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

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36C25022Q0420Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The Department of Veterans Affairs plans to award a sole source, firm-fixed price, two-year indefinite delivery contract to Roche Diagnostics Corporation for SARS-CoV-2 testing supplies, specifically for the LTC Charles S. Kettles VA Medical Center and associated VISN 10 facilities. The contract involves the purchase of Roche’s Cobas SARS-CoV-2 test kits and control kits, which are used on the Roche Cobas 6800/8800 Systems. These kits are essential for qualitative detection of SARS-CoV-2 nucleic acids from various nasal and throat specimens and are authorized for use only under the Emergency Use Authorization (EUA) in CLIA-certified laboratories capable of performing high or moderate complexity tests. Roche has provided documentation that they are the sole manufacturer and distributor for these testing supplies, emphasizing that no other company can supply the required reagents and controls for the existing Cobas systems. The contract covers estimated annual quantities of three specific Roche kits: 360 kits of the primary SARS-CoV-2 test, 120 kits of the negative buffer control, and 120 kits of the SARS-CoV-2 reagent control. This sole source action follows FAR regulations requiring public notice and allows interested parties to express interest or provide evidence supporting competition, though any decision not to compete is at the government’s discretion. Responses to this notice were due by March 20, 2022, and must demonstrate clear and convincing reasons why competition would benefit the government. The contracting activities are managed by the VHA Regional Procurement Office Central, Network Contracting Office 10, with Jeffrey Rozema designated as the point of contact.

General Info

VA awards sole source two-year contract to Roche for SARS-CoV-2 test kits at VISN 10 facilities.

Agency

Department Of Veterans Affairs → 250-NETWORK Contract Office 10 (36C250)

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

Set-Aside

NONE

Documents

36C25022Q0420 Roche SARS-CoV-2 Testing Supplies Sole Source Notice

sources-sought

Low

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Uniform Contract Format

Contract not broken down yet

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Timeline

1 update

PostedMar 16

special-notice

Notice updatedApr 26

Notice details unchanged. Attachments may have changed.

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Organization & Contact Information

AgencyDepartment Of Veterans Affairs → 250-NETWORK Contract Office 10 (36C250)

Contacts1 person available

OfficeDAYTON, OH, 45428, USA

Organization / AgencyDepartment Of Veterans Affairs → 250-NETWORK Contract Office 10 (36C250)

Office AddressDAYTON, OH, 45428, USA

Contacts

Jeffrey RozemaContract Specialist

contact@example.gov

+1 (555) 000-0000

Full Description

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 contact@example.gov. Telephone inquiries will not be accepted.