SSJ Contract Extension 12192025.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an 8(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $22 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Part 13), Federal Supply Schedule orders (FAR 8.4) or task or delivery orders subject to fair opportunity (FAR 16.505).

Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6.3 for guidance. An addendum may be added in case additional space is needed.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

Acquisition Title:

Agency:

Acquisition Year (FY):

Author and Title:

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds:

Name of Proposed Contractor(s):

Street Address:

City, State, Zip:

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis Class Basis

The total estimated value of the proposed action, including all options is $

As applicable, briefly describe the services or supplies required to meet the agency's needs, including make & model number where appropriate. Include quantities of supplies or period of performance for services. Provide information for any options included. If the action is a modification to an existing contract, distinguish clearly between the work covered by the original contract and the work to be obtained by the proposed modification.

https://www.acquisition.gov/far/part-8#FAR_Subpart_8_4 https://www.acquisition.gov/far/part-13 https://www.acquisition.gov/far/part-16#FAR_16_505 https://www.acquisition.gov/far/part-6#FAR_Subpart_6_3 https://www.acquisition.gov/far/part-6#FAR_6_303_1

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actions other than simplified acquisition procedures (select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

Explain why the intended contractor is the only responsible source who can provide the required supplies or s ervices.

Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or servic es will satisfy agency requirements. Explain factors/unique qualifications such as proprietary data or exclusive licensing rights, if applicable. When competition is limited to items particular to one manufacturer, this justification must explain why the particular brand name, product, or feature is essential to the Government's requirements, and that market research indicates other companies' similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the agency's needs in accordance with FAR 11.105. If in connection with a follow-on contract for continued development or production of highly specialized equipment, detail the substantial duplication of cost or unacceptable delays.

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

If unusual and compelling urgency is the basis for the justification, explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved. Describe impact of required delivery/performance date. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. Failure to plan for expiring funds is not a valid reason for citing this exception. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5)

Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.

Other (See FAR Subpart 6.3 for additional authority)

Provide the authority and citation to the applicable section of FAR 6.3.

Provide a full explanation to justify use of the exception.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

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6. Bridge Contracts:

For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize history of current contract and explain the reasons for any delays in the acquisition. Include discussion of the milestones f or the follow-on action; the milestones should be as efficient as possible. Discuss why it would be neither cost effective nor realistic to expect another contractor to perform during the brief interim period; include issues such as start -up costs, phase-in, transfer of GFP, recruitment and staffing, etc. If the action is because of a protest, provide a brief discussion of the protest including the date the protest was filed and the basis of the protest. Explain that the action will provide the minimum quant ity or performance period.

7. Actions to Increase Competition:

Describe efforts made to compete the action, including whether a notice was or will be publicized as required by FAR Subpart

5.2 or which exception under FAR 5.202 applies. If a notice was publicized, discuss the number of written responses to the synopsis and the results of the assessment of the written responses. List sources, if any, that expressed, in writing, an interest in the acquisition. Provide rationale if interested sources were rejected. If applicable, state that no other sources have expressed interest, but all offers received shall be considered. Describe what actions will be taken to increase competition before subsequent acquisition of the supplies or services is required. You may state that an action is a one-time requirement, but if a similar requirement arises, every effort will be made to compete it to the maximum extent possible. If action is sole source because of proprietary data or licensing rights and there will be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement costs/licensing purchase costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new requirement and a competitive follow-on is anticipated, explain that efforts are underway to facilitate a full and open competition.

8. Market Research:

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If ac tion is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

9. Procurement History:

Purchase order or contract number:

Was action competed? Yes No

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_5_202 https://www.acquisition.gov/far/part-10#FAR_10_002 Suma Nair Highlight

10.Additional Information to support the justification:

If applicable, explain why technical packages or specifications to facilitate competition were not developed or available;

describe actions taken to remedy the situation.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this

J&A is accurate and complete.

Program Manager

Name:

Position Title:

Email address:

Phone:

Program Manager Supervisor (or one level above Program Manager)

Name:

Position Title:

Email address:

Signature:

Date:

12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.

Name: Phone:

Signature: Date:

13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name: Phone:

Signature: Date:

https://www.acquisition.gov/far/part-15#FAR_15_402 https://www.acquisition.gov/far/part-15#FAR_15_402 https://www.acquisition.gov/far/part-15#FAR_15_403_4

14. Legal Review:

All J&As greater than $68 million must have a legal review from the General Law Division of the Office of the General Counsel prior to sending it to the Department.

