Clostridium difficile Infection (CDI)
Severe Case Investigation Tool & Guidance Framework
Note:

Updated since the previous version: Severe Case definition (See section 1.3 of this document) changed to align with
revised version of The Guidance on the Prevention and Control of CDI (published by HPS, Sept. 2009)
http://www.documents.hps.scot.nhs.uk/about-hps/hpn/clostridium-difficile-infection-guidelines.pdf
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Please note that in line with the revised guidance the term CDI replaces the term CDAD.
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This Severe Case Investigation Tool should be used for every patient who develops severe CDI to assess their care in relation to
CDI and as a consequence, if necessary, change systems to reduce risk for other patients.
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The Infection Prevention & Control Team should set CDI Triggers for action for clinical areas.

The HPS CDI Trigger Tool should be used whenever a CDI Trigger is breached to assess if infection control systems are
effective (including antimicrobial prescribing, isolation etc).
Final version January 2010
Contents
Section 1: CDI Introduction and context
1.1
Introduction
1.2
Purpose of Guidance Framework and Investigation Tool
1.3
Definition of a Severe Case of CDI
1.4
General Principals for the Investigation of Severe CDI Cases
1.5
Monitoring and Review of Severe CDI events
1.6
Quality Improvement and Associated Actions
Section 2: CDI Severe Investigation Tool
Part 1:
Assessment of the individual patient care
Part 2:
System Assessment
Appendix 1
CDI Severe Case Investigation Tool Flowchart: When to use it and what to do
This flowchart can be used for display as a quick-reference guide for when and how to use the tool
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Final version January 2010
Section 1
CDI Introduction and Context
1.1
Introduction
Healthcare can present a serious risk to patient safety, particularly when it results in healthcare associated infections (HAIs).
Every patient needs to be confident that the care and treatment they receive is safe and meets the highest standard
possible. Patients also need to be assured that serious infections associated with healthcare are thoroughly investigated
and, where necessary, systems and processes improved including lessons shared and learnt
To ensure optimal patient safety it is highly recommended that the framework and investigation tool are integrated and
embedded into the NHS Boards clinical governance and risk management processes, systems and structure i.e. the tool
should be included in the Adverse Incidents and Escalation Policy.
Clinical Team Responsibility
Each NHS Board should determine locally how they will ensure that all the patients who meet the severe disease
definition (as defined in section 1.3) are identified, and that this identification system is robust. Each NHS Board will identify
the trigger as to how the framework and tool will be used if a patient has been identified as meeting the definition.
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Final version January 2010
1.2
Purpose of Guidance Framework and Investigation Tool
The purpose of the Investigation tool and guidance framework is to support the investigation of a severe case or cases of
Clostridium difficile Infection (CDI) cases(s) in order to:
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1.3
Identify if the patient’s care was the best possible
identify if the patient’s clinical care and overall management was optimum
Identify if any improvements can be made
Make it safer for all patients
Determine what can be improved to reduce the risk of future patients developing severe CDI infection and
subsequent more severe disease
Definition of a severe case of CDI
A case of severe CDI should always be considered a significant clinical incident for any clinical team and merit
detailed investigation in order to improve, review systems and processes. A severe case of CDI is defined as any
patient with CDI who:
o Has, or had, two or more severity markers, i.e. temperature >38.5°C, WBC > 15 cells/mm3, creatinine > 1.5 x
baseline, suspicion of PMC, toxic megacolon, ileus, or CT evidence of severe disease.
o Has died within 30 days following a diagnosis of CDI where it is recorded as either the primary or a contributory
factor on the death certificate.
o Has persisting CDI where the patient has remained symptomatic and toxin positive despite 2 courses of
appropriate therapy.
1.4
General principles for the investigation of severe CDI cases
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All patients with CDI require monitoring for possible development of severe CDI. To ensure that all cases of severe
CDI are identified and investigated, CDI care plans and integrated care pathways should enable the clinical team to
identify the need for use of this investigation tool (section 2).
All CDI cases and potential risks should be reported and graded in accordance with the organisation’s risk matrix.
All CDI cases should have a level of investigation that is commensurate with the significance of the event, or the
potential significance of a near miss.
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Final version January 2010
1.5
1.6
Monitoring and Review of Severe CDI events

Without regular and sustained monitoring and review of CDI event/case/episode reports, the benefits of such
reporting cannot be realised. Each NHS board should have an established broad framework, by which events can
be investigated, monitored, trends identified and the effect of events minimised and learned from.

NHS boards should ensure there is a process and structure in place to monitor and review individual CDI events
and trends. The process and structure should be clearly identified within the NHS Boards Risk
Management/Clinical Governance Strategy
Quality Improvement and Associated Actions
If there are clear recommendations for actions in response to quality issues identified these should be formalised in
the NHS Board action plan. It is vital that actions are monitored via local Clinical Governance structures to ensure
sharing of any lessons learned and system changes. It is also important to ensure the identification of any emerging
trends.
The action plan should also consider who in the wider health community could benefit from knowing the
lessons learned. Suggestions for wider dissemination of the lessons could include Health Protection
Scotland and other national NHS agencies, professional organisations and Higher Education facilities.
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Final version January 2010
Section 2
CDI Severe Case Investigation Tool
The tool is divided into two parts:
Part 1: Assessment of the individual patient care
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The initial review and action must be completed by the clinical team.
The clinical team must review the care that was provided to the patient and consider whether everything that
could be done, was done, to recognise any fundamental patient risk, to prevent the patient becoming
predisposed to CDI,
Part 2: The System Assessment – Part 2 should only be completed if the HPS CDI Trigger Tool is NOT in operation
Examples of those identified individuals responsible for the assessment and completion of this documentation include the:
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Infection prevention control team
Representation from the clinical team responsible for the patient’s care
Antimicrobial team
Designated risk manager
Lead clinical nurse to assist in the process
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Final version January 2010
Part 1
Assessment of the individual patient care
! Please refer to section 1.3 above for a definition of a severe case of CDI
Patient name
Chi. No
Date admitted
Reason for admission
Source of admission
Outcome (i.e. date
discharged, transferred, died
etc)
Did this patient have significant co-
Date diarrhoea developed
morbidities on admission?
Was the patient’s Waterlow score >20
Number of admissions in the
on admission (if calculated)
past 3 months
Date CDI diagnosed
Date review
Review team (state name and
profession)
Signature(s)
On completion of the tool the multi-disciplinary teams should discuss and agree the timetable for any actions to optimise the care of patients in the ward.
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Final version January 2010
(1) Predisposition and the patient’s intrinsic risk to CDI
Question
Yes/No
Review suggestions
If “no” give brief notes as to why
How will you improve care
in the future?
During this admission did the patient
e.g. surgical site infection,
develop an HAI other than CDI?
catheter associated urinary
tract infection, infected
pressure ulcer
Were there any identifiable factors
e.g. invasive devices left in situ
that contributed to the development
too long
of this infection(s)?
>>>>>>//
Continued on next page
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Final version January 2010
(1) Predisposition and the patient’s intrinsic risk to CDI
Question
Yes/No
Review suggestions
If “no” give brief notes as to
How will you improve care in the
future?
why
Antibiotics:
If antibiotics were used in the 12
Compare policy with the
weeks before the patient developed
patient’s prescriptions
CDI, were they used in line with the
local policy?
Was the reason for antibiotic use
documented?
Was antibiotic use reviewed
(frequency, duration, dose and type
of antibiotic)?
Were reasons for any variances
from the local policy documented in
the patient’s notes?
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Final version January 2010
(1) Predisposition and the patient’s intrinsic risk to CDI
Question
Yes/No
Review suggestions
If “no” give brief notes as to
How will you improve care in the
future?
why
Was it possible to have avoided
high-risk antimicrobial agents (3rd
generation cephalosporins broad
spectrum penicillins, clindamycin
and fluoroquinolones)?
Was there any documented
e.g. uncontrolled
evidence of exposure to C. difficile?
exposure to faeces,
exposure to other patients
with CDI
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Final version January 2010
(2) Was everything done to identify that the patient had CDI at the earliest opportunity?
Question
Yes/No
Review suggestions
If “no” give brief notes as to
How will you improve care in
the future?
why
Was a stool specimen obtained as
Compare time of onset of
soon as the first onset of symptoms
symptoms to time specimen
and/or admission of patient with
sent
diarrhoea?(after one or two loose
stools)
Did the ward receive a prompt result
from the laboratory
lll
Review time form specimen
in lab to information being
received on the ward that
the patient was positive
Was there any delay in implementing
Review time from
measures (SICPs and antimicrobial
information being received
review) as a result of a positive report
on the ward that the patient
from the laboratory
was positive to active
interventions being applied
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Final version January 2010
(3) Once CDI was diagnosed, was everything done to optimise the care of the patient and reduce the risk of complications?
Question
Yes/No
Review suggestions
If “no” give brief notes as
How will you improve care in
the future?
to why
Once the patient was diagnosed with
CDI:
Was any non-Clostridium difficile
Review any action
antimicrobial treatment stopped (if
documented in the patient’s
possible)?
notes
Was medication that could worsen CDI
Review patient’s drug kardex
reviewed and (if possible) stopped, e.g.
anti-motility agents such as Loperamide?
