6640--Molecular Testing Platform

Statement of Work Molecular Testing Instrumentation for Amarillo VA Health Care System SCOPE Amarillo VA Health Care System and its Community Based Outpatient Clinics (CBOCs) located in Lubbock, TX; Dalhart, TX; Childress, TX; and Clovis, NM, are in need of replacement analyzers to perform molecular testing on our patient population. The PCR system/analyzer shall have the capability of identifying the nucleic acid of targeted pathogens. The analyzers shall be able to integrate sample preparation, amplification, detection and analysis as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). The instrument must be approved by the Food and Drug Administration (FDA). Our current analyzers contract will end 09/30/2026 and a new contract is needed, with instruments validated and ready to run patient samples on 10/01/2026. The vendor shall provide a Cost Per Reportable Result (CPRR) program to include the equipment, service, consumables, reagents, controls, and calibrators necessary to operate system(s). This CPRR program will not include tubes and paper. Training and associated expenses for up to two (2) key operator(s) per instrument is included. Amarillo VA Health Care System Clovis VA CBOC 6010 Amarillo Blvd., West 921 E. Llano Estacado Blvd. Amarillo, TX 79106 Clovis, NM 88101 Lubbock VA Clinic Childress VA CBOC 3510 4th Street 2305 Avenue F NW Lubbock, TX 79415 Childress, TX 79201 Dalhart VA CBOC 325 Denver Ave. Dalhart, TX 79022 TYPE OF CONTRACT This is firm Cost per Patient Reportable Result (CPRR) fixed contract for Indefinite Delivery/Indefinite Quantity (IDIQ) to include all reagents, calibrators, consumables, and services to be delivered upon the ordering facility. Cost per Patient Reportable Result (CPRR) - as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) 5-year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result. The per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required to -- 1 of 9 -- produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI); (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge. The Vendor must provide all equipment, reagent, calibrators, controls, consumable items, parts, accessories, ancillary devices, software updates and upgrades, service plans, shipping costs, installation, validation studies, training, and any other item required to establish instrument operation, and should be from the same family of analyzers as applicable and suitable for the facilities listed. EQUIPMENT REQUIREMENTS 1. Specification of component equipment as set forth in this section are minimum specifications, unless otherwise stated, and shall not be construed as limiting the overall quality, quantity, or performance characteristics of items furnished in the system. The Contractor Furnished Equipment (CFE) shall meet or exceed the minimum requirements and shall be held responsible for the supply, performance, and overall quality of the contractor’s furnished equipment. 2. All equipment to be supplied under this specification shall be the newest and the most current model of standard product of a manufacturer of record. A manufacturer of record shall be defined as a company whose main occupation is the manufacture for sale of items of equipment and which: a. Maintains a factory production line. b. Maintains a stock of replacement parts for the item. c. Maintains engineering drawings, specifications, operating manuals, and maintenance manuals. d. Has published and distributed descriptive literature and equipment specifications on the equipment. 3. Molecular testing equipment must meet the following specifications: a. The vendor shall provide each facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibration materials, disposables, and any consumable parts necessary for analyzing/testing. Tests shall be vendor supported. The analyzer must be able to perform all assays listed. b. It is random access instrument. c. Must allow rapid identification of pathogens from laboratory samples with a turnaround time of 90 minutes or less. d. 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, printer, UPS, interface boxes and surge suppressors. -- 2 of 9 -- e. Must meet performance and characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). f. Bi-directional, bar-coded computer interface. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA VistA hospital information system/and or Cerner LIS system for real time data transmission. Interfacing requirements to be provided by the vendor: I. Instrument LIS physical connection and translation (drive…