Pathology Reagents

The Department of the Army Medical Command at Madigan Army Medical Center is seeking sources for pathology reagents and automated instrumentation for bacterial pathogen detection through this pre-solicitation notice. The procurement involves providing reagents for use with MS Prime and Vitek systems, requiring four integrated components: a Mass Spec analyzer, an Automated ID and AST System, a Nucleic Acid Extraction System, and an Automated Blood and Body Fluid Specimen Incubation and Growth Detection System. Key requirements include FDA-approved reagents, walkaway functionality, continuous culture monitoring, nucleic acid extraction capabilities, mass spectrophotometry for culture identification, and biochemical analysis with complete patient sample traceability. The contractor must provide scheduled maintenance, hardware/software upgrades, emergency service within 24 hours, and ensure the system is validated and operational by September 30, 2025. Interested parties must submit responses via email to wanda.f.williams35.civ@health.mil with organization details, CAGE code, Unique Entity ID, and Original Equipment Manufacturer authorization letter, with responses due June 3, 2025.

This opportunity is classified under NAICS code 325413 for In-Vitro Diagnostic Substance Manufacturing with a small business size standard of 1,000 employees, and no set-aside designation is applied. The systems must demonstrate advanced capabilities including processing at least 100 specimens in an 8-hour shift, bi-directional interfacing with the MHS-Genesis laboratory information system, and maintaining precise technical specifications such as 37-degree Celsius incubation temperature for continuous monitoring. The procurement encompasses comprehensive diagnostic functionality for identifying clinically relevant organisms, performing antimicrobial susceptibility testing, and applying Clinical Laboratory Standards Institute guidelines with standard software rules for resistance reporting. The Nucleic Acid Extraction System must be approved for CDC Emergency Use Authorizations, and all systems must meet quality control requirements consistent with accrediting body standards. The government reserves discretion on whether to compete the requirement or issue a full solicitation based on the sources sought responses, with businesses of all sizes encouraged to participate in this market research effort.