DN226 Clostridium difficile (C. diff) - Procedure

Document title:

Clostridium difficile Procedure

Document number:

DN226

Staff involved in Development (job titles):

Consultant Microbiologist

Document author/owner:

Consultant Microbiologist

Infection Prevention and Control Nurse Specialist

Infection Prevention and Control Nurse Specialist Directorate:

Nurse Management

Department:

Infection Prevention and Control

For use by:

All clinical staff

Review due:

April 2017

This is a controlled document. Whilst this document may be printed, the electronic version maintained on the Trust’s Intranet is the controlled copy. Any printed copies of this document are not controlled. ©Papworth Hospital NHS Foundation Trust. Not to be reproduced without written permission. Key points of this document:   

Guidance on management of hospital inpatients with Clostridium difficile. Roles, responsibilities and measures to be undertaken to identify, treat and limit spread. Monitoring and audit.

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DN226 Clostridium difficile (C. diff) - Procedure Contents Key points of this document: ................................................................................................................. 1 1.

Introduction ................................................................................................................................ 3

2.

Clinical Definitions and Laboratory Diagnosis ............................................................................ 3

3.

When to Send a Sample for C. difficile Toxin Testing ................................................................ 3

4.

Management and Treatment of C. difficile Infection (CDI) .......................................................... 4

5.

Infection Control Precautions ..................................................................................................... 5

6.

Environmental and Equipment Cleaning .................................................................................... 6

7.

Transfer of C. difficile Positive Patients....................................................................................... 6

8.

Advice for Visitors ...................................................................................................................... 6

9.

C. difficile Outbreaks ................................................................................................................. 7

10.

Death Certification ..................................................................................................................... 7

11. Risk Management / Liability / Monitoring & Audit ............................................................................. 7 Appendix A – Outbreak Management

8

Appendix B – Audit Tool - ...................................................................................................................... 9 Appendix C – Copy of Care Bundle for C. difficile -

10

Appendix D – Treatment Guidelines ..................................................................................................... 13

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DN226 Clostridium difficile (C. diff) - Procedure

1.

Introduction

Clostridium difficile (C. difficile) is a common pathogen in older people with an asymptomatic carriage rate between 2-20%. The spectrum of C. difficile associated disease (CDAD) ranges from asymptomatic carrier status through clinical diarrhoea to fulminant colitis and toxic megacolon. Antibiotics have commonly been associated with CDAD but are not the only risk factor. Other associations include exposure to antineoplastic agents, gut motility altering drugs, surgery and chronic illnesses. The ability of C. difficile to produce spores enables the organism to survive in the environment. Faecal-oral transmission allows colonisation of the gastro-intestinal tract. Disruption to the host’s normal bowel flora allows C. difficile to multiply in the colon. Toxins are produced which, on binding to target cells in the colon, cause damage to these cells resulting in inflammation and mucosal injury. Prevention relies on reducing exposure to risk factors so as to limit disruption of host bowel flora. Infection control measures are important in limiting spread. CDAD is of great clinical importance as a cause of hospital acquired diarrhoea and is undergoing an apparent change in epidemiology and disease patterns. A recent United Kingdom outbreak involving C. difficile serotype 027 was investigated by the Healthcare Commission. Serotype 027 is associated with a higher morbidity and mortality where strict infection control practices are paramount in limiting spread. The Department of Health / Health Protection Agency guidance recommends that doctors consider C. difficile infection (CDI) as a diagnosis in its own right, grading each confirmed case for severity, treating accordingly and reviewing each patient daily, monitoring bowel function using the Bristol Stool Form Scale. 2.

Clinical Definitions

C. difficile case: one episode of diarrhoea (Bristol Stool Form Scale 5-7) that is not attributable to any other cause, with a positive toxin assay. A period of increased incidence: two or more cases in a 28 day period on a ward area. C. difficile outbreak: 2 or more cases caused by the same strain related in time and place. 3.

When to Send a Sample for C. difficile Toxin Testing

Commence a chart for the Management of patients with loose stools in the patient’s notes (ND28 immediately after a new episode of diarrhoea (Bristol Stool Form Scale 5-7).  Send a sample of faeces for C. difficile testing as soon as infective diarrhoea is suspected, for example if the patient has raised White Blood Cell Count (WCC), raised CRP,raised serum creatinine, or abdominal pain or distension.  The sample should also be requested for routine culture and norovirus testing where appropriate.  To request testing for C.difficile the C.difficile box on the form must be ticked/requested appropriately on Ordercomms, otherwise the sample will not be tested. Attach all generated Ordercomms stickers for the sample to the container. The sample must be requested as urgent.  Sending the sample to the lab In hours, send the sample to the Papworth Laboratory & ring the Lab Reception on Ex 4321 to inform them that the urgent sample is coming.  Out of hours, contact Addenbrookes switchboard and ask to be put in contact with the on call Microbiology Biomedical scientist, to inform them that the sample is coming and it needs to processed as urgent. The sample will need to be taxied over DN226 Clostridium difficile - Procedure Page 3 of 16 Version: 5.1 Review due: April 2017 

DN226 Clostridium difficile (C. diff) - Procedure to the Addenbrookes lab. Taxi to be arranged by the ward sending the sample, with input from Senior Nurse or Matron on duty. Do not send a sample after the first episode if there are other potential causes of diarrhoea including recent laxatives AND there are no other signs of CDI such as abdominal pain, abdominal distension or high WCC. The suspected cause for the diarrhoea, if not thought to be infective, must be documented on the front of the chart If CDI without diarrhoea (toxic megacolon, pseudomembranous colitis) is suspected, other diagnostic methods such as colonoscopy or abdominal CT (computed tomography) may be required. If after referring to the Management of patients with loose stools flow chart, you are still unsure of whether to send a sample please contact the Infection Prevention and Control Team (IPCT).

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Laboratory Testing   

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Testing for C. difficile toxin is available 7 days per week. The laboratory will communicate positive results to the ward as they become available. There is no need to re-test for C. difficile toxin once in receipt of a positive result. There is no need to test for ‘clearance’, as C.difficile toxin can remain in the gut for many months. The patient will be deemed no longer infectious based upon clinical presentation, i.e. Type 1-4 stool for 72 hours. If further testing is required, then please discuss with microbiology.

Actions on receipt of positive C. diff result The result will be telephone immediately by the microbiologist to the patient’s clinical team, so that clinical management can be discussed. This includes out of hours and bank holidays. If clinical advice is required then the clinical microbiologist should be contacted including out of hours. The Infection Prevention & Control nursing team will inform the ward staff by telephone as soon as the result is available, during normal working hours (Mon-Fri), so that treatment and control measures are instituted promptly. The Infection Prevention Nurse will visit the patient within 24 hours of the result becoming available (during normal working hours, Mon- Fri) to explain the organism and offer advice and reassurance. High Impact 7 for C. diff should be completed for 20 observations (see Appendix D) and the C. diff care bundle (Appendix E) should be commenced and continued until the patient is discharged or no longer isolated.

4.

Management and Treatment of C. difficile Infection (CDI)

SIGHT Doctors and Nurses should apply the following mnemonic protocol when managing suspected potentially infectious diarrhoea: S Suspect that a case may be infective where there is no clear alternative cause for diarrhoea. DN226 Clostridium difficile - Procedure Version: 5.1 Review due: April 2017

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DN226 Clostridium difficile (C. diff) - Procedure I Isolate (if unable to do this within 2 hours escalate the problem and consult with the Infection Control Team. G Gloves and aprons must be used for all contacts with the patient and their environment. H Hand washing with soap and water should be carried out before and after each contact with the patient and the patient’s environment. T Test the stool for toxin, by sending a specimen immediately, if clinically indicated. Clinical management of the patient with CDI       

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Commence C. difficile integrated care bundle (see appendix A). Monitor and record daily for frequency and severity of diarrhoea using the Bristol Stool Scale. Review and stop any unnecessary antibiotics. Stop any laxative treatment. Review the use of Proton Pump Inhibitors with a view to stop or reduce the dose as clinically indicated. Manage patients with CDI as a diagnosis in its own right. Each patient to be reviewed by the medical team on a daily basis regarding fluid resuscitation, electrolyte replacement, abdominal signs, nutrition and severity of disease and findings to be recorded in the medical record. The IPCT will review all patients with CDI at least weekly and liaise with the clinical team accordingly. Consider use of faecal management system - risk assess in consultation with Infection Prevention and Control nurse. Refer to Appendix B for treatment of CDI.

Information for Staff and patients An information leaflet on C. difficile is available to staff and patients on the intranet and must be given to all patients who are diagnosed as C. difficile positive. 5.

