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Risk Assessment

Dr Mike RejmanRisk Assessment Adviser

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Why do Accidents Happen?

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Why do Accidents Happen?

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How do Accidents Happen?Organisation and processes- Deficiencies Prior conditions - basic causes

& contributory factors“Unsafe” acts - active failures (SRK errors)

Multiple Defences

Patient Patient Safety Safety Incident

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Understanding the Problem

• ~ 80% of accidents are attributable to human factors, at the individual level, the organisational level, or more commonly both

• This is a conservative figure and is irrespective of domain

• To manage this we need to identify and understand the risks (causes and contributory factors)

• Without this we can’t put appropriate remedial action in place

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Seven Steps to Patient Safety

1. Build a safety culture

2. Lead and support your staff

3. Integrate your risk management activity

4. Promote reporting

5. Involve patients and the public

6. Learn and share safety lessons

7. Implement solutions to prevent harm

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Step 3 - Integrated Risk Management• All risk management functions and information:

– patient safety, – health and safety, – complaints, – clinical litigation, – employment litigation, – financial and environmental risk

• Training, management, analysis, assessment and investigations

• Processes and decisions about risks into business and strategic plans

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Risky Jobs

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Risky Jobs

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Risk Assessment by Donald Rumsfeld

As we know,There are known knowns. There are things we know we know.We also know there are known unknowns. That is to say We know there are some things we know we do not know.But there are also unknown unknowns - The ones we don’t know we don’t know.

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accidents

serious incidents

incidents

near misses

& hazards

The Accident Iceberg

1

10

30

600

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Prior Indicators of Risk

• Challenger Space Shuttle– evidence of seals shrinking

in cold temperatures, but political pressure to launch

• Columbia Space Shuttle– long-standing problem with

foam falling off (for 9 years)

– even after Columbia disaster, a minority report noted at least 3 crucial issues not actioned

– this endangered Discovery

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Poor Design and Labelling

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Poor Design and Labelling

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Identifying Areas of Risk

• Retrospective – learn lessons– Accidents and incidents, – Root Cause Analysis

• Prospective – anticipate issues– Reporting systems, near misses, reported

hazards– Prospective Risk Assessments, (proactive

hazard assessment)

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Some Risk Assessment Methods • (H)FMEA

– (Healthcare) Failure Modes and Effects Analysis

• HACCP– Hazard and Critical Control

Points• HAZOPS

– Hazard and Operability Studies

• PRA– Probabilistic Risk

Assessment• SWIFT

– Structured ‘What If’ Technique

HRA Techniques• HEART

– Human Error Analysis and Reduction Technique

• THERP– Technique for Human Error

Prediction• SHERPA

– Systematic Human Error Reduction and Prediction Approach

• GEMS– Generic Error Modelling System

• IDEAS– Influence Diagram Error

Analysis System

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Risk Assessment Methods • There are a great many methods• Most were developed in safety-critical industries

other than healthcare, only a few have been adapted to healthcare, with mixed success

• Problems over– some quantitative, some qualitative

– whether they can combine factors or only treat them independently,

– issues over ‘number’ generation

– few experimental comparisons, validation, or guidance

– some very resource intensive

• Which one to use?

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Risk Assessment Methods

NPSA is developing two approaches to the issue –

• (i) Patient Safety Research Fund – longer term research to identify the best methods for healthcare and adapt methods if necessary. Will take 2+ years to produce a toolbox

• (ii) ‘Fast track’ pragmatic approach to produce guidance in the short-term

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Risk Assessment’s Four Basics Questions

What couldgo wrong?

How bad could this

be ?

How often?

Is there aneed foraction,

if so what?

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Lead to Four Management Options

• Terminate

• Treat

• Tolerate

• Transfer

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SWIFT

• Structured ‘What IF’ checklisT

• Good technique for considering both human and organisational factors, as well as equipment factors, that may affect safety

• Structure

• Identification driven by:

– Question driven

• What-if ………?

