65--506-17-1-984-0373 Medtronic Valve TAVR

Chapter VI: Other Than Full and Open Competition (OFOC) SOP Attachment 4: Single Source Justification for SAP under $150K OFOC SOP Revision 05 Page 1 of 1 Original Date: 03/22/11 Revision 05 Date: 05/02/2016 JUSTIFICATION FOR SINGLE SOURCE AWARDS IAW FAR 13.106-1 (OVER MICRO-PURCHASE THRESHOLD($3.5K) BUT NOT EXCEEDING THE SAT ($150K)) IAW FAR13.104, COs must promote competition to the maximum extent practicable to obtain supplies and services from the source whose offer is the most advantageous to the Government, considering the administrative cost of the purchase. When competition is not practicable, IAW FAR13.106-1(b), COs solicit from a single source for purchases not exceeding the simplified acquisition threshold. COs may solicit from one source if the CO determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). IAW FAR13.106-3(b)(3),COs are required to include additional statements explaining the absence of competition (see 13.106-1 for brand name purchases) if only one source is solicited and the acquisition does not exceed the simplified acquisition threshold (does not apply to an acquisition of utility services available from only one source) or supporting the award decision if other than price-related factors were considered in selecting the supplier. This template when completed can be used to document single source awards IAW FAR13.106-3(b)(3). Note: Statements such as "only known source" or "only source which can meet the required delivery date" are inadequate to support a sole source purchase. ACQUISITION PLAN ACTION ID: VA250-17-AP-3105 1A. PROJECT/TASK No. N/A 1B. ESTIMATED AMOUNT: $30,000 2. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE: Purchase of Heart Valve for the Trans-catheter approach for Heart Valve Replacement Need Date: December 30, 2016 Medtronic, Inc., 710 Medtronic Pkwy, Minneapolis MN 55432 UNIQUE CHARACTERISTICS THAT LIMIT AVAILABILITY TO ONLY ONE SOURCE, WITH THE REASON NO OTHER SUPPLIES OR SERVICES CAN BE USED: Of the two manufacturers that produce valves for trans-catheter approach heart valve replacement, only Medtronic s valve has these needed features. This valve is repositionable if necessary during procedure. Is designed for the 1st time positioning accuracy with the assurance to recapture and reposition. Has the lowest delivery profile across all valve sizes through a 14FR equivalent system, and is now indicated for minimum vessel diameters 5.0mm. Provides exceptional valve performance and reduced significant PVL DESCRIPTION OF MARKET RESEARCH CONDUCTED AND RESULTS OR STATEMENT WHY IT WAS NOT CONDUCTED: There are only two manufacturers of products for this Transcatheter Aortic Valve Replacement (TAVR) Edwards Lifescience and Medtronic. There are variances in the products which met the needs of specific criteria of individual patients being treated. This VA stocks both manufacturers products to provide the necessary products based on the individual patient. This request is to replace specific products that were used. The physician has chosen the particular heart valve being ordered during his consult and determined this is the only one deemed appropriate for use in this specific medical situation. 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. Note: COs are required to make a determination of price reasonableness IAW FAR 13.106-3. See the Commercial Supply and Service SOP for Price Reasonableness templates. Signature: ______________________________ Date:____________________ Name:__________________________________ Title:___________________________________ NCO:_________________________________