P03 SSJ.pdf

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

VHAPM Part 813.106 Page 1 of 3 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

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: 36C25023Q0676

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service

Network (VISN) 10, Louis Stokes Cleveland VAMC (CLE VAMC) Network Contracting Office

(NCO) 10.

Transaction: 541‐23‐4‐2321‐0621

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

Network Contracting Office (NCO) 10 intends to award a new, firm fixed price, brand name, purchase order to Ardiem Medical, Inc. This request is for supply probes.

ESTIMATED DOLLAR VALUE: $139,873.91

REQUIRED DELIVERY DATE: 180 Days ARO

2. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Per FAR 11.105 Items peculiar to one manufacturer and 12.4‐Unique Requirements Regarding Terms and Conditions for Commercial Items, Providus Holdings, Inc., is uniquely qualified to provide medical carts based on the following:

Components used for implanting the iSens system must be FDA‐approved under an IDE for this particular use case. These components are the only ones in existence that meet that requirement.

3. Description of market research conducted and results or statement why it was not conducted: Market research was conducted by the Contracting Officer and the service to identify available sources to meet the requirements as follows:

VetCert Vetbiz, Intent to Sole Source, MSPV, DSBS, National Contracts, Interagency Contract Directory, GSA, FSS, ECAT, CM, FPDS and the Internet were reviewed with the following results:

In accordance with January 9, 2023, advisory for VetCert usage, VetCert was queried, as required, using NAICS 334419. The search provided 180 results. Veteran Small Business Certification (sba.gov)

VHAPM Part 813.106 Page 2 of 3

Revision 02 Eff Date: 03/31/2020

In accordance with VAAR Subpart 819.704, 819.7005, 819.7006‐ https://www.vip.vetbiz.va.gov/, a search was conducted on Vetbiz in attempt to locate SDVOSB’s and Veteran Owned Small Business’s (VOSB) concerns using NAICS code 334419.

This search provided 98 SDVOSB and eight (8) VOSB vendors, and 28 SDVOSB and one (1) VOSB vendors using key words “isens smart lead component.” CO Dashboard ‐ Vendor Search Results ∙ VetBiz Portal (va.gov)

An Intent to Sole Source (ISS), RFQ 36C25023Q0676, was posted on SAM.gov, from May 4, 2023, through May 9, 2023, with no inquiries.

Medical Surgical Prime Vendor (MSPV) Contracts: MSPV Generation Z v1:

https://www.va.gov/opal/sac/mspvNG.asp. The Medical Supply Program Office (MSPO) in close coordination with several Clinician‐Led Integrated Product Teams and VHA Procurement has developed and released the solicitation for the items that will supply the MSPV General Z v1 program. Solicitation 36C10ZX22Q0151 for the MSPV Generation Z v1 Program is currently released via Contract Opportunities. The goal of the MSPV Gen‐Z V1 distribution and supply management contractor(s) is to obtain medical/surgical products from VA authorized suppliers utilizing a distribution and supply management system that minimizes VA’s inventory stock on hand, promotes standardization, and allows product selection from a multitude of vendors. There are MSPV transition distribution contracts available for interim use. The MSPV product list was reviewed to determine if these items are available through the transition distribution contracts. The equipment required by this procurement is not included in the MSPV transition distribution contracts product list.

Medical/Surgical Prime Vendor (MSPV) Program ‐ Office of Procurement, Acquisition and Logistics (OPAL) (va.gov)

Small Business Administration (SBA) Dynamic Small Business Search (DSBS): A search was conducted on the SBA’s DSBS at https://web.sba.gov/pro‐net/search/dsp_search ‐ help.cfm?goto=Keywords in an attempt to find small business manufacturers of Isens Smart Lead Component by selecting “manufacturing” in General Nature of Business and using keywords “Isens Smart Lead Component” and NAICS code 334419. No results for applicable small business manufacturers were uncovered using this search. SBA ‐ SBA Quick Market Search Results

National Contracts, BPAs, and BOAs: A search the National Strategic Source Listing found at https://www.va.gov/opal/sac/index.asp. No national contracts are available for use for this requirement. Medical/Surgical Prime Vendor (MSPV) Program ‐ Office of Procurement, Acquisition and Logistics (OPAL) (va.gov)

Interagency Contract Directory: A search of the Interagency Contract Directory tool at https://www.contractdirectory.gov/contractdirectory/ for Isens Smart Lead Component resulted in no contract vehicles available that offer the required equipment. Interagency Contract Directory Portal

VHAPM Part 813.106 Page 3 of 3

Revision 02 Eff Date: 03/31/2020

GSA eLibrary: https://www.gsaelibrary.gsa.gov/ElibMain/home.do: Various GSA searches did not locate a GSA Federal Supply Schedule (FSS) contract that includes the items required and, therefore; GSA is not a source for this requirement. Search Results (gsaadvantage.gov)

Electronic Catalog (ECAT): https://www.medical.dla.mil/WAM/Home/consent;. A search on ECAT did not locate an ECAT contract that includes the items required and, therefore;

ECAT is not a source for this requirement. DMMonline (dla.mil)

An additional search of the Category Management (CM) Quick Decisions Dashboard https://d2d.gsa.gov/report/metrics‐cm‐quick‐decisions‐dashboard was conducted using the product search tool for “isens smart lead component.” There were zero “0” results. As such, there are no available category management solutions for the required equipment.

Equipment Home (dla.mil)

Federal Procurement Data System (FPDS): https://www.fpds.gov. A search on FPDS, with “isens smart lead component” in the search tool, located the following: FPDS‐NG ezSearch – there were zero results

IAW MB Memorandum M‐19‐13 Category Management: Making Smarter Use of Common Contract Solutions and Practices, this requirement cannot be satisfied through Best in Class contracting (BIC).

Based on the results of market research, the Government determined that this will be sole sourced to Ardiem Medical, Inc., a large, via Open Market. The Non‐Manufacturing Rule (NMR) does not apply to this procurement, there is not a class waiver. Based on the market research, the VA Rule of Two cannot be met. There are no Buy American Act (BAA) issues to be concerned with. There are no Trade Agreement Act (TAA) to be concerned with. The Isens Smart Lead Components are MIA.

4. 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.

Rachelle J. Hamer Date

Contracting Officer