Guidelines for the investigation of clinical incidents across health service boundaries

Background

Safety and quality is central to the delivery of health care, with a basic principle of do no harm.

However, errors and mistakes do occur and in these circumstances it is vital that health service personnel learn from these clinical incidents.

In doing this, it is possible that hazards can be identified and treated before they cause harm, with future hazards avoided or eliminated altogether.

In order to learn from clinical incidents, they must be rigorously evaluated and the potential causes for the incidents sought using standardised methodologies.

For example, the Clinical Incident Management Policy states that root cause analysis (RCA), or similar methodology, is used to investigate those clinical incidents with the highest severity assessment code (SAC 1) OD 0611/15 (external site).

Typically the analysis of a clinical incident is conducted by staff with a delegated authority at the hospital/health service where the incident occurred.

(Note: for the purpose of this information the terms ‘hospital/health service’ refers to any service providing health care to patients/consumers in either an inpatient/outpatient or community setting.)

Multi-agency events are defined as events that have resulted during a patient’s journey across multiple health systems, where the transitions in care may have contributed to an adverse outcome for the patient.

Examples of when multi-agency events can include, but are not limited to:

  • transferring a patient between rural and metropolitan hospitals
  • where a patient receives a combination of both private and public health care.

A review of sentinel multi-agency events conducted for the peak incident review committee (PIRC), found that 4 per cent of the total number of sentinel events notified during 1 July 2009 to 15 August 2011 in Western Australia were multi-agency events.

All of these identified events resulted in death of a patient. Contributing factors that were identified included:

  • delays in treatment
  • transportation issues
  • patient management issues
  • clinical co-ordination issues
  • access to resources
  • need for improved communication
  • need for improved policy.

In the circumstances of a multi-agency event, it is often unclear:

  • where the responsibility for the analysis lies
  • how exactly the analysis should be conducted.

In the past, multi-agency events tended to be investigated by each hospital/health service separately, with limited sharing of knowledge, information and outcomes.

However, multi-agency approaches can provide opportunities for engagement in a joint review of the event and shared learning across the health system.

This can enable the development of quality improvement measures and recommendations with system-wide benefits, reflecting the best care possible for the patient within and between agencies.

The Guidelines for the investigation of clinical incidents across health service boundaries (the Guidelines) have been developed to support the collaborative investigation of clinical incidents (SAC 1) associated with more than one health service provider.

The Guidelines are not exhaustive and can be modified to suit local circumstances and the investigative requirements of differing multi-agency events.

Purpose of the guidelines

The Clinical Incident Management Policy states, “for complex clinical incidents involving a number of hospitals and health service providers, all organisations are to be consulted and are expected to participate in a collaborative investigation plan”.

These guidelines have been developed to support the Clinical Incident Management Policy and aim to:

  • outline the principles that should be adhered to when conducting joint investigations of multi-agency events
  • establish guidelines for joint investigations of multi-agency events; and
  • outline how such investigations should be conducted and who should be involved.

Scope

In accordance with the Clinical Incident Management Policy, it is a requirement that all SAC 1 clinical incidents within public hospitals/health services and private licensed/contracted health facilities/services are notified and investigated.

All hospitals/health services are required to maintain systems and processes that provide a consistent approach to clinical incidents including:

  • the investigation
  • analysis
  • reporting
  • monitoring.

The Guidelines therefore apply to all:

  • public hospitals/health services
  • private licensed health facilities
  • contracted health services.

In addition, the Guidelines can be utilised with other non-government care providers, not mandated by the Department of Health to participate in clinical incident management but who have a commitment to patient safety and may voluntarily participate in multi-agency event investigation (for example, Royal Flying Doctor Service).

The inclusive approach promoted by the Guidelines aims to:

  • ensure the development of effective recommendations to address system issues at multiple points across the health system.
  • facilitate the inclusion of transport providers as well as non-government health care providers.

Principles

The principles of the Clinical Incident Management Policy are clearly important to the process of investigations across health service boundaries. These principles include:

  • transparency
  • accountability
  • probity/fairness
  • open just culture
  • obligation to act
  • prioritisation of events.

In particular when conducting analysis of multi-agency events, it is critical that the following principles are also taken into account:

  • A no blame reporting culture is adopted, with a collaborative approach from the outset of the investigation.
  • A lead investigator is appointed, who will take responsibility for the whole investigation.
  • The investigation should be conducted with the view of developing recommendations that are aimed at system improvement and addressing causative factors.
  • Recommendations should be thoroughly implemented and any lessons learned should be shared.

Conducting the investigation

While the Patient Safety Surveillance Unit (PSSU) can provide advice and direction to hospitals/health services seeking to conduct joint investigations following the notification of multi-agency events, the following information may also be of assistance in navigating this process.

Notification of SAC 1 event to the Patient Safety Surveillance Unit

Often multi-agency events come to the attention of the major tertiary hospitals following the deterioration of patients requiring specialist services or an escalation in care.

While the adverse outcome for the patient (such as death/serious harm) associated with the multi-agency event may occur or be identified at the tertiary hospital, clinical incidents may have transpired at other hospitals/health services providing care prior to the transfer.

Where a hospital/health service identifies that serious harm or death is/could be caused by health care rather than the patients underlying condition or illness (SAC1) and that this may have occurred at another health service, steps should be taken to inform that health service.

