A.02.04_JandA_final_redacted.pdf

Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold

(Simplified Acquisition Threshold is $150K)

1. Contracting Activity: U.S. Army Medical Command Regional Health Contract Office - Pacific Bldg 339 Clark Rd Ft Shafter, HI 96858

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: DHP Total Dollar Value: $

Name of Intended Contractor: Abiomed, Inc.

Street Address: 22 Cherry Hill Drive City, State, Zip: Danvers, MA 01923-2575

Phone: 978-646-1467

3. Description of Supplies/Services: The item being purchased are three (3) Impella CP Catheters, part number #0048-0003, with associated purge cassette, part number #0043-0003

This item is an emergency cardiac catheterization device that is required to be on hand in the event of acute heart failure.

4. Authority Cited:

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 8.405-6(a)(1)(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

(d) FAR 8.405-6(a)(1)(i)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; OR

(e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures.

5. Reason for Authority Cited: Abiomed Inc, is the only known manufacturer of this highly specialized catheter system (proprietary), which is designed for patients in critical condition with

17-RHCO-P-738

severe heart failure, cardiogenic shock, and high-risk percutaneous intervention. No other manufacturer in the marketplace makes a catheter that moves the blood from the left ventricle to the rest of the body. This prevents the left ventricle from having to use excess energy while pumping an individual’s heart, thereby allowing weakened or damaged left ventricles time to recover from a heart attack or during shock.

Unlike other catheters, the Impella catheter can remain in the body for as little time as necessary for high risk cardiac interventions, such as placing a stent to open the coronary arteries, or as long as needed, such as reducing the workload of the heart before open heart surgery. It can also be used to help patients in heart failure recovery, as the Impella can do the work of the heart by moving blood in the body. The closest item to this catheter is a left ventricular assist device, which can only be implanted via surgery and remains in the body until a heart transplant is completed or patient death.

For certain cases at TAMC this type of left ventricular assist device will not be practical in providing patient support.

The only catheter in the marketplace that will allow the functionality needed for specific cases where left ventricle intervention is necessary and cannot accommodate the alternative left ventricular assist device is the Impella CP catheter. The Impella CP catheter is only manufactured and distributed by Abiomed, Inc. No other entity supplies this item.

6. Actions to Increase Competition:

Although the Government intends to make a sole source award, a synopsis will be posted on FedBizOps (FBO) and allow other companies to submit proposals which will be evaluated by the government.

7. Market Survey: Market research conducted over the internet within the past 12 months indicates that this product is commercial in nature and is used by other medical facilities across the globe. No other company manufactures or distributes these catheters. The Regional Health Contracting Office – Pacific has procured these supplies in FY15 and 16 under contracts W81K02-15-P-0085 and W81K02-16-P-0134. Further, Abiomed, Inc has provided written confirmation that they are the sole manufacturer/distributor of these catheters.

8. Procurement History:

Previous Contract or Purchase Order Number: W81K02-15-0085 & 16-P-0134 or N/A Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: 13.106-1(b)(1)(i)

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this mini-J&A are accurate and complete to the best of my knowledge and belief.

Submitted By:

Position Title : Healthcare Administrator, Department of Medicine

Email address:

Date: 14 October 2016

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

Typed Name:

Position Title: Contracting Officer

Email address:

Date: