P03 - J and A -u -r.pdf

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: 02/01/2022 Page 2 of 4

0004 9600CM29A 29 mm Edwards SAPIEN 3 Transcatheter Heart Valve (THV) with Commander System 4

The total estimated value of the consigned items stored on-site is . The anticipated annual expenditure is with the estimated total contract value of .

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

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) 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): The Margaret Cochran Corbin VA Campus is seeking to establish a new consignment agreement to maintain the current cabinet inventory. This new consignment will preserve the availability of the same brands and models of implantable surgical items, which is critical to providing veterans with life-saving care. There are currently only two FDA-approved transcatheter valves for the aortic position—one is a balloon-expandable valve intra-annular valve (the Sapien valves manufactured only by Edwards), and the other is a self-expanding supra-annular valve (the CoreValve series manufactured only by Medtronic), which already established the consignment agreement. There are no other brand valves currently approved for use in the United States. Thus, it is crucial to have inventories from both companies available for immediate use during surgery.

Furthermore, the type of valve chosen for any given patient is based on the patient’s aortic valve, ascending aortic, sinus of Valsalva, and coronary artery anatomy. Transcatheter valve programs must have both types of valves on the shelf to safely treat veterans with aortic valve disease. In addition, physicians require both types of valves to be always available for immediate use. Nevertheless, Edwards is the only company manufacturing the FDA-approved balloon expandable intra-annular valve; no other brand or model will meet the agency’s needs.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The OEM, Edwards Lifesciences LLC, does not allow third parties to provide these items on their behalf.

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

The anticipated costs are considered to be fair and reasonable based on the OEM

Effective Date: 02/01/2022 Page 3 of 4 direct pricing with the comparison from the current consignment prices. The OEM also provided an additional discount to the VAMC.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The research was conducted using VIP, FPDS, SBA, and GSA to find the requested items. VIP showed a potential of 0 vendor(s) under the NAICS code 339113 and keyword "Edwards Lifesciences." On GSA, there was 0 vendor available to supply the items. CO also verified with Edwards Lifesciences LLC, the Original equipment manufacturer (OEM), about the consignment agreement and found that it is the only one available to satisfy the requirement.

Therefore, there are not enough small businesses available for competition. Based on the facts and market research findings, the CO determines the Government's best interest is served by a noncompetitive open-market award to the OEM, Edwards Lifesciences, LLC.

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

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

Edwards Lifesciences LLC

SAM UEI: MR4FCKSNGRC1

One Edwards W Irvine, CA 92614-5688 Phil Peters, RDCS, Edwards Lifesciences Representative Office: 631-513-9431

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: Regular communications with the using service have proven to be instrumental in matching the vendor’s capabilities and limitations with the needs of the Government. Therefore, the VA Network Contracting Office 2 will continue to maintain communications with providers and use this engagement to strategize procurement for the long-term requirement.

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.

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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.

Date

Effective Date: 02/01/2022 Page 4 of 4

Contracting Officer (NCO 2)

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.

Branch Chief, Supply Team 1 & Prosthetics (NCO 2)

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Date

VHA Head of Contracting Activity (HCA)