Biosense Webster EP Catheters JA_Redacted.pdf

U.S. DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

Strategic Acquisition Center (SAC) 10300 Spotsylvania Avenue, Suite 400

Fredericksburg, Virginia 22408

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

(1) Identification of the agency and the contracting activity, and specific identification of the document as a "Justification for Other Than Full and Open Competition."

This Justification and Approval (J&A) for Other Than Full and Open Competition is executed by the Strategic Acquisition Center (SAC), Acquisition Service 4 on behalf of the U.S. Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Prosthetic & Sensory Aids Service (PSAS).

(2) Nature and/or description of the action being approved.

There is a clinical need for Biosense Webster Electrophysiology (EP) Catheters to support Veterans Health Administration (VHA) Clinicians nationwide as identified by the Prosthetic & Sensory Aids Services (PSAS) Program Office. Maintaining this source of supply is imperative as the complexity of those items and services increases and program and team involvement have become more complicated. A disruption or delays in supplies could result in Veteran safety concerns. The current VA enterprise-wide Blanket Purchase Agreement (BPA) with Biosense Webster was issued pursuant to FAR 13.303-2(c)(2) and serves to standardize and streamline the acquisition of EP Catheters using a decentralized process. Biosense Webster is the global leader in the science of diagnosing and treating heart arrhythmia disorders. Biosense Webster, a Johnson & Johnson Company, pioneered EP diagnostic catheters more than 20 years ago and continues to lead the industry as an innovative provider of advanced cardiac diagnostic, therapeutic, and mapping tools. Biosense Webster is the sole source for all Biosense Webster disposable products and does not authorize the sale of these disposable products through any third-party distributors. The particular brand name, product, or feature is essential to the Government’s requirements, and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency’s needs. Therefore, a non-competitive, fixed price, Indefinite Delivery Indefinite Quantity (IDIQ) contract will be negotiated on a brand-name, sole-source basis to Biosense Webster Inc., 31 Technology Drive, Irvine, CA 92618 for the procurement of Electrophysiology (EP) Catheters.

A solicitation will be posted on approximately January 25, 2024 – February 8, 2024. The solicitation will allow the Government to solicit and award a long-term IDIQ contract for Biosense Webster EP Catheters and products, which will be structured to meet the VA's need for decentralized ordering.

Strategic Acquisition Center (SAC)

(3) A description of the supplies or services required to meet the agency’s needs (including the estimated value).

Electrophysiology is a medical branch related to the study of electrical activity within the body. Catheters are slim, bendable tubes used in medical procedures or in ablation of cardiac tissues responsible for heart arrhythmia disorders. Physicians pass catheters through veins, arteries, or organs to monitor activity more effectively in various areas of the body. EP catheter placement is done without surgery and the instruments are used to provide electrical pacing, recording, sensing, localization, or mapping. Cardiac ablation is a popular procedure in which physicians guide EP catheters through blood vessels into the heart to destroy diseased tissue. The EP Catheters and products are used for diagnostic testing and treatment for both invasive (intra-cardiac) and non-invasive procedures and are a critical part of cardiac patient care.

An estimated cost for this is for a brand name, sole- source IDIQ contract with a base ordering period of one (1) year and four (4) one (1) year option ordering periods.

(4) An identification of the statutory authority permitting other than full and open competition.

The statutory authority permitting other than full and open competition is Title 41 United States Code (U.S.C) § 3304(a)(1) implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements”.

(5) A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The unique attributes of the Biosense Webster EP Catheters are that they integrate with and enable the use of the Biosense Webster CARTO® 3 System, a capital equipment mapping system. Many Electrophysiology programs within VA Medical Centers currently utilize Biosense Webster’s CARTO® 3 System to map, diagnose and treat cardiac arrhythmia patients which is only possible in conjunction with the Biosense Webster EP Catheters. Biosense Webster EP Catheters are exclusive to Biosense Webster. EP catheters from other manufacturers in the marketplace do not integrate with the CARTO® 3 capital equipment to facilitate navigation or therapy delivery.

The CARTO® 3 System uses current and CARTO® Magnetic Location technologies which integrate with a broad portfolio of diagnostic, ultrasound, and therapeutic

Strategic Acquisition Center (SAC) products, as well as related accessories. Much like a Global Positioning System (GPS), the CARTO® 3 System technology relies on proprietary Biosense Webster disposable catheters which are equipped with internal navigation sensors. These internal navigation sensors provide the specialized capabilities of enabling real-time navigation, ensuring +1mm of location accuracy in maps and integrating 3D ultrasound images.

These capabilities make it possible for Electrophysiologists to utilize the CARTO® 3 System to generate 3D cardiac maps from which they can diagnosis a myriad of cardiac arrhythmias and deliver immediate therapy.

