SFVA Micro Cepheid 2026 SOW.docx

Cepheid Service/Supply Contract Statement of Work

1. Period of Performance:

1. The San Francisco VAHCS utilizes polymerase chain reaction (PCR) testing to detect and diagnose critical illness such as COVID-19, Influenza A & B, Respiratory Syncytial Virus (RSV), Clostridium difficile (C-Diff), Women’s Health (bacterial vaginosis, vulvovaginal candidiasis, & trichomoniasis) and Mycobacterium Tuberculosis (M-TB) infections. The Cepheid GeneXpert analyzer is VA-owned equipment.

SFVAHCS is seeking a five-year indefinite delivery/indefinite quantity (IDIQ) contract to provide service and supplies for the VA-owned analyzer. The contract needs to be IDIQ, “funding over quantity” to allow the service the needed flexibility to respond to unpredictable patient needs.

1. System Service/Support/software:

24x7 Phone Support Onsite 5x10 hours (8AM – 6PM) Annual Preventative Maintenance Check-up performed by Field Service Engineer Includes Parts, Labor & Travel Software Upgrades included 98% Uptime Guarantee Advantage Service Agreement for GeneXpert s/n: 836818

1. Supply

Information Security Overview:

The Cepheid GeneXpert analyzer operates without collecting or storing patient information. For patient reference purpose, an accession number is generated through the Vista labs package. Results are transmitted to CPRS via the Data Innovation software. The device is connected to the internet through VLAN 717. Contractors do not have remote access to the device and are required to be escorted by a lab specialist during any on-site visit. This contract is seeking service from the vendor to provide supplies and device maintenance.

C&A requirements do not apply, and that a Security Accreditation Package is not required: and proceed to the next question.

The contractor will not have access to VA sensitive information or PII/PHI to fulfill the terms of the contract. A BAA will not be required.

Records Management Language

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

1. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

1. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

1. 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 by the Freedom of Information Act.

1. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

1. The Government Agency owns the rights to all data/records produced as part of this contract.

1. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

1. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e- mail, fax, etc.] or state of completion [draft, final, etc.].

1. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

1. 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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.