65--Stryker Simplex Surgical Bone Cement - MPLS OR Department

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 2 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. 1. ACQUISITION PLAN ACTION ID: 618-17-1-029-0071 1A. PROJECT/TASK No. NONE 1B. ESTIMATED AMOUNT: $69,275.32 2. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE: Firm Fixed Price Sole Source Purchase Order for a one year supply of Stryker Orthopedics bone cement and bone cement w/antibiotic, 26 packages of HOWMEDICA 6191-1-010, 10 boxes of HV-Full Dose 6194-1-010, and 10 boxes of HOWMEDICA 6197-9-010. The Minneapolis VA does a large number of procedures that use various types of bone cement and the Simplex bone cements are specifically designed to penetrate into the pores of (porous) cancellous bones to achieve better bonding in joint replacement surgeries. The bone cement w/antibiotic is needed for reduction of risk for surgical site infection in specific orthopedic patient populations. The Simplex bone cement has proven to adequately penetrate the bone in patients that need the extra support. 3. UNIQUE CHARACTERISTICS THAT LIMIT AVAILABILITY TO ONLY ONE SOURCE, WITH THE REASON NO OTHER SUPPLIES OR SERVICES CAN BE USED: Stryker Orthopedics is the Original Equipment Manufacturer of this item. This bone cement is necessary for joint replacement surgery. The bone cement w/antibiotic is needed for reduction of risk for surgical site infection in specific orthopedic patient populations. This bone cement has proven to adequately penetrate the bone. There are two available products Stryker and Zimmer; VA Clinicians have determined that both are required to be on hand so they can choose the cement that offers the best outcome for the patient. Stryker Simplex is the only known supplier of variable viscosity bone cement that demonstrates better penetration of cancellous bones. Stryker Inc. is the manufacturer and sole distributer of this product and does not have authorized resellers. 4. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND RESULTS OR STATEMENT WHY IT WAS NOT CONDUCTED: Market Research included internet searches, SAM was checked for registration status and the FSS Schedule 65 was checked for comparable products. Market research efforts showed there are only two suppliers found that carried bone cement, Stryker Orthopedics and Zimmer Medical. Each company manufacturers their cement for use with different types of bone densities and have been found to provide different surgical results depending on the patient. The VA Clinicians have requested that both types of cement be stocked for the Minneapolis Surgical Center so they have a choice of the product that is best suited to the patient s needs for a more likely positive outcome. For the Stryker cement, GSA searched produced zero vendors for bone cement. VETBIZ searches under, orthopedics, bone cement, and Stryker produced zero vendors. VETBIZ search under Bone produced 19 vendors from which one vendor stated they could provide the bone cement. Stryker Inc stated there are no authorized resellers of their bone cement including no VOSB/SDVOSB vendors so the VETBIZ quote is suspect. 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:_________________________________