Chemistry/Immunochemistry Analyzers
ID: W91YTZ24R0021Type: Combined Synopsis/Solicitation
Overview

Buyer

DEPT OF DEFENSEDEPT OF THE ARMYW40M MRCO EASTFORT BELVOIR, VA, 22060-5580, USA

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

PSC

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

Original Source

https://sam.gov/opp/1a3569dce2be430b9de59fdeafed1db2/view
Timeline
    Description

    The Department of Defense, specifically the Department of the Army, is seeking proposals for the procurement of two automated Chemistry/Immunochemistry analyzers, along with necessary reagents, consumables, operator training, and maintenance support for the Moncrief Army Health Clinic (MAHC) in Columbia, South Carolina. This solicitation, identified as W91YTZ-24-R-0021, covers a base period from November 1, 2024, to October 31, 2025, with four additional option years, emphasizing the importance of reliable analytical testing equipment for maintaining medical readiness for military personnel. Interested vendors must submit their quotes by October 15, 2024, and direct inquiries to the designated government contacts by October 9, 2024. Compliance with the Medical Device and Equipment Risk Assessment (MDERA) is also required to ensure adherence to cybersecurity policies, highlighting the critical nature of safeguarding electronic protected health information (ePHI) in healthcare environments.

    Point(s) of Contact
    Sherina Ross
    sherina.l.ross.civ@health.mil
    Sebrena. L. Lane
    sebrena.l.hackleylane.civ@health.mil
    Files
    Title
    Posted
    Combined Synopsis Solicitation W91YTZ24R0021.pdf
    The Combined Synopsis Solicitation W91YTZ-24-R-0021, dated October 3, 2024, seeks proposals for Chemistry and Immunochemistry Analyzers and Reagents for the Moncrief Army Health Clinic (MAHC) over a five-year period, from November 1, 2024, to October 30, 2029. This unrestricted solicitation invites interested vendors to submit their quotes by October 15, 2024, and directs inquiries via specified government email addresses by October 9, 2024. The delivery method is Cost Per Reportable Result (CPRR), with monthly billing for various tests listed, including Albumin, ALT, and Electrolytes, among many others, each specified with estimated quantities. Offerors must be registered with the System for Award Management (SAM) and submit required representations and certifications with their proposals. The acquisition aims to fulfill medical readiness requirements through reliable suppliers, ensuring availability of essential analytical testing equipment and reagents for healthcare services provided at MAHC. This effort underscores the U.S. government's commitment to ensuring responsive and effective medical support for military personnel.
    Exhibit 1_MDERA.docx
    The Medical Device and Equipment Risk Assessment (MDERA) Version 6 serves to ensure compliance with U.S. federal, Department of Defense (DoD), and Defense Health Agency (DHA) cybersecurity policies for medical systems/devices. Vendors must complete the Medical Device Equipment Readiness Assessment Questionnaire as part of the Request for Offer process, detailing the system's capabilities, security posture, and compliance with cybersecurity principles. The document outlines requirements for system identification, including detailed specifications about device descriptions, operating systems, and data processing functionalities, emphasizing the need for transparency in the information provided. The assessment also highlights the significance of understanding medical device connections, dependencies, and the cybersecurity measures required for both regulated and non-regulated technologies. It mandates a comprehensive account of software and architecture, data encryption methods, and protocols for vulnerability scanning and patch management. Successful compliance not only facilitates the procurement process but also aligns with broader goals of protecting electronic protected health information (ePHI) and maintaining operational integrity within healthcare environments. Ultimately, the MDERA aims to mitigate risks associated with medical device procurement and usage in DoD health systems.
    Lifecycle
    Title
    Type
    Chemistry/Immunochemistry Analyzers
    Currently viewing
    Combined Synopsis/Solicitation
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