Notice of Intent to Sole Source to Fisher Scientific Company LLC for Culture Media, Various Reagents, and Supplies

Notice of Intent to Sole Source to Fisher Scientific Company LLC for Culture Media, Various Reagents, and Supplies

NAICS Code: 325413 – In-Vitro Diagnostic Substance Manufacturing
Product Service Code (PSC): 6640 – Laboratory Equipment and Supplies

Place of Performance:
National Institutes of Health
Clinical Center
10 Center Drive
Bethesda, MD 20892

POTS: 26-001885

Description

This notice is issued for informational purposes only and does not constitute a request for quotations. A solicitation document will not be issued, and quotations will not be requested.

The National Institutes of Health (NIH), Clinical Center, Office of Acquisition and Logistics Management (OALM), on behalf of the Department of Laboratory Medicine (DLM), Microbiology Service, intends to award a firm-fixed-price contract on a sole-source basis to Fisher Scientific Company LLC for the provision of culture media, various reagents, and laboratory supplies.

The anticipated period of performance is:

• Base Year: March 20, 2026 – September 30, 2026

• Option Year 1: October 1, 2026 – September 30, 2027

• Option Year 2: October 1, 2027 – September 30, 2028

The Microbiology Service requires the establishment of a purchase agreement for culture media, reagents, and supplies necessary to support clinical patient testing at the NIH Clinical Center.

The Department of Laboratory Medicine requires continued access to specialized culture media, reagents, and related supplies from Fisher Scientific Company LLC to support routine and specialized microbiological testing performed by the Microbiology Service. While similar materials may be available from other vendors, these alternatives have demonstrated variable performance during internal laboratory validations and published evaluations.

The laboratory has standardized its testing procedures using specific products supplied through Fisher Scientific and has completed the required clinical validations in accordance with Centers for Medicare & Medicaid Services (CMS) regulations for use in patient care. These validated procedures are compliant with Clinical Laboratory Improvement Amendments (CLIA) requirements and the laboratory’s Individualized Quality Control Plans (IQCPs).

To maintain compliance with regulatory requirements and ensure consistent patient testing results, media quality, performance, and tolerance limits must remain consistent across manufacturing lots and shipments. Establishing a purchase agreement with Fisher Scientific will allow the Microbiology Service to sustain uninterrupted testing operations, maintain regulatory compliance, and ensure reliable and timely diagnostic results for patients treated at the NIH Clinical Center.

Minimum Specifications

The contractor shall provide culture media, reagents, and laboratory supplies according to the operational needs of the Microbiology Service. Orders will be placed on an as-needed basis throughout the period of performance.

The contractor shall:

• Provide technical support for all reagents and supplies and their performance characteristics at no additional cost to the Government.

• Provide the following for requested reagents and/or supplies:

  • Same lot release per order per item, when requested

  • Latest available expiration date

• Supply culture media, reagents, and supplies in a timely manner throughout the period of performance.

• In the event of a partial shipment, contact the Microbiology Service to verify whether to ship the available items or place the order on backorder until the requested quantity from a single manufacturing lot is available.

Authority

This acquisition is being conducted in accordance with:

FAR 13.106-1(b)(1) – Soliciting from a Single Source

For acquisitions not exceeding the Simplified Acquisition Threshold (SAT), contracting officers may solicit from one source when the contracting officer determines that only one source is reasonably available to meet the Government’s requirements.

Acquisitions conducted under FAR Part 13 – Simplified Acquisition Procedures are exempt from the competition requirements of FAR Part 6.

Responses

This notice is not a request for quotations.

However, interested parties may submit capability statements demonstrating their ability to provide culture media, reagents, and laboratory supplies equivalent to those required by the Department of Laboratory Medicine.

Capability statements must clearly demonstrate the ability to:

• Provide validated clinical microbiology culture media and reagents suitable for CLIA-regulated laboratory testing

• Maintain consistent lot quality and manufacturing controls

• Provide reliable supply and timely delivery for clinical laboratory operations

• Provide technical support for laboratory reagents and supplies

The Government will evaluate capability statements received in response to this notice. The determination not to compete this requirement based upon responses received is solely within the discretion of the Government.

Submission Instructions

Capability statements or comments referencing POTS: 26-001885 must be submitted electronically to:

Shasheshe Goolsby
Team Leader
Hospital and Laboratory Support Division
Office of Acquisition and Logistics Management (OALM)
NIH Clinical Center

Email: shasheshe.goolsby@nih.gov

Responses must be received no later than March 17 at 12:30 AM EST.