6640--MOLECULAR Analyzer for SARS-COV-2

4 1 Statement of Work Molecular Analyzer for SARS-CoV-2 (COVID) and Respiratory Testing GENERAL INFORMATION Title of Project: Purchase of Molecular Analyzer and Reagents for SARS-CoV-2 (COVID) and Respiratory Testing Type of Contract Contemplated: One time purchase for multiple assay molecular analyzer SCOPE The Syracuse Molecular laboratory requires capacity to expand SARS-COV-2/Influenza/RSV molecular testing to Veteran s in the community in order to provide appropriate care in an inpatient and outpatient setting. Our current analyzer respiratory testing output is not sufficient. Procuring additional equipment and tests for molecular respiratory testing will allow the Syracuse VA Medical Center to manage patient symptoms sooner, decrease inpatient admissions and length of stay, and limit out of pocket expenses to Veteran s whom require respiratory testing but are not admitted to the facility. Larger testing capacities will increase patient satisfaction and prevent some patient visits to the Emergency Room for those needing testing. The analyzer should enhance the laboratory s ability expand PCR testing for other infectious diseases, such as STI s and HPV. REQUIREMENT/SALIENT CHARACTERISTICS/SPECIFICATIONS Common Nomenclature (commercial description): : Molecular Real-Time PCR Analyzer Principles of operation: The analyzer of choice will allow the laboratory to run real-time PCR, TMA, and RT-TMA assays on a single, automated platform. Test assays allow for nucleic acid amplification for qualitative detection of RNA for specific targets. Assays may combine the technologies of target capture, Transcription Mediated Amplification (TMA), and Dual Kinetic Assay (DKA). The analyzer must have the ability to run FDA approved testing for Respiratory and EUA for COVID. The analyzer must also have the ability to run FDA approved testing for STIs, Viral Loads, and BV, as well as have the functionality to run Laboratory Developed Tests (LDTs) all in one single integrated platform. Intended use: To identify infectious diseases in clinical specimens by molecular methods. Equipment with which the item is used : Validation materials, including control materials, must be included with contract purchase. A back-up UPS battery must be included with purchase. Original equipment manufacturer part number: Other pertinent information that describes the item, material or service required: The analyzer must have the capability to test for the following using PCR methods: SARS-CoV-2 virus Influenza A virus Influenza B virus Respiratory Syncytial Virus (RSV) Mycoplasma genitalium Trichomonas vaginalis Chlamydia trachomatis Neisseria gonorrhoeae Pierceable foil caps, no uncapping prior to sample processing. The analyzer must be high throughput with at least 200 samples able to be processed within 8 hours. Laboratory preparedness system to rapidly respond to emerging pathogen(s) in an emergency The analyzer must be fully automated to allow samples to run with minimal to no technologist intervention. A continuous fluids/waste module to the lower bay of the system, allowing access to replace a set of universal fluids when depleted and dispose solid and liquid waste containers during processing, increasing flexibility and throughput to the system. Continuous and random-access sample loading that allows both samples and reagents to be loaded at any time during the day The testing should NOT include extractions or pre-treatment prior to analyzing specimen. The analyzer should NOT require plumbing, as the laboratory does not have the ability to provide plumbing at this time. All tests listed above must be FDA Approved or approved for Emergency Use Authorization (EUA). OTHER UNIQUE REQUIREMENTS Compatibility with Existing Equipment: Applicable DICOM compliance, Directives or IT Policies: Ensure that contractors, third party partners, and servicers implement the VA security and privacy requirements, as defined in the contract. These requirements can also be added to the contract Statement of Work (SOW). The requirements apply to applicable contracts in which VA sensitive information is stored, generated, transmitted, or exchanged by VA, a contractor, subcontractor or a third-party, or on behalf of any of these entities regardless of format or whether it resides on a VA system or contractor or subcontractor s electronic information system(s) operating for or on the VA s behalf. Warranty: One year warranty all parts and labor included. Products shall be free from defects in workmanship and materials for a period of one (1) year from the date of purchase. Training: An application Specialist must be on-site for installation of assay-specific applications and initial verification of assay-specific runs. In addition to verification support, it is required that the application specialist provide primary operator training. It is also requested that additional operator training is available for changes in personnel. DELIVERY Deliver to Syracuse VA loading dock/warehouse Inspection by BioMed/HTM Inspection and acceptance will occur in C322 Delivery within 90 days of award. PLACE OF PERFORMANCE Syracuse VA Laboratory 3rd Floor BILLING/INVOICING Tungsten Network Portal CUSTOMER INFORMATION - Clinical Laboratory, Syracuse VA Medical Center