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