HRSA OPTN Industry Day Transcript - Nov 2023.pdf

Health Resources and Services Administration

OPTN Board Support Industry Day

11/9/2023

Transcript

Good afternoon and good morning depending on where you are in our great nation. On the eve of the veteran’s day celebration, I would like to also thank our veteran participants for their service to our country.

Welcome to the Organ Procurement Transplantation Network Board Support Contract industry day. I know that's a mouthful. It is a pleasure to have so many of you interested in the OPTN initiatives.

Because we do have a large number of participants. We are using the Questions and Answer Pod to receive any comments and questions.

So, during the presentations, if you have any questions, comments, regarding the material presented, please use the Q&A pod to submit them.

Rest assured that it is submitted to HRSA, and we will be addressing accordingly. My name is

Alexandra Bonnie Garcia, and I am the Head of the Contracting Activity for HRSA and with me is Dr.

Suma Nair, Associate Administrator for the Health Systems Bureau, and Mr. Manjot Singh OPTN

Modernization lead.

Before we get started, let's recap a bit on what we have done to help us shape the OPTN procurements.

We have been very, very, busy bees conducting market research with industry and stakeholders.

During or last industry day, we also held focus group. We had over 300 participants from profit and non-profit organizations, Academic institutions, and patient advocates. All that information that you provided us is helping us shape as we move forward with this procurement.

We also, as you recall from the last industry, for some of you that participated, we encouraged you to form contracting teaming arrangements. And we heard from you that you wanted to know, who were those participants. So, we took into practice the listing those attendees and they're available on the HRSA FOIA electronic reading room.

We also hear that you will like transparency on this process, and we have created the OPTN

Modernization initiative site. Where you can see changes in initiative and upcoming events. We also taken as best practice the release of the presentations and relating materials regarding industry day on Sam.gov. Thank you again, for your participation and collaboration.

Let's go over a quick overview of what we're going to cover today.

We're going to go over the background, and OPTN modernization approach. We're going to also go over the OPTN services that are needed for the contract that support the OPTN Board. And then we're going to move over to some of the procurement timelines and finally the question and answers.

And with that, I would like to turn it over to Dr. Nair.

Thank you, Bonnie. Welcome everyone. Very excited to have you all here today. Welcome to our second OPTN modernization industry day.

We are so pleased to be able to bring everyone together to provide updates on OPT and modernization.

And our contracting strategy that will help us realize the aims of OPTN modernization: improving the equity, accountability, and performance of the transplant system. Such that everyone who needs a transplant is able to get one.

This industry day is a significant step towards achieving our critical milestone. A critical milestone in our modernization initiative: the issuance of our transition contract solicitation. As we embark upon our modernization journey, we're fully aware that of the profound impact that this can have on the lives of countless individuals who are awaiting life-saving transplantation.

There are over, as you all know, there are over a 100,000 individuals on the transplant waiting list.

And they're probably likely should be several thousand more added to that list. And every 10 min another individual is added to the waitlist.

And sadly, on average, 17 people die a day waiting for a transplant. So, the need is there, and the need is now.

The OPTN modernization initiative and these transition solicitations represent HRSA’s unwavering commitment to increasing access to organ transplantation, so that everyone who needs a transplant can get one. Through this collaborative effort we aim to foster competition, spur innovation, and propel the field of organ transplantation forward. [indecipherable]. By leveraging a diverse array of perspectives and expertise, the OPTN will be better positioned to overcome challenges, seize opportunities, and improve system performance.

Ultimately, saving the lives of hundreds of thousands of individuals. We are so pleased to be able to be joined by so many interested potential collaborators today.

And because we have so many new folks since we met several months ago in July, I'm going to provide a bit of background.

So, we have, we're all on the same page as we move into our contracting work together.

So, I'll provide a little background on OPTN modernization, our approach to modernization and the related contracting strategies, and before we dive deeper, into our latest component of our contracting work: the OPTN board support effort.

So, I hope this background will get us all on the same page and develop a shared understanding. As we move together on the path ahead.

So, let's go ahead and jump in. So, this is our first slide to give you background on what the OPTN is.

The organ procurement and transplantation network are a unique public private partnership that links together all of the professionals involved in the United States donation and transplantation system.

It's a driving, a driving force of the OPTN is to improve the US system so that lifesaving organs are available for transplant.

The OPTN acts through its board of directors and its committees, ho come from the organ procurement and transplantation community bringing a wealth of technical expertise and commitment to guide policy development and implementation.

