V797D-30214-008.pdf

VHAPM Part 808.405-6 Limiting Sources Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

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: 36C260‐19‐AP‐2569

1. Contracting Activity: Department of Veterans Affairs, VISN 20, Puget Sound VA Medical

Center Cath Lab. Priority Request 663‐19‐2‐044‐8507

2. Description of Action: This new requirement will be a Delivery Order against an established NAC/FSS Contract for Impella Catheters

Order against: FSS Contract Number: V797D‐30214

Name of Proposed Contractor: Abiomed, Inc Street Address: 22 Cherry Hill Dr City, State, Zip: Danvers, MA 01923 Phone: 978‐646‐1808

3. Description of Supplies or Services:

The estimated value of the proposed action is $25,165.63

The Seattle VAMC has a urgent requirement to procure an FDA approved Impella Catheter (Heart Pump) from Abiomed, Inc. The Impella systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high‐risk percutaneous coronary interventions (PCI) performed in urgent, hemodynamically stable patients with severe coronary artery disease.

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);

VHAPM Part 808.405-6 Limiting Sources Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

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:

The nature of this emergency purchase request is urgent and compelling High Risk Percutaneous Coronary Intervention (PCI) surgery requires a back up catheter be on hand for is needed for patent safety. A surgery was performed last week leaving only one impella catheter in stock. A Patient is scheduled this week March 28th who will need an (PCI). If something were to go wrong with the first catheter or it became contaminated, it could be life threatening. The Imella catheter needs to be delivered by COB March 27th in order to be available for surgery scheduled on the 28th.

6. 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.

Gregory Watson Karen Rhodes Contract Specialist Contracting Officer Date: 3/26/2019 Date: 3/26/2019