Clostridium Difficile. Guidance for the Management of Patients with Clostridium difficile Infection(CAI)/Associated Disease (CDAD) in the Community

Clostridium Difficile Guidance for the Management of Patients with Clostridium difficile Infection(CAI)/Associated Disease (CDAD) in the Community Reference No: G_IPC_36 Version: 5 Ratified by: LCHS NHS Trust Board Date ratified: 13 th February 2018 Name of originator/author: Infection Prevention Team Name of responsible committee/individual: Infection Prevention Committee Date issued: February 2018 Review date: January 2020 Target audience: All Staff Distributed via: Website 1

Version Guidance for the Management of Patients with Clostridium difficile Infection/Associated Disease in the Community Section/Para/ Appendix Version/Description of Amendments Version Control Sheet Date Author/Amended by 1 New Document July 2009 Sue Silvester 2 January 2011 Cheryl Day 5.4 Add in A period. of the first case (DH 2008) Jan 2011 Cheryl Day 5.5 Add Section 5.5 Severity of C Difficile infections Jan 2011 Cheryl Day 3 Update information June 2014 Lynne Roberts Whole document Change LPCT to Trust and Infection Prevention and Control Team to Infection Prevention Team Change Lincolnshire Learning Academy to Workforce and Transformation 7 Insert Alert and Read code on SystmOne 11.1.1 and 11.1.2 Details of how to access Patient Leaflet added June 2104 June 2014 June 2014 Lynne Roberts Lynne Roberts Lynne Roberts 15 Replaced RCA with PRI June 2014 Lynne Roberts 16 Removed reference to E-learning 17 Added monitoring template References 4 Whole document 5 Whole document Added The Healthcare Cleaning Manual 2009 Front page Various documents removed to prevent duplication. This document to be used in conjunction with management of patients with diarrhoea and Management of an Outbreak Sporicidal wipes added Updated footers and headers June 2014 June 2014 June 2014 Dec 2015 October 2017 Lynne Roberts Lynne Roberts Lynne Roberts Lynne Roberts Sarah Fixter Page 32 Leaflet changed November 2017 Sarah Fixter Copyright 2018 Lincolnshire Community Health Services NHS Trust, All Rights Reserved. Not to be reproduced in whole or in part without the permission of the copyright owner. 2

Guidance for the Management of Patients with Clostridium difficile Infection/Associated Disease in the Community i. Version control sheet ii. Guidance statement Contents 1. Introduction... 5 2. Purpose of this Guideline... 6 3. Scope of this Guideline... 6 4. Key Responsibilities... 6 4.1 Director of Infection Prevention and Control (DIPC)... 6 4.2 The Infection Prevention Team... 6 4.3 Managers... 6 4.4 Employees... 7 4.5 Education and Workforce Development... 7 4.5.1 Process to Check Training is completed... 7 5 Clinical Features... 7 5.1 Clostridium difficile Infection (CDI) or Clostridium difficile associated disease (CDAD) is defined as:... 7 5.2 Clinical features of C.difficile infection/disease... 7 5.3 Complications of C.difficile infection... 8 5.4 Risk Factors for C. difficile Infection... 8 5.5 Severity of C. difficile infection or associated disease:... 8 5.6 Glutamate Dehydrogenase (GDH)... 8 5.7 Transmission of C.difficile infection (Toxin positive or GDH positive)... 9 6. Diagnosis... 9 6.1. Laboratory Specimens... 9 6.2 Specimen Collection and Transportation... 9 6.3 Additional Information about Specimens... 10 6.3.1 Clearance and Repeat Specimens... 10 6.3.2 Reference Laboratory Typing of specimens... 10 6.3.3 Identification of patients with an alert organism... 10 7. Assessment and Review of the patient with CDAD/CDI... 10 7.1 Daily Monitoring of Patient... 10 8. Medical Management... 11 8.1 Best practice in Anti-microbial prescribing... 11 9. Prolonged Diarrhoea... 12 10. Relapsed / Recurrent C.difficile infection... 12 10.1 For first recurrence... 12 10.2 For subsequent recurrences... 12 11 Clinical management... 12 11.1 Source Isolation requirements... 12 11.1.1 In patient s private residence:... 12 11.1.2 In care settings:... 12 11.2 Transfer / Movement of CDI/CDAD/GDH positive patients... 13 11.3 Discharge / admission of CDI positive patients... 13 11.4 Visitors... 14 11.5 Personal Protective Equipment (PPE)... 14 11.6 Hand hygiene... 14 11.7 Nursing / Medical Equipment... 14 11.8 Linen and clothing management... 14 11.9 Environmental Cleaning... 14 3

11.9.1 Terminal Cleaning... 15 11.9.2 Environmental cleaning in the patient s own home:... 15 12. Outbreaks or Periods of Increased Incidence (PII)... 15 13. C.difficile Infection in the Community... 16 14. Deceased Patients... 16 14.1 Death Certificates... 17 15. Post Infection Review, Surveillance, Mandatory reporting and Audit... 17 16. Education... 18 17. Monitoring... 18 References... 18 Appendix A: Bristol Stool Form Scale... 20 Appendix B: Severity of C.difficile Infection and suggested treatment (DH 2009)... 21 Appendix C: Clostridium difficile Integrated Care Pathway... 22 Appendix D: Stool Chart... 25 Appendix E: Patient Management Checklists In patient areas and care homes... 26 Appendix F: Patient Management Checklists Patient s Own Home... 27 Appendix G: Sight protocol (DH 2008)... 28 Appendix H: Identification of Patients with Alert organisms... 29 Appendix I: Identification of patients with Alert Organisms Letter... 30 Appendix J: Medicines that can produce diarrhoea... 31 Appendix K: Leaflet... Error! Bookmark not defined. Appendix L: Clostridium difficile Transfer/Discharge Checklist... 32 Appendix M: CLOSTRIDIUM DIFFICILE INFECTION CLEANING SCHEDULE... 35 Appendix O: Medical Management of Patients with C.difficile Infection or Associated Disease 37 Appendix P: Department of Health High Impact Intervention... 37 Appendix Q: Clostridium difficile Post Infection Review Toolkit... 41 4

Guidance for the Management of Patients with Clostridium difficile Infection/Associated Disease in the Community Guidance Statement Background Statement Responsibilities The purpose of this guidance is to implement a co-ordinated approach to the management patients with Clostridium difficile in the community in line with current Department of Health requirements. This guidance is comprehensive, formally approved and ratified and disseminated through approved channels. It will be implemented for Lincolnshire Community Health Services. Compliance with the guidance will be the responsibility of all Trust staff. Training The Infection Prevention Team will support/deliver any training associated with this guidance. Dissemination Website Resource implication This guidance has been developed in line with the NHS Litigation Authority guidelines to provide a framework for staff within NHS Organisations to ensure the appropriate production, management and review of organisation-wide policies. 1. Introduction Clostridium difficile (C.difficile) is the major cause of antibiotic associated diarrhoea and colitis, a healthcare associated intestinal infection that mostly affects elderly patients with underlying diseases (DH 2006). C.difficile is a spore forming, anaerobic bacterium. It is estimated that between 2-3% of healthy adults and up to 36% of hospital patients are asymptomatic carriers of C.difficile in their faecal flora. C.difficile Infection (CDI or C.difficile associated disease (CDAD) is frequently associated with antibiotic treatment (Hawker et al 2001). The diarrhoea associated with this disease can range in severity from mild to severe and can rapidly result in deterioration in the patient s condition. The complications arising from this disease include; pseudomembranous colitis, toxic megacolon, colonic perforation and death. C.difficile has the greatest potential for spread within in-patient units, thus prevention and appropriate management of infection is of paramount importance to quality and safety. It has been linked to major outbreaks and large numbers of patient deaths involving the Stoke Mandeville Hospital and Maidstone & Tunbridge Wells NHS Trust (HCC 2007). 5

Key strategies to reduce incidence of CDI include: Minimising susceptibility through disruption of gut flora. This may be implemented through measures to control antibiotic usage such as using narrow spectrum antibiotics and reducing duration of treatment. Preventing exposure to the organism. This may be done through routine infection control procedures. The most important aspects of this are: a) Hand washing by both staff and clients. b) Appropriate disinfection and sterilisation of equipment. c) Environmental cleaning. d) Isolation of all clients with diarrhoea pending diagnosis. 2. Purpose of this Guideline The purpose of this guideline is to provide best practice guidance in relation to infection prevention and control pertaining to Clostridium difficile infection in community and primary care settings. 3. Scope of this Guideline The principles contained within the guideline reflect best practices and apply to those members of staff who are directly employed by Lincolnshire Community Health Services and for whom the Trust has legal responsibility. 4. Key Responsibilities 4.1 Director of Infection Prevention and Control (DIPC) The DIPC will: Provide leadership in relation to the effective management of CDI. Ensure that mandatory audit and surveillance is completed and reported. Ensure that poor practice in relation to CDI s effectively addressed. 4.2 The Infection Prevention Team The Infection Prevention Team will: Review the guidance in response to the publication of any urgent communications from the Department of Health and/or every three years. Will undertake any necessary mandatory surveillance associated with CDI. Will facilitate investigation into all cases notified to them with a purpose to inform future patient care. Assist managers with the audit of compliance with the guidance as part of the audit programme. 4.3 Managers Managers have the responsibility for the standards of clinical practice by their staff in the health care setting. They must: Ensure all individuals are appropriately trained. Inform new employees of their responsibilities under this guidance. Ensure that all employees within their area of responsibility comply with this guidance. Audit compliance to this guideline as required by the organisation. 6

4.4 Employees All employees have a responsibility to abide by this guidance and any decisions arising from the implementation of it. Any decision to vary from this guidance must be fully documented with the associated rationale stated. Employees have a responsibility to attend mandatory training/update training as identified within the Organisation s Mandatory Training Matrix. 4.5 Education and Workforce Development The Education and Workforce has a responsibility to ensure the coordination of the learning and development of staff, as identified within the training matrix. In relation to this guidance they will: In conjunction with the Infection Prevention Team, facilitate any education sessions. Identify and follow-up non-attendance at mandatory training sessions with Line Managers. 4.5.1 Process to Check Training is completed The statement of main NHS terms and conditions for employment for LCHS under Agenda for Change identifies that all staff will be expected to undertake appropriate and relevant training and development to enhance their performance in their post. This will be monitored via Appraisal process. 5 Clinical Features 5.1 Clostridium difficile Infection (CDI) or Clostridium difficile associated disease (CDAD) is defined as: 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 6 7 (Appendix A). Not attributable to any other cause, including other medicines and diet. Occurring at the same time as a positive toxin assay and/or endoscopic evidence of pseudomembranous colitis (PMC) (DH 2008). 5.2 Clinical features of C.difficile infection/disease Mild to severe watery, explosive, foul-smelling diarrhoea (type 6/7 stools). The smell is acutely characteristic and the stools may have a green appearance. Mucus and blood may be present in the stool. Diarrhoeal stools (Appendix A). Abdominal pain/tenderness may also be present. Some patients may develop severe pseudomembranous colitis with ulceration of the colon, toxic megacolon, perforation or peritonitis, all of which may result in death. 7