The committees address issues of concern to the transplant community. The board establishes and maintains the transplant policies and the membership policies that govern the OPTN.

The OPTN was established. By the National Organ Transplant Act in 1984. It's, members include transplant centers, organ procurement organizations, organ procurement organizations, histocompatibility labs, other medical and scientific organizations and individuals who participate in organ procurement organizations and individuals who participate in organ procurement and transplantation process.

The OPTN is responsible for operating and monitoring an equitable system for organ allocation, right?

That includes the wait list and the IT system that facilitates the matching of organs. And they're focused on working to increase the supply of organs. It's charge, and the charge of the OPTN statutorily, is to develop and implement policies regarding organ allocation, assist in the nationwide distribution of organs for transplant patients by operating a 24/7 system to wait list and match people, to actively work on increasing the supply of organs available, support with the adoption and use of different quality standards for organ donation, transportation, providing information to healthcare providers and public about organ donation, collecting, analyzing, and publicly publishing data on organ donation and transplants, and conducting studies and demonstrations to help us improve organ transplant and procurement.

So, next slide. This gives you a high level visual.

Next. There we go. [indecipherable]This gives you a high level visual of the members of the organ procurement and transplantation network. So, as you see for federal agencies, the OPTN is overseen by the health resources and services administration, which is an agency of the US Department of

Health and Human Services. HRSA’s responsible for administering a variety of healthcare related programs and initiatives all across the United States.

And one of our key roles in overseeing the nation's organ transplant system is through our oversight and support of the … We provide, oversight, and ensure compliance with federal rights relations related to organ procurement and transplantation.

And we also work in collaboration with the OPTN to ensure that we're able to support the OPTN with coming up with a fair and efficient system.

And we do that via contract and the infrastructure and support that we provide via contract to the

OPTN to execute their mission.

So, while the OPTN team operates under the oversight of HRSA, it relies on the expertise and efforts of its diverse members and board of directors to carry out its mission.

And so, as you can see here, the OPTN Board of Directors is compromised of, comprised of 42 volunteers representing a variety of categories across the OPTN community, such as transplant surgeons, transplant recipients, organ procurement officials, histocompatibility labs, all of those members are there, and they do their work for the Board of Directors through 26 committees that support the board in executing its governance role.

So now that you have that background, I also will mention our sister agency, the Center for Medicaid and Medicare Services, that's a part of overseeing the entire organ transplant system and while HRSA has the direct authority, to support the OPTN and oversees the OPTN, we work closely with CMS to enhance the performance and equity of the system at large. So, let's jump to the next slide.

Great. So, over the last several years, there's been growing interest in the organ transplant system.

And really the opportunities to strengthen that system. Given the significant growth and need for organ saving transplants. Lifesaving transplant. The items noted here on the slide really reflect the feedback that we've received from our various stakeholder’s engagement efforts from subject matter experts, researchers in the field, the public about the opportunities to strengthen the system moving forward.

And so, as you see here, it really reflects that robust feedback. In fact, one of our first forays around modernization was engaging [indecipherable] with stakeholders to help us drive our modernization efforts moving forward.

And we've engaged with over 800 individuals, more than half representing patients and families, to really give us a good sense of what the opportunities are and how we move forward on those opportunities.

So given some of these opportunities that you see, it became really clear to HRSA, that now is the time to embrace this opportunity to enhance the accountability, equity, and performance of the system by moving forward with our modernization initiative.

And given the complexity and criticality of the system that any modernization effort really needed to be deliberative and really incorporate a modular, deliberative approach that really thinks about each of the components of the system, how do you optimize them, and then how do you have integration across all? And so that's really a key principle in our work moving forward around modernization.

Doing it very thoughtfully. So that we don't disrupt the essential nature of this 24 /7 system and yet we can still move towards making enhancements and improvements that are better much needed.

So that guides our modernization efforts. So, let's jump to the slide to talk a little bit more about our, OPTN modernization initiative.

So based upon all of the feedback that we've received, we announced in March our modernization initiative.

And really, it's an initiative. It's a multi-year initiative to modernize the OPTN with the goal of increasing access to high quality organ donation and transplantation.

And it's designed in a way that really focuses on the needs of patients and families by further strengthening and providing equitable access to transplantation, improving the safety and health outcomes associated with it, and empowering patients.

We also want to make sure we support the organ donation and procurement and transplantation community members who have dedicated their lives to supporting people in need of a transplantation, community members who have dedicated their lives to supporting people in need of a transplant.

