Single Source Justification MPT to SAT.doc

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6515--Department of Veterans Affairs Ann Arbor VA Medical Center STAT - Supply - SAPIEN 3 Transcatheter Heart Valve
Solicitation number
36C25023P1548
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This document is a single source justification for the purchase of an Edwards Sapien 3 Transcatheter Heart Valve Kit from a sole source vendor for a veteran patient at the Department of Veterans Affairs Ann Arbor VA Medical Center. The justification provides that the veteran's attending physician has determined the prescribed device as the best option to treat the patient's medical condition and functional limitations. As substituting another device could be detrimental to the veteran's treatment, the clinical team has specified this product to meet the patient's unique medical needs. The estimated value of the sole source procurement totals $32,500. Due to the sole source selection, no additional market research was conducted beyond the contracting officer's knowledge of pricing for similar recent purchases.

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VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Attachment 1: Single Source Justification for SAP under the SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID: 36C250-23-AP-5001

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10 located at 260 E University Avenue, Cincinnati, OH 45219-2356, in support of VISN 10, VA Ann Arbor Healthcare System (506), 2215 Fuller Road, Ann Arbor, MI 48105-2303.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This requirement is for the purchase of an Edwards Sapien 3 Transcatheter Heart Valve Kit for a veteran patient from a single source per medical determination of need. The estimated amount totals $32,500.00.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Surgically implanted products are specified by the clinical team to meet the unique and comprehensive needs of each veteran with an identified medical indication. The prescribed item will be purchased from the vendor identified because they are able to meet those immediate needs. The veteran's attending Physician has the authority to prescribe the method of treatment to best satisfy the medical condition of his/her patient.

The physician has determined this item as the best device to treat the patient's medical condition and functional limitations. Substituting another device other than that specifically prescribed is beyond the role, competency, and professional functions of the Contract Specialist and would be detrimental to the treatment of the Veteran patient.

4. Description of market research conducted and results or statement why it was not conducted: Due to sole source selection, no additional market research was performed. Based upon the personal knowledge gained by the Contracting Officer’s experience with recent purchases that are similar in nature, the cost of this procurement is consistent with the cost of like items offered by other vendors in the industry and recently purchased at this facility. Subsequently, price is fair, reasonable, and presents the best value for the Government.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

07/10/2023__ Name: Barbara Robertson Date

Title: Contracting Officer Last Updated: 02/01/22

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