Statutory Duty of Candour: Understanding Serious Adverse Events

Although the Statutory Duty of Candour has been in force for nearly three years, many patients remain unaware of their right to receive clear and timely information following an unexpected outcome in their medical care.

This process is particularly important in the context of childbirth, where unexpected adverse events can have significant and lasting impacts. Ensuring openness, accountability, and appropriate support during these times is essential to help families understand what happened and begin to move forward.

This article provides a simplified overview of the key requirements under the Duty of Candour framework, to help patients better understand what they are entitled to when their medical treatment does not go as planned.

What is Statutory Duty of Candour?

The Statutory Duty of Candour came into effect in November 2022 following amendments to the Health Services Act 1988 (Vic). It imposes a legal obligation on health service providers – including public health services, public hospitals, denominational hospitals, private hospitals, day procedure centres, and other prescribed health service establishments – to be open and honest with patients when a Serious Adverse Patient Safety Event (SAPSE) has occurred during their care.

This duty ensures that patients (or their next of kin) are informed about what happened, receive a genuine apology, and are supported through a process of open disclosure.

What is a Serious Adverse Patient Safety Event (SAPSE)?

A Serious Adverse Patient Safety Event refers to an incident that takes place while a patient is receiving health care and, in the reasonable opinion of a registered health practitioner, results in the patient suffering unintended or unexpected serious harm.

In obstetric care, an example of a SAPSE might include a failure to recognise signs of foetal distress during labour. If the hospital does not intervene appropriately and the baby sustains a permanent injury during delivery, this would likely be classified as a SAPSE. In such cases, the mother may also experience significant psychological trauma as a result of the birth experience.

What must the Hospital do when a SAPSE occurs?

SAPSE vs Sentinel Event

A Sentinel Event is a specific type of SAPSE. While all sentinel events fall under the broader category of SAPSEs, they are distinguished by their severity and their underlying causes.

Sentinel events are typically rare but serious incidents that result in a patient’s death or significant physical harm. These events are often linked to systemic failures or deficiencies in the hospital or health service’s processes and procedures. [1]

When a sentinel event occurs, the health service is legally required to make a mandatory notification to Safer Care Victoria.

An example of a sentinel event is when a foreign object, such as a surgical instrument or sponge, is unintentionally left inside a patient after surgery, leading to serious harm or even death.

Sentinel events:

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

Victoria has additional requirements beyond the national framework which includes the following categories:

• clinical process or procedure
• falls
• deteriorating patients
• self-harm
• communication of clinical information
• medical device or equipment
• nutrition
• resource or organisational management
• healthcare associated infection
• patient accidents

Confidentiality

Under the Statutory Duty of Candour, an apology provided to a patient or their family does not constitute an express or implied admission of liability in any civil or disciplinary proceedings.

Additionally, any SAPSE review report or documents prepared specifically for the review process are protected and cannot be used as evidence in any legal action or proceedings before a court, tribunal, board, agency, or any other body or person.

Unfortunately, Brave Legal continues to receive enquiries from patients or their families are unaware of their right to receive information under the Statutory Duty of Candour process.

Even when the process has commenced, delays, particularly in holding the required meetings and providing SAPSE reports, remain a common concern. These delays can add to what is already a distressing experience for those affected.

We hope that, over time, the process becomes more consistent and responsive, allowing families to feel genuinely heard and supported through a clear and open review into their care.

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[1] Regulation 3A of the Health Services (Quality and Safety) Regulations 2020