1. Clinical Governance

Incident management systems and open disclosure

Action 1.11

The health service organisation has organisation-wide incident management and investigation systems, and:

a. Supports the workforce to recognise and report incidents

b. Supports patients, carers and families to communicate concerns or incidents

c. Involves the workforce and consumers in the review of incidents

d. Provides timely feedback on the analysis of incidents to the governing body, the workforce and consumers

e. Uses the information from the analysis of incidents to improve safety and quality

f. Incorporates risks identified in the analysis of incidents into the risk management system

g. Regularly reviews and acts to improve the effectiveness of the incident management and investigation systems

Intent

Clinical incidents are identified and managed appropriately, and action is taken to improve safety and quality.

Reflective questions

How does the health service organisation identify and manage incidents?

How are the workforce and consumers involved in reviewing incidents?

How is the incident management and investigation system used to improve safety and quality?

Key tasks

  • Implement a comprehensive incident management and investigation system for the organisation that:

    • complies with state or territory requirements

    • is appropriately designed, resourced, maintained and monitored

    • clearly designates responsibility for maintaining the system.

  • Train the workforce about the risk management system

  • Inform patients about how they can report risks or concerns.

  • Implement a reporting and management framework to ensure that incident data are used to inform the governing body, the workforce and consumers to drive improvements in safety and quality.

  • Periodically audit the incident management and investigation system to improve its design and performance, and to see whether it is adequately resourced.

Strategies for improvement

Hospitals

Incident reporting can improve safety (especially when it is based on a cycle of quality improvement), improve care processes, change the way clinicians think about risk and raise awareness of good practice. The nature of the risks faced by organisations varies according to the type of organisation and the context of service delivery. This highlights the importance of evaluating the effectiveness of incident management and investigation systems at the local level.1

Review the incident management and investigation system

A well-designed incident management and investigation system should support the workforce to identify, report, manage and learn from incidents. The system should comply with legislative requirements and with state or territory clinical incident management policies.

A well-structured system would generally incorporate the following elements:

  • A clear policy framework that defines the key elements of the system; the roles and responsibilities of individuals and committees; the type of events to be reported; the process for reporting, investigating, analysing and monitoring clinical incidents; and the responsibility of clinicians to report incidents they observe or that arise from the use of healthcare records, including digital healthcare records
  • A focus on managing each incident appropriately from a clinical perspective and ensuring the provision of safe, high-quality care to the patient following the incident, including open disclosure, if appropriate
  • A designated individual with responsibility for maintaining the integrity of the system and coordinating incident management
  • Adequate and appropriate systems (including relevant equipment and technology) to support incident reporting and analysis
  • Workforce responsibilities for managing reported incidents, including grading their severity and leading further investigations
  • Policies, procedures and protocols regarding confidentiality of information and the ability of members of the workforce to report anonymously
  • Responsibilities for analysing incident data, and identifying trends and opportunities for improvement
  • Responsibilities for disseminating information about incidents and their quality improvement implications
  • Responsibilities for following up incidents to ensure that improvements have been made, if appropriate; this may include ensuring that information about relevant incidents is incorporated into the organisation’s risk management processes
  • Responsibilities for reporting incidents to other parties (for example, health departments) under the relevant organisational obligations
  • Links to the organisation’s open disclosure, risk management, and credentialing and scope of clinical practice processes; the state or territory incident management and investigation system, if applicable; and the procedure for communicating with the organisation’s professional indemnity insurers.

Support the workforce

Leaders, including clinical leaders, should encourage the workforce to use the incident management system to report clinical incidents, near misses and adverse events.

Engaging the workforce to find solutions to issues is important for improving safety1, especially when the improvement actions require coordination across teams or departments.

Provide information about the intent and use of the organisation’s incident management and investigation systems to the workforce at orientation and routinely throughout their employment.

Support patients, carers and families

Support patients, carers and families to communicate their concerns by:

  • Distributing information to patients and carers about what incidents and concerns are, and how to report them
  • Training the workforce on how to respond to patients or carers who raise concerns or report incidents
  • Providing, when possible, appropriately skilled members of the workforce to liaise with patients or carers who report concerns or incidents
  • Conducting patient experience surveys or seeking feedback on safety incidents on discharge
  • Providing information about improvement activities that have been implemented based on patient feedback.