15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million (value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name:

Phone:

Signature:

Date:

All J&As greater than $68 million must have a review from the Office of Small & Disadvantaged Business Utilization (OSDBU) prior to sending it to the Department. The OSDBU at their discretion may review any J&A.

16. Office of Small and Disadvantaged Business Utilization Review: (Required for contracts exceeding $68 million (value calculated including all options)):

Concur:

Non-Concur:

17. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million (value calculated including all options)):

18. Department Competition Advocate (Required for contracts exceeding $68 million (value calculated including all options)):

Concur:

Non-Concur:

(The below approval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)

19. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

State supplies/services being procured:

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304:

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.

Under the current contract, HHSH250201900001C, the Contractor continues to perform some operational aspects of the OPTN, including supporting the OPTN policy committees and administration of the OPTN organ matching system, which serves as the nation’s critical infrastructure for all organ matching, advanced data management, and real-time transplant coordination within the country. and is essential to ensuring timely, accurate, and equitable organ allocation nationwide.

To meet its statutory obligations and protect public health, HRSA must ensure continuous, uninterrupted OPTN operations. Any disruption in its operations would have immediate, profound, and potentially catastrophic consequences, including delays in organ offers, loss of viable organs due to preservation limits, and otherwise preventable patient deaths. Even brief outages or system instability directly endanger patient safety, undermine clinical decision-making, and seriously erode public confidence.

This extension will be at a reduced scope of the original contract due to HRSA’s effort to rescoping the work from one, monolithic contract to discrete contracts and task orders. The following services are no longer required under the extension and removed from the performance work statement:

1. OPTN Governance and Board of Directors support

2. OPTN Committee and Policy Development Process support

3. Maintenance and improvement of the OPTN website and Communications support

4. OPTN Membership and Professional Standards Committee support and OPTN member compliance and performance monitoring

5. Logistics Support

The following services will remain on the extension and the performance work statement:

1. Operation of the OPTN electronic organ-matching system, including real-time matching of donor organs to transplant candidates.

2. Operation of and technical support for the OPTN Organ Center, including 24/7 assistance to organ procurement organizations and transplant centers, facilitation of organ placement and logistics, and continuity support during complex cases or system disruptions

3. Collection of official OPTN data needed to support OPTN operations.

4. Coordination of data support activities with the Scientific Registry of Transplant Recipients (SRTR) to ensure data accuracy, consistency, and interoperability.

Period of Performance of this requested action, 12-month extension as follows:

• Option Period 9: 12/30/2025 to 03/31/2026 (3 months)

• Option Period 10: 04/01/2026 to 06/30/2026 (3 months)

• Option Period 11: 07/01/2026 to 09/30/2026 (3 months)

• Option Period 12: 10/01/2026 to 12/29/2026 (3 months)

HRSA launched the OPTN Modernization Initiative to strengthen accountability and performance in the national organ donation and transplantation system. The initiative focuses on modernizing technology, governance, and operations, addressing long-standing challenges including limited system transparency, aging infrastructure, downtime, and cybersecurity vulnerabilities.

To support this Initiative, HRSA began to modernize the OPTN by rescoping the work from one, monolithic contract to discrete contracts and task orders that allow for better expertise and best-in-class Contractors to compete. Contracting for this modernized approach began in 2024 and is scheduled to continue throughout 2026.

Significant progress through competitive actions have been completed and are detailed below in #7 of this document.

HRSA has already begun the work of breaking apart and modernizing OPTN operations, but the modernization activities underway have revealed how complex and interconnected these functions are. As HRSA develops a unified government-managed data system, pilots earlier donor data collection, launches a new OPTN collaboration platform, and begins establishing national safety and quality standards, the agency has gained a clearer understanding of the risks involved in transitioning any portion of OPTN operations. HRSA cannot compete the remaining OPTN operations work within the timeframe before the current contract expires on December 29, 2025. This urgency is not the result of inadequate planning. HRSA initiated modernization immediately following the statutory change in 2023 and has executed a planned, phased procurement approach; however, the scale, interconnectedness, and life-critical nature of OPTN operations inherently require a multi-year transition period that cannot be shortened without unacceptable risk.

Because the OPTN cannot halt or slow operations, any new system must be developed, tested, and validated while the existing legacy system continues to run. Sequential transition is not feasible for a national, real time clinical infrastructure of this scope. The requested extension of up to twelve months represents the minimum amount of time required to safely conduct competition and perform the integration and validation activities necessary to maintain patient safety and system stability.

