JA - OPTN Extension_Redacted.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. ACQUISITION INFORMATION:

Acquisition Title: Organ Procurement and Transplantation Network

Acquisition Year: FY 2024

Agency: Health Resources and Services Administration

2. DESCRIPTION OF ACTION:

Modification to the Existing Contract No. HHSH250201900001C

Contractor: United Network for Organ Sharing

3. DESCRIPTION OF SERVICES OR SUPPLIES:

The total estimated value of the proposed action, including all options is $133,879,990.00.

HRSA oversees the Organ Procurement and Transplantation Network (OPTN), authorized by the National

Organ Transplant Act of 1984, as amended (NOTA), P.L. 98-507 and implemented by 42 CFR part 121, Organ Procurement and Transplantation Network, as amended (Final Rule). The Final Rule establishes a regulatory framework for the structure and operations of the OPTN. Among its statutory responsibilities, the OPTN must operate and monitor an equitable system for allocating organs, maintain a waiting list of potential recipients, match potential recipients with donor organs, work to increase the supply of donated organs, and coordinate, as appropriate, the transportation of organs from organ procurement organizations and transplant centers. The OPTN establishes and maintains membership criteria for institutions, individuals, and interested parties, while establishing and maintaining training and experience criteria for designated transplant personnel at certain transplant programs. Through committees and the OPTN Board of Directors (BOD), the OPTN also establishes, maintains, and monitors compliance with federal laws and OPTN policies, including those for the equitable allocation of donor organs among transplant patients, in accordance with Federal legislation and regulations. The OPTN collects, analyzes, and publishes routine donation, procurement, and transplant data.

The current contract, awarded in FY19, includes a base period and four 1-year option periods, with the contract performance end date of September 29, 2023. Due to the critical role of the OPTN in saving lives, uninterrupted services are imperative. The Government has previously extended the UNOS contract by six (6) months using FAR 52.217-8, and the current contract is set to expire on March 29, 2024.

To ensure service continuity HRSA requires the ability to extend the contract performance period for an additional 21 months. This extension is essential to maintain service consistency and meet the ongoing needs of the OPTN while HRSA works to separate the contract into the OPTN Board of Director Support, Operations Transition and NextGen.

4. AUTHORITY AND RATIONALE:

FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2)

UNOS is the incumbent under the current contract awarded in FY19 and has been the incumbent and only vendor on this scope of work since its initiation in 1984. HRSA is preparing a new competitive approach for this work for award in Q4 of FY24. Until the new competitive contract is awarded, the life-saving and life-enhancing critical work performed on the existing contract must continue without interruption to avoid placing transplant candidates at risk. This modification extends the existing period of performance with a continuation of the scope of work for a total of 21 months (9-month base period, with two 6-month option periods), until a new competitive award can be put in place.

In May 2022, market research was initiated to explore contracting options for the OPTN. Market research continued through November 2023. During this period, the National Organ Transplant Act (NOTA) was amended in September 2023, allowing increased flexibility in contracting approaches.

The amendment to NOTA necessitated additional market research to align with the revised regulations.

As a result of these factors, including the extended market research duration and regulatory changes, makes it extremely unlikely that a new contract could be put in place by the original deadline of

September 2023 or the current extended deadline of March 29, 2024.

If this request for an extension is not approved, critical work under the OPTN will cease, adversely affecting over 104,000 individuals on the national organ transplant waiting list. They will be deprived of access to life-saving or life-enhancing organ transplants essential for their well-being. The OPTN's ability to function is reliant on the continuity provided by the existing contract, and the time constraints make it impractical to conduct a limited competition or award a new contract within the specified timeline.

5. AGENCY ACTIONS TO TAKE OR REMOVE BARRIERS THAT LED TO OTHER THAN FULL AND OPEN

COMPETITION:

In March 2023, HRSA embarked on a major Modernization Initiative and as part of the initiative, HRSA will be restructuring the framework to enable increased accountability, equity and transparency. The new approach will take time to implement and will include the establishment of an independent OPTN board from the vendor, removal of the "non-profit" requirement, allocation of registration fees (which provide for the majority of funding via the current cost sharing contract) and support for multiple vendors.

In January 2024, HRSA issued draft solicitations for new OPTN Transition (Board of Directors &

Operations) IDIQ contracting vehicles to ensure full and open procurement of those services.

6. BRIDGE CONTRACTS:

The primary goal in extending the contract for 21 months (9-month base period, with two 6-month option periods) is to ensure patient safety while a competitive and modular approach is established under the forthcoming award of new IDIQ contracting vehicles in the fourth quarter of 2024. HRSA initiated a focused effort in October 2022, laying the groundwork for internal government capacity building and technology and governance strategies culminating in an executable acquisition approach.

Given the complex subject matter underpinned by legislation, transitioning from a historically single-award contract, performed by a single vendor under a cost sharing type contract for almost 40 years, to a multiple-award IDIQ. This requires a multi-faceted effort which includes diverse stakeholder engagement across the department and agency to develop and execute these upcoming contract actions. HRSA has consulted with USDS who advised the importance of maintaining current functionality as a new system is built, tested, and launched. Beginning in May 2023, HRSA has directly engaged with approximately 15 vendors with an interest in competing for areas of the OPTN. This engagement has informed the initial PWS for the planned IDIQ. HRSA has hosted an industry day with approximately 200 participants on July 21, 2023 and November 9, 2023. Information collected from the industry day has informed the PWS for the IDIQ as well as the initial task orders under the IDIQ. The extension will ensure that HRSA has the time to developed/finalize the PWS and go through the clearance process to ensure an award is in place.

The extension is the only option to ensure continuity of the OPTN. Currently, no vendors have the capacity or capability to jump in and support the current requirements under the OPTN contract. HRSA does not anticipate any protest from this action as we are engaging the industry to increase competition in the next requirement. The industry understands that there will need a transition to ensure continuity of services under the OPTN.

It is not cost effective nor feasible for a new vendor to perform the required contractual tasks during this interim period due to patient safety concerns. The current OPTN contractor - UNOS, acts as the OPTN and operates a proprietary, safety critical, system called UNET, which is responsible for facilitating organ transplantation matching and other operations.

7. ACTIONS TO INCREASE COMPETITION:

HRSA has taken several steps to increase competition of the various functions of the OPTN.

Vendor outreach efforts include press releases, a dedicated website updated regularly, RFIs, one-on-one engagements with vendors and industry day event.

HRSA conducted an initial market research in April 2022 and received 53 responses. HRSA has conducted subsequent market research sessions with interested vendors and conducted industry day(s) on July 21 and November 9 with more than 200 expected participants.

HRSA has focused significant effort into describing agency needs in a manner supporting continuous competition on modular requirements while maintaining patient safety.

8. MARKET RESEARCH:

HRSA has and continues to conduct market research via RFIs, requesting feedback on draft requirements, one-on-one engagements with interested vendors and conducted industry day in Q4 of FY23 and Q1 of

FY24, focused on describing agency needs, evaluating potential vendors, establishing fair opportunity ordering procedures, fostering continuous competition and administering task orders in a multi-vendor environment. This market research informs development of a multiple-award, competitive IDIQ solicitation for issuance in January, 2024 and an additional RFP in the Spring of 2024. This is a complex contract bounds by legislative requirements that HRSA need to address. During the process, HRSA has received additional input from the Senate Finance Committee regarding this contract that needs to be addressed careful. All these necessitate an extension to the existing contract to ensure that HRSA has the time necessary for the next contract.

9. PROCUREMENT HISTORY:

Contract Number: HHSH250201900001C

Action was competed.