Read M45-A2: Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline - Second Edition text version

M45-A2 Vol. 30 No. 18 Replaces M45-A Vol. 26 No. 19

Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline--Second Edition

This document provides guidance to clinical microbiology laboratories for standardized susceptibility testing of infrequently isolated or fastidious bacteria that are not presently included in CLSI documents M02 or M07. The tabular information in this document presents the most current information for drug selection, interpretation, and quality control for the infrequently isolated or fastidious bacterial pathogens included in this guideline. A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

Clinical and Laboratory Standards Institute

Advancing Quality in Health Care Testing

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) 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. It is recognized worldwide for the application of its unique consensus process in the development of standards and guidelines for patient testing and related health care issues. Our process is based on the principle that consensus is an effective and cost-effective way to improve patient testing and health care services. In addition to developing and promoting the use of voluntary consensus standards and guidelines, we provide an open and unbiased forum to address critical issues affecting the quality of patient testing and health care. PUBLICATIONS A document is published as a standard, guideline, or committee report. Standard A document developed through the consensus process that clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form. A standard may, in addition, contain discretionary elements, which are clearly identified. Guideline A document developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. A guideline may be used as written or modified by the user to fit specific needs. Report A document that has not been subjected to consensus review and is released by the Board of Directors. CONSENSUS PROCESS The CLSI voluntary consensus process is a protocol establishing formal criteria for · · · · The authorization of a project The development and open review of documents The revision of documents in response to comments by users The acceptance of a document as a consensus standard or guideline Most documents are subject to two levels of consensus-- "proposed" and "approved." Depending on the need for field evaluation or data collection, documents may also be made available for review at an intermediate consensus level. Proposed A consensus document undergoes the first stage of review by the health care community as a proposed standard or guideline. The document should receive a wide and thorough technical review, including an overall review of its scope, approach, and utility, and a line-by-line review of its technical and editorial content. Approved An approved standard or guideline has achieved consensus within the health care community. It should be reviewed to assess the utility of the final document, to ensure attainment of consensus (ie, that comments on earlier versions have been satisfactorily addressed), and to identify the need for additional consensus documents. Our standards and guidelines represent a consensus opinion on good practices and reflect the substantial agreement by materially affected, competent, and interested parties obtained by following CLSI's established consensus procedures. Provisions in CLSI standards and guidelines may be more or less stringent than applicable regulations. Consequently, conformance to this voluntary consensus document does not relieve the user of responsibility for compliance with applicable regulations. COMMENTS The comments of users are essential to the consensus process. Anyone may submit a comment, and all comments are addressed, according to the consensus process, by the committee that wrote the document. All comments, including those that result in a change to the document when published at the next consensus level and those that do not result in a change, are addressed by the committee in an appendix to the document. Readers are strongly encouraged to comment in any form and at any time on any document. Address comments to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, USA. VOLUNTEER PARTICIPATION Health care professionals in all specialties are urged to volunteer for participation in CLSI projects. Please contact us at [email protected] or +610.688.0100 for additional information on committee participation.

Volume 30 Number 18

M45-A2 ISBN 1-56238-732-4 ISSN 0273-3099

Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline-- Second Edition

James H. Jorgensen, PhD Janet A. Hindler, MCLS, MT(ASCP) Kathryn Bernard, MS Diane M. Citron, M(ASCP) Franklin R. Cockerill, III, MD Thomas R. Fritsche, PhD, MD Guido Funke, MD Henry Heine, PhD Patrick McDermott, PhD Jean B. Patel, PhD, D(ABMM) Paul C. Schreckenberger, PhD, D(ABMM) John D. Turnidge, MD David F. Welch, PhD, D(ABMM)

Abstract

If the susceptibility of a bacterial pathogen to antimicrobial agents cannot be predicted based on the identity of the organism alone, in vitro antimicrobial susceptibility testing of the organism isolated may be indicated. Susceptibility testing is particularly necessary in those situations in which the etiological agent belongs to a bacterial species for which resistance to commonly used antimicrobial agents has been documented, or could arise. A variety of laboratory techniques can be used to measure the in vitro susceptibility of bacteria to antimicrobial agents. Clinical and Laboratory Standards Institute document M45-A2--Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline--Second Edition describes the standard microdilution and agar disk diffusion methods. It also includes a series of procedures designed to standardize test performance. The performance, applications, and limitations of the current CLSI-recommended methods are described. The tabular information in this document presents the most current information for drug selection, interpretation, and quality control for the infrequently isolated or fastidious bacterial pathogens included in this guideline. As more information becomes available, changes will be incorporated into future revisions of this document. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline--Second Edition. CLSI document M45-A2 (ISBN 1-56238732-4). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2010. The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through two or more levels of review by the health care community, is an ongoing process. Users should expect revised editions of any given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI documents. Current editions are listed in the CLSI catalog and posted on our website at www.clsi.org. If your organization is not a member and would like to become one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail: [email protected]; Website: www.clsi.org

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Contents

Abstract ....................................................................................................................................................i Committee Membership........................................................................................................................ iii Foreword ................................................................................................................................................xi 1 2 Scope .......................................................................................................................................... 1 Introduction ................................................................................................................................ 1 2.1 2.2 2.3 2.4 2.5 2.6 2.7 3 4 Resistance Mechanisms in Gram-Positive Rods........................................................... 2 Resistance in Infrequently Isolated or Fastidious Gram-Positive Cocci ....................... 2 Infrequently Isolated Nonfastidious Gram-Negative Rods ........................................... 2 Fastidious Gram-Negative Rods ................................................................................... 2 Moraxella catarrhalis ................................................................................................... 3 Potential Bacterial Agents of Bioterrorism ................................................................... 3 The Development of Interpretive Criteria or Breakpoints ............................................ 3

Standard Precautions.................................................................................................................. 4 Terminology............................................................................................................................... 4 4.1 4.2 4.3 A Note on Terminology ................................................................................................ 4 Definitions .................................................................................................................... 4 Abbreviations and Acronyms ....................................................................................... 5

5 6

Indications for Performing Susceptibility Tests......................................................................... 5 Methods for Dilution Antimicrobial Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria ..................................................................................................................... 6 6.1 6.2 6.3 Selection of Antimicrobial Agents................................................................................ 6 Antimicrobial Agents .................................................................................................... 6 Interpretive Categories .................................................................................................. 7

7 8 9

Methods for Antimicrobial Disk Diffusion Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria ..................................................................................................................... 7 Therapy-Related Comments ...................................................................................................... 7 Quality Control .......................................................................................................................... 7 9.1 Minimum Laboratory Requirements for Testing Infrequently Isolated or Fastidious Bacteria ......................................................................................................................... 8

10

Detection of Resistance to Some -Lactams by a Direct -Lactamase Test ............................. 8

Table 1. Abiotrophia spp. and Granulicatella spp. (Formerly Known as Nutritionally Deficient or Nutritionally Variant Streptococci)--Information and Interpretive Criteria for Broth Microdilution Susceptibility Testing............................................................................................................................ 10 Table 2. Aeromonas spp. (Includes Members of A. caviae Complex, A. hydrophila Complex, and A. veronii Complex) and Plesiomonas shigelloides--Information and Interpretive Criteria for Broth Microdilution and Disk Diffusion Susceptibility Testing ........................................................... 12

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Contents (Continued)

