Limited Source Justification.pdf
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- Solicitation number
- 36C26126Q0674
About this file
This is a Justification for Single Source Award document submitted by the Department of Veterans Affairs for a procurement under the simplified acquisition threshold. The contracting activity is the VA Regional Procurement Office West (RPOW), Network Contracting Office (NCO) 21, acting on behalf of VISN 21 at VA Palo Alto Health Care System (VAPAHCS) in Palo Alto, California. The requirement is to replace a defective EnSite X mapping and ablation amplifier that is integral to the existing EnSite X Electrophysiology (EP) System in the Cardiology/Electrophysiology Lab. The current amplifier has a broken pin rendering it inoperable and preventing the EP lab from conducting cardiac mapping and ablation procedures necessary to diagnose and treat complex arrhythmias.
The justification establishes that only one source can fulfill this requirement because the amplifier is a proprietary Abbott/St. Jude component that must be electrically, mechanically, and digitally compatible with the existing Government-owned EnSite X hardware, proprietary software, and firmware versions. Use of non-original equipment manufacturer (OEM) or non-EnSite-branded amplifiers would alter the validated system configuration, potentially invalidate system performance specifications, introduce unacceptable clinical risk during invasive procedures, and void OEM warranty and technical support agreements. Market research conducted by the requiring activity and Biomedical Engineering confirmed that no third-party manufacturers produce OEM-certified EnSite-compatible amplifiers, and any competition would exist only at the distributor level for the same branded product. The Contracting Officer certified the purchase as approved in accordance with FAR 12.201-1(c)(2).
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Revision: 02 Effective Date: 12/30/2025 Page 1 of 2 Acquisition ID#:
DEPARTMENT OF VETERANS AFFAIRS
Justification for Single Source Awards IAW RFO 12.201-1 For
Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold
Acquisition Plan Action ID:
FY26 JOFOC Number:
1. Contracting Activity: Department of Veterans Affairs (VA), Regional Procurement
Office West (RPOW), Network Contracting Office (NCO) 21, on behalf of the Veterans Integrated Service Networks (VISN) 21, VA Palo Alto Health Care System (VAPAHCS), located at 3801 Miranda Avenue Palo Alto, CA 94304-1207.
2237: 640-26-2-500-0528
2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The VAPAHCS has an immediate requirement to replace the EnSite mapping and ablation amplifier that is part of the existing EnSite X Electrophysiology (EP) System in the Cardiology/Electrophysiology Lab. The current amplifier has a broken pin, rendering the unit inoperable and preventing the EP lab from fully utilizing the EnSite X system for cardiac mapping and ablation procedures necessary to diagnose and treat complex arrhythmias.
The estimated value of the proposed
3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The EnSite X EP System Amplifier is an integral component of the existing Government-owned EnSite X EP System. The amplifier must be electrically, mechanically, and digitally compatible with the existing EnSite X hardware, proprietary software, firmware versions, and clinical workflows. Use of a non-original equipment manufacturer (OEM) or non-EnSite-branded amplifier would alter the validated configuration, could invalidate existing system performance specifications, and may introduce unacceptable clinical risk during invasive EP procedures. Furthermore, the OEM has indicated that use of non-OEM amplifiers or components may void the OEM warranty, service agreements, or ongoing technical support for the EnSite X EP System.
4. Description of market research conducted and results or statement why it was not conducted: Market research conducted by the requiring activity and Biomedical Engineering determined that: (a) the EnSite X EP System is a proprietary Abbott/St.
Jude platform; and (b) there are no known third-party manufacturers producing EnSite-compatible amplifiers that the OEM will certify for use with the existing system. While resellers or distributors may be available, all such vendors ultimately
Revision: 02 Effective Date: 12/30/2025 Page 2 of 2 Acquisition ID#:
supply the same OEM EnSite amplifier. As a result, competition, if any, will be at the distributor level for the same brand name product.
5. Contracting Officer's Certification: Purchase is approved in accordance with FAR
12.201-1(c)(2). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.
Date
Contract Officer
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