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February 2010 M55-R SA M PL E Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and Challenges; A Report This document was developed to provide infection preventionists (infection control practitioners), infectious disease specialists, and microbiologists with the latest information regarding the development and implementation of a successful MRSA surveillance program. A CLSI report for global application. 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 E 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. 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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] M55-R Vol. 30 No. 5 Formerly X07-R Vol. 30 No. 5 ISBN 1-56238-719-7 ISSN 0273-3099 Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and Challenges; A Report Volume 30 Number 5 Abstract E Michele M. Schoonmaker, PhD Jacques Schrenzel, MD Douglas J. Shedden Patricia A. Somsel, DrPH David L. Tison, PhD, D(ABMM) Karine Truchon, MSc Henri Verbrugh, MD, PhD Stephen G. Weber, MD, MS J. Scott Weese, DVM, DVSc Donna Wolk, PhD, D(ABMM) PL Cassandra Salgado, MD, MS Fred C. Tenover, PhD, D(ABMM) Robert D. Arbeit, MD Karen Carroll, MD Phyllis Della Latta, PhD, MSc, D(ABMM) Patrice Francois, PhD Tobi B. Karchmer, MD, MS Lisa Louie, MLT, ART Frederick S. Nolte, PhD Lance R. Peterson, MD SA M Methicillin-resistant Staphylococcus aureus (MRSA) infections continue to be significant causes of morbidity and mortality worldwide in both health care and community settings. One strategy to reduce the transmission, particularly of MRSA, in health care settings is to conduct active surveillance of patients admitted to hospitals or other health care facilities for colonization using culture- or molecule-based identification methods. Because colonized patients serve as a reservoir of infection both for themselves and other patients, placing colonized patients in contact isolation with barrier precautions can reduce the spread of MRSA. Additional steps to decolonize the patient using mupirocin and chlorhexidine baths can further reduce transmission. CLSI document M55-R—Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and Challenges; A Report was developed to provide microbiologists, infection preventionists (infection control practitioners), and infectious disease specialists with both laboratory and infection control information regarding the development and implementation of a successful MRSA surveillance program. Information on surveillance of health care workers and animals for MRSA is also provided. Clinical and Laboratory Standards Institute (CLSI). Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and Challenges; A Report. CLSI document M55-R (ISBN 1-56238-719-7). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 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. Number 5 M55-R Copyright ©2010 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]. E 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 PL CLSI. Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and Challenges; A Report. CLSI document M55-R. Wayne, PA: Clinical and Laboratory Standards Institute; 2010. Report SA Published February 2010 M Approved by Board of Directors February 2010 ISBN 1-56238-719-7 ISSN 0273-3099 ii Volume 30 M55-R Contents Abstract ....................................................................................................................................................i Committee Membership........................................................................................................................ iii Foreword ................................................................................................................................................ix 1 Scope.......................................................................................................................................... 1 2 Introduction ................................................................................................................................ 1 2.1 Rationale ....................................................................................................................... 1 Standard Precautions .................................................................................................................. 2 4 Terminology............................................................................................................................... 2 Characteristics of Methicillin-Resistant Staphylococcus aureus ............................................... 6 5.1 6 Laboratory Methods for Detecting Methicillin-Resistant Staphylococcus aureus in Samples ...................................................................................................................................... 8 6.1 6.2 6.3 7 General Characteristics ................................................................................................. 6 Specimen Collection ..................................................................................................... 8 Anatomical Sites to Sample .......................................................................................... 9 Culture Methods for Methicillin-Resistant Staphylococcus aureus............................ 11 M 5 A Note on Terminology ................................................................................................ 2 Definitions .................................................................................................................... 3 Abbreviations and Acronyms ....................................................................................... 6 PL 4.1 4.2 4.3 E 3 Molecular Detection Methods.................................................................................................. 14 Assay Selection Criteria.............................................................................................. 14 Molecular Aspects of Methicillin Resistance ............................................................. 14 Target Genes and Strategies Allowing for Identification of Methicillin-Resistant Staphylococcus aureus ................................................................................................ 16 Assays Relying on the orfX-SCCmec Junction ........................................................... 17 Limitations of Current Molecular Assays ................................................................... 