SSJ_OVER_SAT VISN 1 Abbott ID NOW Intruments and Reagents COVID-19 v3-signed--.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-2096

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).

Nature and/or Description of the Action Being Processed:

5 Year Firm Fix d Price Blanket Purchase Agreement (BPA) for period 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 patients and maintaining quality healthcare during the Coronavirus Disease (COVID-19) pandemic . To this end we are placing this procurement request for Abbott POC ID NOW testing equipment, test kits and supplies to continue to provide care for our VA patients during this current COVID-19 pandemic Some of our VISN 1 sites already have ID Now instruments in place. This agreement will allow sites to obtain reagents and additional instruments if needed to expand testing as part of VISN 1’s and VA’s Moving Forward Plan.

Abbott’s ID NOW Covid-19 Test kit received FDA Emergency Use Authorization (EUA) 3-28-20 for use on their ID NOW Analyzer. VISN 1 is currently using these analyzers and reagents received through Logistic’s National Covid Response Tool (NCRT), however the national contract will expire September 2021. VA sites were instructed to put local contracts in place to continue testing.

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

ID NOW™ is a rapid, instrument-based, isothermal nucleid acid amplification system for the qualitative detection of infectious diseases. The test produce a positive result in 5 minutes and a negative result in 13 min

This procurement is for acquisition of test instrumentation and supplies for testing patients, employees and staff for the agent that causes COVID-19. This platform also has test kits available for rapid testing of Influenza A&B, Restpiratory Syncytial Virus (RSV) and Strep A, so may have future use in our facilities beyond the COVID-19 pandemic.

Funding will be a combination of 2237’s for multiple sites as well as use of Government Purchase Cards.

3. Description of Supplies/Services Required to Meet the Agency’s Needs Base Period of performance is 10/1/21 through 9/30/22. Extended period of performance is through 9/30/2026.

Product # Product Description Qty Price Extended Amount

NAT024 ID NOW Analyzer 2 $ $ 190-000 ID NOW Covid-19 Test kit (24T) ($37.00 each test) 896 $ $

190-080

ID NOW COVID-19 CONTROL KIT(12 POSITIVE, 12

NEGATIVE) 8 $ $

TOTAL $

5 Year Estimated Total Dollar Value $4,013,230.00

Note: The annual quantity required is only an estimate. Volumes may vary during period of contract.

The Kits come with swabs, there are 24 tests per case. Internal procedural controls.

External Control swab kit comes with 12 positive/ 12 negative.

External Controls are run once when new shipments are received or a new user is trained.

Test kit and Controls shelf life is 6 months from data of manufacture.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Abbott is the only manufacturer of the ID NOW instrument, and only Abbott ID NOW reagents can be used on the ID NOW instrument per their Food & Drug Administration (FDA) Emergency Use Authorization (EUA).

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 ID NOW instruments and only Abbott ID NOW COVID-19 test reagents can be used on the status.

Recommendations from our VISN 1 Clinical Staff are to keep 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 low equipment purchase cost and per test cost not including controls) is less than current commercial reference lab vendors in use Quest conract , Yale and Univ of Washington

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 follow-on to a national contract ending Sept 2021. VISN 1 sites own the Abbott ID NOW analyzers currently in place. Abbott ID NOW COVID-19 test reagents are the only COVID-19 test reagents that can be used on the Abbott ID NOW instruments owned by the VISN 1 laboratories. Reagents from other vendors are not interchangeable with the Abbott ID Now instruments.

VISN 1 is currently using this testing 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 Imprivement 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 in order to control spread of 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

Janet L. Lane 150483

Digitally signed by Janet L. Lane 150483 Date: 2021.05.24 17:45:32 -04'00'

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 1 Duty Title: Division 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 Malleta Executive Director Date VHA Head of Contracting Activity (HCA)

Julie A. Lemire 149432 Digitally signed by Julie A. Lemire 149432 Date: 2021.06.02 09:02:22 -04'00'

Tammy A Fox 706200 Digitally signed by Tammy A Fox 706200 Date: 2021.06.11 11:13:27 -04'00'

JOSEPH MALETTA

1347841

Digitally signed by JOSEPH

MALETTA 1347841

Date: 2021.06.11 14:15:41 -04'00'