P03_ SSJ.pdf

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

Revision: 02 Effective Date: 12/30/2025 Page 1 of 3 Acquisition ID# 36C241-26-AP-3029

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

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

Acquisition Plan Action ID: 36C241-26-AP-3029

1. Contracting Activity: Network Contracting Office 1, Regional Procurement Office East on behalf of the Department of Veterans Affairs, Veterans Integrated Service Networks (VISN 1) on behalf of White River Junction VA Medical Center 163 Veterans Drive White River Junction, VT 05001-0001.

Funding 405-26-3-2008-0196.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This is a new, sole source requirement. White River Junction VA Medical Center is acquiring two (2) Advanced Sterilization Products (ASP) low-temperature hydrogen peroxide gas plasma sterilization systems�the STERRAD 100NX 1-Door with ULTRA GI and the STERRAD NX ALLCLEAR�to replace older-generation units currently in use. These FDA-approved, OEM-installed systems include full installation, a one-year manufacturer�s warranty, user manuals, technical and clinical training, and integration support. Estimated Total Amount of supplies $166,845.00.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The White River Junction VA Medical Center�s Sterile Processing Services (SPS) currently operates STERRAD systems, and the Statement of Work specifically identifies these models as the required replacement units to maintain full compatibility with existing sterilization workflows, validated reprocessing procedures, consumables, cycle parameters, and operational software. Because these units integrate directly with the facility�s established infection prevention infrastructure, no alternative brand of low-temperature sterilizer can be substituted without causing major disruptions to clinical processes, retraining requirements, safety validations, and equipment interoperability.

The unique characteristics of the STERRAD platform, including its proprietary HPGP sterilization technology, documented 100% microbicidal spore kill rate, superior cycle performance compared to competing units, and established compatibility with current VA sterilization workflows, limit availability to a single source. Only ASP manufactures the STERRAD line and is authorized to provide OEM installation, firmware, parts, warranty service, and the mandatory Federal Trade-In Program for removal and disposal of replaced units.

The White River Junction VA Medical Center has an established history of utilizing STERRAD low-temperature sterilization equipment, as evidenced by two prior purchases documented under Purchase Order 405-B08005 for the STERRAD NX system and Purchase Order 405-A14054 for the STERRAD 100NX units. These earlier procurements demonstrate that the station already operates STERRAD technology as part of its standard sterilization workflow. Because Sterile Processing Services relies on the proprietary hydrogen peroxide gas plasma (HPGP) cycles, disposables, software, and operational procedures specific to the STERRAD platform, transitioning to an alternative brand would disrupt validated sterilization protocols, require extensive staff retraining, Effective Date: 12/30/2025 Page 2 of 3 Acquisition ID# 36C241-26-AP-3029 and jeopardize process continuity. The facility has therefore determined that maintaining the same manufacturer is essential to ensure seamless interoperability with existing equipment, compatibility with current cycles and consumables, and consistent adherence to established infection-control practices. The continued use of the STERRAD brand is necessary to avoid clinical risk, maintain workflow efficiency, and uphold the performance standards already in place at the medical center.

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

The Contracting Activity initiated comprehensive market research to determine the availability of Service-Disabled Veteran-Owned Small Businesses (SDVOSBs) and other small businesses capable of fulfilling the requirement for this Sterilization Equipment.

The first step was a search of the SBA database using NAICS code 339113 (Surgical Appliance and Supplies Manufacturing) with a filter for SDVOSB certification. This general search generated a broad pool of 1,227 SDVOSB contractors associated with this NAICS code. However, this only established the potential for SDVOSB involvement at the NAICS category level and did not confirm capability or authorization to distribute the specific brand and model of sterilization equipment required.

The SBA DSBS database was queried using NAICS 339113 along with the keywords �Advanced Sterilization Products�, this targeted search yielded 163 small business profiles that matched the search criteria, none of which were the OEM Advanced Sterilization Products or their sole distributor, TrillaMed.

A subsequent search using the keyword �Sterrad NX System� under Awarding Office 36C241 in the ADDS UP system identified 3 contract actions, one of which was a purchase from Advanced Sterilization Products under contract no. 36C24123P0949 for Brockton VA Medical Center in 2023.

The NAC database was queried using catalog number �10104,� resulting in 35 records, none of which is the Sterrad NX System.

A GSA search with the keyword �Advanced Sterilization Products� identified 1 scheduled contractor, OEM large business Advanced Sterilization Products under contract # 36F79719D0090, however the particular Sterrad 100NX Unit being requested (10104) is not available on GSA contract.

Market research has identified only one small business�TrillaMed, an authorized SDVOSB distributor�that is capable of providing the required STERRAD systems; however, their market research quote submitted totals $218,761.70, which is significantly higher than the OEM�s combined pricing of $166,845, making TrillaMed�s offer unfair and unreasonable for the Government to accept. The OEM, Advanced Sterilization Products (ASP), is the only source able to provide substantial cost-saving trade-in incentives, including the $15,000 LCM Trade-In Program (S/N:

1043150272) and the $8,000 LCM Trade-Out Program (S/N: 4033205449), discounts that ASP confirmed TrillaMed is not permitted to offer, resulting in a 31% price increase if the Government procures through the small-business distributor rather than the OEM itself. Therefore, although a responsible small business source exists, it cannot provide pricing that is fair, reasonable, or competitive with the OEM, and it is my intent to pursue a sole source award to ASP to ensure the Government receives the required equipment at the lowest possible cost, while taking advantage of

Effective Date: 12/30/2025 Page 3 of 3 Acquisition ID# 36C241-26-AP-3029

OEM-exclusive trade-in programs that directly benefit the agency and cannot be replicated through any small business channel. Therefore, due to the substantial cost savings exclusive to the OEM, the inability of the SDVOSB distributor to match mandatory trade-in discounts, and the clear best-value determination in favor of ASP, a sole source award to the large business OEM is fully justified in the government�s best interest.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR 13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Phillip Crockett Date Contracting Officer

NCO 1/ RPO EAST