19 Role of Culture for Additional Testing ....................................................................... 19 Strain Typing of Methicillin-Resistant Staphylococcus aureus Isolates..................... 20 SA 7.1 7.2 7.3 7.4 7.5 7.6 7.7 8 Factors to Consider Before Implementation of a Methicillin-Resistant Staphylococcus aureus Surveillance Program in a Facility ............................................................................... 24 8.1 8.2 8.3 8.4 8.5 9 Methicillin-Resistant Staphylococcus aureus Prevalence........................................... 24 Screening of Patients .................................................................................................. 26 Screening Health Care Workers.................................................................................. 33 Screening in Other Settings ........................................................................................ 34 When to Consider Sampling ....................................................................................... 36 Screening Companion Animals for Methicillin-Resistant Staphylococcus aureus ................. 37 9.1 9.2 9.3 9.4 9.5 Screening Pets ............................................................................................................. 37 Screening Horses ........................................................................................................ 38 Screening Methodology: Sampling Sites .................................................................... 39 Screening Methodology: Laboratory Testing ............................................................. 39 Management of Colonized Animals ........................................................................... 39 vii Number 5 M55-R Contents (Continued) References ............................................................................................................................................. 40 Appendix. Methods ............................................................................................................................... 50 The Quality Management System Approach ........................................................................................ 52 SA M PL E Related CLSI Reference Materials ....................................................................................................... 54 viii Volume 30 M55-R Foreword M Key Words PL E Considerable attention has been given to the subject of methicillin-resistant Staphylococcus aureus (MRSA) colonization and infection in the press, particularly since the emergence of communityassociated MRSA infections. The deaths of otherwise healthy college athletes resulting from MRSA septicemia, the deaths of school-aged children following MRSA wound infections, and the morbidity caused by outbreaks of MRSA infection among professional sports teams are certainly newsworthy. Yet, underlying these news events of community disease is the more troubling reality of the transmission of MRSA and the ensuing morbidity and mortality among hospitalized patients around the world. To be sure, MRSA is only one of several health care–associated pathogens that deserve attention. Yet, that fact does not diminish the impact that this organism is having on health care around the world. The cost of health care–associated MRSA infections in the United States alone is astronomical. Thus, infection preventionists (formerly called infection control practitioners), infectious disease specialists, and clinical microbiologists are pursuing a variety of strategies aimed at reducing health care–associated MRSA (and methicillin-susceptible Staphylococcus aureus [MSSA]) infections. One strategy that is being implemented in multiple centers is active surveillance of patients admitted to hospitals or other health care facilities for MRSA colonization in an effort to identify patients who may serve as a reservoir of infection for other patients. In some cases in the United States, state legislative authorities have mandated such surveillance efforts, whereas other health care systems have initiated such studies prospectively. It has become increasingly clear that there is a dearth of information regarding the “how” of conducting active surveillance (ie, which patient populations to screen, optimal laboratory methods to use, and metrics to assess the effectiveness of the program), more than the “why” of such efforts (ie, reducing infection rates and cross-transmission of MRSA among patients). Therefore, this CLSI document was developed to provide information to those institutions that, for whatever reason, have decided to initiate an MRSA surveillance program. SA Colonization, cross-transmission, epidemiology, infection control, infection prevention, isolation precautions, methicillin resistance, mupirocin, nucleic acid amplification testing, rapid testing, staphylococci, surveillance ix Volume 30 M55-R Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and Challenges; A Report 1 Scope 2.1 Introduction Rationale PL 2 E This report describes a framework for establishing a surveillance program to detect methicillin-resistant Staphylococcus aureus (MRSA) colonization and infection in patients, health care workers (HCWs), and animals. It reviews the characteristics of MRSA isolates; both culture-based and molecular methods for detecting MRSA isolates in clinical samples, surveillance cultures, and environmental reservoirs; strain typing methods; epidemiological issues surrounding the spread of MRSA isolates in health care and other settings; interventions to halt transmission of MRSA; MRSA issues associated with animals; and public health aspects of MRSA transmission. Evidence-based information is presented to assist laboratories that are charged with the task of setting up MRSA surveillance programs for their institution or community. Additional information targeted to infection preventionists (infection control practitioners), clinicians, and public health officials to aid them in implementing a surveillance program for MRSA is also provided. M According to reports from the US Centers for Disease Control and Prevention (CDC) and others, the incidence of infections caused by MRSA has increased dramatically over the last decade, despite widespread measures aimed at preventing spread.1-5 To further complicate matters, the epidemiology of this potentially lethal pathogen has also evolved, with