Signed Sole Source - Impella 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-2664 JOFOC Tracker Number: FY26 - NCO 19 - 1044

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#: 554-26-4-450-0209

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

Amount:

The Rocky Mountain Regional VA Medical Center requires a service agreement for Abiomed Automated Impella Controller (AIC) consoles. This requirement is peculiar to one manufacturer and sole provider (Abiomed Inc). This requirement period of performance is needed for a base year with four (4) one (1) year options.

The total estimated value of the contract, including a base year and four 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 Abiomed Impella AIC Console System, inclusive of preventive maintenance, corrective maintenance, Original Equipment Manufacturer (OEM)-certified replacement parts, depot-level repairs, loaner equipment, and full technical support. These consoles are mission-critical life-support devices that directly enable cardiac procedures requiring temporary mechanical circulatory assistance. Any downtime is unacceptable, as uninterrupted operation is essential to protect patient safety and maintain clinical capability.

The Impella AIC Console delivers the power, control, and real-time monitoring necessary for Impella catheters, which are temporarily inserted into the heart to maintain perfusion and stabilize cardiac function while the myocardium recovers. These systems must remain fully operational at all times; failure or improper servicing would place patients at immediate risk and compromise the Medical Center’s ability to perform critical cardiac interventions.

The Abiomed Impella AIC Console is a proprietary, highly specialized medical device, and all service, maintenance, calibration, and repairs are restricted exclusively to the original equipment manufacturer.

Abiomed has confirmed that: Only OEM factory-trained technicians are authorized to service these systems. All diagnostic software, calibration tools, test equipment, and technical data are proprietary and not available for use by third-party vendors. No authorized or certified service providers exist outside Abiomed.

Because the maintenance and repair infrastructure is entirely 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 Abiomed is the only responsible and compliant course of action. This procurement is required to ensure the continued safe operation of these life-sustaining 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 “Impella Maintenance” to identify potential vendors. SAM.gov search resulted in one (1) vendor: Abiomed Inc. Station conducted market research and direct communication with the manufacturer Abiomed Inc Abiomed confirmed all service must be performed by Abiomed personnel.

Prior awards VA259-16-C-0197 and 36C25921C0145 of the same nature for Eastern Colorado Healthcare System were awarded to the manufacturer and sole provider, Abiomed Inc.

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

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

4/22/26

4/22/26