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Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement PDF

230 Pages·2014·2.57 MB·English
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January 2014 M100-S24 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. An informational supplement for global application developed through the Clinical and Laboratory Standards Institute consensus process. Clinical and Laboratory Standards Institute Setting the standard for quality in clinical laboratory testing around the world. The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. Consensus Process Consensus—the substantial agreement by materially affected, competent, and interested parties—is core to the development of all CLSI documents. It does not always connote unanimous agreement, but does mean that the participants in the development of a consensus document have considered and resolved all relevant objections and accept the resulting agreement. Commenting on Documents CLSI documents undergo periodic evaluation and modification to keep pace with advancements in technologies, procedures, methods, and protocols affecting the laboratory or health care. CLSI’s consensus process depends on experts who volunteer to serve as contributing authors and/or as participants in the reviewing and commenting process. At the end of each comment period, the committee that developed the document is obligated to review all comments, respond in writing to all substantive comments, and revise the draft document as appropriate. Comments on published CLSI documents are equally essential, and may be submitted by anyone, at any time, on any document. All comments are addressed according to the consensus process by a committee of experts. Appeals Process If it is believed that an objection has not been adequately addressed, the process for appeals is documented in the CLSI Standards Development Policies and Process document. All comments and responses submitted on draft and published documents are retained on file at CLSI and are available upon request. Get Involved—Volunteer! Do you use CLSI documents in your workplace? Do you see room for improvement? Would you like to get involved in the revision process? Or maybe you see a need to develop a new document for an emerging technology? CLSI wants to hear from you. We are always looking for volunteers. By donating your time and talents to improve the standards that affect your own work, you will play an active role in improving public health across the globe. For further information on committee participation or to submit comments, contact CLSI. Clinical and Laboratory Standards Institute 950 West Valley Road, Suite 2500 Wayne, PA 19087 USA P: 610.688.0100 F: 610.688.0700 www.clsi.org [email protected] Vol. 34 No. 1 M100-S24 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement Abstract The supplemental information presented in this document is intended for use with the antimicrobial susceptibility testing procedures published in the following Clinical and Laboratory Standards Institute (CLSI)–approved standards: M02-A11—Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Eleventh Edition; M07-A9—Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Ninth Edition; and M11-A8—Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard— Eighth Edition. The standards contain information about both disk (M02) and dilution (M07 and M11) test procedures for aerobic and anaerobic bacteria. Clinicians depend heavily on information from the clinical microbiology laboratory for treatment of their seriously ill patients. The clinical importance of antimicrobial susceptibility test results requires that these tests be performed under optimal conditions and that laboratories have the capability to provide results for the newest antimicrobial agents. The tabular information presented here represents the most current information for drug selection, interpretation, and QC using the procedures standardized in the most current editions of M02, M07, and M11. Users should replace the tables published earlier with these new tables. (Changes in the tables since the most current edition appear in boldface type.) Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement. CLSI document M100-S24 (ISBN 1-56238-897-5 [Print]; ISBN 1-56238-898-3 [Electronic]). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2014. The data in the interpretive tables in this supplement are valid only if the methodologies in M02-A11—Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Eleventh Edition; M07-A9—Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Ninth Edition; and M11-A8—Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard— Eighth Edition are followed. 1 Thisdocumentisprotectedbycopyright. PublishedOn1/1/2014. January 2014 M100-S24 2 Thisdocumentisprotectedbycopyright. PublishedOn1/1/2014. ISBN 1-56238-897-5 (Print) M100-S24 ISBN 1-56238-898-3 (Electronic) Vol. 34 No. 1 ISSN 1558-6502 (Print) Replaces M100-S23 ISSN 2162-2914 (Electronic) Vol. 33No. 1 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement Volume 34 Number 1 Jean B. Patel, PhD, D(ABMM) Franklin R. Cockerill III, MD Jeff Alder, PhD Patricia A. Bradford, PhD George M. Eliopoulos, MD Dwight J. Hardy, PhD Janet A. Hindler, MCLS, MT(ASCP) Stephen G. Jenkins, PhD, D(ABMM), F(AAM) James S. Lewis II, PharmD Linda A. Miller, PhD Mair Powell, MD, FRCP, FRCPath Jana M. Swenson, MMSc Maria M. Traczewski, BS, MT(ASCP) John D. Turnidge, MD Melvin P. Weinstein, MD Barbara L. Zimmer, PhD January 2014 M100-S24 Copyright ©2014 Clinical and Laboratory Standards Institute. Except as stated below, any reproduction of content from a CLSI copyrighted standard, guideline, companion product, or other material requires express written consent from CLSI. All rights reserved. Interested parties may send permission requests to [email protected]. CLSI hereby grants permission to each individual member or purchaser to make a single reproduction of this publication for use in its laboratory procedure manual at a single site. To request permission to use this publication in any other manner, e-mail [email protected]. Suggested Citation CLSI. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement. CLSI document M100-S24. Wayne, PA: Clinical and Laboratory Standards Institute; 2014. Twenty-Fourth Informational Supplement Sixteenth Informational Supplement January 2014 January 2006 Twenty-Third Informational Supplement Fifteenth Informational Supplement January 2013 January 2005 Twenty-Second Informational Supplement Fourteenth Informational Supplement January 2012 January 2004 Twenty-First Informational Supplement Thirteenth Informational Supplement January 2011 January 2003 Twentieth Informational Supplement (Update) Twelfth Informational Supplement June 2010 January 2002 Twentieth Informational Supplement Eleventh Informational Supplement January 2010 January 2001 Nineteenth Informational Supplement Tenth Informational Supplement January 2009 January 2000 Eighteenth Informational Supplement Ninth Informational Supplement January 2008 January 1999 Seventeenth Informational Supplement January 2007 ISBN 1-56238-897-5 (Print) ISBN 1-56238-898-3 (Electronic) ISSN 1558-6502 (Print) ISSN 2162-2914 (Electronic) 4 Thisdocumentisprotectedbycopyright. PublishedOn1/1/2014. Vol. 34 No. 1 M100-S24 Committee Membership Consensus Committee on Microbiology Richard B. Thomson, Jr., PhD Thomas R. Fritsche, MD, PhD John D. Turnidge, MD Chairholder Marshfield Clinic SA Pathology at Women’s and Evanston Hospital, NorthShore Marshfield, Wisconsin, USA Children’s Hospital University HealthSystem North Adelaide, Australia Evanston, Illinois, USA Patrick R. Murray, PhD BD Diagnostics Jeffrey L. Watts, PhD, RM(NRCM) John H. Rex, MD, FACP Sparks, Maryland, USA Zoetis, Inc. Vice-Chairholder Kalamazoo, Michigan, USA AstraZeneca Pharmaceuticals Kerry Snow, MS, MT(ASCP) Waltham, Massachusetts, USA FDA Center for Drug Evaluation and Nancy L. Wengenack, PhD, Research D(ABMM), FIDSA Nancy L. Anderson, MMSc, Silver Spring, Maryland, USA Mayo Clinic MT(ASCP) Rochester, Minnesota, USA Centers for Disease Control and Fred C. Tenover, PhD, D(ABMM) Prevention Cepheid Atlanta, Georgia, USA Sunnyvale, California, USA Subcommittee on Antimicrobial Susceptibility Testing Jean B. Patel, PhD, D(ABMM) Dwight J. Hardy, PhD Mair Powell, MD, FRCP, FRCPath Chairholder University of Rochester Medical Center MHRA Centers for Disease Control and Rochester, New York, USA London, United Kingdom Prevention Atlanta, Georgia, USA Janet A. Hindler, MCLS, MT(ASCP) John D. Turnidge, MD UCLA Medical Center SA Pathology at Women’s and Franklin R. Cockerill III, MD Los Angeles, California, USA Children’s Hospital Vice-Chairholder North Adelaide, Australia Mayo College of Medicine Stephen G. Jenkins, PhD, D(ABMM), Rochester, Minnesota, USA F(AAM) Melvin P. Weinstein, MD New York Presbyterian Hospital Robert Wood Johnson Medical School Jeff Alder, PhD New