Infection Control Precautions

See separate procedure DN611 for patients on ICU and PCU 

All patients with type 5-7 stools should be moved into a single room with clinical hand wash facilities and a self contained toilet within two hours of the second episode and enteric precautions observed. If a single room is not immediately available refer to Trust Procedure Isolation room: Priority for use DN317 and then this should be recorded by the nurse in charge and fed back to the Infection Prevention and Control Team. Until a room becomes available, the patient should be nursed in the bay using strict enteric precautions. The reason for the delay must be documented in the clinical notes.

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The Green isolation sign (enteric precautions) should be placed on the door to the single room. The isolation room door must remain closed unless an appropriate reason is documented by the nursing/medical team in the clinical notes. Where possible an alternative solution should always be sought to prevent the door from remaining open.

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Patients should have their own toilet or dedicated commode.

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Dedicated equipment should be used in the room i.e. blood pressure cuffs, stethoscopes, drip stands and not shared with other patients without thorough cleaning and disinfection. DN226 Clostridium difficile - Procedure Page 5 of 16 Version: 5.1 Review due: April 2017

DN226 Clostridium difficile (C. diff) - Procedure

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Bed sheets and nightwear should be changed when soiled and at least daily and treated as infected linen.

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All staff entering an isolation room containing a patient with type 5-7 stools as defined by the Bristol Stool Scale, should wear disposable aprons and gloves when entering the room.

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Personal protective equipment should be removed prior to leaving the room and treated as clinical waste.

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Hands should be washed with soap and water after removal of PPE and again after exiting the room. Please note: Alcohol hand gel is ineffective in destroying Clostridial spores and must not be used when caring for patient with C. difficile

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Fans should not be used within the room.

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All waste/linen to be treated as infected waste and removed and disposed of in a timely manner. Refer to DN375 Waste Management Policy.

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The patient should remain isolated in the side room until they have been asymptomatic for 72 hours and passed type 1-4 stool in accordance with the Bristol Stool Scale.

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The patient’s room must then be terminally cleaned once type 1-4 stool for 72 hours has been recorded, if they are to remain in the same single room (Refer to the Trust Cleaning & Disinfection procedure DN11/ Isolation ProcedureDN89).

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In the event of a relapse or recurrence of C. difficile disease then the patient should again be isolated in a single room. There is no need to send further stool samples.

6.

Environmental and Equipment Cleaning

Refer to Trust Cleaning and Disinfection Procedure DN11/ Isolation Procedure DN89. 7. 

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8.

Transfer/Discharge of C. difficile Positive Patients Avoid transfer of infected patients to other wards/departments unless required for clinical need and only after discussion with the receiving area, these patients should be moved to the end of the list wherever possible and safe to do so. For transfer to other wards and healthcare providers the receiving area should be notified of the patient’s CDI status in advance of the transfer. Please refer to the Discharge and Transfer procedure DN96. When discharging a patient who has been positive for C.difficile on the current admission, ensure that it is clearly documented on the patient’s discharge letter. This will aid the GP for ongoing care of the patient including the prescription of antibiotics in the future. Advice for Visitors

All visitors entering an isolation room containing a CDI patient should use disposable gloves and aprons for all clinical contact with the patient and the patient’s environment. Visitors must be advised to wash their hands with soap and water on entering and leaving the room. DN226 Clostridium difficile - Procedure Page 6 of 16 Version: 5.1 Review due: April 2017

DN226 Clostridium difficile (C. diff) - Procedure

9.

C. difficile Outbreaks

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Where two or more hospital acquired cases (i.e. who develop symptoms more than 48 hours after admission) are linked by time and location (over and above the usual background rate) the infection control team will investigate a potential outbreak. Samples from affected patients will typed by the laboratory. An outbreak committee will be set up as outlined in Appendix C. A decision to open a dedicated isolation ward will be made by the outbreak committee in the event that numbers of affected patients exceeds the number of side rooms available In the event of a confirmed or suspected C. difficile outbreak, then it may be necessary to cohort* patients in a bay with isolation nursing procedures. *cohort is when several patients with the same disease are isolated together by a team of nurses who do not care for other patients on the ward. A C. difficile outbreak will be confirmed if 2 or more cases caused by the same strain are related in time and place. A C. difficile outbreak must be reported as a Serious Incident (SI) In the event of a confirmed outbreak, the outbreak committee will communicate to the Trust board, Health Protection Agency and the Strategic Health Authority.

