P03 Single Source Justification MPT to SAT_COVID 19 Geno Seq_05122022_Redacted.pdf

Last Updated: 02/01/22 Page 1 of 1

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1

For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($750K for COVID-19)

Acquisition Plan Action ID:___36C261-22-AP-4063___

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional

Procurement Office West, Network Contracting Office 21 (NCO 21) on behalf of Palo Alto VA

Health Care System.

2237: 640-22-3-498-0105

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

This is a request for the reagents and supplies to perform COVID-19 genomic sequencing on the

Clear LABs DX instrument. This instrument is used to test patient samples (from Palo Alto and other

VA Facilities) for Covid-19 and other infectious agents. The DX instrument addresses Palo Alto’s need for higher throughput with an US FDA EUA approved assay. The sample testing volume has increased substantially due to the Covid-19 pandemic and will continue to increase for the unforeseen future. The DX instrumentation enables the VA Palo Alto to determine Covid-19 virus sequences from patient samples in order to track the development of new strains and those associated with vaccine failure.

This will be awarded as a new firm fixed price contract. The estimated cost for this procurement is

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

The requested COVID-19 genomic sequencing reagents are only available through the manufacturer, proprietor and sole authorzed distributor Clear Labs, Inc. Failure and/or faults identified at other locations nationally have caused the Clear Labs DX instrument used in Palo Alto to become more heavily relied upon and used as a standard. Samples are continually being re-routed to the Palo Alto

Public Health Reference Laboratory for processing.

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

Limited market research was conducted due to the proprietary nature of the requested COVID-19 genomic sequencing reagents. These reagents are commercially available through the manufacturer

Clear Labs, Inc., a small business. There are no authorized distributors for these reagents that are proprietary to the Clear Labs DX instrument.

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.

Mandy Thompson Date

Contracting Officer https://www.acquisition.gov/?q=/browse/far/13 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466