Performance Work Statement Vitek 4.0.docx

Department of Defense Defense Health Agency Performance Work Statement

VITEK COMPACT 2 ANALYZER

Directorate of Clinical Support Services (DCSS)

Laboratory

Solicitation Number: HT941024N0161 Version: 4.0 Date: 19 September 2024

PART 1

1.0 GENERAL INFORMATION

1.1. This is a services contract to provide two (2) Vitek 2 Compact Analyzer, capable of performing microbial identification and antibiotic susceptibility testing. Tests are requested by a credentialed provider to obtain critical information about the patient’s microbial infections and appropriate antibiotic treatments. A clinical laboratory scientist performs the requested testing and provides the requesting provider with results of the patient’s microbial identification and susceptibility tests. Refer to Vitek Microbiology reference manual for a list of all Gram-Negative, gram Positive, and Yeast identifications tested through the Vitek.

1.2. Description of services/introduction. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials (including all ID/AST cards, calibrators, consumables parts, software upgrades and accessories), supervision, training, travel, labor, and other items and non-personal services necessary to deliver, install and maintain the Vitek Compact 2 Analyzer as defines in this Performance Work Statement (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 according to the cost-per-test agreement for the Vitek Compact 2 analyzer used in clinical microbiology, 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. The cost-per-test result will also cover all expenses related to dilutions, repeats, and confirmatory testing required to generate a single test reportable result. Additionally, it includes the costs of materials and all other expenses associated with quality controls, calibrations, and correlation studies as outlined by the Clinical Laboratory Standards Institute and the College of American Pathology.

1.4. Objectives. The Vitek analyzer should be capable of identifying base and complex microbiology organisms as listed by Vitek microbiology reference manual. The analyzer should be capable of auto loading and auto analysis.

The analyzer (to include all instrumentation, computer workstation, printer, power supplies, required clearance, etc.) should fit within a six feet workspace each not exceeding the height, width, and depth of 26.3in x 28.3in x 26.8in. The electrical requirements must meet 100-120V. Operating temperature must be within 15⁰C-30⁰C. Operating humidity must be within 20%-80%, ambient relative, and a capacity of 15, 30, or 60 cards.

1.5. Scope. The installation 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 installation. This ensures that the personnel operating the analyzer are well-versed in its use and maintenance. At the end of the contract period or at the government’s discretion, the contractor is responsible for the removal of the clinical Vitek 2 Compact analyzer.

*The contractor shall provide all validation ID/AST cards, calibrators, and consumables required to perform installation and initial validation.

*Key operator (super user) training provided for two staff member per analyzer for base year and one staff member per year thereafter (each option year). All travel expenses including lodging, airfare/travel, and meals should be provided by the contractor.

*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, 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 are 24 hours. The laboratory remains open on a 24 hour 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 ID/AST cards, calibrator, quality control material is exhausted during troubleshooting, it is the contractor’s responsibility to replenish that supply to the government.

*If reagent and Identification requirements change during the period of performance, it is the vendors responsibility to provide the ID/AST cards 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 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 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 Vitek 2 Compact 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).

Option Year 2: 01 October 2026 to 30 September 2027

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

1.7. Administrative specifications.

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

Naval Hospital Guam

1.7.2. Recognized Federal holidays:

Independence Day

1.7.3. 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.

1.7.4. 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 his 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 his 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.

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).

PART 5

2.0 SPECIFIC TASKS

2.1. Deliverables. All analyzer and accessories technology, testing methodologies, quality control, consumables, spare parts used in routine user maintenance, and ID/AST cards used onboard the analyzers will be approved by and compliant with the U.S. Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The analyzer performance characteristics must meet requirements for accuracy and precision as defined in the 1988 Clinical Laboratory Improvement Act (CLIA'88) and the CLSI. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The equipment, and consumables shall be following OSHA requirements.

All equipment and accessories shall be new from the manufacturer. Used or refurbished equipment, or equipment obtained from a third party shall not be accepted.

2.2. Vitek 2 Compact Technical Features.

*Be compatible with and maintain bi-directional interface with the DOD Laboratory Information System, and MHS Genesis interface.

*Be capable of reading MHS Genesis specimen barcode labels.

*Analyzer must have easy access (front and/or top of analyzer) for part/consumable/Card replacement.

*Analyzer must use random access technologies that improve workflow.

*Must have on-board test capacity of 30 to 60 cards for multiple identifications.

*Analyzer will alert the user if an ID/AST card has exceeded on-board stability or has exceeded the lot expiration date.

*Must be capable of performing Gram-Negative, Gram-Positive and Yeast identification and Susceptibility testing.

*Analyzer must offer customized suspect flag settings to optimize review rates.

*Analyzer must include integrated on-board operational manual support to include management of quality control data, training, maintenance, and troubleshooting tips.

*Must have programmable automatic shutdown and startup capability.

*Analyzer must have minimal daily, weekly, and monthly maintenance and downtime. The analyzer must operate in an “on” state which does not require a standby or shut down state to perform maintenance. Daily maintenance should not exceed 10 minutes hands-on time and 10 minutes automated time. Weekly maintenance should not exceed 45 minutes hands-on and automated time, total combined. Monthly maintenance should not exceed 45 minutes hands-on and automated time, total combined.

*Must maintain onboard maintenance records and include an audit trail of who replaced parts.

*Must be able to provide sample management with short sample, clot, air bubble detection and have a liquid-sensing method.

*Must have the capability to store quality control (QC) data on the analyzer and be able to review, print, and save daily/monthly QC data numerically and as Levey-Jennings (LJ) charts.

*Analyzer must prevent the user form performing tests on a Identification Card that has not been calibrated or calibration has expired.

*Audible alarm and/or visual alerts are available to prompt the user to perform calibration.

*Analyzer unit will be supplied with an uninterruptible power supply (UPS). The UPS is a self-operated unit that provides enough power, during a commercial power outage to the analyzer, to ensure that the Vitek 2 Compact system remains operational. In the event of a power interruption, the UPS must be capable of sustaining power for a minimum of 10 minutes.

*Analyzer system will be supplied with a printer.

2.3. Method Performance Verification.

*The contractor will provide trained technical service representative(s) to install instrumentation and assist in performing instrument-to-instrument correlation studies and validation studies necessary to complete all testing functionalities. All validation data will be collected, calculated, and organized into final validation reports for the client to review and approve.

*The analyzer shall have the method performance specifications (including accuracy, precision, linearity, correlation, and normal reference study) performed onsite and training completed by the contractor upon installation of the analyzers.

*The installation and validation period shall not exceed more than 30 calendar days (from the time of installation).

2.4. Service/ Preventive Maintenance.

*A service plan must be included in the contract for the base year as well as all option years. 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.

2.5. Value Added Services:

*Capable of offering remote support capability for analyzer troubleshooting purposes.

*Provide Professional Services to expedite project implementation timeline.

2.6. Identification and AST Card.

* ID and AST cards must be ready to use, without requiring any mixing or dilution processes.

*The contractor will provide a copy of all product recalls which occurred over the past 12 months.

*The contractor will provide Identification and Susceptibility Testing cards with at least a six-month shelf life.

Please refer to the Vitek 2 Compact reference manual for:

Gram Negative/Gram Positive organisms; and Susceptibility Card.

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