JA Sole Source v3 3589 _FINAL._Redacted.pdf

Control Number: (24-RHCO-C-349)

Controlled Unclassified Information (Source Selection Information - See FAR 2.101 and 3.104-4)

August 2022

Controlled by: USAHCA Controlled by: FCHCB CUI Category: SSEL Limited Dissemination Control: FED

ONLY POC:

Justification Review Document

For Sole Source - FAR Part 13.501* (*Format follows FAR 6.303-2, but modified to reflect FAR subpart 13.5 procedures)

Program/Equipment: Brooke Army Medical Center, Department of Cardiology requests an Indefinite Delivery, Indefinite Quantity (ID/IQ) contract for Biotronik Cardiac Surgical Implants and Supplies.

Authority: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items

Amount:

Prepared by:

Typed Name:

Contract Specialist Title: Phone:

E-mail: Date: 07 Aug 2024

Contracting Officer:

Typed Name: Phone:

Date Reviewed: 07 Aug 2024 Email:

Technical / Requirements Representative:

Typed Name: Phone:

Title: Supervisor, Cardiovascular Procedure Unit 07 Aug 2024 Email:

Control Number: (20-RHCO-C-349)

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited:

a. Biotronik, Inc provided a Proprietary Letter, dated 21 April 2024 on company letterhead signed and dated confirming there are no other authorized distributors. Biotronik, Inc is the sole manufacturer and seller of these cardiac devises and supplies. There are no other authorized distributors.

b. The Department of Cardiology requirement is for Biotronik, Inc. pacemakers, implantable defibrillator, and cardiac resynchronization therapy devices which are only compatible with patient’s leads who currently have a Biotronik implanted devices. These leads are implanted in a patient’s heart and are not compatible with any other company’s device. Implanting an incompatible device can lead to patient harm or lead degradation.

c. Biotronik, Inc. is the only means available to obtain the Closed Loop Stimulation myocardial contractility sensor for physiologic rate response, the Defibrillator System (DX), Vertical Dual Defibrillator (VDD), Implantable Cardio Defibrillator (ICD), single chamber ICD with atrial diagnostics, the dedicated automatic MRI safe mode sensor, or the daily Home Monitoring system which has demonstrated a reduction in mortality for heart failure patients.

d. Failure to award a contract to Biotronik Inc to provide the required cardiac devise and supplies could jeopardize the BAMC mission of providing accurate and timely care to its beneficiary population.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR

5.201 and any bids or proposals received shall be considered. IAW FAR 5.203, Publicizing and Response Time, a Notice of Intent to award Sole Source was posted on SAM.gov Contract Opportunities on 22 March 2024 for 7 days with no responses. Biotronik, Inc. provided a quote and email confirming there are no other authorized distributors. Biotronik, Inc. is the only vendor that can meet the requirements for the government requirement. Based on market research and the results of the Notice of Intent, competition is not anticipated for this requirement. Due to the nature of this device, subcontracting opportunities are not available. The J&A will be posted within 14 days after contract award. The Government will continue to assess the market for new entrants.

7. Actions to Increase Competition: After award, this justification will be available on SAM.gov Contract Opportunities. If in the future other compatible products become available, market research will be performed to consider other sources that meet or exceed the current requirement.

Additionally, an evaluation of the market will be conducted prior to any renewal related to this requirement. Pricing, availability, and any alternative solutions will be the focus of that research.

The contract file will be properly documented with any findings.

8. Market Research: IAW FAR Part 10, Market research was conducted in Jul 2024 via the internet, literature review and a comprehensive analysis of different cardiac surgical implants and supplies. The SBA’s Dynamic Small Business Search (DSBS) was reviewed to identify small business vendors and determine potential set-asides or subcontracting possibilities to provide cardiac surgical implants and supplies. The results revealed zero vendors identified.

Although there are some companies that offer cardiac surgical implants and supplies, none of them can meet the specific requirements of the Department of Cardiology at BAMC.

a. The previous requirement was awarded to a large business, Biotronik, Inc. under NAICS 339113. Market research has indicated that this requirement will be sole sourced to Biotronik, Inc., a large business.

b. Cardiac surgical implants and supplies are customarily available in the commercial marketplace. Based on this market research and IAW FAR 10.001(a)(3)(ii), this requirement meets the definition of a commercial items as defined in FAR 2.101(a) “Commercial Item”.

c. Per FAR 19.502-2 a review for small business socioeconomic contracting programs was conducted. A search of the Small Business Administration’s (SBA) Dynamic Business Search (DSBS) using NAICS 339113 and using keyword “Cardiac devices”, identified zero matches.

d. A review of mandatory sources to include GSA/VA Schedules, in addition to open market and knowledge of the current contract indicates, that Biotronik, Inc. is commercial in nature and only available on a sole source basis by Biotronik, Inc.

e. Based on the information collected during the market research process, the cardiac surgical implants and supplies will be sole sourced to Biotronik, Inc. IAW FAR Part 13.5.

