APIC Implementation Guide Guide to Preventing Clostridium difficile Infections About APIC APIC’s mission is to create a safer world through prevention of infection. The association’s more than 14,000 members direct infection prevention programs that save lives and improve the bottom line for hospitals and other healthcare facilities. APIC advances its mission through patient safety, implementation science, competencies and certification, advocacy, and data standardization. About the Sponsor Clorox Healthcare believes that patient care and safety are the cornerstones of infection prevention, and is committed to supporting education that helps advance the professional development of Infection Preventionists and reduce healthcare-associated infections, particularly Clostridium difficile. As a long- standing APIC Strategic Partner, Clorox Healthcare is honored to fund this C. difficile Implementation Guide and congratulates APIC, the authors, and all who were involved in creating a guide that will serve as a free resource to the infection prevention community, with the goal of someday eradicating C. difficile. About the Implementation Guide series APIC Implementation Guides help infection preventionists apply current scientific knowledge and best practices to achieve targeted outcomes and enhance patient safety. This series reflects APIC’s commitment to implementation science and focus on the utilization of infection prevention research. Topic-specific information is presented in an easy-to- understand-and-use format that includes numerous examples and tools. Visit www.apic.org/implementationguides to learn more and to access all of the titles in the Implementation Guide series. Copyright © 2013 by the Association for Professionals in Infection Control and Epidemiology, Inc. (APIC) All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopied, recorded, or otherwise, without prior written permission of the publisher. Printed in the United States of America First edition, February 2013 ISBN: 1-933013-55-9 All inquiries about this guide or other APIC products and services may be directed addressed to: APIC 1275 K Street NW, Suite 1000 Washington, DC 20005 Phone: 202-789-1890 Fax: 202-789-1899 Email: [email protected] Web: www.apic.org Disclaimer APIC provides information and services as a benefit to both APIC members and the general public. The material presented in this guide has been prepared in accordance with generally recognized infection prevention principles and practices and is for general information only. The guide and the information and materials contained therein are provided “AS IS”, and APIC makes no representation or warranty of any kind, whether express or implied, including but not limited to, warranties of merchantability, noninfringement, or fitness, or concerning the accuracy, completeness, suitability, or utility of any information, apparatus, product, or process discussed in this resource, and assumes no liability therefore. Guide to Preventing Clostridium difficile Infections Table of Contents Acknowledgments ................................................................. 4 Declarations of Conflicts of Interest ................................................... 7 Introduction ...................................................................... 8 Section 1: Pathogenesis and Changing Epidemiology of Clostridium difficile Infection (CDI) ........ 9 Section 2: Diagnosis .............................................................. 15 Section 3: Modes of Transmission ................................................... 22 Section 4: Surveillance ............................................................ 24 Section 5: Focusing on Prevention: Hand Hygiene ...................................... 32 Section 6: Focusing on Prevention: Contact/Isolation Precautions ........................... 37 Section 7: Focusing on Prevention: Environmental Infection Prevention ...................... 50 Section 8: Special Considerations in Skilled Nursing Facilities .............................. 67 Section 9: CDI in Special Populations ................................................ 69 Section 10: Antimicrobial Stewardship and Clostridium difficile Infection: A Primer for the Infection Preventionist ........................................................... 73 Section 11: Fecal Bacteriotherapy .................................................... 81 Section 12: Glossary of Terms ........................................................ 87 Section 13: Frequently Asked Questions ................................................ 90 Appendix: Preventing the Transmission of Clostridium difficile in Healthcare Settings ............. 