Inactive

SOURCES SOUGHT The Department of Veterans Affairs, James A, Haley Veterans Hospital (JAVH) located at 13000 Bruce B. Downs, Tampa, Fl. 33612 is issuing sources sought notice as a means of conducting m... SOURCES SOUGHT The Department of Veterans Affairs, James A, Haley Veterans Hospital (JAVH) located at 13000 Bruce B. Downs, Tampa, Fl. 33612 is issuing sources sought notice as a means of conducting market research to identify parties having an interest in and the resources to support this requirement to lease Analyzer Systems and Reagents and Test Kits, that use a Random Access Platform for real-time PCR nucleic acid analysis to rapidly detect Food and Drug Administration (FDA) approved or Emergency-Use-Authorization (EUA) approved patient testing. Emergency-Use- Authorization (EUA) are Laboratories that have developed certain molecular-based tests for SARS-CoV-2. a. Authorized Tests: Certain RT-PCR Molecular-Based Tests for Detection of Nucleic Acid from SARS CoV-2 from Anterior Nasal Respiratory Specimens for Use as Part of a Serial Testing Program. b. Authorized Laboratories: Testing is limited to the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high complexity tests. Testing assays and patient specimen types to include SARS-CoV-2 (COV2), Influenza A, B, and Respiratory Syncytial Virus (FLU/RSV), and Methicillin-resistant-Staphylococcus-aureus (MRSA) detection from nasal/nasopharyngeal swabs; Detection of Mycobacterium tuberculosis resistance to Rifampin (MTB/RIF) from sputum; Clostridium difficile (CDIFF) and Norovirus (NOV) detection from stool; Carbapenem Resistance (CARBA-R) detection from rectal swabs; BCR-ABL (BCR-ABL) gene mutation, Factor II (FII)/Factor V Leiden (FV) gene mutation detection from whole blood, MVP, and Chlamydia & Gonorrhea (CT/NG) from female and male urine, vaginal swabs, endocervical swabs, and female and male pharyngeal and rectal swabs; and any other RT-PCR testing deemed medically necessary by Tampa VAMC Micro/AFB and Molecular Departments, Tampa, Florida, Tampa VAMC Mental Health Clinic, Tampa Florida, New Port Richey (NPR) VA Laboratory, New Port Richey, Florida, Miami VAMC, Miami Florida, West Palm Beach VAMC, West Palm Beach, FL Pathology & Laboratory Medicine Service care-providers. The testing platform shall provide molecular identification of targets by a real-time polymerase chain reaction (PCR) technology that integrates a complete onboard nucleic acid purification system with amplification and detection in a self-contained cartridge system. Equipment shall be able to run individual samples without the need for batching (sequential testing capability) or running external daily Quality Control (QC), use unprepared samples with little or no preparation for rapid turnaround times, provide for reagents room temperature storage conditions, have the ability to run multiple assay protocols simultaneously (without stopping current runs) and include software and/or supporting instrumentation to maintain or improve data management (e.g. epidemiology reports). Configuration shall include an on-board QC program capable of printing/displaying all internal QC/calibrations, to facilitate the detection of outliers or failures. The Contractor shall provide all the necessary instrumentation, employee training, preventive maintenance, repairs, parts, service, hotline services, upgrades, all the necessary software, reagents, controls, calibrators, disposables, consumables, and shipping for in-house testing in the Pathology & Laboratory Medicine Service at the JAH VAMC, Miami VAMC, and West Palm Beach VAMC (within thirty (30) days after receipt of orders), as outlined below. All work shall be performed in accordance with the guidelines established by Federal, State, and local ordinances, FDA manufacturer's guidelines, and with all terms, conditions, provisions, schedules, and specifications provided herein. The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code 334516 Analytical Laboratory Instrument Manufacturing with a size standard of 1,000 employees applies to this procurement. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred. If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, address, email address, Web site address, telephone number, and size and type of ownership for the organization; and 2) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements. The government will evaluate market information to ascertain potential market capacity to 1) provide services consistent in scope and scale with those described in this notice and otherwise anticipated; 2) secure and apply the full range of corporate finance, human capital, and technical resources required to successfully perform similar requirements; 3) implement a successful project management plan that includes: compliance with tight program schedules; cost containment; meeting and tracking performance; hiring and retention of key personnel and risk mitigation. Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed products and services are invited to submit a response to this sources sought notice by 07/14/2023. All responses under this RFI must be emailed to Leonora simmons@va.gov no later than 07/14/2023 at 10 am EST. If you have any questions concerning this opportunity please contact: Leonora Simmons