An appropriate senior health professional (for example director of clinical services or director safety and quality, or similar) should contact the health service/s involved to:

  • provide information about the adverse patient outcome
  • discuss concerns regarding the provision of care possibly contributing to the outcome
  • inform that a SAC 1 event has been identified and notified to the Patient Safety Directorate
  • discuss and plan the investigation of the incident.

Where a SAC 1 event has been notified to the PSSU by one health service however after initial review it is determined that another health service is to take the lead in the investigation or is associated with the clinical incident, the notifying health service can be amended accordingly.

Lead investigator

The Clinical Incident Management Policy states:

“The last hospital/health service providing care (for example rural or metropolitan hospital, Mental Health Service, transport providers, Hospital in the Home or Rehabilitation in the Home Programs) will be responsible for initiating the clinical incident review and engaging other organisations involved in the care of the patient/consumer in establishing the investigation.”

However, it is possible that after an initial review and while establishing the investigation process, it may become apparent that the last hospital/health service to provide care may not be the most relevant to lead the joint investigation (for example, the last hospital/health service may not have been where the clinical incidents occurred).

In addition, an Area Health Service may not necessarily be the best hospital/health service to lead on every investigation, and it is possible that other relevant agencies (WA Health or other) are more appropriate to lead certain investigations.

The final choice of hospital/health service lead for the investigation should be a joint decision made by all the service providers associated with the multi-agency event.

The PSSU may be contacted for support where agreement cannot be reached regarding the appointment of a lead investigator.

Team members

Once the lead investigator has been established, and agreement has been obtained from all service providers associated with the multi-agency event, a team needs to be established to conduct the investigation. Members of the team should be invited on the basis of their:

  • capacity to represent their hospital/health service
  • expertise appropriate to the clinical incident investigation
  • ability to lead individual hospital/health service investigations
  • ability to instigate quality improvement initiatives.

Procedure

The following process serves as a guide for those involved in a multi-agency investigation of a clinical incident:

1. Each hospital/health service should be provided with:

  • A letter of confirmation from the lead hospital/health service regarding:
    • participation in the investigation
    • suggested nominees/representatives
    • ground rules for the investigation process.
  • The Guidelines for the investigation of clinical incidents across multiple hospital/health service boundaries.
  • Relevant clinical documentation and a chronology of events (as known) developed by the lead hospital/ health service.

2. Within a specified time frame (for example, a 2-week period or as agreed by all) each hospital/health service should conduct its own root cause analysis/clinical review relating to any events that occurred within its own service/area.

At this stage, each hospital/health service should focus on identifying any hospital/health service specific system level improvements that could be made.

3. All agencies will then attend a multi-agency meeting (joint review session) at which:

  • The event as a whole will be outlined and discussed, with input from each hospital/health service, the aim of which is to clarify the details and confirm the chronology of the events.
  • System level vulnerabilities will be identified and agreed upon and each hospital/health service will outline planned quality improvements.
  • Each hospital/health service will be invited to comment on emerging issues/ perspectives and planned quality improvements will be summarised.

4. Subsequent to the joint review session, each hospital/health service will have the opportunity to review and refine any quality improvement actions they intend to implement and forward these to the lead hospital/health service investigation facilitator.

5. If necessary, a second meeting will take place at which agencies will share their final quality improvement plans.

Agencies will take responsibility for tracking their own implementations, with an understanding that only once each hospital/health service confirms implementation will the event be closed.

6. A final event report, incorporating the recommendations for quality improvement from all agencies will then be compiled by the lead hospital/health service.

After endorsement from all members of the multi-agency investigation team, the report will be submitted by the lead hospital/health service to the Patient Safety Surveillance Unit for review by the Peak Incident Review Committee (PIRC).

7. Members of the multi-agency investigation team will be reminded that each individual hospital/health service has responsibility for tracking implementation and evaluating the quality improvements.

The PSSU routinely seeks updates from hospitals/health services on the implementation of recommendations on a 6 monthly basis.

The request for an update will be directed to the lead hospital/health service.

Confidentiality and open disclosure

Open disclosure is a key element of managing clinical incidents.

In circumstances where an event is multi-agency there may be issues concerning the open disclosure of the event and the provision of information (including investigation outcomes) to the patient and their nominated relatives/carers.

It is important to coordinate the open disclosure process between all of the agencies involved and ensure that the process is managed accordingly.

There are also potentially important considerations to note about patient confidentiality when undertaking multi-agency investigations.

For further advice with regards to patient confidentiality in a multi-agency investigation, the Department of Health, Legal and Legislative Services Directorate or the State Solicitor’s Office should be consulted as appropriate.

Qualified privilege

The Clinical Incident Management Policy states that the Health Services (Quality Improvement) Act 1994 (external site) provides a framework to facilitate the investigation of clinical incidents.

Investigations are conducted through an approved quality improvement committee established in accordance with the Act.

If a clinical incident, that is to be investigated, occurs over different sites with approved committees, a decision will need to be made as to the appropriate committee to investigate the incident.

Alternatively, hospitals/health services may decide to conduct an investigation outside of the framework established by the Act.

Read more about qualified privilege and the Health Services (Quality Improvement Act) 1994.

Acknowledgements

The PSSU would like to acknowledge the expert advice provided from the WA Country Health Service Area Office Safety Quality and Performance Team in the development of these Guidelines.

More information

Patient Safety Surveillance Unit
Phone: 9222 2238
Email: pssu@health.wa.gov.au

Produced by

Patient Safety Surveillance Unit