The duty was introduced in April 2018 and applies widely across health and social care organisations, including NHS Boards, NHS hospitals, private hospitals and clinics, GP services and dental services and surgeries.
- For over 50 years the MDU has advised doctors to tell patients when things have gone wrong, to apologise and to try and put things right. This is in addition to the ethical requirement to be open and honest.
- The statutory duty includes a requirement to learn from what went wrong in order to improve the quality of service to patients generally, and to share such learning with other health or social care organisations.
Doctors have had a professional duty of candour for many years. In its core guidance for doctors, Good medical practice, the GMC says:
'You must be open and honest with patients if things go wrong. If a patient under your care has suffered harm or distress, you should:
a) put matters right (if that is possible)
b) offer an apology
c) explain fully and promptly what has happened and the likely short-term and long-term effects.'
Statutory duty of candour
The obligations associated with the statutory duty of candour in Scotland are set out in the Health (Tobacco, Nicotine etc and Care) (Scotland) Act 2016 and the Duty of Candour Procedure (Scotland) Regulations 2018. In addition, the Scottish Government has produced guidance, to read alongside the statutory provisions.
The key principles are as follows.
Who does it apply to?
The statutory duty applies to organisations (referred to as the 'responsible person'), not individuals. Organisations are required to provide training to staff who will be involved in the duty of candour procedure, and it is likely this will apply to many clinicians.
The patient who is harmed in a patient safety incident is known as the 'relevant person' and the statutory duty of candour procedures provide several safeguards in respect of them. These include:
- communication with the patient must be understandable (plain English and free from jargon or unnecessarily technical language) and, where reasonably practicable, use the method preferred by the patient (eg written, by telephone or electronic)
- the right to be involved in meetings about what went wrong, to ask questions in advance and to be able to express their views about the incident
- the patient must be told if the organisation's review of the incident has exceeded three months, and the reasons for the delay.
The duty of candour procedure has three main stages.
- Notification to the patient of the incident.
- A face-to-face meeting to enable questions to be asked, information shared with the patient and an explanation given of further steps necessary to investigate and understand what went wrong.
- Review of what occurred, leading to a written report including what was found by the organisation, what learning points arose and all actions taken under the duty of candour procedure.
Apologies form an important part of the procedure.
First, the 2016 Act states that an apology, or a step taken under the statutory duty of candour, does not amount to an admission of negligence or a breach of a statutory duty. Second, the procedure requires that a written apology (which can be electronic) must be offered to the relevant person, whether or not an oral apology has already been made.
It is vital, therefore, that in order to comply with the statutory duty, a written apology must be formally offered in every case that the duty of candour threshold is triggered. However, the patient is free to choose whether they wish to receive the written apology or not.
The duty of candour guidance includes practical advice as well as addressing who, within the organisation, should apologise. The guidance includes an acknowledgment that the person saying sorry may be apologising for something not of their doing, but that the organisationally-focused apology requires this.
Triggering the duty of candour
The threshold of harm that will trigger the statutory duty of candour is complex. To understand it fully, it is best thought of in three parts.
First, is the patient safety incident one that was 'unintended or unexpected' in the context of the care provided? If so, then;
Second, in the reasonable opinion of a registered health professional not involved in the patient's care, did the incident appear to have resulted in, or could result in:
- the death of the patient
- permanent lessening of bodily, sensory, motor, physiologic or intellectual functions (including removal of the wrong limb or organ or brain damage) - 'severe harm'
- harm, which is not 'severe harm', but which results in:
i) an increase in the patient's treatment
ii) changes to the structure of the patient's body
iii) shortening of the patient's life expectancy
iv) impairment of sensory, motor or intellectual functions of the patient which has lasted (or is likely to last) for at least 28 days continuously
v) pain or psychological harm that has lasted (or is likely to last) at least 28 days continuously.
- the patient required treatment by a registered health professional in order to prevent the death of the patient or the types of harm described immediately above.
Third, and finally, in the reasonable opinion of a registered health professional not involved in the patient's care, is the harm related directly to the patient safety incident rather than the natural course of the patient's illness or underlying condition?
