JA Sole Source Abiomed W81K0020Q0008_Redacted.pdf

Control No: 20-RHCO-C-38 Contractor: Abiomed

Program/Equipment: Impella Heart Pumps

Version – September 2018 FOR OFFICIAL USE ONLY

FAR Part 13.501 Brand Name or Equal Justification and Approval for Other than Full and Open Competition

1. Contracting Activity: Regional Health Contracting Office-Central (RHCO-C)

2. Description of Action: San Antonio Military Medical Center (SAMMC), Department of Cardiology Catheterization and Electrophysiology, Joint Base San Antonio-Ft Sam Houston, Texas requests a new IDIQ contract for Impella Heart Pumps and accessories.

Impella heart pumps are designed for patients in critical condition with severe heart failure, cardiogenic shock, and high-risk percutaneous intervention. This system prevents the left ventricle from having to use excess energy while pumping an individual’s heart, thereby allowing weakened or damaged left ventricles time to recover from a heart attack or during shock. The funding type for this requirement is O&M DHP.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

The previous contract W81K00-18-P-0028 was a sole sources contract. That contract was competed under authority 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items. Paragraph 6, “Actions to Increase Competition” of the previous justification, stated:

The requiring activity will continue to monitor the market for sources with the same or similar capabilities. The Government will continue to seek new resources which satisfy this requirement through continue market research, request for capability statement, and telephone inquiries. When an equivalent product becomes available every effort shall be made to increase competition.

Previous contracts were one-time purchases for emergency surgery. This contract will be for a supply of items to be ordered on an as needed basis for surgery.

3. Description of Supplies/Services: The requirement is for the procurement of the Impella Heart Pumps and accessories, which are used to provide mechanical life-saving support to high risk patients.

Estimated Delivery date: 15 January 2019 Base Year: 15 Jan 2019-30 Sep 2020;

Option Year 1: 1 Oct 2020-30 Sep 2021;

Option Year 2: 1 Oct 2021-30 Sep 2022;

Total Value: $ (Includes Base for 2 Option Years)

4. Authority Cited: The statutory authority permitting other than full and open competition is 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited:

(a) Abiomed Inc. is the only known manufacturer of this highly specialized Impella Heart pump and accessories, which is designed for patients in critical condition with severe heart failure, cardiogenic shock, and high-risk percutaneous intervention. This system prevents the left ventricle from having to use excess energy while pumping an individual’s heart, thereby allowing weakened or damaged left ventricles time to recover from a heart attack or during shock. The Impella catheter can remain in the body for as little time as necessary for high risk cardiac interventions, such as placing a stent to open the coronary arteries, or as long as needed, such as reducing the workload of the heart before open heart surgery. It can also be used to help patients in heart failure recovery, as the Impella can do the work of the heart by moving blood in the body. In addition, this system allow a longer and more thorough procedure by preventing episode of hemodynamic instability (poor circulation, low blood pressure) due to temporary abnormalities in heart function. The only catheter in the marketplace that will allow the functionality needed for specific cases. Impella heart pump is FDA approved for use during elective and urgent high-risk of percutaneous coronary intervention (PCI) procedures.

(b) Failure to award a contract to Abiomed Inc. to provide the required Impella heart pumps and accessories for cardiac surgical patients could potentially jeopardize the SAMMC Cardiovascular’ s mission of providing accurate and timely care to its beneficiary population. If the contract is not awarded in time, it could possibly be more expensive for a one-time purchase than compared to the expected cost of this contract;

overall affecting direct patient care.

(c) Salient Characteristics

Device must be compatible with Abiomed controller console to drive pump.

Device must provide percutaneous temporary heart pump support.

Once implanted device must pump blood for the right or left ventricle side of the heart.

Devices must provide right ventricular unloading with 4.0+ liters per minute of continuous flow for immediate improvement in hemodynamic performance. Left Ventricular blood flow at a rate of 4.0 liters per minute. Left Ventricle blood flow of

2.5 liters per minute.

Device must pump blood from a blood vessel outside the heart (inferior vena cava) into a blood vessel leading to the lungs (pulmonary artery).

