Clinical Clostridium Difficile: Standard Operating Procedure Document Control Summary Status: Version: Author/Title: Owner/Title: Approved by: Ratified: Related Trust Strategy and/or Strategic Aims Implementation Date: Review Date: Key Words: Associated Policy or Standard Operating Procedures Replacement. Replaces: Clostridium Difficile Policy v3.1 v1.0 Date: November 2015 Judy Carr - Lead Infection Prevention and Control Nurse Kenny Laing - Deputy Director of Nursing Policy and Procedures Committee Date: 17/12/15 Policy and Procedures Committee Date: 17/12/15 Provide high quality services, built on best known practice and evaluated through clear process and outcome measures December 2015 December 2018 Isolation. C Diff Infection Prevention Control and Decontamination Policy Hand Decontamination SOP Standard Precautions and personal Protective Equipment SOP Decontamination of Reusable Medical Devices Policy SOP Isolation Policy SOP Guidelines for Glove usage in Clinical Practice SOP Mental Capacity Act Antibiotic Policy Contents 1. Introduction... 2 2. Purpose... 3 3. Scope... 3 4. Definitions... 3 5. Clinical Features... 3 6. Diagnosis... 4 7. Laboratory confirmation... 4 8. Risk Factors... 5 9. Transmission... 6
10. Surveillance... 6 11. Patient Management (see Associate documents 2 & 3)... 6 12. Medical Management of C. difficile... 7 13. Visits to other departments... 8 14. Discharge of patients... 8 15. Outbreaks of C. difficile... 9 16. Cadaver... 10 17. Death certification... 10 18. Control of Antibiotic Usage... 10 19. Monitoring Compliance... 10 20. References... 11 Change Control Amendment History Version Dates Amendments 1. Introduction C. difficile is a bacterium of the family Clostridium (the family also includes the bacteria that cause tetanus, botulism, and gas gangrene). It is an anaerobic bacterium (i.e. it does not grow in the presence of oxygen) and produces spores that can survive for a long time in the environment. It is found in the large intestine in approximately 5% of the population. It can cause illness when the balance of the normal gut flora is disturbed by the frequent use of certain antibiotics, e.g. cephalosporins. The antibiotics disturb the balance of bacteria in the large bowel which enables the C. difficile bacteria to proliferate. Once established the bacteria produces toxins, which are responsible for the diarrhoea and which damage the cells lining the bowel. It affects predominately the colon and may result in a wide spectrum of disease ranging in severity from trivial diarrhoea, through moderately severe disease with abdominal pain, diarrhoea and systemic upset to life -threatening pseudomembranous colitis, toxic megacolon and paralytic ileus. The spores produced easily colonise the environment and medical equipment and can also be spread via contact and the faecal-oral route. The prevention and control of this organism is increasingly problematic in UK healthcare. New strains are emerging which are more virulent than previous ones; these have been identified locally. Page 2 of 11
The average increased length of stay of a patient with CDI is 21 days and the cost estimated at over 4000 per case. C. difficile has the potential to cause large outbreaks in healthcare settings if not managed appropriately, i.e. via standard precautions and isolation. If a patient has diarrhoea (Bristol Stool Chart types 5-7, Associate document 1) that is not clearly attributable to an underlying condition (e.g. inflammatory colitis, overflow) or therapy (e.g. laxatives, enteral feeding) then it is necessary to determine if this is due to CDI. Ideally isolate patient in a single room collect a specimen and seek advice from the Infection Prevention and Control (IPC) Team. 2. Purpose Patients have a right to be protected from preventable infections and healthcare staff have a duty to safeguard the well-being of their patients. The Health Act 2008 requires all NHS bodies to have in place appropriate core policies of which Clostridium difficile is one. The purpose of this SOP is to provide guidance about the management and control of Clostridium Difficile (C.difficile) within the healthcare setting. 