Table 18B. MIC: Quality Control Ranges for Campylobacter jejuni (Broth Microdilution Method) (Cation-Adjusted Mueller-Hinton Broth With Lysed Horse Blood [2.5% to 5% v/v]) ........................ 46 Table 18C. MIC: Quality Control Ranges for Agar Dilution Methods (Mueller-Hinton Agar With Aged [ 2-Week-Old] Sheep Blood) .................................................................................................... 47 Table 18D. MIC: Quality Control Ranges for Broth Microdilution Method (Cation-Adjusted Mueller-Hinton Broth + 2% Defined Growth Supplementa) ................................................................ 47 Table 18E. MIC: Quality Control Ranges for Broth Microdilution Methods (Brucella Broth Without Supplements Adjusted to pH 7.1 ± 0.1) .................................................................................. 48 Table 19. Disk Diffusion: Quality Control Ranges for Nonfastidious Organisms (Unsupplemented Mueller-Hinton Medium)...................................................................................................................... 49 Table 19A. Disk Diffusion: Quality Control Ranges for Fastidious Organisms (Mueller-Hinton Medium With 5% Sheep Blood) ........................................................................................................... 50 Glossary I (Part 1). -Lactams: Class and Subclass Designation and Generic Name........................... 51 Glossary I (Part 2). Non­-lactams: Class and Subclass Designation and Generic Name ................... 52 Glossary II. Abbreviations/Routes of Administration/Drug Class for Antimicrobial Agents Listed in M100-S20 ............................................................................................................................................. 53 References ............................................................................................................................................. 56 Additional References ........................................................................................................................... 58 Summary of Consensus Comments and Subcommittee Responses ...................................................... 71 Summary of Delegate Comments and Subcommittee Responses......................................................... 72 The Quality Management System Approach ........................................................................................ 76 Related CLSI Reference Materials ....................................................................................................... 77

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Contents (Continued)

Table 3. Bacillus spp. (Not B. anthracis)--Information and Interpretive Criteria for Broth Microdilution Susceptibility Testing .................................................................................................... 14 Table 4. Campylobacter jejuni/coli--Information and Interpretive Criteria for Broth Microdilution and Disk Diffusion Susceptibility Testing ............................................................................................ 16 Table 5. Corynebacterium spp. (Including C. diphtheriae) and Coryneformsa--Information and Interpretive Criteria for Broth Microdilution Susceptibility Testing ............................................. 18 Table 6. Erysipelothrix rhusiopathiae--Information and Interpretive Criteria for Broth Microdilution Susceptibility Testing .................................................................................................... 20 Table 7. HACEK Group: Aggregatibacter spp. (formerly Haemophilus aphrophilus, H. paraphrophilus, H. segnis, and Actinobacillus actinomycetemcomitans), Cardiobacterium spp., Eikenella corrodens, and Kingella spp.--Information and Interpretive Criteria for Broth Microdilution Susceptibility Testing .................................................................................................... 22 Table 8. Helicobacter pylori--Interpretive Criteria for Agar Dilution Susceptibility Testing............. 24 Table 9. Lactobacillus spp.--Information and Interpretive Criteria for Broth Microdilution Susceptibility Testing............................................................................................................................ 26 Table 10. Leuconostoc spp.--Information and Interpretive Criteria for Broth Microdilution Susceptibility Testing............................................................................................................................ 28 Table 11. Listeria monocytogenes--Information and Interpretive Criteria for Broth Microdilution Susceptibility Testing............................................................................................................................ 29 Table 12. Moraxella catarrhalis--Information and Interpretive Criteria for Broth Microdilution and Disk Diffusion Susceptibility Testing ............................................................................................ 30 Table 13. Pasteurella spp.--Information and Interpretive Criteria for Broth Microdilution and Disk Diffusion Susceptibility Testing ................................................................................................... 32 Table 14. Pediococcus spp.--Information and Interpretive Criteria for Broth Microdilution Susceptibility Testing............................................................................................................................ 34 Table 15. Vibrio spp. (including V. cholerae)--Information and Interpretive Criteria for Broth Microdilution and Disk Diffusion Susceptibility Testing ..................................................................... 36 Table 16. Potential Bacterial Agents of Bioterrorism: Bacillus anthracis, Yersinia pestis, Burkholderia mallei, Burkholderia pseudomallei, Francisella tularensis, and Brucella spp.-- Interpretive Criteria for Broth Microdilution Susceptibility Testing .................................................... 38 Table 17. Summary of Testing Conditions and Quality Control Recommendations for Infrequently Isolated or Fastidious Bacteria .............................................................................................................. 42 Table 18. MIC: Quality Control Ranges for Nonfastidious Organisms (Unsupplemented CationAdjusted Mueller-Hinton Medium) ...................................................................................................... 44 Table 18A. MIC: Quality Control Ranges for Broth Microdilution Methods (Cation-Adjusted Mueller-Hinton Broth With Lysed Horse Blood [2.5% to 5% v/v]) ..................................................... 45 viii

