CPT clinical laboratory immunohistochemistry (IHC) and in-situ hybridization (ISH) analyzer with Reagents

This is a notice of intent to sole source a contract under the authority of RFO FAR 12.102, only one source being available to meet the Government’s need.  The contract is estimated for final completion by 03/31/2031.

The North American Industrial Classification System (NAICS) code for this procurement is 325413, In-Vitro Diagnostic Substance Manufacturing, with a small business size standard of 1,000 employees.  The FSC/PSC is 6550 – In-Vitro Diagnostic Substances, Reagents, Test Kits and Sets.

The Department of Veterans Affairs intends to solicit a firm fixed price contract, base with four (4) option periods, for  Cost-Per-Test (CPT) clinical laboratory immunohistochemistry (IHC) and in-situ hybridization (ISH) analyzer with reagents and supplies to Roche Diagnostics Corporation, 9115 HAGUE RD, INDIANAPOLIS, IN 46256-1025. There are no other sources that will satisfy agency requirements for the necessary equipment and services.

No other vendor is able to service the VASNHCS within the current space provided for automated IHC/ ISH slide staining system at this time. If this analyzer were not procured, there would be a cost associated with sending lab specimens outside the lab for testing if the RocheDiagnostics equipment were not put into place with a degradation of patient care due to the increased wait times for lab results.  Roche Diagnostics’ BenchMark ULTRA system is the only automated IHC/ ISH slide staining system that will fit in the footprint available in the current lab and is compatible with the configuration of the utilities as follows:

- IHC must fit on existing end cap within approximate dimensions of 44”Wx60”Hx33”D

- ISH stainer must attach to existing cover slip and be approximately 50”Wx25”Hx28”D

- Instruments must fit voltage requirements between 110-230V

Any responsible source that feels it is capable in performing this requirement may submit a quote for the listed items from the solicitation and describe and/or submit documentation to support your capabilities.  The response will be considered by the agency.  Responses should be submitted to Leah Smith at leah.smith@va.gov no later than Wednesday, February 18th, 2026, at 11:00 AM Pacific Time to be considered. The Government will not pay for information submitted. Any responses received will only be considered for the purposes of determining whether to conduct a competitive procurement in lieu of sole source contract described in this notice, and such determination shall be made at the sole discretion of the Government. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the requirement. If no responses are received, the government will proceed with the Sole Source acquisition.