Abbott ID NOW J_A Signed _ Redacted.pdf

36C244-22-AP-2653—Abbott ID Now COVID-19 Test Kits—VISN 4

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C244-22-AP-2653

1. Contracting Activity: Network Contracting Office 4 provides contracting support for the

Department of Veterans Affairs, VA Healthcare-VISN 4, 1010 Delafield Road, Pittsburgh, PA 15215.

2237#: 481-22-2-617-0020

2. Nature and/or Description of the Action Being Processed: VISN 04 requires the brand name acquisition of Abbott ID NOW Test Kits 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. VISN 04 medical centers already have the Abbott ID Now analyzers in place.

ID NOW is a rapid, instrument-based, isothermal nucleid acid amplification system for the qualitative detection of infectious diseases. The test produces a positive result in 5 minutes and a negative result in 13 minutes, which satifies the need for rapid test result turnaound time.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

500 Abbott ID NOW COVID-19 Test Kits (190-000)-- Kit size: 24 pouches with reagents per kit

Estimated Total Cost:

4. Statutory Authority Permitting Other than Full and Open Competition:

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

(X) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. 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 COVID-19 Test Kits and they are patented and sold exclusively through Abbott Rapid Dx North America, LLC. Abbott has indicated that it can deliver these tests 30 days ARO. These kits are for use with the existing Abbott ID Now Analyzers used throughout VISN 4 and are the only kits authorized to be used on this system per their Food & Drug Administration (FDA) Emergency Use Authorization (EUA).

Changing instrumentation would require a month-long validation and retraining of employees, in addition to the additional cost to the government to purchase new analyzers. As no other supply will suffice for this requirement and only Abbott is able to fulfill the urgent need for additional test kits for VISN 4, NCO 4 intends to sole source this requirement to Abbott.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Abbott is the manufacturer of the Abbott ID NOW COVID-19 test kits required for use with the Abbott ID NOW analyzers currently owned by the VISN 4 laboratories Recommendations from our VISN 04 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.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: Anticipate that award cost will reflect previous prices paid for ID Now test kit contracts awarded by VA’s Strategic Acquisition Center (SAC). Historical and current contracts include 36C10X20D0019 and 36C10X22P0015, both of which found a price of $888.00 per kit to be fair and reasonably priced.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Researched prior contracts using FPDS and USA Spending, searched for replacement national contract, and verified SAM registration.

VISN 4 medical centers have 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 4 laboratories. Reagents from other vendors are not interchangeable with the Abbott ID Now instruments.

VISN 04 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.

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

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

11. 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 4 will review and consider other testing options.

VISN 4 and NCO 4 are working to prepare a long term, VISN-wide solution for COVID-19 testing. This “bridge” contract is to fulfill a bona fide need for a short duration in the anticipation of competing a longer term contract opportunity in the near future.

12. 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.

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.

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.