Notice of Intent to Sole Source – Bio-Rad Quality Control Material
Closed Pre-Solicitation Posted
- Solicitation number
- 25-005840
- Agency
-
NIH Clinical Center
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325414 Biological Product (except Diagnostic) Manufacturing
- PSC
- 6505 Drugs And Biologicals
- Place of performance
- Bethesda, Maryland 20892, United States
- Points of contact
-
- Shasheshe Goolsby shasheshe.goolsby@nih.gov (301) 827-4879
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health (NIH) Department of Laboratory Medicine - Immunoassay Section intends to sole source an Indefinite Delivery, Indefinite Quantity (IDIQ) contract to Bio-Rad Laboratories Inc. for quality control (QC) materials used with Roche COBAS PRO Solutions analyzers. The procurement will specifically acquire multiple levels of Bio-Rad InteliQ and Liquichek quality control materials for tumor marker, immunoassay, cardiac, and specialty testing purposes. NIH requires these specific QC materials to verify analyzer accuracy and reliability, with Bio-Rad identified as the sole manufacturer capable of meeting their technical requirements. The procurement will be conducted under FAR Part 13 Simplified Acquisition Procedures, which permits solicitation from a single source when only one source is reasonably available. Interested parties are invited to submit capability statements referencing the posting number by May 27, 2024, at 6:30 AM EST to Shasheshe Goolsby, Lead Contract Specialist.
The contract opportunity is not set aside for any specific business classification and will cover a performance period from May 28, 2025 to September 30, 2025. The place of performance is located in Bethesda, MD 20892, with shipments to be made on an as-needed basis. Bio-Rad Laboratories Inc., located at 2000 Alfred Nobel Drive in Hercules, CA, is the sole proposed contractor and manufacturer of the required QC materials. The procurement falls under NAICS Code 325414 for Biological Product Manufacturing and Product Service Code 6505 for Drugs and Biologicals. While no specific contract value is disclosed, the IDIQ structure suggests flexibility in ordering quantities of QC materials throughout the performance period. The solicitation emphasizes that this is a notice of intent and not a request for proposal, and participants should only submit capability statements without including pricing or quotations.
Notice text
Notice of Intent to Sole Source – Bio-Rad Quality Control Material
Product Service Code: 6505
NAICS Code: 325414
Place of Performance:
Bethesda, MD 20892, USA
POTS: 25-005840
This is a Notice of Intent and not a request for quotation. A solicitation document will not be issued, and quotations will not be requested.
The National Institutes of Health (NIH) intends to award an Indefinite Delivery, Indefinite Quantity (IDIQ) contract to Bio-Rad Laboratories Inc., located at 2000 Alfred Nobel Drive, Hercules, CA 94547-1801.
Purpose:
The NIH Department of Laboratory Medicine – Immunoassay Section requires Bio-Rad quality control (QC) materials for use with the Roche COBAS PRO Solutions analyzers. These QC materials are essential to verify the accuracy and reliability of analyzer results.
Bio-Rad QC materials contain known analyte values, enabling validation that instrument outputs are within acceptable limits. This ensures the analyzers function correctly and produce accurate test results. The Immunoassay section specifically requires Bio-Rad materials because they contain the exact analytes at concentrations that match the range of its assays.
Performance Period:
May 28, 2025 – September 30, 2025
Shipments will be made on an as-needed basis.
Items Required:
- Bio-Rad InteliQ Tumor Marker Level 1
- Bio-Rad InteliQ Tumor Marker Level 2
- Bio-Rad InteliQ Tumor Marker Level 3
- Bio-Rad InteliQ Immunoassay Plus Level 1
- Bio-Rad InteliQ Immunoassay Plus Level 2
- Bio-Rad InteliQ Immunoassay Plus Level 3
- Bio-Rad InteliQ Specialty Immunoassay Level 1
- Bio-Rad InteliQ Specialty Immunoassay Level 2
- Bio-Rad InteliQ Specialty Immunoassay Level 3
- Bio-Rad Liquichek Cardiac Advance Level 1
- Bio-Rad Liquichek Cardiac Advance Level 2
- Bio-Rad Liquichek Cardiac Advance Level 3
- Bio-Rad Liquichek Cardiac Advance Level 4
- Bio-Rad Lyphochek Immunoassay Plus Level 1
- Bio-Rad Lyphochek Immunoassay Plus Level 2
- Bio-Rad Lyphochek Immunoassay Plus Level 3
Bio-Rad Laboratories Inc. is the sole manufacturer of the required QC materials. No other vendors are known to offer equivalent products that meet the NIH's technical requirements.
This procurement will be conducted under FAR Part 13 – Simplified Acquisition Procedures, specifically Subpart 13.106-1(b)(1), which permits solicitations from a single source when only one source is reasonably available.
Contracts awarded under FAR Part 13 are exempt from the competition requirements outlined in FAR Part 6.
Interested parties who believe they can meet this requirement are invited to submit a capability statement referencing this posting number.
Deadline: May 27, 2024, at 6:30 AM EST
Submit to:
Shasheshe Goolsby, Lead Contract Specialist
Email: shasheshe.goolsby@nih.gov
Please Note: This is NOT a Request for Proposal (RFP). Do not submit quotations or pricing. Only capability statements will be considered.
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