Presentation on theme: "Navigating the 2012 Changes to CLSI M100, M02 and M07"— Presentation transcript:
1Navigating the 2012 Changes to CLSI M100, M02 and M07 Raymond P. Podzorski, Ph.D, D(ABMM)Clinical MicrobiologistProHealth Care LaboratoriesM100-S22May 10, 2012M07-A9M02-A11
2CLSIClinical and Laboratory Standards Institute (CLSI) is an international, interdisciplinary, nonprofit, standards developing, and educational organization that promotes the development and use of voluntary consensus standards and guidelines within the health care community.Center for Medicare & Medicaid Services (CMS) (via CLIA) incorporates many CLSI susceptibility standards and guidelines into their Regulations and Interpretive Guidelines for Laboratories and they can be found under Standard : Bacteriology
3All Updated in 2012M100 Performance Standards For Antimicrobial Susceptibility Testing – Updated at least Yearly (updated 2X in 2010)M02 Performance Standards for Antimicrobial Disk Susceptibility Tests (Ref. Method) – Updated every 3 yearsM07 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically (Ref. Method) – Updated every 3 years
4Major CLSI Changes in 2012 Enterobacteriaceae M100-S22 Revised breakpoints for ertapenemAdded ciprofloxacin breaks points for use with S. typhi and extraintestinalisolates of Salmonella spp.Pseudomonas aeruginosa M100-S22Revised breakpoints for piperacillin, piperacillin-tazobactam, ticarcillin,tarcarcillin-clavulanic acid, imipenem, and meropenemAdded breakpoints for doripenemStaphylococcus spp. M100-S22, M02-A11, and M07-A9Added penicillin disk zone edge test for β-lactamase production in S. aureus
5Why the Breakpoint δ?CLSI does a reassessment of interpretive criteria when new information concerning antimicrobial resistance becomes available.The CLIS breakpoints are revised to correspond to how particular antibiotics work in treating infections with today’s bacteria.
6Enterobacteriaceae Revised ertapenem breakpoints Added ciprofloxacin breakpoints foruse with S. typhi and extraintestinalisolates of Salmonella spp.
7Enterobacteriaceae Ertapenem CLSI Document MIC (µg/ml) Disk Diffusion (mm)SuscepIntResM100-S192009≤24≥8≥1916-18≤15M100-S202010M100-S20U≤0.250.5≥1≥2320-22≤19M100-S212011M100-S222012≤0.51≥2≥2219-21≤18
8Why did CLSI Revise Ertapenem Breakpoints Twice in 2 Years? The June 2010 Ertapenem breakpoints for Enterobacteriaceae were based primarily on PK/PD review, MIC distributions from limited clinical data with no MICs at 0.5 µg/mlSo a conservative ≤0.25 µg/ml cutoff for susceptibility was chosen for June 2010The January 2012 Ertapenem breakpoints for Enterobacteriaceae were based on further PK/PD review, additional MIC distributions from additional clinical data with MICs of 0.5 µg/ml not having carbapenemases, AND because the lowest concentration on some commercial panels is 0.5 µg/ml thus making it possible to use the 2012 CLSI Ertapenem breakpoint if they wanted to do the verification
9What About ESBL or Carbapenemase Screening and Confirmation? IF Using FDA BreakpointsIF Using CLSI BreakpointsNo ESBL Screen orCarbapenemase screenNeeded Report S/I/R ± MICIf requested for InfectionControl purposesScreen for ESBL orCarbapenemase -If PositivePerform ESBL or MHTConfirmationPerform ESBL or MHTScreen and ConfirmationConfirmation positive –Report M100-S19
11Enterobacteriaceae CLSI M100-S22 Extraintestinal isolates of Salmonella spp. and Salmonella typiNew ciprofloxacin breakpoints specific forextraintestinal Salmonella spp. and for all isolates ofSalmonella typhi
12Extraintes. Test FQ and NalA S. Typhi and extraintestinal Salmonella spp.Table 2A Enterobacteriaceae Ciprofloxacin and Levofloxacin BreakpointsAntibioticOld M100-S21Extraintes. Test FQ and NalANew M100-S22Extraintes. And S. typhiSuscep*Int*Res*SuscepIntResCipro1240.06Levo8-* µg/mlDisk diffusion breakpoints also revised
13Pseudomonas aeruginosa CLSI M100-S22Lowered breakpoints for piperacillin, ticarcillin, piperacillin-tazobactam, and ticarcillin-clavulanic acidLowered breakpoints for imipenem, and meripenemAdded breakpoints for doripenem
14Pseudomonas aeruginosa AntibioticM100-SM100-SSuscep*Int*Res*SuscepIntResPiperacillin≤64-≥128≤1632-64TicarcillinPip/Tazo≤64/4≥128/4≤16/432/4-64/4Ticar/Clav≤64/2≥128/2≤16/232/2-64/2* µg/mlDisk diffusion breakpoints also revised
15Pseudomonas aeruginosa AntibioticM100-SM100-SSuscep*Int*Res*SuscepIntResImipenem≤48≥16≤24≥8MeropenemDoripenem-* µg/mlDisk diffusion breakpoints also revised
17Breakpoint Facts Both the FDA and CLSI set breakpoints for USA Commercial AST systems (Vitek, Microscan, etc.)must use FDA breakpointsClinical Laboratories can use either FDA or CLSIbreakpointsOn commercial AST systems, the CLSIbreakpoints that differ from the FDA breakpointsmust be verified on the system prior to usingthem
18IMPORTANT POINT!Manufacturers of antimicrobial reagents and devices cannot change their device or system breakpoints for a specific antibiotic until the manufacturer of the antibiotic changes the breakpoints in the product insert at the direction of the FDA .
