Introduction to Risk Management and a Just Culture Mary Coffey - - PowerPoint PPT Presentation

Introduction to Risk Management and a “Just Culture”

Mary Coffey

Safety in a Radiotherapy Department

— Delivery of the correct treatment to all

patients in a safety aware environment

• Patient
• Staff
• Public

Safety in a Radiotherapy Department

— Delivery of the correct treatment to all

patients in a safety aware environment

• Radiation safety
• Health and safety
• Infection control

Risk Management – definitions of risk

— Risk: The combination of the probability of

an event and its consequences (ISO/IEC Guide 73)

• can be opportunities for benefit or threats to success

— Risks are about events that, when triggered,

cause problems

(ERM Initiative Faculty)

— Risk is a fact of life in radiotherapy, cannot

be eliminated but it can be reduced and the impact minimised

Risk Management

• “There is no such thing as an accident.

What we call by that name is the effect of some cause which we did not not see”

• Voltaire (courtesy of Rob Lee)

• Traditionally risk management related to

the business and financial world (including aviation and the nuclear industry)

• Adopted by Medical specialities
• Evolved more recently to include human

factors, identification of emerging risk, risk to reputation and the role of risk culture

Risk Management

Risk Management

• In business risk can be viewed as positive
• r negative
• In the business world the choice can be

to eliminate potential risks by not engaging in certain activities – in radiotherapy this is generally not an

• ption

Risk Management

• In the safety field, it is generally

recognised that the consequences are only negative and therefore the management

• f safety risk is focused on prevention and

mitigation of harm

— (A Risk Management Standard – Institute of Risk

Management)

— How are these factors integrated in

radiotherapy risk management?

Risk Management in radiotherapy

• Minimise, monitor and control the

probability and or impact of unfortunate events

• NOT to maximise the realisation of
• pportunities

• Patients have a right to expect high quality

treatment delivered in a safe environment

• Moral and ethical responsibility to actively

address the risk associated with radiotherapy

• Create an environment of openness and

transparency surrounding risk and how it is managed

• Gained significant momentum in recent

years

• Media interest
• Generates fear and uncertainty

Risk Management in radiotherapy

• “For every complex problem there is

invariably a simple solution ….. …. Which is almost always wrong”

H.L. Mencken (courtesy of Rob Lee)

Risk Management in radiotherapy

• Over reliance on rules and regulations
• Too often treated as a compliance issue that can be

solved by drawing up lots of rules and making sure that all employees follow them

• BP example
• Emphasized personal safety and rewarded

supervisors for low occupational accident rates in their teams – very good personal safety record, Glaring warning signals regarding declining process safety were not reacted to or even taken note of

— (Gudela Grote, Safety Science)

Risk Management in radiotherapy

• Over reliance on rules and regulations
• BP example
• Major disaster
• Individuals not enabled to identify, evaluate,

communicate and address risks they faced

• Proactive risk management

Risk Management in radiotherapy

• Over reliance on rules and regulations
• Many rules and regulations are sensible and do

result in risk reduction and damage limitation

• Rules-based risk management however, will not

diminish either the likelihood or impact of a disaster

— Kaplan and Mikes)

Risk Management in radiotherapy

• Over reliance on rules and regulations
• on what to do, what not to do and how to do it

can encourage a ‘checklist’ mentality restricting challenge and discussion

• The lack of opportunity or environment to

question can lead to

• Adherence to rules that result in error
• Deviations from the rules that are not

formally recorded – long term potential for error

Risk Management in radiotherapy

• Over reliance on rules and regulations
• The nature of errors changes with expertise
• Routine based errors increase
• Knowledge based errors decrease

Risk Management in radiotherapy

• The same underlying systemic factors may

be common to many different incident scenarios, each with different combinations of triggering events and circumstances

• Failures of the system rather than simply

human failure

Risk Management in radiotherapy

• Consider every incident as a failure of the

system

• review even the most minor in this context
• Human error or violation will be involved but

not necessarily the cause

• What circumstances/conditions/etc. led to the

human error violation

Risk Management in radiotherapy

• Learning from near incidents and incidents
• Effective risk management will ensure that

reported incidents are

• Investigated
• Analysed
• Discussed
• And that
• Feedback is given to staff
• Appropriate changes are put in place
• Reporting systems have been integrated into safety

management systems in many centres (ad hoc in many instances)

Risk Management in radiotherapy

• Learning from near incidents and incidents
• Most incidents or errors are minor
• Reflect a real opportunity for learning
• The basis of voluntary reporting systems
• Reporting systems (safety information systems)
• Demonstrates transparency
• A department putting safety as a priority
• A department engaged in active learning

Risk Management in radiotherapy

• Learning from near incidents and incidents
• Sharing of information on incidents and near

incidents with the wider radiotherapy community can enhance learning and preempt potential errors

• ROSIS (Radiation Oncology Safety Information System)
• SAFRON (IAEA Safety in Radiation Oncology)
• PRISMA (National – The Netherlands, Belgium)
• Learning is informed by international experience

Risk Management in radiotherapy

• Learning from near incidents and

incidents

• Effective risk management enables all staff to

feel comfortable identifying and discussing things that could go wrong

• “Activities such as peer review, multidisciplinary

team meetings and ‘safety rounds’ help to establish a sense of openness, mutual respect, group participation and responsibility” (Marks et

• al. PRO 2011)

Risk Management in radiotherapy

• Analysing the risk and identifying effective

change

• Incident and near incident reporting is one

element of risk management

• A tool to facilitate analysis
• Identify where change will be most effective

Risk Management in radiotherapy

— Analysing the risk and identifying effective

change

• Radiotherapy is a complex procedure
• “Safety management is not rocket science
• The challenge of rocket science pales in

comparison to the complexities of safety management” (James Reason 2005)

Risk Management in radiotherapy

— Analysing the risk and identifying effective

change

• Range of methodologies for analysis and change

can be used

• Events and Causal Factors Analysis (ECFA)
• Root Cause Analysis (RCA)
• Failure Mode and Effects Analysis (FMEA)
• LEAN (removing unnecessary steps in the process)
• Six Sigma (eliminating the root causes of defect and

errors in a process)

Risk Management in radiotherapy

Retrospective: Cause and Effect (Fishbone)

Treatment Delivery Patient ID RT Setup Pt Position Accessories Dose

Bolus Wedge Compensator Shielding Field omitted Fld re-treated Orientation Field size Collimator Angle Gantry Angle SSD/FSD Isocentre Couch height Unobstructed field # Missed Positioning Aids TBI Screen Couch angle Extra # Energy Undefined Field omitted, field re-treated Undefined Dose

37 56 8 141 5 35 0-4 5-9 10-19 20-29 30+

Retrospective: Events and Causal Factors Analysis

Systemic condtions Contributing factors Contributing factors Primary events Systemic condtions Systemic factors

Treatment Unit Service Patient changed treatment unit Patient positioned on couch Beam selected Beam positioned incorrectly Treated wrong target/isocenter Too many staff Heavy workload Management

• r supervisor

failure Field names confusing Field/target connection missing R/V design flaw Senile Patient Unclear setup instructions Lack of equipment Beam positioned incorrectly Lack of

communication

Staff not familiar w patient Observation failure

Prospective: Failure Modes and Effects Analysis (FMEA)

Steps in process Failure Mode Failure Causes Failure Effects Likelihood

• f

Occurrenc e (1-10 Likelihood

• f

Detection (1-10) Severity (1-10) Risk Priority Number Actions to reduce Occurrenc e of Failure 1 2 3 4 Total RPN

RPN: Likelihood of Occurrence x Likelihood of Detection x Severity

FMEA: The steps in the process

http://www.qualitytrainingportal.com/resources/fmea/fmea_process.htm

Prospective: Failure Modes and Effects Analysis

Guidelines on Risk Analysis (Unpublished)

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1

S = Severity V = Likelihood C = Criticality

Example of LEAN in a Radiotherapy Department (modified from Kruskal et al,

RadioGraphics, RSNA 2012)

Transport Patients and patient information. How many departments are involved and how efficient is patient and information flow? Waiting Are people, equipment, processes or facilities idle at any time? Is use of equipment optimised at all times and on all days? Production Are we taking unnecessary images for diagnosis, planning or verification? Can the number of images be decreased to improve throughput and reduce radiation exposure. Are our imaging protocols regularly reviewed? Inventory Are we storing anything in excessive amounts/ Do we have too many supplies leading to wastage? Processing Are we duplicating images, reports, clinical reviews etc. unnecessarily? Are our reports too long?

