P03 Justification and Approval.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C242-26-AP-1013

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-26-AP-1013

1. Contracting Activity: Department of Veterans Affairs, VISN 02, Samuel S. Stratton, 113 Holland Ave Albany, NY 12208-3410 procuring the requirement for NJ Healthcare Centers 385 Tremont Avenue East Orange, NJ 07018-1023. 2237 is 561-26-2-2238-0010.

2. Nature and/or Description of the Action Being Approved: This procurement for the continuation of support of collaborative research that is advancing the strategic mission of the Post Deployment Cardiopulmonary Evaluation Network (PDCEN).

The Contractor will continue to perform specialized research, including data collection, analysis, and reporting on cardiopulmonary health outcomes in post-deployment veterans. The contractor will continue to enhance and expand the existing research database, ensuring comprehensive and accurate data for current and future studies.

The requirement is adhering to and following the guidelines, policies, and procedures of VA Directive 1215: Standards for Veterans Health Administration Centers of Excellence and VA Directive 1663 which implements the VA HCR sharing authority under Title 38 U.S. Code Sections 8151-8153.

The continuation of Research and Development (R&D) Services for the VA Airborne Hazards and Burn Pits Center of Excellence (AHBPCE). These services will be sought via a sole-source procurement with the educational affiliate, The Regents of The University of California, San Francisco.

3. Description of Supplies/Services Required to Meet the Agency�s Needs: This is a unique field of investigation of which limited research has been performed as acknowledged by the National Academies of Sciences in 2020 report:

https://pubmed.ncbi.nlm.nih.gov/33030852/.

One of the major limiting factors identified in this report is the lack of a proper comparison group that has been evaluated in a manner similar to that of deployed Veterans. Therefore, the objective of this contract is to directly address this concern by recruiting, testing, and developing a control group cohort from which to compare test findings of symptomatic deployed Veterans. There are a few groups in the country that have the expertise and experience in performing such activities.

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This requirement is essential to enhance its control group and further the understanding of deployment-related cardiopulmonary health effects. This requirement specifically aims to recruit and test a second group of �controls� comprising deployed and non-deployed military Veterans free from any symptoms and/or diseases, to provide a robust baseline for comparison against symptomatic Veterans from the initial research.

The importance of this control group cannot be overstated, as it establishes a true baseline of cardiopulmonary health and exposures, allowing clinicians to accurately distinguish abnormalities and outcomes specifically associated with deployment-related airborne hazards from those that reflect the background risk in similar Veterans without exposures or symptoms.

This procurement builds upon the initial success of the PDCEN Control Group and Repository project. The contractor shall leverage the established methodologies and protocols already in place to expand this critical work. The contractor must possess extensive knowledge and expertise in assessing and managing pulmonary diseases stemming from environmental and occupational exposures. They must also have pre-existing procedures and protocols to acquire the necessary human cardiopulmonary physiology data, which is crucial for enriching the repository data maintained by the AHBPCE.

The contract will be awarded as a firm-fixed-price contract for a base year plus two option years, with an estimated value of $1,431,389.65 and an estimated award date effective 01/15/2026 through 01/14/2027 with two provisional option years, ultimate completion date of 01/14/2029.

4. Statutory Authority Permitting Other than Full and Open Competition:

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by

RFO 6.103-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by RFO 6.103-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by RFO 6.103-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by RFO 6.103-4

(X) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by RFO 6.103-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by RFO 6.103-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by RFO 6.103-7;

5. Demonstration that the Contractor�s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Due to the nature of this acquisition, the use of the authority cited above

VHAPG Part 806.3 OFOC Page 3 of Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C242-26-AP-1013 is in the best interest of the VA and will ensure continuity of expertise and methodologies, reduces the risk of data inconsistencies, and enhances the overall robustness and reliability of the PDCEN repository data.

The suggested vendor is a confirmed affiliated institution of the Department of Veterans Affairs. The Office of Academic Affiliations (OAA) collaborates with the Office of Research and Development (ORD), and the affiliated academic institutions and research programs are involved in patient-centered research providing support research initiatives focused on improving healthcare for veterans.

Under 41 U.S.C. § 3304(a)(5) and RFO 6.103-5, the use of noncompetitive procedures is authorized because Title 38 U.S.C. § 8153 expressly permits the Department of Veterans Affairs to enter into contract with affiliated institutions for health care resources in this case professional services regarding Clinical research and development. Therefore, 41 U.S.C. § 3304(a)(5) and RFO 6.103-5 allows for the sole sourcing of commercial services in support of VA Research, as no other services can meet the requirement.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies): While not required in accordance with VAAR 873.108(3)(b), a public announcement does not apply to sole source acquisitions described in 873.107(a)(1). However, a Special Notice of Intent to Sole Source was published on SAM.gov Notice ID: 36C24226Q0213 posted on December 15, 2025, stating that all inquiries must respond indicating their interest and provide their technical capability.