97 Association for Professionals in Infection Control and Epidemiology 3 Guide to Preventing Clostridium difficile Infections Acknowledgments Accomplishing this comprehensive update required input and expertise from a broad array of experts from practice and research settings. The Association for Professionals in Infection Control and Epidemiology acknowledges the valuable contributions from the following individuals: Lead author Ruth M. Carrico, PhD, RN, FSHEA, CIC Division of Infectious Diseases University of Louisville School of Medicine Louisville, Kentucky Contributors Kris Bryant, MD Department of Pediatric Infectious Disease University of Louisville School of Medicine Louisville, Kentucky Fernanda Lessa, MD, MPH Centers for Disease Control and Prevention Atlanta, Georgia Brandi Limbago, PhD Centers for Disease Control and Prevention Atlanta, Georgia Loretta Litz Fauerbach, MS, CIC Shands Hospital University of Florida Gainesville, Florida James F. Marx, RN, MS, CIC Broad Street Solutions San Diego, California 4 Association for Professionals in Infection Control and Epidemiology Guide to Preventing Clostridium difficile Infections Fontaine Sands, DrPH, MSN, CIC Eastern Kentucky University College of Health Sciences Richmond, Kentucky Dana Stephens, RN, CIC Saint Joseph Health System Lexington, Kentucky Kelly Westhusing, MPH, CPH University of Louisville School of Medicine Louisville, Kentucky Timothy Wiemken, PhD, MPH, CIC Division of Infectious Diseases University of Louisville School of Medicine Louisville, Kentucky Reviewers Barbara DeBaun, RN, MSN, CIC Improvement Advisor Cynosure Health San Francisco, California Sherrie Dornberger, RNC, GDCN, CDP, CDONA, FACDONA Executive Director The National Association Directors of Nursing Administration in Long Term Care Cincinnati, Ohio Christina Franic, RN, BSN, ICP, MSc, MBA CHICA – Canada Vancouver Island Health Authority Nanaimo, British Columbia, Canada Candace Friedman, MPH, CIC University of Michigan Hospitals and Health Centers Ann Arbor, Michigan Cindy Friis, MEd, BSN, RN-BC Smith Bucklin Co. Society of Gastroenterology Nurses and Associates, Inc. Chicago, Illinois Association for Professionals in Infection Control and Epidemiology 5 Guide to Preventing Clostridium difficile Infections Ann Herrin, BSN, RN, CGRN Veterans Administration Health Care System Society of Gastroenterology Nurses and Associates, Inc. San Diego, California Phenelle Segal, RN, CIC President Infection Control Consulting Services Delray Beach, Florida Production Team Managing Editor Thomas Weaver Director, Professional Practice Association for Professionals in Infection Control and Epidemiology, Inc. Project Management and Production Oversight Anna Conger Sr. Manager, Practice Resources Association for Professionals in Infection Control and Epidemiology, Inc. Layout Meredith Bechtle Maryland Composition Cover Design Sarah Vickers Art Director Association for Professionals in Infection Control and Epidemiology, Inc. 6 Association for Professionals in Infection Control and Epidemiology Guide to Preventing Clostridium difficile Infections Declarations of Conflicts of Interest Ruth M. Carrico, PhD, RN, FSHEA, CIC – Has nothing to declare. Kris Bryant, MD – Has acted as principal investigator on clinical trials funded by GSK, Novartis, Pfizer, and MedImmune. Barbara DeBaun, RN, MSN, CIC – Has nothing to declare. Sherrie Dornberger, RNC, GDCN, CDP, CDONA, FACDONA – Has nothing to declare. Christina Franic, RN, BSN, ICP, MSc, MBA – Has nothing to declare. Candace Friedman, MPH, CIC – Has nothing to declare. Cindy Friis, MEd, BSN, RN-BC – Has nothing to declare. Ann Herrin, BSN, RN, CGRN – Has nothing to declare. Fernanda Lessa, MD, MPH – Has nothing to declare. Brandi Limbago, PhD – Has nothing to declare. Loretta Litz Fauerbach, MS, CIC – Has nothing to declare. James F. Marx, RN, MS, CIC – Has nothing to declare. Fontaine Sands, DrPH, MSN, CIC – Has nothing to declare. Phenelle Segal, RN, CIC – Has nothing to declare. Dana Stephens, RN, CIC – Has nothing to declare. Kelly Westhusing, MPH, CPH – Has nothing to declare. Timothy Wiemken, PhD, MPH, CIC – Received two grants from Clorox Corporation to act as an investigator for activity of a hypochlorite-based environmental cleaner against C. difficile. Association for Professionals in Infection Control and Epidemiology 7 Guide to Preventing Clostridium difficile Infections Introduction Preventing Clostridium difficile transmission and prevention. Patients, long-term care residents,a infection continues to represent a serious and and families have been increasingly included difficult challenge in infection prevention and in care and care decisions. Patient and resident patient safety. The average total cost for a single education and healthcare professional training inpatient C. difficile