Clinical Care Improvement Strategies:

Preventing Clostridium difficile Infections

Senior Editor: Ilese J. Chatman Project Manager: Andrew Bernotas Manager, Publications: Helen Fry, M.A. Associate Director, Production: Johanna Harris Executive Director: Catherine Chopp Hinckley, Ph.D. Joint Commission/JCR Reviewers: Sophie Duco; Helen Fry; Catherine Chopp Hinckley; Claudia Jorgenson; Louise Kuhny; Paul Reis; Susan Slavish Joint Commission International Reviewer: Ali Nashat Shaar Joint Commission Resources Mission The mission of Joint Commission Resources (JCR) is to continuously improve the safety and quality of health care in the United States and in the international community through the provision of education, publications, consultation, and evaluation services. Joint Commission International Mission A division of Joint Commission Resources, Inc. The mission of Joint Commission International (JCI) is to improve the safety and quality of care in the international community through the provision of education, publications, consultation, and evaluation services.

Joint Commission Resources educational programs and publications support, but are separate from, the accreditation activities of The Joint Commission. Attendees at Joint Commission Resources educational programs and purchasers of Joint Commission Resources publications receive no special consideration or treatment in, or confidential information about, the accreditation process. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. Every attempt has been made to ensure accuracy at the time of publication; however, please note that laws, regulations, and standards are subject to change. Please also note that some of the examples in this publication are specific to the laws and regulations of the locality of the facility. The information and examples in this publication are provided with the understanding that the publisher is not engaged in providing medical, legal, or other professional advice. If any such assistance is desired, the services of a competent professional person should be sought. © 2012 The Joint Commission Joint Commission Resources, Inc. (JCR), a not-for-profit affiliate of The Joint Commission, has been designated by The Joint Commission to publish publications and multimedia products. JCR reproduces and distributes these materials under license from The Joint Commission. All rights reserved. No part of this publication may be reproduced in any form or by any means without written permission from the publisher. Printed in the U.S.A. 5 4 3 2 1 Requests for permission to make copies of any part of this work should be mailed to Permissions Editor Department of Publications Joint Commission Resources One Renaissance Boulevard Oakbrook Terrace, Illinois 60181 U.S.A. [email protected] ISBN: 978-1-59940-606-0 Library of Congress Control Number: 2011932618 For more information about Joint Commission Resources, please visit http://www.jcrinc.com. For more information about Joint Commission International, please visit http://www.jointcommissioninternational.org. Photo Credit: Janice Haney Carr, Centers for Disease Control and Prevention

Contents Contents Introduction ............................................................................................vi Why Should You Read This E-Book? ......................................................................vii Who Should Read This E-Book?............................................................................viii About This E-Book ................................................................................................viii Acknowledgments ....................................................................................................ix Chapter 1: The Impact of Clostridium difficile Infections ....................1 C. difficile: A Crisis in Patient Safety ........................................................................1 What Is C. difficile? ..................................................................................................2 Common Reservoirs for C. difficile ..........................................................................6 At-Risk Populations ..................................................................................................6 Increased Risk Factors for C. difficile ........................................................................7 Efforts to Address C. difficile ....................................................................................8 Chapter 2: Requirements, Guidelines, and Standards of Care Related to Clostridium difficile ........................................................11 Accreditation Requirements ....................................................................................11 Standards Related to C. difficile ..............................................................................14 World Health Organization (WHO) Recommendations and Guidelines ................26 Centers for Disease Control and Prevention (CDC) Recommendations and Guidelines ............................................................................................................27 European Centre for Disease Prevention and Control Recommendations (ECDC) and Guidelines ......................................................................................27 Association for Professionals in Infection Control and Epidemiology (APIC) Recommendations and Guidelines ......................................................................28 Society for Healthcare Epidemiology of America (SHEA) Recommendations and Guidelines ....................................................................................................28 U.S. Centers for Medicare & Medicaid Services (CMS) Recommendations and Guidelines ....................................................................................................29

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Infectious Diseases Society of America (IDSA) Recommendations and Guidelines ............................................................................................................29 Why Use These Evidence-Based Standards of Care?................................................29

Chapter 3: Evidence-Based Best Practices for Preventing and Mitigating Clostridium difficile in Your Organization ....................37 Ensuring the Availability of Supplies ......................................................................37 Establishing Leadership Priority ..............................................................................38 Educating Staff........................................................................................................39 Conducting C. difficile Surveillance ........................................................................45 Collecting and Using C. difficile Data ....................................................................52 Diagnosing C. difficile Infection..............................................................................52 Monitoring, Analyzing, and Reporting ..................................................................54 Establishing an Antimicrobial Stewardship Program ..............................................56 Ensuring Rigorous Hand Hygiene ..........................................................................59 Ensuring Appropriate Cleaning and Disinfection of Equipment and the Environment ........................................................................................................61 Using Disposable or Dedicated Equipment ............................................................69 Using a Laboratory-Based Alert System ..................................................................69 Educating Patients and Families About Risk, Prevention, and Treatment................69 Placing Symptomatic Patients in Contact Precautions ............................................70 Encouraging Staff Compliance................................................................................71 Reassessing Compliance with Environmental Cleaning Protocols After Outbreaks ....................................................................................................73 Chapter 4: Sustaining Improvement ....................................................76 Assessing Incidents Through Root Cause Analysis ..................................................77 Exploring Risk Reduction Strategies with Failure Mode and Effects Analysis (FMEA) ......................................................................................82 Evaluating Improvement Actions ............................................................................84 Tools for Data Surveillance ....................................................................................86 Defining Each Goal, Scope, and Activity ................................................................88 Evaluating Proposed Improvement Actions ............................................................88 Defining the Measurement Plan..............................................................................91 Reevaluating Each Targeted Goal ............................................................................93 Conclusion..............................................................................................................93

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Chapter 5: Case Studies on Clostridium difficile Prevention............94 Duke University Medical Center, Durham, North Carolina ..................................95 Florida Hospital Tampa, Tampa, Florida ..............................................................101 Hospital Carlos Van Buren, Valparaiso, Chile ......................................................107 Providence St. Peter Hospital, Olympia, Washington............................................110

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Introduction

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ince the establishment of the first health care organization, infections have caused innumerable deaths and serious complications, and they have been one of the biggest obstacles health care professionals have faced in any setting. Many advances have occurred in health care, but the problem of infections persists. Today, health care–associated infections (HAIs) such as Clostridium difficile represent a risk to the health and well-being of all individuals and are associated with a remarkable increase in hospital lengths of stay and costs of treatment and reduced quality of outcomes.

Scientists first isolated a gram-positive, cytotoxin-producing anaerobic bacterium in the stool of neonates in 1935, and initially named it Bacillus difficilis (renamed in the 1970s to Clostridium difficile) because it was difficult to isolate and culture. First associated as the cause of antibiotic-associated diarrhea and colitis in 1978, C. difficile infection is currently on the rise, causing more severe diseases and an associated increase in mortality.1 C. difficile infection remains a disease mostly associated with health care settings (at least 80%). Patients most at risk are the elderly, particularly those receiving antibiotics, but the infection has been reported in traditionally low-risk persons, such as healthy people in the community and peripartum women.1 Despite the growing awareness of the problem among health care workers, C. difficile infection has begun to surpass MRSA (methicillin-resistant Staphylococcus aureus), becoming one of the most common causes of HAIs in the United States, and the agent most commonly responsible for health care–acquired diarrhea.2 The growing number of children, adults, and elderly individuals receiving care; the pressures on health care workers to deliver care; and the way in which services (such as cleaning) are provided within health care settings may all affect the growing spread of C. difficile. Frequent antibiotic use is also a likely cause for the rise in C. difficile incidence and the emergence of a new, highly virulent strain of the disease. According to the European Centre for Disease Prevention and Control (ECDC), the new strain of C. difficile is the cause of cases that have been reported in Belgium, Germany, Finland, France, Ireland,

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Luxembourg, the Netherlands, Switzerland, and the United Kingdom. This strain has also been detected in Austria, Denmark, Hungary, Norway, Poland, and Spain.3 The ECDC estimates that C. difficile infection costs the European Union about €3 million (more than U.S. $4.8 million) per year. It expects this figure to double through the next four decades.3 In 2004 the U.S. Centers for Disease Control and Prevention reported the emergence of a new epidemic strain of C. difficile–associated infection that caused outbreaks in several states.1 This epidemic strain appears to be more virulent, with the ability to produce greater quantities of toxins A and B. In addition, it is more resistant to the antibiotic group known as fluoroquinolones (any of a group of fluorinated derivatives of quinolone that are used as antibacterial drugs).1 These factors have led one researcher to characterize C. difficile infection as a “rising-tide situation.”4 The ever-increasing incidence of C. difficile highlights the challenges in controlling this infection. The broad scope of C. difficile infection makes programs targeting this infection complex by their very nature; such programs must involve staff in virtually every department and service of your organization—working together to protect patients. A study of 2,300 hospitals in California, Arizona, and Minnesota demonstrated the need for a comprehensive and collaborative approach to C. difficile infection, noting that hospitals with high rates of C. difficile infection also had high rates of other common infections. The “high” C. difficile–infected hospitals had more than 10 times the number of C. difficile infection cases as other hospitals while also treating a significantly larger proportion of other infections, such as bloodstream infections.5 The Joint Commission has responded to this growing epidemic by specifically identifying C. difficile as an HAI included in one of its National Patient Safety Goals. The aim of the goal and its requirements is to “reduce the risk of health care–associated infections.” Joint Commission International, the international accreditation arm of The Joint Commission, has also made reducing the risk of HAIs one of its International Patient Safety Goals.

Why Should You Read This E-Book? Clinical Care Improvement Strategies: Preventing Clostridium difficile Infections provides information to help in the prevention and mitigation of C. difficile infection. Its concise, need-to-know format provides practical information to clinicians and health care leaders. vii

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Clinical Care Improvement Strategies: Preventing Clostridium difficile Infections provides information and strategies—including real-world experiences of organizations and expert consensus. This publication provides references to Joint Commission requirements for readers in the United States and references to Joint Commission International requirements for organizations outside the United States. Please note that although U.S. and international standards are similar, they are not identical. Many of the concepts discussed, however, are applicable to health care organizations throughout the world. Specifically, readers can use this publication to better understand the following: • How to reduce rates and the incidences of C. difficile • How to improve hand hygiene practices for all staff • The most current concepts guiding The Joint Commission and Joint Commission International standards related to infection prevention and control. This information supports maximum infection prevention and control efforts and patient safety and meets accreditation requirements. • The importance of increased patient and family education and awareness • Information about health care staff education • How to enhance environment of care maintenance programs and equipment cleaning • The need for more aggressive antimicrobial stewardship programs

Who Should Read This E-Book? This publication is intended to benefit infection prevention and control leaders and staff, environment of care leaders and staff, patient safety officers and directors, physicians, nurses, risk managers, performance improvement professionals, and others involved in infection prevention and control at all types of health care organizations.

About This E-Book Chapter 1, “The Impact of Clostridium difficile Infections,” provides information about the impact of C. difficile infections, definitions of C. difficile and C. difficile infection, and information on payment implications and risk factors for C. difficile. Chapter 2, “Requirements, Guidelines, and Standards of Care Related to Clostridium difficile,” includes descriptions and overviews of Joint Commission and Joint Commission International standards related to C. difficile, the National and International Patient Safety Goal to reduce HAIs, and recommendations and key guidelines for combating C. difficile from organizations such as the World Health viii

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Organization, the Centers for Disease Control and Prevention, the Association for Professionals in Infection Control and Epidemiology, the Society for Healthcare Epidemiology of America, the Centers for Medicare & Medicaid Services, and the Infectious Diseases Society of America. Chapter 3, “Evidence-Based Best Practices for Preventing and Mitigating C. difficile in Your Organization,” offers evidence-based best practices for preventing and mitigating C. difficile. This includes ensuring the availability of supplies, training and empowering staff, ensuring proper hand hygiene, and implementing alert systems. Chapter 4, “Sustaining Improvement,” discusses how organizations can analyze and monitor their C. difficile programs and offers tools for surveillance. Chapter 5, “Case Studies on C. difficile Prevention,” features accounts from health care organizations that have reduced the risk of C. difficile or eliminated incidences of the infection. This chapter highlights the tools and best practices these organizations used to lower their rates of C. difficile infection. Informative “Tip” boxes are also provided throughout this e-book that contain advice and additional information on C. difficile and prevention efforts. Website links are also available by clicking on underlined text.

Acknowledgments The Joint Commission and Joint Commission Resources gratefully acknowledge the contributions of the staff at health organizations who agreed to serve as case studies for this publication. Their willingness to participate, desire to share their knowledge, and readiness in sharing resources and materials greatly improved the content of this publication. The following organizations serve as role models for C. difficile prevention and control efforts: • Apollo Gleneagles Hospital, Kolkata, India • Duke University Medical Center, Durham, North Carolina • Florida Hospital Tampa, Tampa, Florida • Hospital Carlos van Buren, Valparaiso, Chile • Providence St. Peter Hospital, Olympia, Washington We also thank freelance writer Janet McIntyre for her diligence in preparing this material on this important topic. ix

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References 1.

2.

3.

4. 5.

Centers for Disease Control and Prevention: Information About the Current Strain of Clostridium difficile. Updated Jan. 25, 2011. http://www.cdc.gov/HAI/organisms/cdiff/Cdiff-current-strain.html (accessed May 9, 2011). Miller B., et al.: The impact of hospital-onset healthcare facility associated (HO-HCFA) Clostridium difficile infection (CDI) in community hospitals: Surpassing methicillin-resistant Staphylococcus aureus (MRSA) as the new superbug. Paper presented at the Fifth Decennial International Conference on Healthcare–Associated Infections, Society for Healthcare Epidemiology of America, Atlanta, Mar. 18–22, 2010. http://shea.confex.com/shea/2010/webprogram/Paper2801.html (accessed May 9, 2011). European Centre for Disease Prevention and Control: Basic Facts. http://www.ecdc.europa.eu/en/ healthtopics/clostridium_difficile_infection/basic_facts/pages/basic_facts.aspx (accessed May 9, 2011). Drabu Y.: Holding back the tide. Nurs Manage (Harrow) 15(3):14–17, Jun. 2008. Ricciardi R., et al.: Predictors of Clostridium difficile colitis infections in hospitals. Epidemiol Infect 136:913–921, Jul. 2008.

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Chapter 1 The Impact of Clostridium difficile Infections C. difficile: A Crisis in Patient Safety While MRSA (methicillin-resistant Staphyloccous aureus) has captured public attention as a “super bug” in recent years, another multidrug-resistant organism (MDRO) has taken hold and is increasing in the United States (see Sidebar 1-1, page 2) and internationally.1,2 C. difficile infection has become more frequent, more severe, and more difficult to treat. Each year, tens of thousands of people in the United States get sick from C. difficile, including otherwise healthy individuals who are taking antibiotics. The U.S. Centers for Disease Control and Prevention estimates that there are 500,000 cases of C. difficile infection annually in the United States, contributing to between 15,000 and 30,000 deaths.3 C. difficile infection rates in Europe are on a similar path,4,5 with C. difficile infections in major European Union countries estimated to be responsible for 1.1 in 1,000 hospital admissions; the European rates are expected to double over the next four decades.6 The Canadian province of Quebec saw a quadrupling of C. difficile infections in a single year after stable rates for the previous 11 years.7 C. difficile infection is also increasing in Central and South America, although at a slower rate than in the United States and Europe.8 In Asia and the Middle East, limited data on C. difficile infections (which come from a different strain than infections occurring in the United States and Europe) suggest that the incidence has increased in Singapore, Japan, Korea, Thailand, Indian, and Taiwan.8 As serious as these statistics are, an Association for Professionals in Infection Control and Epidemiology (APIC) prevalence study of C. difficile in health care organizations in the United States provides even greater cause for concern. The APIC study found that C. difficile bacteria are causing more disease than previously estimated: It found that 13 out of every 1,000 inpatients are either infected or colonized with C. difficile.9 Based on this prevalence study, it is estimated that there are at least 7,100 patients with C. difficile infections on any given day in U.S. health care organizations.10 One study places the annual cost of treating C. difficile infections in U.S. hospitals as high as $3.2 billion.11 In adults, C. difficile infection results in increases in lengths of hospitalization, costs, morbidity, and mortality.12 1

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Sidebar 1-1. C. difficile Overtakes MRSA? C. difficile now rivals MRSA (methicillin-resistant Staphyloccous aureus) as the most common cause of health care–associated infections (HAIs) in the United States13 and the agent most commonly responsible for health care–acquired diarrhea. Between 2000 and 2003, the rate of C. difficile infections doubled in U.S. hospitals, with the greatest number of disease cases occurring in the elderly.13 C. difficile was 25% more common than MRSA in a study of hospitals in the U.S. Southeast. Other data indicate that MRSA rates are falling nationwide, as hospitals devote more attention to that particular HAI.1 In England, C. difficile has been reported as being responsible for more patient deaths than MRSA.14

Hospitalized children in the United States are also suffering from the C. difficile epidemic. Recent research shows that the number of C. difficile infection cases in children increased about 15% in each year studied. Children with the infection had an increased risk of death or surgery to remove all or part of the colon, longer hospital stays, and increased hospital costs.15 On the opposite side of the age spectrum, data from a Pennsylvania study show that almost 40% of gastrointestinal infections in long term care residents are related to C. difficile infection.16 In fact, C. difficile is the fourth most frequent type of infection in long term care facilities.17 These trends make it clear that C. difficile is an epidemic that demands the attention of health care organizations and health care workers.

What Is C. difficile? C. difficile is a spore-forming, gram-positive anaerobic bacillus that produces two exotoxins: toxin A and toxin B. It was recognized in the 1970s as a common cause of antibiotic-associated diarrhea, accounting for 15% to 25% of all episodes of antibioticassociated diarrhea.18 This anaerobic bacteria species began causing increasing numbers of outbreaks of diarrheal disease in hospitals and long term care organizations beginning in the 1980s and 1990s.3 C. difficile infections occur when the spores that are found in feces are spread by contact with infected individuals or through the environment when an uninfected person touches any surfaces or items (such as toilets, bathtubs, blood pressure cuffs, or 2

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Contributions to the Limited Increase of Knowledge About C. difficile

• Clinical contentment that C. difficile was a trouble that was simply controlled • Lack of clinical awareness and tracking of C. difficile infections • Early discovery of treatment (the antibiotics vancomycin and metronidazole) muffled new drug development • The mistaken belief that C. difficile infection is considerably understood • Fading use of anaerobic culture for diagnosis • Restrictions on the use of the hamster model of the infection* • Lack of funding for C. difficile research * The hamster model refers to studies related to colonization with nontoxigenic C. difficile strains that proved highly effective in preventing C. difficile infection in hamsters challenged with toxigenic C. difficile strains. Source: Adapted from Gerding D.N.: Clostridium difficile 30 years on: What has, or has not, changed and why? Int J Antimicrob Agents 33(Suppl. 1):S2–S8, Mar. 2009.

electronic rectal thermometers) contaminated with the bacteria and then the person touches his or her mouth or mucous membranes. The spores then travel through the digestive tract and colonize the intestine. Patients who are colonized with C. difficile are often asymptomatic. However, colonization predisposes a person to an infection, particularly when the intestinal tract’s naturally occurring microorganisms are diminished or eradicated through the use of antibiotics causing the C. difficile bacteria to multiply and produce harmful toxins. Thus, C. difficile may remain in a healthy person’s system without causing the infection until the normal system flora are changed, usually through antibiotic use either for treatment for infection or as prophylaxis before surgery. Unfortunately, almost every type of antibiotic has been found to contribute to C. difficile infection, including fluoroquinolones, which had previously not been associated with C. difficile infection.12 In most cases, it is impossible to determine whether C. difficile is newly acquired in the setting or whether the pathogen was already present in the intestine, suppressed by the presence of other harmless bacteria.

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Colonization Versus Infection

What is the difference between C. difficile colonization and C. difficile infection? With C. difficile colonization (which is more common than C. difficile infection), the following occurs: • The patient exhibits no clinical symptoms. • The patient tests positive for C. difficile organism and/or its toxin. With C. difficile infection, the following occurs: • The patient exhibits clinical symptoms. • The patient tests positive for C. difficile organism and/or its toxin.

The Increasing Severity of C. difficile Many different C. difficile strains are found throughout the world. Since 2000 one particular strain—known in the United States as NAP1 and known in Europe and Canada as 027 or BI strain—has become the most frequently isolated C. difficile strain. The incidence of this epidemic and highly toxic strain of C. difficile has been closely associated with severe C. difficile infections, and its incidence increased shortly after it acquired resistance to fluoroquinolone antibiotics.19 This particular strain also poses new challenges. C. difficile normally makes two toxins—A and B—but a third formerly uncommon and more virulent binary toxin has been seen in C. difficile. The change in C. difficile epidemiology is likely due to a particularly aggressive variant of the organism that constantly produces toxins at a much higher level than past strains.

C. difficile Symptoms Symptoms of C. difficile infection include the following20: • Fever • Loss of appetite • Nausea • Abdominal pain/tenderness • Watery diarrhea (at least three bowel movements per day for two or more days) after undergoing antibiotic therapy. The diarrhea can contain blood and/or mucus.

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C. difficile Treatment

In about 20% of patients, C. difficile infection resolves within 2 to 3 days of discontinuing the antibiotic to which the patient was previously exposed. The infection can usually be treated with an appropriate course (about 10 days) of antibiotics.18 In the United States, vancomycin and fidaxomicin, taken orally, are the only antibiotics approved by the Food and Drug Administration for treatment of C. difficile infection. Metronidazole is, however, commonly recommended for mild to moderate cases. Metronidazole, which can be administered intravenously or orally, costs less than vancomycin and fidaxomicin, and it addresses concerns about vancomycin-resistant organisms such as Enterococcus. After treatment, repeat C. difficile testing is not recommended if the patients’ symptoms have resolved, as patients may remain colonized.21

In addition to diarrhea, C. difficile can cause serious conditions such as colitis (inflammation of the large intestine), perforations of the colon, sepsis, and even death (though rarely) if not properly diagnosed and treated.22

C. difficile Detection Methods Frequently grouped with MDROs, C. difficile cases are detected as diarrhea without other known causes that meet one or more of the following criteria12: • The stool sample yields a positive result for C. difficile toxin A and/or B, or a C. difficile organism is detected in the stool sample by culture or other means. • Pseudomembranous colitis (acute inflammation) is seen by endoscopic examination or surgery. • Pseudomembranous colitis is seen on histopathological examination. An enzyme immunoassay test can be used to detect toxin A only or to detect both toxins A and B. More than 90% of laboratories in the United States have adopted these tests because of their ease of use and lower labor costs compared to other methods, but they are no longer recommended as stand-alone tests.23 To overcome the lack of sensitivity in toxin testing, new expert recommendations emphasize a two-step method 5

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that uses enzyme immunoassay detection of glutamate dehydrogenase (GDH) antigen assays for initial screenings, with cell cytotoxicity assay or toxigenic culture as a confirmatory test for GDH–positive stool specimens. More information about testing is found in Chapter 3.

