P03 Emergency_Limiting_Sources_Justification_Impella Catheters.pdf

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C244‐20‐AP‐4561

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Wilkes‐Barre VA Medical

Center, 1111 East End Blvd. Wilkes‐Barre, PA 18711. Purchase Request (2237) Number 693‐ 20‐4‐134‐0380

2. Description of Action: Urgent Procurement for Abiomed Impella Catheters

Order against: FSS Contract Number: 36F79719D0138

Name of Proposed Contractor:

Abiomed Inc.

22 Cherry Hill Drive City, State, Zip: Danvers MA, 01923‐2575

Phone:978‐777‐8411

3. Description of Supplies or Services:

The estimated value of the proposed action is $ 25,125.63

This justification is for a Abiomed Impella Catheter (0048‐0003) which is required for high risk cardiac interventions. The catheter is compatable with the current equipment alredy in place at Wilkes Barre VAMC. These catheters are used in emergencies when a patient is in cardiogenic shock or needing acute coronary intervention helping to support the ventricular function of the heart.

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107‐107) and implemented by FAR 8.405‐6. Mark the applicable exception:

An urgent and compelling need exists, and following the procedures would result in unacceptable delays(FAR 8.405‐6(a)(1)(i)(A);

5. Rationale/explanation to support cited authority: Impella heart catheters are the only Food and Drug Administration‐approved line of percutaneous heart pumps indicated for patients with advanced heart failure or cardiogenic shock due to a heart attack. Abiomed Inc. is the only company that manufactures this Catheter. There is currently a service contract in place to support the maintenance and repairs of the compatible equipment.

The catheters are compatible with the exisiting systems and third party catheters are not compatible. Due to patient care, the clinic is low on catheters and if the last catheter fails, it will cause delay in patient care. Unicor and AbilityOne do not carry catheters. A search on GSA Advantage and the National Acquisition Center shows that there are catheters, but through different manufatures Abiomed has a NAC contract 36F79719D0138 for the Impella Catheters. In the interest of economy and efficiency, the catheters also represent a logical follow‐on to an original Federal Supply Schedule order for the equipment. There are no known SDVOSBs and/or VOSBs distrubtors. Abiomed, was contacted to see if they had any authorized resellers/distributors, but the company has none. In accordance with FAR 6.302‐ 2, the need in procuring these catheters, to continue patient care, is urgent.

6. BRAND NAME ONLY This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e‐Buy, as required by FAR 8.405‐1(e).

7. Note that this determination satisfies the requirements of FAR 8.405‐6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

Justin Erdley Andrew Taylor Contract Specialist Acting Branch Chief, Commodites 2