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 Central, Network Contracting Office 10, intends to enter into a sole source procurement for SARS-CoV-2 testing supplies for the LTC Charles S. Kettles VA Medical Center, 2215 Fuller Road, Ann Arbor, MI 48105. The Department of Veterans Affairs intends to award a sole source, firm-fixed price 2-year indefinite delivery 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 of the VA Ann Arbor, Saginaw, Battle Creek and the CBOCs (Toledo, Flint, Jackson, and Adrian). Other sites in VISN 10 will also be sending their specimens for testing at VA Ann Arbor. The Cobas SARS-CoV-2, for use on the Roche Cobas 6800/8800 Systems, 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.

The following Roche SARS-CoV-2 kits and estimated annual quantities are required:

1) Kit Cobas 6800/8800 SARS-CoV-2 480T (Part Number 09343733190), 360 Kits

2) Kit Cobas 6800/8800 Buff Neg RMC IVD (Part Number 07002220190), 120 Kits

3) Kit Cobas 6800/8800 SARS-CoV-2 RMC (Part Number 09175440190), 120 Kits

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, March 20, 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 Jeffrey Rozema via e-mail at jeffrey.rozema@va.gov. Telephone inquiries will not be accepted.