Performance Standards for Antimicrobial Susceptibility Testing: Twentieth Informational Supplement PDF
Preview Performance Standards for Antimicrobial Susceptibility Testing: Twentieth Informational Supplement
Product Name: Infobase 2010 - Release Date: February 2010 M100-S20 Vol. 30 No. 1 Replaces M100-S19 January 2010 Vol. 29 No. 3 Performance Standards for Antimicrobial Susceptibility Testing; Twentieth Informational Supplement This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A10 and M07-A8. An informational supplement for global application developed through the Clinical and Laboratory Standards Institute consensus process. This document is protected by international copyright laws. Product Name: Infobase 2010 - Release Date: February 2010 Clinical and Laboratory Standards Institute Advancing Quality in Health Care Testing The Clinical and Laboratory Standards Institute (CLSI, Most documents are subject to two levels of consensus— formerly NCCLS) is an international, interdisciplinary, “proposed” and “approved.” Depending on the need for nonprofit, standards-developing, and educational field evaluation or data collection, documents may also be organization that promotes the development and use of made available for review at an intermediate consensus voluntary consensus standards and guidelines within the level. health care community. It is recognized worldwide for Proposed A consensus document undergoes the first stage the application of its unique consensus process in the of review by the health care community as a proposed development of standards and guidelines for patient standard or guideline. The document should receive a wide testing and related health care issues. Our process is and thorough technical review, including an overall review based on the principle that consensus is an effective and of its scope, approach, and utility, and a line-by-line review cost-effective way to improve patient testing and health of its technical and editorial content. care services. Approved An approved standard or guideline has achieved In addition to developing and promoting the use of consensus within the health care community. It should be voluntary consensus standards and guidelines, we reviewed to assess the utility of the final document, to provide an open and unbiased forum to address critical ensure attainment of consensus (ie, that comments on earlier issues affecting the quality of patient testing and health versions have been satisfactorily addressed), and to identify care. the need for additional consensus documents. PUBLICATIONS Our standards and guidelines represent a consensus opinion A document is published as a standard, guideline, or on good practices and reflect the substantial agreement by committee report. materially affected, competent, and interested parties obtained by following CLSI’s established consensus Standard A document developed through the consensus procedures. Provisions in CLSI standards and guidelines process that clearly identifies specific, essential may be more or less stringent than applicable regulations. requirements for materials, methods, or practices for use Consequently, conformance to this voluntary consensus in an unmodified form. A standard may, in addition, document does not relieve the user of responsibility for contain discretionary elements, which are clearly compliance with applicable regulations. identified. COMMENTS Guideline A document developed through the consensus process describing criteria for a general The comments of users are essential to the consensus operating practice, procedure, or material for voluntary process. Anyone may submit a comment, and all comments use. A guideline may be used as written or modified by are addressed, according to the consensus process, by the the user to fit specific needs. committee that wrote the document. All comments, including those that result in a change to the document when Report A document that has not been subjected to published at the next consensus level and those that do not consensus review and is released by the Board of result in a change, are addressed by the committee in an Directors. appendix to the document. Readers are strongly encouraged CONSENSUS PROCESS to comment in any form and at any time on any document. 