And so, we want to make sure that we are giving them all of the support that they need, the best technology and the best systems and information to facilitate their [indecipherable]. Next, we thought about the interests of researchers, scientists and other stakeholders who are committed to a high functioning, high quality system and the information and resources that they need to support the system and then the public.

This is a very important system.

The trust of the public is essential to the successful operation of the US organ transplant system and consequently we want to make sure that we are providing transparency and accountability to all of those who are interested and care about the success of the system. So, to meet these needs, first is going to focus on 5 areas that you see illustrated on this slide as a part of our modernization initiative.

First, we're starting with the opportunities around technology. The OPTN IT system in our, in our future aim, we're working towards having a highly reliable, secure patient-centered system that is user-friendly and reflective of modern technology and functionality.

We want to make sure there's a continuous ongoing focus on improved IT systems and functionality and security while ensuring the continuity of services, protecting patients’ safety, and accelerating innovation.

So that we have industry leading standards that we're able to employ and benefit all of the members of the community and ultimately patients and families.

And though [indecipherable] data transparency, and analytics, we want to make sure that OPTN data is accessible, user-friendly, and patient-centered.

We want to provide easily accessible data, high quality, timely data. To patients and their clinical team. To support clinical decisions to help us measure and evaluate the performance of the system to inform oversight and compliance activities and to support the advancement scientific research and operations in the organ transplant space.

In the arena of governance, a key focus for us today. We aspire to support an OPTN board of directors that is high functioning, has greater independence, represents the diversity of the communities that they serve and delivers effective policy making and oversight.

In terms of operations, we want to make sure that the [indecipherable] is supported by operations that are effective and accountable, that helps them implement organ policy, patient safety and compliance monitoring, helps them improve organ transportation, provides excellent OPTN member support, and increases the opportunities and meets the needs, educational needs, of patients, families, and public.

And then finally in the arena quality improvement and innovation like any good healthcare system we want to build in a backbone of quality - continuous quality improvement and innovation.

And so, we want to support the OPTN to ensure that it's promoting quality improvement and innovation.

And so, we want to support the OPTN to ensure that it - by leveraging timely data and performance feedback – is supporting collaborative learning and strategic partnerships to advance the equity and performance of the system at large.

So, let's jump to the next slide. To achieve our modernization aims. It's clear that we have to take a different approach than we have previously to get a different outcome into the future and achieve our aims of modernization.

So, when we think about our previous approach versus our modernized approach, there's 3 areas I particularly like to call out to your attention.

First, we're moving from an approach that had a single contract. That allowed one organization and required them to have to do all the work that's required to successfully support the complex organ transplant system that we have.

We are moving towards, in our modernized approach, multiple contracts that allow for domain specific, best in class expertise and support of the OPTN. So, we're bringing in a diversity of experts across different domains to support the OPTN to achieve the modernization AIDS.

Second, we're moving from a previous approach where there was very limited competition. It was limited to organizations, nonprofit organizations, with organ procurement and transplantation expertise.

In all our research, all of our stakeholder engagement, it's become really clear to us that the expertise in organ transplantation comes from the OPTN community itself as there are no other groups who have more expertise in organ procurement and transplantation. And that board of directors that comes from the organ transplant community also has the expertise. So, what we need is to surround the OPTN and the OPTN board of directors is with all the other kinds of expertise to really lift up their ability to execute the mission of the OPTN.

And so, we are moving to our modernized approach. To open and get us the most expansive pool of experts.

For profit, nonprofit, the ability to leverage different award mechanisms to figure out the best way to support the OPTN to execute its mission.

The third area or point of departure and change that I want to point at is the move from one kind of procurement strategy and contract that was really structured in a way that maintained the status quo.

To a new design that's really focused on accountability, transparency, continuous improvement, and innovation. And that's built into the DNA and structure of our contracts and our acquisition approach and the collaboration across all our experts that we are able to secure as they support the OPTN moving forward.

So that's a very important shift in our approach and thinking about how we support the OPTN and the transplant community to get us to this new modernized future.

So, let's talk about on the next slide how we operationalize that, right? How do we operationalize that? So, as we talked in July, we talked about 3 main streams of contracts that we would do to support modernization. First out of the gate we started when we made our announcement in March, we started our work with a program management support contractor who's helping us design out and do project management of this large-scale change and transformation effort that we're trying to undertake.

The first part of that was essential, it was stakeholder engagement to make sure that this modernization effort is driven by the needs of patients and families and the organ procurement and transplantation community.

And so, we're really pleased to say that we've engaged with over 800 individuals so far.

