JA_TBI_Sole_Source_Craig Hospital Final_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

Enterprise Procurement Office 5202 Presidents Ct, Suite 103

Frederick, MD 21703

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

(1) Identification of the agency and the contracting activity, and specific identification of the document as a “Justification for Other Than Full and Open Competition.”

This Justification and Approval (J&A) is executed by the Department of Veterans Affairs (VA), Office of Procurement, Acquisition and Logistics (OPAL), Enterprise Procurement Office (EPO), 5202 Presidents Court, Suite 103, Frederick, MD 21703, on behalf of the Veterans Health Administration (VHA), Physical Medicine and Rehabilitation Program Office.

(2) Nature and/or description of the action being approved.

Approval is requested to negotiate and award a Firm-Fixed-Price commercial services contract to Craig Hospital, Englewood, Colorado, for continued support of the VA Traumatic Brain Injury (TBI) Veterans Health Registry and the VA Polytrauma Rehabilitation Center (PRC)/TBI Model Systems (TBIMS) Longitudinal Research Database. The follow-on contract is required when contract 36C10X21C0074 expires September 29, 2026.

(3) A description of the supplies or services required to meet the agency’s needs, including the estimated value.

The contractor shall provide program management; secure administration of both databases; longitudinal-data processing, validation, quality assurance, and governance; advanced statistical and epidemiological consultation; technical assistance to VA PRCs; recurring and ad hoc reporting; research-methodology support; knowledge translation; database modernization; and harmonization of VA data with the national TBIMS database.

These services support Public Law 110-181, section 1704, which directs VA to conduct TBI research;

improve diagnosis, rehabilitation, and treatment; educate VA personnel; develop improved models of care; maintain the TBI Veterans Health Registry; and collaborate with federally funded TBI rehabilitation-research facilities. The anticipated contract has one 12-month base period and four 12-month options.

The estimated base value is $634,344.00 and the total estimated value, including all options, is $3,371,237.00.

(4) Identification of the statutory authority permitting other than full and open competition.

The authority is 41 U.S.C. § 3304(a)(1), as implemented by FAR 6.302-1(a)(2) and applied in accordance with FAR 6.302-1(b)(1)(i), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

(5) A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The requirement is not routine database or information-technology support. It is uninterrupted operation of a mature, Congressionally mandated rehabilitation-research collaboration that must preserve interoperability with the national TBIMS program, longitudinal-data integrity, standardized methodology, and continuity of research and reporting developed over more than fifteen years.

In 2008, the Department of Veterans Affairs partnered with the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) to establish a VA-specific longitudinal multicenter study that examines the course of recovery and outcomes following inpatient rehabilitation for traumatic brain injury (TBI) within the 5 VA Polytrauma Rehabilitation Centers (PRCs). This lifetime study follows the enrolled cohort longitudinally with follow-up at years 1, 2, 5, and every subsequent 5 years post-injury. Multiple projects and studies are linked to the larger longitudinal research effort with over VA 2,800 enrollees and follow-ups currently extending beyond 25 years post injury.

The VA database parallels the legacy civilian hospital–based Traumatic Brain Injury Model Systems National Database project launched in 1987. The NIDILRR funded TBIMS project is the world's largest prospective, longitudinal research program tracking long-term recovery and outcomes for people with traumatic brain injuries, collecting data from 16 model system programs on over 21,000 participants with follow up data extending past 30 years post injury.

VA’s alignment with the NIDILRR funded TBIMS supports consistency in project syllabi and operations, knowledge translation, and fosters partnered research between the VA and NIDILRR funded research teams. The VA PRC-TBIMS project currently has 30 active projects and has produced over 100 publications and presentations at professional conferences. Common research areas focus on functional recovery, community reintegration, vocational status, and general health and wellness to include analyses on pain, mental health, and long-term care utilization.

Craig Hospital is the current TBIMS National Data and Statistical Center (NDSC), funded by the National Institute on Disability, Independent Living, and Rehabilitation Research. It maintains the national TBIMS database and provides centralized data coordination, statistical methodology, quality assurance, research support, and technical leadership. Craig Hospital has supported VA’s TBIMS collaboration since 2008 and maintains the VA-to-national data harmonization, database architecture, validated controls, secure workflows, procedures, and institutional knowledge required for immediate performance.

No other source demonstrated the NDSC stewardship, VA-specific knowledge, national-infrastructure responsibility, existing secure access, or ability to assume the complete requirement by the required start date. For a new source, transition would require recreating the VA-to-national-TBIMS data mappings and harmonized structures; transferring and validating historical longitudinal data, analytical methods, and quality-control rules; obtaining personnel and system authorizations; rebuilding operating procedures; and reestablishing coordination with the five VA PRCs and national TBIMS research partners. Until those activities were completed and validated, VA would face a material risk of interrupted registry processing, inconsistent longitudinal data, delayed statistical analyses and reports, and loss of reliable national benchmarking.

The Government would also incur duplicated costs to reconstruct mappings, procedures, access, documentation, and validation work that already exists along with additional Government technical oversight and testing before the replacement environment could be relied upon. Craig Hospital is therefore the only responsible source demonstrated to be capable of meeting VA's complete minimum requirement within the required schedule.

(6) A description of efforts made to ensure that offers are solicited from as many potential sources as practicable, including applicable notice requirements.

VA conducted market research consistent with FAR Parts 5 and 10, including reviews of SAM.gov, the SBA Veteran Small Business Certification Database, GSA eLibrary, historical acquisition and performance information, and the draft PWS; consultation with the Program Office and technical subject-matter experts; and publication of Sources Sought Notice RFI-2026-03-018-01 on SAM.gov on March 18, 2026, with responses due April 1, 2026.

