Single Source Justification MPT to SAT.doc

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 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C250-25-AP-4250

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10 located at 260 E University Avenue, Cincinnati, OH 45219-2356, in support of VISN 10, Cincinnati VA Medical Center (CVAMC), 3200 Vine Street, Cincinnati, OH 45220-2213.

2237: 539-25-3-986-0029

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The CVAMC Sterile Processing Service currently utilizes an automated brand name CensiTrac Tracking System to manage inventory and track decontamination processing procedures of reuseable medical devices (RMSs) used in the operating room (OR) and Gastrointestinal (GI) clinic. This new one-time request has been submitted to procure software subscriptions and advanced implementation training services that are compatible with that system.

The required items include the following:

a. IMPPQIR – AI2 3 Modules - Implementation – Advanced Data Analytics AI2 Implementation - Quantity 1 Each

b. SUBPQIR - AI2 3 Modules – Subscription - Advanced Data Analytics AI2 Base YR Subscription - Quantity 1 Each

c. IMSTA101 - ScopeTrac Advanced Implementation

- 1-Week Onsite Training & Install, Project Management, Data Validation - Quantity 1 Each

d. SUBST02

- ScopeTrac Stand Advanced Subscription Base year - Base YR - Annual Subscription - Quantity 1 Each

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Veterans Health Administration (VHA) Directive 1116, Management of Critical and Semi-Critical Reusable Medical Devices (RMDs) provides guidance for sterilization standards and regulatory requirements relating to inventory management and processing procedures for RMDs.

The brand name Censitrac Tracking System is a comprehensive surgical instruments and asset management system that provides transparency, supports reprocessing, and helps with faster turnaround times. It is designed for efficiency, streamlines workflows, supports compliance and prioritizes patient safety. The system tracks every instrument used during surgical procedures, from sterilization to the operating room. It provides real-time tracking at the instrument, procedure, and patient level. These system functions help reduce the risk of cross contamination and possible exposure between patients.

The ScopeTrac Advance software is brand name software that is compatible with the Censitrac Tracking System. It manages endoscopes from bedside to storage, improves reprocessing accuracy, and ensures hands-free workflow with radio frequency identification (RFID) and barcodes. SPS staff can scan entire trays of instruments instead of individual units. Unique unit numbers for each instrument minimizes chances of misplaced instruments or logistical mistakes, manual data entry and potential errors. Tracking instruments down to the individual level with RFID technology assists staff in identifying contaminated instruments during recalls and ensures compliance with sterilizations standards and regulatory requirements outlined in VHA Directive 1116.

4. Description of market research conducted and results or statement why it was not conducted: Market research was conducted using VetCert, SBA DSBS, GSA Advantage, ADDS UP, NASA SEWP databases and other sources. The product NAICS code is not included in the Non-Manufacturer Rule (NMR) Class Waiver. The original equipment manufacturer (OEM), Censis Technologies, Inc. is a large business. A letter on file, dated 04/15/2025, from the OEM confirmed that items requested for this procurement are protected proprietary trade secret products and services registered with the United States Patent and Trade Office. Additionally, the letter states that the OEM is the sole source currently available for this technology. There are no authorized resellers.

There is no reasonable expectation of receiving offers from two (2) or more responsible small businesses that are competitive in terms of fair market prices, quality and delivery. Purchasing alternate supplies/services would result in substantial duplication of costs to the Government that is not expected to be recovered through competition. Additionally, unacceptable delays would occur in fulfilling the agency’s requirements to comply with VHA Directives, policies and procedures.

The VA and SBA Rules of Two cannot be obtained. It is determined that a fair and reasonable price can be obtained with a firm fixed price award to the LB OEM.

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.

Revision: 01

Effective Date: 11/15/2024 Acquisition ID #: 539-25-3-986-0029