P03 SSJ 36C241-25-AP-0667 Impella Heart Pumps MJC CO Signed.pdf

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: 36C241‐25‐AP‐0667

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 1, located at

Bedford MA, in support of VISN 01, VA Health Care System at Boston Medical Center 2237 # 523‐25‐ 1‐7811‐2111

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

Impella CP with Smart Assist Heart Pump Quantity 2 Estimated value of $53,750.00

Impella, the world’s smallest heart pump, is the only FDA‐approved, non‐surgical heart pump to assist the heart's pumping function during stent placement and ensure blood flow is maintained to critical organs. During a Protected PCI or protected stenting procedure, the Impella heart pump is placed temporarily in the heart to assist the pumping function while your physician performs the necessary treatment (angioplasty, stent placement, etc.).

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

Protected PCI is a stenting procedure to treat complex coronary artery disease. It includes the use of the Impella heart pump.

The use of the Impella heart pump during a PCI allows your blood pressure and blood flow to be maintained during the procedure, which may allow your doctor to perform a more complete and optimized procedure.

Impella is temporarily inserted through a small incision and advanced through the arteries and into the heart. Once in place, the Impella heart pump is turned on, pulling blood from the left ventricle and releasing it into the aorta.

When your heart is strong enough to pump on its own and the Impella heart pump is no longer needed, your cardiologist will remove it before you go home from the hospital.

Accordingly, Abiomed Inc. via their SDVOSB distributor GeoMed LLC, is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

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

Previous purchases have been made directly to the OEM via FSS and Open Market. The OEM SAC contract expired. We requested a quote from the vendor, but they did not provide one. Instead, they pointed to SDVOSB GeoMed LLC. as their exclusive distributor to the government.

According to the Buy American Decision Tool Clause and Provision Selection, The Buy American Statute applies. Clauses 52.225‐1 and 52.225‐2 will be used.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by the synopsis of the proposed acquisition, advising the industry of the pending acquisition, and soliciting inquiries from interested parties.

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.

Manasés Cabrera Ashley Zannikos Contracting Specialist Contracting Officer

NCO 1 NCO 1