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Statement of Work- VISN 23
Binax NOW® SARS-CoV-2 Antigen Test Kit (BRAND NAME ONLY)

1. Introduction

The purpose of this Statement of Work (SOW) is to detail salient characteristics for Binax NOW® SARS-CoV-2 Antigen Test Kit (BRAND NAME ONLY) and define the tasks and responsibilities of the successful offeror for the procurement of an FDA-approved or Emergency Use Authorization (EUA) Binax NOW® SARS-CoV-2 Antigen (BRAND NAME ONLY) Test Kit for thirteen (13) VA Midwest Health Care Network (VISN 23) laboratories.

3. Scope

Network Contracting Office 23 (NCO23) intends to award a single agreement to the overall best-value contractor capable of meeting the requirements outlined herein for Binax NOW® SARS-CoV-2 Antigen Test Kit for clinical laboratories located at the following VA facilities:

Black Hills Health Care System, Hot Springs, SD
Black Hills Health Care System, Fort Meade, SD
Black Hills Health Care System, Rapid City, SD
Central Iowa Health Care System, Des Moines, IA
VA Medical Center, Fargo, ND
Royal C. Johnson VA Medical Center, Sioux Falls, SD
VA Medical Center, Iowa City, IA
VA Medical Center, Minneapolis, MN
Twin Ports Community Based Outpatient Clinic, Superior, WI
Nebraska-Western Iowa Health Care System, Omaha, NE
Nebraska-Western Iowa Health Care System, Grand Island, NE
Nebraska-Western Iowa Health Care System, Lincoln, NE
VA Medical Center, St. Cloud, MN

General Requirements: This section defines minimum requirements that must be met or exceeded by this acquisition. Narrative descriptions shall be provided of how these requirements will be met or exceeded:

Technical

The science of the Abbott Binax NOW® SARS-CoV-2 Antigen test shall be lateral flow immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swab collections.
The Abbott Binax NOW® SARS-CoV-2 Antigen test kit and specimen type(s) must minimally have Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) pursuant to Section 564 of the Federal Food, Drug and Cosmetic Act for high complexity and moderate complexity designated laboratories.
The Abbott Binax NOW® SARS-CoV-2 Antigen assay shall also be authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The analytical sensitivity of the Abbott Binax NOW® SARS-CoV-2 antigen test shall be 200 TCID50/ml or lower.   Â
The Abbott Binax NOW® SARS-CoV-2 antigen test result must be available for result reporting within fifteen (15) minutes or less.   Â
The Abbott Binax NOW® SARS-CoV-2 Antigen test system Reagents and collection swabs are included within the test kit.  Â
The Abbott Binax NOW® SARS-CoV-2 collection sample shall be stable for 1 hour or longer at room temperature. Â
The Abbott Binax NOW® Antigen test system shall not require the use of a biosafety cabinet to process sample or perform testing. Â
Internal quality control material must be specific and proprietary to the Abbott Binax NOW® SARS-CoV-2 antigen test system offered and within the scope of the FDA EUA authorization.
Abbott Binax NOW® SARS-CoV-2 External positive and negative quality control material must be compatible for use with the proprietary Abbott Binax NOW® reagent test system.
The products in the Abbott Binax NOW® SARS-CoV-2 reagent test system must not require a storage temperature of less than 8 degrees centigrade. Room temperature storage is preferred. Â

Hardware and Software

Equipment or instrumentation required for the performance of the testing or interpretation/reading of the test result of the proposed equal test system, shall be provided as part of the antigen test kit pricing.Â
If equipment or instrumentation is required for the performance of the testing or interpretation/reading of the test result of the proposed equal test system, an approved VA Enterprise Risk Assessment (ERA) for medical devices is required. The ERA number and a copy of the approved ERA report shall be provided, upon request.  Â
If equipment or instrumentation is required for the performance of the testing or interpretation/reading of the test result of the proposed equal test system, a copy of a completed MDS2 and 6550 shall be submitted with proposal. Â
Network Security and Integration Requirements

If equipment or instrumentation is required for the performance of the testing or interpretation/reading of the test result of the proposed equal test system, compliance of all hardware and software with VA network security, and Enterprise Risk Analysis requirements. The Contractor shall supply responses to required documents for connection of medical devices to the VA network including but not limited to the VA Form 6550, Access Control List (ACL) Communication ports and protocols, services and application inventory, network diagram, and MSD2.
Contractor shall have a Memorandum of Understanding/Information Security Agreement (MOU/ISA) with the VA or the capability to obtain an MOU/ISA without creating significant implementation delays.
https://vaww.portal2.va.gov/sites/infosecurity/FY15CRISPAudit/CRISPRemediationContract/WorkSite/SitePages/MOU-ISA_Version2.aspx
The hardware must meet all VA minimum specifications and the software version must be approved for use on the VA network.
termination.

Troubleshooting

Troubleshooting and assistance with the use of the Abbott Binax NOW® SARS-CoV-2 reagent test system must minimally be available through telephone hotline support.

In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as Legal Federal official holidays .
New Year s Day
January 1st
Martin Luther King s Birthday
Third Monday in January
President s Day
Last Monday in January
Memorial Day
Last Monday in January
Juneteenth
June 19th
Independence Day
July 4th
Labor Day
First Monday in September
Columbus Day
Second Monday in October
Veteran s Day
November 11th
Thanksgiving Day
Fourth Thursday in November
Christmas Day
December 25th

When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies.

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