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.

Legal regulations

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