P03. PG_Part806.3_Atch1_FAR6_JA_OVER_SAT.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 5 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C263-27-AP-0266

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C263-27-AP-0266 (636-27-1-4045-0004)

1. Contracting Activity: Department of Veterans Affairs, VISN 23, Iowa City VA

Healthcare System, 601 Hwy 6 West, Iowa City, Iowa 52246 (636-27-1-4045-0004)

2. Nature and/or Description of the Action Being Approved: This action is a new requirement for an annual OEM Service & Technology Plan for Abbott electrophysiology equipment.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

This procurement provides annual Original Equipment Manufacturer (OEM) service, maintenance, repairs, and technology upgrades for the Abbott electrophysiology systems used at the Iowa City VA Health Care System. Coverage includes the EnSite X cardiac mapping system, Ampere generator, Cool Point pump, TactiSys Quartz, ViewMate Multi ultrasound system, ICE ultrasound probes, EP-4 cardiac stimulator, and Workmate Claris system, along with all associated peripherals.

The service plan includes:

• Preventive maintenance (PM)

• Corrective maintenance, onsite repairs within required response windows

• 24/7 technical support

• Loaner equipment as needed

• Software upgrades, expansion modules, and commercially released hardware updates

• Universal coverage for mapping system peripherals and ICE probes

• Priority overnight shipping of replacement parts

• Remote diagnostics capabilities

• Full-service entitlements for all listed hardware and probes

These items are proprietary to Abbott. The electrophysiology system and all components operate using Abbott-specific software, hardware, firmware, sensors, cables, and integration modules. No authorized third-party service providers exist for the EnSite X platform or Abbott electrophysiology generator and ultrasound systems. If equipment is repaired/altered by a third party, it may void any warranties and require replacement of parts or systems. The value of

VHAPG Part 806.3 OFOC Page 2 of 5 new parts/equipment are listed below.

Ensite X Amp - $55,000

Ensite X DWS - $23,000

Ensite X Field Frame - $10,000

Ensite X Surface Link - $4,336

Ensite X Patient Ref Sensor 1 - $1,212

Ensite X Patient Ref Sensor 3 - $2,400

Tactisys - $15,225

Ampere - $24,602

Ampere Remote - $11,358

Cool Point Pump - $13,475

VMM I/O board - $480

VMM Monitor - $1838

VMM P8-2Ts Transducer - $17,952

VMM P83-TEE Transducer - $80,000

VMM P8-2TS TEE Transducer - $70,000

VMM L9-3s Transducer - $19,000

VMM ViewFlex CIM - $19,000

The contract would cover all associated costs with repairs and replacements, provide newer commercially released software and hardware, and provide peripheries associated with both.

4. Statutory Authority Permitting Other than Full and Open Competition:

(X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by

RFO 6.103-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by RFO 6.103-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by RFO 6.103-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by RFO 6.103-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by RFO 6.103-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by RFO 6.103-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by RFO 6.103-7;

VHAPG Part 806.3 OFOC Page 3 of 5

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 is the sole manufacturer and sole authorized service provider for the highly specialized EnSite X electrophysiology mapping system, the Ampere generator, Cool Point pump, TactiSys Quartz system, ViewMate Multi ultrasound equipment, and all associated ICE transducers. The system’s operation relies on Abbott-proprietary: software, firmware, and version-controlled upgrades, diagnostic tools, calibration utilities, and internal configuration protocols, encrypted mapping algorithms, proprietary sensors, and module-specific hardware OEM-only replacement parts and preventive maintenance kits Abbott does not certify or authorize any third-party entities to service this platform.

The Abbott proprietary equipment are fully integrated technologies unique to Abbott, relying on Abbott’s unified service and technology plan for software, hardware, probe coverage, and next-generation update entitlements.

Abbott’s contractual entitlements include all software upgrades, expansion modules, and next-generation hardware replacement—capabilities unavailable from any other source.

Several covered devices (ICE probes, mapping sensors, EP catheters, field frames, and RF generator interfaces) require proprietary calibration and cannot be serviced by non-Abbott entities. The EnSite X system is currently installed and clinically required for electrophysiology procedures at the Iowa City VA, replacing it with another manufacturer’s platform would be cost-prohibitive, clinically disruptive, and incompatible with existing EP lab workflows.

Thus, Abbott is the only source capable of providing the required OEM service at the necessary level of quality and safety.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies):

This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e-Buy, as required by FAR 8.405-1(e).

The requirement is brand-name only because the service, parts, updates, and hardware are uniquely manufactured and controlled by Abbott.

https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-5

VHAPG Part 806.3 OFOC Page 4 of 5

Acquisition ID#: 36C263-27-AP-0266

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer anticipates that the pricing will be fair and reasonable, as the pricing of past procurements will be used for comparison.

A written fair and reasonable price determination will be made and placed in the contract file

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Equipment is proprietary to Abbott Market research beyond what is mentioned above and the Market Research report was not conducted once the proprietary nature of the requirement was confirmed.

For the reasons stated above, it was concluded that the equipment is proprietary to the OEM. The zero responses to the Notice of Intent to Sole Source on Contract opportunities further established the fact that there are no other businesses able to perform the services required.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

All facts supporting the use of other than full and open competition have been provided.

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

Abbott Laboratories, Inc., Mikayla Graham, Service Contract Sales Specialist, 8701 Bee Cave Road, Building Two, West, Austin, Texas 78745.

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: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

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.

Karen E. Higgins 07/28/2026 Administrative Officer, Engineering Iowa City VA Healthcare System

VHAPG Part 806.3 OFOC Page 5 of 5 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C263-27-AP-0266

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

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

John Milroy Date Contracting Officer Supply Services Team 1&2

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Travis Johnson Date Contracting Officer, Division Chief

Supply Services Team 1&2

08/24/2026 https://dvagov.sharepoint.com/sites/vhapromanual/SitePages/VHAPM-Part-806.3.aspx