NB: Diarrhoea may start during a course of antibiotics (can occur as early as one day or a late as two months after discontinuing therapy). C. difficile infection should be considered in any patient who presents with diarrhoea, particularly if there has been a history of recent anti-microbial usage. 5.3 Complications of C.difficile infection The complications of C.difficile infection include: relapse diarrhoea dehydration pseudomembranous colitis toxic megacolon bowel perforation sepsis death 5.4 Risk Factors for C. difficile Infection Risk factors for Clostridium difficile infections include the following: Elderly (over 65 years). Long length of stay OR multiple stays in healthcare settings. Antibiotics prescribed to treat another condition or given prophylactically. Recent surgery; e.g. gastro-intestinal surgery. Serious underlying disease/illness. Immunocompromising conditions, especially where cytotoxic medications are used. Prolonged use of proton pump inhibitors. Anti-ulcer medications. Presence of a nasogastric tube. A period of increased incidence (PII) of CDI is: Two or more new cases (occurring >48 hours post admission, not relapses) in a 28-day period on a ward (DH 2008). An outbreak of C.difficile infection (Community Hospital and Community) is: 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 (DH 2008). 5.5 Severity of C. difficile infection or associated disease: The severity of CDI is described in appendix B and should be considered on suspected / confirmed diagnosis and during the daily review of the patient. 5.6 Glutamate Dehydrogenase (GDH) Glutamate Dehydrogenase is an antigen which is produced in high amounts by C.difficile bacteria. The laboratories carry out 2 types of test for C. difficile. One of these is Glutamate Dehydrogenase (GDH). If this is positive, it is likely that the patient is carrying the microorganism C.difficile in their bowel. This is unlikely to cause them problems. If the test is GDH positive, the lab will test for C.diff toxins (CDT). If that is positive, it is likely that the Clostridium difficile is causing an infection. The results may show the patient is GHD positive and toxin negative. Therefore the patient is a carrier and whilst they are experiencing diarrhoea, they present an infection prevention risk. 8

5.7 Transmission of C.difficile infection (Toxin positive or GDH positive) A person who is toxin positive and with diarrhoea excretes a large number of spores in their stools. These spores can contaminate the general environment, including toilet / commode areas, bedside areas and sluice rooms. Spores stay viable for long periods of time as they are resistant to heat, alcohol and acids in the stomach. Unclean patient equipment and patient environments provide reservoirs for cross infection. The mode of transmission is usually contact spread by either the direct or indirect route. The bacterial spores are then transported on the hands and contaminated equipment and if ingested by a susceptible person can cause illness. 6. Diagnosis C. difficile should be suspected where there are symptoms of diarrhoea (as stated above). A faecal sample should be taken and tested as soon as practically possible following symptoms. 6.1. Laboratory Specimens Confirmation of CDI s currently via the laboratory detection of C.difficile Glutamate Dehydrogenase (GDH) and Toxins A and/or B in faecal samples. When sending faecal specimens to the laboratory, the laboratory form must include a request for C.difficile toxin investigation and state any recent antibiotic history, frequency of diarrhoea, stool type (e.g. Type 6/7) and date of onset of diarrhoea. The laboratory will first test for GDH. An enzyme which will be present only if there are C.difficile spores present in the sample. If not present then the patient will be negative C.difficile. If present they will test for toxins. Therefore a patient may be GDH positive and Toxins positive. This will indicate that there is a C.difficile Infection. If GDH positive and Toxin negative, it indicates that there is C.difficile present but not currently and infection. This however is still and infection prevention and control risk and patient needs to be Source isolated, medication reviewed and monitored. (See Appendix Q.) More than one test per patient may be required if the first test is negative but where there is a strong clinical suspicion of CDAD/CDI. Retest a second sample 2/3 days later or unless patient s condition deteriorates. If clinically convincing, further samples may be sent on subsequent days; discussion with a microbiologist should take place if in any doubt. Repeat faecal specimens are not needed whilst a person is symptomatic or when diarrhoea ceases. In suspected cases of silent CDAD/CDI, such as ileus, toxic megacolon or pseudomembranous colitis without diarrhoea, other diagnostic procedures such as colonoscopy, white cell count (WCC), serum creatinine and abdominal CT (computerised tomography) scanning, may be required (DOH 2008). If in doubt, please discuss with a microbiologist. Generally it is not advisable to test children under the age of 2 years (DH 2008). N.B. The laboratory will not test formed stools - the sample must take the shape of the container 6.2 Specimen Collection and Transportation Specimens should be sent to the laboratory for C. difficile testing as soon as practicably possible. It is essential that the date and time and result of the specimen are documented in the patient s records. 9

