65--Bone Cement Stryker Orthopaedics Bone Cement for Minneapolis Surgical Stryker Orthopaedics 618A60102 618-16-1-029-1035 Stryker Bone Cement OR MPLS

JUSTIFICATION FOR SINGLE SOURCE AWARDS IAW FAR 13.106-1 (OVER MICRO-PURCHASE THRESHOLD($3K) 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. PURCHASE REQUEST OR REQUISITION NUMBER: 618-16-1-029-1035 1A. PROJECT/TASK NUMBER 1B. ESTIMATED AMOUNT: $55,408.33 2. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE: An estimated year supply of Stryker Orthopaedics bone cement and bone cement w/antibiotic. 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 only known provider of this type of cement. The only other source of bone cement is made by Zimmer called Palacos R which is available on the FSS schedule. Palacos is designed to provide excellent fatigue strength in harder bone, but does not provide enough penetration into porous bones to help stabilize the surgical site. VA Clinicians have determined that both of the Simplex bone cement and the Palacos bone cements are needed to be in stock at the Minneapolis VA because they have no way of knowing which will product is needed for the best patient outcome until surgery is underway. 4. REASON THAT SUGGESTED SOURCE IS THE ONLY SOURCE, WHICH CAN PROVIDE THE SUPPLIES OR SERVICES: Stryker Simplex is the only known supplier of a variable viscosity bone cement that demonstrates better penetration of cancellous bones. 5. 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 Orthopaedics 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. 6. 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. Signature: ______________________________ Date:____________________ Name:__________________________________ Title:___________________________________ Facility:_________________________________