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

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36C24822Q0963Federal

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

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The Department of Veterans Affairs, through its VHA Regional Procurement Office East and Network Contracting Office 8, plans to award a sole source contract to Roche Diagnostics Corporation for the supply of SARS-CoV-2 testing materials for the Miami VA Medical Center. This firm-fixed price contract will cover a base period plus four option years. The testing supplies are specifically for use with the Roche Cobas 6800 System, utilizing the Cobas SARS-CoV-2 real-time RT-PCR test authorized under Emergency Use Authorization (EUA). This test is designed for qualitative detection of SARS-CoV-2 nucleic acids using various swab specimens and meets the requirements for high or moderate complexity testing laboratories certified under CLIA. Roche Diagnostics Corporation has provided documentation confirming that they are the exclusive manufacturer and distributor of the Cobas SARS-CoV-2 test kits and control kits needed for the existing Cobas 6800 System; thus, no other vendor can supply these specific reagent kits and controls. This notice serves to fulfill the regulatory requirement to publicize the intended sole source procurement and invites interested parties to submit evidence if they believe competition would benefit the government. Such responses must demonstrate a clear ability to meet the requirements by the specified deadline and be submitted via email to the contracting officer, Jose Delgado. The solicitation is categorized under NAICS code 325413 for In-Vitro Diagnostic Substance Manufacturing, and the business size standard applies to companies with up to 1,250 employees.

General Info

Sole source contract to Roche Diagnostics for SARS-CoV-2 testing kits at Miami VA Medical Center.

Agency

Department Of Veterans Affairs → 248-NETWORK Contract Office 8 (36C248)

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

FL

Set-Aside

NONE

Documents

1

36C24822Q0963 - Notice of Intent to Sole Source for Roche SARS-CoV-2 Testing Supplies

DOCX, Low priorityspecial-notice
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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 248-NETWORK Contract Office 8 (36C248)
Contacts1 person available
OfficeTAMPA, FL, 33637, USA
Organization / AgencyDepartment Of Veterans Affairs → 248-NETWORK Contract Office 8 (36C248)
Office AddressTAMPA, FL, 33637, USA
Contacts
Jose DelgadoContracting Officer
contact@example.gov
+1 (555) 000-0000

Full Description

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

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Earlier notices in this NAICS code

Posted before this notice, open and closed

NAICS: 325413
Closed
Federal
Miscellaneous Laboratory Reagents and Supplies
Solicitation # GIMC2022-LAB
Navajo Area Indian Health Svc

POSTED

over 4 years ago

CLOSED

over 4 years ago
View Details
NAICS: 325413
Closed
Federal
Reagent rental agreement for Mycobacterium Testing
Solicitation # 36C24422Q0737
244-NETWORK Contract Office 4 (36C244)

POSTED

over 4 years ago

CLOSED

over 4 years ago
View Details
NAICS: 325413
Closed
Federal
Solicitation - Cost-Per-Test- Immunoassay Testing
Solicitation # W81K00-22-Q-0104
W40M MRC0 West

POSTED

over 4 years ago

CLOSED

over 4 years ago
View Details
NAICS: 325413
Closed
Federal
Sources Sought Notice - Cost-Per-Reportable Result Coagulation Reagents for Analyzer
Solicitation # W81K00-22-Q-0105
W40M MRC0 West

POSTED

over 4 years ago

CLOSED

over 4 years ago
View Details
NAICS: 325413
Closed
Federal
Notice of Intent to Sole Source - Illumina, Inc. Miseq System
Solicitation # 2022-65454
CDC Office Of Acquisition Services

POSTED

over 4 years ago

CLOSED

over 4 years ago
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NAICS: 325413
Awarded
Federal
Kayenta Health Center Laboratory - Testing Supplies
Solicitation # KHC-SD-2022-0023
Navajo Area Indian Health Svc

POSTED

over 4 years ago

CLOSED

over 4 years ago
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NAICS: 325413
Closed
Federal
6550--Lab Supplies – COVID test kits - New Requirement (12 months)
Solicitation # 36C24422Q0727
244-NETWORK Contract Office 4 (36C244)

POSTED

over 4 years ago

CLOSED

over 4 years ago
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NAICS: 325413
Awarded
Federal
6515--EYELID/CLEANSER
Solicitation # 36C77022Q0295
National Cmop Office (36C770)

POSTED

over 4 years ago

CLOSED

over 4 years ago
View Details
NAICS: 325413
Awarded
Federal
Purchase of Aptima HIV-1 Quant DX Kits
Solicitation # 75D30122-Q-74551
CDC Office Of Acquisition Services

POSTED

over 4 years ago

CLOSED

over 4 years ago
View Details
NAICS: 325413
Closed
Federal
2022-65160 Abbott
Solicitation # 00HCBBBB-2022-65160
CDC Office Of Acquisition Services

POSTED

over 4 years ago

CLOSED

over 4 years ago
View Details
NAICS: 325413
Closed
Federal
Laboratory Analyzer Reagents for U.S. Naval Hospital (USNH) Okinawa, Japan
Solicitation # DLATSP-22-SS-0004
DLA Troop Support Indo-Pacific

POSTED

over 4 years ago

CLOSED

over 4 years ago
View Details
NAICS: 325413
Awarded
Federal
6515--PCCS Medical
Solicitation # 36C77022Q0305
National Cmop Office (36C770)

POSTED

over 4 years ago

CLOSED

over 4 years ago
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