Report on, and review, incidents

Provide comprehensive information to the governing body and management on all serious incidents, and summary information about all other incidents. Include information such as the actions taken as a result of a specific incident or category of incidents, and indicators such as time to complete actions stemming from incident reports. This will enable governing bodies and management to fulfil their governance responsibilities.

Define a reporting framework that clearly identifies the data that will be available and reported at each level in the organisation. This will enable members of the workforce and the governing body to monitor and respond to system performance.

Ensure that the system facilitates timely and effective review of information about clinical incidents, and that information is used at all levels of the organisation to improve the safety and quality of care.

Ensure that each incident is reviewed by the clinicians involved and the manager responsible for the operational area in which the incident occurred. This enables lessons to be learned and local improvements to be implemented. A system to verify that managers follow up incidents appropriately will ensure integrity of the risk management system.

Set up classification and escalation processes to ensure that serious incidents, and incidents associated with major risk are managed appropriately, including external reviews, it required.

Periodically review the design and performance of the incident management and investigation system. The governing body should consider whether it complies with best-practice design principles, and whether enough resources have been allocated to support effective clinical governance and risk management.

The workforce and consumers can be involved in the review of clinical incidents through:

  • Regular review of reports or data analysis on clinical incidents
  • Periodic review of incident management and investigation systems to ensure that they are effective in improving safety.

Examples of evidence

Select only examples currently in use:

  • Incident management and investigation system in which clinical incidents are documented, analysed and reviewed
  • Policy documents for reporting, investigating and managing clinical incidents
  • Information on clinical incidents, adverse events and near misses, and the actions taken to manage identified risks that are incorporated into the health service organisation’s risk management system or quality improvement plan
  • Training documents on recognising, reporting, investigating and analysing incidents, adverse events and near misses
  • Committee and meeting records that describe the incident management and investigation system, and the strategies and actions to reduce risk
  • Committee and meeting records that show workforce and consumer involvement in the analysis of organisational safety and quality performance data
  • Clinical incident reporting forms and tools that are accessible to the workforce and consumers
  • Information and resources that support the workforce and consumers to report clinical incidents
  • Feedback from the workforce and consumers regarding their involvement in the review and analysis of organisational safety and quality performance data
  • Examples of specific improvement activities that have been implemented and evaluated to reduce the risk of incidents identified through the incident management and investigation system
  • Results of completed clinical incident investigations
  • Audit results of compliance with the incident management and investigation system.
Day Procedure Services

Incident reporting can improve safety (especially when it is based on a cycle of quality improvement), improve care processes, change the way clinicians think about risk and raise awareness of good practice. The nature of the risks faced by organisations varies according to the type of organisation and the context of service delivery. This highlights the importance of evaluating the effectiveness of incident management and investigation systems at the local level.1

Review the incident management and investigation system

A well-designed incident management and investigation system should support the workforce to identify, report, manage and learn from incidents. The system should comply with legislative requirements and with state or territory clinical incident management policies.

A well-structured system would generally incorporate the following elements:

  • A clear policy framework that defines the key elements of the system; the roles and responsibilities of individuals and committees; the type of events to be reported; the process for reporting, investigating, analysing and monitoring clinical incidents; and the responsibility of clinicians to report incidents they observe or that arise from the use of healthcare records, including digital healthcare records
  • A focus on managing each incident appropriately from a clinical perspective and ensuring the provision of safe, high-quality care to the patient following the incident, including open disclosure, if appropriate
  • A designated individual with responsibility for maintaining the integrity of the system and coordinating incident management
  • Adequate and appropriate systems (including relevant equipment and technology) to support incident reporting and analysis
  • Workforce responsibilities for managing reported incidents, including grading their severity and leading further investigations
  • Policies, procedures and protocols regarding confidentiality of information and the ability of members of the workforce to report anonymously
  • Responsibilities for analysing incident data, and identifying trends and opportunities for improvement
  • Responsibilities for disseminating information about incidents and their quality improvement implications
  • Responsibilities for following up incidents to ensure that improvements have been made, if appropriate; this may include ensuring that information about relevant incidents is incorporated into the organisation’s risk management processes
  • Responsibilities for reporting incidents to other parties (for example, health departments) according to relevant organisational obligations
  • Links to the organisation’s open disclosure, risk management, and credentialing and scope of clinical practice systems; the state or territory incident management and investigation system, if applicable; and the procedure for communicating with the organisation’s professional indemnity insurers.