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Foreword

This document was developed for the purpose of providing guidance to clinical or public health microbiology laboratories regarding the performance of standardized susceptibility testing, when needed, of infrequently isolated or fastidious bacteria that are not presently included in CLSI documents M021 or M07.2 Helicobacter pylori, Vibrio cholerae, and several potential agents of bioterrorism were moved from CLSI documents M02,1 M07,2 and M1003 to this document because they are fastidious or infrequently encountered in most microbiology laboratories. Some of the organisms included herein are aerobic gram-negative bacilli that are not members of the family Enterobacteriaceae but may be tested by the standard CLSI broth microdilution or disk diffusion methods in the same manner as the much more common Enterobacteriaceae isolates. Some aerobic gram-positive cocci and bacilli that are encountered periodically by clinical laboratories can likewise be tested reliably by the standard CLSI minimal inhibitory concentration (MIC) or disk diffusion test methods in a manner analogous to Staphylococcus or Enterococcus spp. In addition, several genera of fastidious gram-positive and gram-negative bacteria can be tested in the same manner as the streptococci, using blood-supplemented Mueller-Hinton media. For the purpose of this document, the term fastidious is used to describe bacteria that require media supplemented with blood or blood components and that possibly need an atmosphere other than ambient air (eg, with 5% CO2) for acceptable growth. Because the standard CLSI media, reagents, and procedures can be used to test the organisms included in this guideline, the quality control procedures, strains, and acceptable zone diameter and MIC limits that have been established through previous rigorous studies can be used for tests with the less common organisms that are included in this document. The working group used a thorough search of the published literature in conjunction with the clinical experience of the members to apply or adapt interpretive criteria or breakpoints from other organisms that could best be applied to the interpretation of tests of the less common organisms in this document. Users of the guideline should be aware that the very extensive microbiological, clinical, and pharmacodynamic databases normally employed for setting breakpoints by CLSI did not exist for the collection of "orphan" organisms described in this document. Interpretive breakpoints for cefazolin and for ertapenem, imipenem, and meropenem for the Enterobacteriaceae were voted to be changed by the Subcommittee on Antimicrobial Susceptibility Testing subsequent to final approval of this edition of M45. It is anticipated that those modified breakpoints will be adopted for use with Aeromonas spp. and Vibrio spp. in the next edition of M45 or possibly in a future supplement. It is important for users of M45-A2 to recognize that commercial susceptibility testing devices are not addressed in this guideline. The methods described herein are generic reference procedures that can be used for routine susceptibility testing by clinical laboratories, or that can be used by clinical laboratories to evaluate commercial devices for possible routine use. Results generated by reference methods, such as those contained in CLSI documents, may be used by regulatory authorities to evaluate the performance of commercial systems as part of the approval process. Clearance by a regulatory authority indicates that the commercial susceptibility testing device provides susceptibility results that are substantially equivalent to results generated using the reference methods for the organisms and antimicrobial agents described in the manufacturer's approved package insert. Some laboratories could find that a commercial dilution, antibiotic gradient, colorimetric, turbidimetric, fluorometric, or other method is suitable for selective or routine use. Key Words Agar dilution, antimicrobial agent, antimicrobial susceptibility, broth dilution, disk diffusion, microdilution, minimal inhibitory concentration (MIC), susceptibility testing

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Number 18 Updated Information in This Edition