• Analysing the risk and identifying

effective change

• The selected method will be determined

by the context of the risk, the culture, practice and level of compliance

• Retrospective analysis is useful in identifying

causal factors – Does not show relationships between events – No prospective prediction of magnitude of risk

Risk Management in radiotherapy

Risk Management in radiotherapy

Risk Management in radiotherapy

slideshare

• Analysing the risk and identifying effective

change

• Each layer must be investigated together

with the policies and practices that might create vulnerable situations

Risk Management in radiotherapy

• Analysing the risk and identifying effective

change

• “We identified a problem
• We decided we needed ongoing information
• We set up a system which collected information

about something different

• We then wondered why it was so difficult to see

whether we were making progress”

Charles Vincent (courtesy of Rob Lee)

• Standard reporting systems are ineffective for

radiotherapy

Risk Management in radiotherapy

• Comparison with other high risk industries
• Historically looked to the Aviation and Nuclear

industries

• Should not generalise but look at the specifics of

each situation

• Tasks and work processes – types, complexity,

interdependencies

• People: role, qualifications, contractual arrangements
• Organisational structure: hierarchical, democratic
• Technology: complexity, networking
• External relationships (modified from Grote)

Risk Management in radiotherapy

• Key human factors areas to consider
• Integration of Human Factors into risk

assessment and investigations

• Communications / interfaces
• Organisational culture
• Human factors in design
• Human failures

Risk Management in radiotherapy

• Key human factors areas to consider
• Organisational change
• Staffing levels and workloads
• Training and competence
• Procedures
• Fatigue (shift work/overtime etc

— Quality and Safety UK HSE

Risk Management in radiotherapy

• Human factors - negative and positive
• Human factors are involved in probably 100% of

incidents

• Humans play the primary role in maintaining and

enhancing safety

Risk Management in radiotherapy

• A collaborative approach

—

Establish an environment that is

• Open and transparent
• Inclusive
• Collaborative
• Where communication of potential risks and

how they can be managed is encouraged and supported from every member of staff

Risk Management in radiotherapy

• A collaborative approach
• Evolve from an enterprise-level programme –

managing the risk in one organisation

— To

• A collaborative process in which many
• rganisations work together to assess and

mitigate their shared risks

• Provides the reward of improved

preparedness and response to risk

— Exploring emerging risk – Price Waterhouse Coopers)

Risk Management in radiotherapy

• A collaborative approach
• Organisations are increasingly required to think
• f their risk profile not just as their own
• An integral component of their international partners’

risk profiles

• Take a wide perspective from a range of

contributors

• In radiotherapy this could be
• Clinical
• Academic
• Industry
• Government

— (Exploring emerging risk – Price Waterhouse Coopers)

Risk Management in radiotherapy

• A collaborative approach
• Predicting risk – an example from the

Hospital Corporation of America

• Interview based to all levels of staff
• Top ten risks identified by each group

– Do the risks align vertically and horizontally? – How good is the communication between the groups?

Risk Management in radiotherapy

• A collaborative approach
• Predicting risk – an example from the Hospital

Corporation of America

• Many emerging risks identified by the staff on the

ground hadn’t filtered upwards

• Anonymity led to greater learning, better

information, more candid, direct and specific

• Greater alignment was achieved as a result of

the process

Risk Management in radiotherapy

• A collaborative approach
• Department of Radiation Oncology, University of

North Carolina

• Set up leadership ‘Safety Rounds”
• Personal 15-20 minute interviews by chairmen and

members of the leadership team

• Staff members in groups of 1-3 people at their work

site

• Asked about near-misses or unsafe conditions causing

potential or real harm to patients or employees

• Fostering openness and a safety culture

Risk Management in radiotherapy

• A collaborative approach
• Radiotherapy is complex and requires input

from many different personnel

• All groups have a broad understanding of the

processes involved

• Each group has specific expertise, knowledge and

understanding of their part of the process

• No group has the absolute knowledge and expertise in

all aspects of radiotherapy preparation and delivery

• Good risk management should integrate all

perspectives

Risk Management in radiotherapy

• External influences
• Radiotherapy is not delivered in isolation and can

be affected by many external factors

• Government policy and funding
• Analysis of the functioning of the organisation and its

personal

• Regular clinical audit can identify risk areas
• The full patient pathway must be included in a

comprehensive risk assessment

• These factors may contribute to increased demand

beyond the capabilities of the current facilities

Risk Management in radiotherapy

• A collaborative approach
• Infosys (Indian IT company)
• The Risk Event Card is used to assess its strategic risks
• Potential staff loss due to external employment

possibilities

• Staff recruitment and retention policies put in place

— (Kaplan and Mikes)

