FAR6_JA_OVER_SAT EnSite Signed Redact.pdf

OFOC SOP Revision 09 Page 1 of 4 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C244-20-AP-3824

1. Contracting Activity: Department of Veterans Affairs, VISN 4, Corporal Michael J. Crescenz VA

Medical Center (CMCVAMC) 3900 Woodland Avenue, Philadelphia, PA 19104. Purchase Request (2237) Number: 642-21-1-315-0009.

2. Nature and description of the action being processed: This is a new, brand name requirement for the purchase of one EnSite Precision Cardiac Electrophysiology Mapping and Navigation System.

The system will be utilized to perform radiofrequency ablation procedures. This system has the capability of producing customizable, three dimensional anatomic maps of the heart. The system has an irrigation cooling catheter technology and allows the operator to easily select and manage ablation parameters. The system is interoperable and interfaces with existing Medical Center technology utilized in the Cardiac Electrophysiology (EP) Laboratory, the Electrophysiology Recording System, the X-ray System and the Intra-Cardiac Echo (ICE) Systems. The EnSite Precision cardiac mapping system also allows the operator to choose contact or noncontact mapping. The system improves model accuracy by reducing the tenting effect when creating a model with the ablation catheter and minimize variation in voltage amplitude during mapping with the EnSite Contact Force Module3.

Brand Name: EnSite Precision Cardiac Mapping System

CLIN Description Qty 0001 EnSite Precision™ Cardiac Mapping System Service Coverage: Includes initial one year manufacturer’s warranty. Manufacture Part Number

PRECISION SYS

0002 EnSite™ Contact Force Module Service Coverage: Includes initial one year manufacturer’s warranty CFK300

0003 Ampere™ Generator Kit Service Coverage: Includes initial one year manufacturer’s warranty H700494

0004 Ampere™ Remote Control (includes 15m fiber cord) Service Coverage:

Includes initial one year manufacturer’s warranty H700490

0005 Cool Point Irrigation Pump Service Coverage: Includes initial one year manufacturer’s warranty89003

Total estimated cost of the EnSite Precision Cardiac Mapping System

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for one (1) Ensite Precision Cardiac mapping and Navigation System in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

OFOC SOP Revision 09 Page 2 of 4

Revision 09 Date: 04/17/2020

3. Description of Supplies Required to Meet the Agency’s Needs: The cardiac mapping and navigation system will be used to perform radiofrequency ablation procedures. The system must have interoperability, interface, and connectivity with the following systems; Siemens SC2000 ultrasound;

Siemens ARTIS Q X-ray; and the GE cardiolab EP recording. The system is complete with all hardware, software associated with irrigated ablation, cooling catheters, advanced mapping technology using a completely open platform that uses a primary impedance navigation mode to locate and track catheters within the blood pool. This allows physicians to acquire multiple mapping points simultaneously with a high level of accuracy, thus reducing the amount of catheter manipulation necessary to diagnosing abnormal heart rhythms, which in turn improves safety, effectiveness and efficiency of cardiac ablation procedures. Because of this open platform, the EnSite Precision can collect anatomy and mapping data from any catheter that has electrodes that are pinned out in the EP Recording System. EnSite Precision is the only cardiac mapping system with this type of flexibility and capability. Other cardiac mapping systems require the use of their proprietary catheters to collect anatomy and mapping data, which limits the operator to the use of only the manufactures consumables for the purpose of collecting model and mapping data. The Ensite Cardiac Mapping System does not require the use of proprietary catheters therefore the Ensite Precision model will reduce the cost of consumables utilized during the lifespan of the Ensite cardiac mapping system.

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1

(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 FAR 6.302-1;

Brand Name Justification in accordance with 11.105(a)(1) Items Peculiar to One Manufacturer. This justification shall be posted to Contracting Opportunities upon award in accordance with 11.105 (3).

