36C24619Q0777-001.pdf

VHAPM Part 813.106 Page 1 of 1 Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For

Brand Name Only

Acquisition Plan Action ID: 36C246-19-AP-4268

1. Contracting Activity: Department of Veterans Affairs, VISN 06, Hampton VA Medical Center, 100

Emancipation Drive, Hampton, VA 23667 Purchase Request No. 637-19-3-7791-0167.

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

Asheville VAMC has a requirement to procure the BioCartis Idylla. The BioCartis Idylla will allow the Charles George VA Medical Center to perform genetic tumor marker testing for its own medical center and most facilities in the VISN.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The BioCartis Idylla is the only table top sized FDA approved analyzer for the tumor genetic marker testing. All other platforms are considerably large and performs tests beyond the scope of this facility. The Idylla system has the ability to obtain a minimal sample size for solid biopsies. Compared with NGS and other RT-PCR testing methods, the Idylla system eliminates the need for multiple numbers of instruments, large amounts of consumable items and increased square footage of laboratory space. Everything that is needed to perform tests are provided in a single disposable cartridge. Idylla covers the entire process from sample to result in a time frame of 35 to 150 minutes with less than 2 minutes hands-on time. Idylla is applicable for a wide range of clinical sample types and can analyze both RNA and DNA.

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

Research was conducted using VIP, FPDS, NAC, SAC, GSA, and Internet. When querying VIP using NAICS 339113 and keywords “molecular diagnostics system” 57 SDVOSBs and 10 VOSBs were found. Although multiple vendors were located, this brand is required and preferred due to the integrated system enables clinical laboratories to perform a broad range of applications in oncology, infectious diseases and beyond.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR 8.405-6. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Daleta Coles Jerry Mann

Contract Specialist, Supply Team III Contract Officer, Supply Team III