Root Cause Analysis Education

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Root Cause Analysis Education
Module 1 2
Whats in it for you? Board of
Management Executive Management Team Senior
Clinicians Senior Managers Clinical Risk, Safety
and Quality Managers
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Department of Human ServicesRCA Education Program

• RCA Training Modules available
• Module 1 - Root Cause Analysis - Whats in it
  for you
• Board of Management, Executive
  Team, Senior Clinicians Managers,
  Safety and Quality Team
• Module 2 - Root Cause Analysis - Getting Started
• RCA Program Coordinators/ RCA Facilitators
• Module 3 - Root Cause Analysis - Conducting an
  Investigation
• RCA Program Coordinators/ RCA Facilitators

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Outline of the Session

• What is Root Cause Analysis (RCA)?
• The Victorian RCA Education program
• Ten steps for an effective RCA program
• Principles, tools and techniques used
• Organisational support required
• Governance and medicolegal considerations

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What is Root Cause Analysis?

• What is a Root Cause?
• The root or fundamental issue, is the earliest
  point at which action could have been taken that
  would have reduced the chance of the incident
  happening.
• What is Root Cause Analysis?
• Structured process using recognised analytical
  methods
• Enables you to ask the questions How and Why
  in an objective way to reveal all the causal
  factors that have led to a patient safety
  incident.
• Learn how to prevent similar incidents happening
  again, not to apply blame.

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• Why Do We Need Root Cause Analyses in Healthcare?

Publicised Clinical Safety and Quality Failures

• Bristol - UK
• Shipman UK
• Winnipeg - USA
• King Edward Memorial Hospital Inquiry - Australia
• Royal Melbourne Inquiry Australia
• South Western Sydney Area Health Service
  Australia
• Bundaberg, Queensland - Australia

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There are examples of System Failure (Failure to
Learn)

• Common Features
• Closed culture - cover up
• Failure of management to respond issues raised,
  but not dealt with.
• Poor communication and complaints management
• Inadequate training/credentialling of staff
• Issues with staff support and recruitment and
  retention
• Inadequate morbidity/mortality reviews and non
  existent quality systems
• How does your health service rate?

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• Why Do We Need Root Cause Analyses in Healthcare?

Estimates of the incidence of adverse events in
hospitals

• Quality in Australian Health Care Study
• 16 hospital admissions were associated with an
  adverse event
• 51 judged to be preventable
• Outcomes of those events
• 47 resulted in minimal disability
• 14 resulted in permanent disability
• 5 resulted in death

     
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Preventable Adverse Events

• What Do We Mean?

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Department of Human ServicesSentinel Event
Program

• Sentinel events are
• Clear-cut events that occur independently of a
  patient's condition.
• Commonly reflect hospital system and process
  deficiencies.
• Result in unnecessary or outcomes for patients.

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Department of Human Services (Victoria)
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How Do Problems With Safety and Quality Arise in
Healthcare?

• System Failure
• Human Error

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Professor James Reasons Swiss Cheese Model of
Error
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Human Error is Inevitable

• Human Beings make mistakes because the systems,
  tasks and processes they work in are poorly
  designed
• Professor Lucian Leape
• Harvard School of Public Health

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What Can We Do to Make Health Care Safer?

• Recognise and Manage Human Error
• Redesign the System to Prevent Errors Leading to
  Incidents

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The Systems We Work in

• Health care, like many other industries is
  complex
• Large organisations, many staff
• How can we be sure everyone knows how to do their
  job well?
• What if something unexpected or an adverse event
  happens?

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Looking for System Causes
SYSTEM
Causes are found at the interfaces between
people, procedures and equipment
PEOPLE
PROCEDURE
EQUIPMENT
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Where Does an RCA Program Fit in?

• The RCA Program is part of a Safety and Quality
  Program.
• It sits alongside incident reporting, patient
  safety education and training and feeds into an
  organisations Risk Management Strategy.

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Where Does an RCA Program Fit in?
Incident Response
Quality Management
Risk Management
RCA Investigation
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The Victorian RCA Education Program

• Developed for use in Victorian Health Services
• Based on industry standards and concepts and
  practical experience including
• Civil aviation (CASA)
• Apollo RCA training
• Nuclear and petrochemical industries
• Builds on previous work done in the health sector
  eg VA training, Charles Vincent model , James
  Reasons work, National Patient Safety Agency (UK)

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The Victorian RCA Training Program

• Includes intensive RCA facilitator training.
• Addresses organisational context for conducting
  RCAs
• Training for other groups including Board,
  Executive team , senior clinicians and managers.
• Commissioning of RCAs, Committee structures,
  medicolegal aspects, reporting and responsibility
  for action.
• Takes a system approach to identifying and
  validating recommendations.