And this is going to be a continuous capacity: stakeholder engagement, over time, but in the last couple of months we engaged more than 800 individuals and more than half of those engagements were with patients and families.

So robust information to really help guide our work moving forward. The second arena of work was our transition contract: what we talked about to help us move from the current state, it's our bridge to the future, right?

Given the criticality of this system and the 24/7 nature, you can’t stop the system while we pause to remodel or redesign.

We must continue operations and make sure those essential functions go on. While we start thinking about how do we optimize some of those?

How do we do some of these things differently? And so that transition contract was our opportunity to do that.

And we spent a lot of time together in July, in our first industry day, talking through the domains, the kind of work, and what the... And then we finally said, so while we keep the trains running and we try to make some, you know, enhancements and improvements, we still should carve out the space for us to have bold ideas about where we can innovate, where things can be done very differently, but in a safe space to ideate, pilot on a small scale.

Think about how then you, if it's successful, how you scale up and how you integrate into the system at large.

So, we made a commitment to issue a next Gen contract in 2024 to really create a space to do some of that while the work of transitioning and bridging from today into our future continues with the transition contracts.

And you know at that time we had a lot of, you know all the things that we talked about is this HRSA’s intention of here's how we think we're going to move forward, but there are a lot of moving parts.

And just like our agile approach, we too have to be agile. Giving us the opportunity to make some tweaks to our initial strategy and approach.

So, let's jump to the next slide and highlight one of those really wonderful milestones that we achieved.

So, I think you all are aware of the milestone passage of the securing the US Organ Procurement and

Transplantation Network Act.

We were incredibly excited here at HRSA to see the act get passed and then signed into law at the end of September.

So just a few short weeks ago. And want to highlight a couple of important provisions from the new law and then talk about the implications in our modernization approach and our procurement approach moving forward.

One, it really answers the call that we put out when we asked for different tools to support us on modernization.

They answered the call. And so clearly there was a number one, an opportunity to remove the appropriations cap that was written in NOTA back in 1984 and that really allows for more resources to support our modernization efforts and our improvement efforts moving into the future.

The second important note that I'll flag for you from the law is that it expands the pool of eligible entities and award mechanisms that we have to support the OPTN. It allows the secretary to issue grants, cooperative agreements, or contracts to meet the mission of the OPTN. It also allows for us to engage for profit or nonprofit organizations, to get a wide pool of expertise to support the OPTN system and it removes the barrier to just solely be focused on organ transplant expertise because as we talked about, the best organ transplant expertise resides within the OPTN and its board of directors. And so, we want to surround them with all of the other expertise necessary to really advance the system. So, very excited about those provisions. The third provision, which is really important, and you will see the impact on our contracting strategy momentarily, is it requiring a separation between the organization that supports the OPTN board, and all of the other organizations that provide operational support.

This is to, I think, underscore the importance, from, Congress's side, about the importance of an independent OPTN board and really calls for that separation.

So consequently, let's jump to the next slide and talk about some of the implications of this new law on our strategy.

So, as we talked about, we had initially talked in July about a set of transition contracts like one IDIQ with several different domains.

And as the law requires now, it wants clear lines of distinction through a separate contract for the board support from all of the operational activities.

So, today's focus is on the board support, but I'll spend a little bit of time talking about and reminding us about what we talked about in the operations under our transition contracts.

So, you will now see there are going to be 2 solicitations. One focused on organizations to help us with supporting the OPTN board, and another set of contracts focused on operational support. So, all of the other activities that go into supporting the OPTN. So let's go ahead and drill down a little further into that.

Let's jump to the next slide.

All right, so this visual should look familiar from our time together in July and initially as I said we were thinking about this as all one big IDIQ.

We are now going to have 2 separate contracts. And as you can see from the visual there, really calling out the first one, which is the board support.

And as you can see, we're really focused on a single vendor there. A non-profit to help us with supporting the OPTN board.

All of the other work, all of the other operational activities will fall under our multi-vender IDIQ open to for profits and nonprofits to come in and show us their best ideas in each of the respective domains that are there.

As a reminder for folks who are joining us for the first time, some of the domains to give you a sense of what falls under operations, include operational support, so, running the 24/7 call centers, running the data and information that's needed to support policies, policy development, running some of the compliance elements, some of the patient safety etc. There's also the IT system, right?

A big one that a lot of folks were interested in we talked a lot about last time. So, running that 24/7 matching system that lets us to understand what organs are available, who they're matched with, and then connect them to the, allocated, and then having the full range of data from those essential workflow elements that helps us understand the performance of the system at large.