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

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 Precision cardiac mapping system uniquely combines impedance and magnetics so the operator can enhance model creation. The EnSite Precision cardiac mapping system is built on an open platform, that allows the operator to choose the diagnostic and ablation catheters which best meet the needs of our Veterans. In addition, the EnSite Precision, has an open architecture in terms of receiving catheter signals from any catheter plugged into the EP Recording System. This feature allows for flexibility in in ablative catheter use, opening a wider platform of options for the operator based on clinical presentation. It also allows for cost savings because the system does not require proprietary catheters to be used with their mapping equipment. The system also has an automap module with OneModel and OneMap in one system, achieving 54% faster, real-time model creation with the OneMap tool offering precise anatomic modeling than the other comparible models. The CMCVAMC electrophysiology physicians are credentialed to use this system. CMCVAMC is also an academic affiliate and the affiliate is familiar with this system. It is important for safety of our Veteran’s to maintain consistency across institutions with equipment and supplies. The EnSite Precision system meets all the facility’s requirements and is compatible with all CMCVAMC existing systems. The physicians at the facility and affiliated institution are familiar, competent, and trained

OFOC SOP Revision 09 Page 3 of 4

Revision 09 Date: 04/17/2020 to use the EnSite Precision which enhances the procedures and the Veteran overall experience.

Physician familiarity is critical because there are several processes crucial to set-up, usage, and providing a standard level of care. Accordingly, the Abbott Labratories’ is the only firm capable of providing the supplies without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought notice (36C24420Q0948) was posted on 8-10-2020 and closed on 8-17-2020. The sources sought confirmed the manufacturer Abbott Laboratories is the only manufacturer and distributor of the required Ensite Precision Cardiac Mapping and Navigation system. Two (2) Service Disable Veteran Owned Small Businesses, Veteran Healthcare Supply Solutions and Marathon Medical both provided authorized distributor letters from Abbott Laboratories’. There is a class waiver to the Non-Manufacturing Rule under North American Industry Classification Code 334510 and Product Service Code 6525. Both SDVOSB confirmed that their company does not exceed 500 employees, is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied and that they take ownership or possession of the equipment in a manner consistent with industry practice.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable: The anticipated cost to the government will be determined fair and reasonable based on a comparison of proposed prices. It is anticipated that the government will receive two (2) quotes in response to a Brand Name, Request for Quote (36C24420Q0948) set-aside for Service Disable Veteran Owned Small Businesses. The proposed prices will also be compared to the requesting services Independent Government Cost Estimate and recently awarded contract pricing for the EnSite Precision System. Contract 36C26120P0696 awarded to Veteran Healthcare Supply Solutions awarded in March 2020 at $305,835.00 and 36C24918P4846 award in September 2018 to Abbott Laboratories at $309,800.00 for the corresponding line items.

8. Description of the market research conducted and the results: Market research was conducted by utilizing search engines on the Vendor Information Pages, Multiple Schedule Prime Vendor, National Acquisition Center, General Service Administration, and System for Award Management web sites.

None of the requested items were found on any current supply schedules. A sources sought notice (36C24420Q0948) was posted on 8-10-2020 and closed on 8-17-2020. The sources sought confirmed the manufacturer Abbott Laboratories is the only manufacturer and distributor of the required Ensite Precision Cardiac Mapping and Navigation System. Two (2) Service Disable Veteran Owned Small Businesses, Marathon Medical and Veteran Healthcare Supply Solutions, Inc. both provided authorized distributor letters from Abbott Laboratories. There is a class waiver to the Non- Manufacturing Rule under North American Industry Classification Code 334510 and Product Service Code 6515. Both SDVOSB confirmed that their company does not exceed 500 employees, is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied and that they take ownership or possession of the equipment in a manner consistent with industry practice.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The purchase descriptions suitable for full and open competition have not been developed because the Ensite Precision system is compatible with the CMCVA Medical Center’s existing systems and no other system will meet the CMCVA Medical Center’s requirements.