attachment B.docx

Southern Arizona VA Health Care System

STATEMENT OF WORK for Molecular section Cepheid GeneXpert R2 analyzer

SCOPE

The Southern AZ VA Health Care System Pathology & Laboratory Medicine Service requires a replacement analyzer for our current GeneXpert XVI R1 which provides rapid, high-quality PCR test results in MRSA, Clostridium difficile, Influenza A/B, SARS-CoV2, Factor II/V, and Chlamydia/Neisseria gonorrhoeae for clinical diagnostic use. The vendor sent an end-of-life notification stating the GeneXpert XVI R1 will no longer be supported after June 30, 2023. The GeneXpert XVI R2 is the replacement analyzer.

GENERAL REQUIREMENTS

1. The vendor shall provide the most current cartridges available.

2. The vendor will provide the facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents (when possible), disposables, and any consumable parts necessary for analyzing/testing. All components of the system must function as an FDA In-Vitro Diagnostic test when possible.

3. The vendor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition, such as but not limited to: printers, UPS, and surge suppressors. The cost of the excluded items shall be incorporated in the price proposal.

4. Characteristics

a. Fully automated sample extraction, amplification and detection

b. Minimal hands-on time and walk away capability

c. Fast and accurate results; majority in less than one hour

d. LIS interface capability

e. Closed cartridge technology

f. Larger number of multiplex tests and syndromic panel testing

g. Due to limited space, analyzer shall have the following dimensions:

i. width: 22.75"

ii. height: 25.80"

iii. depth: 13.25"

EQUIPMENT FUNCTIONALITY

1. The analyzers must have a comprehensive QC Program for all tests which includes at a minimum the following options:

a. On-board quality control data storage and reporting capabilities

b. The ability to view and print daily and monthly QC results

2. System shall have a design that removes the possibility of sample carryover.

a. Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of raw data for instrument installed. Vendor shall also provide documented evidence confirming the system design removes the possibility of any reagent or sample carryover.

3. System shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency.

4. Equipment shall be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface downtime.

5. Interfacing requirements to be provided by the vendor:

a. Instrument LIS physical connection and translation (drivers). Must be compatible with Data Innovation system.

b. Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer

c. Instrument-LIS interface must be bi-directional.

INSTALLATION AND VALIDATION

1. Vendor shall move instruments, free of additional charge, to final testing location upon completion of validation process.

2. Vendor shall provide the facility with all cross-over supplies and reagents needed at installation and during training of staff.

3. The vendor shall provide at installation/set-up and when bringing new tests on-line, a technical support specialist who shall perform all validation studies including: installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards) normal range studies, staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. This service shall be available during regular office hours on a 5 days/week basis.

4. Throughout the life of the agreement, the vendor shall provide assistance to the user in setting up and maintaining/trouble shooting as additional tests are brought in-house.

SERVICE AND MAINTENANCE

1. Instrument support service shall provide assistance with troubleshooting and repair of the analyzers. On-site service shall be available Monday through Friday during regular business hours (8am-5pm).

2. The vendor shall provide a twenty-four hour/seven-day service hotline with technical support.

3. The vendor shall provide a preventative maintenance schedule to include timely scheduled vendor preventative maintenance visits as required.

4. Vendor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge to the Government (e.g. upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally).

5. Vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. Vendor shall indicate which tasks are user level and which are service level.

6. For reagents with hazardous constituents, vendor shall provide a mechanism for the Laboratory to meet local discharge requirements. The vendor shall supply information regarding any hazardous chemicals.

TRAINING

1. The vendor shall provide in-depth training for the use and maintenance of the GeneXpert analyzer for at least two individuals.

2. The vendor shall provide in-depth training for at least one individual for any middleware or server hardware provided.

3. The vendor shall provide on-site training for general use and maintenance of the analyzer for all medical technologists that use the analyzer.

OTHER

1. Request for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory with communication to the vendor for modification of the contract. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with other analyzer(s) that can produce the required criteria satisfactorily to the user.

2. In the event that the any consumable, reagent, or other necessary item are found to be defective and unsuitable for use with the vendor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the vendor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed.