Advisory details
| Item | Details |
|---|---|
| Advisory title | Notification of significant risk |
| Advisory number | D25/02 |
| Version number | 1.0 |
| Publication date | August 2025 |
| Replaces | Nil |
| Compliance | It is mandatory for approved accrediting agencies to implement this Advisory |
| Applicable to |
|
| Key relationship | Digital Mental Health Standards and the Digital Mental Health Modules |
| Attachment(s) | Information requirements of the notification to the Commission |
| Note(s) | Nil |
| Responsible officer | Margaret Banks Director, National Standards Email: AdviceCentre@safetyandquality.gov.au |
| Review date | August 2027 |
Purpose
To describe the requirements for accrediting agencies to notify regulators and the Australian Commission on Safety and Quality in Health Care (the Commission) of significant service user risks identified during the assessment of a digital mental health service provider.
Issue
At assessment, assessors may identify a risk that has the potential to cause service user harm and it is sufficiently likely to occur that immediate action is warranted. Accrediting agencies have signed declarations as part of the conditions of approval to notify the Organisation, the relevant regulator, and the Commission when a significant service user risk is identified during assessment of a Service.
Requirements
Risk is where there is a high probability of a substantial and demonstrable adverse impact for service users if the practice is to continue. In each case, a significant risk will be sufficiently serious to warrant an immediate response to reduce the risks of harm to service users. This may include interventions or changes:
- To systems
- To the clinical care service environment
- To clinical practice
- Where there are unmet actions that impact safety and quality systems.
While the focus of reporting by assessors will be on significant risks of service user harm, it will not necessarily exclude other significant risks.
Where an assessor identifies one or more significant risks that could result in significant harm to service users while they are conducting an assessment, the following actions are to be taken:
- Assessors are to notify both the Organisation and their accrediting agency that a significant risk to service users has been identified
- Assessors and/or the accrediting agency are to discuss immediate action to be taken with the Organisation and require them to develop and submit a plan of action to remedy the risk within 48 hours
- The accrediting agency is to notify the relevant regulator and the Commission within 48 hours that a significant risk to service users has been identified and provide a copy of the action plan as soon as practical.
Completion of the online submission form constitutes notification to the Commission.
Accrediting agencies are to inform the Organisation and include relevant clauses in any contractual arrangements that information on significant risk will be provided to the regulators and the Commission when it is required by regulation, or policy of a government agency.
Attachment: Information requirements of the notification to the Commission
Table 1. Information collected through online form for notification of significant risk
| Category | Information | Notes or conditions |
|---|---|---|
| Accrediting agency information | Accrediting agency contact | Including name, email address and phone number |
| Organisation information | Organisation details | Name and address of the digital mental health service provider |
| Facility ID | ID issued by the Commission | |
| Organisation contact | Including name, title/position and phone number | |
| Assessment information | Standard being assessed | |
| Assessment cycle | Standard assessment, out-of-cycle assessment | |
| Stage | Desktop or verification | |
| Number of assessors | ||
| Date significant risk was identified | ||
| Description of the significant risk | ||
| Relevant actions in the standard | ||
| Action taken by the assessor and/or accrediting agency | ||
| Did the organisation provide an action plan? | Upload the action plan |