Serious Clinical Event Investigation Toolkit
For more assistance, please contact:
Lynne Vogt, Risk & Quality Management
(519) 751-5544 ext. 2398
lvogt@bchsys.org
Foreword:
The Brant Community Healthcare System is committed to ensuring that hospital
personnel are given the opportunity to respond in the best interests of the patient,
their family and on behalf of the hospital itself.
The aim of the investigation is to identify the underlying causes of adverse patient
events and facilitate changes in the organization’s systems and processes to reduce
the probability of such an event recurring in the future.
This toolkit is a practical guide to support the members of the Incident Response Team
who are undertaking the investigation of serious clinical/adverse patient events.
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Key Tools for Investigating Serious Clinical Events
Contents of this Toolkit
Section
1. Why Investigate
2. Organizing the Investigation
3. Conducting The Investigation
3.1.
Preserving the evidence
3.2.
Data Gathering
3.3.
Interview Guidelines
3.4.
Undertaking the interview
3.5.
Closing the interview
4. Root Cause Analysis
5. Appendix A – Interview Template
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Key Tools for Investigating Serious Clinical Events
1. Why Investigate
Healthcare Systems are made up of large complex systems and multiple
processes. It sometimes appears to be straightforward to identify a particular
action or omission as the immediate cause of an incident, closer analysis usually
reveals a sequence of events that lead up to a serious clinical event.
Swiss Cheese Model
BLUNT END
Latent Failures:
Many layers of
health care that
effect the person in
direct contact with the patient
Organizational systems,
processes, structures & Culture
SHARP END
Active Failures:
Unsafe Acts Committed by
Person closest to the patient
They are generally readily apparent
(eg, pushing an incorrect button,
ignoring a warning light) and almost
always involve someone at the
frontline.
“…Active failures are like mosquitoes. They can be swatted one by one, but they still keep coming. The best
remedies are to create more effective defences and to drain the swamps in which they breed.”
Reason J. BMJ 2000; 320:768-770.
Only when a thorough investigation of the organization’s systems, processes, structures and
culture together with the examination of the actions at the time of the event occurs can we
hope to reduce the probability of such an event recurring.
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Key Tools for Investigating Serious Clinical Events
2. Organizing the Investigation
Adverse events are multifaceted, with many complexities and therefore the
investigation needs good planning to be effective.
Investigations take time and taking shortcuts may mean missing a critical piece
of information.
Before beginning any investigation all members of the Incident Response Team
must be familiar with the Incident Response Team algorithm (P&P X- 121 Serious
Clinical Events Appendix B)
The investigation plan should set out the steps in the investigation, the roles of
each of the team members and the associated timelines.
Outline of investigation plan:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Preserve the evidence
Frame the problem – establish the circumstances as they initially appear
Decide which part(s) of the process of care requires investigation
Prepare an outline chronology of event – as the staff member saw them
Data gathering – interviews/documentation etc
Establish chronology of event (may be different than outline)
Complete Root Cause Analysis - multidisciplinary
Prepare and present report of Risk Reduction Strategies
Implementation of Risk Reduction Strategies
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Key Tools for Investigating Serious Clinical Events
Conducting The Investigation
Preserving the evidence:
 Secure physical evidence involved in the event, including but not limited
to:
Medical Devices/Equipment
Retained foreign objects
Medications, containers, package labels or inserts
IV bags & tubing, syringes
Supply containers & packaging
Lab & pathology specimens
Any other applicable physical evidence that might be of use
 Take pictures where appropriate
 Do not tamper with, clean or otherwise modify any physical evidence
 Preserve electronic data – consult with IT
Data gathering:
 Medical Records – patient information ie. language/communication
factors, personality/social factors, care plan, complexity/co morbidities,
etc., review paper chart, EMR, PCS and eMAR for relevant or pertinent
information
 Documentation/forms related to care plan and/or the event ie protocols,
P&P’s, minutes from appropriate committees ie product evaluation if
relevant
 Immediate statements/observations
 Interviews –staff/physicians/other witnesses ie family members and
other stakeholders
Interviews
Guidelines:
 Purpose of interviews is to simply find out what happened
 Arrange for interview to be held in as private and relaxed setting as
possible, away from the immediate work area
 Set time/date for interview as soon as possible and communicate to staff
 Provide the Staff member with the Serious Clinical Event P&P X-121
 If the staff member wishes someone else to be present this should be
permitted – stress this is not a disciplinary process
 Allow time to ask questions as well as answer any the staff member may
have – approx 45 mins
Undertaking the Interviews:
 Perform Introductions & open the interview by thanking the staff for
meeting with you
 Explain the purpose of the interview (fact finding only) and what will be
happening in the interview
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Key Tools for Investigating Serious Clinical Events
 Establish the role of the staff member in the event – record the limits of
their involvement
 Establish the chronology of the event according to staff recollection &
record
 Focusing on the most important or pertinent part of the chronology ask the
staff member to provide more detailed information as required ie clarify
processes that may be unit specific vs organizational policy
Closing the Interview:
 Thank the staff and let them know the next steps ie Root Cause Analysis
 Ask staff if they have any other comments or questions to ask
 Remind staff of supports available ie EAP program and how to access
 Provide staff with your contact information in case further details of the
event are recalled later
Communication:
 Provide Manager(s) and Director(s) with an update and let them know the
next steps ie Root Cause Analysis.
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Key Tools for Investigating Serious Clinical Events
Root Cause Analysis
Root Cause Analysis is an intensive assessment conducted to prevent recurrence
of an event by identifying the reason(s) underlying an undesirable condition or
problem in the system. The analysis focuses on systems and processes not
individual performance.
The Response Team will assist in the facilitation of a root cause analysis for all
Serious Clinical Events. Staff, physicians and/or volunteers who are identified by
the Response Team, as integral to the event will participate in the root cause
analysis process.
A valid tool adapted from The Joint Commission will be used in all root cause
analysis (Appendix C: Serious Clinical Events P&P X-121)
The Response Team will document the findings on the above tool and will identify
Risk Reduction Strategies.
The initial meeting of the Root Cause Analysis participants will occur within seven
(7) working days following any Serious Clinical Event.
Risk Reduction strategies developed by the team as a result of the Root Cause
Analysis findings will be circulated to the team members (includes
Manager/Director) for review.
Final risk reduction strategies are then presented to the Operations Team, Senior
Leadership Team and the Quality Committee of the Board.
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Key Tools for Investigating Serious Clinical Events
Appendix A – Interview Template
Risk Pro #
Interview
Date:
Location of Interview:
Interviewer:
Name of Person being interviewed:
Overview of Event:
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Key Tools for Investigating Serious Clinical Events
Statement of Interviewee
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Key Tools for Investigating Serious Clinical Events
Appendix A – Interview Template
Page 2
Witness Statement:
Other Relevant Facts:
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Key Tools for Investigating Serious Clinical Events
References:
 Hicks Morley: How To Conduct An Effective Investigation 2009
 Association of Litigation and Risk Managers (ALARM): Protocol For The
Investigation And Analysis of Clinical Incidents 1999
 Reason’s Adapted Organizational Accident Causation Model
 Institute for Healthcare Improvement (IHI) Effective Crisis Management of
Serious Clinical Events 2010
 The Investigation and Analysis of critical incidents and adverse events in
healthcare: M. Woloshynowych, et al – Health Technology Assessment
2005; Vol.9: No.19
 Partners Healthcare; Guidelines for Responding to Serious Adverse Events
2010
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Key Tools for Investigating Serious Clinical Events