Support the workforce

Leaders, including clinical leaders, should encourage the workforce to use the incident management and investigation system to report clinical incidents, near misses and adverse events.

Engaging the workforce to find solutions to issues is important for improving safety1, especially when the improvement actions require coordination across teams or departments.

Support patients, carers and families

Support patients, carers and families to communicate their concerns by:

  • Distributing information to patients and carers about what incidents and concerns are, and how to report them
  • Training the workforce on how to respond to patients or carers who raise concerns or report incidents
  • Providing, when possible, appropriately skilled members of the workforce to liaise with patients or carers who report concerns or incidents
  • Conducting patient experience surveys or seeking feedback on safety incidents on discharge
  • Providing information about improvement activities that have been implemented based on patient feedback.

Report on, and review, incidents

Provide comprehensive information to the governing body and management on all serious incidents, and summary information about all other incidents. Include information such as the actions taken as a result of a specific incident or category of incidents, and indicators such as time to complete actions stemming from incident reports. This will enable governing bodies and management to fulfil their governance responsibilities.

Ensure that each incident is reviewed by the clinicians involved and the manager responsible for the operational area in which the incident occurred. This enables lessons to be learned and local improvements to be implemented. A system to verify that managers follow up incidents appropriately will ensure integrity of the risk management system.

Set up classification and escalation processes to ensure that serious incidents, and incidents associated with major risks are managed appropriately, including external reviews, if required.

Periodically review the design and performance of the incident management and investigation system. The governing body should consider whether it complies with best-practice design principles, and whether enough resources have been allocated to support effective clinical governance and risk management.

Examples of evidence

Select only examples currently in use:

  • Incident management and investigation system in which clinical incidents are documented, analysed and reviewed
  • Policy documents for reporting, investigating and managing clinical incidents
  • Information on clinical incidents, adverse events and near misses, and the actions taken to manage identified risks that are incorporated into the health service organisation’s risk management system or quality improvement plan
  • Training documents on recognising, reporting, investigating and analysing incidents, adverse events and near misses
  • Committee and meeting records that describe the incident management and investigation system, and the strategies and actions to reduce risk
  • Committee and meeting records that show workforce and consumer involvement in the analysis of organisational safety and quality performance data
  • Clinical incident reporting forms and tools that are accessible to the workforce and consumers
  • Information and resources that support the workforce and consumers to report clinical incidents
  • Feedback from the workforce and consumers regarding their involvement in the review and analysis of organisational safety and quality performance data
  • Examples of specific improvement activities that have been implemented and evaluated to reduce the risk of incidents identified through the incident management and investigation system
  • Results of completed clinical incident investigations
  • Audit results of compliance with the incident management and investigation system.
MPS & Small Hospitals

MPSs or small hospitals that are part of a local health network or private hospital group should adopt or adapt the established incident management and investigation system.

Small hospitals that are not part of a local health network should develop or adapt an incident management and investigation system, and ensure that it:

  • Complies with state or territory requirements
  • Is appropriately designed, resourced, maintained and monitored
  • Clearly designates responsibility for maintaining the system
  • Manages each incident from a clinical perspective.

Organisations should have a clear policy framework that defines the key elements of the system, and the roles and responsibilities of individuals and committees. The framework should describe the type of events to be reported, and the process for reporting, investigating, analysing and monitoring clinical incidents. It should also include the responsibility of clinicians to report incidents they observe or that arise from the use of healthcare records, including digital healthcare records.

