Attachment 2 99MDG IABP JA Redacted.pdf

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

CONTROLLED UNCLASSIFIED INFORMATION

July 2025 CONTROLLED UNCLASSIFIED INFORMATION Page 1 of 4

NOTE: If a Justification was approved for the preceding acquisition, a copy of the approved Justification for the predecessor action must be included in the staff package for approval of the instant Justification. This applies to Justification staff packages that are submitted for review and approval at a level above the contracting officer. The predecessor Justification will be used as a reference document by the approving official.

Is this a new or amended J&A Document? New Amended ( Prior to Award Only! )

Is this a Bridge Action as defined in the AF Bridge Action Reduction Plan? Yes No

Funding level for this acquisition: >SAT and < $750K > $750K and < $15M

Contracting Activity:

99th Contracting Squadron 5865 Swaab Blvd., Building 588 Nellis AFB, NV 89191

Purchase Request / Local ID Number: HT115012323792

Program / Project (and PE, if applicable): AC3 Optimus Intra - Aortic Balloon Pump

Program Type (PEO or Other Contracting): Other Contracting

Authority: DAFFARS 5313.501 - 10 U.S.C. 3572, Implementation of Simplified Acquisition Procedures (41 U.S.C. 1901)

DAFFARS 5313.501 - 10 U.S.C. 3403, Special Emergency Procurement Authority (41 U.S.C. 1903)

Estimated Contract Cost (including options): Justification Type: Class Individual

COORDINATION ( DAFFARS 5306.304(a) )

Date

09 Sep 2025

Contracting Officer Robert J. Trapani, GS-13, DAF

99 CONS/PKB 652-9444

Signature

Date

10 Sep 2025

Competition Advocate Caley S. Horton, GS-14, DAF

99CONS/CD 652-4003

Signature

APPROVAL (DAFFARS 5306.304(a) )

Date

10 Sep 2025

Chief of the Contracting Office (COCO) Justin T. Schneider, LtCol, USAF

99CONS/CC 652-4003

Signature

TRAPANI.ROBERT.JOSE

PH.1234733580

Digitally signed by

TRAPANI.ROBERT.JOSEPH.1234733580

Date: 2025.09.09 13:58:23 -07'00'

HORTON.CALEY.SUNG

MEE CYPHERS.1274810625

Digitally signed by HORTON.CALEY.SUNG

MEE CYPHERS.1274810625

Date: 2025.09.10 09:20:47 -07'00'

SCHNEIDER.JUSTIN.TH

OMAS.1374251976

Digitally signed by

SCHNEIDER.JUSTIN.THOMAS.1374251976

Date: 2025.09.10 09:26:27 -07'00'

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

July 2025 CONTROLLED UNCLASSIFIED INFORMATION Page 2 of 4

I. Contracting Activity.

99th Contracting Squadron 5865 Swaab Blvd., Building 588 Nellis AFB, NV 89191

II.Nature and/or description of the action being processed.

This is a new requirement, for which Government intends to award a firm fixed price, one time purchase order.

This acquisition will be for the delivery of 4ea. - AC3 Optimus IABP (Intra-Aortic Balloon Pump) systems, manufactured by Teleflex, on behalf of the Mike O' Callaghan Military Medical Center ("Cardiology") located at 4700 N Las Vegas Blvd, Las Vegas, NV. The estimated award date is September 19, 2025.

III. Description of supplies/services required to meet agency needs.

This requirement is for the delivery and acquisition of 4ea. - AC3 Optimus IABP (Intra-Aortic Balloon Pump) systems with FiberOptix capability. The IABP is a device that increases myocardial oxygen perfusion and indirectly increases cardiac output through afterload reduction. It consists of a: a) cylindrical polyurethane balloon that sits in the aorta, approximately 2 centimeters (0.79 in) from the left subclavian artery, and b) computer-controlled mechanism (pump). The balloon actively deflates in the systolic deflation and inflates in the diastolic inflation. These actions combine to restore balance between supply and demand for oxygen needed for the heart and other organs to function properly. The instruments are used in the following situations: a) cardiogenic shock, b) reversible mechanical heart defects, c) agina, d) cardiographic surgery, e) preoperative use in high-risk patients, f) non- surgical procedures used to treat heart stenosis of coronary arteries, g) high risk coronary artery bypass graft surgery, and h) breaking down of blood clots formed in blood vessels. The AC3 Optimus brand of IABP (Intra-Aortic Balloon Pump), currently owned by the hospital are approaching the end of their useful life and it is essential that they are replaced. The IABP systems will be procured and delivered under a one time purchase order, funded with FY25 DHP (Defense Health Program) O&M (Operations and Maintenance) money. The estimated delivery date is October 19, 2025.

