Incident management and sentinel events

Well-designed incident management systems assist patients, carers, families and the workforce to identify, report, manage and learn from incidents.

Incident management

An incident is an event or circumstance that resulted, or could have resulted, in unintended or unnecessary harm to a patient or consumer; or a complaint, loss or damage.

In Australia, hospital patient safety incidents are captured through local incident management systems. There are well established and effective process for data analysis and investigations. The Commission is currently undertaking a program of work to further strengthen these processes and support information sharing across the health system.

New incident management guide

The guide provides a brief overview of the incident management process and best practice approaches. It complements state and territory incident management policies, which provide more detailed information on local systems. Links to these policies are included in the guide.

Incident management guide

2021

Guide, user guide or guidelines

Patient safety investigation methodologies

Information on the most common approaches used to understand and learn from patient safety incidents.

Overview

All incidents with the highest severity rating should undergo an in-depth investigation. There are a range of investigation methodologies used, the most common are:

Root Cause Analysis
London Protocol
Failure Modes and Effects Analysis.

For review of low severity incidents and near misses, less resource intensive tools are used, for example, After-Action Review, Debriefing and Huddles, and Swarm.

Each organisation or jurisdiction should have policies and procedures to determine when different types of investigation are appropriate.

Root Cause Analysis

Root Cause Analysis (RCA) is a systematic process that attempts to answer three questions about an incident:

What happened?
Why did it happen?
How can we prevent it happening again?

RCA brings together a small team of diverse set of individuals who are independent to the incident.

RCA represents a toolbox of approaches rather than a single method. More than 40 RCA techniques are described in literature, including brainstorming, cause-effect charts, ‘five whys’ diagrams and fault trees. Regardless of these variations, RCAs are organised in sequential steps. The end point of an RCA is a set of recommendations for an organisation to implement to reduce harm to patients in the future.

Aggregating findings from multiple RCAs, other incident investigations and other data sources can be used to identify future risks and proactively develop improvement programs.

Key steps
1.Team appointed Team should be diverse and representative. Team members should not have been involved in the incident.
2. Initial flow diagram Aim: to develop a chronological map of what is known and the gaps in knowledge of the incident. Method: document review and develop questions based on a guide.
3. Gather information Aim: to complete the gaps in knowledge. Method: interviews, document review, literature review, observation, testing or any other method as appropriate.
4. Final flow diagram Aim: to develop a high level complete chronological map of the key facts of the incident. Method: collation and synthesis of gathered information.
5. Brainstorming Aim: to systematically list the contributing factors that lead to the incident. Method: collation and synthesis of gathered information using the final flow diagram to guide.
6. Cause and effect diagram Aim: to organise the contributing factors identified in the brainstorming and to develop root causes. Method: collation of contributing factors using a diagrammatic representation.
7. Causation statements Aim: to organise the contributing factors in the cause and effect diagram. Method: collation of contributing factors using a structured text-based representation.
8. Formulate recommendations and measures Aim: to develop interventions to prevent a re-occurrence of the incident. Method: brainstorm and prioritise organisational actions that impact on the root causes.
9. Implement, monitor and evaluate recommendations Aim: to ensure interventions are implemented and the effectiveness of interventions are monitored. Method: develop action plan for implementation with tasks and responsibility clearly assigned. Use quality improvement methodologies such as Plan-Do-Study-Act cycle for implementation.

Key steps

1.Team appointed

Team should be diverse and representative. Team members should not have been involved in the incident.

2. Initial flow diagram

Aim: to develop a chronological map of what is known and the gaps in knowledge of the incident.

Method: document review and develop questions based on a guide.

3. Gather information

Aim: to complete the gaps in knowledge.

Method: interviews, document review, literature review, observation, testing or any other method as appropriate.

4. Final flow diagram

Aim: to develop a high level complete chronological map of the key facts of the incident.

Method: collation and synthesis of gathered information.

5. Brainstorming

Aim: to systematically list the contributing factors that lead to the incident.

Method: collation and synthesis of gathered information using the final flow diagram to guide.

6. Cause and effect diagram

Aim: to organise the contributing factors identified in the brainstorming and to develop root causes.

Method: collation of contributing factors using a diagrammatic representation.

7. Causation statements

Aim: to organise the contributing factors in the cause and effect diagram.

Method: collation of contributing factors using a structured text-based representation.

8. Formulate recommendations and measures

Aim: to develop interventions to prevent a re-occurrence of the incident.

Method: brainstorm and prioritise organisational actions that impact on the root causes.

9. Implement, monitor and evaluate recommendations

Aim: to ensure interventions are implemented and the effectiveness of interventions are monitored.

Method: develop action plan for implementation with tasks and responsibility clearly assigned. Use quality improvement methodologies such as Plan-Do-Study-Act cycle for implementation.

Find out more

Hagley G, Mills PD, Watts BV, Wu AW. Review of alternatives to root cause analysis: developing a robust system for incident report analysis. BMJ Open Quality. 2019 Aug 1;8(3):e000646.

National Patient Safety Foundation. RCA2 - Improving Root Cause Analyses and Actions to Prevent Harm. Boston: NPSF, 2015.

