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

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36C25022Q0284Federal

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, through its VHA Regional Procurement Office Central and Network Contracting Office 10, plans to award a sole source, firm-fixed price contract to Roche Diagnostics Corporation for SARS-CoV-2 testing supplies at the LTC Charles S. Kettles VA Medical Center in Ann Arbor, Michigan. This procurement covers the Cobas SARS-CoV-2 test, utilized on the Roche Cobas 6800/8800 systems, designed for qualitative detection of SARS-CoV-2 nucleic acids using nasal and throat swab specimens from individuals who meet specific COVID-19 clinical or epidemiological criteria. The Cobas test is authorized for emergency use under the Emergency Use Authorization (EUA) and is intended for use in certified laboratories meeting the Clinical Laboratory Improvement Amendments of 1988 standards for high or moderate complexity testing. This sole source action is based on Roche Diagnostics’ status as the sole manufacturer and distributor of these test kits and controls, which are essential for use on the existing Cobas systems employed by the VA. The contract supports the COVID-19 testing needs of veterans and staff across multiple VA sites within the VISN 10 region, including Ann Arbor, Saginaw, Battle Creek, and several community-based outpatient clinics. The Department is soliciting expressions of interest and capability from other parties by February 4, 2022, but any decision not to compete will be at the Government’s discretion. Respondents must provide clear and convincing evidence that competition would benefit the Government and demonstrate the ability to fulfill the requirement, with no cost or obligation to the Government for such submissions. The contracting office, located in Dayton, Ohio, is managed by Contract Specialist Jeffrey Rozema, who serves as the point of contact for this procurement.

General Info

Sole source contract to Roche for fixed-price SARS-CoV-2 testing supplies at VA 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

36C25022Q0284 Roche Diagnostics SARS-CoV-2 Testing Supplies Sole Source Notice

sources-sought

Low

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Uniform Contract Format

Contract not broken down yet

CLEATUS splits the solicitation into Uniform Contract Format (UCF) sections: scope, pricing, deliverables, and evaluation criteria.

Timeline

PostedFeb 1

special-notice

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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

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 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. 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 5:00 PM Eastern Time, Friday, February 4, 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.