Proficiency Testing Materials for use with BioFire FilmArray Panels
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1 Proficiency Materials for use with BioFire FilmArray Panels Introduction This document provides a listing of proficiency testing materials that have been tested at BioFire and are compatible with the BioFire Panels indicated. All proficiency testing programs listed are monitored at BioFire. The information in this document is meant to be a guideline and may not be inclusive. Resources The laboratory director is responsible for determining the appropriate proficiency tests for each laboratory. Proficiency testing (PT) requirements can be complicated and are based upon the analytes tested, methods utilized and specialty/subspecialty categories pertaining to the CLIA certification of the individual laboratory. Therefore, the College of American Pathologists () has delegated advisors to assist with defining the appropriate PT programs required for Clinical Laboratory Implementation Act (CLIA) compliance if using BioFire Panels. recommends that the each laboratory contact them directly to ensure they are compliant with current CLIA and regulations. The best way to ensure compliance is to develop your proficiency testing plan in coordination with CLIA or or the regulatory body governing your laboratory. CLIA Brochure #8 PROFICIENCY TESTING CLIA Facts #6 PROFICIENCY TESTING INFORMATION American Proficiency Institute () Website: Phone: (M-F 8:00 AM 5:00 PM ET) Catalog: College of American Pathologists () Phone: (M-F 7:00 AM - 5:0 PM CT) Proficiency Catalog: %6_adf.ctrl-state%D7xz7d7cz_5 1 P a g e FLM1-PRT-05-0
2 Proficiency Manual: Folders/WebContent/pdf/pt-manual.pdf Wisconsin State Lab of Hygiene (WSLH) Phone: (M-F 8:00 AM to 4:0 PM (CT) Proficiency Monitoring Guide 019 Table 1. Proficiency Materials for BioFire BCID Panel Blood Pathogen Panel for Gram Positive Blood Gram Negative Blood 68 GPBC GNBC Blood Culture BCS BioFire FilmArray Blood Culture Identification (BCID) Panel Blood Culture, Staphylococcus aureus BCS1 WSLH Blood Culture Multiplex PT0560 BioFire FilmArray Blood Culture Identification (BCID) Panel BioFire BCID Coverage Gram positive organisms on BioFire BCID Gram negative organisms on BioFire BCID N/A- Graded by blood culture method S. aureus only Identification of bacteria and yeast in Blood Culture for inoculation of blood culture bottles for inoculation of blood culture bottles No coverage of yeasts on panel No coverage of yeasts on panel Challenges growth in blood culture; graded by blood culture method Challenges growth in blood culture P a g e FLM1-PRT-05-0
3 Table. Proficiency Materials for BioFire GI Panel BioFire FilmArray Gastrointestinal (GI) Panel Gastrointestinal Panel for Gastrointestinal Panel for 69 GIP5 Stool Pathogen SP BioFire GI Coverage Adenovirus 40/41, C. difficile, Rotavirus, Shiga toxin Stool Pathogen-1 SP-1 Norovirus only WSLH GI Multiplex PT0580 BioFire FilmArray Gastrointestinal (GI) Panel stool stool x 1.0 ml simulated stool 1 x 1.0 ml simulated stool stool BioFire FilmArray Meningitis/Encephalitis (ME) Panel Table. Proficiency Materials for BioFire ME Panel ME Panel for Molecular Multiplex Users ME Panel for Molecular Multiplex Users Nucleic Acid Amplification, Viruses BioFire FilmArray Meningitis/Encephalitis (ME) Panel 71 IDME ID1 BioFire ME Coverage CMV, Enterovirus, HSV1, HSV, HHV-6, Varicellazoster Virus CNS CNS 8 x 1.0 ml liquid P a g e FLM1-PRT-05-0
4 BioFire FilmArray Respiratory Panels (Including Respiratory Panel (RP), Respiratory Panel (RP) EZ, and Respiratory Panel (RP)) Note: The Manufacturer Master List only provides codes for BioFire (RP and RP) and BioFire waived (RP EZ) methods. There is no visibility with on whether RP or RP panels were used. Table 4. Proficiency Materials for BioFire RP, BioFire RP and BioFire RP EZ BioFire FilmArray Respiratory Panel (RP), Respiratory Panel (RP) and Respiratory Panel (RP) EZ Infectious Disease 70 IDR WSLH Respiratory Multiplex PT0640 BioFire RP and RP EZ Coverage 4 P a g e FLM1-PRT-05-0
5 Table 5. Proficiency Materials for BioFire Pneumonia Panel BioFire FilmArray Pneumonia Panel Pneumonia Panel for users users Blood Pathogen Panel for Infectious Disease Gram Positive Blood Gram Negative Blood BioFire FilmArray Pneumonia Panel TBD IDR GPBC GNBC BioFire Pneumonia Coverage Covers viruses and atypical bacteria bacteria on Pneumonia Panel A. baumannii, Enterobacter sp, E. cloacea complex, E. coli, H. influenzae, Klebsiella oxytoca, K. pneumoniae,proteus sp, P. aeruginosa, S. marscens, S. aureus, S. pneumoniae, S. pyogenes, meca, KPC, CTX-M, IMP, NDM, OXA, VIM Covers viruses and atypical bacteria bacteria on Pneumonia Panel S. aureus, S. pneumoniae, S. pyogenes A. baumanni, E. cloacea complex, E. coli, H. influenzae, Klebsiella oxytoca, K. pneumoniae,proteus sp, P. aeruginosa, S. marscens x 1.0 ml liquid Note: The Pneumonia Panel will be available for shipments in 019, starting with the nd Microbiology event. Three shipments per will occur in subsequent s. * 5 P a g e FLM1-PRT-05-0
6 Technical Support Contact Information BioFire is dedicated to providing the best customer support available. If you have any questions or concerns about this process, please contact the BioFire Technical Support team for assistance. BioFire Technical Support Phone: , select Option 5 6 P a g e FLM1-PRT-05-0
Proficiency Testing Materials for use with FilmArray Panels
Proficiency Testing Materials for use with FilmArray Panels Introduction This document provides a listing of proficiency testing materials that have been tested at BioFire and are compatible with the FilmArray
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