P03 SSJ.pdf

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

Retractor System 541‐23‐3‐703‐3484

Last Updated: 02/01/22 Page 1 of 4

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: 36C250‐23‐AP‐4125

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: 541‐23‐4‐2312‐1040

2. 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, a small business distributor for Deringer‐Ney, via Open Market.

This request is for a retractor system.

ESTIMATED DOLLAR VALUE: $30,129.33

REQUIRED DELIVERY DATE: 180 Days ARO

3. 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, Integra Life Sciences, is uniquely qualified to provide the retractor system:

The Advanced Platform Technology Center, in collaboration with Ardiem Medical, Inc., has pioneered the design, development, and prototyping of the unique implantable devices required for our research and development efforts. These devices, due to their complexity and the specific expertise required for their production, necessitate a very specific set of capabilities that limit their availability to just one source: Ardiem Medical, Inc.

The center lacks both the manpower and facilities necessary for large‐scale manufacturing of these highly specialized electrodes, leading us to engage Ardiem Medical, Inc., a full‐ service medical device design and manufacturing company, as our contracted manufacturer since the early 2000s. Ardiem Medical's ability to produce these specific electrodes according to our stringent specifications demonstrates a unique collaboration and transfer of our specific manufacturing processes that is unmatched elsewhere in the market.

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Notably, Ardiem Medical is the exclusive manufacturer of these implantable devices and several other key components of our systems. This exclusivity is grounded in the company's in‐depth understanding of our technical specifications, refined over years of collaboration, and their distinctive ability to meet our specialized needs.

Engaging with another contract manufacturer would not only be costly but would also necessitate transferring our intricate technology and hard‐earned expertise to a new manufacturer, a process that would be both time‐consuming and potentially risky in terms of quality control and adherence to specifications.

As such, the cost of procuring devices from Ardiem Medical, Inc. is significantly less than the associated cost of producing these devices at the Advanced Platform Technology Center or transferring the requisite technology and experience to another manufacturer.

Consequently, Ardiem Medical, Inc. remains the singular viable source for these unique implantable devices.

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

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

In accordance with January 9, 2023, advisory for VetCert usage, VetCert was queried, as required, using NAICS 334516. The search provided 193 results. Veteran Small Business Certification (sba.gov)

An Intent to Sole Source, RFQ 336C25023Q0915, was posted on SAM.gov, Contract Opportunities on July 12, 2023, with a response date of July 19, 2023, utilizing NAICS code 334516. No potential equals or vendor questions were received in response to posting to SAM.gov, Contract Opportunities.

The OEM, Deringer‐Ney, was contacted to receive a list of authorized distributors, with a concentration on SDVOSB and VOSB authorized distributors and to determine in what country(ies) the IRS/IST Electrodes NNP Modules is manufactured. The IRS/IST Electrodes NNP Modules is manufactured in America. The OEM contact, stated that Deringer‐Ney is the manufacturer of the IRS/IST Electrodes NNP Modules, does utilize an authorized distributor for America, Ardiem Medical, and that they are a small business.

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

Last Updated: 02/01/22 Page 3 of 4 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 IRS/IST Electrodes NNP Modules by selecting “manufacturing” in General Nature of Business and using keywords “IRS/IST Electrodes NNP Modules” and NAICS code 334516. No results for applicable small business manufacturers were uncovered using this search.

SBA ‐ SBA 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 IRS/IST Electrodes NNP Modules resulted in no contract vehicles available that offer the required equipment.

Interagency Contract Directory Portal

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)

Last Updated: 02/01/22 Page 4 of 4

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 “IRS/IST Electrodes NNP Modules.” 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 “IRS/IST Electrodes NNP Modules” in the search tool, located the following: FPDS‐ NG ezSearch ‐there were no 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).

The U.S. Food & Drug Administration (FDA) tool at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151706, was utilized. The IRS IST Electrodes NNP Modules does not need an FDA 510(k) clearance:

510(k) Premarket Notification (fda.gov)

The VA and SBA Rule of Two cannot be met due to sole sourcing to Ardiem Medical, a small business.

There are no BAA or TAA issues.

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.

Rachelle J. Hamer Contracting Officer