TBI Registry Sole Source Justification- To be posted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

(Using Simplified Procedures in FAR subpart 13.5 in accordance with 41 U.S.C.1901)

1. Contracting Activity: This Justification and Approval (J&A) for Other than Full and Open Competition is executed on behalf of the Department of Veterans Affairs (VA), Veterans Affairs Veterans Health Administration (VHA) by the Strategic Acquisition Center- Frederick, 5202 Presidents Court, Suite 103, Frederick, MD 21703.

2. Description of Action: The Contracting Officer proposes a sole-source, firm-fixed price contract with Craig Hospital for support to the Traumatic Brain Injury (TBI) Veterans Health Registry on Post-9/11 Veterans and the VA Polytrauma Rehabilitation Center (PRC) / Traumatic Brain Injury Model Systems (TBIMS) longitudinal research database. VA has an expiring contract with Craig Hospital to support these projects at the National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR) TBIMS National Data and Statistical Center (NDSC). A new contract is required to continue to meet the requirements of Public Law 110-181, upon expiration of the current contract on September 29, 2021.

3. Description of Services: At the direction of Congress, VA, with contractor support, maintains the TBI Veterans Health Registry that includes information about Veterans who served in Operation Enduring Freedom (OEF) or Operation Iraqi Freedom (OIF), who exhibit symptoms associated with TBI, and who seek care or benefits from VA.

VA is required by Public Law 110-181—JAN 28, 2008 122 SEC. 1704 to collaborate with facilities that receive NIDILRR grants and conduct research on rehabilitation for individuals with TBI. In addition to the Registry support above, the contractor will support VA’s required collaboration with NIDILRR funded TBIMS centers through the development and support for the VA PRC/TBIMS longitudinal research database.

The estimated period of performance is five years (base + four options) and the total value of the acquisition is $3,331,523.00.

4. Statutory Authority: The statutory authority permitting sole source acquisitions is FAR 13.501(a), Sole source acquisitions. In accordance with FAR Subsection 13.106-1(b)(2), for purchases exceeding the simplified acquisition threshold, the requirements at FAR Subsection 13.501(a) apply to sole-source acquisitions of commercial items conducted pursuant to Subpart 13.5.

5. Demonstration of Contractor’s Unique Qualifications: Public Law 110-181 requires VA to collaborate with facilities that receive NIDILRR grants. Craig Hospital was awarded the new NIDILRR grant on September 1, 2021. Besides being the grantee and therefore meeting the requirements of the PL, Craig Hospital has developed extensive expertise in the area through direct support to the VA PRC- TBIMS centers since 2009. Craig Hospital is uniquely qualified to provide high quality research data, expert consultative services regarding research data variables, knowledge translation, committee participation, and preparation and presentation of brochures, presentations and reports.

Craig Hospital is the only NIDILRR grantee and the only institution that brings the following critical elements to the collaboration between VA and NIDILRR required to fulfill and support the VA TBI Veterans Health Registry and the VA PRC TBIMS database as required by the PL since 2008. Craig Hospital represents:

• The only NIDILRR grantee charged with responsibility for managing the TBIMS National Database.

• The only NIDILRR grantee charged with responsibility for collaborating the VA on the VH TBI Veterans Health Registry and VA PRC TBIMS database.

• The only NIDILRR grantee to have access to and analysis of large TBI datasets, bringing to bear extensive statistical and methodological expertise; utilizing state- of-the-art analytic approaches;

and applying their extensive TBI expertise to guide the research process and to interpret the findings; and,

• Staff that served as national leaders in the International TBI Common Data Elements (CDE) initiative. Craig Hospital’s TBIMS staff were key figures in all phases of the CDE development effort.

In summary, Public Law 110-181 requires the Secretary of VA to maintain a registry and collaborate with facilities that receive grants from NIDILRR. Craig Hospital was a previous TBIMS NDSC grantee, and on September 1, 2021, was awarded a new 60-month grant. While being a grantee makes it statutorily eligible for a contract, as demonstrated above, Craig Hospital is also uniquely qualified from a technical standpoint.

6. Description of Efforts to Obtain Competition: The TBIMS NDSC grant is awarded every five years through the competitive grant application process. On September 01, 2021, Craig Hospital was awarded the TBIMS NDSC grant for the next five years. The public law specifically directs VA to contract with NIDILRR grant holders-- facilities that conduct research on rehabilitation for individuals with TBI.

Therefore, no additional competition was sought.

7. Determination of Fair and Reasonable Prices:

The Contracting Officer will determine prices to be fair and reasonable prior to award. Historical pricing is readily available as a benchmark for comparison.

8. Market Research: Market Research was not conducted because of public law which specifically directs VA to collaborate with NIDILRR grant holders--facilities that conduct research on rehabilitation for individuals with TBI.

9. Other Facts supporting the use of other than full and open competition: In addition to supporting the requirements of Public Law 110-181, this contract supports Presidential Executive Order (Improving Access to Mental Health Services for Veterans, Service Members, and Military Families) signed August 31, 2012 directing the Departments of Defense (DoD), VA, DHHS, and DOE to develop a National Research Action Plan (NRAP [August 2013]) on posttraumatic stress disorder (PTSD), other mental health conditions, and TBI “to improve the coordination of agency research into these conditions and reduce the number of affected men and women through better prevention, diagnosis, and treatment.”

10. Signatures:

Technical and Requirements Certification: Pursuant to FAR Subsection and FAR Section 13.501(a)(2)(ii), I certify that any supporting data that is my responsibility and which forms a basis for the justification is complete and accurate to the best of my knowledge and belief.

Douglas Bidelspach Date Program Manager Physical Therapy - VHA

Contracting Officer’s Approval: Pursuant to FAR Subsection and FAR Section 13.501(a)(2)(ii), I certify that this justification is accurate and complete to the best of my knowledge and belief and approval is thus provided.

Jacky Jean-Jacques, Contracting Officer Date

Strategic Acquisition Center- Frederick

Competition Advocate Review and Approval ($750K to $15 million): The Agency Competition

Advocate (see VAAR Subpart 806.5) signature below meets the justification approving authority requirements in accordance with VAAR Subpart 806.3 - Other Than Full and Open Competition, and FAR Section 13.501(a)(2)(ii). Proposed contract amount is over $750,000 but not exceeding $15 million.

Efrain J. Fernandez Date

Competition Advocate Strategic Acquisition Center- Frederick