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
• 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
RCA1. 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 • Collect information• Causal factor charting• Root cause identification• Recommendations
Overview of RCA Process
AE occurs
Patient safety reporting system ie Aims call centre 6262/6464
SAC ratingRCA required ?
NO No further action required
YES
Initiate and complete RCA
Implement corrective action plan
Evaluate
Collect information• Gather information already
documented• Review health records• Flow chart/ timeline• Get additional information
–Site visit–Interviews
Map timeline-chain of events
Mary fry chicken in
pan
Fire start on stove
Mary come back – get
fire extinguisher
Mary leave pan
unattended
Fire extinguisher does not work
Throw water in
pan
Kitchen burn
Fire spread
Causal factor charting
Mary fry chicken in
pan
Fire start on stove
Mary come back – get
fire extinguisher
Mary leave pan
unattended
Fire extinguisher does not work
Electric burner short
Oil leak and ignite
Melt hole in pan
Throw water in
pan
Kitchen burn
Fire spread
Causal factor charting
Mary fry chicken in
pan
Fire start on stove
Mary come back – get
fire extinguisher
Mary leave pan
unattended
Fire extinguisher does not work
Electric burner short
Oil leak and ignite
Melt hole in pan
Throw water in
pan
Kitchen burn
Fire spread
CF
CFCF
CF
• 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 diagramsMeasurements PersonnelMaterials
EquipmentMethodsEnvironment
Ishikawa diagramsMeasurements PersonnelMaterials
EquipmentMethodsEnvironment
Callibration
Microscopes
Inspections
Shifts
Training
OperatorsSuppliers
Lubricants
Alloys
Callibration
Speed
WearAngle
Callibration
Callibration
Humidity
Temperature
Causal factor charting
Mary fry chicken in
pan
Fire start on stove
Mary come back – get
fire extinguisher
Mary leave pan
unattended
Fire extinguisher does not work
Electric burner short
Oil leak and ignite
Melt hole in pan
Throw water in
pan
Kitchen burn
Fire spread
CF
CFCF
CF
Why did mary leave the pan unattended?
Was there a policy regarding phone use in the kichen?
Why did she answer the phone
Was that policy in use/known to mary?
Causal factor charting
Mary fry chicken in
pan
Fire start on stove
Mary come back – get
fire extinguisher
Mary leave pan
unattended
Fire extinguisher does not work
Electric burner short
Oil leak and ignite
Melt hole in pan
Throw water in
pan
Kitchen burn
Fire spread
CF
CFCF
CF
Why did the electric burner short?
Is there a replacement policy?
Was the burner checked/ serviced?
Was the policy adhered to?
Causal factor charting
Mary fry chicken in
pan
Fire start on stove
Mary come back – get
fire extinguisher
Mary leave pan
unattended
Fire extinguisher does not work
Electric burner short
Oil leak and ignite
Melt hole in pan
Throw water in
pan
Kitchen burn
Fire spread
CF
CFCF
CF
Why did the fire extinguisher not work?
Was Mary trained on the use of Fire extinguisher?
Was the fire extinguisher checked/ serviced?
Is fire drills done to practice fire emergency procedures?
Causal factor charting
Mary fry chicken in
pan
Fire start on stove
Mary come back – get
fire extinguisher
Mary leave pan
unattended
Fire extinguisher does not work
Electric burner short
Oil leak and ignite
Melt hole in pan
Throw water in
pan
Kitchen burn
Fire spread
CF
CFCF
CF
Did Mary know how to extinguish an oil fire?
Did whe call for help? Why Not?
Was the fire brigade called?
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 addressrequirements 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 strategyto 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 Thoroughness1. 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 the process of evaluation).
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
• 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
Optimal
preventerrors
Training
Too Little
inaccuracy
Training
Too much
Inefficiency
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.
SUMMARYInvestigation: The investigation takes place where the event took place. Get sufficient information by: Studying all relevant documentsObtaining reports and/or sworn statementsConducting interviews with complainant/patient/family and staff, as well as
supervisors/managementDoing observationsBrainstorming sessions Determine cause of adverse event Determine whether precautionary and corrective measures are in placeWrite full report with recommendations to Management and DAEC/PAEC
Disclosure & Rationalisation
• Disclosure to non-physicians• Disclosure to physicians• Disclosure to patients• Disclosure to facility• Rationalisation to cover-up