HRSA cannot conduct even a limited competition within the remaining timeframe because no new vendor could safely assume OPTN operations by the required performance date. A responsible transition would require significant time for solicitation, evaluation, access provisioning, technical assessment, interface development, nationwide integration, operational testing, and clinical readiness validation.

These activities cannot be compressed into the period before December 29, 2025 without compromising patient safety, system reliability, and national transplant operations. The fixed contract expiration date therefore establishes a non-negotiable constraint that prevents any form of competition during this period.

Therefore, HRSA’s unusual and compelling urgency for OPTN Operations support continuity and patient safety requires that the Government limit its sources to the current OPTN Operations Contractor in order to avoid seriously injuring the government, while HRSA continues its modernization effort.

If this justification is not approved, there would be immediate and severe consequences, including the potential for allocation errors, system outages, delays in organ offers, loss of viable organs due to preservation limits, and preventable patient deaths. The inability to maintain operations would also place HRSA in violation of statutory and regulatory responsibilities under the National Organ Transplant Act and 42 C.F.R. Part 121, resulting in significant mission failure and harm to public trust.

BARRIER #1 – Prior to 2023, the Government was only authorized to enter into a single contract with a private nonprofit organization to operate the OPTN BARRIER #2 - $7 million annual funding cap on OPTN contracts BARRIER #3 -The Government had a lack of Government authority to collect waitlisted patient fees BARRIER #4- There is an operational complexity of maintaining uninterrupted national organ allocation and transplant services

Overcoming Barrier #1/2: Single contract with private nonprofit/$7M annual funding cap

- Public Law 118–14, enacted on September 22, 2023, authorized HHS for the first time to award multiple contracts and other vehicles for discrete OPTN functions. This change significantly strengthened HRSA’s ability to improve accountability, enhance system performance, and ensure effective management and oversight of the OPTN.

- As a result of these changes, HRSA has competitively awarded several contracts/vehicles to allow for full and open competition and is working to transition off the current OPTN Operations contracts as detailed in section #6 of this document

- In addition to the aforementioned change, there was historically a $7M annual funding cap on OPTN contracts which greatly impacted HRSA ability to award contracts to anyone other than the incumbent on the OPTN Operations contract. This cap was completely removed in National Organ Transplant Act (NOTA) in Sept 2023. By lifting this cap, HRSA now has the ability to fund and compete OPTN contracts.

Overcoming BARRIER #3 -The Government had a lack of Government authority to collect waitlisted patient fees

- The collection of OPTN fees historically was conducted by the incumbent OPTN operations contractor.

- HRSA received authority to collect fees under the current continuing resolution in November 2025.

- The ability to collect OPTN waitlist fees is essential to modernization because it allows the government to directly manage a core operational function previously controlled by the incumbent contractor. Fee collection provides stable funding needed to support new vendors, modern technology, and improved governance. Without this authority, HRSA could not fully transition to a multi-vendor model or effectively oversee OPTN operations. This authority strengthens transparency, accountability, and long-term system stability.

Overcoming BARRIER #4- There is an operational complexity of maintaining uninterrupted national organ allocation and transplant services

- Progress has been made to increase competition, with some components of this contract having already transitioned to new contracts and contractors. HRSA will continue to transition discrete, modular pieces of the work in 2026 to minimize, and work to eventually fully end, the reliance on a single Contractor.

- Continuation of OPTN operations through UNOS is critical to prevent disruption of national transplant services, which could delay organ matches, result in loss of viable organs, endanger patient lives, and compromise public confidence in the national transplant system.

Text80: Procurement History:

September 30, 1986 United Network for Organ Sharing (UNOS) September 30, 1987 United Network for Organ Sharing (UNOS) September 30, 1990 United Network for Organ Sharing (UNOS) September 30, 1993 United Network for Organ Sharing (UNOS) September 30, 1996 United Network for Organ Sharing (UNOS) HRSA 240-1997-0036 September 28, 2000 United Network for Organ Sharing (UNOS) HRSA 231-2000-0115 September 30, 2005 United Network for Organ Sharing (UNOS) HHSH-234-2005-37001C September 30, 2018 United Network for Organ Sharing (UNOS) HHSH250201900001C

Since 1986, UNOS has managed the OPTN and is currently performing under contract HHSH250201900001C scheduled to conclude on December 29, 2025. UNOS’s responsibilities include overall OPTN management, policy development, compliance oversight, and operation of the OPTN organ matching system technology platform that enables real-time organ matching, allocation, and data management.

HRSA will continue throughout 2026 to break down barriers and transition work using modern, competitive solicitations. It is not cost effective nor feasible for a new contractor to perform the required contractual tasks during this interim period due to patient safety concerns.

