Performance Work Statement - Bactec Equipment Preventive and Corrective Maintenance.docx

Department of Defense Defense Health Agency Performance Work Statement

BACTEC FX ANALYZER SERVICE

Directorate of Clinical Support Services (DCSS)

Laboratory

PART 1

1.0 GENERAL INFORMATION

1.1. This document outlines a service contract for the BACTEC FX analyzer (Serial Number FT1082). The Original Equipment manufacturer specifically designed the BACTEC FX Analyzer for rapid detection of bacteria and fungi in clinical specimens, blood, and blood products. A qualified healthcare provider initiates these tests to gather crucial information about microbial infections in patients and to determine appropriate antibiotic treatments. Samples obtained from patients or blood/blood products are introduced into BD BACTEC vials, which are then placed in the analyzer for incubation and testing. Subsequently, a clinical laboratory scientist conducts the necessary tests and furnishes the requesting provider with the patient's microbial identification and susceptibility test results. The system performs positivity analysis, announcing a positive vial through audible alerts, on-screen indications, and the Positive Vial system indicator. Positive test results are indicated through multiple methods, including photo detector row board test readings and positivity analysis.

1.2. Description of services/introduction. The contractor is responsible for providing all necessary personnel, equipment, supplies, facilities, transportation, tools, materials (including consumable parts software upgrades, and accessories), supervisor, training, travel, and labor required to maintain the BACTEC FX Analyzer as outlined in this Performance Work Statement.

1.3. Background. The contractor is responsible for providing all necessary parts, consumables, and labor for the preventive and corrective maintenance of the BD BACTEC Analyzer utilized in clinical microbiology at the Clinical Laboratory in Naval Hospital Guam. Their primary objective is to ensure the reliable and consistent operation of the equipment. The specified services encompass the provision of all essential labor, equipment, materials, transportation, and components required for conducting repairs on the analyzer. This is crucial to maintain the equipment's operational efficiency and capacity to maintain patient care capabilities.

1.4. Objectives. To establish an agreement to complete corrective and preventive maintenance as required for the BD BACTEC FX analyzer. The BD BACTEC FX analyzer must be capable of identifying base and complex anaerobic/aerobic microbiology organisms and fungi as listed by BD BACTEC microbiology reference manual from BD aerobic, anaerobic, and pediatric bottles. Full functionality is critical to the care of patients at this hospital.

1.5. Scope. Corrective maintenance as requested by Naval Hospital Guam to ensure full functionality of the BD BACTEC FX analyzer. Preventive maintenance as directed by manufacturer requirements to include manufacturer defined intervals. The contractor must schedule Preventive and Corrective maintenance with the customer in advance and must make work reports available within 24-48 hours of services rendered. The contractor shall provide all materials, BD bottles, calibrators, parts, and consumables required to perform maintenance. The contractor shall return the customer’s request for corrective maintenance within 24-48 hours of notification. Upon arrival, the vendor shall ensure the analyzer is fully operational prior to departing. Telephone technical support service availability 24 hours a day, 7 days per week for analyzer troubleshooting.

*Ensure that only FULLY QUALIFIED FIELD ENGINEERS & TECHNICIANS who have completed original equipment manufacturer (OEM) or comparable third-party service school for the above-mentioned equipment shall be employed in the performance of all work performed under this contract. The contractor shall ensure that the highest standard of professional capability and electrical/mechanical workmanship is maintained throughout the life of this contract.

*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, and labor for the analyzer listed in the PWS.

*Correct inoperable conditions in a timely manner with a response, in person, upon customer request as quickly as possible. Service hours for Naval Hospital Guam Laboratory are 24 hours. The laboratory is open 24 hours a day. The contractor must contact the laboratory before arriving to arrange base access.

*Provide the work necessary to restore the equipment to a serviceable/operating condition by adjustments, replacement parts, or minor repairs when it is determined that extensive repairs and parts replacements are not necessary.

*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.

* If extensive consumables (i.e., blood culture bottles), quality control material, is exhausted during troubleshooting, it is the contractor’s responsibility to replenish that supply to the government.

LIABILITY: The contractor shall not be liable for any loss, damage, or delay due to any cause beyond their 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 government will provide the contractor reasonable access to all equipment 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 receiving permission from on duty personnel responsible for such equipment.

CONTRACTOR CHECK-IN/CHECK-OUT: The contractor is required to report to the clinical laboratory for Visitor Badges during the hours of 0730-1600 hours, Monday through Friday, prior to and upon completion of any service/repair performed.

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

1.6. Administrative specifications.

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

Naval Hospital Guam Laboratory

1.6.2. Recognized Federal holidays:

Independence Day

1.6.3. Hours of operation: The contractor is responsible for conducting business Monday through Friday 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 always maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the government facility closes for other reasons.

1.6.4. Emergency Services: On occasion, the government may require the contractor to support an activation or exercise of contingency plans outside the normal duty hours.

1.7. Quality. Quality Control (QC): FIELD SERVICE REPORTS: The contractor shall furnish:

The contractor shall submit a legible copy of the Field Service Report, detailing all work performed, immediately following the service. The contractor or contractor 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.

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