Effective Date: 12/30/2025 Page 1 of 4 Revision: 02 Acquisition ID#: 36C259-26-AP-2582

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

ACQUISITION OF COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

IN ACCORDANCE WITH RFO 12.102

Acquisition Plan Action ID: 36C259-26-AP-2582 Tracking Number: FY26 – NCO 19 - 1421

1. Contracting Activity: Ordering Activity:

Department of Veterans Affairs Department of Veterans Affairs Network Contracting Office 19 Rocky Mountain Regional VAMC 6162 S Willow Dr. Suite 300 1700 N. Wheeling St Greenwood Village, CO 80111 Aurora, CO 80045

2237# 554-26-4-450-0195

2. Nature and/or Description of the Action Being Processed: Eastern Colorado Healthcare System has a follow-on requirement to provide continued Original Equipment Manufacturer (OEM) service, maintenance, and software support for the Abbott Laboratories, Inc EnSite X Cardiac Mapping System currently installed and in active clinical use at the facility. This contract will be for a base plus 2 option years. The base year period of performance will be from September 15, 2026, until September 14, 2027.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This is a contract action for a follow-on requirement to provide continued OEM service, maintenance, and software support for the Abbott Laboratories EnSite X Cardiac Mapping System currently installed and in active clinical use at Eastern Colorado Healthcare System. The contract number for the current contract is 36C25923C0123. The requirement includes comprehensive OEM support services for the EnSite X system, including scheduled preventive maintenance, unscheduled corrective maintenance, emergency repair services, software updates, system calibration, technical support, and access to proprietary diagnostic systems.

The EnSite X system is a complex, integrated platform consisting of hardware, firmware, and proprietary software used to generate real-time cardiac mapping during procedures. Continued system functionality requires access to manufacturer-controlled service tools, system configurations, and software environments that are not publicly available.

These services are essential to maintaining the system’s performance, ensuring clinical accuracy, and supporting uninterrupted lab operations. Failure to maintain OEM-level support would compromise system integrity and the ability to safely deliver patient care.

4. Statutory Authority Permitting Restricted Competition:

RFO 12.201-1 Simplified Procedures. The statutory authority for applying the Simplified Procedures for Commercial Items of RFO 12 is 41 U.S.C. § 1901 and is implemented by RFO 12.102 for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(x) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

() Unusual and Compelling Urgency

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Acquisition ID#: 36C259-26-AP-2582

() Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

() International Agreement () Authorized or Required by Statute () National Security () Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority): Abbott Laboratories Inc is the Original Equipment Manufacturer (OEM) of the EnSite X system and maintains exclusive control over the system’s design, proprietary software, firmware, replacement components, and diagnostic architecture. The EnSite X system is a complex, integrated platform consisting of hardware, firmware, and proprietary software used to generate real-time cardiac mapping during procedures. Continued system functionality requires access to manufacturer-controlled service tools, system configurations, and software environments that are not publicly available.

The EnSite X system requires manufacturer-specific calibration procedures and software-based diagnostics to ensure accuracy and proper functionality. These procedures are embedded within proprietary service environments controlled by Abbott. Without access to these environments, third-party vendors cannot perform maintenance to manufacturer standards.

Additionally, Abbott Laboratories Inc controls the distribution of replacement parts and system updates. Use of non-OEM parts or unauthorized service would risk system malfunction, introduce clinical inaccuracies, and may void system support and update eligibility.

Based on these factors, Abbott Laboratories Inc is the only responsible source capable of providing the required services without unacceptable risk to system performance, patient safety, and clinical operations.

These services are essential to maintaining the system’s performance, ensuring clinical accuracy, and supporting uninterrupted lab operations. Failure to maintain OEM-level support would compromise system integrity and the ability to safely deliver patient care.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The Government conducted market research in accordance with FAR Part 10, including direct communication with Abbott Laboratories Inc to assess the availability of alternative service providers.

Abbott Laboratories Inc confirmed that third-party vendors are not authorized to service the EnSite X system and that all maintenance and repair services must be performed by Abbott or its authorized partners. The Government also reviewed available procurement channels and determined that no alternative sources exist that can meet the requirement.

No capable small business or third-party providers were identified through market research. As a result, competition is not feasible for this requirement.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The price will be analyzed for fair and reasonableness in accordance with RFO 12.204(a)(1). The quoted price will be compared to previous prices paid by the Government for comparable requirements. The quoted price will also be compared to the Independent Government Cost Estimate (IGCE).

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Acquisition ID#: 36C259-26-AP-2582

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research included a search of the Small Business Administration’s Small Business Search (SBS), GSA, FPDS, and SAM.gov to identify potential vendors. Abbott Laboratories Inc, through their subsidiary St. Jude Medical is the only company able to provide the requirement without replacing hardware, software and firmware throughout the facility.

This determination supports the sole source award to Abbott Laboratories Inc and is in the best interest of the Government to ensure OEM service, maintenance, and software support for the Abbott Laboratories EnSite X Cardiac Mapping System currently installed and in active clinical use in accordance with RFO 12.102(a).

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The required service are on equipment proprietary to Abbott and can only be done by Abbott.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Abbott Laboratories Inc., 8701 Bee Cave Rd, BLD 2 West, Austin TX 87746

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: No further actions are contemplated as this requirement is proprietary to the manufacturer.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Date

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Date

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Acquisition ID#: 36C259-26-AP-2582

b. One Level Above the Contracting Officer (Required over $350K but not exceeding $900K):

I certify the justification meets requirements for other than full and open competition.

Sarilynn Thomas Date Branch Chief NCO 19, Supply/Services Denver