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Product Name: Infobase 2010 - Release Date: February 2010 Vol. 30 No. 1 M100-S20 Performance Standards for Antimicrobial Susceptibility Testing; Twentieth 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-A10—Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Tenth Edition; and M07-A8—Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Eighth Edition. The standards contain information about both disk (M02) and dilution (M07) test procedures for aerobic 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 quality control using the procedures standardized in M02 and M07. 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; Twentieth Informational Supplement. CLSI document M100-S20 (ISBN 1-56238-716-2). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2010. The data in the interpretive tables in this supplement are valid only if the methodologies in M02-A10—Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Tenth Edition; and M07-A8—Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Eighth Edition are followed. 1 This document is protected by international copyright laws. Product Name: Infobase 2010 - Release Date: February 2010 January 2010 M100-S20 2 This document is protected by international copyright laws. Product Name: Infobase 2010 - Release Date: February 2010 M100-S20 ISBN 1-56238-716-2 ISSN 0273-3099 Performance Standards for Antimicrobial Susceptibility Testing; Twentieth Informational Supplement Volume 30 Number 1 Franklin R. Cockerill, III, MD Matthew A. Wikler, MD, MBA, FIDSA Karen Bush, PhD Michael N. Dudley, PharmD, FIDSA George M. Eliopoulos, MD Dwight J. Hardy, PhD David W. Hecht, MD Janet A. Hindler, MCLS, MT(ASCP) Jean B. Patel, PhD, D(ABMM) Mair Powell, MD, FRCP, FRCPath, MHRA Richard B. Thomson, Jr., PhD John D. Turnidge, MD Melvin P. Weinstein, MD Barbara L. Zimmer, PhD Mary Jane Ferraro, PhD, MPH Jana M. Swenson, MMSc This document is protected by international copyright laws. Product Name: Infobase 2010 - Release Date: February 2010 January 2010 M100-S20 Copyright ©2010 Clinical and Laboratory Standards Institute. Except as stated below, neither this publication nor any portion thereof may be adapted, copied, or otherwise reproduced, by any means (electronic, mechanical, photocopying, recording, or otherwise) without prior written permission from Clinical and Laboratory Standards Institute (“CLSI”). 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, contact the Executive Vice President, Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA. Suggested Citation CLSI. Performance Standards for Antimicrobial Susceptibility Testing; Twentieth Informational Supplement. CLSI document M100-S20. Wayne, PA: Clinical and Laboratory Standards Institute; 2010. Twentieth Informational Supplement Fourteenth Informational Supplement January 2010 January 2004 Nineteenth Informational Supplement Thirteenth Informational Supplement January 2009 January 2003 Eighteenth Informational Supplement Twelfth Informational Supplement January 2008 January 2002 Seventeenth Informational Supplement Eleventh Informational Supplement January 2007 January 2001 Sixteenth Informational Supplement Tenth Informational Supplement January 2006 January 2000 Fifteenth Informational Supplement Ninth Informational Supplement January 2005 January 1999 ISBN 1-56238-716-2 ISSN 0273-3099 4 This document is protected by international copyright laws. Product Name: Infobase 2010 - Release Date: February 2010 Vol. 30 No. 1 M100-S20 p Committee Membership hi s er b Area Committee on Microbiology m e M e e JCohhanir Hho. lRdeexr , MD, FACP FCreepdh Cei.d T enover, PhD, ABMM JCaennat eMrs. fSowr eDnissoenas, eM CMonStcr ol and mitt m AstraZeneca Sunnyvale, California, USA Prevention o Cheshire, United Kingdom Young Harris, Georgia, USA C John D. Turnidge, MD Mary Jane Ferraro, PhD, MPH Women’s and Children’s Hospital Jeffrey L. Watts, PhD, RM(AAM) Vice-Chairholder North Adelaide, Australia Pfizer Animal Health Massachusetts General Hospital Kalamazoo, Michigan, USA Boston, Massachusetts, USA Advisors Melvin P. Weinstein, MD Nancy L. Anderson, MMSc, Donald R. Callihan, PhD Robert Wood Johnson University MT(ASCP) BD Diagnostic Systems Hospital Centers for Disease Control and Sparks, Maryland, USA New Brunswick, New Jersey, USA Prevention Atlanta, Georgia, USA James H. Jorgensen, PhD Matthew A. Wikler, MD, MBA, University of Texas Health Science FIDSA Barbara Ann Body, PhD, D(ABMM) Center Institute for One World Health Laboratory Corporation of America San