will HRSA bar people from appointments to the OPTN board who have worked for/served in a leadership position of an OPTN contractor for at least one year (to include board members, employees, and consultants)?

For details on the new independent OPTN Board entity, see HRSA's Modernization website.

OPTN BOARD OF DIRECTORS (BOD) SUPPORT IDIQ DRAFT RFP Pg. 5 of 10

Corporate Status of the OPTN and its effect on Board Separation - PART 1

Although the exact status of the OPTN is made very uncertain in statute due to its unique structure, for nearly 40 years the directors of the contractor have served as the OPTN Board. These individuals have benefited from the protection against personal liability provided by the corporate structure of UNOS. Based on the contents of the draft RFP, it is not clear how HRSA intends to preserve these protections.

As we have previously discussed, the UNOS Board has amended the UNOS Bylaws to restructure the composition of the UNOS Board. As has been well documented, both the UNOS Board and the OPTN Board have been working to achieve an orderly separation for more than two years. Both UNOS and the OPTN Boards have called for the incorporation of the OPTN. Because of concerns expressed by HRSA, we do not believe this goal has been achieved. UNOS has done what was necessary to achieve board separation, as requested by HRSA, Members of Congress, the OPTN Board, and the UNOS Board. The effective date of this restructure is March 30, 2024, timed to match the expiration of the current contract, and with the expectation that HRSA would fulfill its responsibilities and adopt a plan for the post-March 29 structure of the OPTN. On February 8, 2024, HRSA notified UNOS of its desire to extend the current contract for up to two years, but so far HRSA has been silent on any plans to incorporate the OPTN.

When the requested separation of the UNOS Board from the OPTN Board takes place, the UNOS Board will no longer satisfy the requirements of the Final Rule for composition of the OPTN Board. For more than two years, both the OPTN and UNOS Boards have been requesting HRSA to incorporate the OPTN in anticipation of this change in the UNOS Board structure. At the request of HRSA, UNOS submitted a plan for Board independence, which included incorporation of the OPTN. The OPTN is a highly complex organization, with hundreds of individuals involved as volunteers, with more than 400 corporate and individual members and with highly varied responsibilities impacting the lives of more than 40,000 recipients annually and more than 100,000 on the waiting list. Throughout the United States, it is inconceivable that any such organization would not be structured as a corporation.

The OPTN Board appreciates the fact that UNOS has acted on its responsibility to serve the best interests of the OPTN. The Board notes that HRSA has never taken action on the contractor’s proposed plan for OPTN Board independence or any of the other options that HRSA indicated it was considering. The implication was that HRSA desired to address this issue in the RFPs. However, the RFPs are silent on OPTN organization after board separation, and the current OPTN Board Requests immediate clarification on how this issue will be addressed now so it can move forward with the knowledge that board members will be protected.

It appears HRSA now seeks and expects the OPTN Board, and by extension the entire OPTN, to operate as an unincorporated association. Without being an incorporated entity, all board members, all volunteers, and all members are put at great risk. A business organization formed under specific state laws, such as those creating corporations and limited liability companies, protects those associated with the business from personal liability. An unincorporated business provides no such protection. Individuals, and business organizations who are members, are liable for the debts and obligations of the organization. The organization cannot hold property or enter into contracts. It is a non-entity for legal purposes.

For details on the new independent OPTN Board entity, see HRSA's Modernization website.

Please explain why the OPTN Board is not permitted to use contract funds to obtain independent legal consultation. The Government is responsible for oversight and coordination of all contracts and contractors. The OPTN Board will provide feedback on contractor performance, OPTN Board needs, and help determine the long and short term priorities of the OPTN.

If OPTN Board legal protections through the formation of a corporate entity are not finalized, what contingency plans are in place to ensure smooth operations of the OPTN on March 30?

For details on the new independent OPTN Board entity, see HRSA's Modernization website.

Attachment A, page 9. The PWS states that “Support for OPTN committee research and analytic services will be provided in OPTN operational contracts.” Can you please confirm that there will be no research or analytic task orders included in the OPTN Board Support IDIQ?

