CQC has for the first time used its criminal enforcement powers against a health and social care provider for a failure to comply with the Duty of Candour under Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (“Regulation 20”). CQC fined Bradford Teaching Hospitals NHS Foundation Trust (the “Bradford NHS Foundation Trust”) £1,250 by way of a fixed penalty notice for failing to apologise within a reasonable time period to a family of a baby boy who died, after there had been delays in diagnosis and missed opportunities to admit him to hospital. Although the Bradford NHS Foundation Trust recorded the events as a notifiable safety incident at the time in July 2016, the family did not receive an apology from the Trust until some three months later in October 2016.
CQC stated that the action taken against Bradford NHS Foundation Trust did not relate to the care provided by it, but to the fact that it was slow to inform the family there had been delays and missed opportunities to treat their child. The decision indicates that CQC is beginning to flex its prosecutorial muscle against providers who are not complying with all aspects of the Health and Social Care Act 2008 and its associated regulations.
The Duty of Candour
The Duty of Candour under Regulation 20 requires health and social care providers to act in an open and transparent manner in respect of the care and treatment of service users.
A key part of the Duty of Candour, as identified in Regulation 20(2)(a), and as reflected in the Bradford NHS Foundation Trust case, is the requirement placed upon the provider to notify relevant persons of notifiable safety incidents as soon as it is reasonably practicable to do so. For health service bodies the term ‘notifiable safety incident’ means any unintended or unexpected incident that occurred in respect of any service user during the provision of a regulated activity which, in the reasonable opinion of a health care professional, could have resulted in or appears to have resulted in: (a) 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 (b) severe harm, moderate harm or prolonged psychological harm to the service user. CQC guidance on the Duty of Candour confirms that where the degree of harm is not yet clear but may fall into the above categories, the relevant person must be informed of the incident in line with Regulation 20.
Regulation 20(3) requires that the notification of the incident must:
- be given in person by one or more representatives;
- provide an account, which to the best of the registered person’s knowledge is true, of all the facts known about the incident as at the date of the notification;
- advise the relevant person what further enquiries into the incident the registered person believes are appropriate;
- include an apology; and
- be recorded in a written record which is kept securely.
Providers are furthermore required to give the relevant person all reasonable support necessary to help overcome the physical, psychological and emotional impact of the incident. CQC’s guidance identifies that such support could include all or some of the following:
- Treating the relevant person with respect, consideration and empathy;
- Offering the option of direct emotional support following a notification, for example, from a family member, a friend, a care professional or a trained advocate;
- Offering help to understand what is being said; for example, through an interpreter, non-verbal communication aids, written information, Braille etc.;
- Providing where appropriate access to any necessary treatment and care to recover from or minimise the harm;
- Providing the relevant person with details of specialist independent sources of practical advice and support or emotional support/counselling;
- Providing the relevant person with information about available impartial advocacy and support services, and local Healthwatch and other relevant support groups to help them deal with the outcome of the incident;
- Arranging for care and treatment from another professional, team or provider if this is possible, if the relevant person wishes; and
- Providing support to access the provider’s complaints procedure.
Compliance with the Duty of Candour is a legal requirement and CQC is able to take enforcement action where relevant breaches are identified. Under Regulations 20(2)(a) and 20(3), CQC can move directly to prosecution without first serving a Warning Notice. If a provider commits a Regulation 20 offence, the maximum penalty is £2,500. In the case of Bradford NHS Foundation Trust, CQC considered that a Fixed Penalty Notice of £1,250 was a proportionate alternative to prosecution.
It should be recognised that the Duty of Candour applies to organisations, not individuals. Therefore, if an individual fails to comply with the Duty of Candour, this will be an internal matter for the provider. Nonetheless, providers should be doing all they can to ensure their staff are aware of the obligation and take appropriate action where required.
To ensure that the Duty of Candour is observed throughout an organisation, it is important that a provider promotes a culture that encourages candour, openness and honesty at all levels. This should be an integral part of a culture of safety that supports organisational and personal learning. There should also be a commitment to being open and transparent at board level, or its equivalent governing body.
Whilst the fixed penalty notice of £1,250 was not a significant sum for an NHS Trust in the wider scheme of things, the message sent by CQC in issuing this penalty notice is clear. Even if this had not been done, the merit in striving to be an open and transparent organisation holds intrinsic value beyond any potential censure by the regulator.