Attachment 1- Performance Work Statement Cepheid Service.pdf

Department of Defense Defense Health Agency

Performance Work Statement

Directorate of Clinical Support Services (DCSS)

Laboratory

Version: 1.0 Date: 26 September 2024

PART 1

1.0 GENERAL INFORMATION

1.1. This is a non-personal services contract to provide one-time repair and service maintenance for the Cepheid GeneXpert Infinity, capable of performing a comprehensive menu of tests to be run on a single system, by a single operator, in a moderately complex, real-time environment. The effort required hereunder shall be performed in accordance with this Performance Work Statement (PWS) and with all other terms and conditions set forth herein.

1.2. Description of services/introduction. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, training, travel, labor, and other items and non-personal services necessary to repair, maintain and service the Cepheid Genexpert Infinity as defines in this PWS, except for those items specified as government-furnished property and services. The contractor shall perform to the standards in this PWS.

1.3. 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. 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.

1.4. Scope. The maintenance and service must adhere to Industry Standards and meet or exceed all applicable codes, including Local/State Regulations, NFPA, building codes, communications codes, and other relevant codes for each utility identified. The analyzer must have its method performance specifications (accuracy, precision, linearity, correlation, and normal reference study) verified onsite. This ensures the analyzer meets the necessary performance criteria in its actual operating environment. The contractor is responsible for completing training on the analyzer upon scheduled service and maintenance if needed. This ensures that the personnel operating the analyzer are well-versed in its use and maintenance. All services, materials, and equipment will be provided by the contractor to conduct one-time repairs for the Cepheid GeneXpert Infinity, an automated cartridge-based nucleic acid amplification testing analyzer able to differentiate fluid contains shreds of the SARS-CoV-2 amongst others.

1.5. U.S. Naval Hospital Guam One-Time Repair Requirements:

a) Contractor shall do a one-time repair of the unit. The repair will involve addressing issues with three of the Cepheid modules, which have reported error readings indicating that they have surpassed the required temperature thresholds. Additionally, we will require the repair of the Gantry system (robotic arm). The contractor will be responsible for executing all necessary repairs to ensure that the unit is fully operational.

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 gone through original equipment manufacturer (OEM), 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.

1.5.1. Response Time:

a. Complete all on site repairs within 2-4 business days.

b. Available hours are Mon thru Fri 0800-1600

*The contractor shall provide all validation, calibrators, and consumables required to perform the one-time repairs, maintenance and initial validation.

1.6. Service/ Preventive Maintenance.

This service plan will include at a minimum all of 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 analyzer preventative maintenance IAW OEM specifications performed by a qualified service engineer at no additional cost.

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

*No later than 24 to 48 hours after telephone notification, to a monitored contractor emergency telephone number to be provided by the contractor to clinical laboratory. Perform service maintenance to industry standards.

*Ensure that only FULLY QUALIFIED FIELD ENGINEERS & TECHNICIANS who have gone through original equipment manufacturer (OEM) or comparable third-party service schools for the above-mentioned equipment shall be employed in the performance of any and all 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.

*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 a response, in person, time of no greater than next day for analyzer inoperability. Service hours for Naval Hospital Guam Laboratory is 24 hours. The laboratory remains open on a 24 hours bases, 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, 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.

*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 cartridges ot quality control material is exhausted during troubleshooting, it is the contractor’s responsibility to replenish that supply to the government.

*If testing requirement change during the period of performance, it is the vendors responsibility to provide the testing cartridges necessary to perform all testing covered by the original contract documentation.

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

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 Cephied GeneXpert Infinity analyzer up on completion of any service, parts replacement, hardware upgrade, software upgrade, etc. prior to end of service.

1.7. Period of Performance (PoP).

Base - From: 15 December 2024 to 14 December 2025 Option 1 - From: 15 December 2025 to 14 December 2026 Option 2 - From: 15 December 2026 to 14 December 2027 Option 3 - From: 15 December 2027 to 14 December 2028 Option 4 - From: 15 December 2028 to 14 December 1029

1.7.1. Transition: Transition-in/transition-out period, not required if incumbent vendor.

Otherwise, ninety (90) days if not incumbent vendor.

1.8. Administrative specifications.

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

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

1.8.2. Recognized Federal holidays:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

1.8.3. 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 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.

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

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

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

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

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 Ave Agana Heights, Guam 96910

1.11.1. 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).

APPENDIX A: Units being covered.

ECN SERIAL COMMON MODEL MANUFACTURER PM INTERVAL

083811 841524 GeneXpert Cepheid Anually