The Board Support contract includes the services necessary to support the work of the OPTN Board, this includes research or analytic requirements within the scope of the Board Support IDIQ. As quoted in the question, analytic and research services in support of OPTN committees are not within the scope of the Board Support IDIQ.

Given how central OPTN committees are to board policymaking, will HRSA move support for the operating and policy committees, as well as their subcommittees and other ad hoc groups and workgroups to the board support contract?

No, HRSA does not intend to move all OPTN Operations Domain 2 work to the Board Support IDIQ. OPTN operations work, including providing professional support services to committees, is distinct from the support the Board of Directors requires to function. Committee work is at the approval of the OPTN Board so the Board Support contractor will be involved with the necessary coordination between the OPTN Board and Committees.

OPTN BOARD OF DIRECTORS (BOD) SUPPORT IDIQ DRAFT RFP Pg. 6 of 10

Corporate Status of the OPTN and its effect on Board Separation - PART 2

Without a defined corporate structure, not only do all involved volunteers have personal risk, questions will be raised about the organization itself, how it is governed, how it operates, and by what authority it enforces policy. It will have bylaws, but if those bylaws are subject to arbitrary override by HRSA, are they bylaws in name only. The ability to enforce members’ compliance with bylaws will be undermined. Corporate law provides a framework in which all who are within and without an organization understand the rights, duties, and relationships of various stakeholders. Similar questions among those involved with unincorporated associations remain subject to conjecture. If not resolved by agreement or the arbitrary use of power, they are ultimately resolved by our legal system. Is that HRSA’s objective?

The use of the term “independent” is interesting. Some outside the community seem to equate independence with separation from the contractor.

That will happen on March 30. However, the OPTN Board strongly feels that independence means free from the influence of the contractor and the ability to be a counter weight to governmental overreach when such actions, as we now experience, run counter to the best interests of the patients it exists to serve. The only way to accomplish true independence is to establish the OPTN as a separate entity, not simply a collection of individuals who are bound only by their interests in transplantation. If there is no entity, who is the beneficiary of the directors’ duties of loyalty and care? There would be no actual OPTN. Who would be the beneficiary of confirmation by a director that the director has no conflict of interest?

The OPTN would simply be a collection of individuals, each with their own objectives and needs.

How does the OPTN convert from a corporate structure within UNOS to a separate organization? Does that require a vote of OPTN members?

What is the role of members? Are members required to apply for membership in an organization that is not an entity? And if not, how will polices be enforced? These are questions that must be addressed, and they can be easily answered with a corporate structure.

HRSA has proposed that D&O insurance can be obtained, but our preliminary inquiries indicate that may be problematic if the OPTN is not a corporation. Even if it is available, will the protection provided be equivalent to that provided by a combination of a corporate structure and insurance? We believe it will not. Will it cover committee leadership and members? Will D&O insurance protect OPTN members from claims made against the OPTN? Claims made against an unincorporated association are most likely initially made against the directors individually, because there will be no OPTN in existence, but creative lawyers find ways to sue everyone involved, and let the courts decide who is actually responsible. That puts individuals and corporate members at risk in ways that they would not be if the OPTN is a corporation.

NOTA was changed last summer so that it no longer requires that the OPTN be a private, not-for-profit entity. However, the Final Rule still requires that the OPTN be an entity and strongly implies that it will be a corporation. How will HSA reconcile this difference?

For details on the new independent OPTN Board entity, see HRSA's Modernization website.

HRSA’s stated goal is to have multiple different “best in class” vendors. What is the workforce plan to manage multiple contractors? HRSA has an established Program Management Office in place and will be further expanding HRSA staffing capacity to successfully manage multiple contractors.

Will HRSA clarify the role and position of the “OPTN Executive Director” so that it is clear that this position is attached to the OPTN’s independently formed nonprofit, and that this person is considered a key hire in the main solicitation?

The Government is responsible for oversight and coordination of all contracts and contractors. The Board Support contract includes the services necessary to support the work of the OPTN Board, including the services of the Executive Director.

OPTN BOARD OF DIRECTORS (BOD) SUPPORT IDIQ DRAFT RFP Pg. 7 of 10

Who will volunteer for the new OPTN?

