In case anyone might have thought otherwise, the CQC has underlined the seriousness and financial consequences of breaching the statutory duty of candour. In a press release released in 2019, the CQC announced it had fined Royal Cornwall Hospitals NHS Trust a staggering £16,250 for failing to comply with the statutory duty of candour. The fine comprised 13 fixed penalty notices of £1,250 relating to seven patient safety incidents where the statutory duty of candour regulations had not been properly adhered to.

The statutory duty of candour was introduced in England for NHS trusts in November 2014 and imposed duties on organisations to act in an open and transparent way when things go wrong. The statutory duty includes an obligation to tell the patient in person, as soon as reasonably practicable, after a 'notifiable' patient safety incident occurs.

This was the reason behind the very first fine for failing to comply with the statutory duty of candour, in January 2019. On that occasion, Bradford Teaching Hospitals NHS Trust was fined £1,250 for failing to notify the parents of a notifiable incident, and to offer an apology, within a reasonable period of time. That incident related to a baby admitted to Bradford Royal Infirmary in July 2016, but there were delays in making a diagnosis and arranging the child's admission to hospital. The trust recognised it was a notifiable incident, but failed to tell the parents for several months, with an apology not being made until October 2016.

Working out whether the notifiable incident threshold has been triggered can be difficult, but in general terms it applies to instances where the patient has suffered, or could suffer, moderate harm (or worse) or prolonged psychological harm.

The duty of candour regulation requires an organisation to provide reasonable support to a patient. This might be, for example, providing an interpreter to patients to help them understand explanations about what happened to them. There are also administrative obligations that form part of the statutory duty, including an obligation to give the patient a copy of a written note of discussions and to keep copies of correspondence and meeting notes. It is unwise to ignore these administrative requirements (see below).

Learning points

Some learning points can be derived from the CQC's findings in respect of the Royal Cornwall Hospitals NHS Trust, which could apply to any provider registered with the regulator. A few of these are discussed below.

  • Have a clear process in place for recording in writing what you as an organisation have done to meet the duty of candour requirements. It is not sufficient for discussions about a notifiable incident to be noted in the clinical record and left at that, because it is then difficult to audit such records and consequently demonstrate that there has been compliance with the regulations.
  • Ensure your system of notification reliably identifies patient safety incidents where the appropriate threshold of harm is met. This may require review of any processes in place and standard template forms used, and regular audits could help ensure that thresholds are correctly understood and consistently applied.
  • The statutory regulations require an organisation to tell the patient promptly when a notifiable patient safety incident has occurred. This may cause the patient distress, but that alone is not a legitimate reason to ignore the requirements of the duty of candour - there is no 'therapeutic exception'. The circumstances where the requirement to speak to the patient may be set aside are limited and are either the patient cannot be contacted in person, or declines to speak to the organisation's designated person (outlined in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, regulation 20(5)).
    • Bear in mind that a new patient safety incident framework will be rolled out in 2021, which should complement the duty of candour by setting expectations for informing, supporting and involving patients and their families when things go wrong.
  • There is a strict obligation to comply with the duty of candour regulation. In its inspection of the Royal Cornwall Hospitals NHS Trust the CQC made it clear that it was not acceptable to set a local target (in that case 80%) for compliance with the statutory duty of candour. Simply put, is to correctly identify and act on notifiable patient safety incidents is a statutory requirement and must be complied with in all cases.

The MDU has detailed, practical guidance on the statutory and ethical duties of candour, and it's an excellent starting point if you want to review systems and processes in your organisation. Even if you're confident that you are doing things as well as you should, there still may be room for improvement and therefore benefit in auditing your outcomes and procedures.


This article was correct at publication on 06/03/2020. 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.

Dr Michael Devlin

Head of professional standards and liaison

Michael was an MDU medico-legal adviser for 15 years, latterly as head of medico-legal services, before taking up the new role of head of professional standards and liaison. He sat on the FFLM's academic committee and was previously treasurer, and an examiner for the MFFLM. He has published widely on medico-legal matters, and has significant experience in teaching and assessing knowledge in medico-legal subjects.

See more by Dr Michael Devlin