Download Management of Clostridium difficile (CDAD) Policy

Policy for the Management of Clostridium difficile
Associated Disease (CDAD) v6
IC06
Version Number:
6
Issue Date:
January 2014
Review Date:
January 2017
Sponsoring Director:
Directors of Nursing
NHS North Durham, NHS Darlington, NHS Durham
Dales, Easington and Sedgefield (DDES) Clinical
Commissioning Groups (CCGs)
Prepared By:
Lead Infection Prevention and Control Nurse
Consultation Process:
Members of Health and Social Care Health Care
Associated Infection (HCAI) Assurance Group
Document History
Version
2
3
4
Date
Nov 2006
Nov 2008
April 2009
5
6
April 2011
Jan 2014
Significant Changes
*
*
To incorporate new DoH guidance on management of
Clostridium difficile
Reviewed
*Amended treatment algorithms p. 17 and 18
POLICY VALIDATION STATEMENT
This policy is due for review on the latest date shown about.
After this date, policy and process documents may become invalid.
Policy users should ensure that they are consulting the current valid version of the
documentation.
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Equality Impact Assessment Statement
Audit Assessment
Date
Result
Risk Audit
14.01.2014
Risks identified and risk assessment included
at Appendix 8
Equality Audit
14.01.2014
No or very low potential for discrimination
Human Rights Audit
14.01.2014
No breach of Human Rights
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POLICY FOR MANAGEMENT OF CLOSTRIDIUM DIFFICILE
ASSOCIATED DISEASE (CDAD)
Contents
Section
Title
Page
1
Introduction
4
2
Definitions
4
3
Clostridium difficile Associated Disease
5
4
Duties and Responsibilities
7
5
Implementation
8
6
Training Implications
8
7
Documentation
8
8
Monitoring, Review and Archiving
9
9
Equality Impact Assessment Statement
10
1
Examples of death certification for CDI patients
14
2
Bristol Stool Form Scale
15
3
Medicines that can produce diarrhoea
16
Appendices
4/5
Treatment Algorithms
17/18
6
Clostridium difficile – Fact Sheet
19
7
Risk Assessment
24
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POLICY FOR THE MANAGEMENT OF CLOSTRIDIUM
DIFFICILE ASSOCIATED DISEASE (CDAD)
1.
Introduction
NHS North Durham, NHS Darlington and NHS DDES CCGs aspire to the
highest standard of corporate behaviour and clinical competence, to ensure
that safe, fair and equitable procedures are applied to all organizational
transactions, including relationships with patients, their carers, public, staff,
stakeholders and the use of public resources. In order to provide clear and
consistent guidance, NHS North Durham, NHS Darlington and NHS DDES
CCGs will develop documents to fulfil all statutory, organisational and best
practice requirements and support the principles of equal opportunity for all.
The aim of this policy is to provide a framework for the effective management
of patients with Clostridium difficile associated disease.
This policy is in line with national guidance from the Department of Health.
1.1
Status
This policy is an Infection Control policy.
1.2
Purpose and Scope
To ensure that patients are managed safely and effectively in order to reduce
cross infection and sustained illness.
This policy applies to all health care workers working within NHS North
Durham, NHS Darlington and NHS DDES CCGs.
ACCESSING ADVICE AND GUIDANCE – Advice and/or guidance on
infection control issues can be obtained by contacting the Infection Prevention
and Control Department between 8.30am – 5.00pm Monday to Friday.
2.
Definitions
Clostridium difficile Associated Disease – occurs when the normal bacteria of
the bowel are altered allowing Clostridium difficile to flourish and produce
toxins.
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3.
Clostridium difficile Associated Disease
3.1
Clostridium difficile are anaerobic, gram-positive, spore forming bacilli. The
spores are resistant to exposure to air, drying, and heat and can survive in the
environment.
Clostridium difficile Associated Disease (CDAD) occurs when the normal
bacteria/flora of the bowel are altered allowing Clostridium difficile to flourish
and produce toxin A and/or B.
The primary cause of CDAD is antibiotic exposure. Gastro-intestinal surgery
can also increase a person’s risk of developing the disease. A long length of
stay in healthcare settings and immuno-suppression leads to an increase in
patients who are carriers.
All age groups can be affected: however, the elderly are most at risk. Over
80% of cases are reported in the over 65 age group. Children under the age
of 2 years are not usually affected.
3.2
Clinical Features




