PWS BacT Alert Virtuo.docx

Department of Defense Defense Health Agency Performance Work Statement

Directorate of Clinical Support Services (DCSS)

Laboratory

Solicitation Number:

Version: 1.0

PART 1

1.0 GENERAL INFORMATION

1.1. This is a non-personal supplies and service contract to provide a leased Biomerieux BacT/Alert Virtuo blood culture test system, consumables to operate analyzer, and preventive/corrective maintenance of the analyzer. All maintenance should be performed Monday through Friday between the hours of 8:00 AM and 5:00 PM. Consumables for use only on the Biomerieux BacT/Alert Virtuo blood culture analyzer must include aerobic, anaerobic, and pediatric blood culture bottles used for inpatient and outpatient beneficiaries as well as required adapters. This test systems provides necessary blood culture results which can help clinicians make timely and informed medical decisions for patients with life-threatening conditions. Performance Work Statement (PWS) and with all other terms and conditions set forth herein.

Description of services/introduction. The contractor is fully responsible for delivering a comprehensive suite of resources essential for the repair, maintenance, and servicing of the Biomerieux BacT/Alert Virtuo blood culture analyzer 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 must be in compliance with manufacturer specifications. Repairs and software updates, upgrades, etc. must be in compliance with FDA and CDC guidelines. Only original equipment manufacturer 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.

The contractor will complete installation and method validation according to The College of American Pathologists (CAP) requirements to include, but not limited to accuracy, precision, linearity, and method comparison studies.

Supplies/consumables to include bottle adapters (all bottle types), aerobic, anaerobic, and pediatric blood culture bottles compatible with the Biomerieux BacT/Alert Virtuo blood culture analyzer must all be delivered according to the enclosed consumable shipping schedule.

1.2. Background. The contractor is responsible for supplying all the necessary services, materials, and equipment, as well as the related consumables and supplies for the Clinical Laboratory at Naval Hospital Guam. Their role is to ensure that the equipment operates reliably and consistently in accordance with manufacturer requirements. The services to be provided under these specifications encompass the provision of all necessary labor, equipment, materials, and components to carry out all repairs on the equipment list. This is to ensure that the equipment continues to operate at its intended efficiency and capacity.

1.3. Scope. The lease of the Biomerieux BacT/Alert Virtuo blood culture analyzer to include all required consumables, and corrective and preventive maintenance. The maintenance and service must adhere to Industry Standards and meet or exceed all manufacturer requirements. Repairs and software updates, upgrades, etc. must be in compliance with FDA and CDC guidelines. Only original equipment manufacturer parts are authorized on this equipment. Supplies/consumables must be available according to the enclosed shipping schedule. Consumables must be readily available and shipped in accordance with the enclosed shipping schedule.

1.4. NMRTC GUAM Corrective Maintenance Requirements:

a) 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.

b) Ensure that only FULLY QUALIFIED FIELD ENGINEERS and TECHNICIANS who have gone through original equipment manufacturer (OEM) training shall be employed in the performance of all work performed under this contract. Maintenance of the Biomerieux BacT/Alert Virtuo blood culture analyzer must be in compliance with manufacturer specifications. Repairs and software updates, upgrades, etc. must be in compliance with FDA and CDC guidelines. Only original equipment manufacturer parts are authorized on this equipment. Upon request, contractor shall provide training certificates (or notarized copies) to the Material Management Department BIOMED division for verification.

1.4.1. Response Time:

1.5. 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 a qualified service engineer 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 only FULLY QUALIFIED FIELD ENGINEERS & TECHNICIANS who have gone through original equipment manufacturer (OEM) training for work performed under this contract. 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 24 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 that utilizes the correct consumables if analyzers must be shipped to the manufacturer for repair/replacement.

*Ensure timely communication of any manufacturer recalls

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

*Extend to the government all commercial warranties or 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 consumables are 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.

*Must provide end-user training (base year only) on-site or via an online means.

TITLE TO EQUIPMENT: The government shall not assume possession of any part of the equipment. The contractor retains ownership to title thereof.

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 (1) one day.

COMPENSATION: Labor: All compensation for labor is included in the contract price. Parts and Materials: All compensation for parts and materials is included in the contract pricing. Parts/Supplies Quality: Parts and Supplies provided under this contract shall be guaranteed to be equal in all respects, including performance, interchangeability, durability and quality to the OEM parts when new or as presently recommended by the manufacturer.

Services include preventative maintenance, software upgrades, firmware upgrades, operational checks, and adjustments to on-site equipment in order to ensure the equipment is fully operational and within OEM specifications. The contractor shall ensure a fully operable Biofire Fire Film Array analyzer up on completion of any service, parts replacement, hardware upgrade, software upgrade, etc. prior to end of service.

1.6. Period of Performance (PoP).

Base - From: 01OCT2025-30SEP2026 Option 1 - From: 01OCT2026-30SEP2027 Option 2 - From: 01OCT2027-30SEP2028 Option 3 - From: 01OCT2028-30SEP2029 Option 4 - From: 01OCT2029-30SEP2030

1.6.1. Transition: Transition-in/transition-out period, not required if incumbent vendor. Otherwise, thirty (30) days if not incumbent vendor.

1.7. Administrative specifications.

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

U.S. Naval Hospital Guam Laboratory Department Building 50 Farenholt Road, 1st Floor Agana Heights, Guam 96910

1.7.2. Recognized Federal holidays:

Independence Day

1.7.3. Hours of operation: The contractor is responsible for conducting business Monday through Friday 0800-1700 except Federal holidays or when the government facility is closed due to local or national emergencies, administrative closings, or similar government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the government facility is not closed for the above reasons.

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

1.8. Contractor travel. Contractor shall not be authorized travel expenses.

1.9. Other Direct Costs (ODC). N/A.

1.10. 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.

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 Road, 1st Floor Agana Heights, Guam 96910

1.10.1. Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

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