M45-A2

Below is a summary of the changes in this document, which supersede the information presented in the previous edition of M45. The list includes "major" changes that appear for the first time in this edition of M45, or were modified since publication of M45-A. Other minor or editorial changes that were made to the general formatting are not listed here. Foreword Added paragraph from current edition of M100 related to using commercial systems vs CLSI reference methods (p. xi). Section 1, Scope Noted that testing of Haemophilus included in M100 relates to H. influenzae and H. parainfluenzae only (p. 1). Section 2, Introduction Updated HACEK group designation for Aggregatibacter (formerly Actinobacillus) (p. 1). Section 4.2, Definitions Added definitions for susceptible, intermediate, resistant, and nonsusceptible (p. 4). Section 4.3, Abbreviations and Acronyms Added a list of abbreviations and acronyms used in the document (p. 5). Section 6.3, Interpretive Categories Deleted only "S" criteria box because the definition of "nonsusceptible" is now in the list of definitions. Section 9, Quality Control Expanded statement about selecting quality control strains (p. 7). Tables 1 through 19A General Modified therapy (Rx) comment for rifampin (Tables 3, 5, 7, and 12) (pp. 14, 18, 22, and 30). Table 2, Aeromonas spp. and Plesiomonas shigelloides Clarified incubation conditions for disk diffusion and MIC testing (p. 12). Added new (revised) breakpoints for cefazolin, cefotaxime, ceftazidime, ceftriaxone, and aztreonam. Also added dosage regimens on which the new breakpoints are based (p. 12). Table 3, Bacillus spp. (not B. anthracis) Added fluoroquinolones to the agents to consider for primary testing box (p. 14). Table 4, Campylobacter jejuni/coli Clarified incubation conditions for disk diffusion and MIC testing (p. 16). Added azithromycin and clarithromycin to the examples indicating macrolide resistance (p. 16). Table 5, Corynebacterium spp. Modified vancomycin breakpoints (p. 18). Clarified scope of recommendations that apply to Corynebacterium spp. and other coryneforms including the genera Arcanobacterium, Brevibacterium, Cellulomonas, Dermabacter, Leifsonia, Microbacterium, Oerskovia, Rothia, and Turicella (p. 19). xii

Volume 30 Table 7, HACEK Group Updated HACEK group designation for Aggregatibacter (formerly Actinobacillus) (p. 22). Table 8, Helicobacter pylori Imported table from M100-S20 (p. 24).

M45-A2

Table 9, Lactobacillus spp. Added breakpoints for daptomycin and linezolid (p. 26). Added intermediate and resistant breakpoints for imipenem (p. 26). Modified breakpoints for clindamycin and vancomycin (p. 26). Added comment to ampicillin regarding combined therapy with a penicillin and an aminoglycoside for treatment of serious infections (p. 26). Updated Derivation of Interpretive Criteria section (p. 27). Table 10, Leuconostoc spp. Added comment regarding combined therapy with a penicillin and an aminoglycoside for treatment of serious infections (p. 28). Table 12, Moraxella catarrhalis Modified MIC breakpoints for amoxicillin-clavulanic acid ("S" only), azithromycin, clarithromycin, and erythromycin (p. 30). Added disk diffusion breakpoints for amoxicillin-clavulanic acid, azithromycin, clarithromycin, erythromycin, tetracycline, and trimethoprim-sulfamethoxazole (p. 30). Updated Derivation of Interpretive Criteria section (p. 31). Table 13, Pasteurella spp. Clarified incubation conditions for disk diffusion and MIC testing (p. 32). Table 15, Vibrio spp. Imported table from M100-S20 (p. 36). Clarified incubation conditions for disk diffusion and MIC testing (p. 36). Listed agents to consider for primary testing for Vibrio spp. and V. cholerae (p. 36). Added MIC breakpoints for azithromycin for V. cholerae (p. 37). Updated Derivation of Interpretive Criteria section (p. 37). Table 16, Potential Bacterial Agents of Bioterrorism Imported table from M100-S20 (p. 38). Added agents to consider for primary testing for Brucella and Francisella (p. 38). Table 17, Summary of Testing Conditions and Quality Control Added Helicobacter pylori, V. cholerae, and potential agents of bioterrorism (pp. 42 and 43). Quality Control Tables Table 18 Added ranges for ampicillin and piperacillin for E. coli ATCC® 35218 (p. 44). Table 18A Added ranges for amoxicillin for E. coli ATCC® 35218 (p. 45). Table 18B Imported Campylobacter quality control from M100-S20 (p. 46).

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Number 18 Table 18C Imported Helicobacter quality control from M100-S20 (p. 47). Table 18D Imported potential bacterial agents of bioterrorism quality control from M100-S20 (p. 47).

M45-A2

Table 19 Added ranges for azithromycin, clarithromycin, and erythromycin for S. aureus ATCC® 25923 (p. 49). Glossaries Glossary I ­ Added new antimicrobial subclass for ceftaroline and ceftobiprole (p. 51). Glossaries I and II ­ Added razupenem to carbapenem subclass (p. 51). Added sulopenem to penem subclass (p. 51). Added linopristin-flopristin to streptogramin class (p. 52). Added mupirocin to pseudomonic acid class (p. 52).