Nicolini D, Waring J, Mengis J. The challenges of undertaking root cause analysis in health care: a qualitative study. Journal of Health Services Research & Policy. 2011;16 Suppl 1:34-41.

Incident management resources published by state and territory health departments.

London Protocol

The London Protocol takes a systems approach to incident investigation. It provides a structure for interviews and the search for information. The interview questions focus on the chronology of the incident, care delivery problems and contributory factors.

What are care delivery problems?	What are contributory factors?
Problems that happen during the process of care, usually actions or omissions by members of staff. An incident can have several care delivery problems. Care delivery problems have two essential features: Care deviated beyond safe limits of practice The deviation had at least a potential direct or indirect effect on the eventual adverse outcome for the patient, staff or general public.	Many factors may contribute to a care delivery problem. The London Protocol provides a framework to classify and examines these factors which includes: Patient factors Task and technology factors Individual (staff) factors Team factors Work environmental factors Organisational and management factors Institutional context factors.

What are care delivery problems?

What are contributory factors?

Problems that happen during the process of care, usually actions or omissions by members of staff. An incident can have several care delivery problems. Care delivery problems have two essential features:

Care deviated beyond safe limits of practice
The deviation had at least a potential direct or indirect effect on the eventual adverse outcome for the patient, staff or general public.

Many factors may contribute to a care delivery problem. The London Protocol provides a framework to classify and examines these factors which includes:

Patient factors
Task and technology factors
Individual (staff) factors
Team factors
Work environmental factors
Organisational and management factors
Institutional context factors.

Key steps
1. Team appointed Team should be diverse and representative. Team members should not have been involved in the incident.
2. Organisation and data gathering Aim: to gather all known facts about the incident. Method: Interviews, document review, literature review, observation, testing or any other method as appropriate.
3. Determine the chronology of the incident Aim: to develop a high level complete chronological map of the key facts of the incident. Method: Collation and synthesis of gathered information using either chronological narratives, timelines, time person grids, or flow charts.
4. Determine care delivery problems (CDP) Aim: to systematically list the CDPs that lead to the incident. CDPs are usually actions or omissions by staff in the process of care. For example, failure to monitor a patient. Method: collation and synthesis of gathered information and brainstorming.
5. Identify contributory factors Aim: to identify and organise the contributing factors for each CDP. Method: collation of contributing factors using a diagrammatic representation.
6. Making recommendations and developing an action plan Aim: to develop interventions to tackle the system’s weaknesses. Method: brainstorm and prioritise organisational actions that impact on the contributory factors.

Key steps

1. Team appointed

Team should be diverse and representative. Team members should not have been involved in the incident.

2. Organisation and data gathering

Aim: to gather all known facts about the incident.

Method: Interviews, document review, literature review, observation, testing or any other method as appropriate.

3. Determine the chronology of the incident

Aim: to develop a high level complete chronological map of the key facts of the incident.

Method: Collation and synthesis of gathered information using either chronological narratives, timelines, time person grids, or flow charts.

4. Determine care delivery problems (CDP)

Aim: to systematically list the CDPs that lead to the incident. CDPs are usually actions or omissions by staff in the process of care. For example, failure to monitor a patient.

Method: collation and synthesis of gathered information and brainstorming.

5. Identify contributory factors

Aim: to identify and organise the contributing factors for each CDP.

Method: collation of contributing factors using a diagrammatic representation.

6. Making recommendations and developing an action plan

Aim: to develop interventions to tackle the system’s weaknesses.

Method: brainstorm and prioritise organisational actions that impact on the contributory factors.

Find out more

Taylor-Adams S, Vincent C. Systems Analysis of Clinical Incidents: The London Protocol. London: Imperial College, London, 2004.

Incident management resources published by state and territory health departments.

Failure Modes and Effects Analysis

Failure Mode and Effect Analysis

Failure Mode and Effect Analysis (FMEA) is a systematic method of identifying clinical problems before they occur. FMEA does not rely on something going wrong as the trigger for an investigation.

It involves proactive hazard analysis and identifying actions to mitigate the risks. The key questions considered during hazard analysis include:

What could go wrong?
Why would the failure happen?
What would be the consequence of each failure?

FMEA is used for:

Evaluating a new process prior to implementation
Assessing the impact of a proposed change to an existing process
System redesign of high-priority processes where the consequence of failure can be high (for example, radiotherapy or blood transfusion).

Barriers for using FMEA

FMEA is time consuming and resource intensive. On average one FMEA requires six to eight meetings of 1.5 hours duration with around eight participants.

Topics should be well-defined and scoped and there should be reasonable certainty that they are high risk if an investment in FMEA is to be undertaken.