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10. Death Certification If C difficile is entered on a Death Certificate in Part 1 (i.e. if CDI was part of the sequence of events leading directly to death or was the underlying cause of death) then the certificate must be completed by the patient’s Consultant and the death must be reported as a Serious Incident (SI). If a doctor is in doubt about the circumstances of death when writing the certificate, they should consult with the Infection Control Doctor or Consultant Microbiologist. 11.

Risk Management / Liability / Monitoring & Audit

Please refer to the monitoring table in DN15 which shows the mechanism for monitoring the controls assurance framework in place for infection prevention and control at Papworth Hospital. The Infection Prevention & Control Committee is responsible for developing measurement tools, reviewing/monitoring practice and instituting action plans as necessary. A monthly surveillance of patients requiring isolation will be undertaken by the Infection Prevention & Control nurses to ensure that the appropriate control measures are taken. For guidance on the priority use of side rooms refer to DN317. A root cause analysis will be carried out by the infection prevention and control team in conjunction with the clinical team for all cases of CDI. The root cause analysis is then reported to the consultant in charge of the patient and to the infection prevention and control committee. An audit of compliance against High Impact Intervention 7 will be completed by staff in the affected ward with support from the Link Practitioner for that ward and the Infection Prevention & Control Team. This will ensure that the appropriate control measures are taken for all cases of CDI. See appendix D.

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DN226 Clostridium difficile (C. diff) - Procedure

F I R S T P H A S E

Appendix A – Outbreak Management

C. difficile Outbreak Suspected Nurse in charge to contact the Infection Control Nurse (bleep 186) or Senior Nurse (out of hours). They will discuss the problem with the Microbiologist. Senior Nurse (out of hours) will inform the On call General Manager.

WARD CLOSED TO ADMISSIONS, TRANSFER OF PATIENTS TO OTHER WARDS, HOSPITALS AND NURSING HOMES. PATIENTS CAN BE DISCHARGED HOME.

Responsibilities S E C O N D P H A S E

Nurse in Charge: Inform: ■ Other patients ■ Relatives/visitors ■ Senior Nurse Implement Guidelines

Infection Control Nurse or Nurse Manager (out of hours):

Microbiologist: ■

■ ■

Inform Domestic supervisor Put up outbreak posters

Next normal working day: ■ E-mail All Users regarding ward closure ■ Inform: Senior Nurse: difficile Inform:- Procedure■ Health Protection Unit DN226 Clostridium ■ Medical staffdue: April 2017 ■ Hotel Services Manager Version: 5.1 Review ■ PALS ■ Bed Manager On confirmation of the outbreak ■ Directorate  Report the outbreak as Manager(s) a serious incident (liaise ■ NHS Professionals /

Consider need for outbreak meeting ■ Arrange for samples to be saved for sending to the Ref Lab. ■ DIPC DIPC: Inform: ■ Chief ExecutivePage 8 of 16 ■ Medical Director ■ Risk Manager ■ Director of Operations

DN226 Clostridium difficile - Procedure

Appendix B – Audit Tool Clostridium difficile review tool (Saving Lives High Impact Intervention No. 7) Aim: To reduce the risk of infection from and the presence of Clostridium difficile Regular Observations

Care bundle to reduce the risk from Clostridium difficile: Prevention of spread - Review tool Elements

Observation

Prudent antibiotic prescribing

Correct hand hygiene

Environmental Decontamination

Personal Protective Equipment

Isolation/Cohort Nursing

Are all elements compliant? (fills in automatically)

1 2 3 4 5 6 7 8 9 10

How to use this review tool Indicate ‘YES’ when the element was performed or considered not applicable and ‘NO’ to show that it was not performed. • The tool is designed to facilitate rapid feedback for improvement and should be repeated at regular intervals to gauge progress • The objective is to ensure that all elements of the clinical process are performed all of the time • The percentage compliance gives an indication of which particular element needs attention DN226 Clostridium difficile - Procedure Version: 5.1 Review due: April 2017

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DN226 Clostridium difficile - Procedure

Appendix C Name: Date of birth: Hospital number: NHS number: Consultant:

