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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) Contracting Activity: Department of Veterans ... 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) Contracting Activity: Department of Veterans Affairs, VISN 17, 549- North Texas Medical Center. 2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This contract is for the purchase of Sie-Spheres Y90 Resign microspheres. This product is required to ensure that Nuclear Medicine has Y-90 micropheres available for Selective Internal Radiation Therapy (SIRT) for patients with liver tumors. Esitmated annual usage is 5 unit doses at $17,750, per dose. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: 3. Sirtex Medical is the sole provider of SIR-Spheres microspheres due to proprietary purposes. The SIRT procedure enables high doses of radiation to be targeted to liver tumors by using the tumor's blood supply. Healthy liver tissue derives up to 90% of its blood supply from the portal vein with only a small amount of the blood supply being derived from the hepatic artery. In contrast, liver tumors derive up to 90% of their blood supply from the hepatic artery since they need a profuse supply of highly oxygenated blood. The hepatic artery therefore provides an ideal channel to deliver targeted treatment to the tumor. SIR-Spheres® Y-90 resin microspheres consist of biocompatible polymer resin microspheres of a median diameter of 32.5 microns (range between 20 and 60 microns) loaded with yttrium-90 (beta radiation penetrating an average of 2.5 mm in tissue to destroy tumor cells). The resin microspheres are small enough to become lodged in the arterioles within the growing rim of the tumor but are too large to pass through the capillaries and into the venous system. Since yttrium-90 has a half-life of 64.1 hours, most of the radiation (94%) is delivered to the tumor over 11 days. 4. Description of market research conducted and results or statement why it was not conducted: Market reach was conducted in accordance with FAR Part 10. A search in VIP was conducted using NAICS Code 325412 and keyword “Radiopharmaceutical” and resulted in 1 SDVOSB vendor. A search in FPDS resulted in multiple purchases using Purchase Orders and IDIQ’s. The last contract awarded to SIRTex Medical, INC., by NCO17 was in 2022, in the amount of $71,000.00. 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. Prepared By: Robert M Clark Jr Contracting Specialist For: Jeffery Crysler Contracting Officer