• A real risk in many radiotherapy departments
• The Balance Score Card (used in The Maastro

Clinic)

Risk Management in radiotherapy

The Risk Event Card

Strategic Objective Risk Event Outcomes Risk Indicators Likelihood / consequences

Management controls Accountable manager

The Balanced Scorecard

• Strategy performance management tool
• Semi-standard structured report
• Used by managers to keep track of the execution of

activities by the staff within their control

• To monitor consequences arising from these actions

(Wikpedia)

• Used in the at least one Clinic in The Netherlands

Financial Customer Processes Learning Objectives Measures Targets Initiatives

Effective Risk Management

• A proactive process designed to improve

quality by reducing risk and the number of incidents that occur in our departments

• Incident reporting with feedback
• Change introduced following full discussion
• The responsibility of all professionals

involved in the preparation and delivery

• f radiotherapy

• Most effective when a strong safety culture

exists that is actively supported by education and research

• Safety training in teams – leadership,

decision making, communication (process safety)

• Multidisciplinary professional teams need to

have a shared understanding of the processes and to appreciate the differences in their backgrounds, education, values and perspectives

Effective Risk Management

• Requires resources
• Staff
• Equipment
• Time
• Must be supported by management who must

recognise its value

• It must fit with the culture of the organisation

and will often necessitate attitudinal change

• Must integrate rules-based and ethics-based

aspects as appropriate

• Will enhance organisational reputation

Effective Risk Management

• Panama Cancer Institute Accident
• Couldn’t afford the treatment-planning software
• ffered with the Cobalt 60 unit
• 100 patients per day on one unit (twice the workload

recommended for the maintenance programme in place)

• Local solution to a software problem
• Low staffing levels
• Poor knowledge in some staff groups
• The staff were trying to do the best for the

patients

Effective Risk Management

Is this effective Risk management?

• ‘Ideally, risk analysis and risk

management should be conducted at a care pathway level, as patients often receive a broad range of treatments’

— (Robert C. Lee in Quality and Safety in Radiotherapy)

• Resource intensive and complex
• Identify the key elements in the

radiotherapy pathway and the personnel involved

Effective Risk Management

• Risk comes from not knowing what you’re

doing

• Warren Buffett
• Primary education programme includes Risk

and Risk Management

• Analysis of risk in new settings
• Analysis of incidents/near incidents with

feedback and involvement in future change

• Risk management is the responsibility of all

Effective Risk Management

AAPM / ASTRO recommendations

• Senior Management must emphasise the

importance of patient safety policies and procedures

• Patient safety is everyone’s responsibility
• Each person should be respected, supported

and appreciated for his/her commitment to safety

• Safety Management rather than Risk

Management?

• Acknowledges issues inherent to teams

and teamwork and the difficulties staff encounter in

• highlighting errors by themselves or others
• Resolving difficulties
• Unequal input into decision making processes
• Lack of discussion

Safety Culture

• Even well trained and well qualified

personnel make errors

• Lack of attention to detail
• lack of alertness, or lack of awareness especially

if they have to work in less that ideal conditions

• Focus on minimising/reducing the potential

for harm and not relying on personal perfection (Bagian J.)

Safety Culture

— Staff fallibility and vulnerability

• Emphasis is on perfection – mistakes are

unacceptable and indicate negligence (Leape)

• Feelings of guilt
• Personal failure

Safety Culture

— Safe organisations

• Preoccupied with failure rather than success

– Encourage the reporting of incidents, near incidents and unexpected occurences – Reluctant to search for simple explanations – Committed to resilience – Show deference to expertise

Safety Culture

• What hinders shared responsibility?
• Territorialism / professional arrogance
• What is the culture of the organisation?