3.3
The illness ranges from mild self-limiting diarrhoea to explosive watery and
foul smelling diarrhea.
Symptoms are often associated with antibiotic therapy.
The patient may also have fever and abdominal cramps.
Occasionally Clostridium difficile can lead to potentially fatal pseudo
membranous colitis and perforation of the bowel.
Definition of Clostridium difficile Diarrhoea
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
(Appendix 2) that is not attributable to any other cause, including medicines
(Appendix 3), 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 pseudo
membranous colitis.
Testing
Stool samples in patients 65years and over will automatically be tested.
Patients under 65years old will be on request. Testing will not be carried out in
general on children under two years of age.
Re-testing of cases will not be carried out within 28 days.
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.
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3.4
Transmission




3.5
Various studies show that 2-3% of healthy adults and up to 36% of
hospitalised patients harbour Clostridium difficile in their faecal flora.
Direct spread from patient to patient by faecal oral route.
Direct spread through the hands of healthcare workers.
Indirect spread from the patient to the environment and from the
environment to the patient.
Care of Patients at Home
3.5.1 On confirmation of a Clostridium difficile positive stool result GPs
should:






Communicate with relevant personnel involved with patient care.
Review patient’s general condition.
Stop any existing antibiotics if possible.
Ensure no laxative or anti-diarrhoeal treatment is prescribed.
Drug therapy – antibiotic as indicated depending on disease severity
shown on the Daily Scorecard (Appendix 4). If the patient’s condition does
not improve after 3 days or there is clinical deterioration contact
Consultant Microbiologist at appropriate hospital for further advice.
Metronidazole syrup is not effective in treating Clostridium difficile if the
patient is on Proton Pump Inhibitors. Treatment Algorithm can be found in
Appendices 5 and 6.
A patient card and information leaflet is available from the Infection
Prevention and Control Team (IPCT).
3.5.2 Infection Control Measures:

Encourage thorough hand washing with soap and water after personal
care by everyone involved, and by patient before meals and after using the
toilet.

Soiled clothing or bedding to be washed at the highest possible
temperature.

Clean the toilet and bathing facilities following each use using a bleachbased product.

Once the diagnosis is confirmed, no further specimens are required unless
another cause of diarrhoea is suspected.
3.5.3 Any primary cause of death resulting from Clostridium difficile must be
reported to the Area Team as an Untoward Incident
(Appendix 1).
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4.
Duties and Responsibilities including the risks
associated with not recognising or treating
Clostridium difficile Associated Disease
4.1
Accountable Officer
The Accountable Officer has overall responsibility for the strategic direction
and operational management, including ensuring that CCG process
documents comply with all legal, statutory and good practice guidance
requirements.
4.2
Director of Nursing
As the nominated director responsible for Infection Prevention and Control the
Director of Nursing has delegated responsibility for ensuring that
arrangements are in place to manage Infection Prevention and Control
including the risks from Clostridium difficile Associated Disease.
In addition the Director of Nursing is responsible for ensuring that the policy is
drafted, approved and disseminated in accordance with ‘Writing Policy
Documents’.
The necessary training and education needs and methods to implement this
document are identified and resourced. Mechanisms are in place for the
regular evaluation of the implementation and effectiveness of this document.
4.3
Lead Infection Prevention and Control Nurse
The Lead Infection Prevention and Control Nurse will:
4.4

Generate and formulate this policy, identifying appropriate processes for
regular evaluation of, and the implementation and effectiveness of, this
policy;

Notify the Policy Coordinator of any revisions to this document;

Ensure the policy is taken to members of ensure the policy is taken to
members of the Health and Social Care HCAI Group for comment;

Arrange for superseded version of this document to be retained in line with
national guidance.
All staff
All staff, including temporary and agency staff, are responsible for:

Compliance with relevant process documents. Failure to comply may
result in disciplinary action being taken;
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
Co-operating with the development and implementation of polices and
procedures as part of their normal duties and responsibilities;

Identifying the need for a change in policy or procedure as a result of
becoming aware of changes in practice, changes to statutory
requirements, revised professional or clinical standards and local/national
directives, and advising their line manager accordingly;

Identifying training needs in respect of policies and procedures and
bringing them to the attention of their line manager;

Attending training/awareness sessions when provided.
5.
Implementation
5.1
This policy will be available to all staff caring for or managing patients with
Clostridium difficile Disease.
5.2
All managers are responsible for ensuring that relevant staff within their own
departments have read and understood this document and are competent to
carry out their duties in accordance with the procedures described.
6.
Training Implications
The sponsoring director will ensure that the necessary training or education
needs and methods required to implement the policy or procedure(s) are
identified and resourced or built into the delivery planning process. This may
include identification of external training providers or development of an
internal training process.
7.
Documentation
7.1
Other relevant policies
Policy for General infection control precautions
Policy for hand hygiene
7.2
Legislation and statutory requirements
None.
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7.3
Best practice documents
Public health England Updated guidance on the management and treatment
of Clostridium difficile infection (2013)
7.4
References
Department of Health. (2005) PL/CMO/2005/6, PLCMO2005/5 Gateway No.
5954 Infection caused by Clostridium difficile. London. DH.
Department of Health and HPA (2008) Clostridium difficile infection: How
to deal with the problem. London. DH
Department of Health (2010) The Health and Social Care Act 2008 Code of
Practice on the prevention and control of infections and related guidance. DH.
London.
Department of Health. (2011) Diagnostic testing for Clostridium difficile
infection Gateway No. 15766. London. DH.
Public Health England (2013) Updated guidance on the management and
treatment of Clostridium difficile infection. London. PHE
8.
Monitoring, Review and Archiving
8.1
Monitoring
The Director of Nursing, as sponsor director, will agree with the Lead Infection
Prevention and Control Nurse a method for monitoring the dissemination and
implementation of this policy. Monitoring information will be recorded in the
policy database.
8.2
Review
8.2.1 The Director of Nursing will ensure that each policy document is reviewed in
accordance with the timescale specified at the time of approval. No policy or
procedure will remain operational for a period exceeding three years
without a review taking place.
8.2.2 Staff who become aware of changes in practice, changes to statutory
requirements, revised professional or clinical standards and local/national
directives that affect, or could potentially affect policy documents, should
advise the sponsoring director as soon as possible, via line management
arrangements. The sponsoring director will then consider the need to review
the policy or procedure outside of the agreed timescale for revision.
8.2.3 If the review results in changes to the document, then the initiator should
inform the policy manager who will renew the approval and re-issue under the
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next ‘version’ number. If, however, the review confirms that no changes are
required, the title page should be renewed indicating the date of the review
and date for the next review and the title page only should be re-issued.
8.2.4 For ease of reference for reviewers or approval bodies, changes should be
noted in the ‘document history’ table on the front page of this document.
NB If the review consists of a change to an appendix or procedure document,
approval may be given by the sponsor director and a revised document may
be issued. Review to the main body of the policy must always follow the
original approval process.
8.3
Archiving
The Policy Manager will ensure that archived copies of superseded policy
documents are retained in accordance with Records Management: NHS Code
of Practice 2008.
9.
Equality Impact Assessment Statement
The tables below summarise reviews with respect to:



Strategic and operational risks, including risks to health and safety.
Current equality and diversity legislation.
Rights under the European Convention on Human Rights.
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9.1
Risk Audit
Risk Audit for
RISK CATEGORIES
1
2
3
4
5
6
7
8
Risks relating to organisational objectives
Risks to patient experience/outcome
Risk to or from service/business interruption
Risks relating to staffing and competence
Financial risks
Risks to compliance with inspection/audit standards
General risks to organisational reputation
Specific health and safety (inc fire) risks to persons
(staff, patients, public, etc)
a
Location (access, environment, working
conditions)
b
Equipment (medical, electrical, other)
c
Hazardous substances
d
Lone working
e
Moving and handling
f
Potential to cause undue stress
g
Anti-social behaviour (violence, harassment,
theft)
Significant Risks
Identified Yes/No
Yes
Yes
No
Yes
No
Yes
Yes
No
No
No
No
No
No
OUTCOME (tick appropriate box)
ACTION
No significant risks
identified
Significant risks identified
Proceed with ratification process.
There is some doubt about
whether risks are significant
or relevant.
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
Complete a full risk assessment form and
action plan for all risks identified. Include in
the Appendices – see Appendix 8.
Take further advice from appropriate
directorate or department. If unresolved,
refer to Governance and Assurance
Committee.
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9.2
Equality Audit
Equality Audit for
QUESTION
RESPONSE
What is the purpose of the proposed policy document
(or changes to policy document)?
Management of Patients
with Clostridium difficile
Associated Disease
Correct patient
management and safety
No
Who is intended to benefit, and how?
Will the proposals involve, or have consequences for,
the people the CCGs serve and employ?
Is there any reason to believe that people could be
affected differently by the proposals, for example in
terms of access to a service, or the ability to take
advantage of proposed opportunities?
Is there any evidence that any part of the proposals
could discriminate unlawfully, directly or indirectly,
against any section of the population?
Is the proposed policy likely to affect relations between
certain groups of people, for example because it is
seen as favouring a particular group or denying
opportunities to another?
Is the proposed policy likely to damage relations
between any particular group(s) of people and the
CCG?
No
No
No
No
OUTCOME (tick appropriate box)
Potential for discrimination
is very low or non-existent
Potential for discrimination
exists
There is doubt about the
potential for discrimination
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
Proceed with ratification process.
Amend the document as appropriate to
clarify exceptions or remove potential. If this
is not possible, take further advice from
Corporate Services Manager and/or the
Equality Lead Manager (HR Department)
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9.3
Human Rights Audit
Human Rights Audit for
QUESTION
RESPONSE
Does the policy document interfere with a Convention
right?
Could the actions described in the policy document
touch on one of the Convention rights?
Is there a victim?
Are there circumstances where the right can
legitimately be limited or interfered with?
Does the interference meet the general criteria
established by the Strasbourg authorities, ie:

The action is prescribed by law

It pursues a legitimate aim.

It is necessary in a democratic society.
No
No
No
No
No
OUTCOME (tick appropriate box)
No rights affected
Potential to affect a right
has been identified
There is doubt about the
potential to affect a right.
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
Proceed with ratification process.
Amend the document as appropriate to
clarify exceptions or remove potential. If this
is not possible, take further advice from
Corporate Services Manager/Legal Advisers.
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APPENDIX 1
Examples of death certification for CDI patients
(Modified from the November 2007 version of Guidance for doctors certifying cause
of death in England and Wales, www.gro.gov.uk/medcert
If a healthcare-associated infection (HCAI) was part of the sequence leading to
death, it should be in Part 1 of the certificate, and you should include all the
conditions in the sequence of events back to the original disease being treated.
Examples:
Ia. Clostridium difficile pseudomembranous colitis
Ib. Multiple antibiotic therapy
Ic. Community-acquired pneumonia with severe sepsis
II. Immobility, polymyalgia rheumatica, osteoporosis
If your patient had an HCAI which was not part of the direct sequence, but which you
think contributed at all to their death, it should be mentioned in Part 2 of the
certificate.
Examples:
Ia. Bronchopneumonia
Ib. Carcinomatosis and renal failure
Ic. Adenocarcinoma of the prostate
II. Clostridium difficile infection secondary to antibiotic therapy for recurrent
bronchopneumonia
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APPENDIX 2
The Bristol Stool Form Scale
Type 1
Separate hard lumps, like nuts (hard to pass)
Type 2
Sausage-shaped but lumpy
Type 3
Like a sausage but with cracks on its surface
Type 4
Like a sausage or snake, smooth and soft
Type 5
Soft blobs with clear-cut edges (passed easily)
Type 6
Fluffy pieces with ragged edges, a mushy stool
Type 7
Watery, no solid pieces ENTIRELY LIQUID
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APPENDIX 3
Medicines that can produce diarrhoea
Diarrhoea is a common adverse drug reaction (ADR) with many medicines.
Antimicrobials account for about 25% of drug-induced diarrhoea though most cases
are benign (Lee, 2006).
While diarrhoea has been seen with most medicines, the ones that are most
commonly implicated are:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
acarbose
antimicrobials
biguanides
bile salts
colchicine
cytotoxics
dipyridamole
gold preparations
iron preparations
laxatives
leflunomide
magnesium preparations, eg antacids
metoclopramide
misoprostol
non-steroidal anti-inflammatory drugs (NSAIDS), eg aspirin, ibuprofen
olsalazine
orlistat
proton pump inhibitors; and
ticlopidine
Alternative diagnoses for the diarrhoea are important; therefore, careful attention
should be paid to the temporal relationship between the time that the medicine is first
taken and when the diarrhoea first appears.
Further information on adverse effects is available from local medicines information
centres or by using the ‘search by section’ facility at http://emc.medicines.org.uk/
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APPENDIX 4
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APPENDIX 5
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APPENDIX 6
CLOSTRIDIUM DIFFICILE – FACT SHEET
What is Clostridium difficile?

