P03 JNA BIOCARTIS.docx

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: 36C246-23-AP-5921

1. Contracting Activity:

Department of Veterans Affairs, VISN 06, Asheville VA Medical Center, 1100 Tunnel Road, Asheville NC 28805. Purchase Number: 637-24-1-167-0028

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

The Asheville VAMC has a requirement for the annual purchase of the BioCartis Idylla Assay Kit. The BioCartis Idylla Assay Kit is the only product that can be used with the existing BioCartis Analyzer at Asheville VAMC. The estimated amount is $98,200.00.

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

This requirement is to provide the Charles George, Asheville VA Medical Center Pathology and Lab department a Brand Name item for their Biocartis Idylla Analyzer. The Biocartis Idylla system allows for molecular testing of tumors and malignancies. The Idylla system has the ability to determine if particular genetic markers are present with these malignant tissue samples, and allows the pharmacists and oncologists determine which course of action is best needed for the patients. The requested cartridges used for conducting test were found to be proprietary products of Biocartis US Inc.(OEM) and the only cartridges that will work in the Biocartis Idylla Analyzer Platform.

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

Market Research was conducted by querying the following government sites

· VetBiz Search using keywords “BIOCARTIS / NAICS 339113”– No Results

· GSA Advantage Search – No Results

· GSA e-Library Search – No Results

· NAC Search - No Results

· SAC Search: - No Results

· FPDS Search using keyword Biotcartis revealed 5 similar VA Department of Veterans Affairs orders placed for BioCatis products.

Further research by contacting Biocartis US Inc (OEM) revealed that the requested reagent cartridges for conducting testing using the Biocartis Idylla Analyer were proprietary products, and that their only authorized reseller/distributor was SDVOSB, Veterans Healthcare Supply Solutions (VHSS).

VHAPG

Part

813.106

Simplified

Acquisition

Procedures:

Soliciting from a

Single

Source Attachment

1:

Single

Source

Justification for

SAP

under the

SAT

Last

Updated:

02/01/22 Page of

Without being able to meet the VA Rule of two for this requirement the CO believes that the most advantageous acquisition strategy for the government is to pursue this acquisition as Open Market Brand Name Only - Unrestricted, IAW FAR Part 16.505 (4)

(a) and FAR Part 13.106-1.

5. Contracting Officer's Certification:

JAMES RISBON

James P. Risbon

Digitally signed by JAMES RISBON Date: 2023.09.14 10:20:50 -04'00'

Contracting Officer Date