Notice of Intent to Sole Source – Werfen USA, LLC
ID: NOI-CC-26-000442Type: Special Notice
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH - CCBETHESDA, MD, 20892, USA

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

PSC

MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES (6515)

Original Source

https://sam.gov/workspace/contract/opp/040486660d914e57abff65aeb113aee2/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health (NIH), intends to award a sole source contract to Werfen USA, LLC for the procurement of kits and reagents essential for patient care testing, specifically for use with the ACL TOP 350 and 750 analyzers. This procurement, valued at approximately $570,000 over a base year and two option years (January 1, 2026, to December 31, 2028), is critical as the reagents are uniquely validated for the existing instruments, ensuring continuity in patient care and research protocols. The acquisition will be conducted under the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, allowing for increased procedural flexibility and efficiency. Interested parties may submit comments regarding this notice to Ryssa Nix at ryssa.nix@nih.gov by the close date of December 23, 2025, at 12 PM EST.

    Point(s) of Contact
    Chris Ryssa Nix
    ryssa.nix@nih.gov
    Files
    Title
    Posted
    JOFOC.pdf
    The Department of Health and Human Services (HHS), National Institutes of Health (NIH), Clinical Center, Department of Laboratory Medicine, is seeking a Blanket Purchase Order for reagents for ACL TOP 750 analyzers. This justification for other than full and open competition is due to the reagents being specific to the currently owned ACL TOP analyzers, making Werfen USA, LLC the sole responsible source. The estimated value of this firm-fixed-price agreement is $570,000 for a base year and two option years (January 1, 2026, to December 31, 2028). The acquisition is justified under 41 U.S.C. 253(c)(1) as set forth in FAR 6.302-1, citing unacceptable delays if full and open competition were pursued. Market research indicated only one source could satisfy the agency's requirements, and the anticipated cost is deemed fair and reasonable.
    NOI to sole source.pdf
    The National Institutes of Health (NIH), Clinical Center, has issued a Notice of Intent to Sole Source to Werfen USA, LLC for a one base year plus two option years contract. This procurement is for kits and reagents essential for patient care testing, specifically validated for use with the existing ACL TOP 350 and 750 analyzers owned by the NIH. Werfen USA, LLC is identified as the sole supplier capable of meeting these specific instrumentation validation and requirements. The acquisition is being conducted under Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.5(a), which allows for simplified procedures for commercial acquisitions exceeding the simplified acquisition threshold but not exceeding $9 million. This method provides contracting officers with increased procedural discretion and flexibility to maximize efficiency and economy while minimizing administrative burdens. Comments regarding this notice, referencing NOI-CC-26-000442, can be submitted via email to Ryssa.nix@nih.gov by the close date of December 23, 2025, 12 PM EST.
    SOW.pdf
    The National Institutes of Health Clinical Center's Department of Laboratory Medicine requires a Blanket Purchase Order for ACL TOP 750 Reagents. These reagents are essential for patient care and research protocols, specifically validated for use with the existing ACL TOP 350 and 750 analyzers. The procurement, valued at $570,000 over a base year and two option years (January 1, 2026, to December 31, 2028), is for kits and reagents used in coagulation assays. Due to instrument-specific validation and requirements, only one supplier can meet the need, ensuring continuity of patient care testing without delays. The agreement specifies minimum acceptable expiration dates for supplies and allows for batch or standing order shipments.
    Lifecycle
    Title
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    Notice of Intent to Sole Source – Werfen USA, LLC
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    Special Notice
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