P03 SSJ Sterrad Tray_redacted.pdf

Last Updated: 02/01/22 Page 1 of 2

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: 36C261‑26‑AP‑4340 – Case Medical Custom STERRAD Container System

1. Contracting Activity: Department of Veterans Affairs (VA), Network Contracting Office 21, in support of Veterans Integrated Service Networks (VISN) 21, Health Service Area (HSA) 5.2, San Francisco VA Medical Center, 4150 Clement Street, San Francisco, CA 94121.

JOFOC: NCO 21- 1822

2237: 662‑26‑3‑7019‑0106

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

The San Francisco VA Medical Center requires brand‑name Case Medical custom STERRAD‑compatible sterilization containers and custom internal MediTray® inserts designed to hold various reusable medical devices during low‑temperature hydrogen‑peroxide sterilization cycles. These items support proper sterilization, protection, and organization of reusable medical equipment (RME) used by Nursing Service (118) in clinical operations.

Estimated Amount: $44,987.58.

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

Case Medical, Inc. is the sole OEM and manufacturer of the SteriTite® STERRAD‑validated rigid sterilization container system and custom MediTray® inserts required for this procurement.

Case Medical holds exclusive FDA 510(k) clearances for STERRAD‑validated use and is the only source able to provide the proprietary designs, validated perforated‑bottom configurations, and custom tray components compatible with STERRAD low‑temperature sterilization cycles.

No other vendor produces STERRAD‑validated rigid containers meeting the VA’s requirements, and no third‑party manufacturer is authorized to fabricate or supply Case Medical’s brand‑name components. As a result, Case Medical is the only contractor capable of providing the brand‑name equipment required to support SPS operations safely and effectively.

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

Market research conducted through SBA Small Business Search, GSA Advantage, GSA eLibary, the VA NAC, and ADDS UP. Searches confirmed that no SDVOSB/VOSB or other small businesses manufacture STERRAD‑validated rigid sterilization containers. GSA Advantage searches showed only Case Medical’s rigid containers under Schedule 65 II A – SIN A‑89, while other vendors (such as Olympus or Karl Storz) only offer instrument trays or sterilizer‑related accessories not meeting the requirement.

https://www.acquisition.gov/?q=/browse/far/13

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

FPDS searches identified only STERRAD service and maintenance contracts, not rigid container systems, confirming that no other vendor supplies STERRAD‑validated container equipment. Based on these findings, only Case Medical can meet the brand‑name specifications of this procurement.

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.

Edward Hunter Date Contracing Officer https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466