Notice of Intent to Sole Source 2 sets of QX200 ddPCR Systems
ID: NOI-CC-26-000112Type: Special Notice
Overview

Buyer

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

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

PSC

MAINT/REPAIR/REBUILD OF EQUIPMENT- INSTRUMENTS AND LABORATORY EQUIPMENT (J066)

Set Aside

No Set aside used (NONE)

Original Source

https://sam.gov/workspace/contract/opp/f104651ce53548bfb49fd50b8d039525/view
Timeline
    Description

    The National Institutes of Health (NIH), specifically the Clinical Center (CC), intends to negotiate a sole-source contract for the renewal of maintenance services for two QX200 AutoDG ddPCR Systems from Bio-Rad Laboratories. This five-year service contract, valued at $151,494, is essential for the ongoing maintenance and support of these systems, which are critical for droplet digital PCR (ddPCR) vector copy number detection and gene modification efficiency testing on clinical cellular products. The contract ensures compliance with FDA regulations and is vital for patient care testing, as failure to secure these services could adversely affect patient safety. Interested parties may submit capability statements by December 18, 2025, to valerie.gregorio@nih.gov, referencing NOI-CC-26-000112.

    Point(s) of Contact
    No information provided.
    Files
    Title
    Posted
    JOFOC Under the SAT -QX200 System Srvc Agr_2025.docx
    The National Institutes of Health (NIH) Clinical Center seeks a five-year service contract renewal for two QX200 AutoDG ddPCR Systems from Bio-Rad, costing $151,494.00. This non-competitive acquisition, justified under FAR 13.106-1(b)(1) due to the Simplified Acquisition Threshold, is essential for patient care testing, specifically for droplet digital PCR VCN detection and gene modification efficiency testing on clinical cellular products. Bio-Rad is the sole vendor capable of providing the necessary preventive maintenance and support for these unique, clinically approved instruments, which are critical for guiding immunotherapy and ensuring patient safety. The urgency and specialized nature of the equipment, along with FDA compliance requirements, preclude full and open competition. Failure to secure this service could lead to patient harm, as these systems are vital for patients with unique conditions undergoing research and testing at the NIH Clinical Center. The anticipated cost is considered fair and reasonable, with Bio-Rad offering a 15% government discount.
    SOW-QX200 Auto DG system Svc. Agr.-5 years of 2025-2030.docx
    This Statement of Work outlines the renewal of a service contract for two QX200 AutoDG ddPCR Systems at the NIH Clinical Center. The contract covers maintenance, support, and emergency servicing for the systems, which are critical for lot release assays of VCN ddPCR on clinical and research cellular products. This preventive maintenance is essential for compliance with manufacturer and FDA 21 CFR 211.67 regulations, as the assays are vital for licensing blood products for patient treatment. The contractor will provide a 5-year full on-site complete support plan, including annual preventive maintenance, unlimited on-site repair visits (parts, labor, and travel included), covering the Auto Droplet Generator and Droplet Reader. The contract duration is from January 23, 2026, to January 22, 2027, with four renewable option years. The vendor will be on-site for 6-8 hours for complex issues but will not have remote access or access to PII/PHI data.
    Lifecycle
    Title
    Type
    Notice of Intent to Sole Source 2 sets of QX200 ddPCR Systems
    Currently viewing
    Special Notice
    Similar Opportunities
    AB Assurance 1 PM plan for the DNA Analyzer 3730XL (UPG)
    Buyer not available
    The National Institutes of Health (NIH), specifically the Eunice Kennedy Shriver National Institute on Child Health and Human Development (NICHD), is seeking to award a sole-source contract for maintenance services for the DNA Analyzer 3730XL (UPG) from Life Technologies Corporation. The procurement involves a one-year maintenance service plan, known as the AB Assurance 1 PM plan, which is critical for ensuring the operational reliability of the DNA analyzer, a vital tool in genetic research and analysis. Interested vendors are invited to submit their quotations by December 14, 2025, at 12:00 PM EST, referencing solicitation number 75N94026Q00006, with evaluations focusing on technical capability and past performance. For further inquiries, vendors may contact Kelly Robinson at kelly.robinson@nih.gov or +1 301 435 2719.
    EZ1 & 2 DNA Blood Isolation Kit and DNA Tissue Kit
    Buyer not available
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), intends to negotiate a sole source contract with Qiagen for the procurement of EZ1 & 2 DNA Blood Isolation Kits and DNA Tissue Kits. These kits are critical for the ongoing clinical research and patient care at the NIH Clinical Center, particularly for Human Leukocyte Antigen (HLA) matching in transplant patients and potential donors. The kits have been extensively tested and are essential for providing high-quality DNA samples necessary for critical Next Generation Sequencing, with an estimated contract value of $29,166.25. Interested parties may submit capability statements by email to valerie.gregorio@nih.gov by 11:00 AM EST on December 13, 2025, referencing NOI-CC-26-000013.
    Service Agreement: ION Sequencing System
    Buyer not available
