THE concept of 'candour' is one that all dentists should be familiar with. According to the dictionary it is "the quality of being open and honest; frankness."
A joint statement on professional duty of candour (DoC) published in 2016 by the General Dental Council (GDC) and seven other UK healthcare regulators stated that clinicians "must be open and honest with their patients when something goes wrong with their treatment or care which causes, or has the potential to cause, harm or distress".
However, dentists may be less clear about their statutory DoC which is dictated by systems regulators (the Care Quality Commission (CQC) and Health Improvement Scotland (HIS)) and applies to organisations rather than individuals.
In Scotland the statutory DoC has been a legal requirement since April 2018. In England it came into force in November 2014 for NHS bodies and was extended in April 2015 to cover all CQC-registered care providers. An organisational DoC is expected to come into force in Wales in 2020, but a statutory duty has not yet been introduced in Northern Ireland.
In Scotland, the statutory duty framework must be followed when an incident occurs during the course of care or treatment which results in death or harm not related to the course of the condition that is being treated. The harm suffered may be physical or psychological. The aim is to encourage health professionals to reflect on their practice when things go wrong, demonstrate personal learning and, where possible, improve practice.
Every organisation covered by DoC legislation is regarded as a "responsible person". In dental practice, the practice principal usually acts as the named "responsible person" for the organisation. As a rule, the treating clinician involved in an incident should not also act as the responsible person. Seek guidance from your health board (for NHS/ mixed practices) or HIS (private practices) where this is problematic, e.g. in single-handed practices.
Under the legislation, the patient who has been harmed, or their representative, is known as the "relevant person".
The threshold is met when the incident was unintended or unexpected; it has led to "severe harm" (death or permanent disability); or "harm" (e.g. changes to the integrity and structure of the body; a shortening of the patient’s life; sensory, motor or intellectual impairment; specific pain or psychological harm).
If you are unsure, seek the advice of a colleague (who is not involved in the incident), or contact MDDUS.
The NES Knowledge Network has a useful online resource. It makes clear that each organisation must decide when the DoC is triggered, based on the individual circumstances of each case.
Once aware of a candour incident, the organisation should correspond directly with the "relevant person". They should be notified within one month and given an account of what has occurred, the next steps, plus a written apology. (For the avoidance of doubt, this is not an admission of liability under the regulations.)
The organisation should also invite the affected individual to attend a meeting to discuss the incident. Be sure to provide the relevant person with a meeting note, including proposals for next steps and details of any known legal/review procedures to be followed.
A review of the circumstances that led to the incident should be undertaken within three months and the findings sent to the relevant person, setting out any agreed changes/service improvements.
Reports and training
Organisations are required to produce an anonymised annual report on statutory DoC incidents. Written records of any incidents should be retained in the practice incident file, not the patient’s notes. HIS (for private practices) or health boards (for NHS/mixed practices) can assist with reporting.
Lastly, practice teams must receive training on DoC procedures and be given appropriate post-incident help and support.
In England, the CQC sets out specific requirements of the regulation for its registered healthcare providers ("providers"). In dental practice, this is likely to be the practice principal. The person harmed, or their representative, is known as the "relevant person".
The statutory DoC in England is triggered by a "notifiable safety incident". According to Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, this 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 healthcare professional, could result in, or 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, or
- Severe harm, moderate harm or prolonged psychological harm to the service user.
Harm is defined as:
- Severe harm – permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong limb or organ or brain damage. As with death, it must be directly related to the incident.
- Moderate harm – significant, but not permanent, and needing a moderate increase in treatment.
- Prolonged psychological harm – for a continuous period of at least 28 days.
The provider must notify the relevant person of an incident as soon as reasonably practicable. Providers who are subject to the NHS standard contract must notify within no more than 10 working days.
The notification must be given in person by at least one practice representative. It must provide a true and accurate account of the incident; provide advice on what further enquiries are required; include an apology; and be recorded in a written record, which should be kept securely.
This should be followed by a written notification to the relevant person and include all the information that was provided in person plus an apology and the progress/results of any enquiries. The outcome of any further enquiries must also be provided in writing, if the relevant person wishes to receive them. The provider must make every reasonable attempt to contact the relevant person and respect their wishes if they do not want to engage. Providers must keep a record of the written notification (in the practice incident file), along with the communications, enquiries and outcomes . The CQC may check this in a practice inspection.
Providers must notify the CQC about incidents such as “never events” and injuries, including those that lead to, or that if untreated are likely to lead to, permanent damage, or damage that lasts or is likely to last more than 28 days.
In England, it is the responsibility of each provider to examine each incident to determine whether the threshold for the statutory DoC has been met. The CQC offers useful examples in its Regulation 20: Duty of Candour guidance.
Candour legislation can be complex but it is important not to lose sight of the goal, which is to be open and honest when something goes wrong, and for all to learn from it.
Sarah Harford is a dental adviser at MDDUS
This page was correct at the time of publication. 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.