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
    Type
    Notice of Intent to Sole Source – Werfen USA, LLC
    Currently viewing
    Special Notice
    Similar Opportunities
    CareDX Lab Solutions Inc. Allo Seq Tx17 Next Generation Sequencing (NGS) Reagent Kits
    Health And Human Services, Department Of
    The National Institutes of Health (NIH) intends to issue a sole-source firm fixed-price purchase order to CareDx Lab Solutions Inc. for the procurement of Allo Seq Tx17 Next Generation Sequencing (NGS) reagent kits. This acquisition aims to secure a one-year supply of NGS reagents necessary for the Human Leukocyte Antigen (HLA) Laboratory within the Department of Transfusion Medicine, ensuring adequate stock for patient testing through quarterly shipments scheduled for February, May, and August 2026. The HLA Laboratory plays a critical role in providing diagnostic testing and consultations for transplant eligibility, maintaining accreditation, and engaging in research for new diagnostic tests. Interested parties may submit their capability statements to Shasheshe Goolsby at shasheshe.goolsby@nih.gov by January 10, 2026, at 6:00 AM EST, as this is not a request for proposals.
    6640--Lab DiaSorin Reagents - VISN23
    Veterans Affairs, Department Of
    The Department of Veterans Affairs, through the Network Contracting Office 23, intends to award a sole source firm fixed price contract to DIASORIN MOLECULAR LLC for the provision of DiaSorin Reagents to support the Veterans Integrated Service Network 23 (VISN23). The procurement aims to secure FDA-approved quality control kits and consumables, including various Simplexa kits for COVID-19, Flu A/B & RSV, and other critical tests, with specific requirements for long outdates and immediate replacement in case of recalls. These reagents are essential for the operation of multiple lab sites across South Dakota, Iowa, North Dakota, Nebraska, Minnesota, and Wisconsin, ensuring the delivery of vital healthcare services to veterans. Interested vendors who believe they can meet the requirements as authorized resellers must submit their capability statements to Contracting Officer Emanuel Nevarez by January 12, 2026, at 13:00 Central Time, referencing solicitation number 36C26326Q0249.
    NOTICE of Intent to SOLE SOURCE - Biolytic Lab Performance INC
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), intends to award a sole source firm fixed price purchase order to Biolytic Lab Performance INC for the maintenance and upkeep of Dr. Oligo 48 Medium Throughput DNA Synthesizers. This procurement is critical for ensuring the operational readiness of a laboratory instrument that plays a vital role in standard laboratory operations and public health emergencies, necessitating regular maintenance and access to proprietary codes and OEM parts. Biolytic is uniquely qualified to provide these services due to their trained engineers and exclusive access to genuine OEM parts, with a response time of 24-48 hours for service calls. Interested parties may submit their interest and capability to respond to this requirement via email to the contract specialist by COB January 22, 2026, although this notice is not a request for competitive quotations.
    Notice of Intent to Sole Source – Preventative Maintenance (PM) Service Contract
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to award a sole source contract to Peak Scientific, Inc. for preventative maintenance services on their PEAK Genius XE SCI gas generators. The objective of this procurement is to ensure the continuous and efficient operation of the gas generators, which are critical for the mass spectrometer used in patient care testing, thereby facilitating timely results. The contract will cover a one-year base period with three option years, emphasizing the necessity of specialized maintenance services that only Peak Scientific can provide due to their unique training and proprietary tools. Interested parties can direct inquiries to Chris Ryssa Nix at ryssa.nix@nih.gov, with comments on this notice due by January 14, 2026.
    Notice of Intent to Sole Source – Sterility Testing Service LIMS Project
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), has issued a Notice of Intent to Sole Source for additional professional services related to the Sterility Testing Service (STS) Laboratory Information Management System (LIMS) project. The procurement aims to secure extra professional service days to support the configuration and rollout of the Portal, addressing compliance gaps and enhancing process efficiencies identified in the original Statement of Work (SOW). LabVantage, the original vendor for the STS LIMS procurement, is the sole source for these additional services due to their established involvement in the project. Interested parties may submit comments regarding this notice via email to Chris Ryssa Nix at ryssa.nix@nih.gov by January 14, 2026, at 12 PM EST.
