P03 - FAR 13.5 Sole Source Justification BC Signed.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24 Page 1 of 3

REVISION: 01

Acquisition ID#: 36C257-25-AP-4420

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN

ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257-25-AP-4420 -JOFOC Tracker #: FY25-NCO 17- 2072

1. Contracting Activity: Department of Veterans Affairs, NCO 17, 5441 Babcock Rd, Suite 302, San Antonio, TX

78240, in support of South Texas Veterans Health Care System (STVHCS).

Requisition Number (2237): 671-25-4-039-0332.

2. Nature and/or Description of the Action Being Processed: This is a request to award a Firm Fixed price Sole Source contract for EnSite™ X EP System for the STVHCS to Abbott Laboratories Inc., sole manufacturer & distributor of the EnSite™ X EP System. The Heart Center Services at STVHCS currently operates two active Catheterization (Cath) Labs with a third under development. In order to support the ongoing needs of our Cardiology Department and enhance our operational efficiency, we require the procurement of the EnSite™ X EP System. The EnSite™ X EP System is designed for catheter navigation and mapping, features include 3-D positioning, comprehensive visualization of cardiac electrical activity, and dynamic 3-D isopotential maps based on patient-specific anatomy. This system is crucial for providing advanced catheter navigation and mapping capabilities during electrophysiology (EP) procedures.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The vendor shall provide one (1) EnSite to the Cath Lab at Audie L. Murphy VA Medical Center. The EnSite™ X EP System is designed for catheter navigation and mapping, featuring 3-D positioning, comprehensive visualization of cardiac electrical activity, and dynamic 3-D isopotential maps based on patient-specific anatomy. This is one-time purchase of equipment, estimated cost for procurement is: $439,615.00, 60 days After Receipt of Order (ARO).

Item# Description Original MFG Part Number

Qty

0001 EnSite™ X EP System. ENSIREX-SYS 1 0002 Advanced Mapping Software License ENSITE-M-2.0 1 0003 AutoMark Distance Software License ENSITE-AMD-01 1

0004 Averaged Impedance Drop Software License ENSITE-IMP-01 1

Pulsed Field Ablation (PFA) Catheter Visualization License ENSITE-FWV-03 1

0006 SENSITHERM Multi Esophageal System monitor ST-MONITOR 1 0007 SensiTherm Cable Holder ST-HLDCBL 1

SensiTherm Mapping System Adapter Cable ST-ADPT-30 1

WorkMate Claris Recording System 120 with EP-4 Cardiac Stimulator H700124 1

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) 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

Effective Date: 11/15/24 Page 2 of 3

Acquisition ID#: 36C257-25-AP-4420

( ) 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): The EnSite™ X EP System can only be provided by Abbott Laboratories, Inc., they are the sole manufacturer and distributor. The EnSite™ X EP System offers unique capabilities for integrating both conventional and Sensor-Enabled™ catheters with real-time, patient-specific 3-D mapping, unmatched by other products on the market. Ensuring compatibility with existing Cath Lab equipment, reducing additional costs, and streamlining implementation. Abbott Laboratories Inc.

provides comprehensive support and training for the systems, crucial for operational success. Standardizing equipment across multiple Cath Labs ensures consistency in patient care and operational procedures. The procurement of EnSite™ X EP Systems from Abbott Laboratories Inc. for multiple contracts within this defined class is essential for enhancing the electrophysiology capabilities of VA facilities. Given the proprietary nature and unique benefits of the EnSite™ X EP System, a sole-source acquisition is justified.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Conducted market research to identify if other potential vendors could provide EnSite™ X EP System. Abbott Laboratories Inc. provided a letter dated May 31, 2025, stating that they are the only manufacturer and distributor for the EnSite™ X EP System. A Notice of Intent to Sole Source to Abbott Laboratories was posted on August 20, 2025, and closed on August 27, 2025. One response was received from Al-Najah Al-Daayin Company based in Baghdad, Iraq. Upon review, it was determined that Al-Najah Al-Daayin Company was unable to confirm that their products were not gray-market items. Consulted with Leanne McGonigle, a sales representative from Abbott Laboratories, confirmed that Abbott Laboratories does not distribute to Al-Najah Al-Daayin Company. Consequently, they were not considered a viable source. It is advantageous to procure all of the items listed above from a sole vendor to ensure there are no delays in helping hospitals perform these procedures, to better focus on operational efficiency.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer shall determine pricing to be fair and reasonable based on a comparison of the proposed prices with prices found reasonable in previously awarded contracts and or procurements.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market

Research Was Not Conducted: Search engines such as VetCert, FPDS (Federal Procurement Data System), DSBS (Dynamic Small Business Search) and Notice of Intent were utilized when conducting market research.

Market research revealed that Abbott Laboratories Inc. is the sole manufacturer and distributor of the EnSite™ X EP System. The Heart Center Service will continually monitor new technology that displays cardiac electrical activity as waveform traces and dynamic 3-D isopotential maps of the cardiac chamber. They will also evaluate these technologies and processes as they improve.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Due to the proprietary nature of the EnSite™ X EP System, it is authorized to be purchased solely from Abbott Laboratories Inc. Abbott Laboratories Inc. has provided a sole source letter as the exclusive manufacturer and supplier of this system.

A Notice of Intent, 36C25725Q0857, was posted, resulting in one interested party from Al-Najah Al-Daayim Company, based in Baghdad, Iraq. The company provided a quote; however, upon verification from Abbott Laboratories, it was confirmed that Abbott Laboratories does not have any authorized distributors, raising concerns about the authenticity of the quoted items. In accordance with VAAR 852.212-71 regarding Gray

Effective Date: 11/15/24 Page 3 of 3

Acquisition ID#: 36C257-25-AP-4420

Market and Counterfeit Items, the quote from Al-Najah Al-Daayim Company was not considered for this acquisition.

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 VA will continue to conduct comprehensive market research to identify any changes in the marketplace that could enable future procurement actions to be conducted competitively. This includes evaluating the availability of alternative suppliers and manufacturers whose products meet the current Standard of Care. The VA is committed to ensuring that future acquisitions for the required supplies or services consider all qualified vendors, thereby promoting competition and potentially integrating new manufacturers' instruments if they meet the necessary standards.

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.

Andrew Baldwin Date Program Specialist Audie L. Murphy VA Hospital

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.

Jose Campa Date Contracting Officer

NCO 17

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Michael J. Tusinger Date Branch Chief

NCO 17

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