– Checklist

• Best done using a multi-professional group

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Risk Assessment Flow DiagramAustralian/New Zealand model

• Risk assessment is a “PROCESS”

• Helps to determine if systems, facilities or activities are acceptable

• Aid to decision making Ris

k A

sses

smen

t

Establish the Context

Identify Risks

Evaluate Risks

Treat Risks

Accept Risks?

Likelihood Consequences

Level of Risk

Analyse Risks

Com

munic

ate

and C

onsu

lt

Monit

or

and R

evie

w

yes

no

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Record Sheet

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Risk Matrices

• Used for:– Qualitative

assessment of the level of risk from an event

• Commonly used in risk assessments

• Found in many forms

Severity

Frequency

Catastrophic Major Severe Minor

4 3 2 1Frequent 6 24 18 12 6

Probable 5 20 15 10 5

Occasional 4 16 12 8 4

Remote 3 12 9 6 3

Improbable 2 8 6 4 2

Incredible 1 4 3 2 1

Tolerable(medium priority)

Intolerable(high priority)

Negligible(low priority)

Severity

Frequency

Catastrophic Major Severe Minor

4 3 2 1Frequent 6 24 18 12 6

Probable 5 20 15 10 5

Occasional 4 16 12 8 4

Remote 3 12 9 6 3

Improbable 2 8 6 4 2

Incredible 1 4 3 2 1

Tolerable(medium priority)

Intolerable(high priority)

Negligible(low priority)

Likely Medium High High

Possible Low Medium High

Likelihood Class

Unlikely Low Low Medium

Minor Moderate Major Example Risk Matrix

Consequence Class

Very Likely Medium High High High High

Likely Medium Medium High High High

Probable Low Medium Medium High High

Possible Low Low Medium Medium High

Unlikely Low Low Low Medium Medium

Very Unlikely Low Low Low Low Medium

Likelihood Class

Almost Impossible Low Low Low Low Low

Minimal Minor Moderate Major Catastrophic Example Risk Matrix

Consequence Class

FREQUENCY4 Frequent 3 Infrequent 2 Improbable 1 Highly improbable

CONSEQUENCE

Likely to occur more Likely to occur more than Unlikely to occur during Event occurs rarely, ifoften than once per year once during the life of the the life of the plant (up to ever, worldwide

plant (up to 50 years) 50 years)4 CatastrophicPublic: Fatalities possiblePersonnel: Fatalities likelyEnvironment: Large adverse impactEquipment: Operations severelydisrupted: some units a total loss3 Very seriousPublic: Injuries possible: major nuisancePersonnel: Serious injuries/disabilities possibleEnvironment: Moderate adverse impactEquipment: Operations disrupted:damage extensive but repairable2 SeriousPublic: Minor nuisance: no injuriesPersonnel: Minor injuries likelyEnvironment: Minor adverse impactEquipment: Minor damage and/ormoderate downtime1 MinorPublic: No effectsPersonnel: Minor injury possibleEnvironment: Contained release*Equipment: Minimal disruption to plantoperations

Urgent High Priority

Medium Priority

Low Priority

No Action Required

* No impact to air, water, soil, treatment plant or other process units.

FREQUENCY4 Frequent 3 Infrequent 2 Improbable 1 Highly improbable

CONSEQUENCE

Likely to occur more Likely to occur more than Unlikely to occur during Event occurs rarely, ifoften than once per year once during the life of the the life of the plant (up to ever, worldwide

plant (up to 50 years) 50 years)4 CatastrophicPublic: Fatalities possiblePersonnel: Fatalities likelyEnvironment: Large adverse impactEquipment: Operations severelydisrupted: some units a total loss3 Very seriousPublic: Injuries possible: major nuisancePersonnel: Serious injuries/disabilities possibleEnvironment: Moderate adverse impactEquipment: Operations disrupted:damage extensive but repairable2 SeriousPublic: Minor nuisance: no injuriesPersonnel: Minor injuries likelyEnvironment: Minor adverse impactEquipment: Minor damage and/ormoderate downtime1 MinorPublic: No effectsPersonnel: Minor injury possibleEnvironment: Contained release*Equipment: Minimal disruption to plantoperations

Urgent High Priority

Medium Priority

Low Priority

No Action Required

* No impact to air, water, soil, treatment plant or other process units.

