6640--VCB COVID-19 BD Max Supplies

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 1

Original Date: 08/30/17

Revision 02 Eff Date: 03/31/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1

For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C257-20-AP-3669

Tracker Number: 2020-07-21T09:18:12

Agency: Department of Veterans Affairs (VA)

Contracting Activity: Network Contracting Office 17 (NCO-17)

7201 W. Interstate 40, Ste 100

Amarillo, Texas 79106-2612

2237 Number: 740-20-4-2051-0371

Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The HCC P&LMS laboratory requires additional reagents and controls to perform 2,000 SARS- CoV-2 tests on the existing BD MAX analyzer. Becton Dickinson & Co (BD) and BioGX have an FDA Emergency Use Authorization for this COVID-19 testing on the BD MAX platform. The estimated amount is $127,890.24 for one year.

Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

These reagents and controls are recently developed and not commercially available. They have been approved by the FDA under Emergency Use Authorization. As part of the agreement between BD and BioGX, BD is the exclusive distributor of the BioGX SARS-CoV-2 Reagents and Controls. Additionally, due to the nature of this requirement related to the current COVID-19 World-Wide Pandemic, BD is the only firm capable of providing the equipment described in Section 2 above without the Veteran s Health Administration experiencing unacceptable delays in fulfilling its requirements. As such, adverse patient outcomes would be unavoidable.

Description of market research conducted and results or statement why it was not conducted:

The BD MAX analyzer was purchased for the purpose of performing testing for COVID-19. With this analyzer, only BioGX has established reagents and controls to perform COVID-19 testing. BD and BioGX have an exclusive agreement and an Emergency Use Authorization through the FDA for this testing. A letter stating exclusive distribution rights was provided by BD.

Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

____________________________ July 22, 2020

Robyn Nussbaum Date

Contracting Officer Awarded contract 36C25720P1203 to BECTON, DICKINSON AND COMPANY for 127890.24000000 on 2020-07-24.