an ever-increasing number of MRSA cases arising among individuals in community settings without prior contact with the health care system.6 These community-associated MRSA strains (CA-MRSA), and the more familiar health care–associated MRSA strains (HA-MRSA), have, in some cases, been associated with more severe clinical outcomes and a substantially increased cost of care for affected patients.7 SA In response to these changes, many clinicians, health care administrators, and those working in infection control and prevention are taking a more aggressive approach toward preventing the spread of MRSA in their health care centers. Yet, a number of patient advocacy groups and public figures have been critical of what they perceive as too little effort to reduce the spread of MRSA. This has led to a series of unfavorable editorial commentaries in the popular press and the enactment of legislative initiatives aimed at promoting additional awareness and control of MRSA.8 Increasingly, a move toward “zero tolerance” of MRSA has been promoted in some regions in which the goal of prevention efforts is not simply to reduce the overall burden of infections caused by MRSA but actually to completely eliminate MRSA from individual units, patient care areas, hospitals, regions, and even entire countries. For the most part, the tools historically available to prevent the dissemination of MRSA and other multidrug-resistant organisms (MDROs) have emphasized the management of patients identified as colonized or infected with these organisms in the course of routine clinical care. In this approach, standard infection control and prevention methods, including hand hygiene and environmental cleaning, are applied uniformly for all patients. In addition, more intensive measures, such as the implementation of isolation precautions (the use of gowns and gloves when in contact with the patient or surrounding environment), are put in place once a patient is identified as colonized or infected with MRSA.9 Because of the renewed focus on MRSA control, even more aggressive measures have been proposed. Specifically, patients in many centers are being screened through culture and more rapid molecular diagnostic methods to identify those who are colonized with MRSA even in the absence of signs or © Clinical and Laboratory Standards Institute. All rights reserved. 1 Number 5 M55-R symptoms of infection. Such active surveillance strategies have been advocated as a key component of MRSA control by the Institute for Healthcare Improvement and the Society for Healthcare Epidemiology of America (SHEA).10 Such guidance has been influential: the US Veterans Administration has implemented a systemwide program in which patients are screened for MRSA colonization at all acute care facilities and laws mandating surveillance have been enacted in multiple US jurisdictions. More intensive surveillance to detect MRSA has not been limited to hospital inpatients. HCWs have been targeted for surveillance in some centers, and environmental sampling has become an increasingly common practice in health care facilities, particularly in those outside the United States. Moving out of the health care setting, there has been increasing appreciation of the potential for MRSA transmission in nonclinical settings, such as long-term acute care hospitals, nursing homes, and other long-term care facilities. Some advocacy groups have called for surveillance of the home environment, household contacts, and even companion and farm animals for evidence of MRSA contamination, colonization, or infection, respectively. Standard Precautions M 3 PL E MRSA infections add considerably to both the morbidity and mortality rates observed in a variety of patient populations and to the cost of health care in many countries.11-14 The spread of MRSA in community settings has complicated the problem of control.15 Efforts to interrupt transmission of MRSA strains, particularly in health care settings, require the identification of patients who are either infected or colonized with MRSA.16,17 Several laboratory methods, including traditional culture methods and nucleic acid amplification methods, are available to identify MRSA carriers. Once carriers are identified, several different infection control strategies may be used to interrupt the transmission of MRSA from patient to patient, from patient to HCW, and from HCW to patient. Preventing the spread of MRSA among patients and HCWs, or in community settings, to family members and other contacts, such as sports participants, is critical to the overall control of MRSA infections worldwide. This document reviews the laboratory and infection control issues surrounding the surveillance for MRSA. SA Because it is often impossible to know what isolates or specimens might be infectious, all patient and laboratory specimens are treated as infectious and handled according to “standard precautions.” Standard precautions are guidelines that combine the major features of “universal precautions and body substance isolation” practices. Standard precautions cover the transmission of all known infectious agents and thus are more comprehensive than universal precautions, which are intended to apply only to transmission of blood-borne pathogens. Standard and universal precaution guidelines are available from the CDC.18 For specific precautions for preventing the laboratory transmission of all known infectious agents from laboratory instruments and materials and for recommendations for the management of exposure to all known infectious disease, refer to CLSI document M29.19 4 4.1 Terminology A Note on Terminology CLSI, as a global leader in standardization, is firmly committed to achieving global harmonization wherever possible. Harmonization is a process of recognizing, understanding, and explaining differences while taking steps to achieve worldwide uniformity. CLSI recognizes that medical conventions in the global metrological community have evolved differently in the United States, Europe, and elsewhere; that these differences are reflected in CLSI, International Organization for Standardization (ISO), and European Committee for Standardization (CEN) documents; and that legally required use of terms, regional usage, and different consensus timelines are all important considerations in the harmonization process. In light of this, CLSI’s consensus process for development and revision of standards and guidelines focuses on harmonization of terms to facilitate the global application of standards and guidelines. 