3481-SSJ-Hamer.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‐4753

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: 541‐23‐3‐703‐3484

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 Buffalo Supply, a small business distributor for Integra Life Sciences, via Open Market. This request is for a retractor system.

ESTIMATED DOLLAR VALUE: $98,712.60

REQUIRED DELIVERY DATE: 90 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:

Flexibility, Interchangeable, Removable Arms & Stable Retraction that lets you perform procedures the way you prefer.

Strong enough for your largest patients. Nimble enough for small‐site work. Always easy to use.

Use one arm, use two arms, take one arm away or use one of each. Choose the frame arm before or during surgery that helps maximize your surgical field:

Ease‐of‐Use Maximize Exposure Minimize Obstructions

Last Updated: 02/01/22 Page 2 of 4

Exchange an Arm Remove an Arm Open the Field

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 339112. The search provided 613 results. Veteran Small Business Certification (sba.gov)

An Intent to Sole Source, RFQ 336C25023Q0913, was posted on SAM.gov, Contract Opportunities on July 12, 2023, with a response date of July 19, 2023, utilizing NAICS code 339112. No potential equals or vendor questions were received in response to posting to SAM.gov, Contract Opportunities.

The OEM, Integra Life Sciences, 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 retractor system is manufactured. The retractor system is manufactured in America. The OEM contact, stated that Integra Life Sciences is the manufacturer of the retractor system, does utilize an authorized distributor for America, Buffalo Supply, and that they are a small business.

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

Last Updated: 02/01/22 Page 3 of 4 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 retractor system by selecting “manufacturing” in General Nature of Business and using keywords “retractor system” and NAICS code 339112. No results for applicable small business manufacturers were uncovered using this search. SBA ‐ Dynamic Small Business Search

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 retractor system 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)

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 “retractor system.” 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 “retractor system” in the search tool, located the following: FPDS‐NG ezSearch ‐ there were several results

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

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 retractory system 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 Buffalo Supply, 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