infection (CDI) is more than continue to expand and evolve, producing new $35,000, and the estimated annual cost burden ways of addressing the problem. There has been for the healthcare system exceeds $3 billion.1 collaboration between environmental services The epidemiology of this infection is changing, professionals and infection preventionists that has and its presence in healthcare settings as well produced innovation in environmental assessment, as the community has caused personnel across cleaning, disinfection, monitoring, and evaluation. the entire healthcare continuum to re-evaluate And, there has been an increased understanding approaches and perspectives. Acknowledging of the need to use antimicrobials wisely. Clearly, this, the U.S. Department of Health and Human prevention of CDI requires a team approach. (See Services (HHS) convened the Federal Steering Appendix 1 for a diagrammatic overview of the Committee for the Prevention of Healthcare- prevention of CDI.) Associated Infections. Members of the steering committee include clinicians, scientists, and This document is an update to the 2008 public health leaders. In April 2012, the steering Elimination Guide and contains both new committee, along with scientists and program material and revised content that reflect the officials across HHS, released the National Action evolving practices and new discoveries. Plan to Prevent Healthcare-Associated Infections: Roadmap to Elimination,2 a healthcare-associated infection (HAI) action plan providing a roadmap References for preventing HAIs in acute care hospitals, 1. Walsh N. C. difficile Inpatient Stays Long, Costly. ambulatory surgical centers, and other facilities. MedPage Today. December 8, 2012. In the first phase, the HAI action plan focused on acute care hospitals where the scientific 2. U.S. Department of Health and Human Services. information on prevention and the capacity to National Action Plan to Prevent Healthcare-Associated measure improvement was most complete and Infections: Roadmap to Elimination. Available at: http:// where the associated morbidity and mortality www.hhs.gov/ash/initiatives/hai/actionplan/. Accessed was greatest. In phase 1, CDIs were specifically February 9, 2013. targeted because CDI rates have been increasing in recent years. Prevention strategies primarily focus on judicious antimicrobial use, environmental aThe authors realize that there are different terms used cleaning, and preventing transmission using basic when referring to persons in facilities. These include, but infection prevention isolation precautions. are not limited to, patient, resident, and client. For the purpose of this guide, the term patient will be used in Much needs to be done, but there has been a new order to avoid sentence structure that detracts from the level of collaboration and partnership to focus on information being conveyed. 8 Association for Professionals in Infection Control and Epidemiology Guide to Preventing Clostridium difficile Infections Section 1: Pathogenesis and Changing Epidemiology of Clostridium difficile Infection (CDI) Background commonly has two essential requirements: (1) exposure to antibiotics and (2) new acquisition Clostridium difficile, an anaerobic, Gram-positive, of C. difficile such as that occurring via fecal–oral spore-forming bacillus, was first detected in transmission. Although some people exposed to 1935 in lower intestinal microbiota of healthy these two factors will develop CDI, others may newborns.1 C. difficile was thought to be only become asymptomatically colonized. A third nonpathogenic for nearly four decades after factor, possibly related to host susceptibility or its initial isolation. It was only in 1978 that C. bacterial virulence, is thought to be an important difficile was identified as the primary cause of determinant for developing disease.6 In contrast pseudomembranous colitis in patients treated with antibiotics.2,3 Figure 1.1. Transmission and impact of C. difficile. Pseudomembranous colitis is an inflammatory condition of the colon that develops in response to toxins produced by microorganisms. This process occurs when the normal microbiota of the intestinal tract are disrupted, which usually happens as a result of antibiotic treatment. This allows organisms not affected by the particular antibiotic(s) to proliferate.4 In the case of C. difficile, this process enables C. difficile to attach to the mucosa of the colon and sets the stage for toxin production and resultant mucosal disease. Toxin-producing strains of C. difficile can cause illness ranging from mild or moderate diarrhea to pseudomembranous colitis, which can lead to toxic dilatation of the colon (megacolon), sepsis, and death. Figure 1.1 provides graphic