CQC duty of candour guidance - Regulation 20 (updated 30 June 2022)

Summary

This guidance was updated on the 30 June 2022 to clarify how healthcare professionals should apply the term “unexpected or unintended” to decide if something qualifies as a notifiable safety event or not. Further detail is included below and you can find the full update here.

Content

Notifiable safety incidents

‘Notifiable safety incident’ is a specific term defined in the duty of candour regulation. It should not be confused with other types of safety incidents or notifications.

A notifiable safety incident must meet all 3 of the following criteria:

1. It must have been unintended or unexpected.
2. It must have occurred during the provision of an activity the CQC regulate.
3. In the reasonable opinion of a healthcare professional, already has, or might, result in death, or severe or moderate harm to the person receiving care. This element varies slightly depending on the type of provider.

If any of these three criteria are not met, it is not a notifiable safety incident (but remember that the overarching duty of candour, to be open and transparent, always applies).

You should interpret "unexpected or unintended " in relation to an incident which arises in the course of the regulated activity, not to the outcome of the incident. By "regulated activity" we mean the care or treatment provided. By "outcome" we mean the harm that occurred or could have occurred. So, if the treatment or care provided went as intended, and as expected, an incident may not qualify as a Notifiable Safety Incident, even if harm occurred.

This does not mean that known complications or side effects of treatment are always disqualified from being Notifiable Safety Incidents. In every case, the healthcare professionals involved must use their judgement to assess whether anything occurred during the provision of the care or treatment that was unexpected or unintended.

The definitions of harm vary slightly between health service bodies and all other providers. This is because when the regulation was written, harm thresholds were aligned with existing notification systems to reduce the burden on providers.

It is possible for an incident to trigger the harm threshold for NHS trusts, but not for other service types, or vice versa.