nurse taking notes Duty of Candour

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 requirements

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 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

Or, 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

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