P03. LSJ Impella CP Catheter_Redacted.pdf

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C244-21-AP-1897

(1) Contracting Activity:

Department of Veterans Affairs, VISN 04. VA Pittsburgh Healthcare System (VAPHS) University Drive Campus University Drive C Pittsburgh, PA 15240.

Purchase Requisition: 646-21-2-126-0098

(2) Description of Action:

The Department of Veteran Affairs NCO 4 Network has a new, sole source requirement for a strategic source procurement for the purchase of Abiomed Impella CP Catheters. This Limited Sources Justification is being issued to document the Procurement Strategy.

Order against: FSS Contract Number: 36F79719D0138

Name of Proposed Contractor: Abiomed Inc.

Street Address: 22 Cherry Hill Drive

City, State, Zip: Danvers Ma, 01923

Phone:

(3) Description of Supplies or Services:

The Department of Veteran Affairs, NCO 4 Network, has a Sole Source requirement for the ongoing purchase of disposable Abiomed Impella CP Catheters. These catheters work in conjunction with the Automated Impella Controllers that are currently utilized within the NCO 4 Network. The Abiomed Impella CP Catheters are used specifically for high risk Cardiac/Coronary Interventions and are typically required for emergency situations. The catheters are used in critically ill patients needing Acute Coronary Intervention to support the ventricular function of the heart by reducing Cardiogenic Shock.

The Total Estimated Contract Value is

VHAPM Part 808.405-6 Limiting Sources Page 2 of 5 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a unique qualifications to provide the required supply or service.

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

FAR 8.405-6(a)(1)(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;

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are eplacem nents for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

The Abiomed Impella Catheters are the only catheters compatible with the existing Abiomed Impella equipment located within the NC04 catchment. Historically, these purchases have been made under Urgent & Compelling circumstances due to emergency patient situations.

This Strategic Sourcing procurement will expedite the procurement process for these purchases by using a Contract Vehicle more suited for the turnaround required for these types of requests. Abiomed, Inc. is the Original Equipment Manufacturer (OEM) and exclusive provider of these products and support services.

The General Services Administration (GSA) and National Acquisition Center (NAC) have already established fair and reasonable pricing for supplies under schedule contracts. The requested item is located on GSA/NAC contract 36F79719D0138. We will be establishing a Delivery Order against that will result in the quickest turnaround at the lowest overall cost to the Government.

VHAPM Part 808.405-6 Limiting Sources Page 3 of 5 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

During the Market Research phase, the following results were found:

An email was sent to Abiomed Inc. (OEM), a large business, regarding the availability of authorized distributors. Abiomed responded that they are the sole distributor.

Federal Supply Schedules were reviewed. The Impella CP Catheter was located on

GSA/NAC Contract 36F79719D0138. This is the only current schedule and vendor that could be located for this product. Contract pricing and expiration date have been confirmed with the vendor.

The Federal P Impella C turned 168 procurement history results. These results were reviewed and indicated that Abiomed was the sole contract awardee for past procurement history dating back to 2009.

A narrowed search via eCMS was then conducted for the Past Performance History in VISN04. This search returned 14 results within the last two years. Thirteen of these procurements were for VA Pittsburgh Healthcare System (VAPHS) and one for Wilkes- Barre VAMC (WBVAMC). All procurements were FSS orders and procured under urgent circumstances and sole sourced to Abiomed, Inc.

The Contract Specialist also queried the Vendor Information Pages (VIP) in search for possible ere utilized and returned 147 results. These results proved to be anyone that offered a Catheter . A more specified query was conducted util Ca four results, these vendors were contacted to determine the capability of providing the requested product and in return received no response.

Lastly, a Request for Information (RFI) was issued on February 12, 2021 and closed on February 17, 2021. After the closing date/time, no responses were received.

Based on the Market Research as stated previously, this requirement will be issued on a Sole Source basis to Abiomed, Inc. OEM (Large Business). This will be awarded against their FSS Schedule.