19Same for Etest Stripts CLSI 2012 R I S ≤19 20-22 ≥23 ≤17 18-20 ≥21 ≤ ≥23≤ ≥21≤ ≥22Same for Etest Stripts
22Reporting of Isolates Resistant to All Antibiotics Tested M100-S22, page 25-26Instructions for Use of Tables 1 and 2I. Selecting Antimicrobial Agents for Testing and ReportingD. Selective Reporting“….each laboratory should develop a protocol to address isolates that are confirmed as resistant to all agents on their routine test panels. This protocol should include options for testing additional agents in-house or sending the isolate to a reference laboratory.”CAP MIC.21944
23Urine - >100,000 cfu/ml, Proteus mirabilis, Severe UTI Antibiotic InterpretationAntibiotic InterpretationA/S RAK RAM RAUG RCAX RCFG RCP RCPE RCRM RETP RFD RGM RIMP RLVX RMER RP/T RTE RTIM RTO RConfirm antibiotic phenotypeHave a procedure in place to deal with this situationMIC Supplemental Antimicrobial Agents Phase IThere are protocols for testing supplemental agents on isolates resistant to routinely tested antimicrobial agents, as needed.NOTE: The protocol may include submission of isolates to an outside reference laboratory if testing is not performed onsite.
25Induced β-lactamase test Incubate at RTFor 1 hourMHABAP
26Penicillin disk “zone edge test” for β-lactamase production in S Penicillin disk “zone edge test” for β-lactamase production in S. aureusNegative for β-lactamase production“Fuzzy” zone edge (beach)Positive for β-lactamase production“sharp” zone edge (cliff)10 U penicillin disk and standard Kirby-Bauer disk diffusion methodQC: S. aureus ATCC positiveS. aureus ATCC negativeInduced Cefinase test – sensitivity 75%; specificity 100%Zone edge test – sensitivity 96%; specificity 100%
27S. aureus Penicillin Reporting S. aureus isolateDeterminePen MIC≥ 0.25PenResistant≤ 0.12Drop DisksFOX, E, CC, PD-test?Zone EdgeReport PenS/ROvernight Incubation
29Zone edge β–lactamase test ONLY for S. aureus that test Susceptible! Penicillin disk “zone edge test” for β-lactamase production in S. aureusNegative for β-lactamase production“Fuzzy” zone edge (beach)Positive for β-lactamase production“sharp” zone edge (cliff)Zone edge β–lactamase test ONLY for S. aureus that test Susceptible!
31M02-A11 and M07-A9 2012 Both Updated for 2012 M02 Performance Standards for Antimicrobial Disk Susceptibility Tests (Ref. Method) – Updated every 3 yearsM07 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically (Ref. Method) – Updated every 3 years
332012 M02-A11 and M07-A9 TECHNICAL UPDATES Reading Plates and Interpreting ResultsStaphylococcus spp. – Cefoxitin disk, read with reflected light- Oxacillin disk, read with transmitted lightVancomycin Resistance in S. aureusVan. Agar Screen – many VISA with MIC of 4 µg/ml will not growS. pneumoniae Zone Diameter Interpretive CriteriaS. pneumoniae isolates with oxacillin zones ≤19 mm, must performpenicillin MIC before reporting as resistantInducible Clindamycin ResistanceClarified testing method to include disk placement distance forStaphylococciβ–lactamase TestsMentions the Pen zone-edge test for β–lactamase testing of S. aureus
34CLSI Antimicrobial Susceptibility Testing (AST) Recommendations M02-A11, M07-A9, and M100-S22 Implementation ChecklistNA, not applicableNew CLSI Documents for ASTHaveWill ObtainNADocumentM100-S Performance standards for antibial susceptibility testing. Twenty-second informational supplement.M02-A Performance standards for antibial disk susceptibility tests. Eleventh edition. Approved Standard.M07-A Methods for dilution antibial susceptibility tests for bacteria that grow aerobically. Ninth edition. Approved Standard.Other CLSI Documents for ASTM11-A Methods for antibial susceptibility testing of anaerobic bacteria. Seventh edition. Approved Standard.M39-A Analysis and presentation of cumulative antibial susceptibility test data. Third edition. Approved Guideline.M45-A Methods for antibial dilution and disk susceptibility testing of infrequently isolated or fastidious bacteria. Second edition. Approved Guideline.
35Summary M100-S22, M02-A-11, and M07-A9 All Updated for 2012 M100-S22, More Breakpoint ChangesM100-S22, Reporting of Isolates Resistant to All Antibiotics TestedM100-S22, Pen zone-edge test for β-lactamase production by S. aureus