P03 JOFOC AP4615__Redacted.pdf

Last Updated: 02/01/22 Page 1 of 2

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: 36C261-24-AP-4615 JOFOC Tracker ID: FY24 - NCO 21 - 2490

1. Contracting Activity: Department of Veterans Affairs, NCO 21 on behalf of VISN 21, VA San

Francisco Healthcare System, 4150 Clement St, San Francisco, CA 94121

2237: 662-24-4-933-0362

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

This is action is for rental equipment for a research grant for immunoassays. The equipment is customized for the research project. This study is funded by a grant from the VA to look for biomarkers for long-COVID. Researchers are looking at plasma levels of certain markers of neuroinflammation Plus, using neuronal derived extracellular vesicles isolated in the plasma and coming from neurons in the brain, to assay picogram levels of toxic protein such as amyloid beta and tau, that the lab has found in people with long-COVID and are associated with Alzheimer's’ disease.

Estimated Value:

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

ProteinSimple is a vendor that develops transformative protein analysis tools, including various immunoassay systems, and provides products for sale or rent. Immunoassay is an essential method for evaluating the circulating biomarker levels in the blood for diagnosis. They are committed to providing exceptional instruments to conduct immunoassay, such as the Ella automated immunoassay system, to meet the research needs of the SFVAHCS. he Ella system is a unique automated immune assay system that provides highly reproducible, validated assay data and consistent biomarker detection with no manual steps. The assay performance behind that data includes sub-picogram level sensitivity, over 4 logs of dynamic range and precision that rivals the best laboratory automation. Developed by ProteinSimple, the Ella system is available for purchase and rent exclusively from ProteinSimple.

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

GSA eLibrary and Advantage was reviewed, where a distributor was found of ProteinSimple (OEM).

(SB) is a distributor that holds a GSA contract under ID

The needed items could not be found.

SAM.Gov was reviewed with no significant results.

Last Updated: 02/01/22 Page 2 of 2

FPDS was reviewed where was found awarded to ProteinSimple for similar items in the amount of on 07/31/2024, by the NIH. Additionally, was found awarded to ProteinSimple for research equipment in the amount of 5/10/2023. Neither action was competed.

The NAC was reviewed with no significant results.

The SCMC was reviewed with no significant results.

SEWP was reviewed with no significant results.

SAM.Gov was reviewed, where ProteinSimple’s reps and certs were reviewed.

This action is for customized research assays, no other OEM has the ability to make the needed equipment.

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.

Mathew B. Czeshinski Date Contracting Officer