Achieving the Duty of Candour
This is the second in a series of four articles on The Francis Report and its impact. We have explored the background to the report in our first article and here we discuss how health providers achieve the duty of candour. In our final two articles we will look at barriers to its use and discuss The Francis Report’s impact on medical practice.
The introduction of the statutory Duty of Candour (also known as Regulation 20) in November 2014 was a direct response to recommendation 181 of the 2013 Francis Report into issues at the Mid Staffordshire NHS Foundation Trust. The aim of the regulation is to ensure that health care providers are open and transparent with patients and their carers. The regulation applies to organisations rather than individuals and details specific requirements that providers are obliged to follow when something goes wrong with patient care or treatment. Regulation 20 is only triggered when a notifiable safety incident occurs, with the definition of this varying slightly between health service bodies, such as NHS hospitals, and all other providers, which includes primary medical and dental practices, adult social care and independent health providers.
For health service bodies, a notifiable safety incident is defined as an unintended or unexpected incident that, in the reasonable opinion of a health care professional, appears to have resulted in the death of a patient or caused them severe or moderate harm or prolonged psychological harm, or has the potential to do so in the future. It does not have to be proved that the incident has caused harm; the possibility that it has or could do is sufficient. While the definition of a notifiable safety incident is similar for all other providers, there is no current requirement to inform patients about incidents which could result in future harm. There is also no requirement for any provider to inform patients about incidents that cause a low level of harm or ‘near misses’, but doing so is encouraged, as providers still have a duty to be open and to learn from their mistakes.
Severe harm includes a permanent reduction in bodily, sensory, motor, physiologic or intellectual function, as long as it is directly related to the incident and not to the natural course of the patient’s condition. Moderate harm is defined as significant, but not permanent, harm requiring a moderate increase in treatment, such as a return to surgery, re-admission, prolonged care, extra time in hospital or as an outpatient, or cancelling of treatment. In relation to psychological harm or pain, ‘prolonged’ is defined as 28 days or more.
Once a notifiable incident has occurred, a provider is required to tell the affected person that it has happened. This notification should be given as soon as is reasonably practicable after the incident in question and should be given in person, in a sensitive manner, by one or more representatives of the provider. The notification should provide an account of all the known facts of the incident to date and must be true to the best of the provider’s knowledge. The patient will also be informed about what will happen next, such as additional safety measures being introduced or whether further enquiries or an investigation will be carried out. The patient, or their carer, should be told about where they can receive appropriate support, including counselling or independent medical advice. Finally, the patient must receive a verbal apology. However, it is important to realise that this apology does not constitute an admission of guilt.
The in-person meeting must be followed up by a written account of the meeting and a further apology. Patients must also be kept informed about the outcome of any investigations into the relevant incident, and the provider is obliged to keep written records of all correspondence with the affected individual.
Regulation 20 is overseen by the Care Quality Commission (CQC), with whom all health care providers must be registered. At the point of registration, a provider must prove that they understand the requirements of the regulation and have adequate measures in place to ensure that those requirements will be met. Possible measures might include staff training on communicating with patients about notifiable safety incidents, support for those members of staff who have to notify patients when such an incident occurs, and the provision of reporting forms on which all notifiable incidents can be recorded. Providers who do not appear able to meet the requirements may be refused registration, or have conditions imposed on them as part of the registration process. During inspections, the CQC will assess whether the provider is delivering high quality care to their patients and following practices that are relevant to the duty of candour, such as encouraging support, fairness, openness and honesty, and learning from any mistakes so that improvements can be made.
If a patient feels that a health care provider has failed to comply with the regulations, initially they can discuss their concerns with a health professional. Additionally, they might choose to raise a formal complaint. A provider who fails to comply could face regulatory action or, if the case is serious enough, criminal prosecution. However, it is unlikely that formal action will be taken unless the breach is deemed to have seriously impacted on the people involved. Where an incident occurred before Regulation 20 came into force, the Care Quality Commission may not be able to prosecute or take any formal regulatory action over a breach of the duty, although it can still examine whether a provider is following the spirit of the Duty of Candour.
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Care Quality Commission. Regulation 20: Duty of Candour [Internet]. [London]: CQC; March 2015 [cited 13 Jan 2020]. Available from https://www.cqc.org.uk/sites/default/files/20150327_duty_of_candour_guidance_final.pdf