Communication, absolutely essential part of that work also. Again, the beauty of the OPTN and its policy making process is that public engagement and transparency, and communications are absolutely essential to that. So that is one of the elements of the operations support. And then finally, data and research, right?

Data is the essential fuel that helps the OPTN system run, helps us understand the implications of our policies. Helps us understand and support matching, helps us understand the performance of the system at large. And so that is really essential, and that's also one of the core functions under the operations support.

So this is a really important distinction and point for everyone to understand. The other point that I will make on this. You can see that clearly, it's going to take both of these contracts and all of these efforts working together to ensure seamless effective support of the OPTN board and the OPTN to execute the mission of the OPTN.

So, we are going to work with all of our vendors to ensure strong collaboration and coordination between our board support vendors.

And all of our operational support vendors to ensure that there's a seamless experience for the OPTN and the board and executing the functions that they have to execute.

So, something to keep in mind from our last industry day.

Alright, go ahead and jump to the next slide.

Alright, so now getting back to the task at hand. So, I gave you a little bit of background about what is the why we're pursuing OPTN modernization and the opportunities around that.

As a result of pursuing OPTN modernization and those bold aims we have. How do we have to approach our support of the OPTN and consequently our procurement or contracting strategy a little differently?

And then we talked about the legislation and how that is also giving us input into how we structure the solicitation.

And so now you know when we talk about transition contracts, there's 2 solicitations.

And I will pass over to Manjot soon to go through the details of that, but I want to give a little background information on what is the OPTN Board, what makes it unique, right?

This is not your average Board. So what are the roles and responsibilities of the OPTN board?

They're responsible for developing, reviewing, approving, and enforcing organ allocation policy and member policies for Organ allocation, procurement, and transplantation. The Board of Directors establishes committees to help them execute their mission and develop the policies and review them, ultimately that are approved and governed by the OPTN board.

They oversee the OPTN systems and operational functions. And they oversee the committee nomination of members of the OPTN board.

They also establish support and enforce OPTN membership criteria, and transplant and OPO program requirements.

As well as they regularly review and evaluate OPTN members, and they take actions as necessary to make sure that the members are complying with the policies consistent with NOTA, the OPTA Final

Rule and the OPTN by laws.

The next slide gives you a visual representation of the OPTN board, as it's structured currently.

The important word there is currently. The OPTN board of directors is a group of 40 plus elected members consisting of OPTN regional counselors, transplant surgeons, transplant positions, histo compatibility experts, transplant coordinators, organ procurement organizations, volunteer health organizations, medical and scientific member organizations, and members of the general public, including individuals who have received a transplant, who are transplant candidates, living donors, and donor family members. So, these are all the members of that board.

The OPTN Final Rule talks about the composition of the Board. They give some direction around the relative distribution of those board members and what categories they come from, but they don't give a definitive number. And so, I will say through a lot of our feedback, and we've heard a lot of feedback and questions, is the current composition and structure of the OPTN board the ideal composition and structure for the future and for a modernized OPTN.

And I think that's definitely something that can be explored into the future. With the... By the OPTN board, with the support of board contract, the board support contractors, in a process. Right, this is in the Final Rule. So, in a process that is transparent, engages the public, and really gets the best thinking for us to make sure we have the most effective board possible. And some of the ability of the board to be as effective as possible may connect back to the composition of that board.

And so, that gives you a sense there and the map just shows you the, OPTN regions, which for those of you who are familiar with all of the regional different subdivisions, it's a little different than HHS regions and other regions that you may have looked at, and hence we wanted to share that with you.

Next slide.

Alright, so now I'm just going to double click, for 2 slides and talk about the process that we undertook to develop the requirements for the board support contract.

So, we started with getting the feedback and doing our market research. So, as we said, when we went down this modernization approach, we heard organically from some stakeholders about opportunities to strengthen the independence, the composition, the role, and the oversight of the

OPTN board.

We heard from - during our focus groups - we heard from OPTN board members, we heard from subject matter experts on governance, researchers, a variety of stakeholders and so we brought all of that feedback together to really inform our effort.

So, know that that is the wide range of inputs that we got to really help inform some of our thinking, in addition to our own research. So. Jump to the next slide and I'll talk a little bit about our process.

We're coming up with the requirements. So, we started with when you develop technical requirements for something and you're working with kind of a process, you know, I'm sure many of you are familiar, right?

With like business process re-engineering or requirements gathering. You go all the way back to the beginning, the presiding legislation, and statue. And that's what we did.

