On 30 June 2022, the CQC updated its guidance on the duty of candour. Under Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, registered persons (providers and registered managers) have a duty to act in an open and transparent way with relevant persons in relation to care and treatment provided to service users. Regulation 20 also defines ‘notifiable safety incidents’ and specifies how registered persons must apply the duty of candour if these incidents occur. This statutory duty of candour was brought into law in 2014 for NHS Trusts and 2015 for all other providers and the CQC regard it as an underpinning aspect of a safe, open and transparent culture.
The CQC’s updated guidance clarifies how the term ‘unexpected or unintended’ should be applied when defining whether something qualifies as a notifiable safety incident.
Notifiable Safety Incident
A notifiable safety incident must meet all 3 of the following criteria:
- It must have been unintended or unexpected.
- It must have occurred during the provision of an activity that the CQC regulate.
- 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 the above criteria are not met, it is not a notifiable safety incident. However, the overarching duty of candour, to be open and transparent, always applies.
A copy of the CQC’s guidance can be accessed using this link:
The duty of candour is one of the fundamental standards and the CQC has said that it is an area of regulation which it pays “special attention to.” It is therefore important that service providers have a strong grasp of the criteria “unexpected or unintended” in relation to notifiable safety incidents.