3. Scope This document applies to all South Staffordshire and Shropshire employees and all those visiting the Trusts premises such as contractors, agency/bank/locum staff, students and volunteers 4. Definitions Clostridium difficile Infection (CDI) 1 episode of diarrhoea, defined as either a stool loose enough to take the shape of a container used to sample it or as Bristol Stool Chart types 5-7 (Associate document 1), that is not attributable to another cause, including medicines and that occurs at the same time as a positive toxin assay (with or without a positive C. difficile culture) and/or endoscopic evidence of pseudomembranous colitis. (DH 2009b) A period of increased incidence (PII) of CDI: 2 or more new cases (occurring >48 hours post admission, not relapses) in a 28 day period in a ward. An outbreak of CDI: 2 or more cases caused by the same strain related in time and place over a defined period that is based on the date of onset of the 1st case (DH 2009b) Diarrhoea - defined by the passage of liquid or watery stools three or more times a day. Bristol Stool Chart - type 5 or 7. Colonisation - A long term relationship in which a micro-organism lives on (or in) a host, without any adverse reaction by the host to its presence Infection - The outcome of an interaction between a host and a micro-organism in which the host reacts in an observable way. The evidence is usually a clinical infection. 5. Clinical Features Usually associated with the prior use of antibiotics Page 3 of 11
Explosive, watery, foul smelling diarrhoea. Abdominal pain/tenderness Fever Predominantly affects the colon, but terminal ileum can also be affected High white blood cell count generally associated with more severe disease Mild CDI Moderate CDI Severe CDI Lifethreatening CDI is not associated with a raised WCC; it is typically associated with <3 stools of types 5 7 on the Bristol Stool Chart per day. is associated with a raised WCC that is <15 109/L; it is typically associated with 3 5 stools per day. is associated with a WCC >15 109/L, or an acute rising serum creatinine (i.e. >50% increase above baseline), or a temperature of >38.5 C, or evidence of severe colitis (abdominal or radiological signs). The number of stools may be a less reliable indicator of severity. includes hypotension, partial or complete ileus or toxic megacolon, or CT evidence of severe disease. 6. Diagnosis This should be based on clinical assessment of CDI, symptoms and risk factors. As speed of diagnosis is important and to ensure the efficient use of isolation facilities, clinicians should, in line with the SIGHT protocol (Associate document 7), ensure that stool specimens are sent for toxin testing as soon as infective diarrhoea is suspected. (DH 2009). All patients with suspected or confirmed CDI must be commenced on the Clostridium difficile Care Pathway immediately (Associate document 3) along with the Bristol Stool Chart (Associate document 1). When sending stool specimens to the laboratory, the form should request C. difficile investigation and state any recent antibiotic history, frequency of diarrhoea, stool type e.g. Type 5-7, date of onset of diarrhoea. The diarrhoea sample should comply with Type 5-7 of the Bristol Stool Form Scale or the sample must take on the shape of the container and ideally be at least ¼ filled (to indicate the patient has diarrhoea).; otherwise the sample will not be tested for C. difficile. 7. Laboratory Confirmation C. difficile infection (CDI) is a clinical diagnosis, but laboratory confirmation should be used to guide therapy and management as there are many causes for healthcare associated diarrhoea. Patients who are otherwise healthy may have carriage of C. difficile. If these patients develop diarrhoea for other causes the C. difficile may be detected as a bystander. For this reason laboratory diagnostics differentiate between detecting toxin that indicates disease and detecting organism by culture or PCR that may represent carriage. Page 4 of 11
Testing methods are as follows: 1) Stool samples are screened with a GDH test; this detects the C. difficile-specific enzyme glutamate dehydrogenase antigen (GDH). If the GDH test is negative the stool is negative and there is no evidence of C. difficile. 2) If the GDH is positive then a toxin test is performed. If this is positive then there is evidence of C. difficile infection. These patients require treatment for CDI and isolation to prevent cross infection. If the toxin test is negative then a PCR (Polymerase Chain Reaction) is performed 3) If the toxin test is negative (and the GDH test is positive) a PCR is performed. If the PCR is negative the stool is negative and there is no evidence of C. difficile. If the PCR is positive there is evidence of potential carriage (or potential excretor ). This means though the diarrhoea may not have been caused by C. difficile there is an infection control risk and these patients should be isolated to prevent cross-infections though they may not require specific therapy. This means there are 3 possible laboratory results. Results Interpretation Action GDH, EIA or (NAAT) -ve C. difficile negative No evidence of CDI look for other causes of diarrhoea GDH, EIA or (NAAT) +ve C. difficile infection Treat CDI, infection control tox +ve GDH, EIA or (NAAT) +ve/ tox ve PCR +ve GDH, EIA or (NAAT) +ve/ tox ve PCR ve Potential C. difficile carriage/( potential excretor ) measures No evidence of CDI look for other causes of diarrhoea. Do not necessarily need to treat CDI, but take infection control measures. C. difficile negative No evidence of CDI look for other causes of diarrhoea 8. Risk Factors Elderly (over 65 years) Long length of stay in healthcare settings Recent use of antibiotics especially broad spectrum e.g. cephalosporins, which are harmful to normal gut flora Recent surgery, especially gastro-intestinal surgery Serious underlying disease/illness Immunocompromising conditions Prolonged use of proton pump inhibitors Poor cleaning or infection control practise Page 5 of 11
9. Transmission C. difficile is easily spread from patient to patient as spores, shed in the faeces, which can survive in the environment on any surface for a long period of time. These spores are resistant to heat, alcohol and acids in the stomach. C. difficile can be spread via the hands of healthcare workers, if they have touched contaminated surfaces or from direct contact with an infected patient 10. Surveillance Confirmation of Clostridium difficile infection is via the laboratory detection of Clostridium difficile Toxins A and or B in stool samples. Do not retest for C. difficile toxin positive cases if patients are still symptomatic within a period of 28 days unless symptoms resolve and then recur and there is a need to confirm recurrent Clostridium difficile illness More than one test per patient may be required if the first test is negative but where there is a strong clinical suspicion of CDI, retest a second sample 24 hours later. Further tests might be necessary in light of clinical evidence. Generally it is not advisable to test children under the age of 2 years in whom toxigenic strains of C. difficile and toxins A and B may be present in the absence of symptoms. Sudden increases in the number and/or severity of cases detected in a ward or across several units within a hospital legitimate reasons for typing requests. However, this is best undertaken in a planned way, following discussion with the relevant microbiology laboratory &/or IPCT. 11. Patient Management (see Associate documents 2 & 3) The tables in the appendices provide an overview of the management of C. difficile positive patients in the inpatient setting. The guidance on general management, record keeping, treatment, hygiene, patient placement and cleaning should be followed carefully to prevent harm and minimise the risk of spread. The Care Pathway and Fluid/Stool chart provided in Associate documents 3 & 4 are to be used in the inpatient setting. Robust infection prevention and control practices are crucial in reducing the incidence of CDI, especially Hand washing with soap and water rather than using alcohol gel The use of gloves and aprons Isolation Decontamination Minimising all unnecessary patient movement Remember wash your hands after any contact with the patient or their environment. Page 6 of 11
12. Medical Management of C. difficile The patient must be medically assessed. Clinicians must consider CDI as a diagnosis in its own right, grading each case for severity, treating accordingly and ensuring the ongoing monitoring of bowel function using the Bristol Stool Chart (If the medical officer requires more information this can be sought from the Microbiologist or Infection Prevention and control Team). Key principles of treatment are: Early treatment is important and should be commenced as soon as the diagnosis is confirmed Medications which alter the gut flora, including aperients, enemas and antacids must be stopped. All antibiotics that are clearly not required and may be contributing to the symptoms should be stopped, as should other drugs that might cause diarrhoea Anti-motility agents such as loperamide must not be prescribed in acute CDI. It is unclear whether proton pump inhibitors (PPIs) are a risk factor in relation to CDI; their use should be reviewed, especially in a patient who experiences recurrent CDI (DOH2009) Fluid management and maintaining electrolyte balance are essential (Associate document 4) Nutrition is very important and early consideration should be given to NG feeding. a low albumin level is associated with more severe disease Treatment must be given for the full course, even if symptoms resolve before the course is completed. (Refer to Treatment Algorithms Associate document 5) Patients to be monitored daily for frequency and severity of diarrhoea using the Bristol Stool Chart (Associate document 1). CDI should be managed as a diagnosis in its own right, with each patient reviewed daily regarding fluid resuscitation, electrolyte replacement and nutritional review. Monitor daily for signs of increasing severity of disease, with early referral to the local acute Trusts as patients may