More than one test per patient may be required if the first test is negative but where there is a strong clinical suspicion of CDAD/CDI. Retest a second sample 2/3 days later or unless patient s condition deteriorates. Where the specimen is taken out of working hours (5pm 8pm, weekends and bank holidays), the specimen must arrive in laboratory first thing in the morning or await until the next working day. Local arrangements regarding transportation apply. i.e. local courier/taxi service 6.3 Additional Information about Specimens 6.3.1 Clearance and Repeat Specimens Repeat stool specimens for C.difficile testing are not necessary within 28 days of initial diagnosis. The laboratory will reject samples within 21 days of a positive result, unless discussed with a consultant microbiologist. Possible exceptions include: Symptoms persist despite treatment - a further test may be undertaken after 28 days. Symptoms resolve and then recur which may suggest a relapse. 6.3.2 Reference Laboratory Typing of specimens Sudden increases in the number and/or severity of cases detected in a ward / across several units within a hospital or in the community are legitimate reasons for typing requests (DH 2008). The decision to type a faecal specimen must be made in conjunction with the Consultant Microbiologist. 6.3.3 Identification of patients with an alert organism SystmOne If the patient has been confirmed as a positive toxin or GDH, the C.difficile alert must be set on SystmOne and a read code for C.difficile input. 7. Assessment and Review of the patient with CDAD/CDI For all patients identified as having CDAD/CDI, daily reviews by healthcare staff must take place and be documented on SystmOne nursing and medical notes (Appendices C and D). See patient management checklist (Appendices E and F). A medical alert and read code must be entered on SystmOne. As speed of diagnosis is important for the efficient use of isolation facilities, healthcare staff should adhere to the SIGHT protocol (Appendix G) and additional precautions as advised in this guidance. 7.1 Daily Monitoring of Patient Each patient should be monitored daily for frequency and severity of diarrhoea using the Stool Chart (Appendix D). Each patient should be monitored for signs of increasing severity of disease, with early referral to GP / Acute hospital / ITU as patients may deteriorate very rapidly. (see Appendix H) 10

Each patient should be reviewed daily regarding fluid, electrolyte replacement and nutrition review. All antibiotics that are clearly not required should be stopped; as should other drugs that might cause diarrhoea (see Appendix K). 8. Medical Management For symptomatic patients it is important to seek prescribing advice from the Consultant Microbiologist (Appendix Q). The antibiotic of choice is Metronidazole 400mg tds orally for a period of 10-14 days. For severe disease Vancomycin 125mg qds orally for 10-14 days is the drug of choice. Oral administration of these antibiotics is more effective than other routes. The GP / Dr must complete an entry in the dosage, stop date, and IV to oral switch box relating to all antibiotics. Patients may receive additional courses. If diarrhoea persists the Consultant Microbiologist should be consulted. In addition to this: All other antibiotics should be reviewed and stopped where possible as should other drugs that might cause diarrhoea (DH 2008) (Appendix K). Oral fluids must be encouraged and the patient monitored for potential fluid imbalance. Fluid deficits should be rectified. Nutrition status addressed any imbalance rectified. Proton pump inhibitors (PPIs) should be used only when there is a clear clinical indication. Opioids and should be avoided as they may prolong or worsen symptoms. There is no evidence to support the routine use of probiotics in the treatment or prophylaxis of C. difficile diarrhoea. If probiotics are being considered, please discuss with a Consultant Microbiologist before commencing. N.B. Anti-motility agents are contra-indicated in patients with antimicrobial associated diarrhoea and should not be prescribed. 8.1 Best practice in Anti-microbial prescribing Prudent antibiotic prescribing and consistent use of infection prevention and control practices have been shown to reduce the incidence of CDAD/CDI Always refer to the local Antimicrobial Prescribing Guidelines. Avoidance of unnecessary antibiotic use. The use of narrow spectrum antibiotics is preferable to the broad spectrum groups. In particular, cephalosporins and fluroquinolones such as ciprofloxacin should be avoided. Review "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. 11

9. Prolonged Diarrhoea If diarrhoea persists despite 20 days treatment but the patient is stable and the daily number of type 6 7 motions has decreased, the white cell count (WCC) is normal, and there is no abdominal pain or distension, the persistent diarrhoea may be due to post-infective irritable bowel syndrome. If all of the aforementioned criteria are met, 2mg prn Loperamide may be cautiously prescribed. The patient must be closely observed for evidence of a therapeutic response and to ensure there is no evidence of colonic dilatation. (DH 2009 p.17) It is advisable to consult the microbiologist in such cases prior to commencing antimotilants 10. Relapsed / Recurrent C.difficile infection The Consultant Microbiologist must be consulted in first and subsequent cases of recurrence, particularly if the case is medically complicated. 10.1 For first recurrence It is advised to 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 discuss possible vancomycin use with a microbiologist (DH 2008)). 10.2 For subsequent recurrences The antibiotic Vancomycin 125 mg q.d.s may be used. However, alternatives may be discussed with the Consultant Microbiologist. 11 Clinical management 11.1 Source Isolation requirements All cases of unexplained diarrhoea should be treated as infective until a specimen has provided microbiological results 11.1.1 In patient s private residence: Isolation is unnecessary for patients living in their own homes. They should be provided with information about the importance of hand and environmental cleanliness, a patient information leaflet and referred to the infection prevention and control team/local health protection nurse if they have any additional queries. It is advisable that symptomatic patients do not partake in social care activities (e.g. day centres). It is advisable that symptomatic patients do not visit sick/vulnerable social contacts (e.g. hospitalised friends/elderly/babies). Patient Information Leaflet can be access via IPC website 11.1.2 In care settings: Patients in community hospitals or care homes with symptoms of diarrhoea must be Source isolated in a single room until microbiological cause is explored and a result received or symptoms have resolved for at least 48 hours and a normal stool has been passed. 12

