Consignment - Heart Valves - Ann Arbor

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5 Effective Date:

11/15/24 Page 1 of 9 REVISION:

01 Acquisition ID#: 36C250-25-AP-3650 DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID:

36C250-25-AP-3650 Contracting Activity: Department of Veterans Affairs, NCO 10, 24 Frank Lloyd Wright Drive, Suite M2200, Ann Arbor, MI 48105 in support of LTC Charles S. Kettles VA Medical Center, 2215 Fuller Road, Ann Arbor, MI 48105. 2237: 506-25-4-1041-0031.

Nature and/or Description of the Action Being Processed: This is an individual justification to support a new firm-fixed price, 5-year ordering period requirements contract with Edwards Lifesciences LLC for different-sized Sapien 3 Ultra Resilia Transcatheter Heart Valves for various scheduled and emergent procedures at the LTC Charles S. Kettles VA Medical Center.

These items must be on-hand in the TAVR Lab Room E747 Cardiology/Medicine Service Department or available just-in-time at all times; therefore, a consignment agreement will be established against the Requirements contract as the method of delivery. The contractor, Edward Lifesciences LLC, shall be responsible for maintaining the agreed-to inventory levels and will retain ownership of the material until the VA uses an item, at which time, the VA will make payment for the used item.

The procurement will be completed 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.

Description of Supplies/Services Required to Meet the Agency s Needs: The proposed Requirements contract is for different-sized Sapien 3 Ultra Resilia Transcatheter Heart Valves for various scheduled and emergent procedures. Therefore, these items must be on-hand in the Operating Room/Surgery Service Department or available just-in-time at all times and a consignment agreement will be used as the delivery method. The exact sizes and/or models are not always known prior to the surgical procedure.

Availability of an array of non-biological implant inventory at any given moment increases timely access to quality patient care. Proposed period of performance will include a 5-year ordering period.

Period of Performance: 8/1/2025 7/31/2030 Description Model# Year 1 Estimated Usage Year 2 Estimated Usage Year 3 Estimated Usage Year 4 Estimated Usage Year 5 Estimated Usage Transcatheter Heart Valve, 26M S3URCM26A 2 3 3 3 3 Transcatheter Heart Valve, 29M S3URCM29A 2 3 3 3 3 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:

       ( ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements        ( ) Unusual and Compelling Urgency        ( )  Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services        ( ) International Agreement        ( X ) Authorized or Required by Statute: 38 U.S.C.

8123        ( ) National Security        ( ) Public Interest Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Consignment agreements allow the VA to keep several of these short shelf-life items in the facility without having to buy them until they are used. Edwards Lifesciences LLC SAPIEN 3 Ultra heart valves powered by RESILIA tissue are the only balloon-expandable heart valves.

The SAPIEN 3 has an advanced calcium-blocking technology and patients with aortic FboNotice anatomy such as low coronary height, effaced sinuses of Valsalva, valve-in-valve can be treated with the SAPIEN 3. As of May 1, 2025, the FDA approved the SAPIEN 3 for the asymptomatic severe aortic stenosis population. This is the only heart valve with that indication.

The SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (failing, stenosed, insufficient or combined) who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.

The cardiologist chooses the particular heart valve being ordered during his consult and this is the only one that the doctor deemed appropriate for use in these specific medical situations. The supplies are selected based on their specific use during procedures.

Edwards Lifesciences, LLC is the only firm capable of providing the supplies described in Section 3 above without the Veterans Health Administration experiencing unacceptable delays in fulfilling its requirements. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An Intent to Sole Source will be posted to Contract Opportunities prior to award to confirm there are no other sources.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer will use the price analysis technique in FAR 13.106-3(a)(2)(ii), comparison of the proposed price with prices found reasonable on previous purchases, and any other techniques necessary to determine the prices to be fair and reasonable.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: In accordance with FAR Part 10 and VAAR 810, market research has been conducted for this acquisition. VetCert was searched under NAICS 339113 and 932 concerns were found. DSBS was searched under NAICS 339113 and keywords heart valve consignment and no results were found. Searched SAM under heart valve consignment agreement . There were 21 results.

Edwards Lifesciences, Abbott Laboratories, Medtronic, St. Jude, and ATS Medical. All are Large Businesses. Searched NAC under Heart Valve and no results were found. Searched SCMC under consignment and refined with heart valve and one result was found from Abbott Laboratories. Searched GSA Advantage under consignment and refined with heart valve and no results were found. Edwards Lifesciences LLC is a large business, and they have no distributors that are authorized to enter into consignment agreements.

Therefore, the VA Rule of Two and the SBA Rule of Two cannot be met. Any Other Facts Supporting the Use of Other than Full and Open Competition: The market for prosthetic heart valves is regulated mainly by which devices are FDA approved. As these devices are typically placed during a complex and life-altering surgery, the specific valve is usually chosen by the patient with input from the surgeon.

Therefore, the expert opinion of the surgeons is of utmost importance when choosing which specific brand a hospital should choose.

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Edwards Lifesciences LLC, 1 Edwards Way, Irvine, CA 92614. 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: Should a requirement of this nature recur, the market will again be surveyed to identify other sources that could result in a competitive procurement.