York, New York, USA New Brunswick, New Jersey, USA Bayer HealthCare Whippany, New Jersey, USA James S. Lewis II, PharmD Barbara L. Zimmer, PhD University of Texas Health Science Siemens Healthcare Diagnostics Inc. Patricia A. Bradford, PhD Center West Sacramento, California, USA AstraZeneca Pharmaceuticals San Antonio, Texas, USA Waltham, Massachusetts, USA Linda A. Miller, PhD George M. Eliopoulos, MD GlaxoSmithKline Beth Israel Deaconess Medical Center Collegeville, Pennsylvania, USA Boston, Massachusetts, USA Acknowledgment CLSI and the Consensus Committee on Microbiology gratefully acknowledge the following individuals for their help in preparing this document: Jana M. Swenson, MMSc Maria M. Traczewski, BS, Consultant MT(ASCP) Chattahoochee Hills, Georgia, The Clinical Microbiology USA Institute Wilsonville, Oregon, USA 5 Thisdocumentisprotectedbycopyright. PublishedOn1/1/2014. January 2014 M100-S24 Working Group on Methodology Stephen G. Jenkins, PhD, Laura M. Koeth, MT(ASCP) Ribhi M. Shawar, PhD, D(ABMM) D(ABMM), F(AAM) Laboratory Specialists, Inc. FDA Center for Devices and Co-Chairholder Westlake, Ohio, USA Radiological Health New York Presbyterian Hospital Silver Spring, Maryland, USA New York, New York, USA Sandra S. Richter, MD, D(ABMM) Cleveland Clinic John D. Turnidge, MD Brandi Limbago, PhD Cleveland, Ohio, USA SA Pathology At Women’s and Co-Chairholder Children’s Hospital Centers for Disease Control and Darcie E. Roe-Carpenter, PhD, CIC, North Adelaide, Australia Prevention CEM Atlanta, Georgia, USA Siemens Healthcare Diagnostics Inc. Melvin P. Weinstein, MD West Sacramento, California, USA Robert Wood Johnson Medical Seth T. Housman, PharmD, MPA School Center for Anti-Infective Research Katherine Sei New Brunswick, New Jersey, USA and Development, Hartford Hospital Siemens Healthcare Diagnostics Inc. Hartford, Connecticut, USA West Sacramento, California, USA Romney M. Humphries, PhD, Susan Sharp, PhD, D(ABMM), D(ABMM) F(AAM) UCLA David Geffen School of Kaiser Permanente-NW Medicine Portland, Oregon, USA Los Angeles, California, USA Text and Table Working Group Jana M. Swenson, MMSc Dyan Luper, BS, MT(ASCP)SM, MB Jeff Schapiro, MD Co-Chairholder BD Diagnostic Systems Kaiser Permanente Consultant Sparks, Maryland, USA Alamo, California, USA Chattahoochee Hills, Georgia, USA Linda M. Mann, PhD, D(ABMM) Dale A. Schwab, PhD, D(ABMM) Maria M. Traczewski, BS, MT(ASCP) Consultant Quest Diagnostics, Nichols Institute Co-Chairholder Sacramento, California, USA San Juan Capistrano, California, USA The Clinical Microbiology Institute Wilsonville, Oregon, USA Susan D. Munro, MT(ASCP), CLS Richard B. Thomson, Jr., PhD Consultant Evanston Hospital, NorthShore Janet A. Hindler, MCLS, MT(ASCP) Campbell, California, USA University HealthSystem UCLA Medical Center Evanston, Illinois, USA Los Angeles, California, USA Flavia Rossi, MD Mary K. York, PhD, ABMM University of Sao Paulo MKY Microbiology Consulting Sao Paulo, Brazil Walnut Creek, California, USA 6 Thisdocumentisprotectedbycopyright. PublishedOn1/1/2014. Vol. 34 No. 1 M100-S24 Quality Control Working Group Steven D. Brown, PhD, ABMM Stephen Hawser, PhD Ross Mulder, MT(ASCP) Co-Chairholder IHMA Europe Sàrl bioMérieux, Inc. Consultant Epalinges, Switzerland, USA Hazelwood, Missouri, USA Wilsonville, Oregon, USA Janet A. Hindler, MCLS, MT(ASCP) Susan D. Munro, MT(ASCP), CLS Sharon K. Cullen, BS, RAC UCLA Medical Center Consultant Co-Chairholder Los Angeles, California, USA Campbell, California, USA Siemens Healthcare Diagnostics Inc. West Sacramento, California, USA Michael D. Huband Robert P. Rennie, PhD AstraZeneca Pharmaceuticals University of Alberta Hospital William B. Brasso Waltham, Massachusetts, USA Edmonton, Alberta, Canada BD Diagnostic Systems Sparks, Maryland, USA Ronald N. Jones, MD Frank O. Wegerhoff, PhD, JMI Laboratories MSc(Epid), MBA Patricia S. Conville, MS, MT(ASCP) North Liberty, Iowa, USA Seattle, Washington, USA FDA Center for Devices and Radiological Health Erika Matuschek, PhD Silver Spring, Maryland, USA ESCMID Vãxjõ, Sweden Staff Clinical and Laboratory Standards Institute Wayne, Pennsylvania, USA Luann Ochs, MS Senior Vice President – Operations Tracy A. Dooley, MLT(ASCP) Staff Liaison Megan L. Tertel, MA Editor Joanne P. Christopher Assistant Editor 7 Thisdocumentisprotectedbycopyright. PublishedOn1/1/2014. January 2014 M100-S24 8 Thisdocumentisprotectedbycopyright. PublishedOn1/1/2014.

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