Integrated Immunoassay and Chemistry Analyzer Reagents and Consumables
ID: W81K0026QA042Type: Sources Sought
Overview

Buyer

DEPT OF DEFENSEDEPT OF THE ARMYW40M MRC0 WESTJBSA FT SAM HOUSTON, TX, 78234-4504, USA

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

PSC

IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS (6550)

Original Source

https://sam.gov/workspace/contract/opp/1a2f3d784e9f425da4da4a8cb87666da/view
Timeline
    Description

    The Department of Defense, specifically the Department of the Army, is seeking sources for Integrated Immunoassay and Chemistry Analyzer Reagents and Consumables for the Lyster Army Health Clinic located in Fort Rucker, Alabama. The procurement aims to acquire a comprehensive chemistry and immunochemistry system that meets stringent technical, operational, and service requirements, including FDA approval, CLIA and CLSI precision standards, and 24/7 technical support. This equipment is critical for performing a wide range of diagnostic tests, ensuring compliance with security regulations, and maintaining high standards of patient care. Interested parties must submit a Statement of Capability by November 18, 2025, and should contact MEDCOM at karan.e.quiles.civ@health.mil for further information.

    Point(s) of Contact
    MEDCOM
    karan.e.quiles.civ@health.mil
    Files
    Title
    Posted
    Draft Statement of Work.docx
    This Statement of Work outlines the requirements for providing Lyster Army Health Clinic (LAHC) with an Integrated Immunoassay and Chemistry Analyzer, including equipment, reagents, consumables, and services, under a Cost Per Reportable Results (CPRR) arrangement. The contractor must deliver and install the analyzer by March 1, 2026, provide comprehensive training, and ensure continuous operational support, including 24/7 technical assistance with a maximum 1-hour callback time and 24-hour on-site service. The analyzer must perform a wide range of tests and meet specific physical and cybersecurity requirements, including obtaining a government-approved Authorized to Operate (ATO). The document also details compliance with security regulations, government holidays, invoicing procedures, tobacco-free campus policies, exclusion from federal healthcare programs, and stringent requirements for handling Personally Identifiable Information (PII) and Protected Health Information (PHI) under the Privacy Act, FOIA, and HIPAA, including breach response protocols.
    Salient Characteristics- Chemistry analyzer.docx
    This document outlines the salient characteristics for a Chemistry Analyzer, detailing technical, implementation, operational, and service requirements. Technically, the instrumentation must meet CLIA and CLSI precision standards and be FDA-approved. Implementation requires availability at proposal submission, installation NLT 30 days before contract initiation, and completion of validation and on-site user training before initiation. Operationally, it must be a random access chemistry and immunochemistry system capable of performing a comprehensive list of assays, including specimen integrity checks, flagging for various sample issues, onboard dilution, and robust reagent and QC management. It must use 115VAC power with a UPS, include a water purifier if wet, fit specific dimensions, and have keyboard/barcode ID capabilities. Compatibility with DoD MHS Genesis and minimal technician intervention are also required. Service and support mandates 24x7x365 technical hotline support with a one-hour callback, on-site repair within 24 hours by factory-trained FSEs, scheduled preventative maintenance, and written reports for all service and PM visits.
    Sources Sought Notice.docx
    The Medical Readiness Contracting Office-West, Fort Hood, TX, issued a Sources Sought Notice for an upcoming requirement for Integrated Immunoassay and Chemistry Analyzers, reagents, and consumables for Lyster Army Health Clinic, Fort Rucker, Alabama. This is a market survey for preliminary planning only, not a solicitation for proposals. The government anticipates a Firm Fixed-Priced contract, with the successful offeror providing all equipment, reagents, consumables, controls, and maintenance on a Cost Per Reportable basis. The purpose of this notice is to gauge interest, capabilities, and qualifications of both small (including 8(a), HUB-Zone, Women-Owned, and Service-Disabled Veteran-Owned) and large businesses. The NAICS code is 325413, "In-Vitro Diagnostic Substance Manufacturing," with a small business size standard of 1,250 employees. Interested parties must submit a Statement of Capability by November 18, 2025, detailing their ability to provide the requested products, including specific reagents, FDA compliance, adherence to performance work statements, and capability to perform a contract of this magnitude. All businesses must be registered in SAM.gov.
    Lifecycle
    Title
    Type
    Integrated Immunoassay and Chemistry Analyzer Reagents and Consumables
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