P03 SSJ_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT

Revision: 02 Effective Date: 12/30/2025 Page 1 of 2 Acquisition ID#36C250-26-AP-3812

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW RFO 12 For

Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID: 36C250-26-AP-3812

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

Network (VISN) 10, Cleveland Veterans Affairs Medical Center (CLE VAMC) Network Contracting Office (NCO) 10.

Transaction: 541-26-3-703-2030

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, sole source purchase order to Johnson & Johnson-DePuy Synthes, for Actis Core Trays for the Cle VAMC.

ESTIMATED DOLLAR VALUE:

REQUIRED DELIVERY DATE: 30 Days ARO

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The ACTIS Core Instruments and ACTIS Core Trays are proprietary to DePuy Synthes (Johnson & Johnson MedTech) and are specifically designed for use with the ACTIS Hip System utilized by the Cleveland VA Medical Center. The required instrumentation includes ACTIS-specific calcar mills, impactors, inserter shafts, reamer shafts, femoral rasps, osteotomes, case bases, and related components engineered to support the design, sizing, alignment, and implantation requirements of the ACTIS Hip System.

These instruments are essential components of the ACTIS surgical platform and are required to support existing orthopedic surgical procedures, maintain compatibility with currently utilized implants, and ensure continuity of established surgical techniques. The ACTIS system incorporates specialized instrumentation intended to support proper implant positioning, alignment, stability, and overall procedural efficiency during total hip arthroplasty procedures. Use of non-compatible instrumentation could adversely impact implant compatibility, surgical workflow, procedural efficiency, and patient care outcomes.

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT

Revision: 02 Effective Date: 12/30/2025 Page 2 of 2 Acquisition ID#36C250-26-AP-3812

Market research and information provided by the requiring activity confirmed that the ACTIS Core Instruments are manufactured exclusively by DePuy Synthes and that no other company produces compatible ACTIS core instrumentation. Due to regulatory, safety, and design requirements, only the original manufacturer can provide ACTIS-approved core trays and associated instrumentation. These instruments are fully compatible with the Government’s existing ACTIS Hip System and are not interchangeable with competing hip systems. Therefore, no other source can provide the required proprietary ACTIS Core Instruments and ACTIS Core Trays necessary to support the Government’s existing orthopedic surgical requirements.

1. 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 determine if there were other vendors capable of providing core trays that meet CLE VAMC's specific requirements. The following sources were reviewed:

6/2/2026 GSA eLibrary, ECAT, SAM.gov, Interagency Contract Directories, NAC, SEWP, FPDS, SCMC, MSVP, BIC, and FDA were reviewed:

o Keywords Used: "core trays” o Results: No results identified for the required ACTIS Core Trays and associated instrumentation.

On 6/2/2026 SBS was reviewed:

o NAICS Code Searched: 339112 o Keywords Used: "core trays" o Results: No results identified for the required ACTIS Core Trays and associated instrumentation.

The NMR does apply to this procurement under NAICS 339112. The SBA does not provide a waiver. The VA and SBA Rule of Two cannot be met, due to being sole sourced to Johnson & Johnson- DePuy Synthes, as large business open market.

4. Contracting Officer's Certification: Purchase is approved in accordance with RFO 12. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Rachelle J. Hamer Contracting Officer

NCO 10

RACHELLE

HAMER

Digitally signed by

RACHELLE HAMER

Date: 2026.06.02 11:12:38 -04'00'