ebook img

Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement. CLSI document M100-S25. Wayne, PA: Clinical and Laboratory Standards Institute; 2015. PDF

240 Pages·2015·5.687 MB·English
by  CLSI
Save to my drive
Quick download
Download
Most books are stored in the elastic cloud where traffic is expensive. For this reason, we have a limit on daily download.

Preview Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement. CLSI document M100-S25. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.

January 2015 M100-S25 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A12, M07-A10, 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. 35 No. 3 M100-S25 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth 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-A12—Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Twelfth Edition; M07-A10—Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Tenth 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 previous edition appear in boldface type.) Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement. CLSI document M100-S25 (ISBN 1-56238-989-0 [Print]; ISBN 1-56238-990-4 [Electronic]). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2015. The data in the interpretive tables in this supplement are valid only if the methodologies in M02-A12—Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Twelfth Edition; M07-A10—Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Tenth Edition; and M11-A8—Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard— Eighth Edition are followed. 1 January 2015 M100-S25 2 ISBN 1-56238-989-0 (Print) M100-S25 ISBN 1-56238-990-4 (Electronic) Vol. 35 No. 3 ISSN 1558-6502 (Print) Replaces M100-S24 ISSN 2162-2914 (Electronic) Vol. 34No. 1 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement Volume 35 Number 3 Jean B. Patel, PhD, D(ABMM) Franklin R. Cockerill III, MD Patricia A. Bradford, PhD George M. Eliopoulos, MD Janet A. Hindler, MCLS, MT(ASCP) Stephen G. Jenkins, PhD, D(ABMM), F(AAM) James S. Lewis II, PharmD Brandi Limbago, PhD Linda A. Miller, PhD David P. Nicolau, PharmD, FCCP, FIDSA 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 2015 M100-S25 Copyright ©2015 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-Fifth Informational Supplement. CLSI document M100-S25. Wayne, PA: Clinical and Laboratory Standards Institute; 2015. Twenty-Fifth Informational Supplement Seventeenth Informational Supplement January 2015 January 2007 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 ISBN 1-56238-989-0 (Print) ISBN 1-56238-990-4 (Electronic) ISSN 1558-6502 (Print) ISSN 2162-2914 (Electronic) 4 Vol. 35 No. 3 M100-S25 Committee Membership Consensus Committee on Microbiology Richard B. Thomson, Jr., PhD, Patrick R. Murray, PhD John D. Turnidge, MD D(ABMM), FAAM BD Diagnostic Systems SA Pathology at Women’s and Chairholder USA Children’s Hospital Evanston Hospital, NorthShore Australia University HealthSystem Jean B. Patel, PhD, D(ABMM) USA Centers for Disease Control and Jeffrey L. Watts, PhD, RM(NRCM) Prevention Zoetis John H. Rex, MD, FACP USA USA Vice-Chairholder AstraZeneca Pharmaceuticals Kerry Snow, MS, MT(ASCP) Nancy L. Wengenack, PhD, USA FDA Center for Drug Evaluation and D(ABMM) Research Mayo Clinic Thomas R. Fritsche, MD, PhD USA USA Marshfield Clinic USA Barbara L. Zimmer, PhD Siemens Healthcare Diagnostics Inc. USA Subcommittee on Antimicrobial Susceptibility Testing Jean B. Patel, PhD, D(ABMM) Janet A. Hindler, MCLS, MT(ASCP) David P. Nicolau, PharmD, FCCP, Chairholder UCLA Medical Center FIDSA Centers for Disease Control and USA Hartford Hospital Prevention USA USA Stephen G. Jenkins, PhD, D(ABMM), F(AAM) Mair Powell, MD, FRCP, FRCPath Franklin R. Cockerill III, MD New York Presbyterian Hospital MHRA Vice-Chairholder USA United Kingdom Mayo Clinic USA James S. Lewis II, PharmD John D. Turnidge, MD Oregon Health and Science University SA Pathology at Women’s and Patricia A. Bradford, PhD USA Children’s Hospital AstraZeneca Pharmaceuticals Australia USA Brandi Limbago, PhD Centers for Disease Control and Melvin P. Weinstein, MD George M. Eliopoulos, MD Prevention Robert Wood Johnson University Beth Israel Deaconess Medical Center USA Hospital USA USA Linda A. Miller, PhD GlaxoSmithKline Barbara L. Zimmer, PhD USA Siemens Healthcare Diagnostics Inc. USA