65--BioFire FilmArray Microbe Detection System

Chapter VI: Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Limited Sources Justification Format >$150K OFOC SOP Revision 05 Page 1 of 4 Original Date: 03/22/11 Revision 05 Date: 05/02/2016 LIMITED SOURCES JUSTIFICATION ORDER >$150,000 FAR PART 8.405-6 Acquisition Plan Action ID:_VA256-17-AP-0452____________________ (INSERT) This acquisition is conducted under the authority of the Multiple Award Schedule Program. The material or service listed in par. 3 below is sole source, therefore, consideration of the number of contractors required by FAR Subpart 8.4 Federal Supply Schedules, is precluded for the reasons indicated below. Restricted to the following source: Provide original manufacturer s name for material or contractor s name for service. (If a sole source manufacturer distributes via dealers, ALSO provide dealer information.) Manufacturer/Contractor: BioFire Diagnostics, LLC Manufacturer/Contractor POC & phone number: Mfgr/Contractor Address: 390 Wakara Way, Salt Lake City, UT 84106 Dealer/Rep address/phone number: x The requested material or service represents the minimum requirements of the Government. (1) AGENCY AND CONTRACTING ACTIVITY: Department of Veterans Affairs Overton Brooks VA Medical Center____ 510 East Stoner Avenue___________ Shreveport LA 71101 VISN: 16 (2) NATURE AND/OR DESCRIPTION OF ACTION BEING APPROVED: Acquisition of the Brand name - FilmArray (BioFire Diagnostics, LLC) automated multiplex polymerase chain reaction (PCR) system which integrates sample preparation, nucleic acid amplification, detection, and analysis into one walk-away testing platform capable of performing separate assay panels for multiple pathogenic organism targets. Those targets include bacteria, viruses, fungi, and parasites, for gastrointestinal, respiratory, blood culture, and meningitis specimen types. The requirement is available on V797D-30085. (a) A DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY S NEED: Complete FilmArray System package including a testing module, a Windows-based computer and analysis software and other included peripheral items as part of the start-up package. Cases of test kits (20 test panels/kit) per year as follows: Gastrointestinal (GI) 18; Respiratory 12; Blood Culture (BCID) 6; Meningitis (ME) 3. Test system must be FDA-approved and contain PCR methodology, a single test, 1-hour turn around and an array (22) of common potential pathogen targets for gastrointestinal specimens to include bacteria, viruses, and parasites. Multiple (20) respiratory pathogen targets including both viruses and bacteria. Blood culture targets (27) including both Gram-positive and Gram-negative bacteria, yeast, and detection of the presence of several major antibiotic resistance genes. A meningitis/encephalitis panel with detection capability of at least 16 potential pathogen targets including bacteria, viruses, and yeast species. The Brand - FilmArray System from BioFire Diagnostics, LLC is the only FDA-approved system that possesses multiplex PCR technology in a single test format with a 1-hour turn- around time to final result with multiple targets tailored to each specimen type. (b) ESTIMATED DOLLAR VALUE: Estimated Value: $342,906.90 Base Year: $139,829.94, Option 1: $101,538.48, Option 2: $101,538.48 (c) REQUIRED DELIVERY DATE: ASAP (4) IDENTIFICATION OF THE JUSTIFICATION RATIONALE (SEE FAR 8.405-6), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE. (CHECK ALL THAT APPLY AND COMPLETE) x Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources. Brand name justification - FilmArray The FilmArray System package including a testing module is the only equipment that has the capability to work with test panels that include gastrointestinal panel more comprehensive than competitors (Nanosphere). Nanosphere does not include parasites. The blood culture panel is the most comprehensive one in a single test including Gram negative and Gram positive bacteria and yeast. Competitor (Nanosphere and Luminix) do not offer yeast identification and different panels are required to use after determining whether a Gram positive or Gram negative panel is required following microscopy and observation of a Gram stain. This procedure adds at least another hour to the testing process. In addition Polymicrobial infections could be missed using this system with these requirements. The meningitis panel is the only complete panel that is FDA-approved for spinal fluid and is only tested by FilmArray system. Nanosphere and Luminix would have to have a separate test done which would take at least an hour of additional preparation and testing. No other system can provide all the tests to include meningitis test that FilmArray system can do. In order to receive the tests not provided in the single process, the lab would have to conduct additional test, which would take additional resources of personnel and time. Furthermore, any delay on getting the results back in the shortest time may negatively impact the well-being of patients and their treatment. The sooner physicians know the test results, the sooner they can start patient treatment and prescribe medication that will help them feel better. A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.) These are direct replacements parts/components for existing equipment. ____________________________________________________________________________ ____________________________________________________________________________ The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system. The new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays. (5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.4 TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: The requirement is on the VA FSS contract V797D-30085. Price has been determined to be fair and reasonable. (6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED: See above for competitor shortcomings versus the BioFire FilmArray. (7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: NA (8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE: The FilmArray System currently is in use at other VISN 16 facility laboratories. Lab personnel and contracting will do market research on every new requirement for this testing to determine if the market has changed and any other testing equipment can provide as efficient testing or better in the future. Furthermore contracting will continue to determine if any SDVOSB contractor is capable to provide this requirement in the future. (9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor s supervisor, fund control point official, chief of service or someone with responsibility and accountability.) SIGNATURE DATE NAME TITLE SERVICE LINE/SECTION FACILITY (10) APPROVALS IN ACCORDANCE WITH THE VHAPM, Volume 6, Chapter VI: OFOC SOP: a. CONTRACTING OFFICER S CERTIFICATION (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. CONTRACTING OFFICER/DESIGNEE S SIGNATURE DATE ______________________________ NAME AND TITLE FACILITY b. Branch Chief review and approval: