P03 Single Source Justification MPT to SAT_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 2

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C260-25-AP-0445

1. Contracting Activity: Department of Veterans Affairs, Regional Procurement Office West, Network

Contracting Office 20 on behalf of Portland Medical Center. Funding: 648-25-1-093-1863

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

This is an urgent requirement for Impella CP catheters. This equipment is vital during high risk procedures on patients with unstable hemodynamic systems. These catheters are used during cardiac procedures on patients that require left ventricular pressure support to improve systemic blood flow. The Portland VA Medical Center had 2 units in stock in August of 2024 and were unable to order due to fiscal year end. Recently, a requirement for 5 units was submitted, the within AP.

However, since that time, an additional unit is no longer functional, leaving them with only 1 unit.

This is not safe as if this only unit malfunctions during a procedure, there is no back up. This equipment has a direct and critical impact on patient care.

This will be a firm-fixed price sole source award in accordance with FAR 6.302-2(a)(2) When the agency’s need for the supplies or services is of such an unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids or proposals, full and open competition need not be provided for.

ITEM PRICE TOTAL

Impella CP with Smart Assist and accessories

Estimated Amount:

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

The requiring facility is in need of an emergency acquisition of Impella CP catheters. The facility recently lost its only back-up and is now down to 1 unit. This is against facility safety protocol, as if there is a malfunction with this unit during a procedure, there is no back-up available. The CP catheter is proprietary to Abiomed and is the only brand compatible with the VA Portland’s owned Impella Control Circulatory Assist Units. Impella Catheters are the only percutaneous heart pump on the market that is FDA approved to be used for hemodynamic support during high risk interventions.

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

Limited market research was conducted, because of its emergent nature, to prevent delay in care and impact on veterans. At minimum, we know the equipment requested meets the facilities’

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 2 of 2 needs. This is a specialized catheter, so the market is limited. Required sources of supply and existing contrat vehicles were searched.

*** Due to its high impact on patient care, this is an emergency request.***

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Gregory G. Watson Contracting Officer

Krystal Weeks Branch Chief

RPO WEST J&A TRACKER # FY25-NCO20-280

GREGORY

WATSON

Digitally signed by

GREGORY WATSON

Date: 2024.11.12 14:08:06 -08'00'

KRYSTAL

WEEKS

Digitally signed by

KRYSTAL WEEKS

Date: 2024.11.12 15:04:37 -08'00'