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 <2 Repairs by quarter by equipment. 95% Monthly monitoring Exercise of Option Period and past performance. 4.2.1 Troubleshooting via phone. Within 24 hours 95% Monthly Monitoring Exercise of Option Period and past performance. 4.5.2 Successful reporting of results Repeat runs are minimal
95% Direct Observation, Quality control reports run as needed. Exercise of Option Period and past performance.
4.5.3 Successful Peer group comparison CAP survey performance 95% Direct Observation CAP survey report Exercise of Option Period and past performance. Documentation 6.5 Invoice Accountability Monthly invoices 100% Invoices received through IPPS Exercise of Option Period and past performance. 6.5.1 Invoice Verification Monthly invoices 100% Invoices contain all necessary information for proper processing. Exercise of Option Period and past performance 6.2.1 Equipment specifications and user manuals Provided prior to delivery of equipment. 100% Up to date information supplied by vendor as changed. Exercise of Option Period and past performance Customer Satisfaction 10.2 Substantiated complaints from lab users 1 complaint per quarter 100% Reports of contacts or other documentation. Exercise of Option Period and past performance
2.2. NARA Records Management Language for Contracts Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. El Paso Veteran Affairs Health Care System (EPVAHCS) and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of EPVAHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to EPVAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to EPVAHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and EPVAHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with EPVAHCS policy. The Contractor shall not create or maintain any records containing any non-public EPVAHCS information that are not specifically tied to or authorized by the contract. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. The EPVAHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which EPVAHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. -End of Document-