The assessment by the registered health professional of whether the incident appears to have resulted in harm will probably be relatively straightforward. More difficult may be assessing whether the incident could result in harm reaching the defined threshold. The duty of candour guidance explains this means that following the incident, the patient is likely to suffer harm of the types defined. 'Likely' in the guidance is not defined, so its ordinary meaning should be used: that something is probable. The guidance also makes clear that 'could' does not mean that there was no harm, but that there could have been (ie, it does not apply to a near miss).
Where the patient lacks capacity
The relevant person (the individual affected by the care or treatment triggering the duty of candour) may be found to lack capacity to understand and take part in the process. The regulations allow someone else to act on behalf of the relevant person. Where the person affected by the incident is a child aged fifteen or under and lacks capacity, the person acting on their behalf is likely to be their parent or guardian.
In the case of adults with incapacity, or where the patient has died, the organisation (responsible person) must treat the person acting on their behalf as the 'relevant person'. The duty of candour guidance provides information about attorneys, guardians and next of kin who may find themselves acting for an adult patient without capacity.
Timescales are not given prominence in the statutory framework, although in regards to notifying the patient affected, the duty of candour guidance states this should be as soon as reasonably practicable and that it is good practice to do so within 10 working days of the procedure's start date.
There are two further points that are required by the regulations.
- The procedure is deemed to start when a registered health professional has provided an opinion to the organisation that the statutory duty of candour is triggered (see the threshold explanation above). Where there is a delay of one month or more between the incident occurring and it being identified as triggering the statutory duty, an explanation for the delay must be given to the patient.
- The patient must be told if the review stage of the procedure has exceeded three months. The expectation is that the procedure should be concluded within a long-stop of four months of the date of the incident, although organisations are likely to wish to proceed in a timely and efficient way.
Organisations must keep records of each incident that triggers the statutory duty. This includes all documentation and correspondence generated by the notification, meeting and review phases of the procedure.
There must also be an annual report produced by the organisation, as soon as reasonably practicable after the financial year-end. This should give information about the number and nature of incidents that occurred, their policies and procedures and whether they were changed as a result of investigations and reviews, and any other relevant information.
The reports must not identify individuals, either directly by name or by providing details which makes them identifiable.
Points of difference
A unique feature of the Scottish statutory duty of candour is the recognition of the need to support healthcare staff. This goes beyond training needed to help staff understand and fulfil their responsibilities under the duty of candour procedures.
It places an obligation on organisations to provide to staff involved in an incident details of 'any services or support…which may provide assistance or support' to that person, taking into account the circumstances of the incident and the staff members' needs.
There is evidence that effective debrief and support of staff provided at a local level can help mitigate the psychological distress that can often accompany patient safety incidents, particularly those associated with death or severe harm.
The statutory duty of candour applies to organisations. However doctors, who are used to having candid discussions with their patients, are likely to be the organisation's representative under the statutory duty, particularly in the notification and meeting phases.
The procedure also requires a registered health professional to review the incident and give an opinion as to its relationship to the harm threshold and to make a judgement as to whether the harm is due to the underlying disease.
Doctors involved in giving these opinions must ensure they have the information they reasonably need to form an opinion as required under the statutory process. The MDU advises that in giving their opinion, doctors bear in mind the need to be impartial and objective, something that is made more difficult by the fact that those involved in the incident may be known to them, perhaps even friends. But for all doctors, it is important that you are familiar and cooperate with your organisation's policies and procedures, including the requirement to alert the organisation when a notifiable patient safety incident occurs.
If you move to a different hospital (or a new practice if you're a GP) it may be that there are differences in the process that is followed, so make sure duty of candour is included in induction training.
An area of difficulty may be deciding whether an incident reaches the threshold for notification under the statutory duty. This may be confusing, as the threshold is low for the doctor's ethical duty (any harm or distress caused to the patient) while the threshold for the statutory duty is higher and complex.
Where an organisation's clinical governance procedures for reporting and investigating incidents are followed, it is unlikely that a notifiable patient safety incident will be overlooked. And in any event, doctors must always follow their ethical duty, irrespective of whether the statutory duty applies.
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This guidance was correct at publication 29/03/2018. 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.