LIKELIHOOD CONSEQUENCES Impossible

0 Rare

1 Unlikely

2 Moderate

3 Likely

4 Certain

5 0 - Negligible 0 0 0 0 0 0 1 - Minor 0 1 2 3 4 5 2 - Moderate 0 2 4 6 8 10 3 - Serious 0 3 6 9 12 15 4 - Major 0 4 8 12 16 20 5 - Critical 0 5 10 15 20 25

Key No

Risk

Low Risk

Moderate

Risk

Significant Risk

High Risk

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Risk Matrix

• Two dimensions– Consequence

• (Also commonly called impact or severity)

– Likelihood• (Also commonly

called frequency or probability)

• How to use– Define for a risk:

• Its consequence• Its likelihood

– Read off the risk level Consequence / Severity / Impact

Freq

uen

cy/L

ikelih

ood

/Pro

bab

ility

Risk

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How to Use a Risk Matrix

• Identification of hazardous event/scenario

• Determining the risk using a risk matrix– Assessment of the

event’s/scenario’s consequence

– Assessment of the event’s/scenario’s likelihood of occurrence

– Determination of risk, (plotting scenarios on the risk matrix)

• Risk evaluation and decision making

Greater than one in ten per patient year

7 Medium High High High High

One in ten to one in a hundred per patient year

6 Medium Medium High High High

One in a hundred to one in a thousand per patient year

5 Low Medium Medium High High

One in a thousand to one in ten thousand per patient year

4 Low Low Medium Medium High

One in ten thousand to one in a hundred thousand per patient year

3 Low Low Low Medium Medium

One in a hundred thousand to one in a million per patient year

2 Low Low Low Low Medium

Less than one in a million per patient year

1 Low Low Low Low Low

A B C D E Negligible / Very Low

Low (Minimal Harm)

Moderate (Short Term

Harm)

Severe (Long

Term/Perm. Harm)

Fatality (one or more)

NPSA’s Patient Safety Risk Matrix

Consequence

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How to Use a Risk Matrix• Assessment of the

event’s/scenario’s consequence– May be a range of

possible outcomes– If possible chose

outcome which is of regular concern

– (Otherwise assess risk for different outcomes)

Likelihood

For example if the consequence of the event/scenario being assessed is the long term disability of a patient, then the consequence class is “D, permanent harm”

Likelihood

For example if the consequence of the event/scenario being assessed is the long term disability of a patient, then the consequence class is “D, permanent harm”

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How to Use a Risk Matrix

• Assessment of the event’s/scenario’s likelihood– Note that the likelihood

is for the outcome being considered

– Common error is to match event likelihood with worst case outcome which only happen in a minority of the event outcomes

Greater than one in ten per patient year

7 Medium High High

One in ten to one in a hundred per patient year

6 Medium Medium High

One in a hundred to one in a thousand per patient year

5 Low Medium Medium

One in a thousand to one in ten thousand per patient year

4 Low Low Medium

One in ten thousand to one in a hundred thousand per patient year

3 Low Low Low

One in a hundred thousand to one in a million per patient year

2 Low Low Low

Likelihood

Less than on e in a million per patient year

1 Low Low Low

A B C Negligible / Very Low

Low (Minimal Harm)

Moderate (Short Term

Harm)

NPSA’s Patient Safety Risk Matrix

Consequence

For example, for the event/scenario resulting in long term disability of a patient ( consequence class “D, permanent harm”, it could be assessed for any patient the likelihood of this happening is in the range 1 in 1,000 to 1 in 10,000 per year. Giving the likelihood class of 4

Greater than one in ten per patient year

7 Medium High High

One in ten to one in a hundred per patient year

6 Medium Medium High

One in a hundred to one in a thousand per patient year

5 Low Medium Medium

One in a thousand to one in ten thousand per patient year

4 Low Low Medium

One in ten thousand to one in a hundred thousand per patient year

3 Low Low Low

One in a hundred thousand to one in a million per patient year

2 Low Low Low

Likelihood

Less than on e in a million per patient year

1 Low Low Low

A B C Negligible / Very Low

Low (Minimal Harm)

