P03 SSJ Covid-19 VA-20-0007105 rev 2 signed 10 27 20--.pdf

OFOC SOP Revision 10 Page 1 of 3 Original Date: 03/22/11 Revision 10 Date: 09/10/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT) Brand Name Only

Acquisition Plan Action ID: VA-21-00007105_ 689-21-1-7455-0081

1. Contracting Activity: Department of Veterans Affairs, VISN 1, White River Junction VA Medical Center

2. Nature and/or Description of the Action Being Processed: VA Connecticut needs a weekly standing order of Diasorin reagents for 24 COVID-19 test kits plus 2 controls per week. This is needed for the increased testing of COVID-19 within the Connecticut area as well as for the testing of Veteran patients from other VISN 1 sites. The estimated cost of this request is $658,880.

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

SIMPLEX COVID-19 DIREST KIT \ MOL4150 680 total SIMPLEX COVID-19 POSITIVE CONTROL \ MOL4160. 56 total

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

( X ) (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): The Diasorin Platform takes up very little space and is easy to use. Other vendors cannot provide enough reagent to satisfy the needs of VISN 1. Diasorin, although also on allocation, can provide 8 test kits per week with 24 tests per kit. This amounts to 192 tests per week and will greatly improve the current reagent shortages we are experiencing, The system has been deemed by the FDA as one that provides high sensitivity for Covid-19. This system is very easy to use.

6.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Extensive market research was performed by VACT laboratory medical directors, this is one of 3 sources available for COVID-19 commercial testing reagents available to VACT lab, all 3 are on allocation and VACT already has contracts in place for the other 2, Roche and Cepheid.

OFOC SOP Revision 10 Page 2 of 3

Revision 10 Date: 09/10/2020

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: There are many Covid platforms available, 3 of which are used by VA Connecticut.

The cost of the Diasorin system is fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Extensive market research was performed by VACT laboratory medical directors, this is one of 3 sources available for COVID-19 commercial testing reagents available to VACT lab, all 3 are on

9. allocation and VACT already has contracts in place for the other 2, Roche and Cepheid.

10. Any Other Facts Supporting the Use of Other than Full and Open Competition: Diasorin reagents are the only reagents approved for testing on the Diasorin analyzer.

11. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: NONE

12. 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:

The nation is currently in a pandemic with thousands of deaths and according to some, has a long way to go. Testing needs to be able to meet the current requests. Many vendors are have already reached capacity and has limited reagents available. If there are other vendors and systems available, they will be considered. As VACT already has the system, the logical choice is to get available reagents to use those instruments.

13. 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.

14.

_____________________________ ________10/16/20________________ Name David McElwee Date Title-Program support VISN 1, NCL Facility Brockton, MA

David G.

McElwee 142454

Digitally signed by David G. McElwee 142454 Date: 2020.10.27 15:09:31 -04'00'

OFOC SOP Revision 10 Page 3 of 3

Revision 10 Date: 09/10/2020

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.

Julie Lemire 10-26-2020 Name Date Title: Contracting Officer Facility-NCO1-Manchester VAMC

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Linda Ward 10-26-2020 Name Date NCO/PCO Branch Chief

Facility -NCO1-Manchester VAMC

Julie A. Lemire 149432 Digitally signed by Julie A. Lemire 149432 Date: 2020.10.27 07:34:04 -04'00'

Linda J. Ward 155235 Digitally signed by Linda J. Ward 155235 Date: 2020.10.27 13:48:36 -04'00'