Text81: This action is not subject to a pre-solicitation notice per the exception listed in RFO 5.101(b)(2).

HRSA has taken several steps to increase competition of the various functions of the OPTN. Ongoing contractor outreach efforts since 2023 include press releases, a dedicated website updated regularly, several RFIs, one-on-one engagements with contractors and industry day events. HRSA has focused significant effort into describing agency needs in a manner supporting continuous competition on modular requirements while maintaining patient safety.

Planning and progress have been made to increase competition, with some components of this contract having already transitioned to new contracts and contractors. HRSA will continue to transition discrete, modular pieces of the work in 2026 to minimize, and work to eventually fully end, the reliance on a single Contractor.

In addition, HRSA has planned and initiated a contract action to migrate the existing OPTN organ matching system environment to a secure, compliant cloud infrastructure, executed by UNOS. Following successful migration, HRSA intends to assess long-term strategies to expand competition, improve flexibility, and reduce vendor dependency.

In the interim, the current migration will substantially reduce barriers to competition by eliminating reliance on obsolete, end-of-life hardware and opaque, and proprietary hosting arrangements. By moving to a secure and standardized cloud platform, HRSA will establish consistent architectural baselines, modern APIs, and documented configurations that will support future integration and Contractor onboarding. The new environment will also facilitate incremental modernization, allowing future vendors to develop, test, and deploy new components without requiring wholesale replacement of the legacy system.

This phased approach reflects HRSA’s deliberate strategy to first stabilize and secure the existing system, then enable broader industry participation through structured and transparent modernization efforts. Each phase of the modernization plan is designed to incrementally reduce vendor lock-in, enhance system interoperability, and expand the competitive field for future OPTN IT requirements.

By establishing a secure, federally visible cloud foundation, HRSA is creating the conditions necessary for future competitive acquisitions, to potentially including source code acquisition, modular development, and multi-vendor operations, which will sustain innovation, reduce costs, and strengthen accountability in the OPTN IT ecosystem.

HRSA then hosted an Industry Day in July 2023 with ~300 people in attendance. The goal of the Industry Day was to: 1) Provide clarity to address common questions about the current state and transition so that the community has an understanding of what it looks like to perform the work; 2) Collaboratively generate ideas for the transition contracts to attract competition while meeting the overarching transition goal to protect patient safety; 3) Collect information to create a transition contracts; and 4) Foster a sense of partnership to drive mutual interest to attract the right contractors. The day kicked-off with an overview of the OPTN Modernization Vision, the current state, and the contract process. This was followed by breakout sessions covering 1) Operations; 2) Multi- contractor Coordination; and 3) Research & Evaluation.

In November 2024, HRSA issued a Request for Information (RFI) to assess contractor capabilities and market interest in OPTN modernization and IT system support. The RFI was released on both the GSA e-Buy platform under Multiple Award Schedule (MAS) 54151S – Information Technology Professional Services and SAM.gov from November 15 through November 20, 2024, reaching more than 5,100 potential contractors. HRSA received 126 capability statements, including responses from at least 11 small businesses and 10 other-than-small businesses, each demonstrating strong technical qualifications in large-scale health IT systems management, modernization, and federal IT program support.

Based on this market response, HRSA issued Request for Quote (RFQ) No. 75P00125Q00003, titled OPTN Next Generation (NextGen) IT Multiple Award Blanket Purchase Agreement (MA-BPA), on January 17, 2025, to establish a competitive framework for future OPTN-related services. However, the RFQ was later cancelled following programmatic reprioritization. Despite the cancellation, the results of this market research confirmed the existence of a robust and diverse contractor base capable of supporting future OPTN operations and modernization efforts once the Government achieves the technical visibility and data access necessary to structure a fully competitive acquisition.

The Government plans to achieve this technical visibility and data access by migrating the existing OPTN organ matching system environment to a secure, compliant cloud infrastructure as described in section 7. By establishing a secure, federally visible cloud foundation, HRSA is creating the conditions necessary for future competitive acquisitions, to potentially including source code acquisition, modular development, and multi-vendor operations, which will sustain innovation, reduce costs, and strengthen accountability in the OPTN IT ecosystem.

The requested extension with UNOS will ensure continuity of OPTN operations and will enable HRSA to maintain compliance with the National Organ Transplant Act (NOTA) and 42 C.F.R. Part 121 while continuing its broader modernization and competition planning.

This action therefore represents a necessary interim measure to maintain uninterrupted national transplant operations while the government continues to plan and conduct competitive acquisitions.