At our recent Executive Committee meeting, multiple current members of the Board have stated categorically that they will not serve on the Board if the OPTN is not incorporated. Other directors have indicated the likelihood that they will not serve. Since the issuance of the RFPs, multiple inquiries have been made by people who are currently candidates for election to the Board, asking questions about liability protection and suggesting the likelihood that they will not serve under the structure proposed by HRSA.

Volunteers populate all OPTN committees. They serve because they hope to help improve transplantation, to respond to needs as changes occur, and to help patients. However, any perception of personal risk as the result of actions they take is a significant disincentive. By way of example, if the allocation policy decisions of the Liver Committee and the Board were made at a time when everyone involved might have personal liability, how would the decision have been different and would have that been in the best interest of patients?

An organization is only as strong as its structure and documentation. A corporation has a long-term, if not indefinite, existence. It operates under the structure of state or federal law and within the charter and bylaws of the organization. Those who are members and those who are leaders know what to expect and what their various rights and duties are. None of these protections are present in an unincorporated association, especially if HRSA takes the position that it has the right to unseat a board or otherwise ignore OPTN Bylaws through contract or administrative action.

On behalf of the Executive Committee of the OPTN, we ask that you review and consider the above, and promptly respond to our interrogatives in writing within one week of receiving this letter. We also request that HRSA communicate directly with the OPTN Executive Committee of the Board of Directors on a private call to discuss meaningful solutions to these challenges. As volunteers, the OPTN Board has been tasked with safe and effective operations of the organ donation and transplant system and protecting the patients it is responsible for serving. This role is taken seriously by each Board member. HRSA must remove any personal risk to Board members so that their decisions can be in the best interest to modernize the transplant system and not be stifled by fear of personal liability.

For details on the new independent OPTN Board entity, see HRSA's Modernization website.

How will funding flow between contractors? Who will oversee the collection, management, and distribution of funds? Who will resolve conflicts between contractors regarding resource allocation?

OPTN activities will continue to be paid for through fees and appropriations. Vendor payments will be identified/determined through Task orders.

Is it absolutely necessary for HRSA to allow for up to five years of performance under this contract? Could HRSA limit the number of option periods further (i.e., to no more than one option period beyond the base)? What will HRSA’s approach be in the first year to overseeing the quality of this contractor’s performance to ensure options periods aren’t utilized if the contractor is a poor performer?

Pursuant to the FAR, the Government is required to monitor and document Contractor performance for all contracts using the Contractor Performance Assessment Reporting System (CPARS), which is also the official source for evaluating past performance information. Additionally, prior to exercising any option, the Government is required to ensure that several standards are being met, and past performance is one of them.

Who oversees the differential distribution of registration fees and federally appropriated dollars? OPTN activities will continue to be paid for through fees and appropriations. Vendor payments will be identified/determined through Task orders.

Can HRSA commit to conducting an evaluation of contractor performance at six months from initial task order, or when more than $250K of task orders are completed, whichever comes first?

Contractor performance is assessed in an ongoing manner throughout a period of performance, and will be documented annually in the CPARS.

Will all contracts be jointly funded by registration fees and appropriations, or will some contracts be funded exclusively by appropriations, while others are funded exclusively by registration fees?

OPTN activities will continue to be paid for through fees and appropriations. Vendor payments will be identified/determined through Task orders.

OPTN BOARD OF DIRECTORS (BOD) SUPPORT IDIQ DRAFT RFP Pg. 8 of 10

Section G.7: The Request for Task Order Proposals (RFTOP) procedure is a good opportunity for HRSA to actively engage in oversight of the contractor and their approach, and to specify requirements, desired outcomes, and principles for performance.

Can HRSA commit to making these RFTOPs publicly available and, ideally, publishing them and seeking public feedback?

Pursuant to the FAR, after providing for full and open competition on SAM.gov in the awarding of multiple Indefinite-Delivery, Indefinite-Quantity (IDIQ) contracting vehicles, the competition requirements have been met and therefore requests for Task Order proposals will only be distributed among the IDIQ Holders throughout the life of the

IDIQ.

How will HRSA partner with the OPTN Board to set registration fees that allow for the continuous operation and enhancement of the OPTN? HRSA does not anticipate modifying the current approach to setting registration fees at this time.

