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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 Comm... 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 Page 1 of 9 Original Date: 08/30/17 Revision 03 Date: 02/11/2021 DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID: 36C252-21-AP-1531 Contracting Activity: Department of Veterans Affairs, VISN 12, Edward Hines Jr. VA Hospital Great Lakes Acquisition Center, 578-21-2-1905-0341 Nature and/or Description of the Action Being Processed: New firm-fixed price contract for Roche Diagnostic Corporation COVID-19 tests. (cobas SARS-CoV-2) Description of Supplies/Services Required to Meet the Agency s Needs: The government has an URGENT NEED for COVID-19 tests from Roche Diagnostic Corporation in the amount of $690,000. These tests are the only tests that are compatible with the Roche C6800 analyzers that are currently in use at the facility. The government currently purchases COVID tests available from all the major manufacturers. Each manufacturers tests are only compatible with that company s respective diagnostic instrument. These tests are for immeadiate delivery to VISN 12. This will be awarded as an emergency IAW FAR 13.106-1(b)(1)(i) urgency and FAR 18.104(procurement flexibilities-urgency) and FAR 18.203 (Emergency Declaration-COVID 19). Statutory Authority Permitting Other than Full and Open 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 (X) 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): Only One Responsible Source (FAR 6.302-1) The COVID tests provided by Roche Diagnostic Corporation (cobas SARS-CoV-2) are the only reagent tests that will work with the Roche Diagnostic c6800 recently purchased and currently in use at Hines. These reagents are not available from any other source except the manufacturer. Other tests currently available in the market are also in use in the facility. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: VISN 12 facilities use every type of reagent test available to identify COVID-19. The government purchases large quantities of most major brands. The VHA owns the Roche Cobas C6800 analyzers and these test are only available and operational on those proprietary units. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: This a commercial product and the government is paying the commercial price. Also, despite the extremely high demand for these items, the price for these tests has not changed significantly since the beginning of the pandemic. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The contractor confirmed these are the only tests compatible with our equipment, and they are the only source for this item. Although this was not submitted as an emergency, the urgent nature of the COVID 19 pandemic makes the need for these items urgent. Due to the high demand, limited supply, and proprietary nature of this procurement, no other market research was conducted. Any Other Facts Supporting the Use of Other than Full and Open Competition: The COVID 19 pandemic is an emergency, which makes the need for these items urgent. High demand and limited supply provide additional justification to award this item without competition. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: NA 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: The government will continue to purchase reagent tests from all manufacturers who provide them throughout the pandemic until demand for testing decreases sufficiently. 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. _____________________________ ________________________ Courtney Feldman Date Business Manager VISN 12 PALMS 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. _____________________________ ________________________ Farrukh Daniel Date Contracting Officer One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ David Picchi Date NCO 12 Supply Branch Chief