Safety Culture

Organisational Culture(s)

— affects the performance of the

• rganisation and its members

Just Culture

— Human error is a fact of life

• Cannot be eliminated
• Frequency can be reduced

Just Culture

— Human error is a fact of life

• Developing a learning rather than a blaming

culture

• Learning from unsafe acts

Blame Culture

— A culture in which, if something goes wrong,

the primary response is to apportion blame to one or more individuals and apply sanction.

JAR OPS

Problems with a blame culture

— In many cases the individual is not the

problem

— Blame culture discourages reporting of

incidents and co-operation with investigations so

• The problem can get worse
• We do not have accurate data on incident

levels

Problems with a blame culture

• We do not gain rich information to understand

incidents

• We have a weak basis for prevention

— It is much easier to blame the last person

who touched the patient than those responsible for their working conditions

Directive 2003/42/EC (Occurrence Reporting)

No-Blame Culture

— A culture where individuals are exempted

from disciplinary action if they report their errors and co-operate with investigations

Problems with a No-blame culture

— Can give immunity to reckless or malicious

individuals

— Can put an organisation out of step with

society and its institutions – regulators, gardai, etc.

— Violation with the intent of self-reporting to

escape sanction

— Introduction of a no-blame policy is not

enough to bring about a no-blame culture; the blame reflex is highly resilient

Directive 2003/42/EC (Occurrence Reporting)

A ‘Just’ Culture

— “Is an atmosphere of trust in which

people are encouraged, even rewarded, for providing essential safety-related information… but in which they are also clear about where the line must be drawn between acceptable and unacceptable behavior.”

• Prof. James Reason

Just Culture

— Blame not automatic or even normal in

response to human error

— Primary objective to understand, explain

and prevent

— Clear policy defining when discipline is

appropriate – e.g. negligence, recklessness

Just Culture

— Genuine errors occur and should be

forgiven

— People need to be held accountable for

intentional or repeated deviations from safe practice

Why we do need a “Just” Culture?

— “…one million people injured by errors in

treatment at hospitals each year in the US, with 120,000 people dying from those injuries

• Dr. Lucian Leape professor at Harvard briefing

a US Congressional subcommittee

Why we do need a “Just” Culture?

— Because of the punitive work

environment, health care workers would report only what they could not conceal (hide) …the single greatest impediment to error prevention is ….that we punish people for making mistakes”

• Dr. Lucian Leape professor at Harvard briefing

a US Congressional subcommittee

Problems with a Just Culture

— Introduction of a “just” disciplinary

policy is not enough to bring about a just culture; the blame reflex is highly resilient

— More difficult to define and

communicate than a blame or no-blame policy

Problems with a Just Culture

— Difficult to clearly define the boundaries

• f acceptable behaviour

— Requires a more sophisticated

understanding of human behaviour and human error than many are willing to take

Just Culture Code of Practice 1

• Free and full reporting is the primary aim
• Use the ‘substitution test’ – would

another individual who was similarly trained and experienced have made the same error?

JAA MHFWG Report

Just Culture Code of Practice – 2

— Individuals should not attract punitive action

unless:

• The act was intended to cause deliberate

harm or damage.

• They do not have a constructive attitude

towards complying with safe operating procedures.

• They knowingly violated procedures that

were readily available, workable, intelligible and correct.

JAA MHFWG Report

Just Culture Code of Practice -3

— Individuals should not attract punitive action

unless:

• The person concerned has been involved

previously in similar lapses.

• The person concerned has attempted to

hide their lapse or their part in a mishap.

• The act was the result of a substantial

disregard for safety.

JAA MHFWG Report

Absence of Just Culture can cause

— Lack of transparency of actual ways of

working

— Unwillingness to report occurrences or

relevant detailed information

— Reduced cooperation with colleagues — Lack of organisational learning — Hard to accomplish changes

Just Culture Values

Recent European research shows the importance of trust and dignity in aviation maintenance organisations

— Trust

• To believe that someone is honest and means

no harm.

• To feel that something is safe and reliable

— Dignity (respect self and others)

• We all have an inherent dignity regardless of

what work we do

• Dr. Marie Ward

School of Psychology, Trinity College

Trust and Dignity

— ‘…when they (employees) are treated with

personal dignity, then their trust in their colleagues and the organisation is built…

— when they are treated in an undignified

manner, then trust is destroyed’ (Gratton,

2003)

— Respecting the dignity of others is what

enables trust to happen