- Statutory duty of candour covers all care providers registered with CQC.
- Applies to organisations rather than individuals, but individuals will inevitably be involved in managing and resolving incidents.
- Some NHS organisations, like hospital and foundation trusts in England, also have a contractual duty of candour with the commissioning body.
- Doctors also have an ethical duty of candour to be open and honest when things go wrong.
Duty of candour categories
- Low threshold for notification - any harm or distress to patients.
A 'duty of candour' is familiar to most doctors, at least in principle. Doctors have an ethical duty to tell patients when things have gone wrong, apologise and try to put things right. The MDU has been advising this approach since the 1950s.
The GMC's 'Good medical practice' (2013) says that doctors 'must be open and honest with patients if things go wrong', and more recent guidance on the professional duty of candour explains what to do if a patient suffers harm or distress.
- Higher threshold than ethical duty.
Providers of services to NHS patients, except for services commissioned under primary care contracts, must comply with a contractual duty of candour.
This is required by the standard NHS contract, and only applies to incidents or suspected incidents that result in moderate or severe harm or death.
- Highest threshold, as with contractual duty, but includes prolonged psychological harm to patient.
The statutory duty was introduced in November 2014 for NHS bodies such as trusts and foundation trusts in England. It was extended in April 2015 to cover all other care providers registered with the CQC.
Statutory duty - key points
The statutory duty of candour has several key principles.
- Care organisations have a general duty be open and transparent in relation to care.
- The duty, like the contractual one, applies to organisations rather than individuals, but staff should cooperate to make sure the organisational obligation is met.
- Patients should be told of a 'notifiable safety incident' as soon as is practical.
- A notifiable safety incident has two statutory definitions, depending on whether the healthcare organisation is an NHS body or not.
- The organisation has to explain to the patient what's known at the time, what further enquiries will be made, offer an apology and keep a written record of the notification to the patient. Failure to do so could be a criminal offence.
- The patient should be given reasonable support. This could be practical (eg, an interpreter) or emotional (eg, counselling).
- The patient must get written notes of the initial discussion and of the notification, including details of further enquiries, their results and an apology. The organisation needs to keep copies of all correspondence.
Threshold for notification
The threshold for what constitutes a notifiable patient safety incident under the statutory duty of candour differs depending on whether the organisation involved is an NHS body. The definitions are set out below.
NHS body (trust, foundation trust, etc.)
Something unintended or unexpected in the patient's care that, in the reasonable opinion of a health care professional, could result in or appears to have resulted in:
- their death (not relating to natural progression of an illness or condition)
- them suffering severe or moderate harm, or prolonged psychological harm - see box below.
Non-NHS body (GP, independent practitioner, etc.)
Something unintended or unexpected occurring in the care of a patient that, in the reasonable opinion of a health care professional, appears to have resulted in:
- their death (not relating to natural progression of the illness or condition)
- impairment of sensory, motor or intellectual function, lasting or likely to last for 28 days
- changes to the structure of the body (eg, amputation)
- prolonged pain or psychological harm (defined as experienced or likely to be experienced for at least 28 days
- shortening of life expectancy
- the need for treatment to prevent death or the above adverse outcomes.
Definitions of harm
Severe harm: a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, directly related to the incident.
Moderate harm: needing a moderate increase in treatment, and significant, but not permanent, harm.
Prolonged psychological harm: experienced or likely to be experienced for at least 28 days.
The statutory duty of candour in Scottish law is governed by the Health (Tobacco, Nicotine and Care etc.) (Scotland) Act 2016 and the Duty of Candour Procedure (Scotland) Regulations 2018. It came into effect on 1 April 2018.
See our full guide to the duty of candour in Scotland.
Summary points and advice
- Ethical duty applies to all doctors, in all parts of the UK, in all circumstances.
- Statutory duty applies to organisations, not individuals - but individuals should co-operate as necessary.
- Patients should be told of a notifiable incident as soon as practical.
- If something has gone wrong, apologise. It's the right thing to do, and isn't an admission of negligence.
- Keep written records of discussions and correspondence with patients.
- The thresholds for notification depend on different factors. If in doubt, it's safer to assume it applies.
- MDU members can contact the advice line if there's any confusion.
This guidance was correct at publication 01/05/2018. It is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.