6550--Notice of Intent to Sole Source - Polymedco iFOBT

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), on behalf of VISN 02 Medical Centers, intends to award a Firm Fixed Price (FFP), sole source action to:

Name of Contractor:

Polymedco Cancer Diagnostic Products, LLC

Street Address:

510 Furnance Dock Road

City, State, Zip:

Cortland Manor, NY 10567

VISN 2 medical centers have a recurring annual requirement for Polymedco OC-Auto® Fecal Immunochemical Test (FIT) kits to screen patients for colorectal cancer across the New York/New Jersey Healthcare Network. FDA approved FIT test kits are available through strategic sourcing priority, Federal Supply Schedule FSC Group 66 III, Clinical Analyzers, laboratory, Cost Per Test (CPT)

In accordance with FAR Part 8.405-6, it has been determined that only one source is reasonably available. Polymedco is the sole vendor that can supply tests compatible with the Polymedco analyzers currently in use in VISN 02 medical centers. Furthermore, Polymedco s OC-Auto FIT is the only test that meets the predictive value capability, automated analysis, and logistical specifications required for VISN 2 average risk colorectal cancer screening program:

capable of producing accurate and reproducible results on fecal specimens by established in vitro immunochemical diagnostic methods.

capable of specifically detecting human hemoglobin, thereby removing the need for dietary restrictions and the collection and testing of more than one sample.

a specimen transport system that is stable for a minimum of 14 days at ambient temperature for those specimens collected in the home setting

mailing system for specimen transport that meets the US Postal Service mailing requirements, including but not limited to specimen collection and labeling instructions, specimen transport tube/vial/card, and mailing envelope.

analyzers capable of providing printouts for all patient results, calibrators, and controls.

a design that supports the result integrity removing the possibility of sample carryover.

equipment that performs satisfactorily at any laboratory relative humidity between 15 and 85 percent and any laboratory temperature between 50- and 90-degrees Fahrenheit (10 to 30 degrees Celsius).

Analyzer equipment which includes 120-volt UPS that has a 2 3-hour back-up capability.

Compatible with multiple barcode formats including but not limited to: Code 39, Code 128, and Codabar or current VA standardized barcode that may be enabled concurrently.

System with ability to store and retransmit records (24 hours of maximum instrument throughput

Sufficient accuracy studies and validation methods to meet current standards defined by Clinical and Laboratory Standards Institute (CLSI).

Market research was conducted in accordance with FAR Part 10 and failed to produce additional sources capable of fulfilling this requirement.

In accordance with Federal Acquisition Regulations (FAR) 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 12:00 PM Eastern Standard Time on September 3, 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.