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

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