P03 CARTO-3 Biosense JA Redacted.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: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257-24-AP-5166 JOFOC: FY25 - NCO 17 – 109

1. Contracting Activity: Department of Veterans Affairs, VISN 17, Central Texas Health Care System, VISN 17, Central Texas VA Medical Center, 1901 Veterans Memorial Drive, Temple, TX 76504, and Network Contracting Office 17 VHA Regional Procurement Office- West (RPOW) Plaza Lecea 5441 Babcock Road Str. 303 San Antonio, TX 776240.

2237 Purchase Request: 674-24-2-024-0003.

2. Nature and/or Description of the Action Being Processed: Request for Brand Name specification for purchases exceeding the simplified acquisition threshold. The requirements at 13.501(a) apply to sole-source acquisitions of commercial products and commercial services conducted pursuant to subpart 13.5.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The contract type is Firm Fixed Price for this procurement of the purchase of the Carto 3 Biosense Webster to includes services in the Medical Services Catheter Laboratory Department at Central Texas VA Medical to facilitate with surgical procedures. Proposed Carto 3 Biosense Webster will reduce liability issues and increase patient satisfaction using the newest technology and quality standards. The CARTO-3 System is an advanced imaging technology that utilizes electromagnetic technology to create real-time three-dimensional (3D) maps of a patient’s cardiac structures. The system is designed to help electrophysiologists navigate the heart by generating an accurate 3D map, as well as pinpointing the exact location and orientation of catheters in the heart during diagnostic and therapeutic procedures for patients suffering from heart rhythm conditions (cardiac arrhythmias)

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 ( ) 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 Carto 3

Effective Date: 02/01/2022 Page 2 of 3

Biosense Webster system is needed in order to accommodate the growing Catheter

Laboratory Surgical Center. The Carto 3 must be compatible with the current system VA owned system that is located at Central Texas VA Medical Center. Contractor is required to provide corrective maintenance on the system if it shall be malfunctioning or inoperable at a mutually agreeable time and provide loaner equipment, when deemed necessary by the

Contractor. Training materials shall be provided for base software upgrades that affect user operation of the base software. The contractor is required to provide all required services including repairs, preventative maintenance, labor, travel, and parts for the Biosense

Webster Carto 3 System in accordance with the original equipment manufacturer (OEM) specifications. This is a preventative maintenance contract in which the contractor will travel to the Temple VA Medical Center to perform the calibration service with all parts required to be certified new from the OE. Currently only Biosense can provide this service. The ASA shall also provide New Equipment /or New Software for the Central Texas Veterans Affairs

Medical Center located in Temple, Texas. The agreement will be a base plus 2-year option contract. Using a different Brand will result in excessive duplication of costs estimated over

$170,000.00 and will result in unacceptable care delays.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market Research was conducted in seeking sources that can meet this need, informing industry of the upcoming acquisition, and reviewing government databases for potential sources. There were no capable sources identified that can provide these items since the equipment is proprietary to Biosense Webster and there are no authorized distributors or resellers at this time.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer will establish pricing fair and reasonable by comparison of the proposed price with prices found reasonable on previous purchases for similar items. Price will also be compared to the Independent Government Cost Estimate.

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

Reasons Market Research Was Not Conducted: As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition, and soliciting inquiries from other interested parties. There are domestic end products available for the supply component of this requirement. FAR 52.225-1 Buy American Act and FAR 52.225-2 Buy American Certificate apply to the resulting contract. Equipment is proprietary and the SAM tool, Vetbiz, FDPS, and the VASCMC showed only the manufacturer can fulfill this need.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: No other facts apply.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: The only capable source that expressed interest in providing this requirement is Biosense Webster:

Biosense Webster Inc, (Large), 31 Technology Drive, 200 Irvine, CA 92618, 512- 484-3089, POC: Aurea (Liz) Slaughter, aslaugh1@its.jnj.com

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 monitor the availability and cost benefit from other Brands to support the Accelerated Solutions Agreement (ASA) Carto 3 mailto:aslaugh1@its.jnj.com

Effective Date: 02/01/2022 Page 3 of 3 and Generator systems and functionality for interoperability with other Brands to compete this requirement in the future.