Cepheid GeneXpert Laboratory Diagnostics Equipment for Veterans Affairs

Statement of Work Procurement of Diagnostic Equipment 1. Purpose The purpose of this Statement of Work (SOW) is to define the

requirements for the one-time purchase of one fully operational Cepheid GeneXpert XVI R2, 16-Module Diagnostic System, including related components such as a printer and charger, for the El Paso VA Health Care System (EPVAHCS). This acquisition aims to enhance the laboratory s molecular diagnostic capacity, reduce turnaround times, and enable rapid, accurate testing for infectious diseases and clinical applications. The purchase includes equipment delivery, installation, instrument verification, interfacing support with existing systems, and initial user training. Upon completion, the system will be owned by the Government with no option years, recurring lease fees, or additional leasing obligations. The Cepheid GeneXpert XVI R2 is a 16-module diagnostic system engineered for rapid molecular testing, utilizing automated real-time polymerase chain reaction (PCR) to detect nucleic acids from pathogens in point-of-care settings. It enables simultaneous processing of up to 16 samples, delivering results in as little as 30 minutes to 2 hours through integrated sample preparation, amplification, and detection within single-use cartridges, minimizing contamination risks. Compatible with a broad range of Cepheid Xpert assays, it supports multiplex testing for infectious diseases such as tuberculosis, HIV, influenza, and COVID-19, with a portable, user-friendly design suitable for clinical, laboratory, or field applications. All operations must adhere to manufacturer guidelines and applicable regulatory standards, including FDA and CLIA

requirements. 2. Scope The Contractor shall provide the following services under the service contract for the diagnostic instruments: phone support available 24 hours per day and 7 days a week; onsite service 5 days a week, Monday through Friday, from 0800 to 1800; annual preventative maintenance check-ups performed by a field service engineer; coverage for parts, labor, and travel; inclusion of software upgrades; and a 98% uptime guarantee. All services must be completed in accordance with manufacturer specifications and relevant regulatory standards. 3. Location Equipment requiring service is located at the El Paso VA Healthcare System Pathology & Laboratory Medicine Services Main Laboratory. 4. Performance

Requirements: 4.1 Maintenance 4.1.1 The Vendor shall perform preventive maintenance at intervals specified by the manufacturer to ensure proper equipment performance. 4.1.2 After Preventative Maintenance (PM), the vendor shall submit a detailed work report to the COR for notice at no additional cost to the government. 4.1.3 Delivery of PM parts or material. The vendor shall provide all preventive service materials at no additional cost the government. 4.2 Service 4.2.1 On-call Repairs: On-call repairs are emergency repairs beyond the scheduled maintenance. 4.2.1 The vendor shall provide technical assistance not limited to test performance, or equipment malfunction twenty-four (24) hours a day, seven (7) days a week, excluding all Federal Holidays, via direct communication thru a telephone bank with technically capacitated and certified personnel by the vendor. 4.2.2. The vendor shall respond to a call for on-site, Monday Friday, 0800 18:00 hours. After repair, the vendor shall submit a detailed work report to include all required materials and is to be at no-charge to the facility. 4.3. For delivery of repairs parts or materials the vendor shall provide all parts and materials at no additional cost the government. 4.3.1 Vendor shall remove all parts, equipment or materials replaced, or upgraded by the vendor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the Government. 4.4 Safety 4.4.1 Vendor shall immediately notify the service of any changes in reagents kits composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulations. 4.5 Test Performance 4.5.1 All test and procedures must comply and be approved by the FDA. 4.5.2. All test, procedures, and equipment must perform at manufacturer specifications, deviations from the performance specifications shall be corrected by the vendor. 4.5.3. All test performance will be evaluated by and not limited for performance thru peer comparison, quality control and CAP peer evaluation according to CLIA. 5.

Period of Performance The start date for future services contract will be the day following the warranty expiration, with subsequent periods adjusted accordingly. Estimated dates, will be subject to after the actual installation date. 6.

Deliverables/Supplies N/A 7. Sole Source Justification 7.1