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Principles for Conducting RCAs

• Focus on problem solving
• Focus on systems and processes, not individuals
• Fair, thorough and efficient

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10 Steps for an Effective RCA Program

• Step 1 Gain Senior Management and Clinician
  Commitment
• Step 2 Implement an Incident Investigation
  Policy
• Step 3 Appoint an RCA coordinator
• Step 4 Establish a Safety and Quality Committee
• Step 5 Establish an Incident Response Process
• Step 6 Establish RCA Investigation Procedures
• Step 7 Recognise Legal Considerations
• Step 8 Establish a Link with the Open Disclosure
  Process
• Step 9 Evaluate the Effectiveness of the RCA
  Program
• Step 10 Establish a set of standardised RCA tools

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Step 1

• Gain Senior Management and Clinician Commitment

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How Should Root Cause Analyses Be Commissioned?

• RCAs should be commissioned at an Executive /
  Executive Committee level
• Executive sponsorship sends a strong message
  through the organisation
• Commissioning and signing off RCA at Executive
  level provides the necessary authority for RCA
  Teams to investigate and identify root causes of
  preventable events

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RCA Commissioning process

• (Insert details including)
• Who can commission an RCA
• What is your process

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Engaging Clinicians

• Involve clinicians early
• Offer training opportunities
• Involve clinical leaders
• Minimise meetings and schedules to fit with their
  clinical commitments
• Prepare well before meetings so they run smoothly
  and tightly

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Provide Relevant RCA training

• Tailor to the needs of each group for example
• Board summary reports and monitoring progress
  on actions
• Executive commission investigations, sign off
  final reports and resource risk reduction action
  plans
• Senior clinicians - provide expert opinion about
  the clinical context and the effectiveness of
  solutions
• Line managers support staff and implement the
  recommendations

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Step 2

• Implement an Incident Investigation Policy

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When Should an RCA be undertaken?

• An Incident response process should determine the
  level of investigation and action needed.
• RCAs are normally only performed on high risk,
  high impact Catastrophic events eg Sentinel
  Events

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Incident Investigation Policy Contents

• Senior managements commitment to the RCA program
• Accountabilities and responsibilities for
  executives, directors, managers and other staff
• Criteria to be used to instigate an RCA
  investigation
• Methods and procedures the organisation will use
  to achieve its incident investigation objectives
• Links to related policy or procedures

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Incident Investigation Policy

• ( Insert relevant details - eg where to find
  policy, responsibilities of key staff etc)

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Step 3

• Appoint an RCA Coordinator

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Who Is Responsible for Undertaking RCA
Investigations?

• An RCA Facilitator will facilitate a particular
  RCA.
• Other RCA team members will be involved in
  gathering and exploring information about an
  incident.
• The people who were actually involved in the
  incident may also be part of the process, for
  example, by being interviewed.
• It is also important to consider how patients and
  their families may be involved in the process.

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RCA Coordinator Responsibilities

• RCA notifications
• Arrange commissioning of investigation
• Convene and manage RCA teams
• Organisational reporting and monitoring of risk
  reduction action plans
• Coordinating RCA program, advising staff and
  training
• Evaluation of RCA program

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RCA Coordinator

• (Insert details ie contact details, location
  etc)

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Step 4

• Confirm Safety and Quality Committee

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What Information on RCAs Should Be Reported to
Senior Management?

• Reports are written to communicate the findings,
  conclusions and recommendations from an RCA
  investigation.
• The report is written after all solutions have
  been considered and recommendations for
  corrective action determined.
•  

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RCA Investigation Governance

• RCA reporting to Executive team and Board  
• Notification of the commissioning of an RCA
  investigation and any immediate actions taken to
  ensure safety of patients and staff
• Notification of any external reporting(
  DHS/College )
• Summary of the RCA report

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RCA Investigation Governance

• RCA reporting to Executive Team and Board
•  
• Risk Reduction Action Plan
• Progress reports on implementation of the Risk
  Reduction Action Plan
• Final report on the Risk Reduction Action Plan
• Monitoring and surveillance plan to assess the
  effectiveness of the actions taken

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Safety and Quality Committee(s)

• (Insert details including)
• Terms of reference
• Membership
• Agendas
• Documentation and reporting

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Step 5

• Confirm Incident Response Process

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Why Is an Incident Response Process Necessary?

• Efficient and effective - assignment of an
  Incident Severity Response (ISR) can be done by
  the person reporting the incident.
• Triggers the appropriate level of management
  response at the time the incident is reported
• Differs from a Risk Rating

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An Incident Is Not a Risk

• An incident when investigated, can expose a
  number of risks
• A risk assessment requires information about the
  consequence (severity or outcome) and the
  frequency (how often this happens)
• Risk assessment can only be done after
  information is obtained about the cause of
  incidents and the frequency of recurrence

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Assessing the Severity of the Outcome of an
Incident
All staff can rate the outcome of an
incident Supervisor /Manager to confirm
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Incident Response Process
Each organisation should have an Incident
Response process
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• Incident Response Flowchart

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  Incident or Near Miss
                                                 
                                                 
   
