Department of Veteran Affairs Chillicothe VA Medical Center Covid testing, ePlex Respiratory Pathogen Panel 2

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 5: Request for Sole Source Justification Format >SAT OFOC SOP Revision 11 Page 1 of 9 Original Date: 03/22/11 Revision 11 Date: 02/11/2021 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C250-22-AP-1172 Contracting Activity Department of Veterans Affairs, VISN 10, Chillicothe VA Medical Center, Chillicothe, Ohio 45601. 2237: 538-22-2-775-0009. Nature and/or Description of the Action Being Processed: The Chillicothe VA Medical Center is requesting COVID19 reagents for the detection of respiratory viruses and a GenMark ePlex analyzer for direct patient care. Description of Supplies/Services Required to Meet the Agency s Needs: This requirement will be awarded as a new firm fixed priced contract for Proprietary Reagents from GenMark Diagnostics. This requirement must be procured for testing on the GenMark ePlex instrument currently in use at the Chillicothe VA Medical Center and needs to be in place by 01/01/2022. Statutory Authority Permitting Other than Full and Open Competition: ( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC 3304(a)(1) as implemented by FAR 6.302-1. (X) (2) Unusual and Compelling Urgency per 41 USC 3304(a)(2) as implemented by FAR 6.302-2. ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC 3304(a)(3) as implemented by FAR 6.302-3. ( ) (4) International Agreement per 41 USC 3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC 3304(a)(5) as implemented by FAR 6.302-5; ( ) (6) National Security per 41 USC 3304(a)(6) as implemented by FAR 6.302-6; ( ) (7) Public Interest per 41 USC 3304(a)(7) as implemented by FAR 6.302-7; Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Chillicothe VA Medical Center previously obtained the GenMark ePlex, a proprietary vendor. This system analyzes RNA using PCR methodology. Testing can be completed in under 2 hours providing clinicians the information required to move forward with treatment. The 65746 SARS-COV-2 PANEL are the only compatible reagents that are required to complete the required testing. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Special notice posted to Contract Opportunities/SAM. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Unusual and Compelling Urgency per 41 USC 3304(a)(2) as implemented by FAR 6.302-2 Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Special notice posted for additional vendors who could provide GenMark Reagents for the Chillicothe VA Medical Center. Any Other Facts Supporting the Use of Other than Full and Open Competition: n/a Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: n/a 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: I will continue to survey the market for available vendors. 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. _____________________________ ________________________ Name Cassandra Smith Date Title Lab Information Manager Facility Chillicothe VA Med Center 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. _____________________________ ________________________ Name Gina Crank Date Title Contracting Officer Facility Louis Stokes Cleveland VA Med Center 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. _____________________________ ________________________ Name Adam Weber Supply 1 Branch Chief, NCO10 Date Facility Louis Stokes Cleveland VA Med Center