P03 Single Source Justification MPT to SAT - TEE Probe Cleaner - Signed - Printed_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 3 Acquisition ID#

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: VA-26-00048205 TEEClean – Probe/Scope Cleaner.

1. Contracting Activity: Department of Veterans Affairs, VISN 4 Pittsburgh PA Medical

Center. Transaction: 646-26-2-233-0295

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

Amount:TEEClean Automated Trans-Esophageal Echocardiography Probe Cleaning system and accessories from CS Medical.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The characteristics that make this a limited availability to one source are based on the replacement of existing unit that is at its end of life. This unit was vetted through facilities and engineering based on the site space constraints, limitations and facility electrical and plumbing configurations. (See Single Source Letter/Documentation from vendor included in Force Package).

The requested TEE Clean system possesses functional and technical characteristics that are not available in alternative commercially marketed probe cleaning systems and are required to support the safe and compliant reprocessing of Transesophageal Echocardiography (TEE) probes within Sterile Processing Services (SPS). TEE probes are classified as semi-critical reusable medical devices (RMD) requiring high-level disinfection in accordance with manufacturer Instructions for Use (IFU), VHA Directive 1116(2), and AAMI ST91 guidance for flexible and heat-sensitive endoscopic devices.

The TEE Clean system is uniquely designed to provide validated, automated lumen and external surface cleaning of TEE probes prior to placement in Automated Endoscope Reprocessors (AERs), thereby ensuring standardized soil removal that cannot be consistently achieved through manual cleaning methods alone. This automated pre-cleaning capability directly supports downstream high-level disinfection efficacy and reduces variability associated with manual reprocessing practices.

Additionally, the system integrates into existing SPS clinical workflow and spatial constraints within the VAPHS reprocessing environment, allowing for:

• Standardized, reproducible cleaning parameters aligned with probe manufacturer IFU

• Reduction in manual handling of delicate probe components, minimizing risk of device damage and costly repairs

Effective Date: 12/30/2025 Page 2 of 3 Acquisition ID#

• Decreased bioburden variability prior to AER processing, supporting HLD cycle effectiveness

• Compatibility with current SPS endoscope reprocessing infrastructure and room configuration

• Support for traceable, policy-compliant reprocessing of semi-critical RMD used in cardiology procedures

No other available system provides equivalent automated pre-cleaning functionality specifically engineered for TEE probes while meeting facility workflow, engineering, and infection prevention requirements. Utilization of an alternative product would introduce non-standardized manual cleaning processes, increasing risk for inadequate soil removal and non-compliance with device IFU and national reprocessing standards.

Accordingly, these unique operational and compliance-based characteristics substantiate the requirement for this specific system to support safe patient care and SPS reprocessing standardization within VISN 4 clinical operations.

4. Description of market research conducted and results or statement why it was not conducted: The Service Line Chief and service line staff recommend this unit based on existing staff familiarity, guidelines on preferred type of scope cleaning and testing encompassed in one unit, facility space constraints. Comprehensive open-market research for alternative TEE probe cleaning platforms was not conducted due to the highly specialized nature of the equipment and the requirement for compatibility with existing clinical reprocessing infrastructure currently in use within Sterile Processing Services (SPS) at VAPHS.

TEE probes are semi-critical reusable medical devices (RMD) requiring validated manual or automated cleaning prior to high-level disinfection in accordance with manufacturer Instructions for Use (IFU), VHA Directive 1116(2), and AAMI ST91. The requested system must support standardized pre-cleaning of TEE probes in a manner that is compatible with the facility’s current Automated Endoscope Reprocessors (AERs), existing chemical disinfectant processes, available physical workspace, ventilation design, and Infection Prevention-approved workflow.

Replacement or introduction of a non-compatible pre-cleaning platform would require:

• Engineering assessment of electrical and plumbing requirements

• Infection Prevention risk assessment and workflow redesign

• Staff retraining on revised cleaning methodology

• Potential modification to downstream AER processing steps

• Revalidation of probe reprocessing procedures for IFU compliance

Effective Date: 12/30/2025 Page 3 of 3 Acquisition ID#

These changes would introduce unacceptable delays to clinical operations and may result in temporary disruption to cardiology procedural capacity requiring TEE utilization.

The recommended system was evaluated and vetted internally by SPS leadership, Cardiology stakeholders, Biomedical Engineering, and Infection Prevention based on its ability to integrate into the existing SPS reprocessing environment without requiring modification to current high-level disinfection practices or facility infrastructure. Based on this interoperability requirement and the absence of alternative systems capable of meeting these minimum operational needs without workflow or infrastructure modification, additional formal market research was determined to be unnecessary in accordance with FAR 10.001(a)(2)(ii).

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.

Name Date Title

ANDREA

AULTMAN-SMITH

Digitally signed by ANDREA

AULTMAN-SMITH

Date: 2026.03.10 13:10:16 -04'00'