deteriorate very rapidly. Treat according to severity See below Mild and moderate CDI Severe CDI Lifethreatening CDI Oral metronidazole 400 500 mg tds for 10 14 days. Oral vancomycin 125 mg qds for 10 14 days. In severe CDI cases not responding to oral vancomycin 125 mg qds, high-dosage oral vancomycin (up to 500 mg qds, if necessary administered via a nasogastric tube) +/- intravenous (iv) metronidazole 500 mg tds is recommended. The addition of oral rifampicin (300 mg bd) or iv immunoglobulin (400 mg/kg) may also be considered. Oral vancomycin up to 500 mg qds for 10 14 days via nasogastric tube or rectal installation plus iv metronidazole 500 mg tds. Such patients should be closely monitored, with specialist surgical input, and should have their blood lactate measured. Colectomy should be considered, especially if caecal dilatation is >10 cm. Colectomy is best performed before blood lactate rises >5 mmol/l, when survival is extremely poor. Page 7 of 11
If diarrhoea persists despite 20 days treatment but the patient is stable and the daily number of type 5 7 motions has decreased, the WCC is normal, and there is no abdominal pain or distension, the persistent diarrhoea may be due to post-infective irritable bowel syndrome. The patient may be treated with an anti-motility agent such as loperamide 2 mg prn (instead of metronidazole or vancomycin). The patient should be closely observed for evidence of a therapeutic response and to ensure there is no evidence of colonic dilatation. For first recurrence, repeat the same antibiotic used to treat the initial episode (unless the first episode was treated with metronidazole and the recurrence is severe CDI, in which case vancomycin should be used). For subsequent recurrences, use vancomycin 125 mg qds. Consider the alternatives listed in the treatment algorithm in Associate document 5. 13. Visits to other departments Visits to other departments should be kept to a minimum Visits that are clinically necessary, for investigation and treatment, prior arrangements should be made and the following principles adhered to: Infected patients should be seen at the end of the working session and only sent for when the department is ready to deal with them. Patients should not be left waiting areas with other patients. Staff should adhere to strict infection control procedures during the investigation or treatment Disposable equipment should be used whenever possible; non disposable equipment must be thoroughly cleaned and decontaminated after use. The patient should return directly to their ward/unit immediately following the procedure. 14. Discharge of patients Patients should only be discharged to residential settings when their stool has returned to normal and the risk of relapse assessed. Patients can be discharged to their own home if they still have diarrhoea but are improving. The patients GP and the residential home, where relevant, should be informed that the patient has been C. difficile positive during their inpatient stay, so that future antibiotic therapy is appropriate (See Associate document 6). Where patients are discharged to their own home the possibility of symptoms recurring should be discussed with the patient and/or carer. If patients have a history of relapse/reinfection a supply of pads, gloves and aprons should be given to the carer to prevent cross infection. A Transfer/Discharge Checklist should be completed and sent to the patient s GP or to the receiving hospital ward (See Associate document 6). Page 8 of 11
15. Outbreaks of C. difficile The Infection control and Prevention Team will: adhere to the following definitions for use in identifying and managing incidents of CDI Single Case C. difficile infection A period of increased incidence (PII) of CDI An outbreak of C. difficile infection One episode of diarrhoea, defined either as stool loose enough to take the shape of a container used to sample it or as Bristol Stool Chart types 5 7 (Associate document 1), that is not attributable to any other cause, including medicines (Associate document 2), and that occurs at the same time as a positive toxin assay (with or without a positive C.difficile culture) and/or endoscopic evidence of pseudomembranous colitis (PMC). Two or more new cases (occurring >48 hours post admission, not relapses) in a 28-day period on a ward Two or more cases caused by the same strain related in time and place over a defined period that is based on the date of onset of the first case. The following actions will be taken if a period of increased incidence of CDI or an outbreak is identified on a ward 1. Ward staff, urgently inform the clinical director, matron, ward manager and directorate manager. 