Re. Section H.1: How will HRSA verify this independence when selecting contractors? Also, this covers conflicts during the life of the contract, but could HRSA also assess recent conflicts over the past 2-5 years? Could HRSA clarify what operational independence includes such as not being controlled by the same majority people/leadership/board as any OPTN Operations IDIQ contractor or subsidiary, etc.?

HRSA appreciates your question and/or feedback. Please see the Final RFP.

How can HRSA help ensure effective collaboration among the OPTN Board, HRSA, and multiple contractors in a way that builds trust among all parties and respects the volunteer nature of the OPTN Board member role?

HRSA appreciates your question and/or feedback. Please see the Final RFP.

Will HRSA amend section H.2.2: Post-Award Organizational Conflict of Interest to include suggested edits as follows “Ongoing Contractor Monitoring and Mitigation: The Contractor shall have programs in place to limit, identify, report to HRSA, and mitigate actual and potential conflicts of interest for itself, its employees, and its board members, subcontractors and consultants. This includes providing information about such programs to applicants for positions that will complete work under this contract and to potential Contractor board members and officers, so as to limit conflicts of interest to the extent possible. Any proposed mitigation plans must be approved by HRSA. Once final, HRSA will post such mitigation plans, conflict disclosures, and waivers, if any, on a publicly available website. The existence of such programs and the disclosure of known actual or potential conflicts are material performance requirements of this contract.”

The Government appreciates all questions received in response to the Draft Solicitation, however, the solicitation documents are written to meet a very specific Government need.

What role will the Board play in effectively facilitating relationships between contractors and providing oversight? How are long- and short-term priorities determined?

HRSA is committed to ensuring effective collaboration across the OPTN and continuing to work with stakeholders, OPTN contractors, and the OPTN Board of Directors through ongoing engagement and transparency. The government is responsible for oversight and coordination of all contracts and contractors. The OPTN Board will provide feedback on contractor performance, OPTN Board needs, and help determine the long and short term priorities of the

OPTN.

For Section L.3.1: will HRSA consider edits as follows “Board Services and Governance: Describe your approach for supporting the Board of Directors by implementing administrative and governance processes that draw from best practices observed in membership organizations within the health sector and other relevant fields. Describe your approach to assisting the Board of Directors in documenting, revising, managing, and implementing essential governance documents, such as the OPTN charter, bylaws, policies, and procedures. Draw upon successful processes from large, complex organizations with, for example, a substantial volunteer component, membership components, and robust stakeholder engagement.” Detail your strategy for enhancing organizational governance structures and performance in supporting the Board of Directors” in various aspects including a process for regular review and mitigation of potential or actual conflicts of interest. Given that outcomes for patients and their families are at the center of this modernization process, detail your strategy for ensuring transparency, public-facing communications, and public participation in the activities of the Board of Directors.”

HRSA appreciates your question and/or feedback. Please see the Final RFP.

If the Board support contractor will be asked to review Board composition and nomination processes, why would the special election take place before this work has been completed? The tasks could be adjusted so they are not simultaneous processes.

HRSA appreciates your question and/or feedback. Please see the Final RFP.

Will HRSA consider edits as follows for section L.3.1.D. “Services for the Board of Directors Independence: Describe your approach, timeline, and key milestones for supporting a special election to establish a new independent OPTN Board of Directors not more than 6 months from the task order award.”

HRSA appreciates your question and/or feedback. Please

OPTN BOARD OF DIRECTORS (BOD) SUPPORT IDIQ DRAFT RFP Pg. 9 of 10

NOTA, the Final Rule, and the OPTN Bylaws do not contemplate special elections or Board member removal (without an action of the existing Board). How does HRSA plan to achieve this?

HRSA appreciates your question and/or feedback. Please see the Final RFP.

