Title:
Management of Serious Clinical Events
Document Number: X-121
Section: Administrative Manual
Date Issued: May 2003
Pages: 1 of 5
Issuing Authority: Board of Directors
Date Revised: March 2010
POLICY STATEMENT:
All Serious Clinical Events will be managed, documented, appropriately communicated
and investigated promptly in a consistent and non-accusatory manner.
Quality Improvement processes such as Root Cause Analysis will be applied to identify
the underlying causes and the opportunities for improvements to the systems and
processes that will reduce the probability of such an event recurring.
DEFINITION(S):
Immediate Crisis Management:
Is the process by which the BCHS immediately responds to an event, which includes
actions within the first 24 hours of the event to: attend to the needs of the patient and
staff involved, secure the area; gather facts and notify all appropriate people. See
Appendix A
Incident Response Team: Is a rapid response team consisting of: Manager Risk &
Quality Management, Patient Safety Coordinator, the Director of Medical Affairs, and the
Patient/Client Relations Officer. This team will oversee the immediate crisis management
(including investigation) and the root cause analysis process. See Appendix B
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.
Serious Clinical Event:
Is defined as an event that results in an undesirable and unexpected patient outcome,
not related to the natural course of the patient’s underlying condition, that involves the
actual or potential loss of life, limb or function. Serious Clinical Events may also be a
series of events, which, cumulatively, have the potential to become serious. These
events are not covered by the usual emergency code procedures.
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic
format on the BCHS intranet site. Any documents appearing in paper form are NOT controlled.
X-121: Management of Serious
Clinical Events
Page 2 of 11
Examples of a Serious Clinical Event may be (but is not limited to):
 Any patient death, paralysis, coma or other major permanent loss of function
associated with an adverse drug event, adverse transfusion reaction, or medical
intervention
 Any patient death, paralysis, coma or other major permanent loss of function
associated with equipment failure or damage.
 Patient death within 72 hours of discharge, including discharge from the
Emergency Department, where death was not an expected/anticipated outcome
 Suicide or suspected suicide of a patient, including suicides following elopement.
 Any surgical procedure on the wrong patient, wrong side of the body or wrong
organ,
 Harm or potential harm resulting from the use of surgical instruments or medical
devices that were or may have been contaminated
 Any intrapartum maternal death
 Any infant death
 Infant abduction or discharge to the wrong family
 Assault, homicide or other crime resulting in patient death or major permanent
loss of function
 A patient fall that results in death
 Sexual assault.
 A series of occurrences which, cumulatively, has the potential to become a
serious clinical event
PROCEDURE:
 The immediate caregiver will stabilize and treat the patient as required
 The Most Responsible Physician/Physician on call will be notified and physician
orders implemented
 The scene will be secured
 Security will be notified if required
 The Most Responsible Nurse (MRN), the IV MRN and/or Administrative Manager
on Call will be notified and provided with the basic facts: Situation, Background,
Assessment and Recommendation
 The Manager and/or Director will be notified
 The Manager, Director will assess the need for critical incident debriefing and
ensure that staff are aware of the support available through the Employee
Assistance Program (EAP)
 The Senior Administrator on call will be notified and will activate the Incident
Response Team
 The Incident Response Team will:
o Conduct appropriate interviews with staff, physicians and other
stakeholders
o Lead a multidisciplinary team in the completion of the Root Cause
Analysis to include; identification of “root” causes and contributing factors,
development of risk reduction strategies, action plans and measurement
strategies for improvement. See Appendix C
 Staff, physicians, volunteers, will participate in the Root Cause Analysis process
at the request of the Incident Response Team.
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic
format on the BCHS intranet site. Any documents appearing in paper form are NOT controlled.
X-121: Management of Serious
Clinical Events
Page 3 of 11
RELATED PRACTICES AND / OR LEGISLATION:








Definition & Philosophy Quality Management P&P #VII-1
Accidents and Incidents to Patients and/or Visitors P&P # VI-05
Event Management P&P # X- 120(a)
Risk Management Program P&P # X-120
Coroner’s Case P&P # N-IV-309
Media Code – Guidelines for Hospital Spokespersons P&P #VI-129
Employee Assistance Program P&P # X-20
Disclosure of Harm P&P # X-9
REFERENCES:



Institute for Healthcare Improvement (IHI) Effective Crisis Management of
Serious Clinical Events - 2010
Healthcare Quarterly Vol. 9, Special Issue- October 2006 - McGill University
Health Centre Policy on Sentinel Events: Using a Standardized Framework to
Manage Sentinel Events, Facilitate Learning and Improve Patient Safety
Detroit Medical Centre – CLN 027 – Unexpected Clinical Events Process Flow
APPENDICES:



Appendix A: Management of Serious Clinical Events Algorithm
Appendix B: Serious Clinical Events – Incident Response Team Algorithm
Appendix C: Root Cause Analysis
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic
format on the BCHS intranet site. Any documents appearing in paper form are NOT controlled.
X-121: Management of Serious
Clinical Events
Page 4 of 11
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic
format on the BCHS intranet site. Any documents appearing in paper form are NOT controlled.
X-121: Management of Serious
Clinical Events
Page 5 of 11
Manager
Risk & Quality
Patient/Client
Relations Officer
Chief of Staff
Pt. Safety
Coordinator
Director
Medical Affairs
Policy X-121 APPENDIX B: Serious Clinical Events - Incident Response Team
CONTACT
CONDUCT
Insurer
if req'd
WITHIN
1 working day
assess potential
for liability
ATTEND
Interviews
MRP and/or Chief of Service
(Pt Safety Coord is lead, Director
Med Affairs is Recorder)
NOTIFY
Attending Physician
if different
from MRP
UPDATE
Interviews
Appropriate staff
(Director of Med Affairs
is lead,
Pt. Safety Coord is
Recorder)
Chief of Staff
&
Mgr Risk &
Quality
IMMEDIATE
Collaborate with MRN/Mgr to identify
key stakholders associated with event
to ensure all parties are attended to
PROVIDE
ATTEND
support to
physicians
interview with MRP
and/or Chief os
Service if Req'd
PROVIDE
support to patients
and/or families
COORDINATE
Provide
Documentation with
Ongoing updates to Mgr
Director of Medical Affairs
Risk & Quality Mgt
INITIATE
WITHIN
action to address immediate physician
performance issues if applicable
2 working days meet with Director of
Medical Affairs & Pt. Safety Coord review preliminary findings
Participate and/ or
Facilitate
Participate & Support
Provide
Root cause Analysis Process
Ongoing updates to Mgr Risk
& Quality Mgt
Disclosure Process
MEET
with Incident
Response Team
WITHIN
1 working
day
WITHIN
1 working day
Initiate & conduct/participate in
physician & staff interviews
UPDATE
SLT
WITHIN
WITHIN
WITHIN
21 Working
Days
1 fiscal quarter recommendattions
presented to Patient Safety, Risk
Mgt, QI Committee of the Board
7 Working
Days
1st
RCA
RCA Risk
Reduction
Strategies
presented to
Operations Team &
SLT for sign off
WITHIN
WITHIN
5 Working Days of sign off
communication of
Recommendations
communicated to Staff
6 months follow-up
meeting to assess
status of
recommendations
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic
format on the BCHS intranet site. Any documents appearing in paper form are NOT controlled.
X-121: Management of Serious
Clinical Events
Page 6 of 11
Policy X-121 APPENDIX C: Serious Clinical Events – Root
Cause Analysis
This
is X-121
a privileged
and confidential
qualityEvents
of care– Root
Policy
APPENDIX
C: Serious Clinical
review
Cause document
Analysis
This template is provided as an aid in organizing the steps in a root cause
analysis. Not all possibilities and questions will apply in every case, and there
may be others that will emerge in the course of the analysis. However, all
possibilities and questions should be fully considered in your quest for “root
cause” and risk reduction.
Findings
What are the details of the
event? (Brief description)
When did the event
occur?
(Date, day of week, time)
What area/service was
impacted?
What are the steps in the
process, as designed? (A
flow diagram may be
helpful here)
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic
format on the BCHS intranet site. Any documents appearing in paper form are NOT controlled.
X-121: Management of Serious
Clinical Events
Page 7 of 11
As an aid to avoiding “loose ends”, the three columns on the right are provided to be checked
off for later reference:
 “Root cause?” should be answered “yes” or “no” for each finding. A root cause is typically
a finding related to a process or system that has a potential for redesign to reduce risk.
 Each finding that is identified as a root cause should be considered for an action and
addressed in the action plan.
 “Ask Why?” should be checked off whenever it is reasonable to ask why the particular
finding occurred (or didn’t occur when it should have) – in other words, to drill down further
“Take action?” should be addressed for any finding that can reasonably be considered for a
risk reduction strategy. Each item checked in this column should be addressed later in the
action plan.
Ask
“Why?
Take
Action
Root
Cause
What steps in the
process contributed to
the event?
What human factors
were relevant to the
outcome?
How did the
equipment
performance affect the
outcome?
What factors directly
affected the outcome?
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic
format on the BCHS intranet site. Any documents appearing in paper form are NOT controlled.
X-121: Management of Serious
Clinical Events
Ask
“Why?
Page 8 of 11
Take
Action
Root
Cause
Are they truly beyond
the organization’s
control?
Are there any other
factors that have
directly influenced this
outcome?
What other areas or
services are impacted
To what degree is
staff properly qualified
and currently
competent for their
responsibilities?
How did actual
staffing compare with
ideal levels?
What are the plans for
dealing with
contingencies that
would tend to reduce
effective staffing
levels?
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic
format on the BCHS intranet site. Any documents appearing in paper form are NOT controlled.
X-121: Management of Serious
Clinical Events
Ask
“Why?
Page 9 of 11
Take
Action
Root
Cause
To what degree is
staff performance in
the operation
process(es)
addressed?
How can orientation
and in-service training
be improved?
To what degree is all
necessary information
available when
needed? Accurate?
Complete?
Unambiguous?
To what degree is
communication
among participants
adequate?
To what degree was
the physical
environment
appropriate for the
processes being
carried out?
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic
format on the BCHS intranet site. Any documents appearing in paper form are NOT controlled.
X-121: Management of Serious
Clinical Events
Ask
“Why?
Page 10 of 11
Take
Action
Root
Cause
What systems are in
place to identify
environmental risks?
What emergency and
failure-mode
responses have been
planned and tested?
To what degree is the
culture conducive to
risk identification and
reduction?
What are the barriers
to communication of
potential risk factors?
To what degree is the
prevention of adverse
outcomes
communicated as a
high priority? How?
What can be done to
protect against the
effects of these
uncontrollable
factors?
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic
format on the BCHS intranet site. Any documents appearing in paper form are NOT controlled.
X-121: Management of Serious
Clinical Events
Risk Reduction Strategies
Page 11 of 11
Measures of Effectiveness
Action Item #1:
Action Item #2:
Action Item #3:
Action Item #4:
Action Item #5:
Action Item #6:
Action Item #7:
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic
format on the BCHS intranet site. Any documents appearing in paper form are NOT controlled.