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VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT 512-4-20-4-874-0382, BioFire FilmArray Torch Respiratory and COVID Dete... VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT 512-4-20-4-874-0382, BioFire FilmArray Torch Respiratory and COVID Detection Laboratory Equipment OFOC SOP Revision 09 Page 1 of 9 Original Date: 03/22/11 Revision 09 Date: 04/17/2020 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C245-20-AP-2375 Contracting Activity: Department of Veterans Affairs, Regional Contract Office-East, Network Contracting Office 5 (NCO), 849 International Drive, Linthicum, MD. 21090. This is for the Department of Veterans Affairs, VISN 05 Capitol Health Care Network, V05 Biomedical Engineer, 849 International Drive, Suite 275, Linthicum, MD. 21090 for multiple VA Medical Centers. The 2237 is funded for $1,504.00.00. Nature and/or Description of the Action Being Processed: This is going to be a purchase order for Firm Fixed Price with BioFire Diagnostics, LLC for the BioFire FilmArray Torch equipment with Respiratory Panel EZ provides respiratory and Coronavirus (COVID) detection laboratory equipment. BioFire FilmArray Torch System is used for syndromic infections disease diagnostics. The total estimated cost for equipment is $1,504,000.00. BioFire FilmArray Torch equipment gives laboratories and healthcare providers the ability of identifying pathogens associated with infectious disease during this critical time in testing and diagnosing those positive for COVID. This requirement is being driven by the current pandemic. BioFire Diagnostics, LLC is the manufacturer of the BioFire FilmArray Panels and Respiratory Panel EZ laboratory detection equipment. The BioFire FilmArray Torch is the latest advancement in molecular infectious disease diagnostics. The high throughput BioFire Torch is a fully integrated, random access system designed to meet laboratory s syndromic infectious disease testing needs. The BioFire Torch is compatible with all FilmArray panels and provides the quickest, most comprehensive, and accurate results. A newly FDA EUA-approved testing kit includes testing for respiratory pathogens and COVID with one sample. Currently two samples are run on separate analyzers. Description of Supplies/Services Required to Meet the Agency s Needs: This requirement is for the purchase of 5 Lab Virus Detection systems for use at the VISN 5 facilities to test for COVID-19 and respiratory pathogens at the simultaneously during the national pandemic. A summary of the equipment needed is as follows: FILMARRAY TORCH SYSTEM BASE BOX qty 5 FILMARRAY TORCH MODULE BOX qty 66 FILMARRAY TORCH DUPLEX MODULE BOX qty 23 BIOFIRE TORCH BASE MFG WARRANTY qty 5 BIOFIRE TORCH MFG WARRANTY qty 66 Estimated total cost: $1,504,000.00 FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for the BioFire FilmArray Torch virus detection system, 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. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(2), as implemented b FAR 6.302-1 (X ) (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; ( ) (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; FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2). Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): BioFire Diagnosis, LLC is the only source that allows for the detection of all three parasite, bacteria and viruses. Additionally, Biofire has an FDA EUA-approved kit that will run respiratory pathogens and COVID at the same time. Currently Biofire is the only manufacturer with this capability. VISN 05 has one of these units at the VA Maryland Healthcare System. Implementation and training will be streamlined. Biofire Torch System is the only product that needs 2 minutes of hands-on time to run the test, and is the only product to be completed the test in one hour. During a run, the BioFire FilmArray System extracts and purifies all nucleic acids from the unprocessed sample. Then performs a nested multiplex PCR. During the first stage, the system performs a single, large volume, multiplexed reaction. Individual, single-plex second-stage PCR reactions detect the products from the first-stage PCR. Using endpoint melting curve data, the BioFire FilmArray software automatically analyzes the result for each target. When the run is complete, the software reports whether or not each pathogen is detected in the sample. This information is printed in an automated response at the end of the test run. Biofire manufactures and distributes the Torch system. All equipment, reagents, and supplies are exclusively sold through Biofire (a subsidiary of Biomerieux). Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market Research was conducted commiserate with the urgency of the requirement was conducted on GSA Advantage, the National Acquisition Center (NAC) Veterans Enterprise Portal (VIP). Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost to the government is considered fair and reasonable the pricing didn t change from the previous purchase order 35C24520P0423. The quote provided by BioFire Diagnostics, LLC, quote 13584 pricing remains the same as discounted pricing for previous order. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Searches of GSA Advantage and NAC indicated that the equipment, BioFire FilmArray Torch, is not on contract (open market). There were no contracts on GSA Advantage under schedules 65 VII Invitro Diagnostics, Reagents, Test Kits and Test Sets, Category 555-6 Microbiology that could provide rapid respiratory and COVID testing simultaneously. A VIP search using Invitro Diagnostics and NAICS code shows there is a combination of sixteen SDVOSB and VOSB vendors that provide medical equipment and supplies, there are none that provide COVID testing lab equipment. Any Other Facts Supporting the Use of Other than Full and Open Competition: BioFire Diagnostics, LLC provided a proprietary letter, stating that they do not sell OEM rapid respiratory and COVID laboratory equipment (with software) and test kits through distributors. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: BioFire Diagnostics, LLC, 515 Colorow Drive, Salt Lake City, UT 84108 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: Market Research will continue to be conducted. 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. XXXXXXXXXXXXXXRedacted ________________________ Angela Mulinix Date Biomedical Engineer VISN 5 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. _ XXXXXXXXXXXXXXRedacted ________________________ Veronica B. Dillard Date Contracting Officer SAO-East, NCO 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. XXXXXXXXXXXXXXRedacted ________________________ Amy Ritchey Date DC Services and 101 Central Office Branch Chief NCO 5 VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition. XXXXXXXXXXXXXXRedacted ________________________ Scott Sands Date NCO 5, Director of Contracting VHA Senior Procurement Executive Approval (over $68 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition. XXXXXXXXXXXXXXRedacted ________________________ Joseph P. Maletta Date Executive Director VHA Regional Procurement Officer East