Clostridium difficile (C diff) are gram-positive, anaerobic, spore forming bacilli.
The spores are resistant to exposure to air, drying and heat, and can thereby
survive in the environment.

Patients may be colonised with C diff but exhibit NO clinical symptoms.

Clostridium difficile infection (CDI) generally occurs as a result of disruption of
gut flora and loss of colonisation resistance, usually following antibiotic
treatment.

CDI symptoms is due to toxins produced by C Diff which attack the gut wall. It
is this toxin which is detected in the laboratory test for C Diff.
CDI
Clinical Features






Diarrhoea ranging from mild self-limiting diarrhoea to a severe illness with
explosive, watery and foul smelling diarrhoea.
Fever.
Loss of appetite.
Nausea.
Abdominal pain/tenderness.
Symptoms are associated with antibiotic therapy.
Risk Factors
All age groups can be affected but the over 65-age group are the most at risk, and
risk increases further with:






Antibiotic exposure – most common cause of CDI.
Gastrointestinal surgery.
Length of stay in healthcare inpatient environment.
A serious underlying illness.
Immunocompromising conditions.
Most infections occur in hospitals, community hospitals and care homes but
they can also occur in primary care settings.
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How Do Patients Become Infected?

Patients usually become colonised with Clostridium difficile during a stay in a
healthcare facility, although community acquisition does occur.

Normal bowel bacteria provide protection against pathogenic organisms
including Clostridium difficile, this is known as colonisation resistance. When
a patient is exposed to antibiotics this disrupts the bowel flora which permits
Clostridium difficile to flourish. Clostridium difficile produces toxins which
damage the cells lining the intestines leading to CDI.

Cross-infection:

Faecal/oral route, either direct person to person, via healthcare
workers, or via a contaminated environment.

Large numbers of spores are excreted in liquid faeces and can survive
for long periods of time in the environment.

Contamination of the patient’s immediate general environment can
occur, including all horizontal surfaces, curtains, bedding, commodes
and equipment; toilet areas, bedpan washers and dirty utility areas.
Prevention

Appropriate prescribing within the antimicrobial formulary.

Implement measures to prevent cross infection.
Protocol for Diagnosis
All patients with unexplained diarrhoea (frequent, loose unformed stools unusual to
that patient):
.

Collect stool specimen, ensuring there is enough sample to ¼ fill the
specimen pot.

