Notice of Intent to Sole Source-Preventative Maintenance Agreements for GeneXpert System Modules GX16-12 and GX4-4

Closed Pre-Solicitation Posted

Solicitation number
25-007059
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Bethesda, Maryland 20892, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The National Institutes of Health (NIH) Clinical Center intends to award a sole-source, firm-fixed-price contract to Cepheid for preventative maintenance agreements covering two specific GeneXpert system modules (GX16-12 and GX4-4) used in the Microbiology Service's Department of Laboratory Medicine. The contract aims to ensure continuous operational capability for critical medical diagnostic equipment that enables rapid nucleic acid amplification and detection of multi-drug-resistant organisms and tuberculosis. Required services include 24/7 telephone support, onsite service during business hours, annual preventative maintenance inspections, and comprehensive coverage for parts, labor, travel, and software updates. NIH has determined Cepheid is the sole manufacturer and authorized service provider, justifying the sole-source procurement under FAR Part 13 Simplified Acquisition Procedures. Interested parties may submit capability statements electronically to Shasheshe Goolsby by May 30, 2025, at 6:30 AM EST, referencing the posting number.

The contract has no specific set-aside designation and will be performed at the NIH Clinical Center in Bethesda, MD. The performance period includes a base year from August 8, 2025 to August 7, 2026, with three additional one-year option periods extending through August 7, 2029. Cepheid, located in Sunnyvale, CA, is the exclusive contractor, with the procurement addressing the upcoming end-of-life status of an existing GeneXpert 4-module instrument that will no longer be supported after June 30, 2023. The procurement falls under NAICS code 811210 for Electronic and Precision Equipment Repair and Maintenance, with a Product Service Code of J066 for maintenance and repair of laboratory equipment. While specific contract value is not disclosed, the multi-year agreement demonstrates a strategic commitment to maintaining critical medical diagnostic infrastructure.

Notice text

Preventative Maintenance Agreements for GeneXpert System Modules GX16-12 and GX4-4

  • Product Service Code: J066
  • NAICS Code: 811210
  • Place of Performance:
    Bethesda, MD 20892
    USA

POTS Number: 25-007059

This is a notice of intent and not a request for quotation. No solicitation document will be issued, and no quotations will be requested.

The National Institutes of Health (NIH) intends to award a firm-fixed-price contract to Cepheid, located at 904 East Caribbean Drive, Sunnyvale, CA 94089-1189, on a sole source basis. The contract is for continued preventative maintenance of the following GeneXpert systems:

  • GX16-12, Serial No. 821814
  • GX4-4, Serial No. 120000023

These instruments are used by the Microbiology Service, Department of Laboratory Medicine, at the NIH Clinical Center.

Period of Performance:

  • Base Year: August 8, 2025 – August 7, 2026
  • Option Year 1: August 8, 2026 – August 7, 2027
  • Option Year 2: August 8, 2027 – August 7, 2028
  • Option Year 3: August 8, 2028 – August 7, 2029

The GeneXpert systems provide rapid and highly sensitive nucleic acid (DNA) amplification from clinical specimens. These instruments enable timely detection of multi-drug-resistant organisms and tuberculosis, directly impacting patient diagnosis, treatment decisions, and public health responses.

To ensure minimal downtime and consistent performance, a comprehensive service agreement is essential. Any lapse in support could result in delayed patient results and compromised care.

Required Services Include:

  • 24/7 telephone support
  • Onsite service between 8:00 AM and 5:00 PM (local time), Monday through Friday (excluding federal holidays)
  • Annual preventative maintenance inspection
  • Coverage for all parts, labor, travel, and software updates

All services will be performed at:
Department of Laboratory Medicine
9000 Rockville Pike, Building 10, Room 2C324
Bethesda, MD 20892

Cepheid is the sole manufacturer and authorized service provider for the GeneXpert system and its associated reagents and components. As the exclusive source, Cepheid is the only vendor capable of providing the necessary maintenance services and upgrades to ensure compatibility and performance.

Additionally, one of the existing GeneXpert 4-module instruments (S/N 704298) is approaching end-of-life and will no longer be supported after June 30, 2023. This contract ensures continued operational capability and supports the expanding needs of the Microbiology Service.

This acquisition is being conducted under FAR Part 13 – Simplified Acquisition Procedures, specifically Subpart 13.106-1(b)(1), which allows for soliciting from a single source when only one source is reasonably available. This procurement is exempt from FAR Part 6 – Competition Requirements.

Interested parties may submit capability statements expressing interest and demonstrating their ability to meet this requirement.

All responses must reference the posting number and be submitted electronically to:

Shasheshe Goolsby
Lead Contract Specialist
Email: shasheshe.goolsby@nih.gov
Deadline: May 30, 2025, 6:30 AM EST

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