Accordingly, the VAAR 873.014(a) and VAAR 873.108(3)(b), and public law exempt public announcements, under 38 U.S. Code § 8153(3)(A), for contracting procedures sole-source acquisitions with affiliated institutions and non-profit to facilitate research and educational partnership activities.

The Regents of The University of California, San Francisco, is a confirmed affiliate of the VA through the Office of Academic Affiliations, Department of Veterans Affairs

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer will determine fair and reasonable pricing prior to award and option periods being exercised. Furthermore, the proposed pricing will be compared against historical data from previous similar procurements and U.S. Bureau of Labor Statistics data tools. This includes past contracts with the same vendor as well as other vendors for comparable services.

The historical pricing data indicates that the current proposed price aligns with what has been paid in the past, it�s adjusted for inflation, additional scope requirements, and an additional option year.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: In accordance

VHAPG Part 806.3 OFOC Page 4 of Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C242-26-AP-1013 with RFO Part 10 and the VA Acquisition Regulation (VAAR) 810.001-70 Market Research Policy, we performed targeted market research to identify potential contractors capable of supporting the VA�s Post-Deployment Cardiopulmonary Evaluation Network (PDCEN) by enhancing our control group. The goal was to find service-disabled veteran-owned small businesses (SDVOSBs) and veteran-owned small businesses (VOSBs) with the expertise in cardiopulmonary research and health data collection.

Limited market research was conducted as this initiative falls under the War Related Illness and Injury Study Center (WRIISC), a national program dedicated to addressing Veterans' unique post-deployment health concerns. Established by Congress under Public Law 105-368, Section 103, WRIISC plays a crucial role in the VA Health System by addressing war-related health concerns, including military environmental or toxic exposures, through clinical care, research, and education from its locations in New Jersey, California, and Washington, DC.

Given the specialized nature of the project, our approach to market research was guided by specific statutory provisions that support efficient and effective contracting for specialized needs.

On December 19, 2025, the Contracting Officer conducted market research to survey the market of SDVOSB and VOSB vendors through Small Business Search (SBS) with the following search criteria NAICS 541715, SBA Certifications: Veteran- Owned Small Business (VOSB) or Service-Disabled Veteran-Owned Small Business (SDVOSB). This search found six profiles that had the following NAICS 541715 listed on their profile: USAFALCON, Inc, River Front Services, Cybernete Security Group, Empennage Strategic Solutions, LLC, Scientic Inc, and Keelpoint Strategies, LLC.

The search NAICS 541715 and SBA certification SDVOSB and VOSB were further filtered with keywords clinical research, this search found zero profiles.

The following search NAICS 541715 and SBA certification SDVOSB and VOSB were further filtered with keywords cardiopulmonary research, this search found zero profiles.

The last search NAICS 541715 and SBA certification SDVOSB and VOSB were further filtered with keywords pulmonary research, this search found zero profiles.

An Internet search was conducted, the keywords used were Veteran Cardiopulmonary Studies regarding burn pit. This search found mainly articles or journals that mention veterans who were deployed were affected by burn pits exposures. Aside from the articles and journals, Boehringer Ingelheim was listed in the search result; however, they are not a study center but instead a resource that provides information to veterans on how to manage chronic lung disease.

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The decision to limit comprehensive market research was based on statutory provisions that align with the specialized and critical nature of this project.

Leveraging existing authorities allows us to engage highly qualified contractors promptly while ensuring compliance with VA procurement regulations. This approach supports the War Related Illness and Injury Study Center's mandate to effectively address post-deployment health expertise for veterans.

Contractors must possess established procedures for acquiring and managing human cardiopulmonary physiological data as required by VA�s PDCEN initiatives.

It's crucial to engage those with pre-existing expertise and infrastructure to avoid delays and ensure high-quality outcomes.

Under 41 U.S.C. § 3304(a)(5) and as implemented by RFO 6.103-5, noncompetitive procedures are justified by statute. Title 38 U.S.C. § 8153 authorizes the VA to enter into agreements with affiliated institutions for health care resources. VHA Directive 1663 supports this by allowing sole source of Clinical research and development (including contracted research efforts) necessary to meet the specific clinical research and educational objectives of post-deployment health concerns.

Therefore, given these statutory authorizations, conducting an extensive market search was deemed unnecessary. The directives align with the VA�s efforts to streamline the procurement process while focusing on securing expert services crucial to the WRIISC�s mission.

This procurement is for services where Buy American Act (BAA) or Trade Agreements Act (TAA) is not applicable.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

None

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

The Regents of The University of California, San Francisco

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Currently, there are no feasible actions to remove or overcome barriers to competition. However, we will continuously monitor the market for any changes or developments that may allow us to enhance competition in future acquisitions for the services required.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

VHAPG Part 806.3 OFOC Page 6 of Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C242-26-AP-1013

Simaran Matharu Date Program Manager

WRIISC

East Orange VA Medical Center

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Mariangie Rivera Date Contracting Officer Stratton VA Medical Center

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Joseph Cellino NCO 2, Branch Chief, Services I

Buffalo VA Medical Center

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $90 million) or approve ($900K to $90 million) for other than full and open competition.

Gerald F. Jacobs