9. Interested Sources: To date, no other sources have written to express an interest in this requirement. As stated in paragraph 6 above, the notices required by FAR 5.201 have been published, and there are none that could provide the entirety of the Government’s requested requirement at this current time. Biotronik, Inc. is the only vendor that can meet the requirements for the government owned systems. Therefore, this will be solicited as a sole source. However, the Government will continue to monitor the marketplace for any new entrants.

10. Other facts:

a. Procurement History.

(1) In the past few years, MRCO-W has issued the following:

Contract Number: W81K00-18-A-0006 Contractor: Biotronik, Inc.

Description of requirement: Cardiac Surgical Implants and Supplies Method of procurement: Full and Open Competition Contract type: Firm-fixed-price

Total awarded amount:

Period of Performance:

Number of Offerors: Three offers were received which resulted in the award of three Blanket Purchase Agreements. W81K00-18-A-0006 (Biotronik), W81K00-18-A-0005 (Boston Scientific), W81K00-18- A-0004 (Abbott Laboratories). Since the award of these contracts, the items associated with Boston Scientific and Abbot are now available thru either the ECAT program or another in-house sources.

The Biotronik cardiac supplies are not available under the ECAT program and the products are specific to patients which have previous used the Biotronik supplies. Patients with existing Biotronik devices will require a new device when their current device’s battery has depleted. Patients that have a change in medical condition may require a device upgrade (such as a permanent pacemaker to a cardiac resynchronization therapy pacemaker).

Biotronik leads that are implanted in the heart are only compatible with a Biotronik cardiac device. These leads are not able to be removed to accommodate a different type of device.

Mixing of Biotronik leads with another brand cardiac device can result in degradation of the leads or patient harm/death.

(2) The competitive status of these actions.

W81K00-18-A-0006 (Biotronik) W81K00-18-A-0005 (Boston Scientific) W81K00-18- A-0004 (Abbott Laboratories)

(3) Authority previously cited if less than full and open competition was used.

Not applicable

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

After award, this justification will be available on SAM.gov Contract Opportunities. If in the future other compatible products become available, market research will be performed to consider other sources that meet or exceed the current requirement. Additionally, an evaluation of the market will be conducted prior to any renewal related to this requirement. Pricing, availability, and any alternative solutions will be the focus of that research. The contract file will be properly documented with any findings.

Explanation of results - a Notice of Intent to award Sole Source was posted on SAM.gov. Contract Opportunities for 7 days with no responses. Based on market research and the results of the Notice of Intent, competition is not anticipated for this requirement. The Government will continue to assess the market for new entrants.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

The previous requirement resulted in the award of three Blanket Purchase Agreements. W81K00-18- A-0006 (Biotronik), W81K00-18-A-0005 (Boston Scientific), W81K00-18- A-0004 (Abbott Laboratories).

The products connected to Abbott and Boston Scientific are now obtainable through the ECAT program.

Biotronik is the sole source manufacturer and does not utilize distributors for these Cardiac surgical implants devices and supplies per the email from the Senior Sales Representative, , dated 25 Mar 2025.

Biotronik is the only supplier with the necessary patient-specific pacemakers and defibrillators.

These devices have a myocardial contractility sensor called Closed Loop Stimulation, which is the only FDA-approved rate response technology for responding to acute mental stress and physiologic demands. It has also been shown to lessen the burden of atrial fibrillation. Biotronik is the only ICD system on the market that can perform dual chamber arrhythmia discrimination and electrograms with a single lead "DX" VDD ICD technology.

This technology improves diagnostic accuracy, aids in the detection of silent atrial fibrillation, lowers the rate of peri- and postprocedural complications, and avoids unnecessary shocks. For the treatment of heart failure, Biotronik cardiac resynchronization therapy pacemakers and defibrillators provide the greatest number of left-ventricular pacing vectors available.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

(7) An explanation of any unusual patterns that may be revealed by the history,e.g., several consecutive, urgent buys.

(8) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

b. Other Facts: Not Applicable