VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5 PM Part 813.5 SAP for Certain Commercial Items Original Date: 08/30/17 Revision 03 Date: 02/11/2021 Page of 3 DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID: 36C260-22-AP-0742 Contracting Activity: Department of Veterans Affairs, VISN 20, Puget Sound VA Medical Center 1660 So. Columbian Way, Seattle, WA, 98108, Building 100, Room 2D196b. PR 663-22-3-062-0024. Nature and/or Description of the Action Being Processed: This procurement is for procurement of TheraSphere for the treatment of Hepetocellular Carcinoma (HCC). This is not a request for contract services. This is for the purchase of goods a therapeutic radioactive drug which will be ordered on a case-by-case basis in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This will be a firm fixed price bulk order contract. This request is for a bulk purchase for 40 bottles of Y90 at $17,300.00 each for a total of $692,000.00 and the period of performance will be 04/01/2022-03/31/2023. Description of Supplies/Services Required to Meet the Agency s Needs: Yttrium-90 is used in radiation therapy to treat certain forms of cancer. TheraSphere is a radiation treatment for people who have a specific type of liver cancer called unresectable hepatocellular carcinoma (HCC). TheraSphere consists of millions of microscopic glass spheres containing yttrium-90. In Y-90 radiotherapy, millions of tiny radioactive beads are injected directly into the arteries that supply blood to the tumor. These beads will stay in the blood vessels around your tumor(s). This allows very strong radiation to reach the tumors directly. Statutory Authority Permitting Restricted Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below: ( x ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): TheraSphere is the only FDA approved Y-90 radio embolization isotope approved to treat unresectable HCC in the United States. TheraSphere Yttrium-90 (Y90) Glass Microspheres are manufactured, sold & distributed exclusively by Biocompatibles UK Ltd, an affiliate of Boston Scientific. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: TheraSphere is the only FDA approved Y-90 radio embolization isotope approved to treat unresectable HCC in the United States. TheraSphere Yttrium-90 (Y90) Glass Microspheres are manufactured, sold & distributed exclusively by Biocompatibles UK Ltd, an affiliate of Boston Scientific. Market research was conducted using NAICS 325412. There were 90 SDVOSB & 6 VOSB vendors with that NAICS registered in VIP. There were 5 SDVOSB vendors with that NAICS registered with the SBA. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Fair and Reasonable price will be determined through an Independent Government Cost Estimate and Historical Pricing that has been paid by the Puget Sound VA Medical Center for this class of drugs. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Even though there were 90 SDVOSB & 6 VOSB vendors registered in VIP with NAICS 325412 this product is manufactured, sold & distributed exclusively by Biocompatibles UK Ltd, an affiliate of Boston Scientific. Biocompatibles UK Ltd is considered a sole source provider for TheraSphere. Any Other Facts Supporting the Use of Other than Full and Open Competition: Even though there were 90 SDVOSB & 6 VOSB vendors registered in VIP with NAICS 325412 this product is manufactured, sold & distributed exclusively by Biocompatibles UK Ltd, an affiliate of Boston Scientific. Biocompatibles UK Ltd is considered a sole source provider for TheraSphere. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Boston Scientific Corporation. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: None Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. Mario M Ramos 3369778 Digitally signed by Mario M Ramos 3369778 Date: 2022.02.28 13:14:54 -08'00' 2/28/2022 Mario Ramos Date Administrative Officer, DIS VA Puget Sound HCS Puget Sound HCS Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Digitally signed by KRYSTAL K. WEEKS 414521 Date: 2022.03.11 15:09:27 -08'00' 3/11/2022 Krystal Weeks Date Contracting Officer NCO 20 Contracting Office JOFOC TRACKER NUMBER 2022-03-02T06:53:25 One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. Brian M. Corey 258998 Digitally signed by Brian M. Corey 258998 Date: 2022.03.14 09:05:16 -06'00' Brian Corey Date NCO 20 Division 1 Chief NCO 20 Contracting Office
