Signed Sole Source - Teleflex Balloon Pump Maintenance.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification for Sole Source Awards IAW RFO 12.102(a) For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($350K)

Acquisition Plan Action ID: 36C259-26-AP-2828 JOFOC Tracker Number: FY26 - NCO 19 - 1520

1. Contracting Activity: Ordering Activity:

Department of Veterans Affairs Department of Veterans Affairs Network Contracting Office 19 Rocky Mountain Regional VAMC 6162 S Willow Dr. Suite 300 1700 N. Wheeling St Greenwood Village, CO 80111 Aurora, CO 80045

2237#: 554-26-4-450-0258

2. Brief Description of Supplies/ Services required and the intended use/Estimated

Amount:

The Rocky Mountain Regional VA Medical Center requires service for Teleflex AC3 Optimus System to keep the equipment in safe, functional, and clinically available working conditions. This requirement is peculiar to one manufacturer (Teleflex). This requirement for performance is needed for the base year with two (2) one (1) year options.

The total estimated value of the contract, including a base year and two option years, is

. The resulting contract will include RFO 52.217-8 – Option to Extend Services.

If exercised for up to 6 months, the 52.217-8 option will be exercised at the same rates as those in effect under the contract at the time the contract is extended.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The Rocky Mountain Regional VA Medical Center requires the Teleflex AC3 Optimus System, an Intra-Aortic Balloon Pump (IABP), maintenance service. The requirements include Original Equipment Manufacturer (OEM) service, scheduled and unscheduled maintenance, software support, preventive maintenance, corrective maintenance, emergency repair services, system calibration, software updates, technical support, and access to proprietary diagnostic tools necessary to maintain system functionality and clinical performance.

The AC3 Optimus IABP is a next-generation mechanical cardiac support device designed to improve outcomes for patients with severe heart failure or cardiogenic shock. It uses IntraBeat Timing technology, which provides intra-beat inflation timing accuracy across a wide range of patient conditions, and the WAVE Algorithm to detect individual aortic valve closure points in real time, enabling precise inflation and deflation timing even in patients with severe arrhythmias or tachycardia (up to 200 bpm).

Teleflex has confirmed that all service procedures for this equipment may only be performed by Teleflex-authorized technicians. Teleflex does not authorize or recognize any third party service providers. Required maintenance relies on specialized test equipment that is available exclusively through Teleflex. As a result, no service vendors outside of Teleflex are capable of providing authorized maintenance or repairs Because the maintenance is proprietary, no alternate vendor can legally or technically meet the Government’s minimum requirements for safety, reliability, performance, or compliance.

Engaging a non-OEM provider would result in: Use of non-certified parts or procedures, violation of manufacturer standards, risk of equipment malfunction, loss of OEM support, and significant patient safety hazards.

Therefore, obtaining OEM-exclusive support from Teleflex is the only responsible and compliant course of action. This procurement is required to ensure the continued safe operation of these devices and to maintain the highest standard of patient care.

4. Description of market research conducted and results or statement why it was not conducted:

Market research included a search of the Small Business Administration’s Small Business Search (SBS), GSA, and SAM.gov using keywords “Teleflex Balloon Pump” and “Balloon Pump Maintenance” to identify potential vendors. SAM.gov search resulted in one (1) vendor: Teleflex. Station conducted market research and direct communication with the manufacturer. No third-party vendors are authorized or capable of meeting the Government’s minimum requirements.

Prior awards 36C25923C0112 and 36C25919P0995 of the same nature for Eastern Colorado Healthcare System were awarded to the manufacturer, Teleflex.

5. Requirements Certification: I certify that the requirement outlined in this document is a Bona Fide need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the document, are accurate and complete to the best of my knowledge and belief.

Date

6. Contracting Officer's Certification: Purchase is approved in accordance with RFO

12.102(a). I certify that the foregoing document is accurate and complete to the best of my knowledge and belief.

Date

6/11/26

6/11/26