36C24219Q0085-003.pdf

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 2

Original Date: 08/30/17

Revision 01 Eff Date: 04/23/2018

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: 36C242-19-AP-0544

1. Contracting Activity: Department of Veterans Affairs, VISN 2, James J. Peters VA Medical Center

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

The estimated value of the proposed action is $6,955.52 plus 4 option years. Total IGCE = $34,777.60.

2237 # - 529-19-1-145-0024

This is a request for Geenius instruments and Geenius Cartridges. The Geenius™ HIV 1/2 Supplemental

Assay is an immunochromatographic test that incorporates highly conserved recombinant proteins and synthetic peptides representing HIV-1 and HIV-2 proteins. The Geenius™ HIV 1/2 Supplemental Assay is simple and easy to use for the detection and differentiation of individual antibodies to HIV-1 and HIV-2 in serum, plasma, or whole blood.

The Geenius™ HIV 1/2 Supplemental Assay can be used in accordance with current CDC recommendations for Laboratory Testing for the Diagnosis of HIV Infection.38 Per the CDC recommended algorithm, specimens reactive on a 4th generation HIV assay should undergo supplemental testing with an immunoassay that differentiates HIV-1 from HIV-2 antibodies.

Geenius ™ HIV 1/2 Supplemental Assay Cat# 72461

Geenius ™ Reader Cat # 92465

Geenius ™ Computer Cat# 92052

Printer Cat # 12000211

Barcode Scanner Cat # 12000019

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

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

A sources sought was posted to both GSA and FedBizOpps for 5 business days on November 8, 2018.

No responses were received. A search of VIP revealed no sources under NAICS 334516, Bio-Rad nor

Bio-Rad Laboratories, Inc., doing business as Bio-Rad Diagnostic, is the sole manufacturer, distributor and supplier in the United States of the Geenius instrument/Geenius Cartridge. Other distributors are not authorized to sell to any customers other than to blood banks in the United States per TXMAS US

Government contract. The Bio-Rad Geenius™ HIV 1/2 Supplemental Assay and the Multispot® HIV-1/

HIV-2 Rapid test are the only tests in the USA to offer detection and differentiation of HIV-1 and HIV-2 antibodies.

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 2 of 2

Original Date: 08/30/17

Revision 01 Eff Date: 04/23/2018

HIV 1/2. Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized. Based on market research, Bio-Rad is the only company which can provided the required instrument and reagents. A sole distributor memorandum was received from the manufacturer, Bio-Rad Laboratories, Inc.

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.

GINA A. BLUM

Contracting Officer