The statutory duty of candour
Dentists have been subject to a professional duty of candour for many years. However, on 1 April 2015, regulation 20 of the Health and Social Care Act (Regulated Activities) Regulations 2014 was afforded universal application to all Care Quality Commission (CQC)-registered providers.
This regulation contains the organisational duty of candour, which requires all providers to act in an open and transparent way in relation to care and treatment provided to service users.
The CQC’s interpretation of what this means is ‘clear, honest and effective communication with patients, their families and carers throughout their care and treatment, including when things go wrong’.
When does the duty apply?
When registered providers become aware of a ‘notifiable safety incident’, they must:
- Notify the relevant person that the incident has occurred
- Provide reasonable support
- Provide an account, true to the best of the provider’s knowledge, of all the facts known about the incident at the time
- Advise about other relevant enquiries
- Include an apology (intended as an ‘expression of sorrow or regret’, not as an admission of guilt)
- Record the account in writing and keep it securely.
What is a ‘notifiable safety incident’?
The definition varies slightly for health service bodies (including NHS trusts and NHS foundation trusts) and other CQC-registered providers (including primary care dental services). For the latter, the definition is:
‘Any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a healthcare professional:
- Appears to have resulted in:
- The death of the service user, where the death relates directly to the incident rather than to the natural course of the service user’s illness or underlying condition
- An impairment of the sensory, motor or intellectual functions of the service user, which has lasted, or is likely to last, for a continuous period of at least 28 days
- Changes to the structure of the service user’s body
- The service user experiencing prolonged pain or prolonged psychological harm
- The shortening of the life expectancy of the service user
- Requires treatment by a healthcare professional in order to prevent:
- The death of the service user
- Any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned in sub-paragraph (a) (regulation 20(9)).
The CQC has produced guidance for providers on the duty of candour. The guidance sets out the CQC’s approach, which is intended to apply the duty proportionately to different services, taking into account the size and type of the service and the relevance of the regulation to the provider’s regulated activity. Helpful examples are provided where the CQC considers that the duty of candour would be triggered. In the dental context, the case studies include an overdose of midazolam as a sedation agent and severe hypochlorite extravasation during endodontic treatment.
Although the CQC will not be rating primary care dental services in 2015/16 as it will only be inspecting 10% of registered dental providers this year, it has stated its intention to work with dental corporate providers (defined as operating in 20 or more locations) in order to develop a positive working relationship and to coordinate inspection activity. When the inspector calls, one of the key lines of enquiry will be to review the systems and processes in place in order to satisfy the duty of candour.
What can you do to enable compliance?
There are a number of practical steps that can be taken to enable compliance with the statutory duty of candour. However, the statutory duty does not apply to all individuals within the dental practice. Rather, it applies to the organisation itself, namely the registered provider.
Nevertheless, individual dentists and dental care professionals are subject to a common professional duty of candour – to be open and honest with patients when things go wrong, a duty that is overseen by the GDC.
If you do not comply, the CQC has the power to issue fixed penalty notices and prosecute registered providers for a breach. Non-compliance could also affect a provider’s continued registration with the CQC.
It can be a tricky path to navigate but the philosophy behind the statutory duty of candour was to force culture change in the ‘organisational mind’.
Essentially the desire is to foster an open and transparent organisation where best practice is lauded and poor practice is openly and constructively challenged. Every dental corporate would, no doubt, be proud to achieve that aim.
For more information visit www.cqc.org.uk/content/regulation-20-duty-candour.