J065--Intent to Sole Source: Cepheid Service Agreement

Form / Attachment / Pricing Sheet

This document, Appendix B, contains a VA Acquisition Regulation Solicitation Provision and Contract Clause related to Information and Information Technology Security Requirements. It outlines a clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by VA and a contractor, subcontractor, or third party.

• SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS: Details the rationale for the clause, citing the threat of data breach and compliance with Federal laws and regulations.
• 839.201 Contract clause for Information and Information Technology Security: Specifies that the VA has developed a security clause for sensitive information.
• 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008): This is the specific clause to be inserted into solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized. It states that the contractor, personnel, and subcontractors must adhere to Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security.

Bidders should note that this clause will be a mandatory part of any contract involving VA sensitive information or IT resources. It highlights the critical importance of adhering to stringent security requirements as defined by Federal and VA regulations. Potential offerors must be prepared to comply with these security mandates.

Solicitation / RFP / RFQ

This document is a solicitation for Preventative & Corrective Maintenance Services for Cepheid GeneXpert Analyzers at the Bay Pines VA Medical Center and Lee County VA Clinic. The services required include emergency service, parts, preventive maintenance, factory-authorized updates/modifications, and technical/application support.

• Provide all labor, equipment, materials, supervision, and disposal for maintenance.

• Ensure equipment functions per manufacturer's technical performance specifications.

• Maintain 98% operational uptime during normal operating hours.

• Guaranteed response time for Field Service Engineers (FSE) within 24 hours of notification.

• Live phone support available 6:00 a.m. - 8:00 p.m. Eastern Time, and 24/7 for after-hours technical assistance.

• Provide periodic software enhancements.

• Perform preventive maintenance according to manufacturer recommendations (at least 4 times annually).

• All parts required for repair (excluding instruments and accessories) are covered.

• Labor and travel expenses during normal business hours (Monday-Friday, 8:00 am - 5:00 pm local time) are included.

• Services must be performed by Cepheid-trained and qualified FSEs.

• Maintain equipment in accordance with manufacturer's specifications, including calibration, cleaning, and part replacement.

• Provide detailed documentation and reports for all maintenance performed.

• Contract Type: Firm-Fixed Price Service Contract.

• Period of Performance: Base Year (June 17, 2026 - June 16, 2027) plus four option years through June 16, 2031.

• Estimated Value: $34 Million (This appears to be an estimated value for the acquisition, not necessarily the total contract value).

• Offers are due by April 24, 2026, at 13:00 EDT.

• Evaluation will be based on Price Only.

• The Government will award to the responsible Offeror whose offer is most advantageous.

• NAICS Code: 811210 (Electronic and Precision Equipment Repair and Maintenance).

• Size Standard: $34 Million.

• The acquisition is listed as UNRESTRICTED.

• The solicitation incorporates FAR clauses by reference, including 52.212-1, 52.212-4, and 52.212-5.

• Specific locations for equipment: Bay Pines VA Medical Center and Lee County VA Clinic.

• Contractor personnel require identification badges and may be subject to escort in sensitive areas.

Solicitation / RFP / RFQ

This document is a Justification for Single Source Awards (IAW Revolutionary FAR Overhaul (RFO) 12.102(a)) for over Micro-Purchase Threshold but not exceeding the Simplified Acquisition Threshold. It outlines the need for renewal of annual service coverage for two GeneXpert diagnostic analyzers.

• Renewal of annual service coverage (Premier Care and Essential Care plans) for GeneXpert diagnostic analyzers.

• Coverage includes Preventative Maintenance, repairs, parts, labor, module swaps, uptime guarantee, and software updates.

• Requires loaner equipment per Original Equipment Manufacturer (OEM) terms.

• Annual Xpert Check kit and performance verification procedures are required.

• Period of Performance: Base Year (June 17, 2026 - June 16, 2027) with four Option Years extending through June 16, 2031.

• Estimated procurement value is not specified.

• This document is a justification for a sole-source award, not a solicitation requiring proposal submissions.

• Market research identified potential Small Business Administration (SBA) vendors, but confirmed that maintenance and repair services can only be obtained directly from the OEM, Cepheid.

• No third-party vendors are authorized or capable of providing OEM-compliant service.

• The GeneXpert Infinity and GXIV-4 systems are proprietary diagnostic systems manufactured exclusively by Cepheid.

• All maintenance activities must be performed by Cepheid-certified field service engineers.

• Use of non-OEM service providers would void manufacturer support and jeopardize system certification.

• All previous federal purchases for GeneXpert service agreements have been awarded directly to Cepheid.

Solicitation / RFP / RFQ

This is a Notice of Intent to solicit and negotiate a Sole Source, Fixed-Price Purchase Order with Cepheid for annual service coverage for two GeneXpert diagnostic analyzers. The government believes Cepheid is the only authorized provider capable of meeting the agency's needs due to the unique nature of the reagents and services required.

• Annual service coverage including Premier Care and Essential Care plans.

• Coverage includes preventative maintenance, repairs, parts, labor, module swaps, uptime guarantee, software updates, and loaner equipment per Original Equipment Manufacturer (OEM) terms.

• Contract Type: Fixed-Price Purchase Order.

• Period of Performance: Base year and four one-year options.

• This notice is not a request for competitive proposals; however, interested parties may identify their interest and capability.

• All responsible sources may submit a quotation, bid, or proposal.

• Responses received will be considered to determine if a competitive procurement is warranted.

• If no responses are received, the government will proceed with the sole source acquisition.

• Email responses to Moneque Rodriguez at moneque.rodriguez@va.gov.

• Response Deadline: April 24, 2026, by 13:00 PM Eastern Standard Time.

• Sole Source acquisition under FAR 12.102(b) and 41 USC §1901.

• The government believes only one source (Cepheid) can meet the needs due to specialized reagents and services.

• Supporting evidence of capability must be provided.

• No solicitation is currently available.