P03.JA IMP DeMayo Adapt Knee Positioners-Redacted.pdf

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Effective Date: 12/30/2025 Acquisition ID# 36C244-26-AP-1308

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1

For Over Micro-Purchase Threshold but Not Exceeding the SAT

Acquisition Plan Action ID: 36C244-26-AP-1308

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Erie Medical Center

2237: 562-26-2-700-0043

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

The Erie, PA VA Medical Center has a new Brand Name Only requirement for surgical positioners and associated components manufactured by Innovative Medical products, Inc. These surgical positions are De Mayo systems which are used to support orthopedic surgical procedures, including knee, hip, and shoulder cases. These procedures are part of the Erie, PA VA Medical Center’s newly authorized Total Joint Program initiative.

The requested surgical positioners are required to safely position patients during total and partial joint replacement and repair procedures, expanding surgical capabilities, reducing reliance on Care in the Community (CITC) referrals, and improving timely access to surgical care for Veterans served by the Erie, PA VA

Medical Center.

Estimated Total Cost:

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The De Mayo surgical positioning systems possess unique clinical and operational characteristics required to safely support total joint procedures. These systems provide enhanced patient stability, precise limb positioning, modular flexibility, and compatibility with the Erie, PA VA Medical Center’s existing operating room tables and surgeon training.

Alternative positioning systems were reviewed and determined to be unsuitable due to limitations in stability, compatibility, and procedural versatility. Use of alternative brands would require additional training, introducing equipment inconsistency within the operating room, and increase the risk of patient positioning errors or procedural delays. Based on our surgeons’ clinical review, no other brand can meet the Surgery

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Effective Date: 12/30/2025 Acquisition ID# 36C244-26-AP-1308

Department’s requirements without negatively impacting patient safety, surgical efficiency, and standardization of care.

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

A Sources Sought 36C24426Q0200) was posted from 01/23/2026 – 02/03/2026 and only one response received from BHPE LLC. (SDVOSB) expressing interest but no evidence that they could provide the products.

Search of “IMP De Mayo Knee Positioner” in the Vendor Information site, VetBiz, SBA, GSA eLibrary found Zero (0) vendors. Searched ADDS UP and found multiple awards to Innovative Medical Products, Inc. (Large Business) as the only entity that can provide the necessary requirement. No Non-Manufacturer Rule waiver was located, and the Rule of Two has not been met.

A search in WWW.fpds.gov (Federal Procurement Data System – Next Generation), produced multiple awards to Innovative Medical Products, Inc. and Howmedia Osteonics Corp (Large) but no longer on eBuy vendor list.

Market Research has indicated one vendor, Innovation Medical Products, Inc.

(Large Business) is the only entity that can satisfy agency requirements.

CS intends to award a Sole Source contract by the authority of 6.302-1 (Only one responsible source and no other supplies or services will satisfy agency requirements) to Innovation Medical Products, Inc. (Large Business).

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..