P03 Sole Source Justification 36C241-25-AP-0511 Impella Heart Pumps_BC signed.pdf

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C241 25 AP 0511

1. Contracting Activity: : Department of Veterans Affairs, Network Contracting Office 1, located at Bedford MA, in support of VISN 01, VA Health Care System at Boston Medical Center 2237 # 523 25 1 7811 1493

2. Nature and/or Description of the Action Being Processed: This procurement is for Impella Heart Pumps in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303 2. The action being reviewed and approved is a new firm fixed price contract.

3. Description of Supplies/Services Required to Meet the Agency�s Needs:

Impella CP with Smart Assist Heart Pump Quantity 24 Estimated value of $645,000.00

Impella, the world�s smallest heart pump, is the only FDA approved, non surgical heart pump to assist the heart's pumping function during stent placement and ensure blood flow is maintained to critical organs. During a Protected PCI or protected stenting procedure, the Impella heart pump is placed temporarily in the heart to assist the pumping function while your physician performs the necessary treatment (angioplasty, stent placement, etc.).

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106 1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

5. Demonstration that the Contractor�s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Protected PCI is a stenting procedure to treat complex coronary artery disease. It includes the use of the Impella heart pump.

The use of the Impella heart pump during a PCI allows your blood pressure and blood flow to be maintained during the procedure, which may allow your doctor to perform a more complete and optimized procedure.

Impella is temporarily inserted through a small incision and advanced through the arteries and into the heart. Once in place, the Impella heart pump is turned on, pulling blood from the left ventricle and releasing it into the aorta.

When your heart is strong enough to pump on its own and the Impella heart pump is no longer needed, your cardiologist will remove it before you go home from the hospital.

Accordingly, Abiomed Inc. via their SDVOSB distributor GeoMed LLC, is the only firm capable of providing the supplies and services described in Section III above without the Veteran�s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The OEM was contacted concerning distributors. The OEM provided a sole source provider letter indicating they are the sole manufacturer, marketer, and US distributor of the Impplella product portfolio. They recently started a relationship with GeoMed to distribute their products to the government via FSS and ECAT. Required items are not on the FSS or ECAT. GeoMed was also contacted and provided a market research quote.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

A search on the FDPS website revealed enough results to determine fair and reasonable pricing based on proposed prices.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Previous purchases have been made directly to the OEM via FSS and Open Market. The OEM SAC contract expired. The Government requested a quote from the vendor, but they decline and instead, confirmed SDVOSB GeoMed LLC. as their exclusive distributor to the government.

According to the Buy American Decision Tool Clause and Provision Selection, The Buy American Statute applies. Clauses 52.225 1 and 52.225 2 will be used.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Abiomed, Inc.

22 Cherry Hill Drive Danvers, MA 01923 USA

Geo Med, LLC Lake Mary, FL

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: None.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Kimberly Shattuck Nurse Manager Cardiac Catheterization & Electrophysiology Labs VA Boston Healthcare System

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee�s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Ashley Zannikos Contracting Officer

NCO1

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Sheryl Anthony Branch Chief

NCO1

Kimberly Shattuck RN

Digitally signed by Kimberly Shattuck RN Date: 2024.10.31 13:04:47 -04'00'

ASHLEY

ZANNIKOS

Digitally signed by ASHLEY

ZANNIKOS

Date: 2024.10.31 14:11:14 -04'00'