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CLSI Subcommittee on Antimicrobial Susceptibility Testing Mission Statement

The CLSI Subcommittee on Antimicrobial Susceptibility Testing is composed of representatives from the professions, government, and industry, including microbiology laboratories, government agencies, health care providers and educators, and pharmaceutical and diagnostic microbiology industries. Using the CLSI voluntary consensus process, the subcommittee develops standards and guidelines that promote accurate antimicrobial susceptibility testing and appropriate reporting. The mission of the CLSI Subcommittee on Antimicrobial Susceptibility Testing is to: · · · · · · · Develop standard reference methods for antimicrobial susceptibility tests. Provide quality control parameters for standard test methods. Establish interpretive criteria for the results of standard antimicrobial susceptibility tests. Provide suggestions for testing and reporting strategies that are clinically relevant and cost-effective. Continually refine standards and optimize the detection of emerging resistance mechanisms through the development of new or revised methods, interpretive criteria, and quality control parameters. Educate users through multimedia communication of standards and guidelines. Foster a dialogue with users of these methods and those who apply them.

The ultimate purpose of the subcommittee's mission is to provide useful information to enable laboratories to assist the clinician in the selection of appropriate antimicrobial therapy for patient care. The standards and guidelines are meant to be comprehensive and to include all antimicrobial agents for which the data meet established CLSI guidelines. The values that guide this mission are quality, accuracy, fairness, timeliness, teamwork, consensus, and trust.

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Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline--Second Edition

1 Scope

CLSI documents M02,1 M07,2 and M1003 describe standardized methods and interpretive criteria for antimicrobial susceptibility testing of common aerobic bacteria, including some fastidious organisms. However, there are a number of less frequently encountered or fastidious bacteria that are not addressed in those CLSI documents. Some are organisms that may cause serious infections, infections associated with trauma and environmental contamination, or device-associated infections in immunocompromised or postsurgical patients. These latter organisms are addressed in this guideline with the goal of providing recommendations for clinical microbiology laboratories on how and when to determine the susceptibility of these diverse organisms. This edition of the guideline also includes some fastidious or unusual organisms, including those potentially associated with bioterrorism, which were previously included in CLSI document M100.3

2

Introduction

Organisms that previously lacked defined methods for susceptibility testing and interpretive criteria included various coryneform bacteria, Bacillus spp. (other than B. anthracis), Abiotrophia and Granulicatella spp., several genera of gram-positive bacteria with intrinsic glycopeptide resistance (eg, Erysipelothrix spp., Lactobacillus spp., Leuconostoc spp., and Pediococcus spp.), as well as several species of fastidious gram-negative bacteria (eg, HACEK group organisms and Pasteurella spp.). In addition, more detailed guidance for test performance and interpretation were needed, especially breakpoints for Listeria spp., Aeromonas spp., Plesiomonas sp., Vibrio spp., Moraxella catarrhalis, and Campylobacter spp. The lack of test methods or interpretive criteria made it difficult to assess the frequency of acquired resistance in these less frequently isolated or fastidious organisms and discouraged the testing of individual patient isolates by clinical laboratories. However, concerns had been raised that resistance exists in some of these organisms, and that laboratories should be prepared to test them when appropriate.4,5 Because infections due to organisms addressed in M45 occur less frequently than many of the organisms presently covered in CLSI documents M021 and M07,2 and because of the fact that many of the antimicrobial agents of interest have been marketed for a number of years, it is not reasonable to expect the intensive CLSI document M236 specified studies to be conducted on this special group of organisms. Instead, the goal of this document is to recommend test conditions and interpretive criteria based on a careful review of published microbiological data (distributions of minimal inhibitory concentrations [MICs]), limited animal model studies, the extant clinical literature regarding therapy for these organisms, and in a few instances, a review of existing pharmacokinetic data on the drugs of interest. In some cases, limited in vitro studies were performed. This edition of M45 includes several potential bacterial agents of bioterrorism that could be encountered initially by clinical microbiology laboratories and that should be forwarded to appropriate reference or public health laboratories for identification, confirmation, and possible susceptibility testing. The procedures included in this document are intended for use by those reference or public health laboratories. It is hoped that this CLSI guideline will assist clinical microbiology laboratories in determining an approach for testing these unusual organisms that is relevant to their individual practice settings.