2 © Clinical and Laboratory Standards Institute. All rights reserved. Number 5 M55-R 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 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: Equipment Purchasing and Inventory Process Control Information Management Occurrence Management Assessments—External and Internal Process Improvement Customer Service Facilities and Safety E Documents and Records Organization Personnel Facilities and Safety Process Control Customer Service Process Improvement Assessments– External and Internal Occurrence Management Information Management Purchasing and Inventory Equipment Personnel PL M07 Organization Documents and Records M55-R 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. X M02 M07 M22 M M31 M40 MM01 MM03 MM10 MM11 MM13 MM17 M29 MM03 SA Adapted from CLSI document HS01—A Quality Management System Model for Health Care. 52 © Clinical and Laboratory Standards Institute. All rights reserved. Volume 30 M55-R 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. M55-R 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. MM01 MM01 MM03 M40 MM01 MM03 MM01 MM03 MM13 MM13 MM13 MM01 MM03 MM10 Sample management E Results reporting and archiving Interpretation Postexamination M02 M07 M31 M02 M07 M31 M02 M07 M31 PL M02 M07 M31 Results review and follow-up Examination Examination Sample receipt/processing Sample transport Sample collection Examination ordering Preexamination MM01 MM03 MM10 MM01 MM10 MM01 MM03 MM10 MM01 SA M Adapted from CLSI document HS01—A Quality Management System Model for Health Care. © Clinical and Laboratory Standards Institute. All rights reserved. 53 Number 5 M55-R Related CLSI Reference Materials Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Tenth Edition (2009). This document contains the current Clinical and Laboratory Standards Instituterecommended methods for disk susceptibility testing, criteria for quality control testing, and updated tables for interpretive zone diameters. M07-A8 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. M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition (2004). This document contains quality assurance procedures for manufacturers and users of prepared, ready-to-use microbiological culture media. M29-A3 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. M31-A3 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. M40-A Quality Control of Microbiological Transport Systems; Approved Standard (2003). This document provides criteria to assist manufacturers and end users of transport devices in providing and selecting dependable products for the transport of microbiological clinical specimens. MM01-A2 Molecular Diagnostic Methods for Genetic Diseases; Approved Guideline—Second Edition (2006). This document provides guidance for the use of molecular biological techniques for clinical detection of heritable mutations associated with genetic disease. MM03-A2 Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline—Second Edition (2006). This guideline addresses topics relating to clinical applications, amplified and nonamplified nucleic acid methods, selection and qualification of nucleic acid sequences, establishment and evaluation of test performance characteristics, inhibitors, and interfering substances, controlling false-positive reactions, reporting and interpretation of results, quality assurance, regulatory issues, and recommendations for manufacturers and clinical laboratories. SA M PL E M02-A10 MM10-A Genotyping for Infectious Diseases: Identification and Characterization; Approved Guideline (2006). This guideline describes currently used analytical approaches and methodologies applied to identify the clinically important genetic characteristics responsible for disease manifestation, outcome, and response to therapy in the infectious disease setting. It also provides guidance on the criteria to be considered for design, validation, and determination of clinical utility of such testing. MM11-A Molecular Methods for Bacterial Strain Typing; Approved Guideline (2007). This guideline examines the biology behind molecular strain typing and the process of characterizing and validating typing systems. The prevalent methods are described with particular attention to pulsed-field gel electrophoresis (PFGE) and multilocus sequence typing (MLST). CLSI documents are continually reviewed and revised through the CLSI consensus process; therefore, readers should refer to the most current editions. 54 © Clinical and Laboratory Standards Institute. All rights reserved. Volume 30 M55-R Related CLSI Reference Materials (Continued) Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline (2005). This document provides guidance related to proper and safe biological specimen collection and nucleic acid isolation and purification. These topics include methods of collection, recommended storage and transport conditions, and available nucleic acid purification technologies for each specimen/nucleic acid type. MM17-A Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline (2008). This guideline provides recommendations for analytic verification and validation of multiplex assays, as well as a review of different types of biologic and synthetic reference materials. SA M PL E MM13-A © Clinical and Laboratory Standards Institute. All rights reserved. 55 PL As we continue to set the global standard for quality in laboratory testing, we’re adding initiatives to bring even more value to our members and customers. E Explore the Latest Offerings from CLSI! Shop Our Online Products Including eM100, the interactive searchable database for drug selection, interpretation, and quality control procedures within M100-S23. 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Join in Our Mission to Improve Health Care Outcomes We’ve made it even easier for your organization to take full advantage of the standards resources and networking opportunities available through membership with CLSI. Find Membership Opportunities See the options that make it even easier for your organization to take full advantage of CLSI benefits and our unique membership value. For more information, visit www.clsi.org today. E PL M SA 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA P: 610.688.0100 Toll Free (US): 877.447.1888 F: 610.688.0700 E: [email protected] www.clsi.org ISBN 1-56238-719-7