6515--NEW - Cepheid GeneXpert Laboratory Diagnostics Equipment

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 Contracting Officer will make the final determination on all justifications and the CO has the warrant to do those decision.

8. Vendor Security Contract Requirements.

The equipment and or instruments will be interfaced to the EPVAHCS information system (VISTA). There will be supervised access when the vendor is physically present for technical support, service calls, and scheduled preventative maintenance. The instrument hard drive will remain on site for external repairs or termination of the lease.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

9. Records Management

All records (administrative and program specific) created during the period of the contract belong to El Paso VA Health Care System (EPVAHCS) and must be returned to EPVAHCS at the end of the contract

10. PERSONNEL QUALIFICATIONS:

10.1.1. The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this SOW. The Contractor shall maintain the personnel, organization, and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements. The work history of each contractor employee must contain experience directly related to the task and functions he/she is intended to perform under this contract. The Government reserves the right, during the life of the resulting contract, to request work histories on any contractor employee for the purposes of verifying compliance with the above requirements; additionally, the Government reserves the right to review resumes of contractor personnel proposed to be assigned. Personnel assigned to, or utilized by, the Contractor in performance of work shall be fully capable of performing the requirements contained in the /SOWPWS in an efficient, reliable, and professional manner. The normal manner of dress is business casual.

10.2. Specific Personnel Qualifications Requirements Personnel assigned to or utilized by the contractor in the performance of this contract shall, as a minimum:

10.2.1. Be qualified by the contractor as capable to perform as a field service representative.

11. PERFORMANCE STANDARDS AND QUALITY MEASUREMENT:

11.1 Performance standards define desired services. The Government performs surveillance to determine if the Contractor exceeds, meets, or does not meet these standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL). The Quality Assurance Surveillance Plan (QASP) method of surveillance will be by random inspection.

11.2 Performance Evaluation: After acceptance of the contract the system will be monitored for equipment performance including but not limited to; safety (recall Notifications and changes in reagents and equipment notifications), quality assurance (emergency repairs response, hot line troubleshooting response, quality of results compared to peer groups and CAP performance) and documentation (invoice accountability and invoice verification, equipment specification and user manuals), customer satisfaction (response to complaints and laboratory employees training)

11. Quality Assurance Surveillance Plan (QASP) and its performance are as follows:

Task

ID

Indicator

Standard

Acceptable Quality Level

Method of Surveillance

Incentive

Safety

4.4.1

Recall Notification

Timely recall notification of reagent and supplies.

100%

Monthly monitoring

Exercise of Option Period and past performance.

4.4.1

Changes in reagent and equipment modifications.

Timely distribution / notification of

100%

Direct Observation

Exercise of Option Period and past performance.

Quality Assurance

4.2.2.1

Emergency Repairs

Within 24 hours