Performance Work Statement Biofire Film Array.docx

Department of Defense Defense Health Agency Performance Work Statement

Maintenance of Laboratory Equipment and Provision of Equipment Consumables

Directorate of Clinical Support Services (DCSS)

Laboratory

Solicitation Number:

Version: 1.0

PERFORMANCE WORK STATEMENT

PART 1

1.0 GENERAL INFORMATION

The equipment and supplies listed herein are essential to support respiratory, gastrointestinal blood culture, meningitis/encephalitis, and tropical fever PCR testing for inpatient and outpatient beneficiaries. These test systems provide comprehensive results in about one hour, which can help clinicians make timely and informed medical decisions.

1.1. This is a non-personal service and provision of supplies requirement to provide Corrective Maintenance, Preventive Maintenance, Repairs, and Test Kits for a:

(i) Biofire Film Array Torch Base with 4 units/modules (SNs TM01467, TM04500, TM07941, TM08266 AND TM03483); and (ii) two Biofire Film Array 2.0 analyzers (SNs 2FA09639 and 2FA09394).

1.2 Description of services. The contractor shall provide all parts, tools, labor, materials, equipment, software upgrades, and transportation to perform the Preventive Maintenance, Corrective Maintenance, and Repairs; and Consumables for use on the Biofire analyzers.

The contractor shall deliver a comprehensive suite of resources essential for the repair, maintenance, and servicing of the Biofire Film Array Torch and Biofire Filmarray 2.0 as specified in this Performance Work Statement (PWS). This includes all necessary personnel equipped with the expertise to carry out these tasks effectively, as well as the requisite equipment and specialized tools designed specifically for the maintenance.

Maintenance of onboard equipment (BioMerieux Biofire Torch-4 modules and BioMerieux Biofire Filmarray 2.0) must be per the Original Equipment Manufacturers (OEM) specifications. Repairs and software updates, upgrades, etc. must be per FDA and CDC guidelines. Only OEM parts are authorized on this equipment. If repairs cannot be done on-site, then "loaner" equipment must be provided for equipment shipped to the vendor for repair/replacement in accordance with the maintenance agreement.

Additionally, the contractor will supply all vital materials and supplies, including any unique components needed for repairs. Adequate facilities for performing these services will also be ensured by the contractor. The contractor is tasked with organizing transportation for both personnel and equipment to and from the work site, along with managing all travel logistics efficiently. All labor associated with maintenance and servicing will be handled by the contractor, who will provide expert supervision and training to ensure a high standard of performance.

Supplies/consumables to include Respiratory Panel (RP) 2.1, Blood culture identification (BCID2) panel, Gastrointestinal panel (GI), Meningitis/encephalitis (ME) panel, RP 2.1 quality control plus panel, BCID2 control panel, GI control panel, and ME control panel must be delivered according to the enclosed consumable shipping schedule.

1.2. NMRTC GUAM Corrective Maintenance Requirements:

a) The contractor shall perform corrective maintenance of currently broken equipment. The repair will involve addressing issues with two of the Biofire Film Array Torch modules, which are currently not operational and able to perform necessary testing due to invalid readings.

b) Perform repair, calibrations, and operational testing to the extent necessary to ensure the function of the equipment so that, it will efficiently serve its intended purpose.

c) Ensure that only fully qualified field engineers and technicians who have completed OEM training shall be employed in the performance of all work performed under this contract. Upon request, contractor shall provide training certificates (or notarized copies) to the Material Management Department BIOMED division for verification.

1.2.1. Response Time:

1.3. Corrective/ Preventive Maintenance.

This service plan will include at a minimum all the following: 24 hours a day/7 days per week telephone technical support with on-site technical support dispatched as necessary, provide hardware and software upgrades when available at no additional cost and in compliance with manufacturer, FDA and CDC requirements. All maintenance must be performed by fully qualified field engineers and technicians at no additional cost and with original parts (no third party parts).

*24/7 customer service hotline for over the phone trouble shooting.

*Ensure that the highest standard of professional capability and electrical/mechanical workmanship is to be maintained throughout the life of this contract.

*Perform required preventive maintenance (PM) as defined by the manufacturer and /or College of American Pathologists (CAP) standards. The contractor will provide in writing the schedule for routine PM and service on all covered equipment. Scheduled PM(s) will be coordinated with the clinical laboratory and shall be documented, with a copy of that documentation being provided immediately following completion.

*Make repairs to the extent necessary (as determined by inspection tests or disassembly) to ensure a functional system that will efficiently serve its intended purpose. The contractor is responsible for all costs to include parts, shipment, travel, and labor for the analyzer listed in the PWS.

*Correct inoperable conditions in a timely manner with communication no greater than 48 hours from the time the request for service was received. Schedule as soon as possible for analyzer inoperability. Service hours for Naval Hospital Guam Laboratory is 24 hours. Contractor will have to call before arriving so arrangements can be made for access to the base.