So, we went all the way back to and looked at the NOTA and the Final Rule and said what has to, what are the functions and authorities and requirements in legislation for the OPTN board. Then from there, we mapped out, we looked at Final Rule, by laws, and other things, and then we have identified the core functions and activities that have to be conducted by the board. And then consequently, we thought about to enable the board to do those core functions.

What kind of support should we provide the governing board to help them be most effective in executing their mission?

And so that really helped us dictate. Okay, here are a set of supports, Services, activities that will help the board.

Then we further looked at, okay, would those be board support contractor functions or operational support functions? And then we really use that critical thinking plus all of the insights gathered through stakeholders and engagement market research before - even from the industry day, previously many of you shared your thoughts to help us develop a and part of that was to really make sure we were minimizing any conflict between the OPTN board, OPTN Board support, and the operational contractors that we would have.

So finally, we had, okay, here are the setup requirements. Our, first foray into what we think is necessary for the appropriate support of the OPTN board so they can function maximally. We then said, given that set of requirements, what kind of organizations do we need to support? What is the essential expertise necessary to support the board and executing its mission?

And it became really clear and further facilitated by the Securing the US OPTN Act, that what was of paramount importance is strong governance chops. The ability to help to aggregate a diversity of information and data. And present it to the board in a way such that they can do their independent look, analysis, and due diligence in their role of developing policy, evaluating policy, implementing policy, and operations of the OPTN and all of the members of the OPTN.

And so that's really where we landed. We really are looking for some mission-driven nonprofit organizations who have expertise in accountability, transparency, and governance to bring forward to complement the existing expertise, to help them execute their mission. So, with that as the overlay and background, I hope it helps you understand why we're proceeding with modernization, how we're approaching a new day, a modernized approach to our contracting and procurement and oversight and support of the OPTN.

And what that means for actual contract strategy and what that means for these transition set of contracts. And so, and then how we arrived at some of the requirements that we developed for OPTN board support.

So, without further ado, I will invite Manjot over to talk through the specific requirements that we've laid out.

Thank you very much, Suma. Good morning, afternoon, everyone. Thank you for letting me, thank you for having me. My name is Manjot Singh. I lead the OPTN modernization initiative.

Today I'll try to break down the OPTN board support contract. I'll break down how the board support contractor directly contributes to the organ transplantation system.

Our aim is clear to ensure the system operates effectively. [indecipherable]We're here to discuss concrete ways to strengthen the board's policy and decision-making process to improve outcomes and save lives. So, let's get into it.

The foundational purpose of the board support contractor is to empower the OPTN board to develop and refine policies that directly affect organ allocation.

And this is more than about just policy. It's about creating an environment where informed, equitable decisions are made.

Decisions that surround the crucial aspects of who receives the organ, the timing of [indecipherable], and optimizing organ allocation across the nation.

The contractor will aid the board in navigating complex information and balancing the varied views of stakeholders with our national health objectives.

The support focuses the board on strategic leadership and informed governance, arming them with comprehensive data necessary for effective oversight. It also involves facilitating discussions and actions that uphold high standards of transplant quality across all centers and for all patients. It's getting to the next slide.

So, the key board support requirements. The board support contractor plays a role, pivotal role, in optimizing the operations of the organ, across 5 main task areas.

The board support contact ensures streamlined board operations, effective governance training, and stringent conflict protocols and administrative services. It enhances coordination and governance standards under the board of director Governance Task Area, while the OPTN governance and functional oversight Task Area focuses on policy updates and strategic oversight.

Collectively, these tasks ensure that the board of directors is equipped with the necessary tools, information, and governance structure to lead them in attaining its mission and adapting to the evolving landscape of the organ, procurement, and transplantation network.

Next, let me go a little bit more detail on each of those task areas within this contact.

Next slide, please. Task area one. As part of task area one, the board support contractor will streamline the board of directors’ operation through comprehensive administrative services.

This includes coordinating meeting logistics, preparing clear agendas and materials presentations, and facilitating effective discussions.

Essential to this task is managing robust document and content platforms for seamless access to information, handling correspondence, and ensuring clear communication within the board and with external parties. Additionally, the contractor will back and distribute information essential for broad dissemination and compile critical data to bolster the board decision making process. Next we'll get into Task Area 2.

Under task area 2, the board support contractor will ensure the effective management support for board of directors and executive director roles.

This encompasses the coordination of Board of director member recruitment oversight, as well as delivering the necessary training and resources for members to effectively execute their duties.

The contractor’s responsible for securing indemnification insurance for board of directors’ members, regularly updating protocols to prevent and address any conflicts of interest, and maintaining accurate board of director and executive committee rosters with detailed member information.

