SSJ OVER SAT VISN 1 Abbott Binax NOW COVID-19 Ag Card Testing Supplies edited 6-4-21 -_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Abbott ID NOW Instruments and Reagents for SARS-CoV-2 testing, VISN 1 Acquisition Plan Action ID:36C241-21-AP-2097

Contracting Activity: Department of Veterans Affairs, Regional Procurement Office East, Network Contracting Officer 1 (New England) on behalf of VISN 1 Network Consolidated Laboratory (NCL). 2237:

multiple sites – unknown if sites will use purchase card or 2237

Nature and/or Description of the Action Being Processed:

5 Year Blanket Purchase Agreement (BPA) for a period of performance of 10/1/21-9/30/26. VISN 1 requires the acquisition of testing platforms that will allow for continued rapid test result turnaround time (TAT) to aid in managing atients and maintaining quality healthcare during the Coronavirus Disease (COVID-19) pandemic . To this end we are placing this procurement request for Abbott Point of Care Binax NOW COVID-19 Ag Card testing supplies to continue to provide care for our VA patients during th current COVID-19 pandemic

Most VISN 1 sites already have this testing in place

This agreement will allow sites to continue to obtain testing supplies as part of VISN 1’s and VA’s Moving Forward Plan.

Abbott Binax Now is only one of multiple SARS-CoV-2 testing platforms in use VISN 1. Currently VISN 1 is using and will continue to use a variety of testing platforms to meet the variety of turnaround time, patient testing, surveillance and monitoring needs our facilities face in providing care to our patients.

Other platforms in use are Abbott ID Now, Abbott Alinity M, BD Veritor, Quidel Sofia2, BioFire, DiaSorin, Luminex, Roche Cobas and Agena MassArray.

Binax NOW™ is a rapid lateral flow immunoassay for the qualitative detection and diagnosis of SARS-Co-V-2 directly from nasal swabs, without viral transport media. Test results are interpreted visually at 15 minutes. The test is totally contained with a standalone test card. No instrument is needed which makes this test extremely portable and categorized as CLIA waived therefore available for point of care testing use.

escription of Supplies/Services Required to Meet the Agency’s Needs Base Period of performance is 10/1/21 through 9/30/22.

Product

Product Description Qty Price Extended Amount

195-000 BinaxNOW COVID 19 Test Card (40 tests per kit) 4398 $ $

Currently, testing supplies are being provided through a national contract, and available to VISN 1 sites through the National COVID Response Tool (NCRT) via Logistics, but this contract is ending September 30, 2021. We have been instructed by VA Central Office to put local contracts in place to continue testing.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: N/A. This is a sole source procurement. Abbott is the only manufacturer of the Abbott Binax NOW COVID-19 Ag Card. This point of care test is needed for the unusual and compelling urgency assosciated with the Covid-19 pandemic. Recommendations from our VISN 1 Clinical Staff are to keep Binax Now rapid in-house testing in place so we can continue to open up healthcare services to our Veterans while maintaining a safe environment for Veterans, staff and visitors.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The vendor has a national contract with the government which will expire in Sept 2021. They are offering the same government pricing to all VAs setting up agreements covering the period beyond the end date of the national contract therefore we will be getting pricing that has previously been determined to be fair and reasonable by the government. Abbott is working to get this product on the Federal Supply Schedule (36F79721D0073) but that is not completed at this time. The quote from the vendor indicates the per test cost ( not including controls) is less than current commercial reference lab vendors in use (Quest conract $ , Yale $ purchase card, Univ of Washington $ purchase card) or other in-houlse testing (Abbott ID Now , Cepheid and Biofire are >$ per test). The low price make this test an affordable way to perform frequent testing in key areas such as our CLCs.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market Research not conducted. This is a sole source national contract ending Sept 2021.

VISN 1 is currently using this testing as part of the VA’s Moving Forward Plan and already performed the required validation studies prior to implementation of patient testing as per the College of American Pathologists (CAP) and The Joint commission (TJC) accreditation agencies and the Clinical Laboratory Impr vement Amendments of 1988 (CLIA) requirements to proceed with patient testing. Other vendor COVID-19 testing platforms are also in use in VISN 1 and it is important to employ a variety of testing platforms for use in the different types of patient care our facilities provide, and for monitoring staff for infectivity risk to control spread of the virus to our patients, staff and visitors.

Any Other Facts Supporting the Use of Other than Full and Open Competition: None

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None

A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: We will continue to follow all normal acquisition processes to the best of our abilities for supplies and services for requests outside of this pandemic.

If there are any quality issues with this testing platform in the future, VISN 1 will review and consider other testing options.

Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Name: Janet Lane Date Title: Program Director Facility: Brockton VAMC

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name: Julie Lemire Date Title: Contracting Officer Facility: Manchester VAMC

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Name: Tammy Fox Date NCO Duty Title: Branch Chief Facility: Manchester VAMC

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Name: Joseph Maletta Executive Director Date VHA Head of Contracting Activity (HCA)

Janet L. Lane 150483 Digitally signed by Janet L. Lane 150483 Date: 2021.05.24 17:49:59 -04'00'

Julie A. Lemire 149432 Digitally signed by Julie A. Lemire 149432 Date: 2021.06.02 13:37:58 -04'00'

Tammy A Fox 706200

Digitally signed by Tammy A Fox 706200 Date: 2021.07.27 12:31:43 -04'00'

JOSEPH MALETTA

1347841

Digitally signed by JOSEPH

MALETTA 1347841

Date: 2021.07.28 16:14:30 -04'00'