Antonio, Texas, USA San Francisco, California, USA Burlington, North Carolina, USA Jean B. Patel, PhD, D(ABMM) Michael L. Wilson, MD Betty (Betz) A. Forbes, PhD, Centers for Disease Control and Denver Health Medical Center D(ABMM) Prevention Denver, Colorado, USA Medical College of Virginia Campus Atlanta, Georgia, USA Richmond, Virginia, USA Gail L. Woods, MD Michael A. Pfaller, MD Central Arkansas Veterans Healthcare Thomas R. Fritsche, MD, PhD University of Iowa College of System Marshfield Clinic Medicine Little Rock, Arkansas, USA Marshfield, Wisconsin, USA Iowa City, Iowa, USA Barbara L. Zimmer, PhD Freddie Mae Poole, BS, MT(ASCP, Thomas R. Shryock, PhD Siemens Healthcare Diagnostics ISCLT) Elanco Animal Health West Sacramento, California, USA FDA Center for Devices and Greenfield, Indiana, USA Radiological Health Upper Marlboro, Maryland, USA Subcommittee on Antimicrobial Susceptibility Testing Franklin R. Cockerill, III, MD George M. Eliopoulos, MD Mair Powell, MD, FRCP, FRCPath Chairholder Beth Israel Deaconess Medical Center MHRA Mayo College of Medicine Boston, Massachusetts, USA London, United Kingdom Rochester, Minnesota, USA Dwight J. Hardy, PhD Richard B. Thomson, Jr., PhD Matthew A. Wikler, MD, MBA, University of Rochester Medical Center Evanston Hospital, Northwestern FIDSA Rochester, New York, USA University Medical School Vice-Chairholder Evanston, Illinois, USA Institute for One World Health David W. Hecht, MD San Diego, California, USA Loyola University Medical Center John D. Turnidge, MD Maywood, Illinois, USA Women’s and Children’s Hospital Karen Bush, PhD North Adelaide, Australia Indiana University Janet A. Hindler, MCLS, MT(ASCP) Bloomington, Indiana, USA UCLA Medical Center Melvin P. Weinstein, MD Los Angeles, California, USA Robert Wood Johnson Medical School Michael N. Dudley, PharmD, FIDSA New Brunswick, New Jersey, USA Mpex Pharmaceuticals Jean B. Patel, PhD, D(ABMM) San Diego, California, USA Centers for Disease Control and Barbara L. Zimmer, PhD Prevention Siemens Healthcare Diagnostics Atlanta, Georgia, USA West Sacramento, California, USA 5 This document is protected by international copyright laws. Product Name: Infobase 2010 - Release Date: February 2010 January 2010 M100-S20 hip Advisors Yoichi Hirakata, MD, FJSIM, PhD Sandra S. Richter, MD, D(ABMM) s Tohoku University Graduate School of University of Iowa Carver College of r be Paul G. Ambrose, PharmD, FIDSA Medicine Medicine m ICPD/Orway Research Institute Sendai, Japan Iowa City, Iowa, USA e M Albany, New York, USA e Ronald N. Jones, MD Flavia Rossi, MD e mitt Patricia A. Bradford, PhD JMI Laboratories University of Sao Paulo Novartis Institutes for Biomedical North Liberty, Iowa, USA Sao Paulo, Brazil m o Research C Cambridge, Massachusetts, USA Gunnar Kahlmeter, MD, PhD Dale A. Schwab, PhD, D(ABMM) ESCMID Quest Diagnostics, Nichols Institute Steven D. Brown, PhD Växjö, Sweden San Juan Capistrano, California, USA The Clinical Microbiology Institute Wilsonville, Oregon, USA Frederic J. Marsik, PhD, ABMM Jana M. Swenson, MMSc FDA Center for Drug Evaluation and Centers for Disease Control and Karen Carroll, MD Research Prevention Johns Hopkins Medical Institutions Silver Spring, Maryland, USA Atlanta, Georgia, USA Baltimore, Maryland, USA Linda A. Miller, PhD Fred C. Tenover, PhD, ABMM Edward M. Cox, Jr., MD, MPH GlaxoSmithKline Cepheid FDA Center for Drug Evaluation and Collegeville, Pennsylvania, USA Sunnyvale, California, USA Research Rockville, Maryland, USA Harriette L. Nadler, PhD Joseph G. Toerner, MD, MPH DJA Global Pharmaceuticals, Inc. FDA Center for Disease Control and William A. Craig, MD Chadds Ford, Pennsylvania, USA Prevention Wm. S. Middleton Memorial Veterans Silver Spring, Maryland, USA Affairs Hospital Freddie Mae Poole, BS, MT(ASCP, Madison, Wisconsin, USA ISCLT) Hui Wang, PhD FDA Center for Devices and Peking Union Medical College Hospital Cynthia L. Fowler, MD Radiological Health Beijing, China bioMérieux, Inc. Upper Marlboro, Maryland, USA Durham, North Carolina, USA Text and Table Working Group Jana M. Swenson, MMSc Janet A. Hindler, MCLS, MT(ASCP) Susan D. Munro, MT(ASCP) Chairholder UCLA Medical Center Stanford Hospital and Clinics Centers for Disease Control and Los Angeles, California, USA Palo Alto, California, USA Prevention Atlanta, Georgia, USA Judy Johnston, MS Dale A. Schwab, PhD, D(ABMM) Siemens Healthcare Diagnostics Quest Diagnostics, Nichols