If Source isolation in a single room is not possible because the single room capacity is exceeded, patients with confirmed CDI should be nursed in a dedicated designated bay / ward (DH 2008). Advice and a risk assessment should be undertaken in collaboration with a member of the infection prevention and control team in these circumstances. The single room should, where possible, have a self-contained toilet and its own hand wash basin. If the room does not have its own toilet facilities then a commode should be designated for that patient, for the duration of their symptoms The patient should remain isolated until there has been no diarrhoea (types 6 7 on the Bristol Stool Chart) for at least 48 hours, and a formed / normal stool has been passed (e.g. types 1 5). A patient will be deemed non-infectious when they have had no diarrhoea / normal bowel function at and beyond 48 hours (assuming no evidence of megacolon etc). Where single-room isolation or cohort nursing in a bay is not halting or reducing the spread of infection and the advice of the Infection Prevention Team is to open or create a designated isolation ward/area (DH 2008) this should be undertaken where possible. Where there are resource issues, a risk assessment must be undertaken. Advice can be sought from the Infection Prevention Team. Patient Information Leaflet can be access via IPC website 11.2 Transfer / Movement of CDI/CDAD/GDH positive patients Transfer and movement of patients should be reduced to an operationally effective minimum. Where patients need to attend GP / departmental / hospital clinics for essential investigations, they should be last on the list unless earlier investigation is clinically indicated. In advance of the transfer, the receiving area should be notified of the patient s CDI status. Complete an inter hospital transfer form. Arrangements should be put in place to minimise the patient s waiting time and hence contact with other patients. Where deemed medically fit, transfer to other healthcare facilities should include notification of the individual s C.difficile infection status (Appendix J). Patients awaiting transfer should not be left in communal waiting areas. Staff, including ambulance personnel, should adopt appropriate infection control precautions when in contact with the patient. 11.3 Discharge / admission of CDI positive patients Patients should only be discharged to residential settings when they are diarrhoea free for 72 hours or have resumed normal bowel function. If the patient still has diarrhoea, a risk assessment for transfer should be undertaken. The patient s GP and the residential home, where relevant, should be informed that the patient has been C.difficile positive during their hospital in-patient stay, so that future antibiotic therapy is appropriate (Appendices M and N). Patients can be discharged to their own home if they still have diarrhoea but their general condition is improving. Where patients are discharged to their own home the possibility of symptoms recurring should be discussed with the patient and/or carer. 13

A Transfer/Discharge Checklist should be completed and sent to the patient s GP/ Nursing home / Community Nurse or to the receiving hospital ward (See Appendix K). 11.4 Visitors It is advisable that visitors are restricted to the minimum and that children and babies do not visit. 11.5 Personal Protective Equipment (PPE) All staff must comply with the guidance for PPE when in direct contact with the patient with CDAD. Staff should wear a disposable plastic apron and non-sterile gloves when caring for the client or when exposure to body fluids or excreta is anticipated. Visitors should be informed of the importance of hand washing. They only need to wear protective clothing if contact with body fluids or excreta are anticipated or assisting with care. 11.6 Hand hygiene It is important to recognise that C.difficile spores are resistant to hand sanitizer. All healthcare workers should wash their hands with soap and water before and after contact with patients with suspected or proven CDI or any other infective diarrhoea. Hands should also be washed after removing PPE and after contact with the patient s immediate environment and contact with bodily fluids. All staff or visitors entering an isolation-room should wash their hands with soap and water before and after each patient contact and after contact with the environment (DH 2008) (Appendix L). 11.7 Nursing / Medical Equipment Medical equipment should ideally be for single patient use. Where this is not possible it should be thoroughly cleaned before and after each new patient use, with a disinfectant that has a sporicidal effect, e.g. Clinell sporicidal wipes. This process should be recorded and audited together with regular checks of equipment. Purchasing of additional disposable equipment must be strongly considered. 11.8 Linen and clothing management In the hospital/care home: All clothing and bedding must be contained as per Guidance on the Management of Linen e.g. red alginate bags, red outer bags. In the patient s own home, all clothing and bedding should be washed on the highest setting the fabric will tolerate, followed by tumble drying (where available). Contaminated items should, ideally, be washed separately from other household laundry. 11.9 Environmental Cleaning In the hospital/care environment: It is essential that fabrics and carpets from environments such as floors and chairs, which may otherwise be damaged by chlorine based products, are removed from the environment (DH 2008). 14

