CEPHEID SOW_FY25_Honolulu.doc

VA Pacific Islands Health Care System

CEPHEID GENEXPERT TEST SYSTEMS

Statement of Work 1.0 General. VA Pacific Islands Health Care System (VAPIHCS) requires an IDIQ contract on a Cost per Test basis for the reagents and services of a Contractor to provide analyzers, computer/laptop to directly control/operate/program the analyzer if needed, supplies, test kits, applicable accessories, service and annual maintenance for the Cepheid GeneXpert systems placed at the following locations: Ambulatory Care Clinic (ACC) Laboratory (GeneXpert XVI & GeneXpert IV Xpress System) and Faleomavaega Eni Fa’aua’a Hunkin VA clinic lab in American Samoa (GeneXpert IV Xpress System). The reagents/test kits required for testing on the GeneXpert platforms shall be on an Indefinite Delivery Indefinite Quantity Cost Per Test basis to include analyzer lease and basic maintenance/service for the duration of the contract. Current Cepheid GeneXpert analyzers acquired via previous contract #36C26123P0816.

2.0 Period of Performance shall be from October 1, 2024 through September 30, 2025

Option Year 1: October 1, 2025 through September 30, 2024

Option Year 2: October 1, 2026 through September 30, 2025

Option Year 3: October 1, 2027 through September 30, 2026

Option Year 4: October 1, 2028 through September 30, 2027 3.0 Place of Performance and Hours of Operation

Services involved shall be accomplished at the VA Pacific Islands Care System located at 459 Patterson Road 1-C11, Ambulatory Care Clinic (ACC) Molecular Laboratory, Honolulu, HI 96819 and the Faleomavaega Eni Fa’aua’a Hunkin VA, Fiatele Teo Army Reserve Building, Pago Pago, AS 96799. The contractor shall provide technical support for the ACC Lab, service 7:00 a.m. to 5:00 p.m. Monday-Friday and annual instrument maintenance and shall be arranged in advance with the COR. Service for the analyzer placed in American Samoa will be accomplished at the ACC Lab following shipment receipt of the analyzer from American Samoa. Onsite maintenance service will not be required for analyzers placed in American Samoa. Any additional services outside this scope of work shall be conducted upon receipt of an approved purchase order from the VAPIHCS.

4.0 Points of Contact:

4.1 COR – Contracting Officer’s Representative – Jodi Liao at (808) 433-7619 or email jodi.liao@va.gov.

4.2 COR Alternate: Catherine Ah Yat (808) 433-7618 or email catherine.ahyat@va.gov

5.0 CO Responsibilities:

5.1 The CO is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the CO on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

5.2 The CO shall resolve complaints concerning Contractor relations with the Government employees or patients. The CO is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the CO without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

5.3 In the event that contracted services do not meet quality expectations the best remedy will be implemented, including but not limited to, a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

6.0 COR Duties and Responsibilities:

6.1 The COR will be appointed by the CO and a copy of the appointment letter outlining the responsibilities of the COR will be provided to the Contractor.

6.2 The COR shall be the VA official responsible for verifying the contract compliance. After contract award, any incidents of Contractor noncompliance, as evidenced by the monitoring procedures, shall be forwarded immediately to the CO.

6.2 The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled.

6.3 The COR will review and certify monthly invoices for payment. If, in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference.

6.4. All contract administration functions will be retained by the VA.

7.0 Contractor Qualifications: Contractor’s technicians performing services shall be professionally trained and qualified to work on all components of the equipment and the latest revisions of hardware and software as required by the manufacturer. Contractor personnel must be able to provide proof of successful completion of training and certification as requested by the COR.

8.0 Contractor Responsibilities:

8.1 Contractor shall provide all analyzers, supplies, test kits, applicable accessories (i.e. analyzer computer & software, printer, UPS, etc.), service and annual maintenance for the Cepheid GeneXpert test systems.

8.2 System Requirements shall include:

8.2.1 The GeneXpert analyzers (on lease from vendor) are used to perform PCR testing for C. difficile, MRSA, SARS-CoV-2, Multiplex test cartridge containing SARS-C0V-2/Flu A/Flu B/RSV, Streptococcus Group A, Chlamydia trachomatis / Neisseria gonorrhea, Trichomonas vaginalis, and Multiplex Vaginitis Panel. These specific tests are required to be available to run on the GeneXpert analyzers.

8.2.2 A total of 3 analyzers are required – one (1) GeneXpert XVI and two (2) Xpert Xpress 4-bay analyzers.

8.2.3 Special laboratory conditions which are required with other PCR test systems are not needed with the GeneXpert PCR test.

8.2.4 Testing can be performed in the general laboratory environment. Reliable PCR test results are available within 1 - 2 hours.

8.2.5 Analyzer shall be able to connect with Data Innovations middleware for data/result transmission into VistA. Note: analyzer will not connect directly to VistA for data/result transmission.

8.2.6 Access to a technical support hotline via phone call shall be available to the Government during normal business hours of Monday thru Friday 7:30 a.m. to 4:30 p.m. for basic troubleshooting assistance.

8.2.7 In the event the technical support hotline identifies an issue requiring onsite repair, the Contractor shall send a service engineer to the laboratory within 24-48 hours or next business day.

8.2.8 Upgrades: The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of-the-art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered (e.g. new version software, upgrade to replace model of equipment no longer Contractor supported, etc.).

9.0 Identification, Parking, Smoking and VA Regulations

9.1 Contractor personnel performing work onsite at the VAPIHCS facility shall wear visible identification at all times while on the premises of VAPIHCS. All personnel entering the VA facility may have to consent to inspection of all categories of packages as a condition of admittance.

9.2 It is the responsibility of contractor personnel to park in the appropriate designated parking areas. VA will not invalidate or make reimbursement for parking violations under any conditions.

9.3 Smoking is prohibited in any VAPIHCS building and the surrounding grounds, including the parking lots. Smoking is permitted only in a designated shelter.

9.4 Intoxication, debilitation resulting from drug use, insubordination, theft, patient abuse, dereliction, or negligence in performing directed tasks and possession of weapons is prohibited and grounds for immediate removal from VAPIHCS by VA Security and/or the Tripler Army Medical Center Provost Marshall Office (PMO). All personnel entering the facility may have to consent to inspection of all categories of packages as a condition of admittance.

9.5 Violations of VA Regulations may result in a citation answerable in the U.S. Federal District Court.