*Provide the work necessary to restore the equipment to a serviceable/operating condition by adjustments, replacement parts (original parts only), or minor repairs when it is determined that extensive repairs and parts replacements are not necessary. Coordinate “loaner” equipment if analyzers must be shipped to the manufacturer for repair/replacement.

*Equipment improvements/modifications shall be made only on written approval.

*Notify the clinical laboratory immediately upon receipt of OEM or replacement parts/equipment safety recall notices.

*Ensure that original design and functional capabilities will not be changed, modified, or altered unless the clinical laboratory authorizes such changes.

*Provide suitable modern recommended repair equipment/tools required for the satisfactory execution of all repairs made.

*Furnish OEM approved lubricants and lubricate wear points within the equipment.

*Extend to the government all commercial warranties on replacement parts, consistent with standard industry practices.

*Maintain an adequate spare parts inventory on parts with a history of high failure/replacement rates on-site for the customer’s use.

* If extensive testing consumables to quality control material is exhausted during troubleshooting, it is the contractor’s responsibility to replenish that supply to the government.

*Must be capable of interfacing to the government laboratory information system, Military Health System (MHS) Genesis.

LIABILITY: The contractor shall not be liable for any loss, damage, or delay due to any cause beyond his reasonable control including but not limited to, acts of government, strikes, lockouts, fire, explosion, theft, floods, riot, civil commotion, war, malicious mischief of acts of God.

UTILITIES: The contractor may use government utilities, (electrical power, compressed air, and water) that is available and required for any service performed under this contract. The building engineer, to ensure compatibility with the Naval Hospital Guam’s electrical wiring and equipment, must approve contractor electrical equipment.

ACCESS TO EQUIPMENT: The contractor shall be provided reasonable access to all equipment that is to be serviced and utility outlets required to do the service. The contractor shall be free to start and stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on duty personnel responsible for such equipment.

CONTRACTOR CHECK-IN/CHECK-OUT: The contractor or his representative is required to report to the clinical laboratory for Visitor Badges during the hours of 0800-1600 hours, Monday through Friday, prior to and upon completion of any service/repair performed.

GOVERNMENT PERSONNEL: Naval Hospital Guam’s Laboratory employees and Biomedical staff will not perform maintenance or attempt repairs to equipment, outside what is expected by the end user as required, while such equipment is under the purview of this contract unless agreed to in writing by the contractor.

PARTS AVAILABILITY: To ensure minimal downtime to equipment, the contractor shall maintain replacement repair parts and materials necessary to perform each repair or supply said parts and materials within (10) ten days.

The contractor shall ensure a fully operable Biofire Fire Film Array analyzer upon completion of any service, parts replacement, hardware upgrade, software upgrade.

1.4. Period of Performance.

Base Year ----- 15 January 2025 to 14 January 2026 Option Year 1 - 15 January 2026 to 14 January 2027 Option Year 2 - 15 January 2027 to January 14 2028 Option Year 3 - 15 January 2028 to 14 January 2029 Option Year 4 - 15 January 2029 to 14 January 2030

1.4.1. Transition: Transition-in/transition-out period, not required if incumbent vendor. Otherwise, ninety (90) days if not incumbent vendor.

1.5. Administrative specifications.

1.5.1. Place of performance: The work shall be performed at:

U.S. Naval Hospital, Guam Laboratory Department Building #50 Farenholt Ave Agana Heights, Guam 96910

1.5.2. Recognized Federal holidays:

Independence Day

1.5.3. Hours of operation: The Military Treatment facility is available for contractor performance of work Monday through Friday, between 0900-1700, except Federal holidays or when the government facility is closed due to local or national emergencies, administrative closings, or similar government directed facility closings.

1.5.4. Emergency Services: on occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours.

1.6. Quality. Quality Control (QC): FIELD SERVICE REPORTS: The contractor or their representative shall furnish to:

Biomedical Repair Division Laboratory Department

The day of a legible copy of the Field Service Report detailing work performed is to be submitted. The contractor or their representative shall complete the government copy of this Field Service Report by including the following:

*Date & Time notified *Date & Time Arrival *BCN (Bar Code Number) Type, serial # and model # of equipment *Time spent repairing/servicing *Description of malfunction *General description of replaced parts and service performed *Comments as to cause of malfunction *Recommendations to prevent future occurrences

FIELD SERVICE REPORTS ARE REQUIRED PRIOR TO APPROVAL OF ALL INVOICES

The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system.

The contractor shall furnish a written or electronic vendor supplied Field Service Report (FSR) to the Duty Staff at:

U.S. Naval Hospital Guam Laboratory Department Building #50 Farenholt Ave Agana Heights, Guam 96910 image1.jpeg