Transcript Clinical governance

Root Cause Analysis
Theory and Practical
Application of adverse event
investigations
MG Schoon
Definition
• Any event in the chain of causes that, when
acted upon by a solution, prevents the
problem from recurring.
Purpose
• Identify causative factors and develop
corrective strategies
• To prevent adverse events/outcomes
• Prevent harm
• Improve quality care and patient safety
Near miss
• A patient safety incident that did not cause
harm
• Near miss in pregnancy
Adverse outcome that did not result in death
PATIENT SAFETY PREVENTION/
IMPROVEMENT TOOLS
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Patient satisfaction survey
Patient complaints
Adverse events assessments
Dashboards/ trend analysis (trigger
tools)
Clinical audits
Clinical case reviews
Clinical guidelines & protocols
Checklists
Fire drills/ simulation exercises
Patient safety culture
Patient safety is
everybody’s
business
ROOT CAUSE
ANALYSIS
An effective tool for
systematically identifying
problems and analysing critical
incidents to generate
systems improvements
ROOT CAUSE
ANALYSIS
Find out:
• What happened
• Why did it happen
• What can be done to reduce
the likelihood of a recurrence
Cases that should not be
subjected to RCA
• Events thought to be the result of
a criminal act
• Purposefully unsafe acts (intended
to cause harm)
• Acts related to substance abuse
• Events involving suspected patient
abuse of any kind
Strong support from upper
management
It must be accepted that
results of any given root
cause analysis will be for
improving situations, not for
assigning blame
Berry & Krizek
RCA
1. is inter-disciplinary, involving experts from
the frontline services;
2. involves those who are the most familiar with
the situation;
3. continually digs deeper by asking why, why,
why at each level of cause and effect;
4. identifies changes that need to be made to
systems; and
5. is as impartial as possible in order to make
clear the need to be aware of and sensitive to
potential conflicts of interest
Success depends on
involvement of the
attending physician,
consulting specialist and
other providers
Check for eligibility for
RCA
• Deliberate harm test
– whether the actions were as intended, not whether the
outcome was as intended
• Incapacity test
– Was a staff member ill or intoxicated
• Foresight test
– Did the individual depart from agreed protocols or
safe procedures?
• Substitution test
– Would another individual coming from the same
professional group, possessing comparable
qualifications and experience, behave in the same way
in similar circumstances?
RCA Steps
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Collect information
Causal factor charting
Root cause identification
Recommendations
Overview of RCA Process
AE occurs
Evaluate
Implement
corrective
action plan
Patient safety
reporting system ie
Aims call centre
6262/6464
Initiate and
complete RCA
SAC rating
RCA required ?
YES
NO
No further
action required
Collect information
• Gather information already
documented
• Review health records
• Flow chart/ timeline
• Get additional information
–Site visit
–Interviews
Map timeline-chain of
events
Kitchen
burn
Mary fry
chicken in
pan
Fire
spread
Mary leave
pan
unattended
Fire start
on stove
Throw
water in
pan
Mary come
back – get
fire
extinguisher
Fire
extinguis
her does
not work
Causal factor charting
Kitchen
burn
Mary fry
chicken in
pan
Fire
spread
Mary leave
pan
unattended
Electric
burner
short
Melt hole
in pan
Oil leak
and ignite
Fire start
on stove
Throw
water in
pan
Mary come
back – get
fire
extinguisher
Fire
extinguis
her does
not work
Causal factor charting
Kitchen
burn
Mary fry
chicken in
pan
Mary leave
pan
unattended
Electric
burner
short
CF
Melt hole
in pan
Oil leak
and ignite
Fire start
on stove
Fire
spread
Throw
water in
pan
CF
CF
Mary come
back – get
fire
extinguisher
Fire
CF
extinguis
her does
not work
• Knowing what adverse events occur is
only the first step. Most adverse events
result from a complex series of behaviours
and failures in systems of care.
Investigation of the patterns of adverse
events requires unearthing the latent
conditions and systemic flaws as well
as the specific actions that contributed to
these outcomes.
Dr. G. Ross Baker & Dr. Peter Norton
Swiss cheese model
most accidents can be
traced to one or more of
four levels of failure
•Organizational influences,
•unsafe supervision,
•preconditions for unsafe
acts, and
•the unsafe acts
themselves.
In many traditional
analyses, the most
visible causal factor is
given all the attention
Root cause
identification
• Do Root cause mapping of causal factors
Ishikawa diagrams
Measurements
Environment
Materials
Personnel
Methods
Equipment
Ishikawa diagrams
Measurements
Training
Lubricants
Microscopes
Inspections
Humidity
Temperature
Shifts
Alloys
Callibration
Environment
Personnel
Materials
Suppliers
Operators
Angle
Wear
Callibration
Callibration
Methods
Speed
Callibration
Equipment
Causal factor charting
Was that policy in use/known
to mary?
Was there a policy
regarding phone use in
the kichen?
Why did she
answer the phone
Why did mary
leave the pan
unattended?
Electric
burner
short
CF
Melt hole
in pan
Oil leak
and ignite
Kitchen
burn
Mary fry
chicken in
pan
Mary leave
pan
unattended
Fire start
on stove
Fire
spread
Throw
water in
pan
CF
CF
Mary come
back – get
fire
extinguisher
Fire
CF
extinguis
her does
not work
Causal factor charting
Kitchen
burn
Was the policy adhered to?
Mary fry
chicken in
pan
Is there a replacement
policy?
Was the burner checked/
serviced?
Why did the electric
burner short?
Electric
burner
short
CF
Melt hole
in pan
Oil leak
and ignite
Mary leave
pan
unattended
Fire start
on stove
Fire
spread
Throw
water in
pan
CF
CF
Mary come
back – get
fire
extinguisher
Fire
CF
extinguis
her does
not work
Causal factor charting
Kitchen
burn
Is fire drills done to practice
fire emergency procedures?
Was Mary trained on the use
of Fire extinguisher?
Was the fire extinguisher
checked/ serviced?
Why did the fire
extinguisher not work?
Electric
burner
short
CF
Melt hole
in pan
Oil leak
and ignite
Mary fry
chicken in
pan
Mary leave
pan
unattended
Fire start
on stove
Fire
spread
Throw
water in
pan
CF
CF
Mary come
back – get
fire
extinguisher
Fire
CF
extinguis
her does
not work
Causal factor charting
Kitchen
burn
Was the fire brigade called?
Did whe call for help? Why
Not?
Did Mary know how to
extinguish an oil fire?
Electric
burner
short
CF
Melt hole
in pan
Oil leak
and ignite
Mary fry
chicken in
pan
Mary leave
pan
unattended
Fire start
on stove
Fire
spread
Throw
water in
pan
CF
CF
Mary come
back – get
fire
extinguisher
Fire
CF
extinguis
her does
not work
Root cause summary
Causal factor # 1
Paths Through Root
Cause Map
Recommendations
Mary leaves the frying
chicken unattended.
• Personnel difficulty.
• Administrative/
management systems.
• Standards, policies or
administrative controls
(SPACs) less than
adequate (LTA).
• No SPACs.
• Implement a policy that hot oil
is never left unattended on the
stove.
• Determine whether policies
should be developed for other
types of hazards in the facility to
ensure they are not left
unattended.
• Modify the risk assessment
process or procedure
development process to address
requirements for personnel
attendance during process
operations.
Root cause summary
Causal factor # 2
Paths Through Root
Cause Map
Recommendations
Description:
Electric burner
element fails (shorts
out).
• Equipment difficulty.
• Equipment reliability
program problem.
• Equipment reliability
program design LTA.
• No program.
• Replace all burners on stove.
• Develop a preventive
maintenance strategy
to periodically replace the burner
elements.
• Consider alternative methods
for preparing chicken that may
involve fewer hazards, such as
baking the chicken or purchasing
the finished product from a
supplier.
Recommendations
• List the recommendations
• Write a report regarding the findings
• Suggest some implementation strategies
RCA Thoroughness
1. an understanding of how humans interact with their
environment;
2. identification of potential problems related to processes and
systems;
3. analysis of underlying cause and effect systems through a
series of why questions;
4. identification of risks and their potential contributions to the
event;
5. development of actions aimed at improving processes and
systems;
6. measurement and evaluation of implementation of these
actions; and
7. documentation of all steps (from the point of identification to
RCA credibility
1. include participation by the leadership of
the organization and those most closely
involved in the processes and systems;
2. be applied consistently according to
organizational policy/procedure; and
3. include consideration of relevant
literature.
Root cause analysis techniques
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Re-enactment ( computer or a simulator)
Comparative re-enactment
Re-construction-reassembling
Barrier analysis
Bayesian inference
Change analysis comparing the way an episode did happen with the way it was intended to
happen.
Current Reality Tree
Failure mode and effects analysis
Fault tree analysis
Five whys
Ishikawa diagrams
Why-Because analysis
Pareto analysis "80/20 rule"
RPR Problem Diagnosis Kepner-Tregoe Approach
PROACT Approach
Project Management Approaches.
USE of training to reduce errors
Training
Training
Training
Too Little
Optimal
Too much
inaccuracy
prevent
Inefficiency
errors
The Institute of Medicine’s Six Elements of
Quality
1. Patient safety. Are the risks of injury minimal for patients in the
health system?
2. Effectiveness. Is the care provided scientifically sound and
neither underused nor overused?
3. Patient centeredness. Is patient care being provided in a way
that is respectful and responsive to a patient’s preferences,
needs, and values? Are patient values guiding clinical
decisions?
4. Timeliness. Are delays and waiting times minimized?
5. Efficiency. Is waste of equipment, supplies, ideas, and energy
minimized?
6. Equity. Is care consistent across gender, ethnic, geographic,
and socioeconomic lines?
Source: Institute of Medicine 2001.
SUMMARY
Investigation:
The investigation takes place where the event took place.
Get sufficient information by:
Studying all relevant documents
Obtaining reports and/or sworn statements
Conducting interviews with complainant/patient/family and staff, as well as
supervisors/management
Doing observations
Brainstorming sessions
Determine cause of adverse event
Determine whether precautionary and corrective measures are in place
Write full report with recommendations to Management and DAEC/PAEC
Disclosure & Rationalisation
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Disclosure to non-physicians
Disclosure to physicians
Disclosure to patients
Disclosure to facility
Rationalisation to cover-up