The duty, which was introduced by the government through regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, applies to NHS organisations such as trusts and foundation trusts, to secondary care clinicians, and to bodies including GP practices, dental practices and care homes.

How it affects you

Under the terms of the duty, you need to make sure that you practise acts in an open and transparent way: 

• With relevant people
• In relation to care and treatment provided
• To service users
• In performing a regulated activity.¹

After becoming aware that a notifiable safety incident has occurred, you must:

• Notify the relevant person as soon as is reasonably practicable (CQC guidance refers to the ten days required by the NHS standard contract)
• Provide reasonable support, such as providing an interpreter for any discussions, or giving emotional support to the patient.

Your notification must:

• Be given in person by at least one representative of the practice involved, and then followed by a written notification
• Provide a true and accurate account of the incident
• Provide advice on what further enquiries into the incident are required
• Include an apology
• Be recorded in a written record, which should be kept securely.

What is a notifiable safety incident?

The regulation states that there are two meanings of a notifiable safety incident; one for a health service body, the other for registered persons – registered persons being secondary care clinicians, GPs and primary care dental practitioners.

According to the regulation:

“In relation to a registered person who is not a health service body, “notifiable safety incident” means 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 health care professional –

(a) appears to have resulted in – 

    i. 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, 

    ii. 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,
 
    iii. changes to the structure of the service user’s body,

    iv. the service user experiencing prolonged pain or prolonged psychological harm, or 

    v. the shortening of the life expectancy of the service user; or 

(b) requires treatment by a health care professional in order to prevent – 

    i. the death of the service user, or

    ii. any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned in sub-paragraph (a).

What is harm?

“Harm”, as listed above, is further defined in the regulation as:

• Prolonged psychological harm – means psychological harm which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days.
• Prolonged pain – means pain which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days.

About the duty of candour

Introduced for NHS bodies in England from 27 November 2014, the key principle of the duty of candour is that care organisations have a general duty to act in an open and transparent way in relation to care provided to patients. The statutory duty applies to organisations, not individuals.

Further information

The Care Quality Commission, Regulation 20: Duty of candour. Issues for all providers: NHS bodies, adult social care, primary medical and dental care, and independent healthcare (March 2015) – cqc.org.uk/content/regulation-20-dutycandour

¹“Regulated activity” is defined by the Safeguarding Vulnerable Groups Act 2006