Specimens to Darlington Memorial Hospital and University Hospital of North
Durham use the microbiology form and request:

microscopy, culture and sensitivity.
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Clostridium difficile infection should be managed as a diagnosis in its own right, the
following mnemonic protocol (SIGHT) can be used when managing suspected
potentially infectious diarrhoea within an inpatient setting.
S
Suspect that a case may be infective where there is no clear alternative
cause for diarrhoea
I
Isolate the patient and consult with the infection control team (ICT)
while determining the cause of the diarrhoea
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
All healthcare workers and GPs must recognise and report to the HPA a potential
outbreak situation within a care home setting.
Any patient with a diagnosis of CDI as major cause of death appearing on part 1 of
the death certificate must be reported as a Serious Untoward Incident.
MANAGEMENT PROTOCOL
Patient No Longer Symptomatic

Do not commence antibiotic therapy and observe.
For Symptomatic Patients
Patient at Home





Communicate with relevant personnel involved with patient care. A patient
card and information leaflet is available from the IPCT.
Review patient’s general condition.
Stop any existing antibiotics if possible.
Ensure no laxative or anti-diarrhoeal treatment is prescribed
Drug therapy: Metronidazole 400mg. Eight hourly orally for 10 days, then
stop. If the patient’s condition does not improve after 3 days or there is
clinical deterioration contact Consultant Microbiologist at appropriate hospital
for further advice. Metronidazole syrup is not effective in treating CDI if the
patient is on Proton Pump Inhibitors.
If the patient requires admission to an inpatient facility ensure all relevant personnel
are made aware of the patient’s C diff result.
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Infection Control Measures





Encourage thorough hand washing with soap and water after personal care
by anyone involved, and by patient before meals and after using the toilet.
Soiled clothing or bedding to be washed at the highest possible temperature.
Clean the toilet and bathing facilities following each use using a bleach-based
product.
Healthcare workers delivering care – hand washing with soap and water,
alcohol gel cannot be relied upon to decontaminate hands in this
circumstance; gloves and aprons to be worn and disposed of with any
wipes/pads etc. as hazardous waste.
Once the diagnosis is confirmed no further specimens are required unless
another cause of diarrhoea is suspected or symptoms re-occur after 28 days.
Patient in Care Home Facility


Management as above.
The patient’s diarrhoea to be monitored preferably using the Bristol Stool
Chart.
Infection Control Measures











Immediately confine patient to a room preferably with own toilet or commode
and implement isolation procedures to prevent cross infection. It is important
to physically separate the symptomatic patient from other vulnerable residents
in order to prevent the spread of CDAD.
All visitors to be advised of any necessary precautions and encouraged not to
perform any personal care.
Hand hygiene – staff and relatives must observe strict hand washing procedures
with soap and water, before and after each patient contact and with the
immediate environment.
Residents should be encouraged to wash hands before meals and after using
the toilet.
Personal Protective Equipment – disposable gloves and aprons should be worn
for direct care of the patient. These should be removed and disposed of as
hazardous waste immediately following the episode of care, and then hand
hygiene performed.
Laundry – should be categorised as infected. Soiled clothing or bedding should
be washed according to local protocol.
Staff to check the integrity of mattress covers.
Any equipment, for example slings/hoists should be allocated to individual
residents and thoroughly cleaned before and after each use.
Environmental cleaning – must be completed daily.
Horizontal surfaces should be cleaned with detergent and water then
disinfected with 1,000 ppm hypochlorite or local alternative chlorine
based agent.
Particular attention must be paid to all contact surfaces such as tables, chairs,
door handles etc.
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



Toilet seats or commodes must be thoroughly cleaned after each use.
Commode liners preferably to be heat disinfected in a mechanical washer or
washed in a designated area with detergent and water followed by a disinfectant
and disposable cloths to be used.
If the patient requires transfer to hospital ensure all relevant personnel are
informed of patient’s C diff result.
Once the patient has been symptom free for 48 hours isolation precautions can
cease and the room to be terminally cleaned.
Following a confirmed diagnosis no further specimens are required unless
another cause of diarrhoea is suspected, or symptoms reoccur after 28 days.
NB
The IPCT will be informed of any patients diagnosed with CDI. Contact with the care
home will be made and practical support will be offered from the team including a care
pathway. A root cause analysis will then be completed.
Advice can be sought from the Infection Control Team on 03000 267 685.
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APPENDIX 7
There is a risk of non-compliance with all infection control policies which would in turn
increase the risk of patients acquiring healthcare associated infections (HCAI), the
organisation not achieving national targets on HCAI and not complying with inspection
audits.
These policies are designed to provide a framework to reduce those risks.
H:Policy Development/Infection Control v5
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