Key steps in a FMEA
1. Define the FMEA Topic New process prior to implementation OR assessing the impact of a proposed change to an existing process OR an identified high risk process.
2. Assemble the team Aim: to develop a chronological map of what is known and the gaps in knowledge of the incident. Method: document review and develop questions based on a guide.
3. Graphically describe the process Aim: identification of all the steps involved in delivering care and gaining a clear picture of the way a specific health service is organised, operated or delivered. Method: Process Mapping- using flow diagrams to create a detailed map of all the processes and sub-processes involved. Use brainstorming, iterations and consensus.
4. Conduct a hazard analysis Aim: to list all possible/potential failure modes for each process step. Method: use triggering questions, brainstorming, cause and effect diagramming to identify potential failure modes. Note: Failure Mode – different ways that a process or sub-process can fail to provide the anticipated result (What could go wrong?). Failure Cause – different reasons as to why a process or sub-process would fail to provide the anticipated result (Why would the failure happen?). Failure Effect – varying results of the failure mode (What would be the consequences of each failure?).
5. Assign a risk score to each failure mode Aim: to assign a numeric score for likelihood of occurrence, likelihood of detection, and severity to each failure mode. Method: brainstorming and use of templates such as severity assessment codes.
6. Identify actions and outcomes measures Aim: determine an action for each failure mode. Method: brainstorm actions to ‘eliminate’, ‘control’, or ‘accept’ the failure mode cause and prioritise these according to risk scores.

Key steps in a FMEA

1. Define the FMEA Topic

New process prior to implementation OR assessing the impact of a proposed change to an existing process OR an identified high risk process.

2. Assemble the team

Aim: to develop a chronological map of what is known and the gaps in knowledge of the incident.

Method: document review and develop questions based on a guide.

3. Graphically describe the process

Aim: identification of all the steps involved in delivering care and gaining a clear picture of the way a specific health service is organised, operated or delivered.

Method: Process Mapping- using flow diagrams to create a detailed map of all the processes and sub-processes involved. Use brainstorming, iterations and consensus.

4. Conduct a hazard analysis

Aim: to list all possible/potential failure modes for each process step.

Method: use triggering questions, brainstorming, cause and effect diagramming to identify potential failure modes.

Note:

Failure Mode – different ways that a process or sub-process can fail to provide the anticipated result (What could go wrong?).

Failure Cause – different reasons as to why a process or sub-process would fail to provide the anticipated result (Why would the failure happen?).

Failure Effect – varying results of the failure mode (What would be the consequences of each failure?).

5. Assign a risk score to each failure mode

Aim: to assign a numeric score for likelihood of occurrence, likelihood of detection, and severity to each failure mode.

Method: brainstorming and use of templates such as severity assessment codes.

6. Identify actions and outcomes measures

Aim: determine an action for each failure mode.

Method: brainstorm actions to ‘eliminate’, ‘control’, or ‘accept’ the failure mode cause and prioritise these according to risk scores.

Find out more

See Institute for Healthcare Improvement or the Department of Veterans Affairs National Center for Patient Safety documents.

Incident management resources published by state and territory health departments.

Australian sentinel events list version 2

Sentinel events are a subset of adverse patient safety events that are wholly preventable and result in serious harm to, or death of, a patient. They are the most serious incidents reported through state and territory incident reporting system.

The purpose of sentinel event reporting is to ensure public accountability and transparency and drive national improvements in patient safety.

Learn more about the Australian sentinel events list

Australian sentinel events (version 2.0)

1	Surgery or other invasive procedure performed on the wrong site resulting in serious harm or death
2	Surgery or other invasive procedure performed on the wrong patient resulting in serious harm or death
3	Wrong surgical or other invasive procedure performed on a patient resulting in serious harm or death
4.	Unintended retention of a foreign object in a patient after surgery or other invasive procedure resulting in serious harm or death
5.	Haemolytic blood transfusion reaction resulting from ABO incompatibility resulting in serious harm or death
6.	Suspected suicide of a patient in an acute psychiatric unit or acute psychiatric ward
7.	Medication error resulting in serious harm or death
8.	Use of physical or mechanical restraint resulting in serious harm or death
9.	Discharge or release of an infant or child to an unauthorised person
10.	Use of an incorrectly positioned oro- or naso- gastric tube resulting in serious harm or death

Specifications

The specifications for the ten national sentinel events were developed to provide clarity about what constitutes a sentinel event. This is intended to aid consistency in reporting.

The Commission has an expert group that oversees local or jurisdictional queries concerning classification of sentinel events. The group consists of clinical, policy and operational experts.

Australian Sentinel Events List (version 2) Specifications

2020

Publication, report or update

Development

The development of versions 2 of the Australian sentinel events list involved an environmental scan and literature review, targeted clinical consultation and broad public consultation.

Australian Sentinel Events List (version 2) Review summary

2020

Publication, report or update

History

The first version of the list was endorsed by Australian Health Ministers in 2002.

In April 2004, Australian health ministers determined that public hospitals should report on sentinel events at the national level. Since 2007, sentinel events have been reported by states and territories in the Productivity Commission’s annual Report on Government Services.

In 2017, the Commission undertook a review of the Australian sentinel events list on behalf of the states, territories and the Commonwealth and, the updated Australian sentinel events list was endorsed by Australian Health Ministers in December 2018.

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For enquiries regarding incident management and sentinel events, please email indicators@safetyandquality.gov.au

Topics

Governance

Measures and indicators

Incident management and sentinel events