Statutory Duty of Candour and protections for SAPSE reviews

The Health Legislation Amendment (Quality and Safety) Act 2022 introduces new reforms and amends the Health Services Act 1988, the Ambulance Services Act 1986, the Mental Health Act 2014, the Public Health and Wellbeing Act 2008, and the Health Complaints Act 2016. The following provisions will come into effect on 30 November 2022.

Statutory duty of candour

Relevant health service entities will be required to provide a patient with a Statutory Duty of Candour (SDC) when they have suffered a serious adverse patient safety event (SAPSE) while receiving health services. The SDC builds on the principles and elements of open disclosure within the Australian Open Disclosure Framework, currently used for all cases of harm and near miss.

When a patient has suffered a SAPSE, the health service entity will be legally required to provide the patient, and/or their next-of-kin (NOK)/carer, with:

• a written account of the facts regarding the SAPSE
• an apology for the harm suffered by the patient
• a description of the health service entity's response to the event
• the steps that the health service entity has taken to prevent re-occurrence of the event.

They will also be required to comply with any timelines and requirements set out in the Victorian Duty of Candour Guidelines (legislative instrument). If the event is classified as a sentinel event, they must also comply with any relevant timelines within the Victorian sentinel event guide. 

View the Victorian Duty of Candour Guidelines. 

To assist health service entities determine if an event is a SAPSE including case examples and patient considerations, SCV have developed a Victorian Duty of Candour Framework.
View the Victorian Duty of Candour Framework.

There will be situations where the patient and/or their NOK/carer can opt out of receiving the SDC, which is outlined within the Health Services Act 1988 and the Guidelines. The definition of SAPSE will be within the amending set of regulations. 

SAPSE reviews (protections for reviews)

Adverse event reviews are valuable quality and safety improvement processes, conducted in relation to serious incidents. However, there is evidence to suggest that clinicians are reluctant to provide information to a review for fear of medico-legal consequences. 

Amendments to the Health Services Act 1988 (Act) introduces protections for adverse event reviews, and these protected reviews will be called a SAPSE review. If the provisions within Division 8 of Part 5A of the Act are followed and a SAPSE review panel is formed, the review process including any documents or reports created as part of the SAPSE review, will be protected and not admissible in legal proceedings. There will also be relevant protections for SAPSE review panel members and participants of the SAPSE review.

The resulting SAPSE review report must be offered and produced to the patient and/or their NOK/carer when accepted , and also made available to the Secretary of the Department of Health on request. 

These reforms will help foster a culture where errors and harm are effectively identified and discussed openly, ensure a better understanding of what occurred in regards to the event, and more comprehensive and effective recommendations for improvements. 

Important note: An internal review of all SAPSE is required, however a SAPSE review is not mandatory for all SAPSE. It simply refers to a protected review process. 

View the Protections for serious adverse patient safety event reviews.

Training

We've developed training modules to support health services rolling out the legislative changes. These modules are designed for those implementing the changes and clinicians needing to understand what is required. Access them here. 

If you wish to implement the modules into your own Learning Management System, please contact: dutyofcandour@health.vic.gov.au.

Reporting

Health service entities must ensure they have an appropriate method of collecting evidence of compliance with the SDC. For example, in a clinical incident management system or Electronic Medical Record (EMR). Relevant services must then report their compliance with the SDC quarterly via an AIMS form, through the HealthCollect portal. This form will be available from 1 July 2023, therefore services can submit their shadow reporting data from this date. Otherwise, the first mandatory form will need to be submitted in January 2024.

The four aggregate data points to be included on this form include:

• number of serious adverse patient safety events (SAPSE) occurring within a three (3) month reporting period. For these SAPSE:
  • instances where the SDC was commenced within the six (6) month reporting period (via an initial apology and acknowledgment) 
  • instances where the SDC report was provided by the health service entity within the six (6) month reporting period 
  • instances where the patient opted out of that SDC within the six (6) month reporting period.

An operational guide for health services will be made available on this webpage by May 2023.

Background

SDC and protections for adverse event reviews, as part of a wider culture of change in health services across Victoria, were key recommendations of the Expert Working Group: A statutory duty of candour report. Also see Victorian Government response to the Expert Working Group report.

The expert working group was established to advise on legislative reforms arising from Targeting Zero: Supporting the Victorian hospital system to eliminate avoidable harm and strengthen quality of care after a series of avoidable deaths occurred within Djerriwarrh Health Services. 

“The recommendation that a statutory duty of candour be introduced was made in the context of fostering just cultures in hospitals and health services to encourage open and honest conversations about opportunities for improvement.” (EWG report)

“The Expert Working Group heard that protections are likely to reduce concern about medico-legal risk, and thereby facilitate more robust discussion and analysis during incident reviews, which in turn will lead to more effective quality and safety improvements.” (EWG report)

Watch Dr Charlotte Hopkins, Chief Medical Officer at University Hospitals Sussex discuss how SDC has made a difference in the UK.

Launch video

In the below video, you can watch SCV CEO Prof Mike Roberts officially launch the changes at an online session for health service CEOs, board members and other leaders.

Webinar videos 

• View the Health Legislation Amendment (Quality and Safety) Act 2022 webinar: Metro public health services
• View the Health Legislation Amendment (Quality and Safety) Act 2022 webinar: Rural and regional health services 
• View the Health Legislation Amendment (Quality and Safety) Act 2022 webinar: Private health services
• View the Health Legislation Amendment (Quality and Safety) Act 2022 webinar: Mental health services

Feedback

You can provide us feedback on the training modules and the resources listed on this page to assist us with future edits.