 
Classify incident (ISR)
Review Aggregate data from incidents, indicators,
peer review, complaints, audit
ISR 3 or 4 Local review
ISR 1 Verification by Risk Manager
  Determine response
Monitor
ISR 2 Review by Risk Manager
RCA Commissioned by Executive Sponsor
Appoint practice improvement group
Decide on response
Appoint team Undertake investigation
Notify Divisional Director
  Report to Executive Sponsor  
Local Case review
Report to Risk Manager within 2 weeks
  Action Plan Developed
Document in risk register  
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Examples of ISR Ratings

• The evening nursing staff found a dementia
  patient on the floor. No obvious injuries were
  reported. The patient was returned to bed. The
  fall was not communicated at handover. Later in
  the night, the patient was found to be
  unconscious. An urgent CAT scan was ordered and a
  subdural haematoma was diagnosed. Despite surgery
  to evacuate the clot, the patient did not regain
  consciousness and died the following day.
• ISR 1 classification
• The incident contributed to the patients death.
  It would be classified as an ISR 1 and a
  recommendation would be made to the appropriate
  Executive Director to commission an RCA
  investigation. The incident would also be
  reported to the Coroner, the insurer and the
  Department of Human Services.

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Step 6

• Confirm RCA Investigation Procedures

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What Steps Are Involved in an RCA Investigation?

• 
  Facilitator Team
• Verify event define problem
• Commission RCA investigation
• Form the RCA team
• Gathering information/mapping the event
• Identify critical events
• Analyse critical event (CE Chart)
• Identify root causes
• Add evidence
• Select best solutions
• Write the Root Cause Statements
• Develop recommendations
• Write report
• Present to commissioning sponsor

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RCA Timeframe
Incident Response Days 1-2
Root Cause Analysis Process Days 3 - 45
Risk Management Days 45-60
Quality Management - Ongoing
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Step 7

• Recognise Legal Considerations

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Legal Considerations (see Module 2)

• The meaning of legal professional privilege
• Statutory Immunity does it apply to us?
• Risk of defamation
• Insurance considerations
• Freedom of Information considerations
• Document management
• Expert advice (DHS Legal /Policy Pauline
  Ireland)

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Step 8

• Link With the Open Disclosure Process

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Open Disclosure Process

• Principles of Open Disclosure
• How incident response and RCA investigation
  processes are integrated with the application of
  the open disclosure procedures.

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Step 9

• Evaluate the Effectiveness of the RCA Program

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RCA Program Evaluation

• Periodic Evaluation to ensure
• Objective have been met
• Program still meets the needs of the organisation
• Outcomes are being achieved
• RCAs are being completed in time
• Adequate number of RCA Facilitators
• RCA Facilitators are maintaining skills

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Step 10

• Use of a Set of Standardised RCA Tools

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Standardised RCA Tools

• Use of a set of standardised tools will assist
  staff to implement the RCA process consistently
• Worksheets - Module 3
• allows the RCA team facilitators and members
  to become familiar with the range of analytical
  methods used
• Reporting template
• assists executive sponsor to quickly identify
  the key issues and assess achievability of
  recommendations

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What Tools and Techniques Are Used in RCA?

• RCA tools including
• Mapping the event
• Change analysis
• Hazard, Barrier, Target analysis
• Cause and effect analysis

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Mapping the Event
Why?
O2 tubing Attached to wall
Air mattress inflated
Patient Placed on bed
Patient Lit cigarette
Mattress exploded
Patient burnt
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Change Analysis
baseline comparison
What should have happened?
What happened this time?
differences
impact
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Hazard, Barrier, Target Analysis
Barrier
Hazard
Target
Dog
Child
High Fence
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• The Organisational Readiness Checklist

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Assessment against the Organisational Readiness
Checklist

• Are all the following elements in place?
• Senior management commitment with an Executive
  sponsor
• Incident Investigation policy
• RCA Coordinator appointed
• Commissioning processes in place
• Committee structure and reporting processes in
  place

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Conducting Successful RCAs

• RCA is an important tool for organisations to use
  in identifying and acting on system failures.
• Poorly conducted RCAs may not accurately identify
  the root causes and can have adverse effects on
  an organisation

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10 Steps for an Effective RCA Program

• Step 1 Senior Management and Clinician
  Commitment
• Step 2 Application of Incident Investigation
  Policy
• Step 3 RCA Coordinator
• Step 4 Safety and Quality Committee oversight
• Step 5 Appropriate Incident Response Process
• Step 6 Use of RCA Investigation Procedures
• Step 7 Recognition of Legal Considerations
• Step 8 Links with the Open Disclosure Process
• Step 9 Evaluation of the Effectiveness of the
  RCA Program
• Step 10 Use of Standardised RCA tools

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Questions?
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Self Assessment

• What is Root Cause Analysis?
• Why conduct Root Cause Analysis?
• When should an RCA be conducted?
• What tools and techniques are used in RCA?
• What organisational structures and support are
  required?