Inactive

STATEMENT OF WORK POC Molecular PCR Testing for Influenza A/B and SARS-CoV-2 Lexington VA Healthcare System 1. INTRODUCTION/BACKGROUND: The purpose of this activity is to acquire Point of Care (POC) M... STATEMENT OF WORK POC Molecular PCR Testing for Influenza A/B and SARS-CoV-2 Lexington VA Healthcare System 1. INTRODUCTION/BACKGROUND: The purpose of this activity is to acquire Point of Care (POC) Molecular Polymerase Chain Reaction (PCR)Testing Services for the Clinical Laboratory at the Lexington VA Healthcare System to be implemented at VA Outpatient Clinics. Rapid testing at clinic locations will improve patient care and reduce over prescribing antibiotics. 2. OBJECTIVE: To purchase four (4) rapid molecular test analyzers, reagents, and service for performing Influenza A/B and SARS-CoV-2 testing on a base year plus four (4) option year contract. 3. MAJOR REQUIREMENTS: The analyzer shall have: Influenza A/B and SARS-CoV-2 tests performed by molecular methods, real time polymerase chain reaction (PCR) and testing performed on the same instrument system/platform, one test yielding Influenza A, influenza B, and SARS-CoV-2 as separate results with no operator interpretation required. Influenza A/B and SARS-CoV-2 tests that are CLIA waived, meet the performance characteristic for accuracy and precision as defined by the 1988 Amendments to the Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute (CLSI). Automatic recalibration must be done by the analyzer. thirty (30) minutes or less for set up and run time for the Influenza A/B and SARS-CoV-2 tests with minimal testing steps. a tabletop model; a one cubic foot or less footprint is preferable. ability to interface with Abbott RALS system to transmit results to VISTA/CPRS. ability to lock out system operators if not authorized user. must have fully contained reagents, with no operator exposure and minimized cross-contamination between samples. ability to utilize current universal transport media. barcode scanner for reagents and specimens. The Vendor shall: provide 4 analyzers, reagents and consumables for ~2400 Influenza A/B and SARS-CoV-2 tests per year install, validate and provide training to clinical laboratory staff for use of the test system. All costs associated with staff training shall be included in the purchase pricing. 24/7 customer support for analyzers provide list of items/parts with cost that would not be covered under contract/ warranty. perform upgrades, hardware and software, to equipment at no additional cost. 4. GOVERNMENT FURNISHED INFORMATION OR MATERIAL: There are no government furnished materials in support of this contract activity. 5. MEETINGS AND REVIEWS: The vendor shall meet with Pathology and Laboratory Service Personnel on an as needed basis. Pathology and Laboratory Service may request meetings to occur by telephone or in person at the Lexington Healthcare System. 6. TRAVEL REQUIREMENTS: All cost associated with travel for instrument service/repair, routine maintenance, meetings, or employee training shall be included in the reagent rental pricing. 7. CONTRACTING OFFICER'S REPRESENTATIVE (COR): a. The COR is Susan Thompson, phone 859-233-4511 ext 4520. Shalane Butler is the alternate COR. No government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification. 8. REPORTS/DELIVERABLES: Deliverables Four (4) Rapid Molecular Testing Instrument Platforms. Deliverables Reagents/Controls on an as needed or quarterly basis. Deliverables Training for Laboratory Staff. Deliverables Technical Service for Periodic Maintenance and Repairs. 9. PERIOD OF SERVICE: Periods of service will be performed in base year plus 4 Option years. 10. CONTRACTOR QUALIFICATIONS: The successful contractor shall be able to provide an FDA approved (including EUA), CLIA waived test system to fulfill the test requirements listed in the Statement of Work. 11. SECURITY/NATIONAL AGENCY CHECK REQUIREMENTS: All media (hard drives, DVD s, Floppies, etc.) that contains sensitive data must be surrendered to the Medical Center (Biomedical Engineering) any may not leave VA property.  All Contractor-owned media (USB drives, DVD s, CD s, Floppy disk) that is to be inserted into a medical device must be scanned by Biomedical Engineering prior to being placed in the medical device. The Authorization requirements do not apply, and that a Security Accreditation Package is not required.