The Health Legislation Amendment (Quality and Safety) Act 2022 introduced new reforms and amended 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 came into effect on 30 November 2022.
Statutory duty of candour
Relevant health service entities are 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.
SAPSE reviews (protected 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) introduced 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 SDC compliance data, e.g. in a clinical incident management system or Electronic Medical Record (EMR).
Relevant entities must report their compliance with the SDC quarterly via an AIMS form through the HealthCollect portal. This form became available as of 1 July 2023. Mandatory reporting commenced in Quarter 1 2023-24.
To request a HealthCollect login for a new user or to have this new data collection assigned to an existing HealthCollect user, the staff member must complete the HealthCollect Portal User Request form.
SDC data is to be reported:
- at quarterly intervals
- by the 14th day of the month after the end of each calendar quarter
- for SAPSEs that are identified in one quarter and the SDCs conducted or opted out of in that quarter and the following quarter, arising from those SAPSEs.
Mandatory reporting applies to all SAPSE events: SAPSEs identified within each calendar quarter, and the SDCs for those SAPSEs conducted or opted out of in the six months beginning on the first day of the calendar quarter, must be reported by the 14th day of the month after the end of the 6-month SDC reporting period.
| Quarter SAPSE identified | 6-month period of SDC process | Due date for submission | Reporting Status | Aims Selector Year: | AIMS Selector Period |
|---|---|---|---|---|---|
| Apr-Jun 2024 | Apr-Sep 2024 | 1-14 Oct 2024 | Mandatory | 2023–24 | 4th quarter |
| Jul-Sep 2024 | Jul-Dec 2024 | 1-14 Jan 2025 | Mandatory | 2024-25 | 1st quarter |
| Oct-Dec 2024 | Oct 23-Mar 2025 | 1-14 Apr 2025 | Mandatory | 2024-25 | 2nd quarter |
| Jan-Mar 2025 | Jan-June 2025 | 1-14 Jul 2025 | Mandatory | 2024-25 | 3rd quarter |
| Apr–Jun 2025 | Apr–Sep 2025 | 1–14 Oct 2025 | Mandatory | 2024–25 | 4th quarter |
Statutory Duty of Candour Data Collection Reporting Guidelines have been created to outline the reporting due date, frequency, and what data to report. Information on how to access the HealthCollect portal to submit data, is available in the Agency Information Management System (AIMS) Manual on the AIMS webpage.
View the Statutory Duty of Candour Data Collection Reporting Guidelines.
Background
As part of a wider culture of change in health services across Victoria, SDC and protections for adverse event reviews 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.
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
- View the Statutory Duty of Candour forum (April 2023)
We have created a summary report of the April SDC forum, which includes some additional information. View the SDC Forum summary report.
View the recording of our August 2023 SAPSE and Statutory Duty of Candour forum. You can also view the forum presentation slides.
Feedback
You can provide us feedback on the training modules and the resources listed on this page to assist us with future edits.