For section M.5.1.C, will HRSA consider suggested edits as follows? “Board Services and Governance: The Government will evaluate proposals based on the capacity to establish and document a governance structure that efficiently manages Board of Directors operations, functions, and processes. The Government will assess for evidence demonstrating the effectiveness of the proposed approach in other organizations. The Government will evaluate the offeror’s ability to showcase a deep understanding of how to navigate and oversee governance processes effectively, emphasizing ethical standards and principles of transparency, inclusivity, and a track record of implementing and enforcing inclusive policies and mitigating conflicts of interest. Additionally, the government will evaluate the vendor’s capacity to implement methods for effectively investigating and proposing options when unique organizational requirements arise, demonstrating adaptability and problem-solving skills. The Government will evaluate the vendor’s ability to establish, document and carry out a comprehensive structure for OPTN Board of Directors oversight and management, encompassing all OPTN functions. Additionally, the Government will assess whether the proposed approach incorporates a participatory public engagement process that involves all OPTN stakeholders, ensuring inclusivity and collaboration in policy development and governance documentation and management. The Government will evaluate the proposed approach to formulating and executing impactful policies leading to enhanced procedural efficiency, increased transparency, and elevated performance and ethical standards.”

HRSA appreciates your question and/or feedback. Please see the Final RFP.

Which of the current committees are Board committees, and which are not? Which contractor will support each group of committees? Please explain your rationale.

HRSA appreciates your question and/or feedback. Please see Attachment A of the Final RFP for which OPTN committees are part of the Board Support IDIQ.

For section M.5.1.D, will HRSA consider suggested edits as follows? “Services for the Board of Directors Independence: The Government will evaluate the feasibility of offeror’s proposed approach, timeline, and key milestones for supporting a special election not more than 6 months from the task order award, including by capturing stakeholder inputs, including HRSA and the public. The Government will evaluate the quality of the proposal's ability to solicit and seat a transitional nominating committee vetted for conflicts of interest in a timely manner.”

HRSA appreciates your question and/or feedback. Please see the Final RFP.

The OPTN will be independent of both the contractor and HRSA. Will the Board support contractor have their own researchers, statisticians, lawyers, policy analysts, accountants? Or will they rely on other contractors for these functions? If resources will be shared, who will oversee the effective use of such resources?

The Board Support contract includes the services necessary to support the work of the OPTN Board. The government is responsible for the oversight of the contracts, including the use of resources, but the OPTN Board's feedback will be part of that oversight.

Will HRSA consider the following edits in bold to also be carried over to the Operations Transition solicitation’s Attachment A: “Conducting a special election to establish a new independent OPTN Board of Directors not more than 6 months from the task order award.” “Reviewing and providing recommendations for strengthening and modernizing OPTN bylaws and conflict of interest and whistleblower policies and processes, with public input, in accordance with proven and effective governance practices.”

“Reviewing Board composition and structure and making recommendations for reforms, including reforms that would require action by HRSA, to improve functionality, system effectiveness, and patient outcomes.”

“Supporting the new Board of Directors in executing its oversight and management responsibilities for OPTN organ matching policy and operations, OPTN membership standards, OPTN budget and financing, stakeholder engagement, and other functions, including through administration of the various OPTN committees.”

Adding this line, in parallel to the front-matter content in attachment A about the operations transition contracts: “No member of the OPTN Board of Directors may serve as an officer or employee of the Board Support Contractor, or any board member, advisor, or principal of an entity bidding for any OPTN contracts.” (suggest making this retroactive for a window of, say, 2-5 years)

HRSA appreciates your question and/or feedback. Please see the Final RFP.

We believe the OPTN Board should have a role in responding to feedback for items identified in the transformation domain. What is the role of the OPTN Board in the transformation domain?

There is no transformation domain under the Board Support IDIQ. The Board Support contractor will provide the services necessary to support the work of the OPTN Board. The transformation domain referenced is part of the OPTN Operations IDIQ.

Will HRSA consider mentioning stakeholder engagement and public participation processes as one of the key services the contractor will provide? HRSA appreciates your question and/or feedback. Please

OPTN BOARD OF DIRECTORS (BOD) SUPPORT IDIQ DRAFT RFP Pg. 10 of 10

The OPTN Executive Committee noted a theme of redundancy and duplicative effort of checking the work of multiple contractors (Task 4 #s 6, 7, 8, 9, and 10). What oversight responsibilities will the OPTN Board have?

The Government is responsible for oversight and coordination of all contracts and contractors. The OPTN Board will provide feedback on contractor performance, OPTN Board needs, and help determine the long and short term priorities of the OPTN.