Critical to this task area is the establishment of rigorous policies for hiring, evaluating, and if necessary, dismissing the OPTN executive director, alongside managing their compensation. The focus is on maintaining operational integrity and governance excellence within the board. With that lets move forward to Task Area 3.

In task area 3, the board support contractor is tasked with bolstering the governance capabilities of the board of directors.

Key functions include facilitating seamless coordination between the board of directors and related parties and providing proficient program and project management.

The contractor will guarantee the board of director access to the specialized information and expert knowledge in relevant subjects.

They will also manage board of directors processes and policies, so governance actions are up to standards. Furthermore, the contractor’s responsible for ensuring the continuity of BOD operations through established performance metrics, regular monitoring, and comprehensive risk management strategy. All aimed at maintaining governance stability and effectiveness.

Moving to Task Area 4. The board support contractor will bolster the board of directors’ capacity to govern and oversee OPTN functions comprehensively. The contractor will regularly review and propose revisions to refresh the OPTN Charter and bylaws, so they remain current and compliant.

They will be responsible for crafting and applying organization-wide policies and for orchestrating both internal and external review processes. Essential services also include providing independent evaluations and financial analysis to support informed decision making. Furthermore, the contractor will support the BOD with technical expertise necessary to scrutinize, endorse, execute, and oversee strategic initiatives and policy frameworks strengthening the OPTN mission and objectives.

So, with these areas together they form a seamless narrative that reflects the contractor’s pivotal role in maintaining the governance and operational excellence of the OPTN. And the one task area I did not go over, which is Task area 5, is synonymous across all/the entirety of the transition contracts, in that it enforces collaboration and coordination of all OPTN.

So, with that, let me turn it back over to Bonnie to go over some acquisition spots.

Thank you, Manjot. Thank you. So, next. Next slide, please.

We want to do a little, just a little refresher on the whole basis of the current procurement process.

First, we start with is to find a need. Then we refined it by conducting a lot of market research, which is what we've been doing.

In collaborating, trying to collaborate, build a partnership to help us shape, the procurements that we want to put out.

We want to make sure we innovate. We want to ensure we hear everyone. And that's where we are right now.

We started in July and now we have the November industry day.

That's going to help us to put out the solicitations. And I know you see a term RFP that is request for proposals. RFPs solicitations that we plan to issue. That's another phase in the procurement process.

Then eventually we'll move to our award of the contract and finally the performance, right? Which deals with the contract administration and ensuring that the contractor meets the metrics that we set out, and the terms and conditions of the contact. So just giving you a quick refresher on the whole procurement process.

But let's talk about that: the transition contracts.

Due to the industry, the engagement, and as you heard from Suma, and Manjot, it helps us shape where we're going.

In July, we were thinking of that one solicitation with all of the domains.

Now we have research, our research, better informed where we're going to be issuing 2 solicitations.

One solicitation for the board support contract. We intend to issue indefinite delivery and indefinite quantity type of contracts to provide us flexibility and innovation. Today we're focusing on an industry day for this contract. As Manjot went over in detail regarding the tasks that are going to be in the performance work statement. Of course, right now we are welcoming questions and comments because as I stated, we're shaping those procurements as we move forward.

The other solicitation deals with the operation support contracts, again indefinitely delivery indefinite quantity type of contracts. With several domains, soon I will go over those domains. The Domains are operations, communication, matching system, research, and evaluation. Please note that that is a multiple vendor contract. We want multiple vendors. We want your expertise in those domains.

We are encouraging industry out there to bid for one or more of those domains. It is open. It is a full and open competition.

So, and what are those anticipated vendor requirements that we're talking about?

Let's talk a little bit about the operations support contracts. It is unrestricted. This is what we are planning. This is what we're anticipating: allowing everyone, every eligible entity to compete. What are we looking for regarding expertise?

Excellence in innovation through best class experience under each domain. What does that mean?

Each of the domains when we set out in the solicitation is going to require specific experience under those domains.

Vendors are encouraged to create contracting teaming arrangement, to bid for the different domains that we have.

There is an award limitation. And what do we mean by that? The vendors that win the transition operations contracts will not be able to perform the functions of the OPTN Board support contract. As you recall we mentioned that independence of the boards is crucial to us, and we want to avoid any organizational, conflict of interest. Hence that limitation.

To be eligible to for any contract, any award, whether it’s a grant, cooperative agreement, or contract with the federal government, you must register in SAM.GOV.

