6640--6640--Roche SARS-CoV-2 Testing Supplies - Notice of Intent to Sole Source

INTENT TO SOLE SOURCE The Department of Veterans Affairs, VHA Regional Procurement Office East, Network Contracting Office 8, intends to enter into a sole source procurement for SARS-CoV-2 testing supplies for the Miami VA Medical Center, 1201 NW 16th Street Miami, FL 33125. The Department of Veterans Affairs intends to award a sole source, firm-fixed price contract for a base and 4 option years contract to Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN 46256. The associated North American Industry Classification System (NAICS) Code is 325413 In-Vitro Diagnostic Substance Manufacturing, and the Business Size Standard is 1,250 Employees. The Pathology & Laboratory Medicine Services, Molecular Department, performs COVID testing for screening and monitoring patients and employees at the Miami VA Medical Center. The Cobas SARS-CoV-2, for use on the Roche Cobas 6800 System, is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in clinician-instructed self-collected nasal swab specimens, and clinician-collected nasal, nasopharyngeal and oropharyngeal swab specimens from individuals who meet COVID-19 clinical and/or epidemiological criteria. Cobas SARS-CoV-2 is for use only under Emergency Use Authorization (EUA) in laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meets requirements to perform high or moderate complexity tests. Roche Diagnostics Corporation has provided supporting documentation stating they are the sole manufacturer and distributor of Cobas SARS-CoV-2 test kits and control kits, under Emergency-Use-Authorization (EUA) only and no other company can provide the reagent kits and controls to be used on the existing Cobas 6800 System. A large variety Cobas test kits will used to satisfy this requirement. This notice satisfies the requirement at FAR 5.201(b)(1) to publicize the proposed contract action. This notice of intent is not a request for competitive proposals or quotes. Interested parties may identify their interest and capability to respond to the requirement. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Interested persons may identify their interests and capability to respond to this requirement no later than 11:59 PM Eastern Time, Sunday, May 17, 2022. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to meet the subject requirement. This information shall be provided at no cost or obligation to the Government. Interest/capability statements shall be submitted to Jose Delgado via e-mail at [email protected]. Telephone inquiries will not be accepted.