P03_Emergency_Catheter_Impella_Limiting_Sources_Justification_MPT-SAT.pdf

VHAPM Part 808.405-6 Limiting Sources Page 1 of 2 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C246-19-AP-1212

1. Contracting Activity: Department of Veterans Affairs, VISN 06, Hampton VA Medical

Center, 100 Emancipation Drive, Hampton, VA 23667 Purchase Request No. 652-19-1-089-

0275.

2. Description of Action: The Richmond VAMC has an emergency need of (2) two Impella CP Pump

Sets to provide support during upcoming high risk coronary cath interventions. The OEM for this requirement is ABIOMED Inc. (Small Business; DUNS: 050636737).

Order against: FSS Contract Number: V797D-30214

Name of Proposed Contractor: ABIOMED, Inc.

Street Address: 22 Cherry Hill Drive City, State, Zip: Danvers, MA 01923-2575 Phone: 1-800-422-8666 ext. 2

3. Description of Supplies or Services: The Impella CP® heart pump pulls blood from the left ventricle through an inlet area near the tip and expels blood from the catheter into the ascending aorta. The device will aide the Richmond VAMC in patients experiencing advanced heart failure, cardiogenic shock, and postcardiotomy cardiogenic shock. The Impella CP heart pump stabilizes hemodynamics, unloads the left ventricle, perfuses end organs, and allows for recovery of the native heart.

The estimated value of the proposed action is $ 50,251.26

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);

https://www.acquisition.gov/?q=/browse/far/8

VHAPM Part 808.405-6 Limiting Sources Page 2 of 2 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

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)(i)(B));

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

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

5. Rational/explanation to support cited authority: This is an emergency procurement for the Richmond VAMC. Items for this acquisition are proprietary to ABIOMED Inc. and recent market research indicates that ABIOMED is without any authorized resellers/distributors.

The items in need for this requirement can be procured from ABIOMED’s mandatory source NAC Contracting vehicle (V797D-30214). ABIOMED is the only manufacturer of the Impella device, which is the only percutaneous heart pump on the market and the only device FDA approved to be used for hemodynamic support during interventions.

6. BRAND NAME ONLY: This buy is estimated to exceed $25,000. Due to the emergency nature of this acquisition, an intent to sole source will not be posted to FBO along with the Justification documentation.

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.

JERRY L MANN

Contracting Officer Date: _______________

12/18/18 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/6