Organisations need to ensure that:

  • The workforce is trained in the assessment and use of the risk management system
  • Patients are informed about and supported to report risks or concerns
  • A reporting and management framework is implemented to routinely report incident data to the governing body, the workforce and consumers, and to drive improvements in safety and quality
  • The incident management and investigation system is periodically audited to improve its design and performance, and to determine if it is adequately resourced
  • Processes are in place to ensure the confidentiality of information and the ability of the workforce to report anonymously
  • Analysis of incident data is used to identify trends and opportunities for improvement, and is disseminated to the workforce and consumers
  • The incident management and investigation system is linked to the organisation’s open disclosure, risk management, credentialing and scope of clinical practice processes; the state or territory incident management and investigation system, if applicable; and the procedure for communicating with the organisation’s professional indemnity insurers.

Examples of evidence

Select only examples currently in use:

  • Incident management and investigation system in which clinical incidents are documented, analysed and reviewed
  • Policy documents for reporting, investigating and managing clinical incidents
  • Information on clinical incidents, adverse events and near misses, and the actions taken to manage identified risks that are incorporated into the health service organisation’s risk management system or quality improvement plan
  • Training documents on recognising, reporting, investigating and analysing incidents, adverse events and near misses
  • Committee and meeting records that describe the incident management and investigation system, and the strategies and actions to reduce risk
  • Committee and meeting records that show workforce and consumer involvement in the analysis of organisational safety and quality performance data
  • Clinical incident reporting forms and tools that are accessible to the workforce and consumers
  • Information and resources that support the workforce and consumers to report clinical incidents
  • Feedback from the workforce and consumers regarding their involvement in the review and analysis of organisational safety and quality performance data
  • Examples of specific improvement activities that have been implemented and evaluated to reduce the risk of incidents identified through the incident management and investigation system
  • Results of completed clinical incident investigations
  • Audit results of compliance with the incident management and investigation system.

Action 1.12

The health service organisation:

a. Uses an open disclosure program that is consistent with the Australian Open Disclosure Framework

b. Monitors and acts to improve the effectiveness of open disclosure processes

Intent

An open disclosure process is used to enable the health service and clinicians to communicate openly with patients following unexpected healthcare outcomes and harm.

Reflective questions

How are clinicians trained and supported to discuss with patients incidents that caused harm?

How is information from the open disclosure program used to improve safety and quality?

Key tasks

  • Adopt and implement the Australian Open Disclosure Framework in a way that reflects the context of service provision.

  • Ensure that members of the workforce who will be involved in open disclosure are trained.

  • Periodically conduct audits that focus on the management of clinical incidents and consistency with the Australian Open Disclosure Framework.

Strategies for improvement

Hospitals

Open disclosure is a discussion with a patient or carer about an incident that resulted in harm to the patient. Open disclosure is:

  • A patient and consumer right
  • An essential professional requirement and institutional obligation
  • A normal part of an episode of care should the unexpected occur
  • An attribute of a high-quality service organisation and an important part of healthcare quality improvement.

An open disclosure discussion should include:

  • The elements of an apology or expression of regret (including the word ‘sorry’)
  • A factual explanation of what happened
  • An opportunity for the patient to relate their experience
  • An explanation of the steps being taken to manage the event and prevent a recurrence.

Governing bodies should lead the implementation of an effective open disclosure program by:

  • Requiring organisations to adopt the Australian Open Disclosure Framework
  • Ensuring that enough resources are allocated to support implementation of the framework
  • Ensuring that the responsibility for implementing the framework is allocated to an individual or committee
  • Ensuring that there is a system in place for monitoring compliance with the framework; all variations from the framework should be investigated and addressed
  • Reviewing regular reports on open disclosure to ensure that the principles and processes of the framework are met
  • Leading a ‘just culture’ marked by openness and constructive learning from mistakes.

Health service organisations implementing an open disclosure program should:

  • Develop or adapt policies, procedures or protocols that are consistent with the Australian Open Disclosure Framework
  • Implement a monitoring and reporting process for open disclosure events to ensure that they are followed up and improvements are actioned
  • Review open disclosure events to find out how the open disclosure program could be improved
  • Provide access to training and support for relevant members of the workforce who have responsibility for managing issues involving open disclosure within the organisation
  • Provide access to, or require proof of, training for any credentialed clinicians who will be involved in open disclosure processes
  • Learn from system errors that culminate in poor patient outcomes.

