Statutory Duty of Candour

As of 30 November 2022, Victorian health services entities have a statutory “duty of candour” (SDC), following amendments to the Health Services Act 1988 (Vic) (the Act).

This statutory obligation applies to public health services, public hospitals, denominational hospitals and extends further to private hospitals, day procedure centres, and other prescribed health service establishments.

The SDC applies where a patient suffers a serious adverse patient safety event (SAPSE), meaning an event that:

(a) resulted in harm to one or more individuals;
(b) occurred while the patient was receiving health services from a health service entity (including an event identified following the patient’s discharge); and
(c) in the reasonable opinion of a registered health practitioner, resulted in, or is likely to result in, unintended or unexpected harm being suffered by the patient.

Unless the patient has opted out, where a patient suffers a SAPSE, health service entities must provide the patient, or their next-of-kin or carer, with:

(a) a written account of the facts regarding the SAPSE;
(b) a genuine apology for the harm suffered by the patient;
(c) a description of the health service entity’s response to the event; and
(d) the steps that the health service entity has taken to prevent reoccurrence of the event.

The Victorian Duty of Candour Guidelines promulgated by the Minister for Health set out detailed steps and strict timelines regarding this duty, including obligations to:

(a) provide a genuine apology within 24 hours;
(b) organise a meeting with the patient within three business days of the SAPSE being identified; and
(c) hold the meeting within 10 business days.

The meeting must include:

(a) a factual explanation of what occurred;
(b) an apology for the harm suffered by the patient;
(c) an opportunity for the patient to relate their experience and to ask questions;
(d) an explanation of the steps that will be taken to review the SAPSE and any immediate improvements that have been made; and
(e) any implications and follow-up for the patient.

A copy of the meeting report must be provided to the patient within 10 days of the meeting taking place. The amendments also provide that when a SAPSE occurs a health service entity may appoint a SAPSE Review Panel, and must do so if directed to by the Secretary of the Department of Health. The panel cannot include a person directly involved in the SAPSE. Where a health service entity receives a report from a SAPSE panel, the entity must offer copies of the report to the patient, the patient’s nominated person and next of kin or carer where those persons have sufficient personal or professional interest in the report. The Act also contains protections limiting the use of a SAPSE Review Panel report.

Health services have been, and still are, subject to the existing Australian Open Disclosure Framework. The 2016 Hospital Safety and Quality Assurance review in Victoria — the Targeting Zero report — found there was a widespread lack of compliance within Victorian Health services with the principles of open disclosure. That report recommended introducing a statutory duty of candour to ensure that any person harmed while receiving care in a hospital was informed of the fact and apologised to by an appropriately trained  professional in a manner consistent with the national Open Disclosure Framework.

Issues to note

The apology will not constitute an implied admission of liability in civil or disciplinary proceedings.

Factual statements, including the written reports of SDC meetings, are not privileged or protected.

Resourcing issues will no doubt arise within health service entities in attempting to ensure compliance with the SDC, including whether there are adequate, appropriately trained, staff and adequate reporting systems.

The SDC process is not mandatory — a patient can opt out. Provided that the health service entity asks the patient to sign a statement to this effect and provides a point of contact should the patient wish to participate in the SDC process in the future, the health service entity does not have to comply further with the SDC process.

If it is identified during the SDC process that an  individual health practitioner has acted in a way that constitutes notifiable conduct under the Health Practitioner Regulation National Law Act 2009, a staff member of the health entity must submit a concern to the Australian Health Practitioner Regulation Agency (Ahpra).

Unless directed to do so by the Secretary of the Department of Health, it is a matter for the health service entity to decide whether to  establish a SAPSE Review Panel in a particular case, or to investigate by some other means. Factors relevant to that decision will include resourcing, and the relative utility of a Review Panel report compared with a report generated through existing quality  assurance mechanisms.

The SDC process may have the potential to reduce notifications to Ahpra that arise from complaints made by patients or their families where they feel that they have not been able to obtain an explanation or an apology following an adverse outcome.

Despite the fact that an apology cannot be taken to be an admission of fault, the SDC process could lead to an increase in civil claims, as hospitals are obliged to provide patients and their families with factual descriptions and explanations of serious and moderately serious adverse events. Patients’ medical records are discoverable.

Established quality assurance activities in many health services include peer discussion of patient outcomes in regular Morbidity and Mortality meetings which facilitate shared learning and practice improvement. Records of such quality assurance meetings are protected by qualified privilege under the Health Services Act 1988 to enable open discussion between practitioners. Health service entities should consider how the existing quality assurance processes and the SDC processes should relate to one another.

The process will likely be a bureaucratic one, carried out by hospital administrators and consumer relations officers, not by the treating doctors. It will be important to ensure that treating doctors (who may be liable to be notified to Ahpra or be sued in the civil courts as a consequence) have sufficient input in the process and in the terms of descriptions, explanations and apologies to ensure that they  accurately reflect the clinical circumstances.

 

This article was co-authored by Cara Cross, Paralegal, and originally published in the 2023 winter edition of AMA Victoria's VicDoc magazine.