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking a service agreement for the ION Sequencing System, which includes maintenance and support for critical laboratory equipment. The contract will cover a one-year AB Assurance plan with Life Technologies/ThermoFisher Scientific, ensuring comprehensive service including parts, labor, travel for repairs, and priority technical support for the ION S5 XL and S5 Prime sequencers, as well as the Ion Chef system. This procurement is vital for maintaining the functionality of advanced sequencing equipment used in medical research, which supports various health-related studies. Interested vendors must submit their quotations by December 9, 2025, to Tina Robinson at robinsti@mail.nih.gov, referencing solicitation number 75N94026Q00008, and must comply with all applicable FAR clauses and requirements.
    Maintenance and Service Contract for various Government-Owned Becton Dickinson and Company Flow Cytometer Equipment
    Buyer not available
    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.
    Preventative Maintenance Agreement for 36 Heracell Vios 160i CO2 incubators
    Buyer not available
    The Department of Health and Human Services, through the National Institutes of Health (NIH), intends to award a firm-fixed-price contract to Thermo Fisher Scientific for a preventative maintenance agreement covering 36 HERA VIOS 160i CO2 incubators. This sole-source acquisition is essential for maintaining critical equipment used in the manufacturing of cell-based therapies, as mandated by the FDA's regulations on controlled maintenance of such equipment. The estimated cost for this project is $55,311.32, and it is crucial for ensuring the continuous, compliant operation of equipment vital for patient care. Interested parties may submit capability statements by email to valerie.gregorio@nih.gov by 11:00 AM EST on December 18, 2025, referencing the notice of intent (NOI-CC-26-000054).
    Notice of Intent to Sole Source – Agilent Technologies
    Buyer not available
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), intends to award a sole source contract to Agilent Technologies for a Software Maintenance Agreement related to the existing Agilent OpenLab/ECM data system. This acquisition aims to ensure continued support and maintenance of proprietary software that is critical for the NIH's Clinical Center's operations, including software license upgrades and dedicated technical support. The contract will be awarded on a firm fixed price basis, with a total quantity of two software maintenance agreements for a one-year renewal period. Interested parties may express their interest and capabilities to the NIH's Office of Purchasing and Contracts, with comments due by December 12, 2025, at 12 PM EST, directed to Kristin Nagashima at kristin.nagashima@nih.gov.
    Renewal of Leica Microsystems Maintenace for the Division of Intramural Research (DIR)
    Buyer not available
    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.
    SERVICE AGREEMENT FOR THERMO ELECTRON LABORATORY EQUIPMENT (AMBIS 2247584)
    Buyer not available
    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 soliciting quotes for maintenance agreements on Thermo Electron laboratory equipment, critical for research involving complex proteomic data. The procurement, identified by solicitation number RFQ-NIAID-25-2247584, requires comprehensive service plans for various mass spectrometry instruments, ensuring prompt maintenance response times, priority technical support, and regular preventive maintenance visits. This equipment is essential for analyzing high-value samples in ongoing research projects, and the contract period spans from March 19, 2025, to March 18, 2026. Interested vendors must submit their quotes electronically by December 30, 2024, and can contact Kimberly Rubio at kimberly.rubio@nih.gov for further information.
    Renewal of Maintenance Services for Philips Imaging Equipment at the Integrated Research Facility (IRF) at Fort Detrick, Maryland
    Buyer not available
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to renew maintenance services for Philips imaging equipment located at the Integrated Research Facility (IRF) in Fort Detrick, Maryland. This procurement aims to ensure the continued operational efficiency and reliability of critical imaging equipment used in research and clinical applications. The maintenance services are vital for supporting ongoing research initiatives and ensuring compliance with safety and operational standards. Interested vendors can reach out to Danielle Tines at danielle.tines@nih.gov or by phone at 406-363-9251, or Tamara McDermott at tamara.mcdermott@nih.gov or 406-375-7487 for further details regarding the justification and approval documentation.
    DW USC C DocuWare Update/Support Contract
    Buyer not available
    The Department of Health and Human Services, through the National Institutes of Health (NIH), intends to award a firm-fixed price contract to DocuWare Corporation for a one-year license and annual maintenance and software support services for its document management system. This procurement is essential for the Department of Transfusion Medicine (DTM) to effectively manage patient and donor medical records, leveraging DocuWare's capabilities for document digitization and workflow automation. The contract, valued at approximately $25,151.16, is justified as a sole-source acquisition due to the unique requirements of DTM and the significant costs associated with migrating to an alternative system. Interested parties may submit capability statements by December 14, 2025, to Valerie Gregorio at valerie.gregorio@nih.gov for consideration.