Soiled fabrics can be handled as outlined in the Guidance on the Management of Linen. Soft furnishings may be cleaned with detergent / chlorine containing agents / steam cleaned. Consideration must be given to replacement of an item if heavily stained. Environmental cleaning of rooms or bed spaces of C. difficile patients should be carried out at least daily using sporicidal wipes. All commodes, toilets and bathroom areas of CDI patients should be cleaned after each use with sporicidal wipes. Faecal soiling should be cleaned with detergents then treated using sporicidal wipes. NB: Chlorine is an irritant to the skin and may damage soft furnishings and carpets. It should be used with caution. Always refer to manufacturer s instructions for equipment cleaning and disinfection before applying chlorine based-products. 11.9.1 Terminal Cleaning Terminal cleaning of a mattress, bed space, bay or ward area after the discharge, transfer or death of a patient with CDI should be thorough (Appendices O and P). Reference must be made to section 5 of The Revised Healthcare Cleaning Manual 2009 The local guidance on cleaning vacated bed spaces and decontamination guidance. All areas should be cleaned using sporicidal wipes, and the curtains should be changed. Careful attention must be paid to patient bed areas, toilets, bathrooms and sluices, commodes and bedpans. Where in place, steam cleaning of soft furnishings is highly advisable. 11.9.2 Environmental cleaning in the patient s own home: Particular attention to good cleaning/disinfection must be given to toilet areas, using proprietary household cleaners and single use cleaning cloths/paper towels. In the patient s own home, soiled fabrics should be washed on the highest setting the fabric will tolerate, followed by tumble drying (where available). 12. Outbreaks or Periods of Increased Incidence (PII) An outbreak of C. difficile is defined as two or more associated cases, where there is a likely link i.e. in time and place. It is essential that staff notify the Infection Prevention Team immediately when there is the suspicion of an outbreak. Where this occurs outside normal working hours the on call manager must be notified. The presence of an outbreak will be confirmed after discussion by Infection Prevention Team/Duty Manager in the first instance with advice from Consultant Microbiologist/DIPC where appropriate and in collaboration with the local HPU. Reference must be made to the Guidance on Outbreaks in the Community / Community Hospitals. Where the outbreak involves LCHS Community Hospitals the following must be undertaken: An audit should be done of the numbers of patients isolated and the percentage of suspected and confirmed cases isolated during the working day. The infection control link person will have a key role in this process. 15

The Infection Prevention Team should carry out an automatic review of ward PIIs each week. Designated others may be involved in this process. Conduct a weekly C. difficile ward audit using the Department of Health s C. difficile High Impact Intervention (HII) tool (Appendix R). The audit should continue until the weekly score is >90% in three consecutive weeks and there have been no further >48 hours cases of CDAD on the ward during that period. Audit results must be fed back to the Matron/Ward manager, Infection Prevention Team. A weekly antibiotic review in the ward / department must be undertaken (using local tools); this is the responsibility of the antibiotic pharmacist or designated personnel. Ensure that daily and terminal cleaning takes place as advised. An outbreak 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. All outbreaks must be treated as serious incidents (SIs) and are subject to a Post Infection Review (PIR) and a STEIS must be raised and a Datix completed 13. C.difficile Infection in the Community In addition to the above guidance: All cases of diarrhoea among people in the community aged 2 years and above should be investigated for CDI unless there are good clinical or epidemiological reasons not to. Faecal specimens should indicate clearly who should be informed of the result. Cases in which specimens were taken before admission of the patient to hospital / care home or within 72 hours of admission should be termed community-onset CDI. In a home setting, advice must be given on general cleanliness and hand hygiene. Where possible, in care homes, patients with suspected potentially infectious diarrhoea (at least one episode of diarrhoea) should be moved immediately into a single room with a selfcontained toilet and its own hand basin. If the room does not have its own toilet facilities then a commode should be arranged. If liquid soap is not available in the person s home, any liquid soap-based product can be used to wash hands. Bar soap should be used as a last resort. Staff in the community must adhere to full Standard Infection Prevention and Control precautions. There should be no restriction on institutions, such as care homes, receiving patients who have had CDI and are now clinically asymptomatic. Care should be taken to communicate the individual s infectious status clearly to staff and GPs, issuing a proforma letter and Healthcare Inter transfer form (Appendices M and N). If there are a significant number of cases of community-onset CDI, further investigations should be undertaken to assess whether they reflect true community-acquired infections or recent discharges from hospital. If more than two cases of diarrhoea that are suspected or known to be infectious and occur in a care home or other community institution, the registered manager is responsible for reporting this to the Public Health England/Consultant in Communicable Disease Control / Infection Prevention Team. The Consultant Microbiologist must be informed of any outbreaks thus informing and enabling ribotyping of the strains. Outbreaks of CDI in institutional settings should be investigated in the same way as in the acute hospital setting. 14. Deceased Patients Infection prevention and control precautions for handling deceased patients are the same as those used when the patient is alive. 16

Plastic body bags are not necessary. Faecal soiling around the cadaver should be cleaned first with detergent and then with a chlorinecontaining cleaning agent. 14.1 Death Certificates Doctors have a legal duty to mention C.difficile infection on a death certificate if it was part of the sequence of events directly leading to death or contributed in some way. Deaths associated with C.difficile must be categorised as attributable or contributory and adequately recorded on the death certificate (DH 2008). If a patient with C.difficile infection dies, the death certificate should state whether C.difficile infection 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. 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. 15. Post Infection Review, Surveillance, Mandatory reporting and Audit There should be continuous local surveillance of cases of CDAD, with: LCHS will report all cases of CDI s notified to them to the Board on a quarterly basis. The information will include analyses of trends and exceptional reports. They are also reported to the CCG and Trust Development Agency (TDA) A Post Infection Review will be completed for all cases of C.difficile and Serious Incident (SI) where the DH criteria are met. Review of these reports will be a standing item on the agenda for the LCHS Local clinical governance meetings, Infection Prevention Committee/ Patient Safety and Safeguarding/ Quality and Risk Meetings and lessons learnt shared. Where appropriate, local surveillance will include a 30 day follow up and will record the number of patients with severe infection, the number requiring surgery and the number dying where CDI caused or contributed to the death. Additional audit and monitoring may be undertaken in the event of PII and outbreak situations (DH 2008) and may include: Environmental cleanliness Isolation Hand Hygiene Personal Protective Clothing Antibiotic prescribing Daily audit of affected patients Duty of candour Best Practice Guidance and monitoring tools: Up to date information may be obtained from the Lincolnshire Community Health Services web site, from www.dh.gov.uk and www.clean-safecare.nhs.uk 17

