SAM #36C24226Q0960

Sole Source QuantiFERON TB Gold Test Kits for VA VISN2 Medical Centers

This notice announces the VA's intent to award a sole source contract for QuantiFERON TB Gold testing kits to Qiagen LLC for VISN2 South Medical Centers. - Sole source Firm Fixed Price contract to Qiagen LLC - Product: QuantiFERON TB Gold test kits (FDA-approved IVD cell mediated immunity (IGRA) tests) - Used for detecting Mycobacterium infections via chemiluminescence immunoassay (CLIA) - Compatible with LIAISON analyzers already in use at VA facilities - Qiagen LLC is the only manufacturer and distributor able to meet compatibility and quality requirements - No other sources or products found suitable; market research confirmed sole capability - Gray market items are prohibited; all products must be sourced through OEM's intended channels - No subcontracting opportunities available - Not a request for quotes, but capability statements may be considered - Commercial opportunity for FDA-approved IGRA test kits compatible with LIAISON analyzers

Description

This is a notice of intent to award a sole source contract and is not a request for quotes. The Department of Veterans Affairs (DVA) Network Contracting Office NCO2, on behalf of VISN2 South Medical Centers, intends to award a Firm Fixed Price (FFP), sole source action to: Name of Contractor: QIAGEN LLC Street Address: 19300 Germantown Road City, State, Zip: Germantown, MD 20874-1415

VISN02 medical centers have a recurring requirement for US Food & Drug Administration (FDA) approved In Vitro Diagnostic (IVD), cell mediated immunity (IGRA) tests for detecting Mycobacterium infections using chemiluminescence immunoassay (CLIA) on LIAISON analyzers. Market research was conducted in accordance with FAR Part 10, reviewing the offerings and capabilities available through the current marketplace. In accordance with the Revolutionary FAR Overhaul (RFO) Part 6.103-1, it has been determined that only one source is reasonably available, QIAGEN LLC. QIAGEN is the manufacturer and sole distributor of the QuantiFERON TB Gold testing. QuantiFERON is the only test capable of meeting the salient characteristics of the requirement and providing the necessary compatibility with the Department of Veterans Affairs existing LIAISON analyzers. Market research failed to produce additional sources capable of fulfilling this requirement as a whole; No subcontracting opportunities are available for this requirement. In accordance with the Revolutionary FAR Overhaul (RFO) this notice of intent to sole source with justification to limit sources, satisfies the public posting requirements. Veterans Health Administration prohibits the use of gray market items in their Medical Centers. Gray market items are considered to be items outside of the original equipment manufacturer s intended distribution channels. This notice is not a request for quotes; however, all responsible sources may submit a capability statement which shall be considered by the Government. All capability statements must be received by no later than 10:00 AM Eastern Standard Time on September 15, 2025. Responses to be submitted to Lindsay Goldsmith, Contracting Officer at lindsay.goldsmith@va.gov. A determination by the Government not to compete this proposed contract based on responses to this notice is solely within the discretion of the Government.

View original listing