P03- Single Source Justification MPT to SAT-Sterilizer Cases.pdf

Revision: 01 Effective Date: 11/15/2024 Acquisition ID# 36C242-26-AP-0917

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

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 12.102 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($350K)

Acquisition Plan Action ID: 36C24226AP0917

1. Contracting Activity: Department of Veterans Affairs, VISN 2 Albany Stratton VHA Medical Center.

2. Brief Description of Supplies/ Services required and the intended Use/Estimated Amount: : The Department of Veterans Affairs requires sterilizer cases specifically designed and validated for use with Arthrex surgical instrument sets. These sterilizer cases are essential to ensure compliance with manufacturer Instructions for Use (IFUs), protect delicate instruments, and maintain patient safety during surgical procedures. Arthrex surgical instruments are proprietary devices used in orthopedic surgeries at this facility. The manufacturer has validated only Arthrex sterilizer cases for proper reprocessing and sterilization. Use of generic sterilizer trays is not FDA-cleared for Arthrex instruments and could result in noncompliance with Joint Commission, VA Sterile Processing Services (SPS) policies, and FDA requirements. In addition, improper sterilization or instrument damage could cause surgical delays and increase patient risk. $38,700.00.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: : The required items are rigid sterilizer cases manufactured and validated by Arthrex Inc. These cases provide:

Custom-fit brackets and inserts designed to secure Arthrex instruments.FDA-cleared and validated sterilization parameters per Arthrex Instructions for Use (IFU).Compatibility with steam sterilization cycles used in VA Sterile Processing Services (SPS).Protection against instrument damage during sterilization, storage, and transport. Standardization of sets will support efficiency in the operating room.

Vendor representatives confirmed that only Arthrex produces and distributes this product. Since these items are already in use within the Albany VA facility it is parament to maintain seamless continuity with surgical equipment.

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 Acquisition ID# 36C242-26-AP-0917

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

Market research determined that no alternate vendor provides sterilizer cases validated for Arthrex surgical instruments. Generic sterilizer trays are not FDA-cleared for use with Arthrex instruments and are not listed in the manufacturer’s validated IFUs. Using a different brand or vendor could jeopardize the life-span and integrity of the surgical equipment.

GSA was searched for the terms “Surgical Sterilizer Cases,” yielding 3 pages of results, however these items appear to be generic and non-compliant for the specific Arthrex Glenoid Reamer system tools requested.

GSA was searched for the term “Sterilizer Cases,” and 5 plus pages of results were located. None of the results appeared compatible with Arthrex equipment.

GSA was searched for the term “Arthrex Sterilizer Cases,” and no results were populated.

FPDS was searched for the term “Arthrex Sterilizer Cases,” and 0 past contracts were located.

FPDS was searched for the terms “Surgical Sterilizer Case,” and 7 past contracts were located for the Department of Veterans Affairs. These appeared to be more generic items upon further research.

SBA was searched for the term “Surgical Sterilizer Cases,” NAICS code 339112, and SDVOSB as a demographic group and 0 results were located.

SBA was also searched for the term “Surgical Sterilizer Cases,” and NAICS code 339112 yielding 346 total small businesses. Arthrex however as indicated that they are the sole OEM and distributor of the cases necessary for the requested Reamer System.

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.

Jonathan Kilgore Date Contracting Officer