Notice of Intent to Sole Source - Impella Automated Impeller Controller (AIC) Preventive and Corrective Maintenance Services

Notice of Intent to Sole Source - HT941026N0111

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE PURCHASE ORDER CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES.

The Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division - West (HCD-W), intends to negotiate and award a firm-fixed-price service contract for annual preventive and corrective maintenance services for two (2) government-owned Impella units to the Original Equipment Manufacturer (OEM):

J&J MEDTECH (ABIOMED)
22 CHERRY HILL DRIVE
DANVERS, MA 01923

The North American Industry Classification System (NAICS) code for this requirement is 811210 (Electronic and Precision Equipment Repair and Maintenance); the business size standard is $34.0 Million. The Product Service Code (PSC) is J065 (Maintenance, Repair, and Rebuilding of Equipment: Medical, Dental, and Veterinary Equipment).

The requirement is for comprehensive scheduled (preventive) and unscheduled (corrective) maintenance services for the following systems:

1. Impella Automated Impeller Controller (AIC) (Serial Number: IC11925)

2. Impella Automated Impeller Controller (AIC) (Serial Number: IC11940)

The proposed Period of Performance is a 12-month Base Year (September 1, 2026 – August 31, 2027) with four (4) subsequent 12-month option years. While the government-owned equipment is clinically utilized and based at the Mike O’Callaghan Military Medical Center (MOMMC) Cardiac Cath Lab, Nellis AFB, NV, services will be executed utilizing the OEM’s manufacturer-certified mail-in depot service program, inclusive of all pre-paid round-trip FedEx Priority shipping.

Based on market research and technical assessments, the Government has determined that J&J MedTech (Abiomed) is the only source capable of fulfilling this requirement. The Impella Automated Impeller Controller (AIC) units, including proprietary software coding and data, are highly proprietary. MOMMC Biomedical Equipment Technicians (BMETs) cannot support or perform this maintenance due to the restricted, proprietary nature of these medical devices.

To maintain patient safety, operational readiness, and compliance to regulatory requirements, all repairs must utilize factory-qualified OEM parts and subassemblies, and must include the installation of certified factory revisions and quality improvements. Furthermore, this clinical mission requires specialized support parameters that only the OEM can reliably secure, including:

1. A guaranteed service turnaround time within forty-eight (48) hours of depot receipt (with average turnaround times of 1–2 days).

2. 24-hour expert telephonic technical support.

3. The immediate provision of manufacturer-certified service loaner units to prevent clinical downtime while government-owned systems are undergoing depot service.

4. One (1) rent-free operational backup rental (up to 5 days) per contract year for each covered system.

This notice of intent is not a request for competitive proposals, and no solicitation document exists for this requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required manufacturer-certified maintenance and support services.

Capability statements shall not exceed six (6) pages (8.5 x 11 inch) using a font size no smaller than 10-point. All capability statements received by the closing date and time of this notice will be considered by the Government.

A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole-source award.

If a vendor challenges the basis of this requirement, please email capability statements as a Microsoft Word or Adobe PDF attachment to Dominic Gonzales at dominic.n.gonzales.civ@health.mil. The closing date for challenges is no later than 10:00 a.m. August 21st, 2026 PDT.

NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.