Regulation 20: Duty Of Candour

The key principle of the ‘duty of candour’ is that general practices must act in an open and transparent way in relation to care and treatment provided to patients

The statutory duty applies to organisations, not individuals, though it is clear from CQC guidance that it is expected that an organisation's staff must co-operate with it to ensure the obligation is met.

This is an entirely new requirement from CQC and general practices will have to ensure they have:

• systems in place to capture notifiable safety incidents
• processes to inform the patient and provide support.

It is likely that if the practice has robust systems for incident reporting and reporting of significant events, then this will capture these notifiable safety incidents.

The regulations define a notifiable safety incident as:

“In relation to any other registered person, "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—

    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, or
• the shortening of the life expectancy of the service user; or

    requires treatment by a health care professional in order to prevent—

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

The practice must, as soon as possible after becoming aware that a notifiable safety incident has occurred, inform the patient and provide reasonable support to him/her in relation to the incident.

It will be a criminal offence to fail to notify a patient of a notifiable safety incident and the organisation is liable to a potential fine of up to £2,500.

The practice must:

• Inform the patient (or their representative) in person, which must then be followed by written notification of the incident.
• Provide an account of the incident and apologise.
• Inform the patient what further enquiries into the incident are to be undertaken.
• Provide support to the patient to ensure that the patient understands the discussions (this may include providing emotional support).
• Keep a written record of all discussions and correspondence.

Achieving compliance with the ‘duty of candour’ regulation

General practices should consider the following key points in training their staff on the duty of candour:

1. The practice should promote the reporting of incidents and ensure that all staff are aware of the organisational reporting requirements where the duty applies.
2. Ensure that staff understand that the new duty sits alongside existing professional responsibilities, eg, GMC Good medical practice, NMC The Code. Staff must understand the consequences of not complying with the duty and how this could lead to disciplinary proceedings or professional conduct issues for them personally.
3. Staff must be able to raise concerns where they think the duty has not been complied with by others. They need to understand their role in keeping the organisation compliant and they should be aware of the ways that they can receive support once they identify a patient safety concern.
4. The practice should have robust systems for investigating underlying causes of patient safety incidents, eg, using significant event audit and root cause analysis.

Further information

Medical Protection Factsheet, Duty of Candour