Common Reservoirs for C. difficile C. difficile spores are transferred to patients mainly via the hands of health care personnel who have touched contaminated surfaces or items.18 C. difficile spores can live on environmental surfaces for months because of their resistance to traditional disinfectants, drying, and heat. Therefore, all surfaces, supplies, and equipment that come into contact with an individual with C. difficile infection can be contaminated. Common reservoirs for C. difficile in health care settings can include bedrails, thermometers, stethoscopes, blood pressure cuffs, doorknobs, light switches, IV fluid pumps, toilet seats and handles, TV remotes, hospital bed remotes, call buttons, telephones, floors, sinks, wheelchairs, and so on. In one study, researchers were able to find C. difficile on at least one surface or device in every sampled room of hospital patients with C. difficile infection.24 Patients with C. difficile infection also have C. difficile contamination on their skin. One study showed that 93% of patients with C. difficile infection had contamination of at least one cutaneous site, such as the groin, abdomen, chest, hand, and/or forearm.25 Even asymptomatic carriers have high rates (69%) of skin contamination.26

At-Risk Populations Although the rising incidence of C. difficile shows that the infection can strike a wide variety of people, advanced age is the most important risk factor. Patients older than age 65 have a C. difficile infection rate five times higher than patients ages 45 to 64 and a rate 20 times higher than patients ages 15 to 45.13 In addition, anyone who has received antimicrobials—even a single-dose surgical antibiotic—is at increased risk for C. difficile infection because these drugs allow C. difficile to grow.23 Other populations at risk for C. difficile infection include cancer patients receiving chemotherapy, people infected with HIV, and individuals who have had gastrointestinal surgery or manipulation of the gastrointestinal tract, including tube feeding.23 C. difficile infection is also increasing in peripartum women, a trend that is concerning because pregnant women tend to be much younger and healthier than the general hospitalized population.27 The majority of the C. difficile infection cases in this 6

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population were seen in women who underwent C-sections, leading researchers to theorize that the use of antimicrobial prophylaxis before surgery is leaving this population vulnerable to C. difficile infection.27

Increased Risk Factors for C. difficile Any factor associated with disruption of the normal gut flora increases the risk for C. difficile, and most C. difficile cases occur in health care settings. The risk for C. difficile infection increases in patients with the following risk factors18,28–37: • Antibiotic exposure: Preceding antibiotic administration is demonstrated in roughly 95% of inpatient C. difficile infection cases. • Gastric acid suppression/proton pump inhibitors: Hospitalized patients are more than twice as likely to develop C. difficile infection if prescribed proton pump inhibitors. Gastric acid suppression with this group of drugs is common in intensive care unit patients because of drug interactions and organ dysfunction that typically occur in the intensive care unit. C. difficile infection is the most common infectious cause of diarrhea in the intensive care unit. • Nasogastric tube or tube feedings: Enteral feeding, or tube feeding, is another common practice in the intensive care unit that may be a contributing factor in developing C. difficile infection. Factors that may contribute to increased infection risks include contamination of the formula or equipment during handling or changes in the colonic environment associated with the special formulas. Studies have shown that enteral feeding doubles the risk of C. difficile infection. • Long length of stay in health care settings: Extended lengths of stay in health care organizations pose significant risks, presenting increased opportunities for patients to be exposed to C. difficile. In addition, individuals who have long lengths of stay frequently receive antibiotic therapy, again increasing the risk of C. difficile infection. • Serious underlying illness/compromised immune system: Individuals who are undergoing chemotherapy or have HIV are at risk for C. difficile infection, likely because of antibiotic use and compromised immune systems. • Infants: Although C. difficile infection is less common in children than in adults, infants in the neonatal intensive care unit may be at risk for C. difficile because contamination is frequently found in this setting. Studies have also shown that infants are more likely than adults to be asymptomatically colonized with C. difficile, with colonization rates from 2% to 70%. Young children who are colonized with C. difficile but show no symptoms represent a reservoir for transmission of the disease to others. • Malnutrition: A U.K. study showed that patients with a high Malnutrition Universal Screening Tool (MUST) score were at increased risk of C. difficile infection. 7

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• Placement in a room with an individual with C. difficile: Having a roommate with C. difficile and having exposure to hospital units with high prevalence of C. difficile are associated with increased risks.

Efforts to Address C. difficile Spreading prevention, not the infection, is at the heart of efforts to reduce C. difficile infection and colonization rates. Success requires clinical and administrative commitment to improving prevention rates through, for example, environmental cleaning and disinfection, early detection, and aggressive treatment measures. There are numerous evidence-based strategies and best practices to prevent and control C. difficile, as well as guidelines and reports produced by a variety of health care organizations, government agencies, and patient safety organizations. Nevertheless, C. difficile is spawning infections at growing rates in the United States and poses an ever-increasing threat around the world. This may be due to overuse of antibiotics, the complex nature of implementing the recommended best practices, the difficulty in changing hand hygiene patterns, problems allocating the required staff and resources, difficulty adequately training staff, and a host of other issues. The following chapters will help your organization use requirements, guidelines, and standards of care related to C. difficile; adopt evidence-based best practices to prevent and mitigate C. difficile ; sustain improvement; and learn from the experiences of other organizations. References 1.

2. 3.

4. 5.

Miller B., et al.: The impact of hospital-onset healthcare facility associated (HO-HCFA) Clostridium difficile infection (CDI) in community hospitals: Surpassing methicillin-resistant Staphylococcus aureus (MRSA) as the new superbug. Paper presented at the Fifth Decennial International Conference on Healthcare–Associated Infections, Society for Healthcare Epidemiology of America. Atlanta, Mar. 18–22, 2010. http://shea.confex.com/shea/2010/webprogram/Paper2801.html (accessed May 17, 2011). World Health Organization (WHO): WHO Guidelines on Hand Hygiene in Health Care. Geneva: WHO, 2009. Tenover F.C.: U.S. Centers for Disease Control Congressional Testimony: United States Senate Committee on Health, Education, Labor and Pensions, Jun. 24, 2008. http://www.cdc.gov/washington/testimony/2008/t20080624.htm (accessed May 14, 2011). Asenio A., et al.: Increasing rates in Clostridium difficile infection (CDI) among hospitalised patients, Spain 1999–2007. Euro Surveill 13:18943, Jul. 31, 2008. Coignard B., et al.: Emergence of Clostridium difficile toxinotype III, PCR-ribotype 027associated disease, France, 2006. Euro Surveill 11:E060914.1, Sep. 14, 2006.

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Kuijper E.J., et al.: Emergence of Clostridium difficile–associated disease in North America and Europe. Clin Microbiol Infect 12(Suppl. 6):2–18, Oct. 2006. Pépin J., et al.: Clostridium difficile–associated diarrhea in a region of Quebec from 1991 to 2003: A changing pattern of disease severity. CMAJ 171:466–472, Aug. 31, 2004. Chen L.F., Sexton D.J.: CDI: A Global Perspective of an Epidemic, Sep. 30, 2008. http://www.medscape.org/viewarticle/580913 (accessed May 14, 2011). Association for Professionals in Infection Control and Epidemiology: Press Release: Intestinal Infection Afflicts 13 of 1,000 Hospital Patients: Infection Rates 6.5–20 Times Greater Than Previous Estimates, New Study Says. Nov. 11, 2008. http://www.apic.org/Content/NavigationMenu/ResearchFoundation/ NationalCDiffPrevalanceStudy/C_diff_study_release_FINAL.pdf (accessed May 20, 2011). Dubberke E.R., et al.: Short- and long-term attributable costs of Clostridium difficile–associated disease in nonsurgical inpatients. Clin Infect Dis 46:497–504, Feb. 15, 2008. Dubberke E.R., et al.: Strategies to prevent Clostridium difficile infections in acute care hospitals. Infect Control Hosp Epidemiol 29(Suppl. 1):S81–S92, Oct. 2008. Nylund C.M., et al.: Clostridium difficile infection in hospitalized children in the United States. Arch Pediatr Adolesc Med 165:451–457, May 2011. Jarvis W.R., et al.: National point prevalence of Clostridium difficile in US healthcare facility inpatients, 2008. Am J Infect Control 37:263–270, May 2009. Report: Deaths involving MRSA and Clostridium difficile by communal establishment: England and Wales, 2001–06. Health Stat Q 38:74–76, Summer 2008. http://www.statistics.gov.uk/downloads/ theme_health/HSQ38_MRSA_CDiff.pdf (accessed May 20, 2011). Pennsylvania Patient Safety Authority: Press Release: Studies Show Significant Increases of C. difficile Infections (CDI). Mar. 18, 2010. http://patientsafetyauthority.org/NewsAndInformation/ PressReleases/2010/documents/pr_2010_March_18.pdf (accessed May 14, 2011). Nicolle L.E.: Long-term care issues for the twenty-first century. In Wenzel R.P. (ed.): Prevention and Control of Nosocomial Infections, 4th ed. Philadelphia: Lippincott Williams & Wilkins, 2003, pp. 66–86. Centers for Disease Control and Prevention: Frequently Asked Questions About Clostridium difficile for Healthcare Providers. Updated Mar. 22, 2011. http://www.cdc.gov/HAI/organisms/ cdiff/Cdiff_faqs_HCP.html (accessed May 14, 2011). Jump R.L.P., et al.: Multihospital Outbreak of Clostridium difficile infection, Cleveland, Ohio, USA. Emerg Infect Dis, May 2010. http://www.cdc.gov/EID/content/16/5/827.htm (accessed May 14, 2011). Centers for Disease Control and Prevention: Clostridium difficile Infection (C. diff, CDI, C. difficile). Updated Mar. 22, 2011. http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_infect.html (accessed May 14, 2011). Joint Commission Resources: Minimizing the growing threat of Clostridium difficile. Joint Commission Perspectives on Patient Safety 6:5–6, Jun. 2006.

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21. Bobulsky G.S., et al.: Clostridium difficile skin contamination in patients with C difficile–associated disease. Clin Infect Dis 46:447–450, Feb. 2008. 22. Cohen S.H., et al.: Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol 31:431–455, May 2010. 23. Dubberke E.R., et al.: Prevalence of Clostridium difficile environmental contamination and strain variability in multiple health care facilities. Am J Infect Control 35:315–318, Jun. 2007. 24. Riggs M.M., et al.: Asymptomatic carriers are a potential source for transmission of epidemic and nonepidemic Clostridium difficile strains among long-term care facility residents. Clin Infect Dis 45:992–998, Oct. 2007. 25. McDonald L.C., Owings M., Jernigan D.B.: Clostridium difficile infection in patients discharged from U.S. short-stay hospitals, 1996–2003. Emerg Infect Dis 12:409–415, Mar. 2006. 26. Kuntz J.L, et al.: Trends in Clostridium difficile infection among peripartum women. Infect Control Hosp Epidemiol 31:532–534, May 2010. 27. Calfee D.P.: Clostridium difficile: A reemerging pathogen. Geriatrics 63:10–21, Sep. 2008. 28. Marra A.R., et al.: Hospital–acquired Clostridium difficile–associated disease in the intensive care unit setting: Epidemiology, clinical course and outcome. BMC Infect Dis 7:42, May 21, 2007. 29. Dubberke E.R., et al.: Clostridium difficile–associated disease in a setting of endemicity: Identification of novel risk factors. Clin Infect Dis 45:1543–1549, Dec. 15, 2007. 30. Brett S.: Science review: The use of proton pump inhibitors for gastric acid suppression in critical illness. Crit Care 9:45–50, Feb. 2005. 31. Polin R.A., Saiman L.: Nosocomial infections in the neonatal intensive care unit. NeoReviews 4:81–89, 2003. 32. Henrich T.J., et al.: Clinical risk factors for severe Clostridium difficile–associated disease. Emerg Infect Dis 15:415–422, Mar. 2009. 33. Asha N.J., Tompkins D., Wilcox M.H.: Comparative analysis of prevalence, risk factors, and molecular epidemiology of antibiotic-associated diarrhea due to Clostridium difficile, Clostridium perfingens, and Staphyloccus aureus. J Clin Microbiol 44:2785–2791, Aug. 2006. 34. Stabler R.A., et al.: Comparative genome and phenotypic analysis of Clostridium difficile 027 strains provides insight into the evolution of a hypervirulent bacterium. Genome Biol 10(9):R102, Sep. 25, 2009. 35. Association for Professionals in Infection Control and Epidemiology (APIC): Guide to the Elimination of Clostridium difficile in Healthcare Settings. Washington, DC: APIC, 2008. 36. Farrer K.: Malnutrition universal screening tool: A risk factor for Clostridium difficile infection in hospital? Proc Nutr Soc 68:E46, 2009. 37. Lawrence S., et al.: Clostridium difficile in the intensive care unit: Epidemiology, costs, and colonization pressure. Infect Control Hosp Epidemiol 28:123–130, Feb. 2007.

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Chapter 2 Requirements, Guidelines, and Standards of Care Related to Clostridium difficile

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he Joint Commission, Joint Commission International, and other safety-focused organizations around the world are committed to helping health care organizations reduce the incidence of C. difficile. This chapter discusses different requirements, recommendations, guidelines, and evidence-based standards of care that health care organizations can follow to effectively address the C. difficile problem. Applicable accreditation standards and requirements from the 2011 Comprehensive Accreditation Manual for Hospitals and Joint Commission International Accreditation Standards for Hospitals, 4th edition, are outlined, along with a discussion of the requirements of the National Patient Safety Goal and International Patient Safety Goal to reduce the risk of health care–associated infections (HAIs).*

Accreditation Requirements HAIs such as C. difficile are a critically important issue for patient safety and quality care. The Joint Commission accredits and certifies more than 19,000 health care organizations, and HAIs are a significant daily risk in all health care settings. For this reason, The Joint Commission makes infection prevention and control a component of both its accreditation standards and its National Patient Safety Goals requirements.

Reducing the Risk of HAIs The purpose of The Joint Commission’s National Patient Safety Goals is to promote specific improvements in patient safety. The goals highlight problematic areas in health care and describe evidence-based, expert-supported, and often systemwide solutions that address these areas. By complying with the goals, organizations can promote patient safety and minimize or prevent the potential for errors. Joint Commission National Patient Safety Goal (NPSG) 7 requires organizations to reduce the risk of HAIs, and it specifically addresses C. difficile in NPSG.07.03.01 (see Table 2-1, pages 12–13). * The accreditation manuals listed were in effect at the time of this e-book’s publication. Be sure to check the most up-to-date edition of the accreditation manuals for the current requiremetns.

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Table 2-1. National Patient Safety Goal (NPSG) 7 Goal 7 Reduce the risk of health care–associated infections. NPSG.07.03.01 Implement evidence-based practices to prevent health care–associated infections due to multidrug-resistant organisms in acute care organizations. Note: This requirement applies to, but is not limited to, epidemiologically important organisms such as methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile, vancomycin-resistant enterococci (VRE), and multidrug-resistant gram-negative bacteria. Elements of Performance for NPSG.07.03.01 1. Conduct periodic risk assessments (in time frames defined by the organization) for multidrug-resistant organism acquisition and transmission. 2. Based on the results of the risk assessment, educate staff and licensed independent practitioners about health care–associated infections, multidrugresistant organisms, and prevention strategies at hire and annually thereafter. Note: The education provided recognizes the diverse roles of staff and licensed independent practitioners and is consistent with their roles within the organization. 3. Educate patients, and their families as needed, who are infected or colonized with a multidrug-resistant organism about health care–associated infection prevention strategies. 4. Implement a surveillance program for multidrug-resistant organisms based on the risk assessment. Note: Surveillance may be targeted rather than organization-wide. 5. Measure and monitor multidrug-resistant organism prevention processes and outcomes, including the following: • Multidrug-resistant organism infection rates using evidence-based metrics • Compliance with evidence-based guidelines or best practices (continued)

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Table 2-1. National Patient Safety Goal (NPSG) 7, continued

6.

7.

8.

9.

• Evaluation of the education program provided to staff and licensed independent practitioners Note: Surveillance may be targeted rather than organization-wide. Provide multidrug-resistant organism process and outcome data to key stakeholders, including leaders, licensed independent practitioners, nursing staff, and other clinicians. Implement policies and practices aimed at reducing the risk of transmitting multidrug-resistant organisms. These policies and practices meet regulatory requirements and are aligned with evidence-based standards (for example, the Centers for Disease Control and Prevention [CDC] and/or professional organization guidelines). When indicated by the risk assessment, implement a laboratory-based alert system that identifies new patients with multidrug-resistant organisms. Note: The alert system may use telephones, faxes, pagers, automated and secure electronic alerts, or a combination of these methods. When indicated by the risk assessment, implement an alert system that identifies readmitted or transferred patients who are known to be positive for multidrug-resistant organisms. Note 1: The alert system information may exist in a separate electronic database or may be integrated into the admission system. The alert system may be either manual or electronic or a combination of both. Note 2: Each organization may define its own parameters in terms of time and clinical manifestation to determine which re-admitted patients require isolation.

Joint Commission International also emphasizes prevention and control of infections in its standards, measureable requirements, and the International Patient Safety Goals (see Table 2-2, page 14). Development of Joint Commission International’s standards is actively overseen by an international task force whose members are drawn from each of the world’s populated continents. Although many of the international standards are similar to domestic standards, the Joint Commission’s domestic standards reflect the 13

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Table 2-2. International Patient Safety Goal (IPSG) 5 IPSG.5 Reduce the risk of health care–associated infections. Measurable Elements of IPSG.5 1. The organization has adopted or adapted currently published and generally accepted hand-hygiene guidelines. 2. The organization implements an effective hand-hygiene program. 3. Policies and/or procedures are developed that support continued reduction of health care–associated infections.

many local, state, and national laws that govern health care in the United States and do not apply internationally. International standards are broader based in order to respect country and cultural differences. Joint Commission International standards are comparable to U.S. standards in expectations and intensity, but they are different.

Standards Related to C. difficile Health care practitioners are all too familiar with HAIs such as C. difficile. Despite making great strides in preventing and treating disease, modern health care has yet to conquer the risk to patients of acquiring an infection in the very place where infection should be least present. In addition to the National Patient Safety Goal and International Patient Safety Goal to reduce the risk of HAIs, The Joint Commission and Joint Commission International standards (see Table 2-3, pages 15–19, and Table 2-4, pages 20–26) require organizations to address the risk of acquiring and transmitting infections such as C. difficile. Organizations need to establish a comprehensive and systematic infection prevention and control program. The design and scope of the program are determined by the specific risks faced by each facility’s location, the population(s) served, and the types of services provided. The infection prevention and control activities adopted should also be practical and reasonable to follow. No organization wants to jeopardize a patient’s health because its infection prevention and control activities are outmoded or too confusing to practice daily. After an effective program is in place, organizations must take measures to ensure that the program operates according to plan and is evaluated appropriately. 14

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Table 2-3. Joint Commission Infection Prevention and Control (IC) Standards Standard IC.01.02.01 Organization leaders allocate needed resources for the infection prevention and control program. Elements of Performance for IC.01.02.01 1. The organization provides access to information needed to support the infection prevention and control program. 2. The organization provides laboratory resources when needed to support the infection prevention and control program. 3. The organization provides equipment and supplies to support the infection prevention and control program. Standard IC.01.03.01 The organization identifies risks for acquiring and transmitting infections. Elements of Performance for IC.01.03.01 The organization identifies risks for acquiring and transmitting infections based on the following: 1. Its geographic location, community, and population served. 2. The care, treatment, and services it provides. 3. The analysis of surveillance activities and other infection control data. 4. The organization reviews and identifies its risks at least annually and whenever significant changes occur with input from, at a minimum, infection control personnel, medical staff, nursing, and leadership. 5. The organization prioritizes the identified risks for acquiring and transmitting infections. These prioritized risks are documented. Standard IC.01.04.01 Based on the identified risks, the organization sets goals to minimize the possibility of transmitting infections. Note: See NPSG.07.01.01 for hand hygiene guidelines. (continued)

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Table 2-3. Joint Commission Infection Prevention and Control (IC) Standards, continued Elements of Performance for IC.01.04.01 The organization’s written infection prevention and control goals include the following: 1. Addressing its prioritized risks. 2. Limiting unprotected exposure to pathogens. 3. Limiting the transmission of infections associated with procedures. 4. Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies. 5. Improving compliance with hand hygiene guidelines. Standard IC.01.05.01 The organization has an infection prevention and control plan. Elements of Performance for IC.01.05.01 1. When developing infection prevention and control activities, the organization uses evidence-based national guidelines or, in the absence of such guidelines, expert consensus. 2. The organization’s infection prevention and control plan includes a written description of the activities, including surveillance, to minimize, reduce, or eliminate the risk of infection. 3. The organization’s infection prevention and control plan includes a written description of the process to evaluate the infection prevention and control plan. 5. The organization describes, in writing, the process for investigating outbreaks of infectious disease. 6. All organization components and functions are integrated into infection prevention and control activities. 7. The organization has a method for communicating responsibilities about preventing and controlling infection to licensed independent practitioners, staff,

(continued)

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Table 2-3. Joint Commission Infection Prevention and Control (IC) Standards, continued visitors, patients, and families. Information for visitors, patients, and families includes hand and respiratory hygiene practices. Note: Information may be in different forms of media, such as posters or pamphlets. 8. The organization identifies methods for reporting infection surveillance and control information to external organizations. Standard IC.01.06.01 The organization prepares to respond to an influx of potentially infectious patients. Elements of Performance for IC.01.06.01 1. The organization identifies resources that can provide information about infections that could cause an influx of potentially infectious patients. Note: Resources may include local, state, and federal public health systems. 2. The organization obtains current clinical and epidemiological information from its resources regarding new infections that could cause an influx of potentially infectious patients. 3. The organization has a method for communicating critical information to licensed independent practitioners and staff about emerging infections that could cause an influx of potentially infectious patients. 4. The organization describes, in writing, how it will respond to an influx of potentially infectious patients. Note: One acceptable response is to decide not to accept patients. 5. If the organization decides to accept an influx of potentially infectious patients, then the organization describes in writing its methods for managing these patients over an extended period of time. 6. When the organization determines it is necessary, the organization activates its response to an influx of potentially infectious patients.

(continued)

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Table 2-3. Joint Commission Infection Prevention and Control (IC) Standards, continued Standard IC.02.01.01 The organization implements its infection prevention and control plan. Elements of Performance for IC.02.01.01 1. The organization implements its infection prevention and control activities, including surveillance, to minimize, reduce, or eliminate the risk of infection. 2. The organization uses standard precautions, including the use of personal protective equipment, to reduce the risk of infection. Note: Standard precautions are infection prevention and control measures to protect against possible exposure to infectious agents. These precautions are general and applicable to all patients. 3. The organization implements transmission-based precautions in response to the pathogens that are suspected or identified within the organization’s service setting and community. Note: Transmission-based precautions are infection prevention and control measures to protect against exposure to a suspected or identified pathogen. These precautions are specific and based on the way the pathogen is transmitted. Categories include contact, droplet, airborne, or a combination of these precautions. 5. The organization investigates outbreaks of infectious disease. 6. The organization minimizes the risk of infection when storing and disposing of infectious waste. 7. The organization implements its methods to communicate responsibilities for preventing and controlling infection to licensed independent practitioners, staff, visitors, patients, and families. Information for visitors, patients, and families includes hand and respiratory hygiene practices. Note: Information may have different forms of media, such as posters or pamphlets. 8. The organization reports infection surveillance, prevention, and control information to the appropriate staff within the organization. (continued)

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Table 2-3. Joint Commission Infection Prevention and Control (IC) Standards, continued 9.

The organization reports infection surveillance, prevention, and control information to local, state, and federal public health authorities in accordance with law and regulation. 10. When the organization becomes aware that it transferred a patient who has an infection requiring monitoring, treatment, and/or isolation, it informs the receiving organization. 11. When the organization becomes aware that it received a patient from another organization who has an infection requiring action, and the infection was not communicated by the referring organization, it informs the referring organization. Note: Infections requiring action include those that require isolation and/or public health reporting or those that may aid in the referring organization’s surveillance. Standard IC.03.01.01 The organization evaluates the effectiveness of its infection prevention and control plan. Elements of Performance for IC.03.01.01 1. The organization evaluates the effectiveness of its infection prevention and control plan annually and whenever risks significantly change. The evaluation includes a review of the following: 2. The infection prevention and control plan’s prioritized risks. 3. The infection prevention and control plan’s goals. 4. Implementation of the infection prevention and control plan’s activities. 6. Findings from the evaluation are communicated at least annually to the individuals or interdisciplinary group that manages the patient safety program. 7. The organization uses the findings of its evaluation of the infection prevention and control plan when revising the plan. Source: The Joint Commission: 2011 Comprehensive Accreditation Manual for Hospitals. Oakbrook Terrace, IL: Joint Commission Resources, 2011.

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Table 2-4. Joint Commission International Prevention and Control of Infections (PCI) Standards Standard PCI.5 The organization designs and implements a comprehensive program to reduce the risks of health care–associated infections in patients and health care workers. Measurable Elements of PCI.5 1. There is a comprehensive program and plan to reduce the risk of health care–associated infections in patients. 2. There is a comprehensive program and plan to reduce the risk of health care–associated infections in health care workers. 3. The program includes systematic and proactive surveillance activities to determine usual (endemic) rates of infection. 4. The program includes systems to investigate outbreaks of infectious diseases. 5. The program is guided by appropriate policies and procedures. 6. Risk-reduction goals and measurable objectives are established and regularly reviewed. 7. The program is appropriate to the organization’s size and geographic location, services, and patients. Standard PCI.5.1 All patient, staff, and visitor areas of the organization are included in the infection prevention and control program. Measurable Elements of PCI.5.1 1. All patient care areas of the organization are included in the infection prevention and control program. 2. All staff areas of the organization are included in the infection prevention and control program. 3. All visitor areas of the organization are included in the infection prevention and control program.

(continued)

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Table 2-4. Joint Commission International Prevention and Control of Infections (PCI) Standards, continued Standard PCI.6 The organization uses a risk-based approach in establishing the focus of the health care–associated infection prevention and reduction program. Intent of PCI.6 Each organization must identify those epidemiologically important infections, infection sites, and associated devices, procedures, and practices that will provide the focus of efforts to prevent and to reduce the risk and incidence of health care–associated infections. A risk-based approach helps organizations identify those practices and infections on which they should focus their programs. A risk-based approach uses surveillance as an important component for gathering and analyzing the data that guide the risk assessment. Organizations collect and evaluate data on the following relevant infections and sites: a) Respiratory tract—such as the procedures and equipment associated with intubation, mechanical ventilator support, tracheostomy, and so on b) Urinary tract—such as the invasive procedures and equipment associated with indwelling urinary catheters, urinary drainage systems, their care, and so on c) Intravascular invasive devices—such as the insertion and care of central venous catheters, peripheral venous lines, and so on d) Surgical sites—such as their care and type of dressing and associated aseptic procedures e) Epidemiologically significant diseases and organisms—multidrug resistant organisms, highly virulent infections f) Emerging or reemerging infections within the community

(continued)

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Table 2-4. Joint Commission International Prevention and Control of Infections (PCI) Standards, continued Measurable Elements of PCI.6 1. The organization has established the focus of the program through the collection of data related to a) through f) in the intent statement. 2. The data collected in a) through f) are evaluated/analyzed. 3. Based on data evaluation/analysis, actions are taken to focus or to refocus the organization’s infection prevention and control program. 4. The organization assesses these risks at least annually, and the assessment is documented. Standard PCI.7 The organization identifies the procedures and processes associated with the risk of infection and implements strategies to reduce infection risk. Measurable Elements of PCI.7 1. The organization has identified those processes associated with infection risk. 2. The organization has implemented strategies to reduce infection risk in those processes. 3. The organization identifies which risks require policies and or procedures, staff education, practice changes, and other activities to support risk reduction. Standard PCI.7.1 The organization reduces the risk of infections by ensuring adequate equipment cleaning and sterilization and the proper management of laundry and linen. Measurable Elements of PCI.7.1 1. Equipment cleaning and sterilization methods in a central sterilization service are appropriate for the type of equipment. 2. Equipment cleaning, disinfection, and sterilization methods conducted outside a central sterilization service are appropriate for the type of equipment.

(continued)

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Table 2-4. Joint Commission International Prevention and Control of Infections (PCI) Standards, continued 3. Laundry and linen management are appropriate to minimize risk to staff and patients. 4. There is a coordinated oversight process that ensures all cleaning, disinfection, and sterilization methods are the same throughout the organization. Standard PCI.7.2 The organization reduces the risk of infections through proper disposal of waste. Measurable Elements of PCI.7.2 1. Disposal of infectious waste and body fluids are managed to minimize transmission risk. 2. The handling and disposal of blood and blood components are managed to minimize transmission risk. 3. Operation of the mortuary and postmortem area are managed to minimize transmission risk. Standard PCI.9 Gloves, masks, eye protection, other protective equipment, soap, and disinfectants are available and used correctly when required. Measurable Elements of PCI.9 1. The organization identifies those situations for which gloves and/or masks or eye protection are required. 2. Gloves and/or masks or eye protection are correctly used in those situations. 3. The organization identifies those situations for which hand washing and hand disinfection or surface disinfecting procedures are required. 4. Handwashing and hand disinfection procedures are used correctly in those areas. 5. The organization has adopted hand-hygiene guidelines from an authoritative source. (continued)

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Table 2-4. Joint Commission International Prevention and Control of Infections (PCI) Standards, continued Standard PCI.10 The infection prevention and control process is integrated with the organization’s overall program for quality improvement and patient safety. Standard PCI.10.1 The organization tracks infection risks, infection rates, and trends in health care–associated infections. Standard PCI.10.2 Quality improvement includes using measures related to infection issues that are epidemiologically important to the organization. Standard PCI.10.3 The organization uses risk, rate, and trend information to design or to modify processes to reduce the risk of health care–associated infections to the lowest possible levels. Standard PCI.10.4 The organization compares its health care–associated infection rates with other organizations through comparative databases. Standard PCI.10.5 The results of infection prevention and control measurement in the organization are regularly communicated to leaders and staff. Standard PCI.10.6 The organization reports information on infections to appropriate external public health agencies.

(continued)

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Table 2-4. Joint Commission International Prevention and Control of Infections (PCI) Standards, continued Measurable Elements of PCI.10 1. Infection prevention and control activities are integrated into the organization’s quality improvement and patient safety program. 2. The leadership of the infection prevention and control program is included in the organization’s quality and patient safety program’s oversight mechanism. Measurable Elements of PCI.10.1 1. Health care–associated infection risks are tracked. 2. Health care–associated infection rates are tracked. 3. Health care–associated infection trends are tracked. Measurable Elements of PCI.10.2 1. Infection prevention and control activities are measured. 2. The measures identify epidemiologically important infections. Measurable Elements of PCI.10.3 1. Processes are redesigned based on risk, rate, and trend data and information. 2. Processes are redesigned to reduce infection risk to the lowest levels possible. Measurable Elements of PCI.10.4 1. Health care–associated infection rates are compared to other organizations’ rates through comparative databases. 2. The organization compares its rates to best practices and scientific evidence. Measurable Elements of PCI.10.5 1. Measurement results are communicated to medical staff. 2. Measurement results are communicated to nursing staff. 3. Measurement results are communicated to management.

(continued)

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Table 2-4. Joint Commission International Prevention and Control of Infections (PCI) Standards, continued Measurable Elements of PCI.10.6 1. Infection prevention and control program results are reported to public health agencies as required. 2. The organization takes appropriate action on reports from relevant public health agencies. Standard PCI.11 The organization provides education on infection prevention and control practices to staff, physicians, patients, families, and other caregivers when indicated by their involvement in care. Measurable Elements of PCI.11 1. The organization develops an infection prevention and control program that includes all staff and other professionals and patients and families. 2. The organization provides education about infection prevention and control to all staff and other professionals. 3. The organization provides education about infection prevention and control to patients and families. 4. All staff are educated on the policies, procedures, and practices of the infection prevention and control program. 5. Periodic staff education is provided in response to significant trends in infection data. Source: Joint Commission International: Joint Commission International Accreditation Manual for Hospitals, 4th edition. Oakbrook Terrace, IL: Joint Commission Resources, 2010.

World Health Organization (WHO) Recommendations and Guidelines The WHO Infection Prevention and Control in Health Care Initiative focuses on evidence-based strategies to address HAIs. WHO serves as a coordinating body to inform member states of infectious outbreaks and assembles data on the incidence of HAIs worldwide, portraying the scope of the problem and encouraging action to fight 26

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this serious public health issue. WHO’s Guidelines on Hand Hygiene in Health Care, published in 2005, is a major component of efforts to reduce and prevent HAIs such as C. difficile infection. WHO also launched the Clean Care Is Safer Care program to bring attention to the battle against HAIs; it specifically addresses C. difficile, particularly in relation to hand hygiene.1 Clean Care Is Safer Care provides information about preventing and controlling C. difficile in a question-and-answer format.

Centers for Disease Control and Prevention (CDC) Recommendations and Guidelines The CDC is the leading government agency in the United States that deals with infection prevention and control activities at national, regional, and local levels. CDC guidelines for HAIs such as C. difficile are translated into practice in hospitals and other health care organizations across the United States, and several of the CDC’s recommendations have been incorporated into Joint Commission standards and National Patient Safety Goals, such as NPSG.07.01.01. The CDC offers a free Clostridium difficile Infections Toolkit that provides background, prevention strategies, measurement, and tools for implementation.2 In addition, the CDC is developing a national collaborative with the U.S. Department of Veterans Affairs to reduce C. difficile infection rates through antimicrobial stewardship interventions and partnering with the U.S. Centers for Medicare & Medicaid Services on a quality improvement pilot intervention targeting C. difficile infection. The CDC also assists with outbreak investigations in states and offers the Guidelines for Environmental Infection Control in Health-Care Facilities to help organizations in their efforts to control C. difficile.3 In addition to guidelines and best practices, the CDC maintains the National Healthcare Safety Network, formerly the National Nosocomial Infection Surveillance System.4 Hospitals and state health departments use this Web-based tool to track and perform surveillance on HAIs. C. difficile is included in the network.

European Centre for Disease Prevention and Control (ECDC) Recommendations and Guidelines Established in 2005, the ECDC is a European Union (EU) agency that aims to strengthen Europe’s defenses against infectious diseases. The ECDC’s mission is to identify, assess, and communicate current and emerging threats to human health posed by infectious diseases.

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To achieve this mission, the ECDC works in partnership with national health protection bodies across Europe to strengthen and develop continentwide disease surveillance and early warning systems. By working with experts throughout Europe, the ECDC pools Europe’s health knowledge to develop authoritative scientific opinions about the risks posed by current and emerging infectious diseases. The ECDC, in collaboration with the European Society of Clinical Microbiology and Infectious Diseases study group on C. difficile, produced a background document on C. difficile infections and a guidance document on the prevention and control of C. difficile infections. It also sponsored the first pan-European, hospital-based survey. Based on the results of a European C. difficile infection study, the study suggests providing support for further capacity-building for surveillance of C. difficile infections by enhancing the laboratory capacity for C. difficile infection diagnosis in EU member states, by establishing a European ribotyping nomenclature and a comprehensive reference collection of strains (including a Web-based database), and by developing a European C. difficile infection surveillance protocol.

Association for Professionals in Infection Control and Epidemiology (APIC) Recommendations and Guidelines The mission of the 12,000-member, Washington, D.C.–based APIC is to improve health and patient safety by reducing risks of infection and other adverse outcomes. APIC offers guidelines and standards related to infection definitions and surveillance, environmental services, health care workers and infection prevention, multidrugresistant organisms, a zero-tolerance culture for noncompliance with HAI prevention measures, and surveillance technology resources. APIC has conducted a C. difficile prevalence study in the United States, as well as the C. difficile Pace of Progress Survey.5,6

Society for Healthcare Epidemiology of America (SHEA) Recommendations and Guidelines SHEA was founded in 1980 to advance the application of the science of health care epidemiology and includes a variety of disciplines and activities, such as epidemiologic and laboratory investigation, surveillance, risk reduction, policy, education, and cost–benefit assessment. SHEA has published (alone and in collaboration with other organizations and agencies) important infection prevention and control recommendations and guidelines, such as guidelines for developing an institutional program for infection control, guidelines for antimicrobial stewardship, guidelines for 28

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the prevention of antimicrobial resistance in hospitals, recommendations for surveillance of C. difficile, infection prevention and control in long term care organizations, guideline for hand hygiene in health care settings, recommendations for metrics for multidrug-resistant organisms in health care settings, and others. In collaboration with the Infectious Diseases Society of America, SHEA published a 2010 update to the “Clinical Practice Guidelines for Clostridium difficile Infection in Adults.”7

U.S. Centers for Medicare & Medicaid Services (CMS) Recommendations and Guidelines CMS plays a role in addressing HAIs such as C. difficile through its infection control–related Conditions of Participation (CoPs) that hospitals and other health care organizations must follow to receive federal reimbursement for Medicare patients. Hospitals also use CMS’s Hospital Inpatient Quality Reporting Program to report several infection-related measures. Data are then publicly reported for individual hospitals on CMS’s Hospital Compare Web site. In addition, CMS’s Medicare Patient Safety Monitoring System identifies the rates of specific adverse events within the Medicare population, using inpatient medical records and administrative data selected as part of the Medicare Hospital Payment Monitoring Program. The U.S. Agency for Healthcare Research and Quality uses the Medicare Patient Safety Monitoring System data for its National Healthcare Quality and Disparity Reports, which provide reliable data on rates for specific HAIs in the Medicare population.

Infectious Diseases Society of America (IDSA) Recommendations and Guidelines IDSA represents physicians, scientists, and other health care professionals who specialize in infectious diseases. IDSA offers clinical practice guidelines for antimicrobial agent use, C. difficile infection, strategies to prevent HAIs in acute care hospitals, hand hygiene in health care settings, and so on. As previously mentioned, IDSA collaborated with SHEA to publish a 2010 update to the “Clinical Practice Guidelines for Clostridium difficile Infection in Adults.”7

Why Use Evidence-Based Standards of Care? There are many reasons people acquire C. difficile infections in health care organizations. Some patients have conditions that result in compromised immune systems, making them especially vulnerable to infection. Poor hand hygiene among staff and improperly cleaned and sterilized equipment also may lead to the transmission of C. difficile.8 As previously mentioned, C. difficile infections occur due to 29

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microorganisms becoming increasingly resistant to antibiotics due to the overuse and misuse of these drugs. Lack of infrastructure and resources to support an effective infection prevention and control program can also lead to the spread of C. difficile infection. For example, leadership support is essential for resources such as educational materials for health care staff, a sufficient amount of supplies for safe care of patients and protection of health care staff, computers and software to perform surveillance, adequate infection control staff, sufficient patient care staff, and promotion of infection prevention as a priority of the organization.9 The expertise of the organizations previously discussed in this chapter provides health care organizations with a foundation for an effective program to prevent and mitigate C. difficile. The following sections offer information about specific standards of care. Additional information about these topics will also be addressed in Chapter 3.

Hand Washing Because C. difficile can contaminate the skin and is spread by touching contaminated surfaces, it is imperative for health care workers and patients to perform effective hand hygiene. One study that demonstrated the need for hand hygiene reported that C. difficile was found on the hands or gloves of 59% of health care workers treating patients with C. difficile infection.10 Although experts agree that hand hygiene is fundamental to stopping the spread of C. difficile, there is debate about whether to use alcohol-based hand rubs or soap and water. Alcohol-based hand rubs are not as effective against spores, but hand hygiene with soap and water is associated with lower hand hygiene compliance. Both the CDC and the consensus document “A Compendium of Strategies to Prevent Healthcare–Associated Infections in Acute Care Hospitals” recommend routine hand hygiene with soap and water or alcohol-based hand rubs to prevent C. difficile infection.11,12 However, in outbreak situations or when other practices have failed to lower the rate of C. difficile infections, soap and water is the preferred hand hygiene method.13 Families and visitors should also wash their hands with soap and water when entering and leaving the patient’s room. It is imperative that care providers perform hand hygiene when moving from a C. difficile–colonized or infected patient to a noninfected patient to prevent transmission. Joint Commission’s National Patient Safety Goal 7 requires health care workers to perform 30

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CDC– or WHO–compliant hand hygiene before entering a patient room, after exiting, and before and after gloving. These internationally accepted hand hygiene guidelines are also cited in the intent of International Patient Safety Goal 5 and are central to efforts to elimininate infections. A summary of CDC and WHO guidelines appears in Sidebar 2-1, page 32, and Sidebar 2-2, pages 33–34. Information about Joint Commission’s Targeted Solutions ToolTM for hand hygiene compliance is available in Chapter 3 (see Sidebar 3-3, page 60) and online at http://www.centerfortransforminghealthcare.org/tst.aspx.

Contact Precautions Contact isolation is vital to efforts to curtail C. difficile. This includes the use of a private room, when available, especially for patients with stool incontinence.13 If a single-patient room is not available, patients with C. difficile can share a room (cohort) with other patients who also have C. difficile. Health care workers need to use barrier precautions—a gown and gloves—on entry to the patient’s room and discard the gown and gloves when moving from one patient to another. Gloves should also be changed when they become soiled or after touching surfaces visibly contaminated with feces.13 The CDC notes that because C. difficile–infected patients continue to shed the organism for a number of days following cessation of diarrhea, some institutions routinely continue isolation for either several days beyond symptom resolution or until discharge, depending on the type of setting and average length of stay.12 Maintaining contact precautions is recommended for the duration of illness when caring for patients with C. difficile infection. Requiring patients or visitors to use contact precautions has not, however, demonstrated a decrease in the rates of C. difficile infection at this time.11 Finally, APIC recommends that contact precautions for patients with C. difficile infection include the use of dedicated equipment, such as blood pressure cuffs, thermometers, and stethoscopes. Additional information about contact precautions is found in Chapter 3.

Additional Standards of Care In addition to hand hygiene and contact precautions, your organization should consider other standards of care in efforts to eliminate C. difficile. These standards of care include the following, all of which are discussed in more detail in Chapter 3: • Disposable or dedicated equipment: It is preferable to use disposable equipment and supplies with C. difficile patients. C. difficile spores can survive up to five months on environmental surfaces and can be easily transferred to equipment in the patient’s 31

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Sidebar 2-1. CDC Guideline for Hand Hygiene The CDC “Guideline for Hand Hygiene in Health-Care Settings” is designed to improve the hand hygiene practices of health care workers and reduce the transmission of pathogenic microorganisms to patients, residents, and personnel in health care settings. The CDC guideline addresses the following topics: • When to decontaminate hands: The guideline recommends decontaminating hands before patient contact, before putting on gloves, before invasive procedures, and after contact with patients. • Whether to use soap and water or an alcohol-based hand rub: The guideline requires health care workers to use soap and water to wash hands when they are visibly dirty, contaminated with proteinaceous material, or visibly soiled with blood or other bodily fluids. If hands are not visibly soiled, health care workers may use an alcohol-based hand rub or soap and water for routine hand decontamination. • Hand hygiene technique: This includes the process to effectively decontaminate hands. • Surgical hand antisepsis: The guideline offers a specific process that should be used to clean hands before surgery. • Selection of specific types of hand hygiene agents: The guideline offers suggestions for selecting appropriate cleaning agents for use in the organization. • Skin care: The guideline offers tips to protect the skin, including providing lotions or creams. • Specific conditions: The guideline discusses other aspects of hand hygiene, including the use of artificial nails and gloves. • Education: The guideline recommends that organizations provide education and monitor health care workers’ adherence to hand hygiene practices. • Administrative measures: The guideline recommends that organizations develop a hand hygiene program and offer readily accessible alcohol-based hand rubs.

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Sidebar 2-2. WHO Guidelines on Hand Hygiene The WHO Guidelines on Hand Hygiene in Health Care represent the consensus of more than 100 international experts on the actions health care workers should take for hand hygiene. The guidelines provide a comprehensive review of scientific data on hand hygiene rationale and practices and are intended to support training materials and implementation strategies in health care organizations. The WHO guidelines are separated by categories (Category IA, IB, IC, and so on). Following is an overview of the WHO guidelines: • Expand hand hygiene implementation to both before and after patient contact. • Emphasize hand hygiene after the health care worker’s gloves are removed. • Use hand hygiene before insertion of all invasive devices, regardless of glove use. • Use alcohol rub or soap and water before handling medications. • Remove visible dirt with soap and water prior to surgical hand preparation. • Simplify soap terminology; do not differentiate between non-antimicrobial and antimicrobial soap, unless specified. • Prohibit artificial nails for health care workers in all settings, surgical and nonsurgical. • Do not add soap to a partially filled soap dispenser. If dispensers must be reused, they should be cleaned thoroughly between refills. • Use alcohol-based hand rub for hand hygiene when water quality cannot be assured. • Ensure that individual alcohol-based hand rub dispensers and their storage cabinets are flame retardant. • Evaluate sink design to minimize risk of splashing and water contamination. • Emphasize single-use (no reuse) of hand hygiene cloth towels by individuals. • Encourage flexibility in the location of hand hygiene dispensers. • Offer alternative hand hygiene products for health care workers with skin allergies or reactions. • Implement a glove reprocessing program for areas in which glove reuse may be necessary. (continued)

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Sidebar 2-2. WHO Guidelines on Hand Hygiene, continued If an organization decides to use the WHO guidelines, WHO suggests practicing proper hand hygiene during the following five key moments in the patient care process: 1. Before patient contact 2. Before an aseptic task 3. After body fluid exposure risk 4. After patient contact 5. After contact with patient surroundings

environment. If the equipment is used on multiple patients, the spores can be transmitted from patient to patient. If reusable equipment or other items are used on a patient with C. difficile, restrict their use to the infected patient only. If the reusable items must be shared, adequate cleaning must occur between use by different patients. • Appropriate cleaning and disinfecting: As mentioned previously, C. difficile spores can live on environmental surfaces because of their resistance to traditional disinfectants, drying, and heat. Therefore, all surfaces, supplies, and equipment that come into contact with a C. difficile–infected patient need to be cleaned regularly and when soiled. This includes patient room furnishings, toilets, patient care equipment, and frequently touched surfaces. Proper cleaning and disinfecting best practices for areas with C. difficile infection include the following14: – Identifying the rooms of patients with C. difficile infection – Cleaning the rooms of patients with C. difficile infection at least once a day or when they become soiled – Using scrubbing or friction to physically remove C. difficile spores – In the United States, using Environmental Protection Agency (EPA)–approved disinfectants – Performing terminal cleaning after a C. difficile–infected patient has been discharged. Do not use quaternary ammonium, phenolic disinfectants, or alcoholbased cleaning agents; these have proven ineffective against C. difficile spores. • Continuous prevention and control: Most efforts to prevent C. difficile infection occur after a patient develops symptomatic infection, but an emphasis on early control measures (for example, hand hygiene, cleaning and disinfecting, judicious use of 34

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antibiotics) is necessary to stop the spread of C. difficile. An organization must focus on creating a culture in which infection prevention and control is a top priority. These organizations make it clear that preventing C. difficile infection is key to improving patient safety and that infections cannot be tolerated as an inevitable part of health care. Infection prevention and control is not something that can be delivered by an individual or a specific team or even a separate service; an organizational approach is required.15 • Judicious use of antibiotics: Antimicrobial stewardship is an important component of C. difficile prevention activities. C. difficile infection is often seen in patients who have received antibiotic therapy, and appropriate antibiotic use is crucial. Judicious use of antibiotics should be governed by the following16: – Written guidelines for use of specific antimicrobials that have been developed using evidence as a basis and that involve input from clinicians – Accurate microbiologic results and prompt reporting of those results – Antibiograms compiled and disseminated in a manner that enables clinicians to select the appropriate agent(s) for empiric therapy – Systems that minimize opportunities for inappropriate duration of therapy – Processes that actively support de-escalation of therapy to a more narrow-spectrum agent – Feedback on adherence to guidelines – Monitoring of systems that support the total program By using expert standards, guidelines, and recommendations, your organization can develop a planned approach to address and minimize or eliminate C. difficile risk and evaluate how these approaches affect patient outcomes. Chapter 3 provides additional information on strategies that help prevent and mitigate C. difficile. References 1. 2.

3.

World Health Organization: Clean Care Is Safer Care. http://www.who.int/gpsc/en/ (accessed May 14, 2011). Centers for Disease Control and Prevention: Clostridium difficile (CDI) Infections Toolkit. http://www.cdc.gov/HAI/pdfs/toolkits/CDItoolkitwhite_clearance_edits.pdf (accessed May 14, 2011). Centers for Disease Control and Prevention: Guidelines for Environmental Infection Control in HealthCare Facilities: Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC) 2003. http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_HCF_03.pdf (accessed May 14, 2011).

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6.

7.

8.

9. 10. 11.

12.

13.

14. 15. 16.

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Centers for Disease Control and Prevention: National Healthcare Safety Network (NHSN). Updated May 6, 2011. http://www.cdc.gov/nhsn/ (accessed May 14, 2011). Association of Professionals in Infection Control and Epidemiology: Press Release: National Prevalence Study of Clostridium difficile in U.S. Healthcare Facilities: Overview and Key Findings. Nov. 11, 2008. http://www.apic.org/AM/CM/ContentDisplay.cfm?ContentFileID=11410 (accessed May 14, 2011). Association of Professionals in Infection Control and Epidemiology: 2010 Clostridium difficile Pace of Progress Survey: Results of an Online Poll of Infection Preventionists. May 2010. http://www.apic.org/AM/Template.cfm?Section=Featured_News_and_Events&TEMPLATE=/ CM/ContentDisplay.cfm&CONTENTID=15496 (accessed May 14, 2011). Cohen S.H., et al.: Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol 31:431–455, May 2010. Stone P., et al.: Nurses’ working conditions: Implications for infectious disease. Emerg Infect Dis 10, Nov. 2004. http://www.cdc.gov/NCIDOD/eid/vol10no11/04-0253.htm (accessed May 14, 2011). Soule B.M., Memish Z.A.: Best Practices in Infection Control: An International Handbook. Oakbrook Terrace, IL: Joint Commission Resources, 2007. Dubberke E.R., et al.: Strategies to prevent Clostridium difficile infections in acute care hospitals. Infect Control Hosp Epidemiol 29(Suppl. 1),S81–S92, Oct. 2008. Siegel J.D., et al.: 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Isolation2007.pdf (accessed May 14, 2011). Centers for Disease Control and Prevention: Frequently Asked Questions About Clostridium difficile for Healthcare Providers. Updated Mar. 22, 2011. http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_faqs_HCP.html (accessed May 14, 2011). Boyce J.M., et al.: Lack of association between the increased incidence of Clostridium difficile–associated disease and the increasing use of alcohol-based hand rubs. Infect Control Hosp Epidemiol 27:479–483, May 2006. Joint Commission Resources: Minimizing the growing threat of Clostridium difficile. Joint Commission Perspectives on Patient Safety 6:5–6, Jun. 2006. Holmes A.H.: Can organisational change reduce hospital acquired infections? J Hosp Infect 65:(Suppl. 2):191–192, Jun. 2007. Association of Professionals in Infection Control and Epidemiology (APIC): Guide to the Elimination of Clostridium difficile in Healthcare Settings. Washington, DC: APIC, 2008.

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Chapter 3 Evidence-Based Best Practices for Preventing and Mitigating Clostridium difficile in Your Organization

T

o accomplish the daunting task of controlling and preventing C. difficile infection, organizations should look to evidence-based best practices that encompass the major components of sound infection prevention and control. The information in this chapter builds on the requirements, guidelines, recommendations, and standards of care discussed in Chapter 2 to help your organization examine important C. difficile infection prevention issues, such as availability of supplies, staff education, surveillance, antimicrobial stewardship, hand hygiene, environmental cleaning, equipment use, and alert systems to strengthen safety, improve efficiency, identify challenges, justify needs, and avoid preventable adverse events.

Ensuring the Availability of Supplies It is difficult for organizations to hold individuals accountable for preventing the spread of C. difficile if leadership and managers do not make the necessary supplies and equipment available to frontline staff to allow them to properly perform their duties. Nursing staff and other care providers must have ready access to hand hygiene supplies, personal protective equipment (PPE), disposable equipment, and cleaning and disinfecting agents. If caregivers do not have or cannot find the needed supplies, their time is wasted, and compliance with best practices may be compromised. Isolation carts are stocked with PPE and other supplies that help ensure easy accessibility of supplies such as disposable stethoscopes, disposable blood pressure cuffs, thermometers, and disinfectant wipes. Your organization may also want to keep extra bundles of these disposable items in the clean supply room. Responsibility for ensuring the availability of these supplies and restocking them when necessary should be assigned to one or more individuals. It may also be useful to provide a visual cue, such as a red arrow at a designated level on the wall-mounted isolation rack, to help staff easily recognize when supplies are getting low.1 In addition to the supplies that direct patient care staff need, supplies for environmental cleaning and disinfection, such as prepackaged wipes, spray bottles and cloths, and saturated cloths, should be readily available to housekeeping staff for cleaning surfaces and reusable equipment that cannot be dedicated to one patient. 37

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Establishing Leadership Priority Although health care workers and staff from housekeeping and environmental services are on the front lines of preventing C. difficile infection, leaders must be at the forefront of this issue. There are many elements to leadership support and involvement, but all efforts should be based on the concept that C. difficile prevention and control is an organizational priority. This includes ensuring appropriate financial and resource support for programs to reduce and prevent C. difficile. Leaders are also in a position to remove barriers to better C. difficile practices by addressing organization culture issues and access to information. For example, leaders can make it clear that C. difficile is an issue that matters by setting expectations that staff and physicians should attend education sessions as well as follow policies and best practices, providing adequate staff to follow necessary practices to reduce or prevent C. difficile infection, and holding accountable units or individuals who do not comply with standards and protocols. Leaders can take the following actions to support the C. difficile prevention program: • Ensure adequate infection prevention and control staff and housekeeping staff to effectively design, implement, and monitor C. difficile and educational programs. Also, provide laboratory support, technical support, administrative support, and supplies and equipment. • Serve as champions for initiatives related to C. difficile. • Allow infection prevention and control staff access to patient records, performance improvement data, and other systems to help them fulfill their collection, analysis, reporting, and modification duties, as applicable. • Discuss C. difficile during leadership rounds and key meetings. • Actively attend meetings of a multidisciplinary C. difficile improvement team. • Participate in educational efforts on preventing and controlling C. difficile infection. This could include being part of video presentations, attending in-service educational programs, and being involved in other projects. • Celebrate success and publicly acknowledge improvements, such as reduced C. difficile infection incidence. Leaders can also support C. difficile prevention efforts by considering the following environment of care issues: • Design and construction to minimize infection transmission: Single-patient, or “private,” rooms help reduce the transmission of C. difficile infection, and easily accessible hand sinks and alcohol-based hand rub dispensers should also be part of the design and construction process. 38

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• Construction and availability of isolation rooms: Leaders need to collaborate with architects, engineers, infection preventionists, and others to ensure that isolation facilities or rooms are constructed according to established guidelines, receive the proper maintenance, and are used properly. • Location and availability of hand hygiene stations: Good hand hygiene is the preferred method for reducing the spread of C. difficile spores. To increase compliance with hand hygiene protocols, leaders need to ensure that it is easy for staff members to wash their hands. See also the “Hand Hygiene Factors and Solutions” that provides specific compliance suggestions at http://centerfortransforminghealthcare.org/tst.aspx. These solutions are also available on the Targeted Solutions Tools accredited organizations can access on The Joint Commission ConnectTM at http://www.jointcommissionconnect.org. (Also see Sidebar 3-3, page 60.) • Housekeeping and sanitation: Proper cleaning and disinfection of the care environment reduces the risk of transmission of C. difficile, and leaders must devote adequate resources for staffing and training in these areas to support direct caregivers. They must also ensure that the housekeeping department develops and complies with consistent equipment and environment cleaning procedures and adheres to established guidelines. • Availability of PPE: Staff should not have to search for PPE; leaders should ensure that PPE is readily and easily available. Leaders should also work with infection prevention and control personnel to make sure the right types of PPE are being used for C. difficile infection isolation practices.

Empowering Staff Frontline staff, physicians, housekeeping personnel, and all other health care workers need to have the ability to ask questions and raise concerns when they observe instances of noncompliance, high-risk situations, barriers to proper care, or anything that poses risk to patients and staff. For example, because proper cleaning is vital to stop the spread of C. difficile, it is important to involve housekeeping staff in discussions about C. difficile–related cleaning and encourage them to identify barriers in their work. It is not enough to permit individuals to simply voice problems, however. All health care workers need to be empowered to seek solutions, enact programs, and take corrective action when necessary.

Educating Staff The epidemic of C. difficile has prompted many organizations to devote staff attention to the transmission of this infection in health care facilities. Caregivers must regularly wash 39

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their hands; housekeeping staff must properly clean; and nurses, physicians, and other staff must identify and promptly isolate infectious patients to prevent the spread of C. difficile. One of the biggest obstacles to eradicating health care–associated infections (HAIs) is a failure to implement and sustain best practices despite research and evidence that establish their effectiveness. This failure can be addressed, in part, through a systematic, organizationwide, and sustained education program and behavior modification program. A report by the World Health Organization (WHO) describes health care worker education and training as key investment tools: “Unlike material capital, knowledge does not deteriorate with use. But, like equipment, old skills become obsolete with the advent of new technologies . . . Continuing education and on-the-job training are required to keep existing skills in line with technological progress and new knowledge.”2(76) Education should address risk factors, routes of transmission, local C. difficile epidemiology, patient outcomes and treatment, and prevention measures (including the Centers for Disease Control and Prevention [CDC] and WHO recommendations for proper hand hygiene, contact precautions, and management of C. difficile). Although most organizations teach prevention and mitigation practices to health care workers who provide direct care, they sometimes overlook health care workers who might act as carriers of C. difficile infection. In addition to the direct care clinical staff, other individuals who interact with patients or might have contact with patients or their environment, equipment, or waste also need education about how to prevent or reduce C. difficile. These include biomedical technicians, patient transport workers, facilities staff, waste and garbage handlers, dietary services personnel, plumbers, electricians, delivery personnel, personal aides, housekeepers, admission and registration staff, and others. To help implement evidence-based best practices that lead your organization toward success in preventing and mitigating C. difficile, make sure to get buy-in from individuals across your organization, including representatives from the following areas: • Senior leadership • Infection preventionists • Nursing staff • Medical staff • Housekeeping staff • Technical support staff (respiratory therapy, physical therapy) • Equipment maintenance personnel 40

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• • • • •

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Facilities management personnel Information management personnel Laboratory staff Patient safety/performance improvement officers Pharmacists

Education is the best way to get health care workers—including the medical staff, nurses, therapists, and others—to adopt evidence-based best practices to prevent C. difficile infections. Education programs should foster understanding of the following: • The importance of infection prevention and control and preventing C. difficile infections • The misconceptions about C. difficile (for example, that C. difficile is not a big concern) • How C. difficile is spread • The consequences of C. difficile (clinical and financial) • Policies and procedures related to C. difficile • The responsibilities of all staff in preventing and mitigating C. difficile infection Surveying health care workers about their awareness of the importance of prevention and their knowledge of strategies to prevent and control C. difficile can help to focus education efforts and address areas in which health care worker knowledge is deficient. The Joint Commission National Patient Safety Goal related to C. difficile (see Sidebar 21 on pages 12–13) has an education component that specifies that health care workers need to receive education about HAIs in general and C. difficile in particular. This education needs to include training on the importance of prevention and effective C. difficile prevention strategies. The education and training needs to take place when staff and licensed independent practitioners are first hired and annually after hire. For example, health care worker education on preventing C. difficile could occur on a regular basis and consistently emphasize the importance of this effort and how to effectively comply with strategies to prevent C. difficile infections (see Sidebar 3-1, page 42). Education could be provided at different times, including the following: • During organizationwide, department, and unit orientation • During regular in-services • When C. difficile infection rates change • When rates of compliance with specific protocols (for example, hand hygiene) change 41

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Sidebar 3-1. Using Different Educational Platforms To be effective, education should take many forms. Different modes of training accommodate the different learning styles of health care workers and reinforce messages. For example, health care workers can learn from lectures and discussions by experts such as epidemiologists and infection preventionists. This can be supplemented by self-guided training sessions or a computer-based tutorial. In addition to in-service sessions or conferences related to C. difficile, platforms for education may include the following: • Pamphlets • Posters • Demonstrations of specific strategies or techniques for preventing and controlling the spread of C. difficile • Videos • Slide presentations • Screen savers with targeted messages • E-mail reminders • Stories that link specific behaviors to C. difficile infections • Voice messages from senior leadership, physician, and nursing champions about the importance of guarding against C. difficile infections • Informal, on-the-spot opportunities • Online training modules

Be sure to provide specific examples during health care worker education. Figure 3-1, page 43, provides a C. difficile prevention checklist that your organization can use as a best practice tool. A bundled checklist such as this can be a valuable educational opportunity and reminder to health care workers (such as nursing, environmental services, or housekeeping staff ) about C. difficile prevention. If the “N” is marked for any of the bundle prevention questions, appropriate staff, such as the nursing director or environmental services director (in addition to the staff member using the checklist) are then prompted with feedback on appropriate procedures or protocols to use. For example, to ensure that proper cleaning protocols are followed, it may be useful to create a separate checklist for proper cleaning procedures for C. difficile patient rooms that housekeeping staff can follow. The checklist can be posted next to or on the back 42

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Figure 3-1. Clostridium difficile Prevention Bundle Checklist for Health Care Workers Date: ___________________________

Name: _____________________________

Patient Name: ___________________

Room/Bed Number: _________________

Instructions: Check whether the best practice was completed or not for newly admitted patients. Return completed form to Infection Prevention and Control.

Clostridium difficile Prevention Bundle

Y

N

Comments

Newly diagnosed or transferred C. difficile patient is identified? Antibiotic not on formulary restriction list? Preauthorization to use antibiotic obtained from pharmacy? Is patient placed in private room? Hand hygiene performed before and after contact? Gown and gloves worn before patient contact? Is equipment dedicated to patient? If not, are cleaning supplies available to clean equipment between patients? Daily and terminal cleaning of rooms performed correctly (see cleaning checklist)? Source: The Joint Commission: Toolkit for Preventing Health Care–Associated Infections. Oakbrook Terrace, IL: Joint Commission Resources, 2010.

of signage in housekeeping closets, on cleaning carts, or in supply areas, indicating precautions to be used. In addition, the infection prevention and control staff can identify the rooms of C. difficile infection patients and send the information electronically to the nursing director and the environmental services director. These individuals can then identify C. difficile-infected patient rooms to housekeeping staff to ensure proper cleaning protocols are followed. 43

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Increasing Staff Awareness to Take Action

Early detection is important in the effort to fight C. difficile infection. To help increase staff awareness, your organization can consider placing a sticker on the front of the chart of a patient receiving antibiotics. The message might read: Antibiotics are a risk factor for the development of C. difficile infection. Consider evaluating for C. difficile infection if the patient develops diarrhea while receiving antibiotics or has received antibiotics within the past 60 days. For organizations using electronic medical records, the same message could be automatically generated when the antibiotic is entered into the computerized order entry system and sent to the attending physician, as well as trigger a flag on the nursing care plan. Liquid stool output (measured in ml) also can be added to electronic documentation. If the patient is receiving antibiotics and a number is entered into the diarrhea field, a notice or message is automatically triggered to remind the physician to test for C. difficile infection. Source: Association for Professionals in Infection Control and Epidemiology (APIC): Guide to the Elimination of Clostridium difficile in Healthcare Settings. Washington, DC: APIC, 2008. http://www.apic.org/Content/NavigationMenu/PracticeGuidance/APICEliminationGuides/ C_diff_guide.htm (accessed May 16, 2011).

Educating Housekeeping Because cleaning and disinfecting the environment is one of the keys to stopping the spread of C. difficile, educational programs aimed specifically at housekeeping personnel are crucial. Housekeeping staff may face challenges, such as language barriers, high turnover rates, or cultural variances. Educational campaigns—provided in languages appropriate for staff and accommodating a variety of learning skills—should occur at hire and continue. Adequate housekeeping staffing is also necessary for health care workers can do their part to stop the spread of C. difficile. For example, C. difficile may be unintentionally spread if housekeeping staff are not always available in all areas of the organization, and nurses who have not had the appropriate training or lack sufficient time to perform proper cleaning procedures are expected to clean patient rooms and equipment. One 44

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housekeeping team identified the limited amount of time dedicated to cleaning rooms of patients with C. difficile infection and the short notice given when these rooms were ready for cleaning as barriers to effective housekeeping services for patients with C. difficile infection. These staff members requested, and were granted, additional time to clean the rooms of C. difficile–infected patients and were given rapid notification that these rooms required cleaning.3 More information about appropriate cleaning and disinfection can be found in this chapter, pages 59–68.

Conducting C. difficile Surveillance Patients with C. difficile need to be identified as soon as possible to place them under contact precautions and prevent the spread of the spores. If your organization has highrisk patients, such as elderly patients or people who have undergone surgery or have compromised immune systems, it is important to be vigilant. The surveillance data your organization collects and analyzes show changes in C. difficile trends, providing information to guide an effective program to lower C. difficile infection rates. Surveillance is “information for action” and enables an organization to do the following4: • Recognize changes in patterns of infection against baseline data. • Identify the size of the problem. • Monitor trends and compare rates. • Evaluate the effectiveness of interventions. • Identify areas for further investigation or research. • Reinforce good practice. • Influence key organization staff and decision makers. Surveillance is typically maintained in a retrievable database file and should include at least the following information1: • Patient identification (name or unique identifier, such as medical record number) • Date of birth • Admission date • Patient location (unit and room) at the time of stool collection • C. difficile symptom onset date (for example, diarrhea) • Stool collection date • Discharge date 45

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Other information that your organization might want to collect could include underlying diagnosis, treatment (antibiotics), procedures such as endoscopy or surgical interventions, or circumstances that led to C. difficile exposure or risks. Your organization might also want to add information about when or if a previous admission took place, residence or location prior to admission, and discharge status. Most organizations do not have the resources to complete total surveillance, so surveillance needs to be simple, practical, and focused. There are two types of focused surveillance: Targeted surveillance concentrates on specific patient populations or procedures, and problem-oriented surveillance measures the occurrence of a specific problem, such as C. difficile infection in multiple patients at the same time. In addition to targeted and problem-oriented surveillance, organizations typically use surveillance to focus on processes and outcomes. Process monitoring focuses on C. difficile–related processes or procedures before and as they are implemented. For example, a process monitor could measure the frequency and consistency with which staff perform hand hygiene, how nurses and other health care workers use appropriate PPE, or compliance with contact precautions. The purpose of a process monitor is to determine whether staff are following policies and best practices that can minimize C. difficile infection risk. Outcome measures examine the results of infection control processes, patient care practices, or other procedures after they are implemented and performed. Outcome measures include the rates of C. difficile infections. Sidebar 3-2, pages 47–49, provides ideas for methods to collect surveillance data. Apollo Gleneagles Hospital, a 24-hour, 405-bed tertiary care hospital in Kolkata, India, uses surveillance data to plan, implement, and evaluate health care services, including C. difficile infection prevention and control. Apollo Gleneagles’ approach to combating C. difficile infections relies on a combination of priority-based surveillance and hospitalwide surveillance. The hospital’s comprehensive approach is based on concurrently running three parallel systems: (1) to comply with good infection prevention and control practices, (2) to prevent the occurrence of infections, and (3) to maintain a comprehensive antibiotic stewardship program to monitor use of antibiotics. All three of these systems are important to the prevention of C. difficile infection. Apollo Gleneagles uses a multidisciplinary and systematized approach to collect C. difficile infection rate data. Physicians assess the patient who is suspected of having the infection and order tests based on patient assessment and review of past patient records. Nursing collects the requisite test samples and sends them to the microbiology 46

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Sidebar 3-2. How to Collect Data Following are some practical suggestions on how to easily and thoroughly collect data and gather information as part of your organization’s effort to improve C. difficile infection rates: • Reporting systems: These systems allow health care workers to phone, email, or write reports about patients with potential C. difficile infection. Each potential infection should be reviewed to determine whether it meets the criteria for an infection and whether any intervention is needed. When a cluster of infections is reported, infection preventionists and epidemiologists should advise staff of actions to address the infection and control its transmission. Reporting systems can involve the following passive and active surveillance: – Passive surveillance might rely on health care or laboratory personnel reporting potential infections either from clinical symptoms, or laboratory reports, or both. Passive reporting systems are not as reliable as active surveillance because some infections will not be recognized or reported. To avoid problems with underreporting, organizations should make it easy for health care workers to report their concerns about one or more particular patients. Those who report should be acknowledged and thanked. There should be no punishment and/or blame for reporting issues. Health care providers must believe that by reporting infections they are helping to improve the safety of patients across the organization. Passive surveillance often requires follow-up to determine whether the patient does, in fact, have a true infection or just colonization. – Active surveillance is a proactive methodology that often involves record review. Organizations can collect data regarding infections from a variety of records, including the following: • Admission logs • Incident reports • Laboratory records • Patient records • Pharmacy records • Reports on numbers/types of diagnostic workups and care • Treatment plans (continued)

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Sidebar 3-2. How to Collect Data, continued

•

•

•

•

An organization can review records for surveillance measures through automated means or manually, depending on the size and scope of the organization’s activities and resources. Although data can be collected manually, electronic programs can sort and analyze data and generate rates, graphs, charts, and reports. Walking rounds: This active surveillance process allows infection preventionists to collect infection data on weekly or daily rounds, depending on the organization’s size. During rounds, infection preventionists consult with other team members, can make clinical observations; review charts, lab reports, treatment plans, and antibiotic reports; and provide “teaching moments.” Data mining: This technique, which is generally employed for active surveillance, involves using specialized computer programs to discover patterns, associations, changes, anomalies, and structures from a variety of sources, such as patient records or incident reports, that might reveal trends not shown by traditional record review methods. Definitions and forms: Health care organizations should use consistent definitions or criteria to determine whether an infection is caused by C. difficile and whether it is truly an infection. Many organizations create simple tools to collect data regarding surveillance measures. An organization can use forms for monitoring active or passive surveillance processes. For example, a hospital can create a form on which medical staff note their use of antibiotics. Information from this form can be converted into a chart or graph that, when taken in aggregate, will quickly reveal antibiotic use trends over time. Patient surveys: Telephone surveys can be helpful in collecting information postdischarge or after treatment. In such a survey, health care workers ask whether any signs of C. difficile infection are present and ask what drugs, if any, are being taken. When an infection is suspected, the health care worker can ask the patient to return to the organization or his or her primary care provider for examination. (continued)

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Sidebar 3-2. How to Collect Data, continued In addition to the data gathering methods outlined here, an organization can conduct a literature review to gather information to help in the fight against C. difficile infection. Although internal data are important in the discovery of infections, infection preventionists should also keep an eye on infection prevention and control literature for important C. difficile trends. Reliable sources for this type of information include the following: • The Association for Professionals in Infection Control and Epidemiology (APIC) • The Centers for Disease Control and Prevention (CDC) • The World Health Organization (WHO) • The Society for Healthcare Epidemiology of America (SHEA) • The Infectious Diseases Society of America (IDSA) • The American Journal of Infection Control • “A Compendium of Strategies to Prevent Healthcare–Associated Infections in Acute Care Hospitals,” published by SHEA and IDSA in partnership with The Joint Commission

laboratory. The laboratory performs a gram stain and culture of the sample. While waiting for the results and to initiate antibiotic therapy, the charge nurse collects the data and instructs the nurses on initiating the appropriate infection prevention and control practices. The infection prevention and control nurse coordinates with the primary physician and the consultant microbiologist (infection prevention and control officer). The pharmacy practices strict vigilance in tracking the use of empirical and targeted antibiotics to fight the pathogen. The findings and reports of all the departments are reported back to the quality assurance office. After the surveillance data are collected, quality assurance staff analyze the data. The organization also tracks operational data, such as hand hygiene compliance, alcoholbased hand rub usage per patient days, and performance data by ward. The data are reported to the infection prevention and control nurse, nursing department, and the infection prevention and control officer. Trends are presented during monthly infection prevention and control committee meetings, at which staff explore root causes and develop action plans. See Figure 3-2, page 50–51, for the indicator matrix used by the infection prevention and control committee to track annual priorities. 49

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Figure 3-2. Apollo Hospitals Group, India: Infection Control Risk Assessment Matrix (ICRAM)

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Figure 3-2. Apollo Hospitals Group, India: Infection Control Risk Assessment Matrix (ICRAM), continued

Source: Developed at Apollo Hospital, Hyderabad, India. Used with permission.

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Collecting and Using C. difficile Data To perform surveillance, it is necessary to use a defined calculation method to arrive at incidence rates. C. difficile infection can be defined as a case of diarrhea or toxic megacolon without other known etiology that meets one or more of the following criteria5: • The stool sample yields a positive result for a laboratory assay for C. difficile toxin A and/or B, or a toxin-producing C. difficile organism is detected in the stool sample by culture or other means. • Pseudomembranous colitis is seen during endoscopic examination or surgery. • Pseudomembranous colitis is seen during histopathological examination. Your organization might implement the case definition for laboratory-based reporting systems by focusing only on the criterion that the stool sample yield a positive result for a laboratory assay for C. difficile toxin A and/or B or a toxin-producing C. difficile organism be detected in the stool sample by culture or other means, if the laboratory routinely performs tests for C. difficile only on unformed stools. Rates of C. difficile infection cases are expressed as case patients per reporting period (for example, per month) per 10,000 patient-days.5 The calculation of this rate is as follows:

Number of C. difficile infection patients per month × 10,000 = Rate per 10,000 patient days Number of inpatient days per month

The rate reflects the per-day patient risk for C. difficile infection and is useful across varying health care settings with varying lengths of stay.

Diagnosing C. difficile Infection Accurate and rapid diagnosis of C. difficile infections is important in efforts not only to treat the disease but to prevent outbreaks. The following laboratory tests are commonly used to diagnose C. difficile infections6: • Stool culture: This is the most sensitive test available for C. difficile isolates, but it is the one most often associated with false-positive results due to the presence of nontoxigenic C. difficile strains. False-positives can be overcome by testing isolates for toxin production (that is, “toxigenic culture”). The downside of stool cultures is that these tests are labor 52

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•

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intensive, require an appropriate culture environment to grow anaerobic microorganisms, and have a relatively slow turnaround time (48 to 96 hours). Molecular tests: Polymerase chain reaction (PCR) assays, which test for the gene encoding toxin B, are highly sensitive and specific for the presence of a toxinproducing C. difficile organism. These tests provide same-day results. Antigen detection: These tests, which can be completed in less than one hour, detect the presence of C. difficile antigen by latex agglutination or immunochromatographic assays. Because results of antigen testing alone are nonspecific, antigen assays have been employed in combination with tests for toxin detection, PCR, or toxigenic culture in two-step testing algorithms. Toxin testing: Tissue culture cytotoxicity assay detects toxin B only. This assay requires technical expertise to perform, is costly, and requires 24 to 48 hours for a final result. Although toxin testing has traditionally been the gold standard for diagnosing clinically significant disease caused by C. difficile, PCR or toxigenic culture tests are more sensitive for detecting C. difficile in patients with diarrhea. Enzyme immunoassay to detect toxin A, toxin B, or both A and B: Due to concerns over toxin A-negative and B-positive strains causing disease, most laboratories employ a toxin B-only or A and B assay. These same-day assays are relatively inexpensive and easy to perform, making them popular with clinical laboratories; however, there are increasing concerns about sensitivity (less than tissue culture cytotoxicity and much less than PCR or toxigenic culture).

It should be noted that C. difficile toxin is very unstable. The toxin degrades at room temperature and may be undetectable within two hours after collection of a stool specimen. False-negative results occur when specimens are not promptly tested or are not kept refrigerated until testing can be done. The issue of testing accuracy is a significant one, with positive results leading to the use of antibiotics and longer hospitalization. It was reported in one New York hospital that of the estimated 85% of patients with suspected C. difficile infections whose tests were negative by toxin A/B EIA, 10% to 12%, or about 100 patients, were false by cytotoxicity testing. Many of these patients with negative tests were treated, with approximately 40% undergoing a full 10-day C. difficile infection course of antibiotics.7 Other infection prevention interventions also add up. For example, PPE costs approximately $2 per patient visit.7

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Monitoring, Analyzing, and Reporting Most infection prevention and control teams track C. difficile laboratory rates, and often hospitals may calculate rates at the unit and organization levels to identify the areas with the highest C. difficile rates (see Table 3-1, page 55, for the types of C. difficile that can be tracked).5 Although data help understand the endemic C. difficile infection rate at your organization, specific definitions for what constitutes an “outbreak” or “hyperendemic” rate are not available.8 It should also be noted that although one of the most effective ways to analyze data is through benchmarking, there are no established benchmarks for C. difficile infection. Your organization should strive for the lowest rate possible. Ideally, the goal should be zero C. difficile infections.9 The Joint Commission’s National Patient Safety Goal 7 related to C. difficile requires organizations to establish a surveillance program to measure and monitor MDROs (multidrug-resistant organisms)—that includes C. difficile. Joint Commission International Prevention and Control of Infections (PCI) standards require that organizations collect and evaluate data on epidemiologically significant diseases and MDROs or highly virulent infections. As previously mentioned, active surveillance can place enormous logistical strains on medical staff, available rooms for isolation, clinical laboratories, and other resources, but when practiced in conjunction with other C. difficile prevention programs, on high-risk patients, or in outbreak situations, active surveillance can be invaluable to your organization’s prevention efforts. Active surveillance helps an organization monitor the rate of infection, identify trends, and track the C. difficile rate across departments or across the entire organization; provides performance improvement measures; raises awareness of the issue; and so on. Every health care organization needs to make its own decisions regarding the use of active surveillance in its MDRO prevention strategy, using evidence-based guidelines, and then develop its own policies and protocols that outline steps and actions physicians and staff need to follow. Recognizing the complexities of identifying patients with C. difficile infection, Texas Medical Center, a 700-bed, university-affiliated hospital in Houston, decided to create an electronic surveillance network to detect patients with diarrhea who were most likely to test positive for C. difficile. The hospital began electronically recording bowel movements for all patients outside the intensive care unit. Patients with more than three stools during a 24-hour period were assessed for diarrhea, and data were collected on the number of diarrhea stools per day and the number of days with diarrhea. 54

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Table 3-1. C. difficile Infection Types and Definitions Case Type

Definition

Health care organization–onset, health care organization–associated

C. difficile infection symptoms onset more than 48 hours after admission

Community-onset, health care organization–associated

C. difficile infection symptom onset in the community or within 48 hours from admission, provided that symptom onset was less than 4 weeks after the last discharge from a health care organization

Community-associated

C. difficile infection symptom onset in the community or within 48 hours after admission to a health care facility, provided that symptom onset was more than 12 weeks after the last discharge from a health care facility

Indeterminate onset and unknown onset

C. difficile infection case patient who does not fit any of the above criteria or lack of available data prevents determination of exposure setting

Recurrent C. difficile infection

Episode of C. difficile infection that occurs 8 weeks or less after the onset of a previous episode, provided that the symptoms from the prior episode resolved

Source: Dubberke E.R., et al.: Strategies to Prevent C. difficile infection among hospitalized patients. Infect Control Hosp Epidemiol 29(Suppl. 1):581–592, Oct. 2008.

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Information was also available about any current antibiotic treatment, surgical procedures, admission through the intensive care unit, and so on. Based on these data, the patient’s physician would decide whether to order C. difficile testing (via tissue culture cytotoxicity assay). The hospital found that the number of days of diarrhea was the stronger predictor of increased risk of C. difficile infection, although the number of stools in a 24-hour period was also associated with an increased risk of C. difficile.10 Noting reports in the United States that nearly 65% of all C. difficile cases enter the hospital through the emergency department (ED), hospitals can begin increasing screening for ED patients.11 Patients can be asked at triage about recent hospitalization or treatment with antibiotics, specifically clindamycin, penicillin, and cephalosporin. Residents in long term care organizations can also be flagged. Stool cultures can be performed for all diarrhea patients with risk factors, and the patients can be placed on contact precautions immediately if C. difficile infection is suspected. Other methods for C. difficile monitoring include strategies such as the following: • Daily review of laboratory results to identify new patients in a timely manner • Posted contact isolation lists on care units so staff can identify positive patients • Weekly 15-minute briefings on MDROs and other serious pathogens such as C. difficile, including receiving reports on patients in isolation and compliance with organization hygiene and decontamination policies

Establishing an Antimicrobial Stewardship Program Studies have shown that the single most successful strategy in preventing the development of C. difficile infection may be antimicrobial stewardship.12–15 Because C. difficile infection is caused when antibiotics upset the gastrointestinal tract’s normal bacteria levels, ensuring the judicious use of these drugs is crucial in preventing C. difficile infections from occurring. The Joint Commission and Joint Commission International do not require an organization to have an antimicrobial stewardship program. However, this type of program requires organizations to examine how to select the most appropriate antibiotic for the particular pathogen, determine the correct dosing, determine the length of time each antibiotic should be administered, decide the best route for delivery, and prescribe antibiotics only when they will be beneficial to the patient.16 As Burgess et al. stated, an antimicrobial stewardship program can be characterized as “bugs versus drugs.”17 56

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Studies of antibiotic prescribing practices estimate that 30% to 50% of hospitalized patients receive antibiotics, and almost all intensive care unit patients are prescribed antibiotics, but that as many as 50% of these antibiotics are used inappropriately.18,19 Therefore, hospitals must look to antimicrobial stewardship programs as the best approach to decrease the numbers of C. difficile infections and MDROs. A successful antimicrobial stewardship program uses the following strategies15: • A prospective audit with intervention and feedback: The goal of this approach is to reduce the inappropriate use of antibiotics by reviewing prescribing practices and providing feedback to the prescribing physician, often with recommendations for other antibiotics to prescribe. One hospital found it useful to establish a multidisciplinary team that included a physician and pharmacist. The team reviewed antibiotic prescribing practices daily and provided feedback by using notes in the patients’ charts.18 • Formulary restriction and preauthorization: The goal of this approach is to reduce the number of antibiotics that are used by restricting the use of antibiotics to indications that have been preapproved. This system prompts physicians to prescribe narrow-spectrum instead of broad-spectrum antibiotics. For example, a program may require prior approval before the pharmacy dispenses certain antibiotics that have the potential to be used inappropriately, removing or adding certain antibiotics from the formulary, restricting other antibiotics to only approved indications, and instituting stop orders. An example of this practice may be requiring a pharmacy to secure authorization from an oncologist before antibiotics are dispensed to patients undergoing chemotherapy. Other successful interventions include using a continuation form that must be filled out by the prescribing physician, a computerized physician antibiotic order entry system that provides reminders of guidelines for appropriate use, pharmacist notes on patient charts, pharmacist review and stopping of orders when inappropriate, monthly medical resident educational conferences, and standardized antibiotic order forms that contain automatic stop orders.19 Royal Free University College Medical Center in the United Kingdom found success in improving antibiotic prescribing and reducing C. difficile infection rates by establishing an audit and feedback program. A policy in three acute care wards for elderly patients recommended less use of amoxicillin/clavulanate and increased use of benzylpenicillin, trimethoprim, and amoxicillin and further restriction of cephalosporin use. The hospital gave physicians on the wards pocket-size, laminated versions of the policy to carry with them and provided feedback every 8 to 12 weeks on individual antibiotic use and C. 57

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Using Antibiotics in C. difficile Infection Treatment

Although use of antibiotics is thought to be a contributing factor to development of C. difficile infection, antibiotics have traditionally been the drugs of choice to treat C. difficile infection. The problem with such treatment is that the use of antibiotics does not allow for the reestablishment of normal bowel flora. The result is that C. difficile infection recurrences are common. One recent trial showed that use of human monoclonal antibodies may prevent recurrent infection. Although monoclonal antibodies are unlikely to be used for primary treatment, this new approach may allow for a reduction in the number of days of standard antibiotic therapy for C. difficile infection.21

difficile infection rates. The hospital reported a statistically significant reduction in the use of all targeted broad-spectrum antibiotics and an increase in all targeted narrowspectrum antibiotics. All other antibiotic use remained unchanged. There was also a significant fall in C. difficile infection rates.12 In the Netherlands, St. Jansdal Hospital experienced a five-month epidemic of C. difficile infections and found effective outbreak control only after implementing restrictions on cephalosporin use and a complete ban on the use of fluoroquinolones. The hospital also used general hand hygiene measures, cohorted patients in a separate ward, educated staff, and intensified environmental cleaning. When fluoroquinolones were re-introduced, an increase in C. difficile infection cases was reported.20 Health care workers seeking assistance to establish an antimicrobial stewardship program in their organization can turn to a number of guidelines. The Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America have published “Guidelines for Developing an Institutional Program to Enhance Antimicrobial Stewardship,” and the CDC has developed A Public Health Action Plan to Combat Antimicrobial Resistance.

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Ensuring Rigorous Hand Hygiene Hand hygiene is one of the most basic methods of preventing the spread of C. difficile (also see Chapter 2, pages 29–35). It is imperative that care providers perform hand hygiene when moving from a C. difficile–colonized or –infected patient to a noninfected patient to prevent transmission. Both the CDC and the consensus “A Compendium of Strategies to Prevent Healthcare–Associated Infections in Acute Care Hospitals” recommend hand hygiene with soap and water or alcohol-based hand rubs for routine hand hygiene against C. difficile infection.8,22,23 However, in outbreak situations or when other practices have failed to lower the rate of C. difficile infection, soap and water hand washing is the preferred method.8 Proper hand hygiene technique is critical to the effectiveness of the soap-and-water method in removing spores from hands. Families and visitors should also wash their hands with soap and water when entering or leaving the patient’s room. (See page 69–70 for information about education for patients and families.) To be sure that visitors and staff are aware of the need to wash with soap and water, some hospitals use visual cues such as a specific color for signs posted in visible areas (for example, the door of the patient’s room) to indicate that soap and water must be used for hand hygiene.1 The National Patient Safety Goal and International Patient Safety Goal related to reducing the risk of HAIs, including C. difficile, spell out hand hygiene requirements. Organizations must follow either the WHO or CDC guidelines (see Chapter 2 for a summary of these guidelines) because proper hand hygiene reduces the transmission of infectious agents, including HAIs, from health care workers to patients and among health care workers. Despite these requirements and the requirements of all health care organizations, health care workers may not always practice good hand hygiene. Creating an organizational culture in which hand hygiene is a priority requires visible leadership support and involvement, repetition, reminders throughout the workplace, monitoring, and nonpunitive feedback (see Sidebar 3-3, page 60). Hand hygiene must become part of the daily practice of health care workers. It is also worth noting that compliance with good hand hygiene practices is significantly worse in groups in which a ranking member of the group does not perform hand hygiene. An important factor in hand hygiene compliance is monitoring adherence to hand hygiene guidelines. For example, The Joint Commission Center for Transforming 59

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Sidebar 3-3. Hand Hygiene Resources The Joint Commission Measuring Hand Hygiene Adherence: Overcoming the Challenges White paper designed to help health care organizations measure hand hygiene performance and provide practical solutions to monitoring and performance improvement activities. http://www.jointcommission.org/Measuring_Hand_Hygiene_Adherence_ Overcoming_the_Challenges_/ The Joint Commission Center for Transforming Healthcare Hand hygiene project storyboards, hand hygiene solutions, and the Targeted Solutions Tool™. http://www.centerfortransforminghealthcare.org Centers for Disease Control and Prevention Posters, brochures, and a media kit. http://www.cdc.gov/handhygiene/ Institute for Healthcare Improvement How-to Guide: Improving Hand Hygiene: A Guide for Improving Practices Among Health Care Workers http://www.ihi.org/IHI/Topics/CriticalCare/IntensiveCare/Tools/ HowtoGuideImprovingHandHygiene.htm World Health Organization WHO Guidelines on Hand Hygiene in Health Care http://www.who.int/patientsafety/information_centre/documents/en/index.html U.S. Department of Veterans Affairs Infection: Don’t Pass It On (posters, stickers, and buttons) http://www.publichealth.va.gov/InfectionDontPassItOn/

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Healthcare found that random observation is not a sufficient monitoring process. In fact, a recent project involving eight leading hospitals and health care systems in the United States found that caregivers washed their hands less than 50% of the time.24 The organizations had thought prior to the project that their hand hygiene compliance rates were at 80% and above.24 Causes for the low compliance rates included not collecting or reporting hand hygiene compliance data accurately or frequently, having a safety culture that did not stress hand hygiene at all levels, ineffectively placing hand rub dispensers or sinks, and having full hands.24 See Sidebar 3-4, pages 62–63, for information about a hand hygiene tool available from the Center for Transforming Healthcare. The CDC and WHO recommend observation of practice; in fact, many consider observation to be the gold standard for assessing hand hygiene adherence. Hospitals should use trained observers and standardized methods to watch health care workers perform hand hygiene. For example, observers may either directly or covertly monitor staff and physicians as they enter or leave the room of a patient or resident, during the care of a patient or resident, and following environmental contamination. Hospitals may also track compliance by monitoring the amount of hand hygiene supplies used. The resources that are monitored can include the following: • Soap • Alcohol-based hand rub • Paper towels • Use of sinks Typical calculations for this type of indirect monitoring are based on the volume of material used per 1,000 patient-days. This type of monitoring can be accurate, efficient, and cost-effective, but it does not indicate that hand hygiene products were used appropriately, and it does not show an individual’s adherence rate.

Ensuring Appropriate Cleaning and Disinfection of Equipment and the Environment Along with hand hygiene, proper cleaning protocols are key to controlling the spread of C. difficile. All surfaces, supplies, and equipment that come into contact with a C. difficile–infected patient need to be cleaned regularly and when soiled. This includes the following surfaces and areas8: • Furnishings in the patient’s room, such as over-bed tables, bed rails, furniture, sinks, floors, bathing tubs, and toilets 61

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Sidebar 3-4. Hand Hygiene Help from the Targeted Solutions ToolTM Joint Commission–accredited health care organizations have access to an application that simplifies the process of solving some of the most persistent health care quality and safety problems in our health care system. The Joint Commission Center for Transforming Healthcare developed the Targeted Solutions Tool (TST) to greatly enhance the efforts that Joint Commission– accredited organizations are already making to tackle these difficult and pressing problems. Non-accredited organizations can also access causes and solutions on the Center’s website at http://www.centerfortransforminghealthcare.org/tst.aspx. The TST application guides a health care organization through a step-by-step process to accurately measure its actual performance, identify barriers to excellent performance, and direct the organization to proven solutions that are customized to address the particular barriers. The first set of targeted solutions was created by eight of the country’s leading health care organizations, which worked with the Center for Transforming Healthcare to tackle hand hygiene. The TST provides the foundation and framework of an improvement method that, if implemented well, will improve an organization’s hand hygiene compliance and contribute substantially to its efforts to reduce the frequency of health care–associated infections. Together, the leading hospitals that developed the hand hygiene solutions have achieved and continue to show major and sustained gains in hand hygiene. At the start of the project in April 2009, they were surprised to learn that their rate of hand hygiene compliance averaged 48%. By June 2010, they had reached an average rate of 82% that had been sustained for eight months. Many other hospitals across the country—small, medium, and large—collaborated with the Center to test the work of the original eight hospitals and provide guidance on the development of the TST. These hospitals are experiencing the same gains as the original eight. The original eight participating hospitals used systematic process improvement methods to identify the targeted solutions. First, they measured the problems with rigor and learned that they were not doing as well as they thought they were. (continued)

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Sidebar 3-4. Hand Hygiene Help from the Targeted Solutions ToolTM, continued Then they identified exactly why the processes were failing, created solutions that were each targeted to the most critical contributing factors, and proved the effectiveness of those solutions. The same process improvement methods used by the participating organizations are made available to all organizations in a simplified form via the TST. Organizations do not need statistical data analysis capabilities or any specialized performance improvement expertise to use the TST. It is designed to be clearly understood and used by an organization’s current staff so that no special training is required. The TST is accessible via an accredited organization’s Joint Commission Connect™ extranet site at no cost. Data entered into the TST are confidential; they will not be shared with The Joint Commission. The TST is not tied to accreditation; it is voluntary.

• Patient care equipment that comes in direct contact with patients, such as thermometers, stethoscopes, and blood pressure cuffs • Frequently touched surfaces, such as doorknobs, light switches, toilet seats and handles, IV fluid pumps, TV remotes, hospital bed remotes, call buttons, and telephones Proper cleaning and disinfecting protocols for areas with C. difficile infections include the following: • Identifying the rooms of patients with C. difficile for housekeeping staff • Following manufacturer recommendations (on product labels and equipment manuals) for cleaning equipment To ensure that staff members consistently follow established protocols for C. difficile cleaning, consider the following strategies: • Place on all equipment easy-to-read labels that detail how the equipment should be cleaned. 63

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Choosing Cleaning Products

U.S. hospitals should use an Environmental Protection Agency (EPA)–registered hypochlorite-based disinfectant for environmental surface disinfection after cleaning, in accordance with label instructions. Generic sources of hypochlorite (for example, household chlorine bleach) also may be appropriately diluted and used. (Note: Alcohol-based disinfectants are not effective against C. difficile and should not be used to disinfect environmental surfaces.) EPA–registered hospital disinfectants are recommended for general use whenever possible in patient care areas. If an EPA–registered hypochlorite product is used, consult the label instructions for proper and safe use conditions.6 The intent of Joint Commission International’s PCI.9 standard explains that hand hygiene, barrier techniques, and disinfecting agents are fundamental tools for proper infection prevention and control. Organizations should identify situations in which masks, eye protection, gowns, or gloves are required and provide training on their correct use. The organization should adopt hand hygiene guidelines and post them in appropriate areas in addition to educating staff on proper hand-washing, hand disinfection, and surface disinfection procedures.

• Create a checklist of the necessary steps to clean each piece of equipment. • Educate responsible staff on how to properly clean equipment and make checklists visible and readily accessible. • Conduct regular audits of log books. • Observe—directly and indirectly—compliance with cleaning protocols. • Provide frequent reminders of the importance of proper cleaning. • Share compliance data and information about changes in infection rates related to medical equipment, devices, and the environment. See Figure 3-3, pages 65–67, for an environmental services checklist.

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Figure 3-3. Environmental Services Checklist

(continued)

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Figure 3-3. Environmental Services Checklist, continued

(continued)

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Figure 3-3. Environmental Services Checklist, continued

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Outlining Cleaning Protocols

To reduce the risk of spreading C. difficile, hospital protocols should clearly detail the following: • Which equipment and supplies must be cleaned as opposed to which are disposable • How often equipment and supplies must be cleaned • How equipment and supplies must be cleaned Nursing, infection control professionals, housekeeping, biomedical technicians, and other key staff should be involved in developing these protocols.

One organization turned to daily use of germicidal bleach wipes to reduce C. difficile in two units. Abandoning the quaternary ammonium compound solution previously used, environmental services began cleaning every room in the units with bleach wipes. Although no other interventions were instituted, the organization reported that health care–acquired C. difficile infection fell from 18.4 per 10,000 patient-days to 3.7, and the time between health care–acquired cases of C. difficile infection went from 13 to 74 days.25 Issues related to the use of bleach were addressed by issuing surgical masks to environmental services workers using the wipes and ensuring proper ventilation in rooms and tight spaces such as bathrooms. Hospitals are also exploring other means for cleaning. For example, two French hospitals affected by C. difficile compared a hydrogen peroxide dry-mist system with a 0.5% hypochlorite solution. The hospitals found a 50% decrease in environmental contamination after use of hypochlorite and 91% after hydrogen peroxide decontamination. The study’s authors reported that the dry-mist disinfection system was easy to use compared to hypochlorite disinfection.26 UV-C light also shows promise in eradicating C. difficile spores. One recent study at an acute care hospital found that use of the UV-C radiation eliminated 99.8% of C. difficile spores on environmental surfaces within 50 minutes.27 The use of UV technology provides a rapid way to disinfect without the health and safety concerns associated with bleach; disadvantages of this cleaning method include the fact that decontamination is performed only at terminal cleaning, all patients and staff must leave the room for cleaning, and the cost of UV-C devices.28 68

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Using Disposable or Dedicated Equipment One way to prevent the spread of C. difficile is to dedicate equipment for the sole use of patients infected with C. difficile.29 Whenever possible, each patient should be assigned his or her own equipment to minimize cross-contamination.1 It is preferable to use disposable equipment and supplies with patients known to be infected with C. difficile because C. difficile spores can survive on environmental surfaces and can be easily transferred to equipment in the patient’s environment. If the equipment is used on multiple patients, the spores can be transmitted from patient to patient. Therefore, if reusable equipment or other items are used on a patient with C. difficile infection, they should be restricted for use only on the infected patient. If the reusable items must be shared, adequate cleaning and disinfection must occur between uses by different patients.

Using a Laboratory-Based Alert System A laboratory-based alert system provides immediate notification to infection preventionists and clinical staff about patients who are newly diagnosed with C. difficile. This type of system allows hospitals to place patients infected with C. difficile on contact precautions in a timely manner. Options for issuing the alert include fax, phone calls, pages, or automated secure alerts. If a patient has active C. difficile infection and is being transferred to another health care organization, this information should be communicated as soon as possible to allow the receiving facility to use the proper precautions.

Educating Patients and Families About Risk, Prevention, and Treatment Becoming active, informed members of the health care team helps patients at your organization prevent C. difficile infection. Health care professionals should educate patients and families about the possibility of complications related to antibiotic use, including C. difficile. Researchers in Pennsylvania found that many patients who were discharged from the hospital developed symptoms after release.30 This illustrates the need for strong education about C. difficile; patients must know what to look for when they are released from a health care organization so they can consult a physician if they develop symptoms rather than ignoring possible danger signals. Patients should also be taught how to prevent transmission of the disease, including effective hand hygiene. This education should include a list of signs and symptoms of C. difficile infection and proper use of antibiotics. For confirmed cases of C. difficile 69

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infection, patients and family should be taught about the risk of transmission to family and visitors. Patients should be taught how to wipe surfaces at home with a hypochlorite-based solution and about avoiding the spread of bacteria and spores through personal items and soiled linens. While in the hospital, patients and family members should also receive information on the need for isolation. Explaining the necessity of isolating can go a long way toward alleviating patient and family concerns and increasing patient satisfaction with his or her care.

Placing Symptomatic Patients in Contact Precautions One way your organization can attempt to prevent and control the spread of C. difficile is through the use of contact isolation—well-established transmission-based precautionary techniques that reduce the risk of infection and overall disease transmission. In the United States, the CDC’s 2007 guideline for isolation precautions serves as the principle foundation of transmission-based precautions, including contact precautions.23 The “Compendium of Strategies to Prevent Healthcare–Associated Infections in Acute Care Hospitals” reinforces these principles.8 Contact precautions include the use of a private room, when available, especially for patients with stool incontinence.6,8 If a single-patient room is not available, patients with or suspected of being infected with C. difficile can share a room (cohort) with other patients who are also infected with C. difficile. If single rooms or cohorting is not available, other options to consider include implementing at least three feet of separation between beds to reduce opportunities for inadvertent sharing of items and drawing a privacy curtain between patients to promote separation. Some organizations place colored tape on the floor to identify areas with restricted access that require contact precautions.1 Health care workers need to use a gown and gloves on entry to the patient’s room and discard the gown and gloves when moving from one patient to another.23 Gloves should be changed when they become soiled or after touching surfaces visibly contaminated with feces.8 The “dos and don’ts” of glove use include the following30: • Work from clean to dirty. – Don’t touch clean body sites or surfaces after touching dirty/heavily contaminated areas. For example, take a patient’s blood pressure before dressing wounds. • Limit opportunities for “touch contamination.” – Don’t touch your face or adjust PPE with used gloves. 70

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– Don’t touch environmental surfaces, except as necessary, during patient care. For example, it is necessary to touch the infusion pump, but don’t rearrange the sheets, pillows, and items on the bed tray and then touch the patient. • Change gloves when required. – Don’t continue to use gloves if they are torn or heavily soiled (even during use on the same patient). – Don’t use the same gloves on different patients. For example, if gloves are torn with a needle or scissors, immediately dispose of them and put on a fresh pair. • Discard gloves in an appropriate receptacle. – Don’t wash or reuse disposable gloves. For example, if gloves appear to be clean, do not wash them and then reuse them on a different patient. It is also important to limit the transportation or movement of C. difficile patients outside their room to medically necessary purposes only. Patients should be taught to perform hand hygiene before leaving their room, and health care workers should don clean PPE to handle the patient at the transport destination. Some experts recommend continuing contact precautions for at least 48 hours after diarrhea ends. Requiring patients or visitors to use contact precautions has not, however, demonstrated a decrease in the rates of C. difficile infection to this time.23 See Sidebar 3-5, page 72, for practices to avoid related to C. difficile infection.

Encouraging Staff Compliance The success of transmission-based precautions depends on two main points: 1. The identification of confirmed and suspected C. difficile–infected patients 2. Strict and consistent adherence to contact precautions for health care workers and visitors Health care workers are often challenged to deal with a colleague or another employee who fails to follow contact precautions. The following suggestions can help staff at your organization handle the situation when it occurs31: • In the case of a single event, colleagues should be encouraged to provide immediate feedback to remind the staff member about proper procedures.

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Sidebar 3-5. Practices to Avoid This chapter focuses on strategies to prevent and mitigate C. difficile infection, but there are specific practices that should not be considered routine in the care of patients with C. difficile infections, such as the following8: • Do not test patients who do not have signs or symptoms of C. difficile infection. Studies have shown a high incidence of false-positive results. Falsepositive results can take up the valuable time of nurses and lab personnel, inconvenience patients, and lead to the unnecessary use of antibiotics (which can increase antimicrobial resistance) and increased costs for these needless tests and antibiotics. • Do not treat patients who are colonized with C. difficile but who are asymptomatic. Like unnecessary testing, this leads to increased costs and increases a patient’s chances of developing C. difficile infection due to the overuse of antibiotics. • Do not isolate patients who are colonized with C. difficile but who are asymptomatic. Although asymptomatic colonized patients can serve as a source of transmission, they are much less likely to transmit C. difficile than are infected patients. Therefore, it is debatable whether asymptomatic colonized C. difficile patients should be placed on contact precautions. Some hospitals keep these patients on contact precautions for the duration of hospitalization, regardless of test results. • Do not repeat C. difficile testing at the end of successful therapy for a patient recently treated for C. difficile infection. The patient may still be colonized and will continue to shed spores.

• If a staff member consistently fails to adhere to appropriate protocols, an organizational strategy is needed to provide guidance. • Rather than use punitive measures, such as “writing up” a noncompliant staff member, a more straightforward peer-to-peer reminder may be more effective. It is helpful if your organization provides and promotes scripted reminders that staff can use. For example, a scripted reminder could include the following: “C. difficile infections are a big problem in our organization, and we help these dangerous bacteria spread when we do not follow basic infection prevention practices.” 72

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• Strict compliance with practices that prevent the spread of C. difficile should be expected of all clinicians. For example, some hospitals have incorporated adherence to infection prevention standards into the criteria on which respiratory therapists, physical therapists, transporters, physicians, and others are evaluated. • If peer pressure and persuasion are not sufficient to change the behavior of a noncompliant health care worker, more serious steps need to be taken, including disciplinary action. Fundamentally, not following contact precaution protocols when managing C. difficile–infected patients represents a departure from the standard of care. Not only does this behavior put other patients and staff at risk, but it places the organization in a tenuous position from a medical liability standpoint.

Reassessing Compliance with Environmental Cleaning Protocols After Outbreaks By using evidence-based best practices to prevent and mitigate C. difficile infections, your organization can have a positive impact on improving patient outcomes. If an outbreak does occur, your organization should monitor whether environmental cleaning protocols are being consistently carried out. The best method to accomplish this task is observation. For example, if your hospital uses a checklist, evaluate whether tasks on the checklist are being accomplished. It also makes sense to work with unit and specialty groups to refine checklists to improve adherence with cleaning protocols or work with these groups to develop checklists. As this chapter shows, developing and maintaining a focus on preventing C. difficile is challenging. Chapter 4, “Sustaining Improvement,” provides strategies to meet this test. References 1. 2. 3.

4.

Association for Professionals in Infection Control and Epidemiology (APIC): Guide to the Elimination of Clostridium difficile in Healthcare Settings. Washington, DC: APIC, 2008. World Health Organization (WHO): The World Health Report 2000: Health Systems: Improving Performance. Geneva: WHO, 2000. Eckstein B.C., et al.: Reduction of Clostridium difficile and vancomycin-resistant Enterococcus contamination of environmental surfaces after an intervention to improve cleaning methods. BMC Infect Dis 7, Jun.21, 2007. http://www.biomedcentral.com/1471-2334/7/61 (accessed Aug. 1, 2011). Aziz A.M., Murphy P.: Clostridium difficile infection-A tool for improving practice and reducing rates. Br J Nurs 18:659–664, Jun. 11–24, 2009.

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7. 8. 9.

10. 11.

12.

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14. 15. 16.

17. 18. 19.

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McDonald L.C., et al.: Recommendations for surveillance of Clostridium difficile–associated disease. Infect Control Hosp Epidemiol 28:140–145, Feb. 2007. Centers for Disease Control and Prevention: Frequently Asked Questions About Clostridium difficile for Healthcare Providers. Updated Mar. 22, 2011. http://www.cdc.gov/HAI/organisms/ cdiff/Cdiff_faqs_HCP.html (accessed May 17, 2011). Currie B.: Real-time PCR testing for CDI improves outcomes and reduces costs. MLO Med Lab Obs 41:18–20, Oct. 2009. Dubberke E.R., et al.: Strategies to prevent Clostridium difficile infections in acute care hospitals. Infect Control Hosp Epidemiol 29(Suppl. 1):S81–S92, Oct. 2008. International Infection Control Council: Global Consensus Conference on Infection Prevention and Control Practice for Clostridium difficile Associated Disease (CDAD). http://www.chica.org/pdf/2008_C_DIFF_RECOMM.pdf (accessed May 16, 2011). Yadav Y., et al.: Automated system to identify Clostridium difficile infection among hospitalised patients. J Hosp Infect 72:337–341, Aug. 2009. Elixhauser A., Jhung M.A.: Clostridium difficile–Associated Disease in U.S. Hospitals, 1993–2005. HCUP Statistical Brief No. 50. Rockville, MD: Agency for Healthcare Research and Quality, Apr. 2008. Fowler S., et al.: Successful use of feedback to improve antibiotic prescribing and reduce Clostridium difficile infection: A controlled interrupted time series. J Antimicrob Chemother 59:990–995, May 2007. Valiquette L., et al.: Impact of a reduction in the use of high-risk antibiotics on the course of an epidemic of Clostridium difficile–associated disease caused by the hypervirulent NAP1/027 strain. Clin Infect Dis 45(Suppl. 2):S112–S121, Sep 2007. Poutanen S.M., Simor A.E.: Clostridium difficile–associated diarrhea in adults. CMAJ 171:51–58, Jul. 6, 2004. McFarland L.V., et al.: Implications of the changing face of Clostridium difficile disease for health care practitioners. Am J Infect Control 35:237–253, May 2007. Dellit T.H., et al.: Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis 44:159–177, Jan. 15, 2007. Burgess D.S., Rapp R.P.: Bugs versus drugs: Addressing the pharmacist’s challenge. Am J Health Syst Pharm 65(Suppl. 2):S4–S15, May 1, 2008. Carling P., et al.: Favorable impact of a multidisciplinary antibiotic management program conducted during 7 years. Infect Control Hosp Epidemiol 24:699–706, Sep. 2003. Guglielmo B.J., et al.: Impact of a series of interventions in vancomycin prescribing on use and prevalence of vancomycin-resistant enterococci. Jt Comm J Qual Patient Saf 31:469–475, Aug. 2005.

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20. Debast S.B., et al.: Successful combat of an outbreak due to Clostridium difficile PCR ribotype 027 and recognition of specific risk factors. Clin Microbiol Infect 15:427–434, May 2009. 21. Kyne L.: Clostridium difficile—Beyond antibiotics. N Engl J Med 362:264–265, Jan. 21, 2010. 22. Boyce J.M., et al.: Lack of association between the increased incidence of Clostridium difficile–associated disease and the increasing use of alcohol-based hand rubs. Infect Control Hosp Epidemiol 27:479–483, May 2006. 23. Siegel J.D., et al.: 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Isolation2007.pdf (accessed May 17, 2011). 24. Joint Commission Center for Transforming Healthcare: Hand Hygiene Project Storyboard. http://www.centerfortransforminghealthcare.org/UserFiles/file/hand_hygiene_storyboard.pdf (accessed May 17, 2011). 25. Orenstein R., et al.: Sustained Elimination of Clostridium difficile Infection, abstract. Society for Healthcare Epidemiology of America 2011 Annual Scientific Meeting, Dallas, TX, Apr. 1–4, 2011. http://shea.confex.com/shea/2011/webprogram/Paper4014.html (accessed May 28, 2011). 26. Barbut F., et al.: Comparison of the efficacy of a hydrogen peroxide dry-mist disinfection system and sodium hypochlorite solution for eradication of Clostridium difficile spores. Infect Control Hosp Epidemiol 30:507–514, Jun. 2009. 27. Rutala W.A., Gergen M.F., Weber D.J.: Room decontamination with UV radiation. Infect Control Hosp Epidemiol 31:1025–1029, Oct. 2010. 28. Joint Commission Resources: Minimizing the growing threat of Clostridium difficile. Joint Commission Perspectives on Patient Safety 6:5–6, Jun. 2006. 29. Patient Safety Authority Commonwealth of Pennsylvania: Clostridium difficile: A sometimes fatal complication of antibiotic use. Pennsylvania Patient Safety Advisory 2:1–8, Jun. 2005. 30. Centers for Disease Control and Prevention: Guidance for the Selection of Personal Protective Equipment (PPE) in Healthcare Settings. http://www.cdc.gov/ncidod/dhqp/pdf/ppe/PPEslides6-2904.pdf (accessed May 17, 2011). 31. The Joint Commission: Staff Pocket Guide to MDROs. Oakbrook Terrace, IL: Joint Commission Resources, 2009.

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reating and sustaining a dynamic and comprehensive program to prevent and mitigate Clostridium difficile (C. difficile) infections is an ongoing process. Although each health care organization faces unique challenges, successful programs share the following common characteristics1: • Team driven, staff empowered • Administration commitment • Practice leader involvement as champions • Uniform policies and procedures that include evidence-based practices • Readily available supplies to facilitate adherence to recommended practices • Education and competency verification • Surveillance to monitor practice and outcomes • Communication, including outcome feedback to staff • Evaluation of interventions and continuous improvement • Hardwiring of intervention into culture to maintain gains • Celebration of success For an organization that already has a program for reducing C. difficile risks, it is important to reassess the program, determine any gaps, and use this information to refine and improve the program. Launching new initiatives or education programs and saying “we’re done” is not sufficient. Instead, leaders and staff must constantly revisit the issue; ensure that interventions and education are appropriate, effective, and reliable; and monitor adherence to guidelines. Questions to keep in mind when reviewing your program include the following: • Does the program assess risks, set priorities, determine goals, and strive to meet those goals? • What data are collected? • Are there measures of success? • Have our interventions been effective?

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• Does the culture encourage and include a focus on the prevention of C. difficile infection? • How are we doing at targeting a zero infection rate? • Do we involve health care workers in making improvements or changes? • Are education efforts efficient at getting the message across? • Are we sustaining our C. difficile prevention program? • Are patients and their families involved in the effort? • Are staff satisfied with the C. difficile prevention program? A multidisciplinary C. difficile prevention team should commit to regularly reviewing questions such as these to identify areas of improvement and work together to sustain compliance. If the answer to any of these questions is “no” or is in some way unsatisfactory, the team should redesign and improve the C. difficile prevention program.

Assessing Incidents Through Root Cause Analysis C. difficile is a major health care problem around the world—so it may be problematic in your organization. Root cause analysis is a useful tool for finding ways to address C. difficile infection. Root cause analysis is useful in determining how a patient became sick when a C. difficile infection occurred because it focuses on systems and processes rather than, for example, on whether a nurse failed to wash her hands or a housekeeper did not properly clean a patient’s room. Using the root cause analysis process as part of your efforts to fight C. difficile is crucial in digging to a deeper level to determine the systematic root of the problem. Getting to the root cause of C. difficile infections takes a great deal of time and effort because it involves asking “Why?” until root causes are identified and then exploring the ramifications of each response. Root cause analysis can do more than determine that “Action 1” caused “Result 2.” Instead, the process can help your organization see that “If we change Action 1, we can reduce the possibility of Result 2 recurring or, in fact, prevent Result 2 from occurring in the first place.” Although root causes analysis is a familiar process for organizations accredited by The Joint Commission and Joint Commission International, knowledge of the process does 77

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not make it easy. Organizations often struggle to identify root causes because they are reluctant to confront sensitive, politically charged issues such as organizational culture, resources, and lack of leadership or support. Employees may be reluctant to address the problems they perceive because they fear that their candor could cause repercussions within the organization. As a result, for root cause analysis to be successful, it must be seen as confidential and nonpunitive. It is also critical to keep the focus on probing for systems or common-cause problems rather than concentrating on human errors. The process should identify potential improvements in processes or systems that would likely reduce the chance of C. difficile infection in the future. To conduct a root cause analysis, your organization should use the following steps: • Organize a team. • Define the event or problem. • Study the event or problem. • Determine what happened. • Identify the contributing factors. • Collect and asses data on proximate and underlying causes. • Design and implement interim changes. • Determine the root causes. • Explore and identify risk reduction strategies. • Evaluate proposed actions. • Design, test, and implement improvements. • Evaluate and communicate the results of improvements. See Figure 4-1, page 79, and Figure 4-2, page 80, for tools that can help you determine proximate (obvious, superficial) causes and contributing (additional action, influencing) causes during a root cause analysis. Your organization can use the following questions to probe for systems problems that underlie problematic processes: • Can staff performance be improved, and if so, how? • How can in-service training be improved? • How appropriate is the physical environment for the processes being carried out? Can it be improved? If so, how? • To what degree are systems in place to identify C. difficile environmental risks? Can these systems be improved? If so, how?

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Figure 4-1. Probing for Underlying Causes The team might find it helpful to use a worksheet when probing for the underlying causes of proximate causes. For example, in the case of C. difficile infection, the worksheet could be organized (and begun) as follows: Proximate Causes

Underlying Causes

1. Incomplete risk assessment at intake

_________________________________ _________________________________

2. Incomplete examination of the individual; failure to diagnose infection

_________________________________ _________________________________

3. _____________________________

_________________________________ _________________________________

_____________________________

• How conducive is the culture to C. difficile risk identification and reduction? Can the culture be improved? If so, how? • What are the barriers to communication of potential C. difficile risk factors? Can these barriers be reduced or eliminated? If so, how? • To what degree is the prevention of C. difficile infection communicated as a high priority? How is such prevention communicated? Can this communication be improved? If so, how? • What can be done to protect against uncontrollable factors associated with C. difficile infection? It is highly likely that your team will identify more than one root cause for C. difficile infections, and it is likely that these root causes will be interrelated. For example, your organization might identify root causes such as the following: • The environment of care, such as inadequate cleaning procedures • Patient assessment methods, such as incomplete assessment for diarrhea or previous antibiotic use at intake and absent or incomplete reassessment 79

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Figure 4-2. Differentiating Root Causes and Contributing Causes To differentiate root causes from contributing causes, ask the following questions of each of the causes on the team’s list. If the answer is “no” to each of the three questions, the cause is a root cause. If the answer is “yes” to any one of the three questions, the cause is a contributing cause. Cause: _________________________________________________________________ 1. Would the problem have occurred if Cause had not been present? ❏ No = root cause ❏ Yes = contributing cause 2. Will the problem recur due to the same causal factor if Cause is corrected or eliminated? ❏ No = root cause ❏ Yes = contributing cause 3. Will similar conditions recur if Cause is corrected or eliminated? ❏ No = root cause ❏ Yes = contributing cause

• Lack of procedural compliance, such as with use of personal protective equipment (PPE), inadequate hand hygiene, or testing for C. difficile • Staff-related factors, such as insufficient orientation or training, incomplete competency review, and inadequate staffing levels • Information-related factors, such as incomplete communication among and between caregivers and information being unavailable when needed See Sidebar 4-1, page 81, to learn how one hospital used root cause analysis to target C. difficile infections. The identification of all root causes is essential to preventing C. difficile. Why? Because the interaction of the root causes is likely to be at the root of the problem. If you eliminate only one root cause, it is possible that the other root causes could interact in another way to cause the same problem. The root causes collectively represent latent conditions— conditions that exist as a consequence of management and organizational processes and that can be identified and corrected before they contribute to infections. Effective identification of all root causes and an understanding of their interaction can aid your 80

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Sidebar 4-1. Using Root Cause Analysis to Target C. difficile Infections University Hospital of South Manchester, Wythenshawe Hospital, Manchester used a root cause analysis tool to reduce C. difficile infection incidence and rates as part of a countrywide program. The hospital used the following action plan: • The infection prevention and control team is notified when the laboratory reports a positive result, and an e-mail goes to the physician, the nurse in charge of the unit, and other designated staff. • The e-mail includes information about appropriate C. difficile infection protocols, such as hand hygiene and isolation, as well as root cause analysis. • The root cause analysis identifies evidence of important interventions such as daily cleaning of the patient’s room and compliance with organizational antibiotic policies prior to diagnosis. • Staff and physicians return the root cause analysis and completed action plan to a surveillance officer. The hospital reports that the root cause analysis process has helped the infection prevention and control team identify antimicrobial prescribing issues and cleaning problems, and it has also enhanced teamwork among infection prevention and control specialists and clinicians.2

organization in changing processes to eliminate a whole family of risks (for example, other types of health care–associated infections in addition to C. difficile infection). Most root cause analysis teams ultimately reach a point where they ask themselves, “When can we stop asking ‘Why’? questions?” This question is best answered by considering whether an identified cause is actionable in a way that will likely prevent recurrences or otherwise protect patients from recurrences. If the answer is “yes,” then it might be acceptable to stop there, but it is by no means necessary to stop there. Even root causes can have deeper root causes.

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Exploring Risk Reduction Strategies with Failure Mode and Effects Analysis (FMEA) Beyond studying the root causes of an identified case of C. difficile infection, your organization can implement a strategy of assessing the risk of C. difficile infection (in other words, before an infection occurs) by using FMEA. The goal of FMEA is to proactively prevent poor results, which in health care means harm to patients. Its greatest strength lies in its capability to focus users on the process of redesigning potentially problematic processes to prevent the occurrence of failures. See Sidebar 4-2, page 83, for more about the relationship between root cause analysis and FMEA. FMEA offers a systematic way of examining a design prospectively for possible ways in which failure can occur. Potential failures are identified in terms of failure modes or symptoms. For each failure mode, the effect on the total system or process is studied, and factors that might cause or enable those failures are identified. Actions (planned or already taken) can be reviewed for their potential to minimize the probability of failure or to reduce the effects of failure. The steps in FMEA include the following: • Select a high-risk process and assemble a team. • Diagram the process. • Brainstorm potential failure modes and determine the effects of the failure modes. • Prioritize failure modes. • Identify root causes of failure modes. • Redesign the process. • Analyze and test the new process. • Implement and monitor the redesigned process. In using FMEA to examine methods to improve processes to prevent C. difficile infection, the question “What if?” is particularly relevant. For example, your organization could ask “What if our organization better identified patients with diarrhea?” The FMEA team might, for example, look at patients admitted through the emergency department to the intensive care unit to proactively analyze and reduce the spread of C. difficile infection. Risk points might include the following: • Identifying and documenting diarrheal patients • Timely notification to infection prevention and control staff and the attending physician

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Sidebar 4-2. The Interrelationship Between Root Cause Analysis and FMEA Failure mode and effects analysis (FMEA) and root causes analysis differ in critical ways but also share similarities. The fundamental difference in the two tools is timing: Root causes analysis is a retrospective approach, whereas FMEA is a proactive approach, designed to keep unwanted events from occurring in the first place. Root cause analysis asks “Why?” after an event has occurred to identify the root causes of the event. FMEA asks “What if?” to explore what could happen if a failure occurred at a particular step in a process. FMEA and root cause analysis have the following characteristics in common: • They are both nonstatistical methods of analysis. • The goal of both is to reduce the possibility of future patient harm. • They both involve identifying conditions that lead to harm. • They are both team activities. In addition, the two methodologies can be—and often are—interconnected. FMEA can be used during a root cause analysis to help evaluate various improvement strategies that resulted from root cause analysis. FMEA can look at where the various strategies might fail and identify any new failure modes that have been introduced as a result of new design processes. Root cause analysis can be used to identify the root causes of failure modes.

• Information transfer to the receiving department (for example, the intensive care unit) • Appropriate laboratory testing • Use of routine precautions • Performance of appropriate hand hygiene • Access to PPE • Consistent use of PPE • Cleaning of patient rooms and terminal cleaning upon discharge or transfer

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Creating a Process Improvement Team

Whether your organization uses failure mode and effects analysis (FMEA) or root cause analysis to improve C. difficile infection, using a team process is the best way to achieve desired results. A process improvement team should include the following members: • Individuals closest to the issues involved • Individuals closest to implementing potential changes • A leader who has a broad knowledge base and is respected • Someone who has decision-making authority • A facilitator who is familiar with process improvement activities such as root cause analysis or FMEA • Individuals with diverse knowledge bases

Team members would then identify the root causes of the failure modes and redesign processes to improve the management of patients with diarrhea. For example, an organization might redesign the infection prevention and control admission screening tool, develop new core competencies for C. difficile practices, provide additional education related to hand hygiene and use of PPE, and improve signage for patients on contact precautions or isolation.

Evaluating Improvement Actions An organization can use numerous techniques to assess the data collected. Most types of assessment require comparing data to a point of reference. These reference points may include the following3: • Internal comparisons, such as unit-to-unit or time-to-time: A team can compare its current performance with its past performance, using statistical quality control tools. Two such tools are particularly helpful in comparing performance with historical patterns and assessing variation and stability: control charts and histograms. These tools show variation in performance and the stability of performance. • Aggregate external reference databases: In addition to assessing an organization’s historical patterns of performance, a team can compare performance with that of other organizations. Expanding the scope of comparison helps draw conclusions about an organization’s performance and learn about various methods to design and carry out processes. Although benchmarking for C. difficile infection rates is not 84

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available, your organization can study exemplary performance for a similar process (for example, hand hygiene, use of PPE) in another organization and, to the greatest extent possible, adapt this information for your own use. Or, your organization may be able to compare its results with those of other organizations or with current research, professional standards, or literature. • Desired performance targets, specifications, or thresholds: A team may establish targets, specifications, or thresholds for evaluation against which to compare current performance. Such levels can be derived from professional literature or expert opinion within your organization.

Taking Additional Action After evaluating the effectiveness of improvement actions, it is time to act. If established targets or goals are being achieved, efforts should focus on communicating and standardizing the successful C. difficile improvement actions. For example, your organization should examine how to revise processes and procedures so that the improvement is realized and sustained in everyday work and complete necessary training so that all staff members are aware of the new process or procedure. It is also important to ensure that communication about results is ongoing and reinforces the reasons for the improvement initiative. If your organization’s C. difficile program is not producing the desired results, consider these three common reasons for failures and how your organization can work to overcome these challenges3: • Lack of knowledge: Staff may not know how to perform the task correctly, or they may not understand the policy or process or why it is important. • Inadequate system support: The lack of equipment or supplies, or barriers to getting or using the equipment or supplies, may hamper progress in containing C. difficile. In these circumstances, staff members know how to do the task, but the equipment or supplies do not support the task or are unavailable or do not work. • Lack of motivation or management reinforcement: Staff members may know how to perform the task correctly, and equipment and supplies may be appropriate, but staff still do the task incorrectly.

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Tools for Data Surveillance As discussed in Chapter 3, surveillance is an important component of an effective program to reduce C. difficile infections. Surveillance involving C. difficile–related data collection is conducted for a variety of reasons, including the following: • To assess the organization’s risk for C. difficile infection by identifying areas that need further investigation, such as areas where patients seem to be at higher or lower risk for developing C. difficile infection • To identify problems such as the emergence of new C. difficile strains or outbreaks • To seek out cases of C. difficile infection • To determine whether processes used to prevent and control C. difficile infections are functioning properly and whether revisions or improvements to systems are necessary • To check the success of any changes made to a system or process to prevent C. difficile infection Surveillance and measurement present many challenges, such as outcomes being complicated by diagnostic limitations or an inadequately funded laboratory being unable to meet surveillance demands. Other challenges may be technological (for example, computers and software) or labor related (for example, staff hours necessary to collect, analyze, and report surveillance data). Despite these challenges, experts believe that certain processes reduce the likelihood of infections such as C. difficile and, therefore, surveillance and measurement of C. difficile infection must occur.4 Process measures for C. difficile infection include compliance with hand hygiene guidelines (for example, number of observed adequate hand hygiene episodes performed by health care personnel / number of observed opportunities for hand hygiene × 100 = % compliance), compliance with contact precautions (for example, number of observed patient care episodes in which contact precautions are performed / number of observed patient care episodes in which contact precautions are indicated × 100 = % compliance), and compliance with environmental cleaning procedures. An outcome measure for C. difficile infection might be C. difficile infection cases per 1,000 patientdays. Hospitals in states that have mandatory reporting requirements for C. difficile infection must collect and report the data required by the state.5 See Sidebar 4-3, page 87, about defining data.

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Sidebar 4-3. Defining Your Data How your C. difficile data will be used affects how they will be collected, so your organization needs to make certain determinations before beginning the collection and surveillance process: • Be sure to clearly define not only the actual infection events (the numerator) but also the population to be measured (the denominator). • Decide whether the denominator will be based on an ideal number, historical data, or some other number that is meaningful to your facility. The more closely the denominator reflects the population at risk, the more accurately the numbers will describe the true infection rate. • Determine how data will be calculated: Will you use a rate percentage? A rate per 1,000 patient-days (incidence density)? A simple comparison of raw numbers? Maintaining uniformity allows for true accurate comparisons. • Use technology, when possible, to allow for timely access to information, manipulation of infection data by several variables, evaluation of patterns of infections, and easy generation of reports.

Collecting data about the various components of the Joint Commission National Patient Safety Goal or Joint Commission International Patient Safety Goal to reduce HAIs is not enough by itself. For example, collecting data about hand hygiene compliance is not sufficient. Organizations must also do the following: • Review and analyze the data. • Identify areas for improvement and possible interventions. • Implement improvement strategies. • Evaluate the effectiveness of these strategies.

Involving the Right People To achieve and sustain improvements in fighting C. difficile infection, the right people must be involved. Your organization should think about who is closest to this process and should therefore “own” the improvement activity. Who will be accountable at various stages? To a great extent, the success of a specific C. difficile improvement effort hinges on involving the right people from all disciplines, services, and offices in the process being addressed.

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The group or team that creates the process should include the people responsible for the process, the people who carry out the process, and the people affected by the process. If a group finds that it needs a perspective not offered by current representatives, it should conduct interviews or surveys outside the group or invite new members into the group. It is important to consider customers and suppliers such as purchasers, payers, physicians, referral sources, accreditors, regulators, and the community as a whole. See Figure 4-3, pages 89–90, for more information on key players at each stage.

Defining Each Goal, Scope, and Activity Defining the goals and scope of C. difficile improvement activity is critical. To understand the potential effects, your organization should determine which dimension of performance—safety, effectiveness, patient-centeredness, timeliness, efficiency, or equity—will be affected.6 Although safety may be the main focus, improvements may affect other dimensions. To define the goals, scope, and activities, the team should answer the following questions: • What goals does the organization have in implementing necessary improvements related to C. difficile? • What measures will be most affected by the change? • What specific activities must be carried out to reach the goals and affect the dimensions of performance? (Provide a clear statement of the essential features of each proposed solution.) What are the sequential steps required to accomplish the proposed improvement?

Evaluating Proposed Improvement Actions After studying the problem of C. difficile in your organization, you may have a long list of possible improvement actions. How do you decide which ones to pursue first? In evaluating potential improvement actions, the improvement team should consider the impact of the suggested improvements on organization processes, resources, and schedules. Answering some key questions will help your team identify potential barriers to implementation for each improvement action. Relevant questions include the following: • How does the proposed action relate to other projects currently under way in the organization? Are there redundancies? • How does the action affect other areas and processes? • What process-related changes might be required? • Can affected areas absorb the changes or additional responsibilities? 88

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Figure 4-3. Determining Who to Involve Involving the right people at each stage of an improvement process is critical to the success of the improvement initiative. Consider which individuals should be involved at each stage and write their names in the appropriate spaces below. Designing the action. In general, the group that participated in the root cause analysis should have the necessary expertise to recommend improvements and may be in the best position to design or redesign the improvements. This group should include those who carry out or are affected by the process. They are __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ Approving recommended actions. When substantial resources are involved and the potential effects are significant, the organization’s leaders have to approve the action. If a group has obtained the necessary input and buy-in while devising an improvement, the approval should come readily. The appropriate leaders are __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ (continued)

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Figure 4-3. Determining Who to Involve, continued Testing the action. Testing should occur under real-world conditions, involving staff who will actually be carrying out the process. Effects can be measured with the same methods used to establish a performance baseline. Appropriate staff members include __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ Implementing the action. Although full-scale implementation of a process change should have positive results, any change can create anxiety. Therefore, care should be taken to prepare people for change and to explain the reason for the change in an educational, nonthreatening way. Cooperation is essential for changes to succeed, but it cannot exist if people believe a change is being forced on them without good reason. An effective team should have already acquired much of the necessary buy-in during earlier phases of the improvement process or during the early stages in the root cause analysis. Appropriate staff members include __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________

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• What financial resources will be required to implement the action? Include both direct and indirect costs—that is, costs associated with the necessary changes to other procedures and processes. How will these resources be obtained? • What other resources (for example, staff, time, management) are required for successful implementation? How will these resources be obtained? • What resources (for example, capital, staff, time, management) are required for continued effectiveness? How will these resources be obtained? • What other activities will have fewer resources as a result of shifting resource allocation for this change? • In what time frame can implementation be completed? • How will implementation of this action affect other schedules? How can this be handled? • What initial and ongoing training will be required? • Is there a process in place to analyze and take action if there are unintended negative consequences from implementing this action?

Defining the Measurement Plan Collecting data about the performance of your organization in implementing C. difficile prevention activities is crucial in determining whether further actions are necessary. To design the measurement plan, consider the following questions: • What is the scope of measurement for the improvement project? • Have any portions of the process under study been measured in the past, or are they currently being measured? If so, are assessments available? • What measurement tools will be used? • Will the tools provide reliable data? Have they been tested? • What costs are associated with collecting the necessary data? Do benefits outweigh costs? • Can the data generated by the selected measurement tool be transformed into meaningful and useful information? • How can the team ensure that the data are complete, accurate, and unbiased? • How will the staff collecting data be educated? • What format(s) will be used to report the data? • Where and how will any additional required data be obtained? • How will the success of the improvement be measured?

Reevaluating Each Targeted Goal The final step in achieving and sustaining improvement is monitoring progress. Your organization can create a simple reporting log or worksheet to plan and track progress in measuring the effectiveness of each improvement goal (see Figure 4-4, page 92). 91

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Figure 4-4. Progress Worksheet Date: ________________________________ Completed by: ___________________________ Description of concern identified: ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ What was the expected performance level? What was actual? Is it a valid concern? How is data collected? Is it a high-risk area? Is it a problem-prone area? Is it a high-volume area? Is it related to a National Patient Safety Goal or an International Patient Safety Goal? Have we received complaints from patients or staff in this area? Identify changes needed. Who is responsible for what, using which tools/training, when, and for how long? Record current level of performance.

Current level:

Implement change: What is being learned? Are refinements needed during implementation of change? Ongoing data: What is the impact? Analyze data: What was learned? Does data show process improvement? Any more changes needed? Is it identified as potentially problematic in the literature or by professional associations or other sources? What else should be done? How long to continue to monitor change? Have current measurement activities shown performance to be low? Recommended change to policy? Completed by: ___________________ Date: ________________ Forward to: ______________

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This simple tool should spell out the goal, the measure, the person responsible, and the results of the review completed.

Conclusion With growing public demand for reducing infections, it is easy to focus on public health solutions such as hand hygiene. While this is one piece of the puzzle, the issue is much more complex. An organization must have a culture of safety that strongly encourages established, science-based procedures for preventing the transmission of infections such as C. difficile. Reading this publication is an important step in learning to adequately address this complex, complicated, and worldwide issue that is fundamental to safe, high-quality health care. The case studies illustrated in Chapter 5 demonstrate how organizations are making a difference in efforts to reduce the risk and spread of C. difficile infection. References 1. 2. 3. 4. 5. 6.

Arias K.M., Soule B.M.: The APIC/JCAHO Infection Control Workbook, 2nd ed. Oakbrook Terrace, IL: Joint Commission Resources, 2010. Aziz A.M., Murphy P.: Clostridium difficile infection-A tool for improving practice and reducing rates. Br J Nurs 18:659–664, Jun. 11–24, 2009. Soule B.M., Memish ZA.. (eds.): Best Practices in Infection Control: An International Handbook. Oakbrook Terrace, IL: Joint Commission Resources, 2007. Singh N., Brennan P.J., Bell M.: Primum non nocere. Infect Control Hosp Epidemiol 29(Suppl. 1):S1–S2, Oct. 2008. Dubberke E.R., et al.: Strategies to prevent Clostridium difficile infections in acute care hospitals. Infect Control Hosp Epidemiol 29(Suppl. 1):S81–S92, Oct. 2008. Institute of Medicine: Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press, 2001.

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reventing C. difficile infection is particularly challenging in health care organizations because the spread of C. difficile is extremely difficult to control, the mortality and morbidity rates are rapidly increasing, and treatment options are limited. The following case studies show how some organizations have put various evidencebased concepts into practice on the front lines of health care. Sidebar 5-1, below, explores areas where research continues in efforts to find additional evidence-based practices to mitigate and prevent C. difficile infections.

Sidebar 5-1. Concepts in C. difficile Prevention Research Although a great deal of information exists about evidence-based practices to prevent and control C. difficile infection, there are also many concepts that require additional research. The following areas have been targeted by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA) for a C. difficile research agenda*: • Epidemiology: What is the epidemiology of C. difficile? For example, research should focus on identifying the incubation period for C. difficile, determining the magnitude of risk associated with administration of proton pump inhibitors, and learning whether exposure to antimicrobials (or equivalent agents, such as chemotherapy drugs) is required for susceptibility to C. difficile infection. • Diagnostics: Is glutamate dehydrogenase detection in stool sufficiently sensitive as a screening test for C. difficile colitis? Which commercial polymerase chain reaction assay for toxin B performs best, compared with culture for toxigenic C. difficile? Is there any role for repeated C. difficile stool testing during the same episode of illness? • Management: If a validated severity-of-illness tool for C. difficile infection is developed, how will treatment recommendations be modified for primary C. difficile infection? What is the best approach to treatment of fulminate C. difficile infection? • Prevention: What preventive measures can be taken to reduce the incidence of C. difficile infection? For example, research should examine whether probiotics or biotherapeutic agents can prevent C. difficile infection, as well as the most effective antimicrobial stewardship strategies to prevent C. difficile infection. • Basic research: What is the biology of C. difficile spores that lead to infection? What is the basic relationship of C. difficile to the human gut mucosa and immune system? * Cohen S.H., et al.: Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol 31:431–455, May 2010.

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Duke University Medical Center, Durham, North Carolina A tertiary and quaternary care organization, Duke University Medical Center, located on the campus of Duke University in Durham, NC, includes Duke University Hospital, outpatient specialty clinics, a children’s health center, an eye center with five operating rooms, an ambulatory surgery center with nine operating rooms, and the Center for Living. Consistently rated as one of the top hospitals in the United States by U.S. News & World Report, the hospital has 924 acute care beds, and 19 psychiatry beds. The organization offers comprehensive diagnostic and therapeutic facilities including a regional emergency/trauma center; a major surgery suite containing 31 operating rooms; an endosurgery center; and an extensive diagnostic and interventional radiology area. The organization also functions as a research hospital where medical advances are achieved and applied and as a teaching hospital for students of medicine, nursing, and the allied health sciences. In 1997 Duke University Medical Center along with five local community hospitals collaborated to form the Duke Infection Control Outreach Network (DICON). DICON focuses on improving member’s infection prevention and control programs by compiling data on nosocomial infections, identifying trends and areas for improvement, and providing ongoing education and leadership to community providers. DICON has grown to include more than 40 hospitals, medical centers, and surgical centers across five states that focus on improving quality of care, enhancing patient safety, and minimizing costs by using evidence-based patient care approaches to infection prevention and control. The primary focus of DICON is to improve outcomes for patients by reducing the rate of nosocomial infections and minimizing the costs associated with nosocomial and community-acquired infections. Duke’s physicians and nurses specializing in infection prevention and control work with existing hospital staff to identify practices and policies to improve patient care and/or reduce unnecessary medical supply costs, additional inpatient days, unreimbursed readmissions, and any related causes of patient dissatisfaction. When problems in infection prevention and control or patient safety policies or practices are identified, staff design corrective action plans to both correct the immediate problem and prevent its recurrence. Using regular visits by four full-time infection prevention and control nurse practitioners, a standardized database, and uniform surveillance methods designed to provide meaningful and useful local data to doctors and nurses in community hospitals, newsletters, a Web site, periodic symposia, and educational lectures, DICON has had 95

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significant and substantial impact on reducing the risk of post-surgical, device-related, and bloodstream infections, as well as helping to reduce the risk of blood and body fluid exposures for employees in DICON-affiliated hospitals.

Identifying a Threat Although MRSA (methicillin-resistant Staphylococcus aureus) has received considerable attention as a public health plague, Duke University researchers found that C. difficile infection was a far greater threat in community hospitals. Using hospital ICD-9-CM (International Classification of Diseases, Ninth Revision, Clinical Modification) discharge diagnosis codes at 30 community hospitals in the southeastern United States, researchers found that health care–associated C. difficile infections had a per incident rate of 3.7 per 1,000 in comparison to the per incident rate of 2.2 per 1,000 for MRSA cases. C. difficile infection was found to be as common as bloodstream infection. The study, the first such large examination using patient-level surveillance data to compare health care–associated C. difficile infection and MRSA rates showed that C. difficile infection was the most common health care–associated infection in DICON participating hospitals.* The researchers noted that further studies are needed to determine whether prescribing practices, geographic differences, improved infection prevention and control practices leading to a reduction in infections due to MRSA, or other patient factors are involved. Implementing Solutions The study also pointed out the need for the development of effective C. difficile infection prevention strategies—an effort that DICON is actively pursuing through its Clostridium difficile Infection Prevention Initiative. Focusing on the “three Es”—epidemiology, education, and environmental cleaning—DICON designed the program to help hospitals develop systems and processes that reduce the risk of C. difficile infection. It relies on simple, low-tech, and relatively inexpensive measures designed to do the following: • Improve the chances of quickly recognizing and treating patients with C. difficile infection. • Reduce the risk of person-to-person transmission of C. difficile, using simple prevention measures. • Reduce the risk of environmental transmission of C. difficile through better cleaning protocols. • Assess the effectiveness of prevention and control measures through relatively simple surveillance programs and feedback on these data. * Kaye K.S., et al.: Favorable impact of an infection control network on nosocomial infection rates in community hospitals. Infect Control Hosp Epidemiol 27:228–232, Mar. 2006. 96

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This initiative provides information on practical system controls, protocols, recommendations, and educational material designed to systematically address the following common problems: • Lack of simple, focused, and practical educational programs for housekeeping/environmental services staff • Lack of simple system controls to monitor the efficacy of cleaning patient rooms • Lack of simple and practical protocols for managing the infection prevention and control aspects of caring for patients with diarrhea that answer the following questions: – When should diagnostic testing for C. difficile infection be ordered? – What is/are the preferred diagnostic test(s) for C. difficile? – What is the duration of isolation? – What are the cleaning protocols during hospitalization and after discharge? • Lack of understanding of the role and efficacy of antibiotic stewardship programs in preventing C. difficile infection • Lack of focused educational materials about C. difficile infection for medical and nursing staff The program emphasizes the importance of leadership support—from administrative leadership, chief nursing officers, and medical officers at participating organizations—noting that the success of the protocols and processes depend on leadership’s commitment. For example, nursing leaders must provide input, direction, authority, and support for issues related to isolation protocols; medical leadership buy-in is crucial to the use of diagnostic algorithms and protocols as well as hand hygiene; and administrative leadership of environmental services is necessary for cleaning protocols (see Figure 5-1, page 98). DICON offers sample templates and methods to help hospitals devise protocols and procedures to isolate patients with known or suspected C. difficile infection; educate nursing and medical staff about key features of the biology, epidemiology, diagnosis, and pathogenesis of C. difficile infection; and devise cleaning protocols. DICON provides flow diagrams, case definitions, surveillance definitions, methods for C. difficile infection surveillance, and videos for environmental service supervisors and staff about the importance of environmental cleaning and prevention of C. difficile infection. Figure 5-2, page 99, provides a portion of the Table of Contents that is provided to DICON C. difficile initiative members.

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Figure 5-1. DICON Flow Diagram of Proposed Overall Strategic Plan for Preventing C. difficile Infections

Duke Infection Control Outreach Network (DICON) Clostridium difficile Infection (CDI) Prevention Initiative I. B.—FLOW DIAGRAM OF PROPOSED OVERALL STRATEGIC PLAN FOR PREVENTING CLOSTRIDIUM DIFFICILE INFECTIONS (CDIs): ↓

Chief Executive Officer COMMITMENT

Chief Nursing Officer COMMITMENT

*Commission a dedicated team to oversee implementation

Develop an education program to accurately, rapidly, and reliably identify patients with CDI

Chief Medical Officer COMMITMENT

**Develop a timeline for implementation and identify responsible persons

Develop an epidemiology program to collect and monitor accurate surveillance data and feedback these data to caregivers

Identify Physician Leaders (Champions)

Develop a program to ensure environmental and equipment cleaning is thorough and effective

Implement programs to reduce risk of CDI

* **

Team should include nurses, physicians, administrators, and infection control Timeline component can be sequentially or simultaneously introduced

Source: Duke University Medical Center, Durham, NC. Used with permission.

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Figure 5-2. DICON C. difficile Infection Prevention Program Table of Contents

DICON C. difficile Infection (CDI) Prevention Initiative Table of Contents I. Information for Senior Leadership A. Letter to CEO and Other Senior Leaders B. Flow diagram of proposed overall strategic plan for preventing CDIs C. Summary description of CDI prevention initiative II. Component # 1—Epidemiology of C. difficile Infection: Surveillance Data Collection and Feedback A. Summary description of component # 1 B. Case definitions for CDI C. Surveillance definitions for CDI D. Methods for CDI surveillance E. Rationale for contact precautions for CDI F. Worksheet for diagnosis and isolation III. Component # 2—Education: How to control and manage CDI A. Summary description of component # 2 B. PowerPoint slides for use in local education programs C. Poster—Treatment recommendations for CDI D. Poster—Prevention and Control DOs and DON’T’s E. Poster—Diagnosis F. Fact sheet for nurses and medical personnel G. Fact sheet for patients and families H. Posters for use in clinical areas IV. Component # 3—Environmental Cleaning and Prevention of CDI A. Summary description of component # 3 B. Sample Letter to Environmental Services supervisors C. PowerPoint slides of educational programs for Environmental Services supervisor training Source: Duke University Medical Center, Durham, NC. Used with permission.

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Data collection, assessments, and evaluations continue with DICON participating members. Important factors when evaluating and determining future prescribing practices will be the introduction of new medications for the treatment of C. difficile infections, hospital geographic differences, improved infection prevention and control practices, and other patient factors in the prevention and treatment of C. difficile infections.

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Florida Hospital Tampa, Tampa, Florida Florida Hospital Tampa in Tampa, Florida, is a 431-bed organization that is home to five centers of excellence that focus resources on major disease areas including cancer treatment, women’s health, pediatrics, diabetes management, and orthopedics. Florida Hospital’s mission is to offer patients access to the most advanced technology and treatment options available. In 2008 the Florida Hospital Tampa noticed an increase in the number of positive C. difficile cultures in its patient population based on laboratory test results as well as reports from infectious disease physicians. The hospital initiated an investigation to determine the etiology of increased incidence of health care–associated C. difficile cases, to prevent the spread and development of this active organism, and to develop a protocol to prevent the transmission of this highly infectious disease among the patient population. The infection prevention and control director, infection prevention and control practitioners, nursing leaders, physicians, and environmental services director collaborated on the project. The resulting C. difficile protocol included the following interventions: • Disinfection using 10% hypochlorite (that is, chlorine bleach) • Hand hygiene using soap and water • Contact isolation placard and sign for suspected and confirmed cases (see Figure 5-3, page 102) • Automated reports of multidrug-resistant organism (MDRO) history for patients • Education for patients and visitors (see Figure 5-4, pages 103–104) • Daily isolation rounds by nursing • Automated nursing unit rounds report, with isolation category type and rationale for isolation • Standardized nursing unit process to organize isolation reports • Formulary restrictions to prevent the overuse of antibiotics During the investigative stage the infection prevention and control practitioner and nurse leaders acknowledged a discrepancy in staff understanding regarding the spread of C. difficile and methods to prevent contamination in the health care environment. As a result, nurse leaders conducted training sessions in English and Spanish for physicians, nurses, environmental service technicians, and any other employees who have contact with patients. The education focused on staff ’s role in reducing infection risk and early identification of patients who might be infected. 101

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Figure 5-3. Contact Precautions Placards and Sign

Source: Florida Hospital Tampa, Tampa, FL. Used with permission.

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Figure 5-4. C. difficile Guide for Patients and Families

(continued)

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Figure 5-4. C. difficile Guide for Patients and Families, continued

Source: Florida Hospital Tampa, Tampa, FL. Used with permission.

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If a patient experiences three or more loose, watery stools in a 24-hour time frame, staff initiate the testing process for C. difficile infection. After a positive test for C. difficile toxin, staff enter the patient’s identification number, room number, and unit into the electronic medical record. The infection prevention and control practitioner generates a daily report of laboratory test results on all current C. difficile infection cases and sends it to all unit directors, nurse leaders, and the environmental services director to ensure that staff follow the isolation protocol, prompt environmental service technicians to use the bleach disinfection protocol, and alert ancillary staff and physicians to C. difficile cases. This report includes the patient’s name, room number, date of test, and specimen type, as well as whether it is a community-acquired infection or health care–associated infection. The infection prevention and control practitioner updates and resends the report, as needed, when new information is received from the laboratory. These daily reports also allow infection prevention and control specialists to calculate monthly infection rates and identify trends. Staff place patients who are suspected or confirmed to have C. difficile in contact isolation. The nurse will place a sign on the door and small placard on the medical record (for easy recognition in ancillary departments). The sign and placard indicate that bleach clean orders and soap and water hand hygiene are required. Environmental service technicians servicing units that are on “bleach clean” orders receive the report on blue colored paper. This is a visual cue for staff to use bleach to clean and disinfect the unit. An order for ancillary services placed in the electronic medical record will print isolation information as part of the request to alert the receiving department before the patient arrives. In addition, transporters receive the information in transport tickets to ensure safe transport of the patient through the organization. The infection prevention and control practitioner and nursing staff conduct daily rounds to help identify environmental factors that may promote the spread of the C. difficile organism and identify breaks in infection prevention and control protocols, as well as provide opportunities to reinforce proper infection prevention and control techniques. After the infection prevention and control practitioner and nursing staff conduct rounds, an automated nursing unit rounds report is generated daily on each nursing unit and contains patient demographic information, the unit name, the patient room number, the type of isolation, and the dates of test-positive cultures including the site and type of organism. The report also includes the date that staff provided isolation 105

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education to the patient and/or family members. The nursing unit rounds reports are posted on a yellow clip board in the same location on each nursing unit so that any clinician can readily access patient isolation information. The nursing staff also use the clipboard when making isolation rounds with the infection prevention and control practitioners. After the initial roll out, the hospital implemented the following further improvements to the protocol: • Environmental services staff use hypochlorite to clean every room after patient discharge, regardless of whether a known C. difficile patient occupied the room. • Bleach wipes are available on nursing units for use on reusable medical equipment. Laminated placards list the steps for cleaning and disinfection on all reusable medical equipment. • A UV-C short wavelength ultraviolet light device for disinfection is being tested on medical-surgical units, with promising results to date. When laboratory staff identify two or more positive C. difficile test results on a unit, the nurse manager of the unit is notified, personal protective equipment is used by staff, and proper hand hygiene is reinforced. Environmental services staff perform extensive cleaning of all common use lateral surfaces to avoid possible serial transmission of the organism.

Outcomes The standardized C. difficile protocol produced dramatic results—a 66% reduction in the number of C. difficile infection cases at the hospital, from a high of 1.33 per 1,000 patient days in 2003 to 0.45 after implementation of the protocol. In 2010 the rate fell by an additional 56%, to 0.2 per 1,000 patient days and is currently sustained at 0.3 per 1,000 patient days. Pilot units detected no MDROs for the two months of the trial. In addition, a separate trial of 30 patient rooms demonstrated a 98% reduction in microorganisms detected using environmental culture plates after the environmental service technicians clean and disinfect the patient rooms. In the current pilot of the UV-C device, there has been no evidence of serial transmission of MDROs in the patient rooms. Leadership is in the process of requesting additional UV-C devices from the chief financial officer to make the device available on every campus and nursing floor.

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Hospital Carlos Van Buren, Valparaiso, Chile Hospital Carlos Van Buren in Valparaiso, Chile, is a public hospital of the V region in Chile (Chile is divided into regions; all regions are given a roman numeral). It is a 550bed tertiary care organization with approximately 365,000 annual patient visits per year, and is a teaching hospital with a staff of nearly 2,000, including 535 physicians. The hospital serves as a reference center for oncology and neurosurgery and specializes in nephrology, ophthalmology, orthopedics, urology, and obstetrics. The organization also provides intensive care services to neonatal, pediatric, and adult patient populations. Leadership at Hospital Carlos Van Buren noted a large number of C. difficile infections among the internal medicine patients during the months of June and July 2010—the infection affected 15 patients in the moderately complex internal medicine ward with an overall rate of 29.4%. Leadership sought to understand the epidemiology and risk factors associated with the C. difficile infections and to identify strategies to control this infection.

Findings Among the 15 case patients, the average age was 73.9 years old; 66% were male. Prior to admission, 67% were in the community, 20% were on another ward in Hospital Carlos Van Buren, and 13% were transfers from another hospital. Underlying medical conditions included cerebrovascular (stroke) disease (33%) and pneumonia (27%). The onset of diarrhea occurred between 4 and 40 days after admission. All the cases had antimicrobial therapy for an average of 10.7 days prior to developing diarrhea. The most common antibiotics used were clindamycin and cefotaxime. When compared to controlled patients without C. difficile infection, previous use of clindamycin was independently associated with C. difficile infections with a high statistical significance (P=0.0006). Length of stay was three times higher among case patients compared with noninfected controlled patients. Interventions The strategies adopted to control the outbreak included the following: • Cohorting patients • Isolation with contact precautions, including the following: – Enhanced hand hygiene – Personal protective equipment (such as aprons and gloves) – Surface disinfection – Restriction of visitors – Limitations on teaching in the affected wards • Restrictions in clindamycin use 107

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In the beginning, physician and staff compliance rates with each strategy differed. In the case of cohorting and restriction of teaching, there was low compliance due to lack of awareness and education among physicians and staff. With respect to personal protective equipment, staff adhered to the use of gloves but not to apron use, perhaps due to lack of resources. In general, good compliance with hand hygiene and clindamycin restriction was observed, and very good compliance was noted in restriction of visitors (over 90%). These practices were measured by a checklist applied 4 times per day by the nurse supervisor (see Figure 5-5, page 109). The hospital evaluated surface disinfection by measuring the amount of adenosine triphosphate (bioluminescence) used to clean the bedrails. C. difficile infection cases did not decrease during the use of the initial control strategies that were implemented during June and July. Leadership decided to implement a bundle approach that included the following five measures: 1. Cohort isolation 2. Personal protective equipment 3. Dedicated equipment used exclusively for one patient 4. Surface disinfection 5. Only one person (personnel or visitor) in the patient’s room at a time Leadership also ensured the availability of resources to comply with these strategies. While personal protective equipment was available in the organization, leadership requested additional dedicated equipment and managed the use of the equipment to comply with these strategies. In-service education on the bundle approach was conducted with physicians, nurses, technicians, and environmental service staff, and a daily audit was performed on each staff member.

Results After implementation of the bundle approach (third week of July), the outbreak was controlled and no new C. difficile infection cases occurred after one week of the bundle implementation (first week of August 2010). Staff continued using the bundle approach until the last C. difficile infection case was discharged. Lessons Learned The following lessons were learned from implementing the C. difficile bundle: • Ensure ongoing appropriate use of antimicrobials; routinely audit compliance with policies • Implement an alert system when patients with C. difficile infection are identified in order to implement early strategies to prevent larger outbreaks 108

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Figure 5-5. Bundles Checklist to Evaluate Compliance of Measures to Control C. difficile Outbreaks Date: ___________________________ Topic to Be Observed

9:00 A.M.

1:00 P.M.

5:00 P.M.

9:00 P.M.

There are only patients with C. difficile in the room. Are disposable aprons available? Are individual equipment and items per patient? Are soap and paper towels available for hand hygiene? Disinfection of surfaces with chlorine is registered according to norm (4 times per day). Are gloves available? There is no more than one person in the room.* Bundle compliance (Yes/No) * Visitor, student, or personnel Source: Hospital Carlos Van Buren, Valparaiso, Chile. Used with permission.

• • • •

Include emergency physicians in the educational programs Establish a bundle approach at the beginning of similar outbreaks Ensure quality and quantity of resources is available to comply with each strategy Secure ongoing leadership involvement and collaboration among clinical services staff to ensure compliance with strategies, including restriction of clindamycin

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Providence St. Peter Hospital, Olympia, Washington Providence St. Peter Hospital is a 390-bed, not-for-profit, acute care hospital in Olympia, Washington, that annually serves nearly 20,000 inpatients. The organization provides Level 3 trauma services to five counties in southwest Washington. Providence St. Peter Hospital is a regional provider for cardiac surgery, cancer treatment, neurology services, and diagnostic imaging, and it provides a practical learning environment for family practice residents and nursing students. Several off-site locations provide care, treatment, and services for chemical dependency, sexual assault victims, sleep disorders, and diabetic patients.

Strategies In 2007 Providence St. Peter Hospital’s medical-renal unit set out to reduce C. difficile infections by 30% or greater by focusing on hand hygiene, contact precautions, and environmental cleaning and disinfection. Actions included the following: • Conduct direct observation (via secret observers) of staff hand hygiene compliance • Share hand hygiene observation data with staff on the medical-renal unit • Develop and implement preprinted nursing isolation orders (see Figure 5-6, page 111) • Develop an environmental services cleaning checklist for rooms occupied by known C. difficile patients (see Figure 5-7, page 112) • Implement a new isolation sign (see Figure 5-8, page 113) • Use bleach for terminal cleaning for rooms of known C. difficile patients Staff observers, or “secret shoppers,” trained by the infection prevention and control staff, used direct observation of staff hand hygiene practice to gather data on all health care staff who were in contact with patients in the medical-renal unit. The unit reported hand hygiene data on a monthly basis to the infection prevention and control committee and to nurse and physician leadership. Infection prevention and control staff encouraged observers on the medical-renal unit to not only use the observation audit process strictly for data collection, but rather use observed lapses in precautions as staff learning opportunities. The unit received monthly feedback on its performance, and observer data appeared as screen savers on the nursing station computers and computers in other clinical areas in the hospital, increasing staff awareness of the initiative and its outcomes.

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Figure 5-6. Isolation Nursing Orders

Note: This nursing order is applicable to this organization. Because nursing orders vary from state to state, please check your state/government requirements to ensure compliance. Source: Providence St. Peter Hospital, Olympia, WA. Used with permission.

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Figure 5-7. Occupied Patient Room Cleaning Checklist

Environmental services staff at Providence St. Peter Hospital use this cleaning checklist when cleaning rooms occupied by known C. difficile patients. Source: Providence St. Peter Hospital, Olympia, WA. Used with permission.

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Figure 5-8. Isolation Sign

This precautionary isolation sign warns visitors and staff to check in at the nursing station and that personal protective equipment is required when entering a C. difficile infected patients’ room at Providence St. Peter Hospital. Source: Providence St. Peter Hospital, Olympia, WA. Used with permission.

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Measures that were collected by the infection prevention and control committee include the following: • Percentage of patients with hospital-acquired C. difficile infection • Days between hospital-acquired cases of C. difficile on the medical-renal unit • Percentage of occupied patient rooms with complete environmental cleaning of hightouch surfaces • Percentage of hand hygiene observations during a patient encounter • Percentage of patient encounters with compliance for contact precautions • Percentage of patient encounters in which the preprinted isolation order was used Information technology staff shared hand hygiene data outcomes with all staff to support the spread of the C. difficile infection reduction initiative and collected contact precaution data for all nursing units. The focus on increasing hand hygiene compliance prompted a change in the organization’s culture by encouraging all staff to take responsibility for preventing the spread of C. difficile infection (see Figure 5-9, page 115).

Results The medical-renal C. difficile infection reduction initiative resulted in C. difficile rates falling from a baseline of 0.57% to a mean of 0.34%—a 40% reduction—over an 18month period in the medical-renal unit. The unit also reported going 235 days without a case of C. difficile infection. Disinfection of high-touch surfaces in occupied patient rooms reached 95% following the introduction of the checklist, and the rate has been sustained. The overall hand hygiene rate averaged greater than 80%, and the organization continues to target a 95% compliance rate. Staff found that streamlining the isolation cart process improved access to needed isolation supplies. Changing physician hand hygiene practice remains challenging. Providence St. Peter Hospital has found that designing small tests of change and expanding in small increments created more enduring change. In 2010 the success of a 40% reduction in C. difficile infections on the medical-renal unit prompted Providence St. Peter to take the initiative hospitalwide, targeting a 30% reduction in C. difficile infection across the entire organization. Hospitalwide reduction of C. difficile infections has not yet been realized, and the current goal is to continue achieving a downward trend with basic prevention strategies and interventions.

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Figure 5-9. Computer Screen Saver on Hand Hygiene

This screen saver can be viewed on nursing station computers at Providence St. Peter Hospital to remind staff of the importance of hand hygiene compliance. Source: Providence St. Peter Hospital, Olympia, WA. Used with permission.

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In 2011 Providence St. Peter Hospital added a present-on-admission C. difficile infection risk assessment process to its admission procedures. This process allows nursing to identify patients with potential C. difficile infection during the admission process and prompts nursing to immediately test and isolate the patient, if warranted. Environmental services instituted bleach cleaning after discharge of each inpatient room in May 2011 and continue to evaluate the process. In addition, the hospital plans an antibiotic optimization program to help support efforts to prevent and control of C. difficile infection.

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