Biomed_SSJ.pdf

Section A: General Contract Information

Contracting Activity: 81 CONS

Project/Program Name: PUMP PERFUSION IMPELLA CARDIOPULMONARY BYPASS NONROLLERSTERILE LATEX FREE DISPOSABLE

Purchase Request/Identification Number: FM301090810026

Estimated Contract Cost (including Options):

Section B: Description of the Supplies/Services Required

81 MDOS/SGOMCC requests the sole source procurement from Abiomed Inc. for two lmpella 2.5 circulatory support devices ($20,155.78 each).

Section C: Justification for Soliciting from a Single Source or Brand Name

The Impella CP is a percutaneously inserted circulatory support device that can provide direct, active uploading of the left ventricle without the need for atrial (transeptal) puncture. This minimally-invasive technology employs a microaxial pump which is placed into the aorta by means of a catheter that is inserted into the femoral artery and can only be acquired from this company. It only requires access to one vessel in order to provide direct circulatory support of up to 4.2 liters/minute. The lmpella CP also provides pressure measurements which is required when detennining intravascular pressure. IA W FAR 6.302, the statutory authority permitting other than full and open competition for this acquisition is 10 USC 2304( c ), the 81 MODOS/SGOMCC has performed an internet search which returned three vendors (St. Jude Medical, Arrow, and Abiomed) who can provide circulatory support devices. St. Jude Medical's circulatory device has been repeatedly pulled off the market due to safety concerns with use and delivery of the product which increases the risk of thrombotic complications and has led to patient deaths. Therefore, St. Jude Medical does not meet the requirement. Contact was then made with Arrow and Abiomed, who, although they are similar circulatory devices,Abiomed can function independently to push blood from the left ventricle of the heart to the aorta unlike the Arrow, which has to use the patients heartbeat to increase blood flow. Abiomed circulatory devices are needed for more cardiac compromised patients. Therefore, Abiorned equipment is the only vendor able to meet this requirement. Furthermore, there are no other vendors on the market authorized to distribute this item.

Section D: Efforts to Obtain Competition

Market research was conducted on GSA and the Internet to find the circulatory support devices. Three contractors (St. Jude Medical, Arrow, and Abiomed were found. Only Abiomed can meet the customer's requirement because St. Jude Medical's circulatory support devices has been pulled from the market due to safety issues. Arrow's circulatory support devices uses the patients heartbeat to increase blood flow, therefore it does not meet the government's requirement.

Section E: Steps to Preclude Future Single Source or Brand Name Awards

81 MDOS/SGOMCC will continue to conduct market research and monitor the market for new products that may meet requirements on a semi-annual basis.

Section F: Contracting Officer's Determination

I have determined, in accordance with FAR 13.106-1(b)(1), that the circumstances of this contract action deem only a single source is reasonably available.

Date

09-Apr-2019

Typed Name and Rank/Grade of Contracting Officer

Timothy M. Thulin, MSgt, USAF

Signature of Contracting Officer

THULIN.TIMOTHY.MICHAEL.10

96909035

Digitally signed by

THULIN.TIMOTHY.MICHAEL.1096909035

Date: 2019.04.09 08:28:11 -05'00'