Duty of Candour
All providers of health and social care services who are registered with the Care Quality Commission (CQC) are required to comply with a statutory duty of candour.
The relevant regulations concerning duty of candour are:
- Section 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulation 2014 – see below
- Applies to NHS Bodies (NHS Trusts, NHS Foundations Trusts, and Special Health Authorities) from November 2014
- It was introduced for all other Care Quality Commission (CQC) registered persons in England including Care Homes from April 2015
- CQC registered persons are obliged to act in an ‘open and transparent way in relation to service user care and treatment’
- CQC may refuse providers who cannot demonstrate they will meet the regulation requirements
- Providers who do not comply with the regulations may be fined or receive penalties
What is duty of candour?
The regulations require that when a notifiable incident occurs during the provision of a regulated activity, registered persons must notify the relevant person, and:
- Provide an account of all the facts known at the time
- Advise about other relevant enquiries
- Include an apology
- Make a written record and keep it securely
- The notification should be conducted in person by a representative of the service provider with followed by a written notification which should be sent as soon as possible after the event
What is a notifiable incident?
A notifiable incident is defined as any unintended / unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional
a. Appears to have resulted in the
• The death of the service user, where the death relates directly to the incident
• An impairment of the sensory, motor, or intellectual functions of the service user lasting 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 psychological harm
• Shortening of the life expectancy of the service user
b. Requires treatment by a health care professional to prevent
• The death of a service user
• An injury to the service user which, if left untreated, would lead to at least one of the outcomes in mentioned in a.
What should notifications include?
- Notification the incident has happened
- An apology
- What further enquiries will be taking place
- A factual account of the incident
- Confirmation of when an update will be provided
What can you do to ensure you comply?
- Prepare guidance for staff on steps to take when a notifiable incident occurs
- Create a notification letter template
- Prepare policy documents outlining the organisations commitment to candour
- Train staff on all areas mentioned above
- Identify who should be informed when a notifiable incident occurs and ensure mechanisms are in place for this to happen promptly
- Identify who can support the service user to ensure they are involved and regularly informed throughout the investigation process