CLOSTRIDIUM DIFFICILE (C. DIFF) Care Bundle

ENSURE NAME, DESIGNATION, SIGNATURE, INITIALS AND DATE ARE DOCUMENTED ON THE MAIN DOCUMENTATION FOR THE PATIENT AND INITIAL UNDER DATE/TIME COLUMN EACH TIME TASK IS COMPLETED. Ward: IMMEDIATE ACTION DAY 1

ACTION Date of onset of suspected infective diarrhoea Date toxin positive stool specimen result received Date/time patient isolated into single room, enteric sign (within 2 hours of second episode of diarrhoea as per DN226) Medical team informed and treatment algorithm started (see below) Patient/relatives informed and information leaflet given Stop laxatives Stop anti-motility agents Inform domestic manager Inform antibiotic pharmacist Inform dietician

DATE/TIME

CLOSTRIDIUM DIFFICILE (C. DIFF) Care Bundle

Name: Date of birth: Hospital number: NHS number: Consultant:

Ward: DN226 Clostridium difficile - Procedure Version: 5.1 Review due: April 2017

INITIALS

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DN226 Clostridium difficile - Procedure

Date (DD/MM/YY) Time – use 24 hour clock Hand hygiene: every patient care episode with soap and water only Personal protective equipment: every patient care episode Stool chart: Ensure stool chart completed Isolation: Ensure enteric precautions sign in place and door closed Environmental cleaning: Performed with chlorine-based product or sporicidal wipes if clinically indicated Prudent prescribing: Ensure antibiotics and (PPIs) are regularly reviewed Medical team review: Ensure carried out daily CLOSTRIDIUM DIFFICILE (C. DIFF) Care Bundle

Name: Date of birth: Hospital number: NHS number: Consultant:

Ward DN226 Clostridium difficile - Procedure Version: 5.1 Review due: April 2017

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DN226 Clostridium difficile - Procedure

Variance code RA MC SC SR

Date and time

Descriptor If an episode of care occurs which is not covered in the care bundle, details must be documented in the medical notes. Patient has mental capacity but has refused assessment and/or will not comply with agreed plan of care Patient does not have mental capacity to comply Carers not implementing plan Unable to isolate within timescale – single room not available

Record element

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Code

Reason for not delivering care

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Initials

DN226 Clostridium difficile - Procedure

Appendix D Figure 1 - Treatment Algorithm for primary treatment regimens (adapted from C. difficile: How to deal with the problem. DH 2008)

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DN226 Clostridium difficile - Procedure

Figure 2 - Treatment algorithm for recurrent CDI

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Further document information Approved by Executive Director/local committee (required for all documents): Approval date (this version): Approved by Board of Directors or Committee of the Board (required for Strategies and Policies only): Date: This document supports: standards and legislation – include exact details of any CQC & NHSLA standards supported

Infection Prevention and Control Committee Minor amendments by Chair’s Action 02/2012 04/2014 N/A

N/A 2009 DH, HPA. C. difficile Infection: How to deal with the problem 2008 Department of Health. (2008) The Health and Social Care Act: Code of Practice for the prevention and control of healthcare associated infection. 2010 DH “Saving Lives” High Impact Intervention No.7 2007 HCC Stoke Mandeville Report 2009 Care Quality Commission Core Standard C4(a) Updated guidance on the management and treatment of Clostridium difficile infection. Public Health England 2013. http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1317138914904

Key related documents:

Isolation Procedure DN89 Personal Protective Equipment DN441 Cleaning and Disinfection DN 11 Transfer and Discharge Procedure DN96 Isolation room: Priority for use DN317 Management of Inpatient with Loose Stool ND28

Equality Impact Assessment: Does this document impact on any of the following groups? If YES, state positive or negative, complete Equality Impact Assessment form from DN507 Single Equality Scheme, and attach. Groups: Disability Race Gender Age Sexual Religious & Other orientation belief Yes/No: No No No No No No No DN226 Clostridium difficile - Procedure Version: 5.1 Review due: April 2017

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Positive/ N/A N/A N/A N/A N/A N/A N/A Negative: Counter Fraud In creating/revising this document, the contributors have considered and minimised any risks which might arise from it of fraud, theft, corruption or other illegal acts, and ensured that the document is robust enough to withstand evidential scrutiny in the event of a criminal investigation. Where appropriate, they have sought advice from the Trust’s Local Counter Fraud Specialist (LCFS).

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