Attachment 2 - Brand name justification.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID# 36C250-25-AP-1281

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: 36C250-25-AP-1281

1. Contracting Activity: Department of Veterans Affairs, VISN 10, VA Northeast Ohio

Healthcare System (VANEOHS) Cleveland Ohio Medical Center is submitting to Network Contact Office (NCO) 10 at 6100 Oak Tree Blvd, Independence, OH 44131 for purchase of Epic Plus Valves.

Purchase request # 541-25-1-783-0185

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Brand name Epic Plus Mitral Heart Valves (2) of each sizes E200-25m, E200-27m, E200-29m, E200-31m, and E200-33M. The Epic Plus valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: They are biological versuses non biological valves. These are tissue based valves and all the others are mechanical based.

It may also be used to replace a previously implanted prosthetic mitral valve. The platform boasts the low ventricular protrusion in all valve sizes, a flexible polymer stent, individually selected porcine leaflets to ensure optimal coaptation, and a flexible sewing cuff designed to minimize both in-implant suture drag and post-implant paravalvular leak.

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

An email was sent to Abbott, manufacturer of the required products, seeking small business and socioeconomic subcategory distributors. Response from Abbott provided 2 SDVOSB, 1 WOSB, and 2 SB distributors.

VetCert was queried using NAICS 339113. The search provided 934 results.

A search was conducted in Small Business Administration (SBA) Dynamic Small Business Search (DSBS) SBA - SBA Search Results under NAICS CODE 339113.

The search yielded 5,555 results. A more targeted search including keywords "mitral heart valve" yielded zero results.

A search was conducted on GSA eLibrary for key words ‘mitral heart valve’ which yielded zero results.

https://www.acquisition.gov/?q=/browse/far/13

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID# 36C250-25-AP-1281

A search was conducted on ECAT for key words ‘mitral heart valve’ which yielded zero results.

A search was conducted on MedPDB for key word ‘E200’ (model number) which yielded three results.

A search was conducted on SCMC for key words ‘mitral heart valve’ which yielded 31 results.

A search was conducted on SAM.gov for NAICS 339113 and key words ‘mitral heart valve’ which yielded 5 results.

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.

Contracting Officer Date https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466