Device must pump blood for patient while the patient’s right or left side of the heart has time to rest and recover its ability to pump blood on its own.

Device must provide hemodynamic support for high risk patients.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered. A Sources Sought notice was posted to the Government Point of Entry (GPE) FedBizOpps on 28 Oct 2019, with no responses. Based on market research and the results of the Sources Sought Notice, competition is not anticipated for this requirement. Due to the nature of this device, subcontracting opportunities are not available. The Government will continue to assess the market for new entrants. Abiomed is a large business.

7. Actions to Increase Competition: After award, this justification will be available at the GPE, www.fedbizopps.gov. If in the future other compatible products become available, market research will be performed to consider other sources that meet or exceed the current requirement. Additionally, an evaluation of the market will be conducted prior to any renewal related to this requirement. Pricing, availability, and any alternative solutions will be the focus of that research. The contract file will be properly documented with any findings. In accordance with FAR Subpart 19.705-2, the Contracting Officer has taken actions to determine whether the proposed contractual obligation requires a sub- contacting plan. The Contracting Officer has determined that a subcontracting plan is not applicable for this requirement.

8. Market Research: Market research was conducted 23 Oct 2019 via; internet, brochures, literature review and a comprehensive analysis of different heart pumps and accessory products. The SBA’s Dynamic Small Business Search (DSBS) was reviewed to identify small business vendors and determine potential set-asides or subcontracting possibilities to provide heart pumps. The results revealed zero vendors identified. Although there are some companies that offer heart pumps, none of them meet the requirements of the Department of Cardiology at SAMMC.

9. Interested Sources: A Sources Sought for this requirement was posted to the GPE on 28 Oct 2019; no responses were received. Future requirements of this type will be researched within the market to ascertain if additional vendors have entered the market offering the required products. To date, no other sources have written to express interest in this acquisition.

10. Other Facts:

a. Procurement History:

(1) Contract numbers of the last several contracts for these same requirements.

W81K00-17-P-0132, Awarded 1 Feb 2017 W81K00-18-P-0028, Awarded 27 Oct 2017 W81K00-17-P-0051, Awarded 4 Dec 2017

(2) The competitive status of these actions.

W81K00-17-P-0132, Sole Source W81K00-18-P-0028, Sole Source W81K00-17-P-0051, Sole Source

(3) Authority previously cited if less than full and open competition was used.

W81K00-18-P-0028, FAR 13.501(a)(1)(ii), sole source (Including brand name) under the authority of the simplified procedures for certain commercial items.

(4) A justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 5 and 6 of the justification for that procurement and an explanation of the results is a follows:

Abiomed Inc. is the only known manufacturer of this highly specialized catheter (heart pump) system and does not have any authorized distributors. The Government will continue to seek new resources which satisfy this requirement through continue market research, request for capability statement, and telephone inquiries. When an equivalent product becomes available every effort shall be made to increase competition.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstance causing this action to now limit the sources. Not Applicable.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. Not Applicable.

(7) Justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes: Abiomed Inc. is the only known manufacturer of this highly specialized catheter (heart pump) system (proprietary). There are no known authorized dealers that have expressed an interest in this acquisition.

11. Technical Certification: I certify 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.

Date:

Title: Supply Technician Signature:

12. Requirements Certification: I certify 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.

Title: Supply Technician Signature:

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable. A price analysis will be conducted to compare the proposed prices to competitive contracts within RHCO-C for the same or similar requirements.

This determination will be made using the following: IGCE.

As a part of this basis, in accordance with FAR 15.403-1(b)(3) certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Title: Contracting Officer Signature:

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Title: Contracting Officer Signature:

Approval

Based on the foregoing justification, I hereby approve the procurement of Impella heart pumps and accessories from Abiomed Inc. on a sole source basis or brand name equal heart pumps and accessories on a sole source basis for an estimated amount of $ pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5, subject to availability of funds, and provided that the requirement herein described have otherwise been authorized for acquisition.

Special Advocate for Competition Signature:

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