6640--Clinical Laboratory Microbiological System - Instruments, Reagents, & Supplies

STATEMENT OF WORK DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTERS VA Palo Alto Healthcare System (VAPAHCS) CLINICAL LABORATORY MICROBIOLOGICAL SYSTEM FOR IDENTIFICATION AND ANTIBIOTIC SUSCEPTIBILITY OF MICROORGANISMS Scope: The Contractor shall provide VAPHCS with standardized microbiological system for the identification (ID) and antimicrobial susceptibility testing (AST) of microorganisms which shall have the capability of performing or reporting the clinical parameters as defined for the VAPHCS facilities. The instruments shall be able to simultaneously perform the complete profile 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 Contractor shall quote the suggested/recommended equipment VAPAHCS sites that meet the requirements of the facility. Contractor shall provide all equipment, standards, controls, supplies, parts, accessories, Uninterruptible Power Supply UPS, printers, barcode and laser, and any other item required for the proper operation of contractor owned organism identification (ID) and antimicrobial susceptibility (AST) analyzer for microbiology and peripherals necessary for the generation of Microbiology Cost Per Reportable Result (CPRR) services for VAPHCS. The Contractor shall provide analyzers and supplies to facility in accordance with the estimate given. Definitions: Cost Per Reportable Result (CPRR): The per reportable result price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, Uninterruptible Power Supply UPS, printers, barcode and laser and any other item required for the proper operation of the contractor’s equipment and necessary for the generation of a patient reportable result. This does not include those items approved for exclusion by the government such as printer paper, labels etc. This per patient reportable result price shall also encompass all costs associated with dilution, repeat and confirmatory testing required producing a single patient reportable result. It will also include the material to perform as well as all other costs associated with quality control, and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI) (c) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs and (d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. Pricing: VAPHCS will provide the equipment requirements needed by the medical center. Pricing shall be based on fair market value. Offerors shall provide pricing for all equipment, components, training, and service. All necessary maintenance to keep equipment in manufacturer's operating conditions, both preventive maintenance, and emergency repairs. Training for VAPAHCS personnel operating equipment. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. Requirements: Each model of clinical laboratory analyzer offered shall comply with all general requirements stated herein. Each Contractor shall submit as part of their offer, technical data or descriptive literature to ascertain that the equipment offered meets the requirement. The Contractor shall provide FDA approved automated identification and antibiotic susceptibility systems/analyzers. Remanufactured or discontinued models are unacceptable. The Contractor shall state the failure mean time (between failure and mean time to repair) for each piece of equipment offered. Emergency replacement of equipment shall be provided by the Contractor. Offered testing equipment shall be new state-of-the-art equipment. Remanufactured and discontinued models will not be accepted Utilities specification Microbiologic System Specific Requirements: The Contractor shall assess equipment, workflow, volumes and space to meet the individual VAPAHCS site’s requirements with minimum cost. General Requirements: The system shall provide self-contained, automated identification and antibiotic susceptibility testing system for aerobic, facultative, fastidious, and anaerobic microorganisms and yeasts. The system shall have a data management system with varied options for analysis and reporting/review of cumulative patient data on organism’s isolated and antimicrobial profiles and allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until the vendor applies necessary software updates. Clinical laboratory assays currently performed at the VAPAHCS Pathology and Laboratory Medicine Services shall include, but may not be limited to the following assays: Organism Identification Antimicrobial Susceptibility, by truly measured MIC method Detection of antibiotic resistance Expert rule for Unusual ID & AST results Software to prepare site specific reports The system should have battery backup UPS capable of maintaining data for at least 24 hours in the event of a facility power failure. This will be maintained or replaced by the contractor. The Contractor shall provide hardware/software upgrades necessary to maintaining the integrity of the system at no additional charge to the government. These must be provided as they become available and as they are being offered to commercial customers. Changes in CLSI guidelines shall be implemented into the software upgrades in a timely manner. The Contractor shall provide to each facility a copy of operating procedures in Clinical and Laboratory Standards Institute (CLSI) digital format at time of installation using software compatible with VA (Microsoft Office WORD). Offered models of organism identification and antimicrobial susceptib…