©

Clinical and Laboratory Standards Institute. All rights reserved.

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The Quality Management System Approach

Clinical and Laboratory Standards Institute (CLSI) subscribes to a quality management system approach in the development of standards and guidelines, which facilitates project management; defines a document structure via a template; and provides a process to identify needed documents. The approach is based on the model presented in the most current edition of CLSI document HS01--A Quality Management System Model for Health Care. The quality management system approach applies a core set of "quality system essentials" (QSEs), basic to any organization, to all operations in any health care service's path of workflow (ie, operational aspects that define how a particular product or service is provided). The QSEs provide the framework for delivery of any type of product or service, serving as a manager's guide. The QSEs are as follows:

Documents and Records Organization Personnel Equipment Purchasing and Inventory Process Control Information Management Occurrence Management Assessments--External and Internal Process Improvement Customer Service Facilities and Safety

M45-A2 addresses the QSEs indicated by an "X." For a description of the other documents listed in the grid, please refer to the Related CLSI Reference Materials section on the following page.

Purchasing and Inventory Process Improvement Facilities and Safety M29 M31

Organization

Information Management

Occurrence Management

Assessments --External and Internal

Documents and Records

Equipment

Personnel

M07

X M02 M07 M23

Adapted from CLSI document HS01--A Quality Management System Model for Health Care.

Path of Workflow

A path of workflow is the description of the necessary steps to deliver the particular product or service that the organization or entity provides. For example, CLSI document GP26Application of a Quality Management System Model for Laboratory Services defines a clinical laboratory path of workflow, which consists of three sequential processes: preexamination, examination, and postexamination. All clinical laboratories follow these processes to deliver the laboratory's services, namely quality laboratory information. M45-A2 addresses the clinical laboratory path of workflow steps indicated by an "X." For a description of the other documents listed in the grid, please refer to the Related CLSI Reference Materials section on the following page. Preexamination

Sample Collection Sample Receipt/processing Sample Transport

Examination

Results Review and Follow-Up Interpretation

Postexamination

Results Reporting and Archiving

M02 M07 M31

M02 M07 M31 M100

M02 M07 M31 M100

M02 M07 M31 M100

Adapted from CLSI document HS01--A Quality Management System Model for Health Care.

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Clinical and Laboratory Standards Institute. All rights reserved.

Sample Management

Examination Ordering

Examination

Customer Service

Process Control

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Related CLSI Reference Materials

M02-A10 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard--Tenth Edition (2009). This document contains the current Clinical and Laboratory Standards Institute-recommended methods for disk susceptibility testing, criteria for quality control testing, and updated tables for interpretive zone diameters. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard--Eighth Edition (2009). This document addresses reference methods for the determination of minimal inhibitory concentrations (MICs) of aerobic bacteria by broth macrodilution, broth microdilution, and agar dilution. Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline--Third Edition (2008). This document addresses the required and recommended data needed for the selection of appropriate interpretive criteria and quality control ranges for antimicrobial agents. Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline-- Third Edition (2005). Based on US regulations, this document provides guidance on the risk of transmission of infectious agents by aerosols, droplets, blood, and body substances in a laboratory setting; specific precautions for preventing the laboratory transmission of microbial infection from laboratory instruments and materials; and recommendations for the management of exposure to infectious agents. Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Approved Standard--Third Edition (2008). This document provides the currently recommended techniques for antimicrobial agent disk and dilution susceptibility testing, criteria for quality control testing, and interpretive criteria for veterinary use. Performance Standards for Antimicrobial Susceptibility Testing; Twentieth Informational Supplement (2010). This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A10 and M07-A8.

M07-A8

M23-A3

M29-A3

M31-A3

M100-S20

CLSI documents are continually reviewed and revised through the CLSI consensus process; therefore, readers should refer to the most current editions. Clinical and Laboratory Standards Institute. All rights reserved.

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