65--CryoLife Bioglue Adhesive - MPLS VA

Chapter VI: Other Than Full and Open Competition (OFOC) SOP Attachment 4: Single Source Justification for SAP under $150K 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. 1. ACQUISITION PLAN ACTION ID: 618-17-1-029-1231 1A. PROJECT/TASK No. NONE 1B. ESTIMATED AMOUNT: $83,430.00 2. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE: A firm fixed price purchase order for 18 boxes of 10ML syringes, 5 per box, NG3510-5-US Adhesive Cryolife Bioglue. Bioglue begins to polymerize within 20 to 30 seconds and reaches full strength within two minutes. Bioglue also adheres to synthetic graft materials through mechanical bonding within the interstices of the graft matrix and is used in the OR by the Cardiologists during open heart surgery. Required by November 10th, 2016. 3. UNIQUE CHARACTERISTICS THAT LIMIT AVAILABILITY TO ONLY ONE SOURCE, WITH THE REASON NO OTHER SUPPLIES OR SERVICES CAN BE USED: This is critical for O.R. Surgical use. This is used during open heart surgery and is used in connecting (gluing) arteries together during open heart procedures. Research was conducted by Clinicians and this product was selected because it offered the best surgical outcomes. Experience with other products has not provided the same quality, consistency and successful outcomes compared to BioGlue. The Minneapolis VA clinical staff is trained to use this product. Cryolife is the sole manufacturer, creator, distributor, and patent owner of BioGlue. They are the only authorized seller of the BioGlue line in the United States. Per Cryolife, there are no other authorized resellers. Without this product the OR could not conduct the procedures and patients would have to wait or be fee based out to local hospitals. 4. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND RESULTS OR STATEMENT WHY IT WAS NOT CONDUCTED: Federal Supply Schedules, VETBIZ, Internet and NAC Schedule 65 were searched. GSA search for Bioglue yielded zero matches/results. VETBIZ search for Bioglue yielded zero matches/results. Internet search found only Cryolife sells this product. Contacted vendor and they confirmed that Cryolife is the sole manufacturer, creator, distributor, and patent owner of BioGlue. They are the only authorized seller of the BioGlue line in the United States. Per Cryolife, there are no other authorized resellers or VOSB/SDVOSB vendors for this product. 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:___11/2/16________________ Name:___ ______________________________ Title:____ __________________________ NCO:_____23__________________________