P03 - JOFOC Biostatistician FINAL.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C248-26-AP-3613

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C248-26-AP-3613

1. Contracting Activity: Department of Veterans Affairs, VISN 08, James A. Haley Veterans Hospital (JAHVH), 13000 Bruce B. Downs Blvd., Tampa, FL 33612. Facility Supported Research Department, 2237#673-26-3-042-0117.

2. Nature and/or Description of the Action Being Approved: This Justification and Approval is for the procurement of proprietary biostatistician research assistance for JAHVH, Tampa, FL. The requirement is for the University of South Florida to provide research support under NAICS Code 541990 (All Other Professional, Scientific, and Technical Services). This is a new requirement.

Estimated contract value: $1,061,827.16.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: USF will provide the specialized research support JAHVH requires to strengthen its research culture, attract and retain clinicians, and expand access to innovative treatments. Through a firm-fixed-price contract, USF will supply biostatisticians and data analysts to perform essential statistical modeling; lab technicians and research assistants to support hands-on experimental work;

epidemiologists and health economists to advance population-level and economic studies; and clinical trials managers to ensure regulatory compliance and efficient protocol execution.

Project managers will coordinate cross-service-line research activities and help novice investigators develop competitive grant proposals. Together, these roles fill critical methodological gaps at JAHVH, enabling timely analyses, high-quality research execution, and greater competitiveness for grants and awards. Period-of-performance is:

Period of Performance Amount Base Year: 08/28/2026 through 08/27/2027 $200,000.00 Option Year 1: 08/28/2027 through 08/27/2028 $206,000.00 Option Year 2: 08/28/2028 through 08/27/2029 $212,180.00 Option Year 3: 08/28/2029 through 08/27/2030 $218,545.40 Option Year 4: 08/28/2030 through 08/27/2031 $225,101.76

Total: $1,061,827.16

No alternate sources exist that can deliver equivalent content, accreditation, or expertise.

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

(X) (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;

Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C248-26-AP-3613

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

( ) (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): Market research confirms that the University of South Florida (USF) is the only institution capable of delivering the research support services required by the James A. Haley Veterans’ Hospital (JAHVH). The unique qualifications are the legally established affiliation under 38 U.S.C. § 7302 and VA Directive 1663, along with the integrated research structure in which JAHVH principal investigators hold concurrent USF faculty appointments, rely on USF’s IRB and COI oversight systems, and operate within shared laboratories, physical space, and jointly maintained research information systems.

This integration is essential for fulfilling JAHVH’s mission, particularly its mandated mentoring and career-development pipeline. Career Development Award recipients and new VA investigators depend on USF faculty with dual appointments for mentorship in grant development, regulatory navigation, and methodological training. These relationships and systems cannot be replicated by an unaffiliated institution without disrupting ongoing research, delaying active CDA projects, and jeopardizing career progression for early-stage investigators.

Replacing USF would require creating a new affiliation agreement, re-credentialing all dual-status investigators, transferring or re-reviewing all active research protocols under a new IRB, renegotiating data use agreements, and rebuilding both physical and digital research infrastructure. No other institution possesses an equivalent affiliation or integrated research environment with JAHVH. Therefore, only USF can meet the agency’s requirements without unacceptable delay, increased cost, or harm to research continuity, making it the only responsible source under 41 U.S.C. § 3304(a)(1).

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): A Special Notice of Intent to Sole Source was posted on SAM.gov on 06/24/2026 and closed on 07/01/2026. No responses were received from any vendor able to provide these services. The VetCert database was searched for SDVOSBs/VOSBs; none were found capable. All reasonable efforts to identify alternate sources were made, including review of catalogs, industry standards, and consultation with experts.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Independent Government Cost Estimate (IGCE) indicates that the contractor’s proposed price of $1,061,827.16 falls within the expected range for the required effort and cost.

Market research also identified a comparable prior VA contract, VA24117J1697, valued at

Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C248-26-AP-3613

$975,000.00 across its base and four option years for similar biostatistical and research support services. Compared to that award, the current proposed amount reflects only a 3% increase, which remains below the national inflation rate of 3.5% for the corresponding period. This supports the conclusion that the contractor’s proposed price is fair, reasonable, and consistent with historical federal pricing trends for comparable work.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted in accordance with FAR Part 10 and VAAR 810.001-70. The SBA Small Business database was searched for SDVOSBs/VOSBs;

none were found capable. The University of South Florida is the only proprietary provider. No alternate sources exist.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The curriculum is proprietary to the University of South Florida. No other vendors possess the necessary accreditation or expertise. Requirements suitable for full and open competition are not available.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No sources other than the University of South Florida expressed interest in writing or responded to the Special Notice of Intent to Sole Source.

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: No actions are planned at this time, as the curriculum is proprietary. If alternate sources become available in the future, the VA will conduct additional market research and consider competitive acquisition.

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.

Lorraine Acosta-Rivera Date Budget Analyst Tampa VAMC

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.

J’Vonne Wilson Date Contracting Officer NCO 8 - Tampa Services/Commodities Team

Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C248-26-AP-3613

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.

Jose Ortiz-Velez Date Senior Contracting Officer NCO 8 - Tampa Services/Commodities Team

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.

Date Brent Goe Acting Executive Director, Regional Procurement Office East