P03 SSJ - Covid-19 VISN 1 Diasorin Reagents - DMC-TNeubelt - 11.30.2020 Signed_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: VA-21-00017560____________ Contracting Activity: Department of Veterans Affairs, VISN 01, Path and Lab Service.

Nature and/or Description of the Action Being Processed: VISN 1 laboratories at VA Togus, VA WRJ, VA Manchester, VA West Roxbury, VA Brockton, VA Jamaica Plain and VA Connecticut need a weekly standing order of Diasorin reagents for 136 COVID-19 test kits plus 12 boxes of controls per week.

This is needed for the increased testing needs due to the COVID-19 pandemic within VISN 1 . The estimated cost of this request is $5,155,744.

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

SIMPLEX COVID-19 DIRECT KIT \ MOL4150

SIMPLEX COVID-19 POSITIVE CONTROL \ MOL4160.

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;

( ) (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;

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 has a small footprint which is critical in the labs due to the limited bench space. The controls and operation are very user friendly. Another critical factor is the inability of the other vendors to provide an adequate amount of supplies in support of their equipment and testing. As a result, the 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 per instrument and will greatly improve the current reagent shortages we are experiencing, The Diasorin system has been deemed by the FDA as one that provides high sensitivity for Covid-19 testing.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: