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Procedure for the Prevention Control and Management of Clostridium difficile Infection in Care PDF

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Procedure for the Prevention Control and Management of Clostridium difficile Infection in Care Settings in Shetland Adapted from: Model Infection Control Policies (Transmission Based), HPS ICT September 2007; Guidance on Prevention and Control of Clostridium difficile Infection (CDI) in Healthcare Settings in Scotland, Health Protection Network Scottish Guidance, September 2009; and HPS Interim Guidance on Prevention and Control of Clostridium difficile infection in Care Settings in Scotland, October 2008 (Revised January 2014). Date: May 2017 Version number: Version 1.7 Revised to incorporate changes to HPS Guidance on Prevention and Control of Clostridium difficile Infection (CDI) in Healthcare Settings in Scotland, October 2008 (Revised 2014), Author: Wendy Hatrick INTERIM UNTIL REVISED HPN GUIDANCE AVAILABLE Review Date: May 2017 For approval by: Infection Control Team May 2017 If you would like this document in an alternative language or format, please contact Corporate Services on 01595 743069. Procedure for the Prevention Control and Management of Clostridium difficile Infection in Care Settings in Shetland Table of Contents List of Abbreviations 2 1. Introduction 3 1.1 Aims and Scope of Procedure 3 1.2 Background 4 2. Recommendations 9 2.1 Roles and Responsibilities 9 2.2 Prevention, Control and Management of CDI 10 2.2.1 Early Diagnosis 19 2.2.2 Surveillance 21 2.2.3 Education 24 2.2.4 Management of CDI 25 2.2.5 Isolation precautions 26 2.2.6 Stop inappropriate antimicrobial therapy 27 2.2.7 Hand Hygiene Measures 28 2.2.8 Personal protective equipment 28 2.2.9 Environmental cleaning 29 2.2.10 Use of Care Equipment 30 2.2.11Safe Management of Linen and Waste 31 2.2.12 Antimicrobial stewardship 31 2.2.13Specific measures in CDI outbreaks 33 2.2.14 CDI in the community 34 2.3 Best practice on antimicrobial treatment on CDI 39 2.3.1 Treatment and management of Clostridium difficile 41 2.3.2 Algorithm 1 - Treatment of first episode of CDI 46 2.3.3 Algorithm 2 - Treatment of first recurrence of CDI 47 2.3.4 Algorithm 3 - Treatment of second and subsequent recurrence of CDI 48 2.4 Special contact precautions for members of staff with 46 diarrhoea and/or confirmed CDI 3. References 49 4. Appendices 51 Appendix A: Leaflet links (leaflets can also be found at 51 http://intranet/clinical/infectioncontrol/index.html Appendix B (i): Short guide to managing CDI in healthcare settings 54 (ii) Short guide to managing CDI in the community Appendix C: Bristol Stool Chart 56 Appendix D: Associated documents 57 Appendix E: Glossary 59 1 Procedure for the Prevention Control and Management of Clostridium difficile Infection in Care Settings in Shetland List of Abbreviations AMT Antimicrobial management team b.d. Twice a day CDC Centers for Disease Control and Prevention CDI Clostridium difficile infection COSHH Control of Substances Hazardous to Health ESCMID European Society of Clinical Microbiology and Infectious Diseases ESGCD European Study Group on Clostridium difficile GDG Guidance Development Group GHD Glutamate dehydrogenase HAI Healthcare Associated Infection HAITF Healthcare Associated Infection Task Force HICPAC Healthcare Infection Control Practices Advisory Committee HPA Health Protection Agency HPN Health Protection Network HPS Health Protection Scotland HPT Health Protection Team ICU Infection Control Unit IDSA Infectious Diseases Society of America ITU Intensive Treatment/Therapy Unit i.v. Intravenous MHRA Medicines and Healthcare products Regulatory Agency NES National Education for Scotland NHS QIS National Health Service Quality Improvement Scotland NIP&C National Infection Prevention and Control (Manual) OCBD Occupied bed days o.d. Once a day PCR Polymerase chain reaction PMC Pseudomembranous colitis PPE Personal protective equipment PPM parts per million q.d.s Four times a day QoE Quality of Evidence RCA Root cause analysis RIDDOR Reporting of Infections, Diseases and Dangerous Occurences SAPG Scottish Antimicrobial Prescribing Group ScotMARAP Scottish Management of Antimicrobial Resistance Action Plan SGHD Scottish Government Health Department SHEA Society of Healthcare Epidemiology of America SICPs Standard Infection Control Precautions SIGN Scottish Intercollegiate Guidelines Network SoR Strength of recommendation SMC Scottish Medicines Consortium SPC Statistical Process Control t.d.s Three times a day TBPs Transmission-Based Precautions US United States VRE Vancomycin resistant Enterococci WBC White blood cells 2 Procedure for the Prevention Control and Management of Clostridium difficile Infection in Care Settings in Shetland 1. Introduction Clostridium difficile infection (CDI) is the most common healthcare associated infection in healthcare settings in Scotland 1. This procedure provides easily accessible advice covering key aspects of prevention and control of CDI. The recommendations in this procedure are based on a systematic literature review produced by the European Study Group on Clostridium difficile (ESGCD) in 20082. This procedure is a revised version of the previous Shetland procedure3. This procedure is intended for use in all healthcare settings in Shetland including Gilbert Bain Hospital. A section on ‘CDI in the Community’ (see section 3.2.12) was added into the previous version of the procedure, with advice directed primarily at NHS board Infection Control Teams to enable them to deal with incidents in the community. Shetland Care Centres and other facilities (outside of the NHS) need only adhere to the recommendations given in section 3.2.12; however this section should not be considered as a comprehensive guidance for these settings. This revised guidance provides a standardised evidenced-based approach to diagnosis, prevention and control and treatment of CDI to help staff deliver safe care and support the reduction of CDI. New element s of the guidance are primarily around:  A new treatment section following recently updated guidelines on the treatment of CDI from Public Health England (PHE), Europe (European Society of Clinical Microbiology and Infectious Diseases (ESCMID)) and the US. This includes recommended treatment options according to the severity of CDI, and recommendations on the use of the new antibiotic fidaxomicin and use of faecal transplant in the treatment of CDI;  Updates to key recommendations on infection prevention and control following a rapid literature review of new evidence published since 2009;  Alignment with the HPS National Manual on Infection Prevention & Control, especially around Standard Infection Control Precautions (SICPs) and Transmission Based Precautions (TBPs), as well as updated roles and responsibilities; and  Integration of the previously separate community CDI section within the main guidance to provide a more streamlined document. The procedure is intended for use alongside methods of the Scottish Patient Safety Programme of work, which provide a standardised approach to implementation of the recommendations of this procedure. 3 Procedure for the Prevention Control and Management of Clostridium difficile Infection in Care Settings in Shetland 1.1 Aims and Scope of Procedure This procedure provides a standardised evidence-based approach to diagnosis, prevention and control of CDI to enable staff to deliver safe healthcare and support the reduction of CDI in the organisation. Professionals who have key roles, including:  Chief Executive/Senior Managers,  Infection Control Team (including Infection Control Managers and Public Health/Infection Control Nurses and Doctors),  Ward Managers,  Facilities Manager,  Consultants in Microbiology,  Healthcare Workers,  General Practitioners and Providers of Care Services such as Shetland Care Centres. It is important that managers, clinicians and other staff are aware of their roles in containing CDI and all other healthcare associated infections. The guidance provides a standardised evidence based approach to prevention and control of CDI. The guidance aims to:  Outline roles and responsibilities.  Prevent transmission of C.difficile to patients and staff in all healthcare settings.  Share best practice on antibiotic treatment of CDI.  Improve patient safety in relation to the acquisition and management of patients with CDI.  Improve morbidity, mortality and service disruption as a result of CDI. The guidance does not provide guidance for diagnostic laboratories. In order to control CDI, the NHS Shetland Antibiotic Policy must be adhered to in addition to following this procedure. Medical staff can refer to the NHS Grampian Consultant Microbiologist, Public Health Department or Hospital Pharmacist. Limiting the use of especially high-risk agents is of paramount importance. Antibiotic stop/ review dates should be written at the time of prescription. 1.2 Background Clinical aspects CDI is the most common cause of intestinal infections (and diarrhoea) associated with antimicrobial therapy. It develops after patients acquire the organism in the gastro-intestinal tract, which is, or becomes, susceptible to infection following antibiotic therapy. Antibiotics destroy the normal gut flora and allow the organism to flourish. Some strains of C.difficile are more virulent that others. 4 Procedure for the Prevention Control and Management of Clostridium difficile Infection in Care Settings in Shetland Clinical disease comprises a range of toxin mediated symptoms from mild diarrhoea, which can resolve without treatment, but C.difficile produces powerful toxins which destroy the lining of the gut and can cause inflammation and profuse diarrhoea. Other clinical features consistent with more severe forms of CDI include abdominal cramps, fever and leukocytosis3. Severe cases such as pseudomembranous colitis (PMC), toxic megacolon, colonic perforation and peritonitis can lead to death. The pathology of CDI in children is not well described as the symptoms and immune response towards C.difficile in children differ from those in adults. Routine testing in children aged 15 and under is not recommended. C.difficile is transmitted via contact (both direct with those persons carrying it and indirect through contaminated environments) and in addition via the faecal-oral route. C.difficile poses significant problems in healthcare settings because:  The majority of patients will, as a consequence of healthcare or predisposing conditions, require antibiotics during their admission making them vulnerable to CDI.  The organism produces spores which can survive for months in the environment and germinate into viable bacteria when ingested.  The spores can also survive routine cleaning and alcohol hand gel is ineffective at removing C.difficile. C.difficile can survive on equipment such as baths, commodes, stethoscopes, washbowls, etc. for months. C.difficile is found as part of the normal large bowel flora in approximately 3% of adults and is thought to cause about a quarter of cases of antibiotic-associated diarrhoea overall. Carriage rate increases with age, the elderly are particularly at risk. Acquisition is influenced by recent antibiotic exposure and time spent in an environment where there is likelihood of exposure, i.e. Hospital. C.difficile is carried in the gut of 20% of hospital patients 4. The elderly living in care homes or staying in long-term care are more likely to carry C.difficile than other adults. In studies from the US, 20% of care home residents and 50% of patients in long-term care facilities, respectively were colonised with C.difficile5,6 Aetiology and Risk Factors C. difficile can cause infection when the balance of the normal gut flora (microflora) is disturbed by the use of any type of antimicrobial agent, even in patients exposed to short-term prophylactic antimicrobial courses4. The normal gut flora provides resistance against invading pathogens by competing for the same resources (such as amino acids and carbohydrates) and thereby protecting people from gastrointestinal infections. This is also referred to as ‘colonisation resistance’. The C. difficile spores must be ingested for a person to become colonised and subsequently develop CDI. When the spores enter the colon they germinate into viable bacteria, and, if the strain is toxigenic, produce toxins (toxins A/B) that interact 5 Procedure for the Prevention Control and Management of Clostridium difficile Infection in Care Settings in Shetland with the epithelium of the gut, which cause damage to the epithelial cells and inflammation of the gut4. Antimicrobial treatment is the risk factor that is most often associated with the development of CDI7 (see text box Major risk factors for CDI on page 18). However, gastric acid suppressant agents, chemotherapy and other agents that destroy or modulate the normal gut flora and/or immune functions have also been implicated in the development of CDI. The effects of antimicrobial (and other drug) treatment on the normal gut flora can persist for weeks to months. The onset of diarrhoea is typically during, or shortly after, receipt of a course of antimicrobial treatment but may occur from a few days to as long as 8 weeks after the termination of the therapy3. In elderly people, the normal gut flora is less dense and contains fewer bacterial species. This reduces the colonisation resistance to invading pathogens such as C.difficile. Although CDI can be treated with certain antimicrobials, immune function is also very important for the individual patient outcome. Healthy people with no underlying diseases and a high serum antibody response to toxin A are less likely to develop CDI after ingestion of C. difficile spores7,8. It is recognised that gut immunity declines with increased age9. Other patient risk factors for developing CDI include: increased age (over 65 years), prolonged stays in healthcare settings, serious underlying disease, surgical procedures and immunocompromising conditions. Antimicrobial resistance (typically to cephalosporins, fluoroquinolones and clindamycin) in C. difficile strains may be playing an increasingly important role in the development and epidemiology of CDI; when a carrier of a resistant C.difficile strain (or infected person) is treated with one of the above antimicrobial drugs, the colonising strain of C. difficile is given a growth advantage over the normal gut flora, which enables it to proliferate and reach high densities in the gut and potentially cause infection and transmission to others10, 11. Transmission Since C. difficile is an anaerobic bacterium, viable bacteria will quickly die when exposed to air. However, C. difficile produces hardy spores that can tolerate air, heat and resist various detergents and disinfectants, and are able to survive for extended periods in the environment. C. difficile is transmitted between people via spores that are picked up either by direct contact with an infected (or contaminated) person or by indirect contact with a contaminated surface. The ability of these spores to survive in the environment, even when disinfectants are used, has contributed to the wide spread of C. difficile in healthcare facilities. Direct and indirect contact represent the main routes of transmission of C.difficile. 6 Procedure for the Prevention Control and Management of Clostridium difficile Infection in Care Settings in Shetland Symptomatic CDI patients shed spores via their faeces into the environment at a high rate. Symptomatic CDI patients are considered the main source of contamination of the environment of healthcare facilities 12. Toilets, commodes and the environment of CDI patients (including frequently touched surfaces around toilets and beds) are likely to be contaminated. The hands of healthcare workers are also likely to be contaminated, and if hand hygiene is not optimal C. difficile will spread to other patients or the environment. Alcohol-based hand rubs are not effective in removing C. difficile spores from hands – additional hand washing with liquid soap and water is therefore necessary to prevent the spread of the spores. As mentioned above, some people carry C. difficile in their gut without having any symptoms. Sometimes people who have been treated and recovered from CDI will still be carrying C. difficile in their gut. In a recent study in the US, it was found that up to 50% of patients in a long-term care facility were asymptomatic carriers of C. difficile6. These carriers were shedding spores into the environment although at lower concentrations than observed from patients with diarrhoea. However, no studies to date have shown that asymptomatic carriers have been involved in transmitting C. difficile to other patients. Special contact precautions (or other interventions) are not recommended for asymptomatic carriers. C.difficile can cause infection when the balance of the normal intestinal flora (microflora) is disturbed by the use of any type of antimicrobial agent, even in patients exposed to short-term prophylactic antimicrobial courses4. Whilst C.difficile has been reported with use of virtually all antibiotics it is most commonly associated with third generation cephalopsorins, e.g. Cefcapene, Cefdaloxime and Ceftibuten. Clindamycin and Amoxicillin are also strongly implicated. Other patient risk factors for acquiring CDI include: increased age (over 65 years), prolonged stays in healthcare settings, serious underlying disease, surgical procedures and immunocompromising conditions. Most patients who develop this infection have received antibiotics in recent weeks. Some patients may be admitted from the community with this infection. There has been an increase in the numbers of reported cases of C.difficile nationally. This is due to:  More use of antibiotics  More high – risk antibiotics in use (third generation cephalosporins)  More virulent strains of the organism  Increasing asymptomatic carriage in patients  Environmental contamination  Increased movement of patients within hospitals. Diarrhoea can be a side effect of antibiotic therapy and a patient may have bowel movements several times a day. C.difficile is complicated by more frequent watery bowel movements. The diarrhoea associated with this infection can be profuse and 7 Procedure for the Prevention Control and Management of Clostridium difficile Infection in Care Settings in Shetland many times a day. It can take several weeks for some patients to become diarrhoea free. Prevention of C.difficile infection relies on limiting patients’ exposure to the organism, and ensuring that they do not become susceptible through disruption of their normal gut flora. Thus, interventions for the control of C.difficile infection can be divided into infection control measures and antibiotic manipulations. These strategies can be applied together. The transmission of C.difficile can be patient to patient, via the contaminated hands of health care workers, or via environmental contamination including healthcare equipment. It is therefore important that the symptomatic patient is promptly isolated and the isolation policy strictly followed (see also NHS Shetland Patient Placement Procedures). C.difficile produces hardy spores that can resist various detergents and disinfectants and are able to survive for extended periods in the environment. Direct and indirect contact represents the main routes of transmission of C.difficile. Most patients with this condition have recently received antibiotics and hospital staff - such as nurses and doctors, and patients’ relatives are at little risk of catching the illness themselves. However, should these people be receiving antibiotics then they may be at some risk of infection, and therefore they should be especially scrupulous in their hand washing. Prevention and Control of CDI There is evidence that a range of infection prevention and control measures are essential to limiting the spread of C. difficile in the healthcare setting. These measures are included in this procedure within Section 2.2, but are described in more detail in separate procedures (http://intranet/clinical/infectioncontrol/index.html. These need to be implemented in conjunction with effective antimicrobial stewardship (see NHS Shetland Antimicrobial Policy). Epidemiology of CDI in Shetland In Scotland, a significant increase in the number of reported cases of CDI was observed in the period 1995-2005. In 2006, a mandatory surveillance programme monitoring CDI in persons over 65 years was introduced in all healthcare settings (including acute and non-acute hospitals and primary care) in Scotland. The first annual report (October 2006 - September 2007) showed that more than 6000 patients, aged 65 years and older, had acquired CDI in Scotland while receiving healthcare13. Recently, many of the elements of this guidance have been implemented. This has resulted in a sustained decrease in incidence14. Hypervirulent strains of C. difficile A rapid change in the epidemiology of CDI has been reported in many European countries and North America, probably due to the spread of a new hypervirulent strain known as polymerase chain reaction (PCR) ribotype 02715. This strain of C. difficile has recently been associated with outbreaks in hospitals in Scotland. The hypervirulence of ribotype 027 is believed to be associated with its ability to produce high concentrations of toxins and high transmissibility. 8 Procedure for the Prevention Control and Management of Clostridium difficile Infection in Care Settings in Shetland Anecdotal evidence and observational epidemiological studies suggest that infections with ribotype 027 cause more severe disease and excess mortality relative to other strains 15, 16. However, a recent case review study showed that there was no statistically significant difference in severity of disease or in 30-day all- cause mortality between patients infected with ribotype 027 and patients infected with other strains17. Importantly, other strains of C. difficile (including PCR ribotype 078) may have similar molecular mechanisms that result in hypervirulence and high transmissibility. CDI caused by any strain (of any ribotype) should be considered potentially hypervirulent; therefore all recommended infection prevention and control measures should be applied. 2. Recommendations This part of the procedure presents key recommendations on how to prevent and control CDI in the healthcare setting. Throughout the text, references are made to the existing National Infection Prevention and Control Manual - see appendix D for the full list of associated documents. An overview of the recommendations of this guidance can be found in appendix B (Quick Reference Guide (QRG) to managing CDI in healthcare settings/in the community).  Local procedures can be obtained on the intranet at: http://intranet/clinical/infectioncontrol/index.html  Other documents on existing guidance can be obtained at the HPS website: http://www.hps.scot.nhs.uk/haiic/ic/index.aspx 2.1 Roles and Responsibilities The recommendations set out in this procedure are based on the assumption that NHS Shetland has infection prevention and control systems in place in line with existing guidance. It is also assumed that NHS Shetland is working towards meeting the NHS QIS Standards on Healthcare Associated Infection18, and that all adult care centres in Shetland are working towards meeting the Scottish Executive Infection Control Standards for Adult Care Homes: Final Standards, and the Regulations and National Care Standards produced by the Scottish Government and used by the Care Commission. 9

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