RFO Part 12 LSJ - AP 4701_Redacted.pdf

Revision: 02 Effective Date: 12/30/2025 Page 1 of 2 Acquisition ID#: 36C261-26-AP-4701

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW RFO 12.102(a) For

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

Acquisition Plan Action ID: 36C261-26-AP-4701

1. Contracting Activity: Department of Veterans Affairs (VA), Regional Procurement

Office West (RPOW), Veterans Integrated Service Networks (VISN) 5, Health Service Area (HSA) 52, Network Contracting Office (NCO) 21 on behalf of VA Southern Nevada Health Care System (VASNHCS) located at 6900 North Pecos Road N. Las Vegas, NV 89086-4400.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This acquisition is for an integrated surgical energy platform to support continued use of the VA-owned Ethicon GEN11 electrosurgical generators in the operating rooms. The GEN11 generators deliver radiofrequency and ultrasonic energy to HARMONIC and ENSEAL instruments used to cut and coagulate tissue during open and laparoscopic procedures, but they are at manufacturer end-of-life and no longer eligible for technical support or repair. If one or more generators fail, surgeons would need to revert to alternative energy modalities or cancel cases, which may be clinically suboptimal and could present safety risks to Veterans who depend on this platform for effective cutting and coagulation with minimal thermal injury. To mitigate this risk and maintain continuity of surgical care, the facility must procure four Ethicon Single TES (Total Energy System) packages and one Energy Output Verification Key, which are specifically engineered to interface with and verify the performance of the existing GEN11-based energy system.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Because the GEN11 energy system and its associated HARMONIC/ENSEAL instruments are proprietary and clinically embedded at the facility, only Ethicon-branded TES packages and the ETHOVK verification key can safely and effectively support and validate the installed generators. Any attempt to use non-Ethicon components or switch to another surgical energy platform would (1) require wholesale replacement of equipment and instruments, (2) result in substantial duplication of cost not expected to be recovered through competition, and (3) create unacceptable delays and Veteran safety risks in ongoing surgical care.

Revision: 02 Effective Date: 12/30/2025 Page 2 of 2 Acquisition ID#: 36C261-26-AP-4701

4. Description of market research conducted and results or statement why it was not conducted: Reviewed prior VA market research report 36C261-26-AP-3721 (VA Central California HCS) for a similar Total Energy System requirement, where the Contracting Officer recommended an open-market sole-source purchase to a large vendor based on the lack of alternative manufacturers or authorized distributors for the Ethicon energy platform.

Reviewed contract 36C24126P0288, awarded June 30, 2026 to Johnson & Johnson as a sole-source procurement of Ethicon Single TES packages and an Energy Output Verification Key for the DUALTO Energy System, confirming that another VA facility recently satisfied an identical requirement through a sole-source award to the same manufacturer.

Searched the VA Analytics, Data and Decision Support Unified Platform (ADDS UP) for “energy system,” which identified 36C24126P0288 as the only relevant award for the Ethicon Total Energy/DUALTO Energy System, further indicating that VA has relied on this single source to procure this requirement.

Performed a search of Contracting Opportunities (SAM.gov) using the keyword “DUALTO Energy System.” This search returned:

Notice ID 36C26126Q0779: an intent-to-sole-source the DUALTO Energy System to Johnson & Johnson issued by NCO 21.

A sources-sought notice for a DUALTO Energy System issued by NCO 1 that culminated in a sole-source award under contract 36C24126P0288 to Johnson & Johnson.

5. Contracting Officer's Certification: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

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