2. IPC team, conduct a weekly C. difficile ward audit using the Department of Health s C. difficile High Impact Intervention (HII) tool. The audit should continue until the weekly score is >90% in three consecutive weeks and there have been no further >48 hours cases of CDI on the ward during that period. Feed back the audit results to the matron or ward manager. 3. The antibiotic pharmacist, Carry out a weekly antibiotic review in the ward (using local tools); 4. Clean the whole ward with chlorine-containing agent until no further symptomatic patients are present on the ward. Emphasise that each bed space needs to be cleaned separately with separate cloths. 5. Use the HPA Clostridium difficile Ribotyping Network for England (CDRNE) or Centre for Infections to undertake PCR (polymerase chain reaction) ribotyping of all isolates from patients in the ward. 6. The ICT should carry out an automatic review of ward PIIs each week. 7. An incident meeting should be held as determined by the size and rate of growth of the PII by assessment of the situation by the DIPC and/or the duty microbiologist with the clinical director and consultants, depending on the number of cases. The Trust will report any outbreak as a serious untoward incident (SUIs) to the relevant organisations and subject them to root cause analysis. Page 9 of 11
16. Cadaver Infection control precautions for handling deceased patients are the same as those used when the patient is alive. Faecal soiling around the cadaver should be cleaned first with detergent and then with a chlorine- containing cleaning agent. Plastic body bags are not necessary, but may be used as part of general practice in accordance with standard precautions for all patients. There is negligible risk to undertakers provided that standard infection control precautions are used. 17. Death certification If a patient with CDI dies, the death certificate should state whether CDI was part of the sequence of events leading directly to death or whether it was the underlying cause of death. If either case applies CDI should be mentioned in Part 1 of the certificate. B If CDI was not part of the sequence of events leading directly to death but contributed in some way to it, this should be mentioned in Part 2. If a doctor is in doubt about the circumstances of death when writing the certificate, they should consult with the trust s multidisciplinary clinical review team for CDI. B Doctors have a legal duty to mention CDI on a death certificate if it was part of the sequence of events directly leading to death or contributed in some way. 18. Control of Antibiotic Usage Avoidance of unnecessary antibiotic use. The use of narrow spectrum antibiotics whenever the causative pathogen is known. Review of "blind" empirical antibiotic therapy as soon as the causative pathogen has been identified Avoidance, wherever possible, of the use of antibiotic "cocktails". Regular chart review to ensure that antibiotics are discontinued as soon as possible. 19. Monitoring Compliance This policy will be reviewed three yearly or earlier in light of new national guidance or other significant change in circumstances. Compliance with this policy will be monitored through the mechanisms detailed in the table below. Where compliance is deemed to be insufficient and the assurance provided is limited then remedial actions will be drawn together through an action plan. This progress against the action plan will be monitored at the specified committee/group. The results of the annual audit will be escalated to the appropriate committee/group where appropriate. Page 10 of 11
20. References Centre for Disease Control (2005) Clostridium Difficile: Information for Healthcare Providers. Updated July. www.cdc.gov. Clostridium Standards Group. (2003) Report to the Department of Health. DH Publications. Department of Health (2006) A Simple Guide to Clostridium Difficile. DH Publications. Healthcare Commission (2005) Management, Prevention and Surveillance of Clostridium Difficile. December. Johnson, S. & Gerding, DN. (2004) Clostridium Difficile. (in) Mayhall, CG. ed. Hospital Epidemiology and Infection Control. 3 rd ed. Lippincott Williams & Wilkins. Lincolnshire Care Pathway Partnership. March 2006. Mallett. J, Bailey. C, ed (2004) Manual of Clinical Nursing Procedures. 6 th edition. Royal Marsden NHS Trust. Poxton, IR. (2005) Clostridium Difficile Issues Explored. The Clinical Services Journal. November. Department of Health (2009).Clostridium Difficile Infection: How to deal with the problem. London. Department of Health. Department of Health (2008) The Health and Social Care Act 2008. Code of Practice for the NHS on the prevention and control of Healthcare associated infections and related guidance. London. Department of Health Department of Health (2012) Updated guidance on the diagnosis and reporting of Clostridium Page 11 of 11