Institute Donald R. Callihan, PhD West Sacramento, California, USA San Juan Capistrano, California, USA BD Diagnostic Systems Ronald N. Jones, MD Sparks, Maryland, USA Albert T. Sheldon, Jr., PhD JMI Laboratories Antibiotic & Antiseptic Consultants North Liberty, Iowa, USA Franklin R. Cockerill, III, MD Cypress, Texas, USA Mayo Clinic and Mayo College of Dyan Luper, BS, MT(ASCP)SM Medicine Richard B. Thomson, Jr., PhD BD Diagnostic Systems Rochester, Minnesota, USA Northwestern University Feinberg Sparks, Maryland, USA School of Medicine Sharon K. Cullen, BS, RAC Linda M. Mann, PhD, D(ABMM) Evanston, Illinois, USA Siemens Healthcare Diagnostics Siemens Healthcare Diagnostics West Sacramento, California, USA West Sacramento, California, USA Mary K. York, PhD, ABMM MKY Microbiology Consulting Walnut Creek, California, USA 6 This document is protected by international copyright laws. Product Name: Infobase 2010 - Release Date: February 2010 Vol. 30 No. 1 M100-S20 Quality Control Working Group hip rs e Steve Brown, PhD Michael D. Huband Paul E. Oefinger, PhD, D(ABMM) b m Co-Chairholder Pfizer Global R&D Covance Central Laboratory Services e The Clinical Microbiology Institute Groton, Connecticut, USA Inc. e M Wilsonville, Oregon, USA Indianapolis, Indiana, USA e Ronald N. Jones, MD mitt Sharon K. Cullen, BS, RAC JMI Laboratories Jean Patel, PhD, D(ABMM) m Co-Chairholder North Liberty, Iowa, USA Centers for Disease Control and o C Siemens Healthcare Diagnostics Prevention West Sacramento, California, USA Ann Macone Atlanta, Georgia, USA Paratek Pharmaceuticals, Inc. William Brasso Boston, Massachusetts, USA Robert P. Rennie, PhD BD Diagnostic Systems University of Alberta Hospital Sparks, Maryland, USA Ross Mulder, MT(ASCP) Edmonton, Alberta, Canada bioMérieux, Inc. Stephen Hawser, PhD Hazelwood, Missouri, USA IHMA Schaumburg, Illinois, USA Susan D. Munro, MT(ASCP) Stanford Hospital and Clinics Janet A. Hindler, MCLS, MT(ASCP) Palo Alto, California, USA UCLA Medical Center Los Angeles, California, USA Staphylococcal Working Group Fred Tenover, PhD, ABMM Michael N. Dudley, PharmD, FIDSA Maria M. Traczewski, BS, MT(ASCP) Chairholder Mpex Pharmaceuticals The Clinical Microbiology Institute Cepheid San Diego, California, USA Wilsonville, Oregon, USA Sunnyvale, California, USA George M. Eliopoulos, MD Melvin P. Weinstein, MD Karen Bush, PhD Beth Israel Deaconess Medical Center Robert Wood Johnson University Indiana University Boston, Massachusetts, USA Hospital Bloomington, Indiana, USA New Brunswick, New Jersey, USA Daniel F. Sahm, PhD Patricia A. Bradford, PhD Eurofins Medinet Novartis Institutes for Biomedical Herndon, Virginia, USA Research Cambridge, Massachusetts, USA Jana Swenson, MMSc Centers for Disease Control and William A. Craig, MD Prevention University of Wisconsin Atlanta, Georgia, USA Madison, Wisconsin, USA Enterobacteriaceae Working Group Michael N. Dudley, PharmD, FIDSA Ronald N. Jones, MD Jana Swenson, MMSc Chairholder JMI Laboratories Centers for Disease Control and Mpex Pharmaceuticals North Liberty, Iowa, USA Prevention San Diego, California, USA Atlanta, Georgia, USA Jean B. Patel, PhD, D(ABMM) Centers for Disease Control and Lauri D. Thrupp, MD Paul G. Ambrose, PharmD, FIDSA Prevention University of California Irvine Medical ICPD/Ordway Research Atlanta, Georgia, USA Center Albany, New York, USA Orange, California, USA David Paterson, MD Karen Bush, PhD Melvin P. Weinstein, MD University of Pittsburgh Indiana University Robert Wood Johnson University Pittsburgh, Pennsylvania, USA Bloomington, Indiana, USA Hospital Paul C. Schreckenberger, PhD, New Brunswick, New Jersey, USA William A. Craig, MD D(ABMM), F(AAM) University of Wisconsin Barbara L. Zimmer, PhD Loyola University Medical Center Madison, Wisconsin, USA Siemens Healthcare Diagnostics Maywood, Illinois, USA West Sacramento, California, USA 7 This document is protected by international copyright laws. Product Name: Infobase 2010 - Release Date: February 2010 January 2010 M100-S20 p hi Staff rs e b Clinical and Laboratory Standards m e Institute M Wayne, Pennsylvania, USA e e mitt Lois M. Schmidt, DA m Vice President, Standards Development Co and Marketing Tracy A. Dooley, BS, MLT(ASCP) Staff Liaison Melissa A. Lewis, ELS Editorial Manager Carol DiBerardino, MLA, ELS Assistant Editor 8 This document is protected by international copyright laws.
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