PHX/644_ IMPELLA CATHETER W/HEART ASST_644A50173

VHAPG Part 813.106 Simplified Acquisition Procedures:

Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT 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:

36C262-25-AP-7047__ 1. Contracting Activity: Department of Veterans Affairs, Regional Procurement Office West (RPOW), Network Contracting Office 22 (NCO 22), 4811 Airport Plaza drive, Suite 600, Long Beach, CA 90815. Transaction Number: 644-25-425-0084 2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This acquisition is in support of the VA Phoenix Healthcare system Medicine Services department that ensures patients receive excellent care.

This department needs to replace the depleted inventory supply of Impella CP Pump with Smart Assist sets, as this medical instrument must be kept on hand in cases of emergency. The device will be used on patients with cardiogenic shock or patients undergoing severe heart failure. This procurement for the supply items will be used to further the procedures of stabilizing patients that experience the above-mentioned coronary trauma and need circulatory blood flow to the left ventricle of the heart.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The department currently uses Impella Smart Assist technology which allows the staff to monitor patients that have undergone the invasive procedure of having the pump administered. The software technology used in conjunction with the items found in this requisition are compatible and cannot be used with any other brand name item which works to achieve the same outcome.

Failure to purchase the items in this request is not an option as the VA is required to keep the devices on hand; both in cases of emergency, and other instances in which operative procedures are necessary. 4. Description of market research conducted and results or statement why it was not conducted: Market research was done using FPDS, GSA, and AddsUp. A search of SAC rendered that these items are not on mandatory contract.

After further market research it was revealed by the manufacturer, Johnson & Johnson; that Geo-Med LLC is the sole authorized distributor for Abiomed products. A search of ADDSup rendered multiple historical procurement awards to Geo-Med LLC for this same item. A review of SAM.gov conveys that the vendor is registered and is not listed on the Exclusion Parties list. Further past procurement data renders information that this vendor can provide the needed supplies at a fair and reasonable price.

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.

Prepared by:

Approved by:

Rochelle Malveaux

Shavon Bogan

Contracting Officer