Use of the CARTO® 3 System is not possible without Biosense Webster disposable products. Disposable products of other Original Equipment Manufacturers (OEMs) are not functional for cardiac navigation, map generation, ultrasound image integration or therapy delivery with Biosense Webster’s CARTO® 3 System. Additionally, the proprietary Biosense Webster catheters with navigation sensors enable visualization of the expanded portfolio of non-sensor based Biosense Webster products through the hybrid current and magnetic framework of the CARTO® 3 System. Through Biosense Webster’s Connection of Choice functionality, use of the non-sensor based Biosense Webster products with the CARTO® 3 System ensures a seamless interface and is enabled by CARTO hardware configuration featuring a central connection point for all Biosense Webster catheters and equipment. The Connection of Choice functionality works in tandem with the Advanced Catheter Location (ACL), which supplies location data from each electrode connected to the CARTO® 3 System, and Fast Anatomical Mapping (FAM), which allows clinicians to rapidly create a map of the heart with Computed Tomography (CT) like resolution, which minimizes the need for fluoroscopy radiation during catheter ablation procedures.

Lastly, for magnetic-based location accuracy and mapping of the CARTO 3 System, Biosense Webster has an important sensor-based catheter. The catheters are equipped with a passive Biosense Webster location sensor. The sensor provides real-time information that is used for calculating catheter location, based on the magnetic fields generated by the Location Pad. As stated above, use of the CARTO® 3 System is not possible without Biosense Webster disposable products. Sheath visualization aids in understanding the special relationship between the catheter and the sheath during navigation in the cardiac chambers. CARTO VIZIGO Sheath visualization in the CARTO 3 System is based on Advanced Catheter Location (ACL) technology and the CARTO VIZIGO Sheath and sensor-based catheter are paired and visualized as one unit during procedure. Disposable products of other Original Equipment Manufacturers (OEMs) are not functional for cardiac navigation, map generation, ultrasound image integration or therapy delivery with Biosense Webster’s CARTO® 3 System.

(6) A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or

Strategic Acquisition Center (SAC) will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

Market research was conducted as indicated below in paragraph 8. This effort did not identify any additional sources that can meet the Government’s requirements.

There is no competition anticipated for this acquisition. A notice of the proposed action will be synopsized via the Government Point of Entry (GPE) in accordance with FAR Section 5.201. Any proposals that are received shall be evaluated.

(7) A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

This determination will be based on a comparison of current contract pricing, and Independent Government Cost Estimate, past proposal submission (if available) and other information as made available. No award shall be made until the Contracting Officer determines the cost to the Government to be fair and reasonable.

(8) A description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted.

In accordance with FAR Part 10 and VA Acquisition Regulation (VAAR) Part 810, VA has conducted extensive market research to arrive at the most suitable approach to acquiring EP Catheters and maintaining the necessary supply chain. This market research was conducted in a collaborative effort by PSAS and SAC contracting personnel by, but not limited to, reviewing the results of recent market research undertaken to meet similar or identical requirements, reviewing catalogs and other generally available product literature published by manufacturers, distributors, and dealers or available online, and reviewing systems such as the System for Award Management (SAM), the Federal Procurement Data System-Next Generation (FPDS- NG), and the Small Business Administration's Dynamic Small Business Search.

A pre-solicitation notice was posted on July 6, 2023, to Contract Opportunities, in search of small businesses or alternative sources that are capable of providing the brand name catheters provided by Biosense Webster. This effort did not yield any additional sources that can meet the Government’s requirements. No technical capability statements or responses were received.

In accordance with FAR 8.002 and VAAR 808.002, the following priorities for use of sources were reviewed: VA inventories and VA supply stock program, excess from other agencies, the Federal Prison Industries (FPI), and covered products by the Committee for Purchase from People Who are Blind or Severely Disabled. No supplies were found at these sources.

Strategic Acquisition Center (SAC)

Market research revealed that the manufacturer’s patented and trademark EP Catheters are unique and proprietary to Biosense Webster. Biosense Webster is the sole source for all Biosense Webster disposable products and does not authorize the sale of these disposable products through any third-party distributors.

Additionally, a search was conducted on 6/5/2023 using Dynamic Small Business Search (DSBS) using the applicable NAICS code 339112. The search resulted in 14 firms being selected. After review of the “capabilities narrative”, none of the vendors can provide the supplies required under the requirement.

Based on the information obtained through extensive market research, Biosense Webster is the sole provider of Biosense Webster EP Catheters and associated products which integrate with and enable the use of the Biosense Webster CARTO® 3 System and does not authorize the sale of these products through any third-party distributors.

(9) Any other facts supporting the use of other than full and open competition.

Biosense Webster is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition.

(10) A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

None.

(11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition 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. All future requirements will be handled on a case-by-case basis to determine any future acquisition strategy.

Strategic Acquisition Center (SAC)

(12) Technical and Requirements Certification:

I certify that the supporting data under my cognizance, which are included in this J&A, are accurate and complete to the best of my knowledge and belief.

Deputy Program Manager Medical Supplies Program Office (MSPO) VHA Procurement and Logistics (10NA2) Department of Veteran Affairs

(13) Contracting Officer Certification:

Pursuant to FAR 6.303-2(a)(12). I certify that this justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer Strategic Acquisition Center