Single Source Justification MPT to SAT.pdf

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6550--Notice of Intent to Sole-Source T-SPOT. TB® Reagents and Kits
Solicitation number
36C24227Q0036
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This is a Single Source Justification document for a federal procurement conducted by the Department of Veterans Affairs, Network/Program Contracting Office 02 in support of the Buffalo VA Medical Center's Pathology and Laboratory Medicine department. The acquisition seeks FDA-approved T-SPOT.TB® tuberculosis testing kits and reagents, including T-SPOT.TB® kits, T-Cell Xtend® reagent, and AIM-V™ medium, to be procured through a Blanket Purchase Agreement (BPA) with a base year plus four option years (November 1, 2026 through October 31, 2031). The estimated contract amount is redacted in the document.

The justification establishes that Euroimmun Oxford Immunotec is the sole provider capable of supplying FDA-approved, OEM-authorized T-SPOT.TB® reagents due to proprietary patent authority. The document cites market research confirming no alternate vendors exist for these specific reagents, prior VA procurement history identifying only Euroimmun US Incorporated as the approved federal supplier, and prior BPA documentation confirming recurring demand and brand-specific need across VISN 2 sites. The contracting officer certifies the single source award is approved in accordance with RFO FAR 12.201-1 for acquisitions exceeding the micro-purchase threshold but not exceeding the simplified acquisition threshold. The certification was digitally signed by Myra Florisa N. Green, Contracting Officer, on October 2, 2026.

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VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT

Acquisition ID: 36C242-27-AP-0216

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW RFO FAR 12.201-1 For

Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID: 36C242-27-AP-0216

1. Contracting Activity: Department of Veterans Affairs, Network/Program

Contracting Office 02, located at 20 Madison Avenue Ext., Albany, NY 12203, in support of Pathology and Laboratory Medicine of VISN 2 VA Western New York Healthcare System – Buffalo VA Medical Center at 3495 Bailey Avenue, Buffalo, NY 14215.

2237#: 528-27-1-4307-0004

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

This procurement is for FDA‑approved T‑SPOT.TB® tuberculosis testing kits and reagents, including:

• T‑SPOT.TB® kits

• T‑Cell Xtend® reagent

• AIM‑V™ medium

These reagents are essential for performance of the proprietary IGRA test used for tuberculosis infection detection at Buffalo VAMC. A Blanket Purchase Agreement (BPA) with a abase plus 4 option years will be pursued with Euroimmun, the sole provider of T-SPOT.TB® reagents.

Base Year (11/01/2026 – 10/31/2027) Option Year 1 (11/01/2027 – 10/31/2028) Option Year 2 (11/01/2028 – 10/31/2029) Option Year 3 (11/01/2029 – 10/31/2030) Option Year 4 (11/01/2030 – 10/31/2031)

Estimated amount:

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT

Acquisition ID: 36C242-27-AP-0216

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

Euroimmun Oxford Immunotec is the sole supplier of FDA approved T-SPOT.TB® reagents, holding a patent with proprietary authority. The reagents are essential in performing T-SPOT.TB® testing for the government. T-SPOT.TB® is the most sensitive and specific testing for tuberculosis, and sisgnificantly reduces test turnaround time over competing test methods.

Euroimmun Oxford Immunotec is the only firm capable of providing the kits and reagents without the Veterans Health Administration experiencing substantial duplication of costs that could not be expected to be recovered through competition.

4. Description of market research conducted and results or statement why it was not conducted:

Market research showed:

• No alternate vendors capable of supplying FDA‑approved, OEM‑authorized T‑SPOT.TB® reagents

• Prior VA procurement history identifies only EUROIMMUN US INCORPORATED as the approved federal supplier

• Prior BPA documentation confirms recurring demand and brand‑specific need across VISN 2 sites

5. Contracting Officer's Certification: Purchase is approved in accordance with RFO

FAR 12.201-1. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name: Myra Florisa N. Green Date: 10/02/2026 Title: Contracting Officer

2026-10-02T15:53:55-0400
MYRA GREEN

File details come from the government source that posted it. Updated .