CG7 – Managing clinical risks and incidents

Mitigating clinical risk improves the quality of patient care. A clinical risk register identifies and records potential risks so that the practice can take action to reduce the likelihood of risk-related incidents recurring.

Patient safety incidents in clinical care occur in all health settings. Incidents that cause harm are referred to as ’significant clinical incidents’. Those that had the potential to cause harm, but did not, are referred to as ‘near misses’.

Having a system to record and analyse near misses and significant clinical incidents helps practices to identify, implement, and test solutions to reduce the likelihood of recurrence.

It is good practice to share learnings from significant clinical incidents and near misses with the practice team. This could include learnings from positive experiences as well, such as when a system or process prevented a significant clinical incident.

Information about reporting incidents through the Australian open disclosure process can be found at PP7 – Open disclosure and complaints.

The clinical risk register used to identify, monitor and document clinical risk could be a simple tool such as a table or spreadsheet.

After clinical risks have been identified, the practice could develop a risk matrix to assess and define the level of each identified risk (for example, low, moderate, high, extreme) based on a combination of:

• the nature of the harm that could be caused by a particular risk
• the likelihood of an event occurring due to that risk
• the severity of its impact if it were to occur.

To proactively identify, assess, and further mitigate risk, the practice could:

• schedule regular risk management meetings and/or include risk management as a standing agenda item of clinical meetings
• implement continuous quality improvement processes that directly address risk, including risks identified in the risk register, in order to make improvements to care (for example, audits, peer reviews, reviews of clinical guidelines)
• foster a strong safety culture (for example, promote open communication among the practice team that encourages members of the practice team to report risks)
• maintain a clinical governance framework that promotes accountability, transparency, and quality in clinical practice
• provide ongoing risk management training and education to members of the practice team.

A sound approach to managing significant clinical incidents is to foster a ‘just culture’, which recognises significant clinical incidents as opportunities to understand the cause rather than immediately assign blame⁽²⁶⁾. It enables members of the practice team to voice concerns and learn when something has gone wrong without fear of blame or retribution.

To promote a ‘just culture’ and reduce near misses and significant clinical incidents, the practice could:

• develop mechanisms for practitioners to talk to trusted peers and supervisors for advice and support
• implement ‘Plan, do, study, act’ (PDSA) cycles to improve the quality and safety of care
• have the practice’s medical defence or medical indemnity insurer check and approve the process for recording and responding to near misses and adverse events.

If the practice uses artificial intelligence (AI) tools, its incident management process needs to include steps for identifying, documenting, and responding to AI-related issues.

Identifying AI-related issues must not rely solely on feedback or complaints.

Examples of AI-related incidents include:

• incorrect or misleading outputs
• system failures or outages
• breaches of privacy or data handling protocols
• clinician or patient concerns about safety or appropriateness
• unexpected changes in AI behaviour after updates to the software.

If AI tools are provided by third parties, the practice could coordinate with vendors to report issues and track corrective actions.