Posters and Leaflets: Up to date information may be obtained from the LCHS web site, from www.dh.gov.uk and www.clean-safe-care.nhs.uk 16. Education This guidance will be referred to in the mandatory education of staff.. Medical directors should ensure that training is provided on death certification and should audit certificates to check that they accurately record HCAI. 17. Monitoring Minimum requirement to be monitored Process for monitoring e.g. audit Compliance Audit with Guidelines Responsible individuals/group /committee Frequency of monitoring /audit Managers/Infec Monthly tion Link Champions/ Infection Prevention Team Responsible individuals / group / committee (multidisciplinary) for review of results Infection Prevention Committee Responsible individuals / group / committee for development of action plan Infection Prevention Committee Responsible individuals / group / committee for monitoring of action plan Infection Prevention Committee References Clostridium Standards Group (2003) Report to the Department of Health. DH Publications. Healthcare Commission (2005) Management, Prevention and Surveillance of Clostridium difficile. December. Department of Health (2006) Clean Safe Care at www.clean-safe.care.nhs.uk Mallett. J, Bailey. C, ed (2004) Manual of Clinical Nursing Procedures. 6th edition. Royal Marsden NHS Trust. Commission for Healthcare Audit and Inspection (2006). Investigation into outbreaks of Clostridium difficile at Stoke Mandeville Hospital, Buckinghamshire Hospitals NHS Trust, Healthcare Commission, London. http://www.healthcarecommission.org.uk/ Prevention and Management of C.difficile Guidance 2008, Richmond & Twickenham PCT Department of Health (DH) (2005). A simple guide to Clostridium difficile DH, London. Available at www.dh.gov.uk/hcai Department of Health (DH) (2005). Surveillance of Clostridium difficile associated disease 18

(CDAD) DH Publications, London Department of Health (DH) and Chief Medical Officer and Chief Nursing Officer (2005). Infection caused by Clostridium difficile, (Professional letter; Chief Medical Officer PLCMO (2005) Chief Nursing Officer PLCNO (2005)). DH, London. Available at http://www.dh.gov.uk/assetroot/04/12/55/23/04/25523.pdf Department of Health (DH) (2009) Clostridium difficile infection: How to deal with the problem. Gateway 9833, DH Publications. J Hawker N Begg R Reintjes J Weinberg (2001) Communicable Disease Control Handbook, National Patients Safety Agency (NPSA) (2009) The Revised Healthcare Cleaning Manual (2009) 19

Appendix A: Bristol Stool Form Scale 20

Appendix B: Severity of C.difficile Infection and suggested treatment (DH 2009) C.difficile Infection Mild CDAD Moderate CDAD Severe CDAD Lifethreatening CDAD Severity Description 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 x10 9 /L; it is typically associated with 3 5 stools per day. Is associated with a WCC >15 x 10 9 /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 Suggested treatment oral metronidazole 400mg- 500mg tds for 10-14 days. oral metronidazole 400 mg 500mg tds for 10-14 days. Discuss with the Consultant Microbiologist Discuss with the Consultant Microbiologist Note: The patient should be reviewed daily in respect to fluid resuscitation/electrolyte replacement and nutrition. The severity of disease should be assessed at least weekly by a multi-disciplinary team to ensure that optimal treatment is being provided. 21

Appendix C: Clostridium difficile Integrated Care Pathway Patient s Name. DOB... NHS Number Ward / Area/Care Home.Consultant / GP. Inclusion Criteria - This ICP is for use with known and newly diagnosed Clostridium difficile adult patients, including GHD positive patients Exclusion Criteria - This ICP is not for use with patients 16 years or younger. Signature Record - All members of staff using this Integrated Care Pathway complete this section. You can then use initials when recording care. Print Name Job Title Signature Initials History 1. Date of admission 2. Admitted from where? Hospital Care home Home Other. 3. Date patient first started with diarrhoea? 4. Date first stool sample sent. 5. Result of stool sample Neg Pos C.diff Other.. 6. Has the patient previously has C.difficile In last month In last 3 months No 7. Has the patient received any antibiotics in the last 2 months? Yes No 8. Is the patient on antimotility drugs? Yes.if yes, please stop. No 9. Has the High Impact interventions been commenced Nursing / Medical Interventions Elimination Yes No if no please start. YES NO Date Time Signature 1. Has the initial assessment of their bowel function Review been reviewed 2. Is the patient on a stool chart. Commence Isolation 3. Has the patient been isolation in single room Isolate Contact IPT 4. Is there ensuite facilities Designate Use commode Contact IPT 5. Has an explanation been given to the patient as to why they have been isolated. Explain Leaflet 6. Standard precautions implemented by all HCWs that have contact with the patient. Obtain PPE 22

