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VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT VHAPM Part 813.106 Page 1 of 1 Original Date: 08/3... VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT VHAPM Part 813.106 Page 1 of 1 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020 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) Acquisition Plan Action ID: 36C246-20-AP-4506 Contracting Activity: Department of Veterans Affairs, VISN 06, Durham VA Medical Center NCO 6, PR # 558-20-4-086-0446. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Estimated Amount $118,724.00 Durham VAMC has an urgent and compelling need to expand their testing capabilities due a significant rise in COVID-19 testing. Currently Durham VAMC is the sole Medical Center for COVID-19 testing for VISN 6. The NUCLISENS easyMAG is an IVD labeled automated system for total nucleic acid extraction. It is specifically optimized total nucleic acid extraction from biological samples. The system automates and allows a flexible workflow and efficient operation. The system uses easyMAG extraction reagents, magnetic silica and lysis buffer. The system incorporates thorough sample and reagent traceability. The system automates and allows a flexible workflow and efficient operation. This system is intended for use as the extraction instrument for COVID PCR testing for the Argene assay, to urgently expand our current SARS-CoV-2 test capabilities. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The system uses easyMAG extraction reagents, magnetic silica and lysis buffer. The system incorporates thorough sample and reagent traceability. This system is FDA EUA approved for SARS-CoV-2 PCR extraction, it uses easyMAG reagents, easyMAG magnetic silica, easyMAG disposables, easyMAG lysis buffer, easyMAG wash buffers 1,2,3. and Biohit pipette tips. Biomerieux is able to provide the two systems requested in an expedited time frame that works for the facility. Due to the urgent need and global demand for COVID-19 testing systems Biomerieux is in a unique position to fulfill the Durham VAMC needs and is the only source able to do so. Description of market research conducted and results or statement why it was not conducted: VIP was searched using NAICS code 334516 and Keyword search Nuclisens Easymag. The search yielded 0 potential SDVOSB and VOSB vendors. Correspondence was exchanged with owner of product Biomerieux to see if they had any SD/VOSB or small business partnerships to procure through. Biomerieux replied they are the sole providers of this system and provided me with a sole source letter. ECAT, Mandatory Source Listing/SAC website, NAC MedSurg Catalog, and GSA Advantage were searched and found no contracts in place for the requested product. Biomerieux the manufacturer provided a sole source letter, and have stated through correspondence that they do not have any small business partnerships for the requested product. 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. ____________________________ ________________________ Isaac Hernandez Keeshia Newman Contract Specialist Branch Chief-Supervisor