Acknowledgment CLSI, the Consensus Committee on Microbiology, and the Subcommittee on Antimicrobial Susceptibility Testing gratefully acknowledge the following volunteers for their important contributions to the development of this document: Jana M. Swenson, MMSc Maria M. Traczewski, BS, USA MT(ASCP) The Clinical Microbiology Institute USA 5 January 2015 M100-S25 Working Group on AST Breakpoints George M. Eliopoulos, MD David P. Nicolau, PharmD, FCCP, Simone Shurland Co-Chairholder FIDSA FDA Center for Devices and Beth Israel Deaconess Medical Hartford Hospital Radiological Health Center USA USA USA Mair Powell, MD, FRCP, Lauri D. Thrupp, MD James S. Lewis II, PharmD FRCPath UCI Medical Center (University Co-Chairholder MHRA of California, Irvine) Oregon Health and Science United Kingdom USA University USA Michael Satlin, MD, MS Hui Wang, PhD Weill Cornell Medical College Peking University People’s Karen Bush, PhD USA Hospital Indiana University China USA Paul C. Schreckenberger, PhD, D(ABMM), F(AAM) Melvin P. Weinstein, MD Marcelo F. Galas Loyola University Medical Center Robert Wood Johnson University National Institute of Infectious USA Hospital Diseases USA Argentina Audrey N. Schuetz, MD, MPH, D(ABMM) Matthew A. Wikler, MD, MBA, Amy J. Mathers, MD Weill Cornell Medical FIDSA University of Virginia Medical College/NewYork-Presbyterian The Medicines Company Center Hospital USA USA USA Barbara L. Zimmer, PhD Siemens Healthcare Diagnostics Inc. USA Working Group on Methodology Stephen G. Jenkins, PhD, Laura M. Koeth, MT(ASCP) Susan Sharp, PhD, D(ABMM), D(ABMM), F(AAM) Laboratory Specialists, Inc. F(AAM) Co-Chairholder USA American Society for Microbiology New York Presbyterian Hospital USA USA Sandra S. Richter, MD, D(ABMM) Cleveland Clinic Ribhi M. Shawar, PhD, D(ABMM) Brandi Limbago, PhD USA FDA Center for Devices and Co-Chairholder Radiological Health Centers for Disease Control and Darcie E. Roe-Carpenter, PhD, CIC, USA Prevention CEM USA Siemens Healthcare Diagnostics John D. Turnidge, MD Inc. SA Pathology at Women’s and Seth T. Housman, PharmD, MPA USA Children’s Hospital Hartford Hospital Australia USA Katherine Sei Siemens Healthcare Diagnostics Romney M. Humphries, PhD, Inc. D(ABMM) USA UCLA Medical Center USA 6 Vol. 35 No. 3 M100-S25 Working Group on Quality Control Steven D. Brown, PhD, ABMM Stephen Hawser, PhD Ross Mulder, MT(ASCP) Co-Chairholder IHMA Europe Sàrl bioMérieux, Inc. USA Switzerland USA Sharon K. Cullen, BS, RAC Janet A. Hindler, MCLS, MT(ASCP) Susan D. Munro, MT(ASCP), CLS Co-Chairholder UCLA Medical Center USA Siemens Healthcare Diagnostics Inc. USA USA Robert P. Rennie, PhD Denise Holliday, MT(ASCP) Provincial Laboratory for Public William B. Brasso BD Diagnostic Systems Health BD Diagnostic Systems USA Canada USA Michael D. Huband Frank O. Wegerhoff, PhD, Patricia S. Conville, MS, MT(ASCP) AstraZeneca Pharmaceuticals MSc(Epid), MBA FDA Center for Devices and Radiological USA USA Health USA Erika Matuschek, PhD Mary K. York, PhD, ABMM ESCMID MKY Microbiology Consulting Robert K. Flamm, PhD Sweden USA JMI Laboratories USA Working Group on Text and Tables Jana M. Swenson, MMSc Linda M. Mann, PhD, D(ABMM) Dale A. Schwab, PhD, D(ABMM) Co-Chairholder USA Quest Diagnostics Nichols Institute USA USA Melissa B. Miller, PhD, D(ABMM) Maria M. Traczewski, BS, MT(ASCP) UNC Hospitals Richard B. Thomson, Jr., PhD, Co-Chairholder USA D(ABMM), FAAM The Clinical Microbiology Institute Evanston Hospital, NorthShore USA Susan D. Munro, MT(ASCP), CLS University HealthSystem USA USA Janet A. Hindler, MCLS, MT(ASCP) UCLA Medical Center Nancy E. Watz, MS, MT(ASCP), Flavia Rossi, MD USA CLS University of São Paulo Stanford Hospital and Clinics Brazil Peggy Kohner, BS, MT(ASCP) USA Mayo Clinic Jeff Schapiro, MD USA Mary K. York, PhD, ABMM Kaiser Permanente MKY Microbiology Consulting Dyan Luper, BS, MT(ASCP)SM, MB USA USA BD Diagnostic Systems USA Staff Clinical and Laboratory Megan L. Tertel, MA Standards Institute Editorial Manager USA Joanne P. Christopher, MA Luann Ochs, MS Editor Senior Vice President – Operations Patrice E. Polgar Tracy A. Dooley, MLT(ASCP) Editor Project Manager 7 January 2015 M100-S25 8

See more

The list of books you might like

Most books are stored in the elastic cloud where traffic is expensive. For this reason, we have a limit on daily download.