IV. Statutory authority permitting other than full and open competition.

FAR 13.106-1(b)(2), FAR 19.203(c), and FAR 19.1405(b). NAICS the requested commodity falls under has been granted a blanket waiver from the Small Business Administration regarding the non-manufacturer rule

(NMR).

V.Demonstration that the contractor's unique qualifications or nature of the acquisition requires the use of the authority cited above (applicability of authority).

This will be an individual, brand name justification based on the following information: The AC3 Optimus IABP (Intra-Aortic Balloon Pump) is manufactured by Teleflex. Due to the proprietary nature of the real-time WAVE® Algorithm, no other brand of equipment can provide the required IABP. The main feature of this product is the Pro-Active Counter Pulsation system enabling 98% inflation timing accuracy during IABP therapy, even when patients have severe arrhythmias. This provides the unique ability of the AutoCAT2 WAVE system with FiberOptix® catheter technology to proactively anticipate individual arterial pressure closures before they occur, and provide accurate inflation timing, as well as triggering even during severe arrhythmias.. The FiberOptix® catheter captures and transmits the high-fidelity arterial pressure signal at the speed of light, Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

July 2025 CONTROLLED UNCLASSIFIED INFORMATION Page 3 of 4 overcoming the delays seen with traditional fluid-filled arterial pressure (AP) signal systems. The proprietary real time WAVE® Algorithm is the brain of the pump, it calculates aortic flow based on the AP signal for each beat (using real-time data). This enables it to capture every single heartbeat and then signal the pump to inflate.

In heart failure cases, precisely timed IABP is critical for generating beat-to-beat improvements in systolic and diastolic left ventricular performance. A failure of this brand of IABP has never been reported over its lifetime.

This is important because a mechanical failure of the balloon requires immediate removal, which can lead to serious complications caused by micro clots that form on the balloon surface, e.g.; a) peripheral thrombosis, b) myocardial ischemia, c) hemodynamic decompensation, and d) late pseudoaneurysm.

VI. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Originally, this requirement was thought to be a brand name, sole source acquisition. It was thought that Marathon Medical was the only known SDVOSB who could provide the required AC3 Optimus IABP Systems.

Consequently,a Notice of Intent to Sole Source was posted to SAM.gov from 22 August 2025 through 29 August 2025. The purpose of this notice was to give the public a chance to review the Government's intended course of action and to either comment on said action, refute it or propose another alternative. No responses, other than one Marathon Medical, confirming their interest, were received. However, after this notice closed and upon further investigation, it was discovered that another potential SDVOSB distributor, for the required equipment existed. As a result, plans were made to solicit this requirement as a brand name, SDVOSB set-aside.

VII. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

Price fair and reasonable will be determined by a competitive acquisition, as the acquisition is a brand-name requirement and not a single/sole source action. In addition, the Government has pricing from Marathon Medical, provided to the Department of Veteran Affairs (VA), as well as previous purchases made by other Government agencies, searched on usaspending.gov.

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

Both SAM.gov and FPDS-NG were searched. This research showed that the majority of awards for the AC3 Optimus Intra-Aortic Balloon Pump were awarded on a sole source basis to Marathon Medical. Another award was competed on an unrestricted basis. Two responses were received, as a result of that solicitation. Marathon Medical was the awardee. A list of distributors, for the AC3 Optimus Intra-Aortic Balloon Pump, was obtained from Teleflex's website. This website listed two distributors as SDVOSB. The current certification of both SDVOSB distributors was verified at https://veterans.certify.sba.gov. As a result of this verification, this requirement will be solicited as an SDVOSB set-aside.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

IAW FAR 19.1405(a)(3), the contracting officer shall consider SDVOSB set-asides before considering SDVOSB sole source awards (see 19.1406) or small business set-asides (see subpart 19.5).

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

July 2025 CONTROLLED UNCLASSIFIED INFORMATION Page 4 of 4

X. List of any sources that expressed, in writing, an interest in the acquisition.

Teleflex authorized reseller Marathon Medical, a certified SDVOSB concern has expressed interest in the acquisition.

XI. 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 99th Contracting Squadron will continue to promote the use of Defense Logistics Agency Electronic Catalog and Prime Vendor among 99th Medical Group Logistics team to procure medical supplies, which would preclude the use of brand name justifications.

XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.