NAME BRAND JUSTIFICATION .pdf

BRAND NAME JUSTIFICATION

FAR PART 13 SIMPLIFIED ACQUISITION PROCEDURES

PROCUREMENT REQUEST 629-20-1-043-0008

In accordance with Federal Acquisition Regulation (FAR) 11.105(a)(1), the particular brand name, product, or feature is essential to the Government’s requirements, and 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

For brand name acquisitions of commercial items in excess of the simplified acquisition threshold conducted pursuant to FAR subpart 13.5 (13.501(a)). Justification for other than full and open competition under the authority of section 4202 of the Clinger-Cohen Act of 1996 or the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

Department of Veterans Affairs, VISN 16, New Orleans VA Medical Center

NCO 16 DIV II CONSTRUCTION B – 502

New Orleans VAMC Pathology & Lab Medicine Service requires a firm fixed-price long term contract for Oxford T-Spot TB testing services.

T-Spot testing services with estimated quantity of 1500 tests per year @ estimated cost o /test for a total estimated contract value of over a period of 5 years

Oxford Immunotec’s T-Spot TB testing is required by NOLA VAMC P&LMS to accurately detect tuberculosis in patients. T-Spot TB Test is a single visit blood test also known as Interferon-Gamma Release Assay (IGRA) for TB infection. The Centers for Disease Control (CDC) recommend that IGRAs be used in all situations where the tuberculin skin test (TST) is currently used. This is the only FDA approved IGRA that uses Elispot technology to reduce the risk of false negative and invalid test results. Prior to using T-Spot testing, NOLA P&LMS was experiencing invalid results to include a large volume of false-positives and indeterminate results. This test is the only TB screening test with sensitivity and specificity exceeding 95% in FDA pivotal trials. P&LMS depend on simple, accurate screening for staff, patients, and others for this important transmissible disease. Use of the T-SPOT TB test prevents the limitations of the previously used Tuberculin Skin Test, such as false positive test results and poor reliability in immunocompromised patients at New Orleans VAMC.

The solicitation for the T-Spot TB testing services is being issued on the open market on an unrestricted basis and, therefore, competition is expected. Market research has identified at least two vendors, Quest Diagnostics, Inc. (Large Business) and NEO Services, LLC (SDVOSB), who are apparently capable of providing the required testing as per the draft PWS.

These vendors have indicated they are interested in providing the service required by NOLA

VAMC P&LMS.

It is in the best interest of the government to post an unrestricted solicitation on Contract Opportunities to allow all capable vendors an opportunity to respond and be considered for award, thereby increasing competition in an effort to provide the government with fair and reasonable pricing on a long-term contract for T-Spot TB testing required at New Orleans

VAMC.

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

NEO Services, LLC.

MCI Diagnostic Center, LLC.

Quest Diagnostics, Inc.

In an effort to mitigate barriers to competition, the government will conduct market research for future requirements for TB testing to determine any other TB testing methods which would meet or exceed the current validity rate of the Oxford Immunotec T-Spot tests.

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.

Approval of the Brand Name Justification:

Contract Specialist Date

Contracting Officer Date (Proposed contract not exceeding $550,000)

FELICIA LOVELADY 618668

Digitally signed by FELICIA LOVELADY 618668 Date: 2020.04.09 09:10:13 -05'00'

Benjamin J. Dufour 987184

Digitally signed by Benjamin J.

Dufour 987184 Date: 2020.04.09 10:47:12 -05'00'