Four substantive responses were received: Craig Hospital; KBR Wyle Services, LLC (KBR); Virginia Institute of Neuropsychiatry (VIN); and Vizlesan, Inc. VA evaluated each against the same PWS-based criteria and conducted a focused technical exchange with KBR on April 20, 2026. Craig Hospital’s response demonstrated the capability to satisfy the complete requirement. VIN proposed only a limited subcontractor role. Although Vizlesan’s response contained sufficient information for the Government to assess its capabilities, Vizlesan did not demonstrate the ability to satisfy the Government’s complete requirement within the required timeframe and without unacceptable transition and performance risk. VA will comply with all applicable synopsis and posting requirements, including FAR 6.305, following approval and award.

(7) A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

Before award, the Contracting Officer will determine the price fair and reasonable using price analysis under FAR 15.404-1(b), including comparison with historical prices, the independent Government estimate, relevant market benchmarks, applicable labor rates, and other data as necessary. Award will not be made until the proposed price is determined fair and reasonable.

(8) A description of the market research conducted and the results.

Market research did not identify two independent, capable small-business sources; therefore, the Rule of Two was not satisfied. A GSA eLibrary exact-phrase search for “traumatic brain injury model systems” returned no matches. SBA searches produced profile leads, but the profiles did not establish capability to perform the integrated national-TBIMS/VA requirement.

• Craig Hospital demonstrated the complete capability as the current TBIMS NDSC, including national infrastructure, VA-specific operations, harmonization, validated controls, a secure research environment, and continuity.

• KBR demonstrated Federal health-research and analytics experience but not the NDSC role, national- TBIMS stewardship, or ability to assume the full VA requirement without material transition and validation risk.

• VIN proposed a limited subcontractor role and did not represent that it could perform the complete requirement as prime contractor.

• Vizlesan demonstrated health-data and analytics experience but not the NDSC role, national-dataset stewardship, mature VA environment, or continuity without substantial transition and validation risk.

Only Craig Hospital demonstrated the existing national-TBIMS responsibility, harmonized VA data environment, secure access, approved procedures, and research relationships needed to begin the complete requirement without transition delay. KBR and Vizlesan demonstrated broader health-data capabilities but did not demonstrate the NDSC role, control or maintenance of the national TBIMS database, existing VA/TBIMS harmonization, or established VA operating environment; VIN sought only a limited subcontractor role. Award to another source would therefore require the Government to fund the reconstruction of existing data mappings, procedures, system access, documentation, and research coordination, followed by validation and quality-assurance testing before operational use. These efforts would duplicate established work and could interrupt registry processing, longitudinal database administration, statistical support, data-quality monitoring, national benchmarking, and required reporting after the incumbent contract expires.

(9) Any other facts supporting the use of other than full and open competition.

The current contract expires September 29, 2026, and the follow-on work must begin immediately to avoid a lapse in service. A new vendor would first have to recreate VA-to-national-TBIMS mappings and harmonized data structures; transfer and validate historical longitudinal data, analytical methods, and quality-control rules; obtain required personnel and system authorizations; rebuild operating procedures and secure workflows; and reestablish working relationships with the five VA PRCs and national TBIMS research partners. Any failure or delay in any of these activities could cause incomplete or inconsistent longitudinal data, interrupt registry and database operations, delay statistical analyses and required reports, impair national benchmarking, and reduce the reliability of information used for program oversight and evidence-informed TBI rehabilitation decisions. Associated duplicated costs consist of paying to reconstruct existing mappings, procedures, access, documentation, and research coordination and to repeat validation and quality-assurance testing, together with the additional Government oversight needed before a replacement environment could be accepted for operational use. Market research did not identify another source that had already completed these prerequisites or could complete them within the required schedule without these performance and cost risks.

(10) A listing of the sources, if any, that expressed in writing an interest in the acquisition.

Craig Hospital; KBR Wyle Services, LLC; Virginia Institute of Neuropsychiatry; and Vizlesan, Inc.

responded to RFI-2026-03-018-01. Their capabilities and the Government’s conclusions are summarized in Section 8.

(11) Actions the agency may take to remove or overcome barriers to competition before any subsequent acquisition.

Before any subsequent acquisition, VA will conduct new FAR Part 10 market research and reassess whether competition is practicable. VA will monitor marketplace and NIDILRR award changes; publish a new sources-sought notice as appropriate; review SAM.gov, SBA veteran-certification records, GSA eLibrary, and other vehicles; consult technical experts; evaluate emerging rehabilitation-research organizations; and assess technological or acquisition approaches that could reduce transition barriers or permit additional responsible sources to compete.

(12) Certification by technical or requirements personnel that supporting data under their cognizance are accurate and complete.

I certify that the supporting data under my cognizance, which form a basis for this justification, are accurate and complete to the best of my knowledge and belief.

(13) Contracting Officer certification that the justification is accurate and complete.

I certify that this justification is accurate and complete to the best of my knowledge and belief. Because the total estimated value is $3,371,237.00, approval by the procuring activity Competition Advocate is required under FAR 6.304(a)(2).

For proposed contracts over $900,000 but not exceeding $20 million

Approval

In my role as the procuring activity Competition Advocate, and based on the foregoing justification, I approve this acquisition on an “other than full and open competition” basis pursuant to 41 U.S.C. § 3304(a)(1), as implemented by FAR 6.302-1(b)(1)(i). The estimated value of $3,371,237.00 exceeds $900,000 but does not exceed $20 million; therefore, this approval satisfies FAR 6.304(a)(2).