7. Are hand washing facilities available. NB do not use Alcohol hand rub 8. Patients can wash their hands with soap and water or hand wipes following toilet/commode use, before meals. 9. Carers aware of the isolation measures and reasons Obtain No alcohol rubs YES NO Date Time Signature Obtain wipes Advise Leaflet 10. Visitors to wash hands using soap and water Advise leaflet 11. Has information leaflet been given to patient/carers 12. Is hazardous waste being disposed of inside the room 13. Are red bag available for containment of soiled linen 14. Does the patient have his own dedicated equipment: BP, sling, wash items. Medical Management 15. Doctor informed of specimen result 16. Has the Dr / GP reviewed the patients existing antibiotic therapy Obtain equipment Obtain bags Obtain Decontaminate YES NO Date Time Signature Must be done within 24hrs of diagnosis GP to 17. Has the Dr/GP prescribed antibiotic treatment, Metronidazole with a stop date. Vancomycin prescribe 18. Has the Dr /GP reviewed all patient s Dr/GP to medications; Proton pump inhibitors, laxatives, review Anti-peristaltic, Statins 19. Have laxatives been stopped Stop 20. Is the Dr/GP going to review the patient on a Advise daily daily basis 21. Is the Dr/GP aware of isolation procedure, PPE Inform and hand decontamination Environmental Cleaning and Decontamination of Medical Devices YES NO Date Time Signature 22. Have team been advised of need for enhanced isolation cleaning daily or more frequently if Advise Checklist required 23. Is the room being cleaned with a chlorine based Advise solution 24. Are domestic staff completing the daily checklist Complete Staff: 25. Are Staff aware of need to clean toilet facilities or undertake commode following each bowel action and wipe over with hypochlorite 1000 ppm solution twice a day Transfer / Discharge 26. Has the patient been 72 hours free of symptoms and passed a normal stool? 27. Has receiving facility been informed of infective diarrhoea status? 28. Has the patient s GP/community nurse been informed? Patient should not be transferred Complete Transfer form Complete Transfer form 29. Has the patient received discharge information. advise 23

Discontinuation of Pathway Pathway discontinued Terminal clean or room undertaken Decontamination of all re-usable equipment Service User outcome Resolved infection without treatment Resolved infection with treatment Discharged home / care facility Discharged to hospital Died unrelated cause Died related to C.difficile (1a on death certificate) Date Signature Date / Time Variance Initials 24

Appendix D: Stool Chart Patient Details or Address: Name: DOB: NHS NO: Ward: Patients Bowel pattern: BRISTOL STOOL CHART Date Time Colour Amount Bristol Blood Mucous Specimen Result Signature Amount Guide SMALL ¼ of bedpan / pad MEDIUM ½ of bedpan / pad LARGE most of bedpan / pad 25

Appendix E: Patient Management Checklists In patient areas and care homes General Care Treatment Hand Decontamination Standard Precautions Environmental Cleaning and Decontamination Patients to be isolated in a single Send stool sample to confirm diagnosis. Standard precautions to be used room, preferably ensuite. Follow Medical management flow chart. at all times, by all staff. Commence: care pathway, & fluid/stool chart Review bowel pattern with initial assessment. Observe for signs of: Dehydration, fever, Abdominal pain / distension. passing blood, hypotension, Tachycardia. Encourage good oral fluid intake. Patients should not move to other areas in care facility.. Patient leaflet to be provided Visitors to be kept to minimum. Support services must continue where condition dictates. Continue to monitor patient s bowel patter post infection as relapse may occur. Discharge see main Guidance GP to review and stop current antibiotics. Stop / avoid antimotility drugs Review / Stop use of laxatives, proton pump inhibitors, steroid & opioids Probiotics should not be used immunocompromised patients. IV fluids may be considered to prevent dehydration. NB If a patient is asymptomatic i.e. does not have diarrhoea but has a positive C-difficile sample - no treatment is required but standard precautions must be maintained Staff should wash their hands with soap and water following any patient contact, contact with faeces or contact with potentially contaminated equipment Remove alcohol hand rubs Visitors should wash their hands with soap and water before leaving the ward Patient must wash hands after toileting and before feeding. The need for good hand hygiene and personal hygiene to be discussed with the patient Isolation guidance to be adhered to. If single room unavailable, cohorting Is to be considered. Soiled linen to be placed in red dissolvable bags and outer red infected linen bag Waste to be disposed of as hazardous Urine and faeces in bedpans should be disposed of, if possible, down a lavatory in the room. if not, bedpans should be taken to the macerator. Isolation precautions may be removed if patient has normal stools and has been asymptomatic for at least 48hours Patients environment to cleaned at least daily with soap and water, followed by Sporicidal wipes. Isolation areas to cleaned be last A separate mop, bucket and cleaning utensils to be used in each isolation area All nursing equipment must be disposable where possible OR appropriately decontaminated. Spillages soiled with faeces to be promptly cleaned using a Spill Kit. Air flow pressure relieving mattresses to be returned to the contracted cleaning company for decontamination, (with appropriate decontamination request form attached) When patient is symptom free or after discharge, the patient area is to be terminally cleaned 26