Was the patient assessed for the
Disease severity and therapy
following CDI severity markers: how
should be documented in the
often?
patient’s notes
a) temperature >38.5C
b) colonic dilation
Daily assessment and stool
chart completed
c) pseudomembranous colitis
d) toxic megacolon
e) ileus
f) WCC >15X106cells/l
g) Creatinine >1.5 X baseline
h) albumin <2.5mg/dl –
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Final version January 2010
(3) Once CDI was diagnosed, was everything done to optimise the care of the patient and reduce the risk of complications?
Question
Yes/No
Review suggestions
If “no” give brief notes as
How will you improve care in
the future?
to why
If the patient initially had mild to
Review patient’s drug kardex
moderate disease were they treated (as
per national guidance) with oral
metronidazole 400mg or 500mg t.d.s. for
10-14 days?
Was the patient’s hydration needs
Review fluid charts, U&Es,
assessed and corrected as appropriate?
clinical assessment
Was there a daily assessment of the
Daily assessment to include
patient’s CDI condition?
from date of diagnosis until
date asymptomatic and
stable
If after day 5 there was no clinical
Vancomycin may be
improvement, was metronidazole
prescribed first if the patient’s
switched to vancomycin 125 mg q.d.s. for
disease is initially diagnosed
a further 10-14 days?
as severe
5 day review documented in
the patients’ notes
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Final version January 2010
(3) Once CDI was diagnosed, was everything done to optimise the care of the patient and reduce the risk of complications?
Question
Yes/No
Review suggestions
If “no” give brief notes as
How will you improve care in
the future?
to why
Were consultations requested from
Consider time to seeking
surgery, gastroenterology and
referral and, time to referral
microbiology depts.?
taking place
If ileus was detected was 500mg
metronidazole IV t.d.s. added to the
regimen until the ileus resolved.
Was all monitoring continued until the
Review patient’s notes
patient was symptom free for 48hours?
If the patient re-developed symptoms
Bowels monitored for
after 48hours symptom free, were
duration of admission?
precautions reintroduced promptly?
If the patient developed recurrent disease
Review patient’s drug kardex
(from third and subsequent episodes),
was the treatment regimen as per the
national guidance?
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Final version January 2010
Part 2
Systems Assessment
This part of the assessment should be completed by the Infection Control Team and the Lead Clinical Nurse
How many patients on average develop CDI on this ward in a
year?
How many patients were in the ward with CDI when this patient
developed symptoms?
Number of single rooms on the ward with en suite facilities?
Is there sufficient equipment to allow patients with CDI to have
dedicated personal equipment? (e.g. commodes)
What process data are available?
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Data on adherence to SOPs, policies and national cleaning
services standards
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Data on hand hygiene
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Data on cleanliness of equipment
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Data on antibiotic stewardship
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Data on failures to isolate CDAD patients
Were there any other atypical factors present around the time that
patient became ill that could have contributed to the patient developing
CDI or severe CDI disease e.g. was there a cluster of cases at the
same time?
Were the staffing levels reviewed to reflect the patient need?
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Final version January 2010
Summary
Summary
Response
Any Identified
Was everything done to
minimise the predisposition
to CDI and assess individual
patient risk? (particularly
infection control measures
and optimal antimicrobial
prescribing)
Was everything done to
ensure prompt diagnosis?
Was everything done to
optimise care once CDI was
diagnosed?
Consider the findings obtained from the systems assessment review and summarise the main findings below, highlighting any
areas where improvements can be made either regarding clinical care or the care environment.
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Final version January 2010
Action Plan
Ref Action
Resource Requirements
Status
Owner Due
Completed Date
Date
Local Actions (within area of incident)
Directorate/ Partnership Actions (those actions beyond affected area and across Directorate/ Partnership)
Board Actions (those actions to be communicated out with Directorate/ Partnership for further learning)
Reference; Guidance on Prevention and Control of Clostridium difficile Associated Disease (CDI) in Healthcare settings in Scotland
http://www.documents.hps.scot.nhs.uk/hai/sshaip/guidelines/clostridium-difficile/guidance-CDI-2008-10.pdf
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Final version January 2010
Appendix 1
! This flowchart can be used for display as a quick-reference guide for when and how to use the tool
Clostridium difficile Infection (CDI) Severe Case Investigation Tool:
WHEN TO USE IT AND WHAT TO DO
Develop a process to identify CDI
Severe Case patients
!
Once Severe Case patient (s) has
been identified, UTILISE TOOL
Undertake an investigation using
CDI Severe Case tool if identified
uUSEUUSED
Identify if the patient’s care and
overall management was optimum
Identify issues for improvement
Develop a plan to change practice
and initiate changes
Final version January 2010
!