Moderate (Short Term

Harm)

NPSA’s Patient Safety Risk Matrix

Consequence

For example, for the event/scenario resulting in long term disability of a patient ( consequence class “D, permanent harm”, it could be assessed for any patient the likelihood of this happening is in the range 1 in 1,000 to 1 in 10,000 per year. Giving the likelihood class of 4

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How to Use a Risk Matrix

• Determination of risk– Plot scenario on the

risk matrix

Greater than one in ten per patient year

7 Medium High High High High

One in ten to one in a hundred per patient year

6 Medium Medium High High High

One in a hundred to one in a thousand per patient year

5 Low Medium Medium High High

One in a thousand to one in ten thousand per patient year

4 Low Low Medium Medium High

One in ten thousand to one in a hundred thousand per patient year

3 Low Low Low Medium Medium

One in a hundred thousand to one in a million per patient year

2 Low Low Low Low Medium

Likelihood

Less than on e in a million per patient year

1 Low Low Low Low Low

A B C D E Negligible / Very Low

Low (Minimal Harm)

Moderate (Short Term

Harm)

Severe (Long

Term /Perm . Harm)

Fatality (one or more)

NPSA’s Patient Safety Risk Matrix

Consequence

Greater than one in ten per patient year

7 Medium High High High High

One in ten to one in a hundred per patient year

6 Medium Medium High High High

One in a hundred to one in a thousand per patient year

5 Low Medium Medium High High

One in a thousand to one in ten thousand per patient year

4 Low Low Medium Medium High

One in ten thousand to one in a hundred thousand per patient year

3 Low Low Low Medium Medium

One in a hundred thousand to one in a million per patient year

2 Low Low Low Low Medium

Likelihood

Less than on e in a million per patient year

1 Low Low Low Low Low

A B C D E Negligible / Very Low

Low (Minimal Harm)

Moderate (Short Term

Harm)

Severe (Long

Term /Perm . Harm)

Fatality (one or more)

NPSA’s Patient Safety Risk Matrix

Consequence

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Risk Evaluation and Decision Making• The risk classes help drive risk mitigation decision making• Common approach:

– Where the risk is assessed as:• “Low”

– Evaluate as tolerable– No risk mitigation recommendations needed

• “High”– Evaluate as intolerable– Risk reduction is required - aim to reduce medium or

low• “Medium”

– Evaluate as tolerable if ALARP demonstrated– Practical and cost effective recommendations to

reduce risk needed

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For Example - IT Systems

• Introducing IT systems can greatly increase capacity AND help eradicate certain errors

BUT

• Unless systems are carefully designed to take account of human factors, they can actually increase errors and even introduce new ones, with catastrophic consequences

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New Technology in Airbus 320

• ‘Glass cockpit’ and ‘fly by wire’ state of the art technology

• Multifunction displays with many ‘pages’ some of which are remarkably similar

• Operator awareness issues - leading to the introduction of a new error - ‘mode error’

• 87 people died in a crash at Strasbourg

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‘New’ Error

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Results from NPSA Funded Study on GP IT Systems (University of Nottingham)

• Allergy alert may not be generated• Hazard alert generated every third prescription

– Single keystroke to over-ride alert– No audit trail

• Not all safety functionality activated (e.g. contra-indications)

• Hazards generated by drop-down menus (wrong selection made – awareness)

• GPs unsure of safety functionality on systems– Some think functionality is present when it isn’t (e.g.

contra-indications)

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Risk Assessment To ensure safe operation …

Systems and Processes need:

• To be well designed (human factors) and thoroughly risk assessed

• To be more intuitive• To make wrong actions more difficult• To make correct actions easier (telling

people to be more careful doesn’t work)• And it should be easier to discover error

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Hospital at Night (HaN) Risk Assessment Guide

• Presents an approach to risk assessing Hospital at Night solutions

• Available on the NPSA web site