36C25720P1203_1.docx

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Contract Opportunity Justification and Approval Notice

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

DELIVERY/TASK ORDER NUMBER

(Required when using Statutory Authority FAR 6.302-1(c))

BASE NOTICE TYPE

ARCHIVE

DAYS AFTER THE POSTING DATE

RECOVERY ACT FUNDS

NAICS CODE

CONTRACTING OFFICE

ADDRESS

DESCRIPTION

See Attachment

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

STATUTORY AUTHORITY

AWARD NUMBER

(Not required when using Statutory Authority FAR 6.302-1(c))

MODIFICATION NUMBER

AWARD AMOUNT

LINE ITEM NUMBER

AWARD DATE (MM-DD-YYYY)

(Not required when using Statutory Authority FAR 6.302-1(c))

AWARDEE NAME

AWARDEE ADDRESS LINE 1

AWARDEE ADDRESS LINE 2

AWARDEE ADDRESS LINE 3

AWARDEE ADDRESS LINE 4

AWARDEE CITY

AWARDEE STATE

AWARDEE ZIP CODE

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

AWARD INFORMATION

ADDITIONAL INFORMATION

GENERAL INFORMATION

* = Required Field Contract Opportunity Justification and Approval Notice VCB COVID-19 BD Max Supplies 79106

36C257-20-AP-3669

36C25720P1203 N 334516 00504 Department of Veterans Affairs Contracting Section 7201 I-40 West Suite 100 Amarillo TX 79106 Robyn Nussbaum robyn.nussbaum@va.gov

FAR2

36C25720P1203 $127,890.24 07-24-2020

BECTON, DICKINSON AND COMPANY

7 LOVETON CIR

SPARKS

MD

21152

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

1. Agency: Department of Veterans Affairs (VA)

Amarillo, Texas 79106-2612

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

2. 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.

3. 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.

4. 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.

5. 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.

Contracting Officer

VHAPM Part 813.106 Page 3 of 3 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020