CQC Factsheet
Issue 3 – Duty of Candour
The statutory Duty of Candour (Regulation 20 of the Health and Social Care Act) was
enacted in October 2014. Regulation 20 requires that NHS organisations ensure service
users are fully informed where death or moderate/severe harm has occurred as a result
of a Notifiable Safety Incident.
A joint statement in relation to the Professional Duty of Candour was made in July 2015
by the professional bodies. The statement emphasises:
‘Every healthcare professional must be open and honest with patients when
something goes wrong with their treatment or care which causes, or has the
potential to cause, harm or distress.
This means that healthcare professionals must:
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tell the patient (or, where appropriate, the patient’s advocate, carer or family)
when something has gone wrong;
apologise to the patient (or, where appropriate, the patient’s advocate, carer
or family);
offer an appropriate remedy or support to put matters right (if possible); and
explain fully to the patient (or, where appropriate, the patient’s advocate, carer
or family) the short and long term effects of what has happened.
Healthcare professionals must also be open and honest with their colleagues,
employers and relevant organisations, and take part in reviews and investigations
when requested. Health and care professionals must also be open and honest
with their regulators, raising concerns where appropriate. They must support and
encourage each other to be open and honest and not stop someone from raising
concerns’.
Duty of Candour also forms part of NHS organisations CQC registration requirement and
has been included in The Standard NHS Contract since 2013.
Duty of Candour is an essential element of patient safety and is a major driver towards
an open and honest culture. The CQC use the standard in the NHS contract in relation
to compliance including timescales. This states that the patient/relative must be informed
of incidents causing moderate to severe harm or death within 10 days of the incident
occurring.
What does this mean for you?
If a Notifiable Safety Incident occurs, the patient or his/her next of kin (in the event of the
death of the patient or a lack of capacity) must be informed that the incident has
occurred.
Wherever possible, this should be carried out by the responsible clinician in person and
must:a) Give an account of known facts
b) Advise about investigations that are being carried out
c) Include an apology
d) Be recorded in writing
Following the face to face meeting, a letter must be sent to the relevant person.
This will be co-ordinated by the Patient Safety/Patient Relations team.
What is a Notifiable Safety Incident?
The Regulation states:‘any unintended or unexpected event/incident that in the reasonable opinion of a
healthcare professional could result in or appears to have resulted in:
a) The death of a service user where the death relates directly to the incident or
b) Severe harm, moderate harm or prolonged psychological harm to the service
user’
How is harm defined?
Regulation 20 states:a) Severe harm is defined as ‘a permanent lessening of bodily, sensory, motor
physiological or intellectual functions, including removal of the wrong limb or
organ or brain damage that is directly related to the incident
b) Moderate harm is defined as a moderate increase in treatment, significant but not
permanent harm, or prolonged psychological harm
A moderate increase in treatment is defined in the Regulation as ‘unplanned return to
theatre, unplanned readmission, a prolonged episode of care, extra time in hospital or as
an outpatient, cancelling of treatment or transfer to another treatment area (such as
intensive care)’. The increase in treatment would be directly related to a notifiable safety
incident (see below).
As soon as it is confirmed that Duty of Candour applies, then arrangements will be made
for the initial face to face meeting.
Support for Duty of Candour
Dr Louise Holland (Associate Medical Director) has taken responsibility as advisor on
Duty of Candour and the Patient Safety Team can also offer advice.Training sessions
are to be held in July, August and September, please contact the Learning Centre to
book a place.
Who to contact
All information about our CQC inspection will be available on the CQC intranet with
regular updates in Trust Connect, our internal news bulletin. There will also be a range
of information and materials to support you and your colleagues, as we approach this
inspection. For more information please visit the CQC Forum, click here or to ask a
question please email us click here.