The GDC, along with other healthcare regulators, recognises a common professional duty to be open and honest when things go wrong.
When something goes wrong with patients' treatment or care which causes (or could cause) harm or distress, dental professionals must:
- tell the patient (or their representative) when something has gone wrong
- apologise to the patient
- offer an appropriate remedy or support to put matters right, if that is possible, and
- explain fully to the patient the short- and long-term effects of what has happened.
Clear, honest, and effective communication is key.
As well as an individual professional duty, a statutory duty of candour may also apply in some circumstances. Statutory duty of candour applies to organisations rather than individuals. While the legislation and the procedural requirements differ across the four nations, the broad principles are the same.
Statutory duty of candour: England
Since April 2015, Organisations who are registered with CQC have a statutory duty of candour, required and enforceable by law. The Statutory duty therefore applies to both NHS and independent general dental practices.
The obligations associated with the statutory duty of candour are contained in regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (as amended). The statutory duty applies regardless of whether a complaint has been made or a question asked about it.
The key principles are outlined below.
- Care organisations have a general duty to act in an open and transparent way in relation to care provided to patients. This means that an open and honest culture must exist throughout an organisation.
- The statutory duty applies to organisations, not individuals, though it is clear from CQC guidance that an organisation's staff are expected to cooperate with it to ensure the obligation is met.
- As soon as is reasonably practicable after becoming aware of a notifiable patient safety incident, the registered person must notify the patient (or their representative) about it in person. The notification can be given by a representative of the registered person.
- The circumstances that give rise to a requirement to tell the patient or their representative about something that has gone wrong are the same as those that are required to be notified without delay to the CQC. This notification to CQC is separate from and in addition to the statutory duty of candour, which requires the organisation to keep copies of correspondence with the patient.
- The organisation has to give the patient a full explanation of what is known at the time, including an apology, what further enquiries will be carried out and the results of any further enquiries into the incident
- Once the patient has been told in person about the notifiable patient safety incident, the organisation must provide the patient with a written note of the discussion, and copies of correspondence must be kept. Failure to make that notification may amount to a criminal offence.
- There is a statutory duty to provide reasonable support to the patient. Some examples of the type of support include providing an interpreter to ensure discussions are understood or giving emotional support to the patient following a notifiable patient safety incident. It is important to remember that these are just examples.
A notifiable patient safety incident has a specific meaning which is defined by the law. It applies to incidents where something unintended or unexpected has occurred in the care of a patient and appears to have resulted in:
- their death, where this relates to the incident and is not simply due to the natural progression of the illness or condition
- impairment (of sensory, motor, or intellectual function) that has lasted or is likely to last for 28 days continuously (for example, prolonged or permanent inferior dental nerve paraesthesia)
- changes to the structure of the body (for example, erroneous extraction)
- prolonged pain or prolonged psychological harm (the pain or psychological harm must be, or likely to be, experienced continuously for 28 days or more)
- shortening of their life expectancy
- or where the patient requires treatment by a healthcare professional in order to prevent death, or the adverse outcomes listed above.
The equivalent statutory duty in Scotland is known as the organisational duty of candour and is governed by the Health (Tobacco, Nicotine and Care etc) (Scotland) Act 2016 and the Duty of Candour Procedure (Scotland) Regulations 2018.
The organisational duty of candour was introduced in Scotland in April 2018. The provisions are very similar to the English duty, but with slight differences.
- In both countries, a notifiable incident is something that a reasonable health care professional would view as resulting in one of the defined outcomes.
- In Scotland, the person giving this view must not have been involved in the incident itself.
- Activation of the organisational duty and notification to the affected person or their representative, must occur as soon as reasonably practicable (usually within ten working days) after knowledge of the incident.
- As to the notification procedure itself, the Scottish Act says that the patient involved should have a choice about whether they want to receive more information about the incident.
The Scottish government has provided more information on the implementation of the organisational duty of candour.
In 2018, The Department of Health (Northern Ireland) established a 'Duty of Candour work stream' to develop policy proposals for a statutory organisational duty of candour for Northern Ireland. The proposals set out are broadly consistent with the approach taken in England and Scotland.
Responses from a stakeholder consultation exercise were published in November 2021 and updated in February 2022. A statutory, organisational duty of candour is expected to be enacted imminently.
On 1st June 2020, The Health and Social Care (Quality and Engagement) (Wales) Act 2020 became law, and established an organisational duty of candour for Wales. The duty is expected to be enacted in spring 2023 and will apply to providers of NHS services, including primary care providers.
The Welsh government also plans to make separate regulations (under the Care Standards Act 2000) to place a duty of candour on regulated independent healthcare providers in line with the NHS.
Although the statutory duty of candour applies to organisations, the treating clinician is likely to be the most appropriate person to provide comprehensive information about any incident which occurs.
Dental professionals, who are used to having candid discussions with their patients, might become the organisation’s representative under the statutory duty. It is important to cooperate with your organisation's policies and procedures, including the requirement to alert the organisation when a notifiable patient safety incident occurs.
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 a dental professional's ethical duty (any harm causing distress to the patient), but higher and more complex for the statutory duty.
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, dental professionals must always follow their ethical duty, irrespective of whether the statutory duty applies.
Legislation and guidance
The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015
Care Quality Commission (Registration) Regulations 2009
CQC Regulation 20: Duty of candour - information for all providers
Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016
The Duty of Candour Procedure (Scotland) Regulations 2018
Scottish government guidance on the organisational duty of candour
NES Knowledge Network factsheets
Duty of candour - being open consultation document (Department of Health)
Duty of candour & being open - public consultation - organisational responses (Department of Health)
Health and Social Care (Quality and Engagement) (Wales) Act 2020
This page was correct at publication on 14/07/2022. Any guidance 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.