demonstration of the transmission and impact of C. difficile. C. difficile infection (CDI) is the leading cause of antibiotic-associated diarrhea and a highly Modified from: Sunenshine RH, McDonald LC. Clos- Modified from: Sunenshine RH, McDonald LC. Clostridium difficile-associated problematic healthcare-associated infection tdrisiedaisue:m ne dwi cfhfiacllielneg-eass fsroomci aant eedsta dbliissheeads pea: thnoegwen . cChleavlel eCnling Je sM efrdo m an 2006;73:187-197. (HAI).5 The development of CDI most established pathogen. Cleve Clin J Med 2006;73:187-197. Association for Professionals in Infection Control and Epidemiology 9 Guide to Preventing Clostridium difficile Infections to many other HAIs, people who are colonized for preoperative prophylaxis has been associated (asymptomatic) with C. difficile appear to be at with CDI.17–19 Several studies suggest restriction decreased risk of developing CDI.7 of certain antibiotic classes or changes to the formulary that promote the use of narrow- Acquisition of C. difficile occurs by ingestion of spectrum antibiotics will reduce the incidence of spores, usually transmitted from other patients. CDI and control outbreaks.20–22 These activities This may occur as a result of contamination of form the basis for antimicrobial stewardship the patient environment, of shared equipment, or programs. via the hands of healthcare personnel (HCP).8,9 The spores resist the acidity of the stomach and In some studies, proton pump inhibitors (PPIs), germinate into vegetative bacteria in the small a group of drugs whose main action is reduction intestine. Alteration of the normal lower intestinal of gastric acid production, have shown a tendency microbiota by exposure to antibiotics provides an to increase the risk of both community- and environment that allows C. difficile to multiply, healthcare-associated CDI. The U.S. Food flourish, and produce toxins that cause colitis. and Drug Administration (FDA) issued a The virulence of C. difficile is caused primarily by communication (February 8, 2012) advising two large exotoxins, toxins A and B, which cause physicians to consider the diagnosis of CDI in inflammation and mucosal damage. An exotoxin patients taking PPI.23–25 However, no data are is a protein produced by a bacterium and released currently available suggesting that restriction of into its environment, causing damage to the host PPI use will decrease CDI incidence. Although by destroying other cells or disrupting cellular the mechanism by which PPI increases the risk of metabolism. Toxin-negative C. difficile strains are CDI is not understood, it has been suggested that considered nonpathogenic. Recent studies suggest PPI may play a more important role in patients that toxin B, not toxin A as previously thought, with minimal or no antibiotic exposure.26 is the major toxin responsible for C. difficile virulence.10,11 Available evidence suggests that the incubation period of C. difficile following acquisition is The major risk factors for CDI are exposure short (median of 2–3 days).9,27 Acquisition of to antibiotics, hospitalization, and advanced C. difficile is more likely to occur in the setting age.12 Nearly all antibiotics have been where patients become symptomatic and CDI is implicated in CDI, but certain antibiotic diagnosed.28 In contrast, the effect of antibiotics classes, such as cephalosporins, clindamycin, on the lower intestinal microbiota is much longer and fluoroquinolones, seem to have a higher lasting. Recent epidemiologic evidence indicates risk for causing disease. This may be related to patients remain at elevated risk for CDI for 3 or those antibiotics’ ability to disrupt normal lower more months after they have stopped antibiotic intestinal microbiota in addition to the antibiotic treatment.29,30 resistance patterns of prevalent C. difficile strains. In recent CDI outbreaks, fluoroquinolones have Changing epidemiology been the major class of antibiotics implicated in CDI,13–15 an association that has been attributed In recent years, the epidemiology of CDI has to high-level resistance to fluoroquinolones of the changed dramatically, with increases in incidence current epidemic strain, BI/NAP1/027.16 and severity of cases being reported across the United States, Canada, and Europe.31–34 In at Despite the fact that exposure to multiple least one U.S. region, C. difficile has replaced antibiotic classes and longer courses of therapy methicillin-resistant Staphylococcus aureus (MRSA) appear to increase an individual’s risk of CDI, as the most common cause of HAI.35 In the exposure to even a single dose of antibiotic given United States, the rate of hospital discharges 10 Association for Professionals in Infection Control and Epidemiology