A.02.04_JA_ImpellaKO_signed.pdf

Control Number: 18-RHCO-A-799

RFQ #: W91YTZ18Q0112

Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold

(Simplified Acquisition Threshold is $250K)

1. Contracting Activity:

Regional Health Contracting Office – Atlantic (RHCO-A) Bragg Health Contracting Cell 6021 5th Street, Building 1467 Fort Belvoir, VA 22060-5505

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _________ Total Dollar Value: $127,485.42

Name of Intended Contractor: ABIOMED Street Address: 22 CHERRY HILL City, State, Zip: DANVERS, MA 01923

Phone: 800.422.8666

3. Description of Supplies/Services: Womack Army Medical Center (WAMC) has a requirement to purchase an Impella Device that provides cardiac support in the event of coronary dissection. The Impella Device is the only Food and Drug Administration (FDA) approved percutaneous left ventricular assist device that provides cardiac support in the event of coronary dissection, and/or cardiovascular instability, acting as a life sustaining bridge until the patient can receive cardiothoracic surgery. Below are the items to be purchased as part of the Impella Device by 28 September 2018:

Quantity Part Number Product 3 0048-0003 Impella CP Pump Set 2 0042-0000 Automated Impella

Controller 2 0042-0020 Assembly, Cart, Impella

Controller 2 0043-0003 Purge Cassette 5 Pack 4 0042-0002 AIC Connector Cable

Delivery Date: 29 September 2018

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: The Impella Device is the only FDA Device approved percutaneous left ventricular device that provides cardiac support for cardiovascular instability, acting as a life sustaining bridge until the patient can receive cardiothoracic surgery. This device is necessary to begin interventional cardiology. The interventional cardiologist is available and is ready to begin percutaneous interventions to support the mission at Womack Army Medical Center. Abiomed, Inc. is the sole manufacturer, marketer and US distributor of the Impella product portfolio. Additionally any services rendered is to be performed by a factory trained and certified technician and requires the use of specialized test equipment which are only available from Abiomed, Inc. Failure to provide the requested supplies/parts will lead to diminished healthcare for the WAMC patient population. (See attached Sole Source Letter in PCF, A.02.04 dated 29 August 2018).

6. Actions to Increase Competition: A sources sought was posted on the Federal Business Opportunities (FBO) 28 August 2018 through 3 September 2018 with no interested parties to date having interest or questions. A synopsis was posted to FBO on 12 September 2018.

7. Market Survey: Market Research conducted in accordance with FAR Part 10. I researched by using the General NAICS code 339112, General Services Administration (GSA), Small Business Administration and Google websites. Search produced no results and found no small business contractors having the capability to provide the parts.

8. Procurement History:

Previous Contract or Purchase Order Number: or N/A Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: NA

9. Technical / Requirements Certification: I certify that the supporting 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:

Melissa Broadwater

Position Title : CNOIC Cardiology Services Email address: melissa.a.broadwater.civ@mail.mil

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: Donna Blossom Position Title: Contracting Office

Email address: Donna.l.blossom.civ@mail.mil

Date:

mailto:Donna.l.blossom.civ@mail.mil