P03_ SSJ_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 2 Revision: 00 Acquisition ID#: 36C241 25 AP 0200

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 0200

Contracting Activity: Network Contracting Office 1 New England, Regional Procurement Office East on behalf of The Department of Veterans Affairs, VISN 1, West Roxbury VA Medical Center, 1400 VFW Parkway, West Roxbury, MA 02132. Funding 523 25 1 7811 0019.

Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This is a new, sole source requirement. The Contracting Activity intends to purchase (4) Impella CP Pump Sets (Model No. 0048 0003) solely manufactured and solely distributed by LB OEM ABioMed Inc.

(UEI: KBGSE7HJSDE3), 22 Cherry Hill Drive Danvers, MA 01923. The Impella CP, the world’s smallest heart pump, is intended for temporary (less than or equal to six hours) use to maintain stable heart function. The Impella CP can potentially lower certain risks in patients with severe coronary artery disease who otherwise have stable heart function and are undergoing percutaneous coronary intervention (PCI) such as an angioplasty or stenting, when a team of doctors that includes a heart surgeon has determined that a PCI with Impella is appropriate for this patient The Impella CP Pump is a minimally invasive heart pump with intelligent technology to improve patient outcomes with peak flows up to 4.3 L/min. The estimated value of the proposed action is

Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Impella Catheter (Pump) is the only percutaneously inserted circulatory support device that provides direct unloading of the left ventricle without the need for atrial transseptal puncture. This system provides direct active unloading of the left ventricle. This in turn increases cardiac output and perfusion to coronary arteries and vital organs. This equipment is urgently needed at West Roxbury VAMC’s Cardiology department. This system is needed during complicated coronary interventions, such as unprotected Left Main Coronary Artery PCI, or in instances where the patient has a low ejection fraction. It is also needed for Electrophysiology patients undergoing Ventricular Tachyarrhythmia ablations. It is also a necessary lifesaving device in instances of Cardio pulmonary arrest. Theirs is no competing technology to the Impella and no third party product available. This piece of equipment enables the functioning of the Impella Catheter to provide Circulatory support to patients in Cardiogenic shock, or patients with poor cardiac output and low left Ventricular ejection fraction undergoing Coronary angiogram, percutaneous coronary interventions, or percutaneous valve insertions. West Roxbury currently owns 2 of these consoles, and the Staff responsible are fully trained on their use. There is no substitution for these catheters.

West Roxbury VAMC’s staff used one device last week and there is only one left in the hospital. The need for these devices is often unpredictable and needed urgently to save a patient’s life. As the requirement for these devices is in emergency situations and unplanned, they need a certain par level to maintain our ability to provide life saving procedures the patients.

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

Limited market research was conducted by the station as ABIOMED brand pumps and catheters are

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 2 of 2 Revision: 00 Acquisition ID#: 36C241 25 AP 0200 currently in use by West Roxbury’s Cardiac Cath Lab however the Contracting Activity conducted its first search on VetCert under NAICS 339112 which yielded broad results, none of which are authorized to provide these heart pumps. SBA DSBS search using NAICS 339112 along with keyword “ABioMed” yielded 0 results. GSA e Library search using keyword “ABioMed” yielded 0 results. Las search was on FPDS using keyword “Impella Heart Pump” which yielded 47 contract actions from past procurements for the same pump being requested all purchased directly through OEM ABioMed Intent to Sole Source Notice will be published on Contract Opportunities under solicitation ID 36C24125Q0006 since this requirement is above OEM LB ABioMed Inc states they are the sole manufacturer, marketer and US distributor of the Impella product portfolio. This equipment can only be acquired solely from LB OEM ABioMed Inc.

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.

Phillip Crockett Date Contracting Officer

NCO 1/ RPO EAST

PHILLIP

CROCKETT

Digitally signed by

PHILLIP CROCKETT

Date: 2024.10.02 12:00:14 -04'00'