So, we wanted to put that little nugget -- that it is the first step that is necessary to obtain an award.

But now let's look at the board support contract. Our anticipated requirements for that.

It is a competitive requirement. But it is limited to non-profit. What we're saying, is still competitive requirement. It's just limited to non-profits. And how we made those decisions: again by research.

Market research done by speaking and engaging with stakeholders from all over. This industry day is another engagement so please we welcome your comments again to help us plan and inform the solicitation.

The experience that we're looking for: strong experience in accountability, transparency, and governance. That is the experience that we're looking for.

Like the other procurements, this will also have an award limitation. If you win the award of the OPTN

Board support contract, you cannot perform the functions of the other OPTN operations contracts.

There is also the SAM registration eligibility, please make sure that you registered in SAM.GOV And why do I keep emphasizing that? It takes about 30 days to register.

To win a contract or a federal award, you must be registered. You do not have to have full registration by the time that you submit a solicitation, but by time of award when it comes to that, we need you to be registered.

Let's go over now, the estimated transition contracts timeline that we have. So, we started, last year, we started in March, we've been conducting market research, in July and November, we held industry days.

Our intention based on feedback that we receive at this point is to issue the 2 solicitations by the end of the calendar year.

We want to ensure that we provide a fair and a proper competition to everyone. Therefore, when we issue the solicitations, we have a questions and answer period to ensure that we get last minute questions, based on those we probably have to make changes or not to the solicitation. It depends on what we hear from you. We anticipate having some contract clinics, but our timeline is very aggressive. And why we're doing that because we want to make sure that everyone understands the requirements that we're laying out.

We want to make sure that everyone has a fair opportunity to compete. And that's why we are taking in and taking all of those steps. We then are going to move to proposals evaluation and then eventually in the early spring, negotiations and late spring, the award of the contract. It is a very, very aggressive timeline that we have set up, but we know that with your collaboration, with you participation, we can do this.

This has been a journey for us. That we really need you help with that. And I will leave you with a quote from Joel A Barker. Vision without action is just a dream. Action without vision is passing time.

Vision with action can change the world. Let us together change how we procure the OPTN

[indecipherable] contracts. And with that, I'm going to turn it over to Manjot for questions and answers.

We will work on responding as many questions as possible, within the time that we have.

Thank you, Bonnie.

Hi, this is Manjot again. So, we have a number of questions that have been coming in throughout the pod.

And I really appreciate the, the engagements. So let me start with the first question. Will both solicitations go out around the same time, and can I apply or propose for both?

Yes, they're both are going to go out the same time. Yep. That's our intention to have both of our transition solicitations: the board support contract solicitation, and the operations support contract solicitation to go out. You know, as we mentioned in some of our pre solicitation notifications and others in the next several weeks.

And, so the second part of the question, can you apply as an organization to both?

You may certainly, offer your proposal on both solicitations, but as we stated at the top, the new act calls for separate organizations: a separate organization to support the board, the OPTN board. That is a separate organization from all of the organizations that provide operational support. So, if you win the board support contract, you will not be able to win one of the operations support contracts and vice versa.

Thank you. So, there's a follow-up question to this is: can the same organization win multiple support contracts?

Yes, right, Bonnie? That's the beauty of dividing up by domains. We're letting people come in where they feel they have the best expertise. You may partner, you might have expertise in several domains.

You can when we are allowing the bidding to be for one or more of the domains. You must have the expertise. Once we put out the solicitation, it's going to give in detail that expertise that we're looking for.

So yes, please, it is open. To everyone.

Thank you. So, another question that's coming is:

Are the other contractors supporting the OPTN going to report to the OPTN board? If not, to whom will they report to?

It's a good question, an important point for me to clarify. All of these contracts that we've been talking about, the solicitations, they are federal contracts. They are contracts with HRSA, so we have the responsibility to oversee those contracts. So here to be clear, the board support contractor and the range of operations support contractors that may come in.

Now, this was my top point when I talked about our different roles with the OPTN. We have an oversight role of the OPTN, and we have a support role. In the support role, we support through soliciting, awarding, and managing contracts for the services necessary to execute the OPTN and

OPTN board’s mission.

And so, in that role, we are going to solicit...so will be making awards and we, HRSA, will be overseeing those contracts in service of the OPTN and the OPTN Board of Directors. And so, part of our multi-vender collaboration, process and approach will be to make sure we have the right accountability and information flows in coordination across all of those vendors.

So, we're clear on the need to support the board’s decision-making oversight roles, etc. That's in fact one of the important functions of the board support contractor to bring together information from all of these…