AMENDMENT Solicitation 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)
Timeline
    Description

    The Department of Defense, specifically the Department of the Army, is seeking proposals from Women-Owned Small Businesses (WOSB) for the procurement of an Integrated Immunoassay and Chemistry Analyzer, along with associated reagents and consumables, for the Lyster Army Health Clinic located in Fort Rucker, Alabama. The contract will be based on a Cost-Per-Reportable-Result pricing model and will include various assay types, such as Hemoglobin A1C and Alanine Aminotransferase, while ensuring compatibility with the DoD laboratory information system, MHS Genesis. This procurement is crucial for enhancing the clinic's diagnostic capabilities and ensuring timely medical services for military personnel. Interested vendors must submit their proposals by January 16, 2026, at 2:00 p.m. CST, and direct any inquiries to the primary contact, Karan E. Quiles, at karan.e.quiles.civ@health.mil, or the secondary contact, Fredicinda D. Jones, at fredicinda.d.jones.civ@health.mil.

    Point(s) of Contact
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    Title
    Posted
    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.
    The Defense Health Agency (DHA) Cyber Logistics Cybersecurity/Risk Management Framework (RMF) Requirements document outlines the cybersecurity obligations for vendors providing equipment, products, and software to the DHA. Vendors must comply with various regulations and guidance, including NIST, FIPS, and DoD instructions, and ensure their systems meet stringent security standards throughout their lifecycle. Key requirements include continuous patching and updates, vulnerability mitigation, and maintaining an Authority to Operate (ATO) or Approved Product List (APL) approval. Pricing for cybersecurity, including initial ATO costs and ongoing maintenance, must be included in vendor offers. Systems must pass pre-validation technical screenings for vulnerabilities and adhere to strict timelines for RMF assessments and documentation. Additionally, vendors requiring privileged access to government networks must meet specific training, certification, and background investigation requirements. The document emphasizes continuous monitoring, incident reporting, and the ability to support IPv6, ensuring the confidentiality, integrity, and availability of government data.
    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.
    This government solicitation, W81K0026QA048, is for a Women-Owned Small Business (WOSB) to provide an integrated immunoassay and chemistry analyzer system, along with associated reagents and consumables, for Lyster Army Health Clinic, Fort Rucker, AL. The requirement is based on a Cost-Per-Reportable-Result pricing arrangement and includes several assay types such as Hemoglobin A1C, Alanine Aminotransferase, Albumin, and various other chemistry and immunoassay tests. The solicitation outlines technical features, implementation requirements, operational features (including compatibility with the DoD laboratory information system MHS Genesis), and instrument service/technical support capabilities with 24/7 hotline support and 24-hour on-site repair. The contract includes initial requirements for FY26 funding and multiple option line items for subsequent fiscal years (FY27).
    The document is an amendment to Solicitation Number W81K0026QA048, dated December 16, 2025, issued by the MEDICAL READINESS CONTR OFFICE WEST. This amendment, identified as W81K0026QA0480001, was issued on December 18, 2025. Its primary purpose is to update the solicitation document by removing a "Draft" watermark and loading the revised version as a separate document into the Government Point of Entry-SAM. Additionally, the requirements text has been modified to specify the procurement of an "Integrated Immunoassay and Chemistry Analyzer (leased) Reagents, and Consumables" for Lyster Army Health Clinic, Fort Rucker, Alabama. The amendment extends the offer receipt date, and offers must acknowledge its receipt to avoid rejection. This modification ensures clarity and updates the scope of the solicitation.
    The solicitation W81K0026QA048 from Lyster Army Health Clinic, Fort Rucker, AL, seeks proposals for a leased Integrated Immunoassay and Chemistry Analyzer, along with necessary reagents and consumables. Vendors must submit complete pricing for all listed items on the SF1449, as this is an "all or none" solicitation. Adherence to special instructions in the 52.212-1 ADDENDUM is mandatory for consideration. Proposals must include the company's CAGE Code, name, and address in block 17a, and be signed and dated in blocks 30 a, b, and c. Completed solicitations are due via email by January 16, 2026, at 2:00 p.m. CST. All questions must be submitted via email by December 29, 2025, at 1:00 p.m. CST, with answers provided around January 6, 2026.
    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
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