Will HRSA amend eligibility in light of earlier question/suggestion to allow law firms to be eligible given the need for the OPTN board to be supported in exercising its fiduciary responsibilities?

No. HRSA does not plan to change eligibility requirements.

Please see Final RFP.

We believe the OPTN Board should have a role in making decisions regarding Board composition. How will the OPTN Board be engaged in making decisions about future Board composition?

HRSA appreciates your feedback. This is a matter outside of the solicitation scope.

Will HRSA consider defining and explaining “Operating committees” to clarify scope, noting the board’s role related to Committees? HRSA appreciates your question and/or feedback. Please see the Final RFP.

We believe the OPTN Board should have a role in making decisions regarding changes to the Final Rule. Task Area 2, #4 states that the OPTN Board Support contractor will “Support HRSA in developing materials to update the OPTN Final Rule as necessary”. How will the OPTN Board be engaged in pursuing changes to the Final Rule?

The OPTN Board will be engaged during the development of OPTN regulations and also involved through the Rulemaking process.

Re. task area 1, will HRSA amend the RFP in keeping with earlier question/suggestion so that the OPTN board is appointed by the Administration, in keeping with what happens in other national policymaking bodies (versus leaving to industry-led election as has happened in the past for the

OPTN)?

HRSA appreciates your question and/or feedback. Please see the Final RFP.

For the Next Gen contracts, the OPTN Board must be involved with RFP development, vendor selection, and how task orders are issued. How will this be accomplished?

The Government will provide oversight of the contracts, including their development and solicitation, but the OPTN Board will provide feedback and help determine the long and short term priorities of the OPTN.

In task area 1, will HRSA consider potential edits “Provide recommendations and work with the newly appointed Board to update existing OPTN bylaws and procedures addressing OPTN Board of Directors nominations and appointments process and OPTN committee nomination and selection processes for transparency, fairness, ethics, and effectiveness in recruiting and seating Directors and committee members that represent and reflect the multiple communities the organ transplant community serves. Support the implementation of the recommendations once approved. The Contractor may make recommendations on reforms to OPTN bylaws, policies, and procedures that would require action by HRSA for consideration by the Government.”

“Support communications with the public and community on the updated bylaws and procedures for OPTN nominations, Board appointments, and committee member selection process. This should include strategies and tactics to engage stakeholders and the public in the work of the Board, through a comprehensive plan for public participation and engagement, building on effective and inclusive proven practices.” In task area 2, will HRSA consider the following edits: “Review current OPTN Board of Directors structure and composition requirements within NOTA, the OPTN final rule, and OPTN bylaws, and review and analyze stakeholder feedback, public input, and industry best practices to produce a report for HRSA on the most effective governance structure for the OPTN Board of Directors. Support the implementation of the recommendations once approved. The Contractor may make recommendations on reforms to Board structure and composition that would require action by HRSA or Congress for consideration by the Government.” Will HRSA also consider breaking whistleblower protections into its own bullet for emphasis, and adding in explicit reference to protection of patient advocates from contractor retaliation.: “Review and in consultation with HRSA, work with the Board to update Board of Directors whistleblower and member code of conduct and ethics policies and procedures (appreciating that HRSA will have its own whistleblower/patient advocate protection policies), including conflict of interest policy, including a process for regular review of potential and current conflicts and conflict mitigation plans, to reflect best in class standards for avoiding conflicts affecting Board decision-making. Support the implementation of the recommendations once approved.” Will HRSA also make conflict disclosures and conflict mitigation plans, and any waivers, publicly available?

6.2.2: Will HRSA draft template data sharing agreements consistent with federal data management and cybersecurity policies? Will template agreements be provided to OPTN contractors pre- or post-award, to confirm feasibility and buy-in among the contractors? All entities contracted to support the OPTN, including the Board Support Contractor, shall enter into data use agreements for OPTN data with other entities contracted to support the OPTN, as necessary and at the direction of HRSA.” and “Implement all appropriate privacy and security protections for OPTN-related materials, as outlined in the attachments and future task orders.” and “Share all data and information necessary to enable OPTN and all entities supporting the OPTN to successfully perform. This includes assisting with access to OPTN data, process and procedure documentation, and other data necessary to complete OPTN activities.