    Clinical Research Products Management Center (CRPMC)
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH) through the National Institute of Allergy and Infectious Diseases (NIAID), is seeking qualified small business sources for the Clinical Research Products Management Center (CRPMC) contract. This contract aims to provide comprehensive management and oversight of investigational study products for clinical trials, ensuring compliance with federal regulations and supporting critical research in HIV/AIDS and related areas. The anticipated contract will span seven years, beginning approximately March 16, 2027, and will require the delivery of 27 full-time equivalents (FTEs) annually, with options for increased labor as needed. Interested parties must submit a capability statement by January 23, 2026, to Shawnice Williams at shawnice.williams@nih.gov, adhering to specified formatting guidelines.
    Renewal of Leica Microsystems Maintenace for the Division of Intramural Research (DIR)
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to renew maintenance services for Leica Microsystems equipment utilized by the Division of Intramural Research (DIR). This procurement aims to ensure the continued operational efficiency and reliability of critical laboratory instruments and equipment, which are essential for ongoing research activities. The maintenance services will be performed in Rockville, Maryland, and interested vendors can reach out to Hershea Vance at hershea.vance@nih.gov or 301-761-6404, or Tamara McDermott at tamara.mcdermott@nih.gov or 406-375-7487 for further details. The opportunity is categorized under the PSC code J066, which pertains to maintenance, repair, and rebuilding of laboratory equipment.
    6550--Sources Sought: Cepheid GeneXpert Infinity Reagents
    Veterans Affairs, Department Of
    The Department of Veterans Affairs, specifically the Network Contracting Office 8, is seeking to award a Sole Source, Fixed-Priced Single Award Indefinite Delivery Indefinite Quantity (IDIQ) contract to Cepheid for the procurement of Multi-Drug-Resistant Organism (MDRO) reagents for use with the existing Cepheid GeneXpert Infinity system. This procurement is critical for conducting a wide range of infectious disease testing, including tests for MRSA, C. difficile, CRE, CT/NG, Group A Streptococcus, SARS-CoV-2, and other pathogens. Interested parties are invited to demonstrate their capability to fulfill this requirement by submitting supporting evidence to the Contracting Officer, Moneque Rodriguez, at moneque.rodriguez@va.gov by 1:00 PM Eastern Standard Time on January 9, 2026. This notice is not a request for competitive proposals, and the government will proceed with the sole source acquisition if no viable alternatives are presented.
    GraphPad Prism Subscription Renewal
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to renew a contract for 500 subscriptions of GraphPad Prism software, which is critical for biostatistical analysis and scientific graphing. This non-competitive procurement is justified under the Federal Acquisition Regulation (FAR) due to GraphPad Software, LLC being the sole provider of the software, with the renewal period set from April 8, 2025, to April 7, 2026. GraphPad Prism is widely utilized by research institutions and pharmaceutical companies, ensuring the accuracy and efficiency of scientific data analysis within the NIH. Interested vendors may express their capabilities, but the government retains discretion over competitive offers, with the total contract value not exceeding $250,000. For inquiries, contact Verne L. Griffin at verne.griffin@nih.gov or 301-594-7730, or Michael L. Falzone at michael.falzone@nih.gov or 301-827-1873.
    Maintenance and Service Contract for various Government-Owned Becton Dickinson and Company Flow Cytometer Equipment
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking a contractor to provide maintenance and service for various government-owned Becton Dickinson and Company flow cytometer equipment. The procurement aims to ensure the operational efficiency and reliability of these critical laboratory instruments, which are essential for various biomedical research applications. Interested vendors should note that the place of performance is located in Bethesda, Maryland, and they can direct inquiries to John Russell, the Contract Specialist, at John.Russell3@nih.gov for further details. The contract is categorized under the PSC code J066, which pertains to maintenance, repair, and rebuilding of laboratory equipment.