Examples of evidence

Select only examples currently in use:

  • Policy documents that are consistent with the principles and processes outlined in the Australian Open Disclosure Framework
  • Reports on open disclosure that are produced by the health service organisation
  • Information and data on open disclosure presented to the governing body and relevant committees
  • Committee and meeting records about issues and outcomes relating to open disclosure.

See the Australian Open Disclosure Framework web page for more information.

Day Procedure Services

Open disclosure is a discussion with a patient or carer about an incident that resulted in harm to the patient. Open disclosure is:

  • A patient and consumer right
  • An essential professional requirement and institutional obligation
  • A normal part of an episode of care should the unexpected occur
  • An attribute of a high-quality service organisation and an important part of healthcare quality improvement.

An open disclosure discussion should include:

  • The elements of an apology or expression of regret (including the word ‘sorry’)
  • A factual explanation of what happened
  • An opportunity for the patient to relate their experience
  • An explanation of the steps being taken to manage the event and prevent a recurrence.

Health service organisations implementing an open disclosure program should:

  • Develop or adapt policies, procedures or protocols that are consistent with the Australian Open Disclosure Framework
  • Ensure that responsibility for implementing the framework is allocated to an individual or committee
  • Ensure that a system is in place for monitoring compliance with the framework; all variations from the framework should be investigated and addressed
  • Review regular reports on open disclosure to ensure that the principles and processes of the framework are met
  • Provide training and support for the relevant members of the workforce who will be involved in open disclosure in the organisation, including those responsible for managing open disclosure issues.

In a day procedure service, open disclosure incidents are most likely to occur in the theatre setting, and involve the surgeon or anaesthetist. The organisation should ensure that credentialed medical and other practitioners are aware of policies, procedures, protocols and by-laws regarding open disclosure, and cover this requirement through their contractual arrangements.

The performance of credentialed medical and other practitioners who participate in open disclosure incidents should be monitored by a medical advisory committee or through the incident management and investigation system.

Examples of evidence

Select only examples currently in use:

  • Policy documents that are consistent with the principles and processes outlined in the Australian Open Disclosure Framework
  • Reports on open disclosure that are produced by the health service organisation
  • Information and data on open disclosure presented to the governing body and relevant committees
  • Committee and meeting records about issues and outcomes relating to open disclosure.

See the Australian Open Disclosure Framework web page for more information.

MPS & Small Hospitals

MPSs or small hospitals that are part of a local health network or private hospital group should adopt or adapt the established open disclosure framework.

Small hospitals that are not part of a local health network or private hospital group should develop or adapt and implement the Australian Open Disclosure Framework in a way that reflects the context of services provided.

An open disclosure discussion should include:

  • The elements of an apology or expression of regret (including the word ‘sorry’)
  • A factual explanation of what happened
  • An opportunity for the patient to relate their experience
  • An explanation of the steps being taken to manage the event and prevent a recurrence.

Health service organisations implementing an open disclosure program should:

  • Develop or adapt policies, procedures or protocols that are consistent with the Australian Open Disclosure Framework
  • Ensure that responsibility for implementing the framework is allocated to an individual or committee
  • Ensure that a system is in place for monitoring compliance with the framework; all variations from the framework should be investigated and addressed
  • Review regular reports on open disclosure to ensure that the principles and processes of the framework are met
  • Periodically conduct audits that focus on the management of clinical incidents and consistency with the Australian Open Disclosure Framework
  • Provide training and support for the relevant members of the workforce who will be involved in open disclosure in the organisation, including those responsible for managing open disclosure issues.

Examples of evidence

Select only examples currently in use:

  • Policy documents that are consistent with the principles and processes outlined in the Australian Open Disclosure Framework
  • Reports on open disclosure that are produced by the health service organisation
  • Information and data on open disclosure presented to the governing body and relevant committees
  • Committee and meeting records about issues and outcomes relating to open disclosure.

See the Australian Open Disclosure Framework web page for more information.

Last updated 30th May, 2018 at 09:35pm
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References

Anderson JE, Kodate N, Walters R, Dodds A. Can incident reporting improve safety? Healthcare practitioners’ views of the effectiveness of incident reporting. Int J Qual Health Care 2013;25(2):141–50.