Q301--RTPCR GI and Respiratory Testing

BACKGROUNDDepartment of Veterans Affairs, Veterans Health Administration, Rocky Mountain VA Medical Center (RMRVAMC) located at 1700 N. Wheeling Street, Aurora, CO, 80045, has a requirement for a firm-fixed price contract for Reverse Transcription Polymerase Chain Reaction (RT-PCR) GI and Respiratory Testing. SCOPE Contractor shall provide all equipment, reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, and any other item required for the proper operation of it’s contractor owned real-time polymerase chain reaction (PCR) testing instrument and peripherals necessary for the generation of reportable patient test results for GI and Respiratory Testing services on behalf of Rocky Mountain Regional VA Medical Center (RMRVAMC) Pathology and Laboratory Medicine department at 1700 N. Wheeling St., Aurora, CO 80045. A service component is necessary to provide all maintenance, repairs, upgrades, training, and a quality control program. Equipment, supplies, and services shall be provided. DEFINITIONS Cost Per Kit (CPK): Contractor is required to provide a price for each Reagent Kit that can be used on its equipment. GENERAL REQUIREMENTS Contractors are required to provide delivery, installation, set-up, validation and method comparison studies (including the supplies required to perform them) and removal of equipment at the completion of this agreement at no additional charge to the Government. All hard drives are to be removed and handed over to the facilities for destruction upon removal of equipment at the completion of this agreement. Offered models of clinical laboratory PCR instrumentation shall be capable of producing accurate and reproducible assays on stool and respiratory specimens. Instruments shall provide accurate test assay result for sample specimens up to the manufacturer’s defined maximum test per hour without excessive malfunctions, breakdowns, or service calls. Current waste stream analysis and Safety Data Sheets (SDS) shall be provided to RMRVAMC. The awarded contractor shall provide all upgrades to the equipment hardware and operating system software at no additional cost to the Government. These enhancements shall be delivered and installed at the medical facility within 60 days of issuance to the commercial market and must remain in compliance with VA security and medical device operating system security compliance. Offered equipment shall be in current production as of the date of this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. An operator’s manual shall be furnished with each instrument supplied to RMRVAMC and updates to the manual shall be provided in a timely manner. Editable electronic copy in Clinical and Laboratory Standards Institute (CLSI) format of operating procedures shall be furnished with each instrument supplied to RMRVAMC. Contractors offered PCR instrument shall conform to RMRVAMC’s existing space and structural parameters in terms of delivery, installation, and lab space (i.e., equipment size, weight, packaged size for delivery, electrical/voltage). Laboratory assays performed, and organisms tested within, shall include but may not be limited to the following: Gastrointestinal Panel RT-PCR FDA-Approved assay for bacteria and parasite targets Targets: bacterial and parasites Bacterial: Campylobacter (C. jejuni, C. coli and C. upsaliensis) Shigella/Enteroinvasive Escherichia coli (EIEC) Enteropathogenic Escherichia coli (EPEC) Enterotoxigenic Escherichia coli (ETEC) It/st Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 (including specific identification of E. coli O157 serogroup within STEC) Salmonella Plesiomonas shigelloides Yersinia enterocolitica Parasite: Cryptosporidium Cyclospora cayetanensis Entamoeba histolytica Giardia lamblia** (Giardia intestinalis and Giardia duodenalis) Respiratory panel FDA-Approved SARS-CoV-2 Targets: Bacterial and Viral: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. Testing Requirements: Open platform for RT-PCR, closed, and independent modules. Ease of use - intuitive workflow with minimal hands-on time for ease of use by all shifts Load sample and walk away Real-time PCR to deliver comprehensive results in about an hour preferred. Final result should be available in not more than 70 minutes. Internal control included in test kit ≤3% run failure due to reagent/instrument failure (based on quarterly data) Delivers Ct values and amplification curves for all detected pathogens directly on the instrument touchscreen No precision pipetting required and direct swab protocol for input into the cartridge Bi-directional interface Minimum of 4 modules to accommodate the test volume. Minimum maintenance – daily, weekly, monthly, and annual. Daily, weekly maintenance not more than 1-5 minutes. No special specimen collection kit requirement. Room temperature reagent/kit storage Pricing: Offerors shall provide pricing for each test, in accordance with the CPK definition contained above in Section B, that can be performed on the equipment. The pricing shall include all costs for: Equipment use. All reagents, calibrators, 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 and reporting of …