- The Care Quality Commission (CQC) has recently taken a firmer stance when enforcing the duty of candour.
- The duty of candour was implemented as a direct response to recommendation 181 of the Francis Inquiry report into Mid Staffordshire NHS Foundation Trust and has been in place for adult social care providers since 1 April 2015.
- The duty requires registered providers to ‘act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity’.
Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 imposes a duty of candour on health and social care providers that goes above and beyond any contractual or professional requirements for candour.
It emerged as a direct response to recommendation 181 of the Francis Inquiry report into Mid Staffordshire NHS Foundation Trust and has been in place for adult social care providers since 1 April 2015. In view of CQC’s recent approach to prosecutions for breaches of the duty of candour, this article is intended to refresh your memory of the duty and emphasise its importance.
The requirements imposed by regulation 20 are as follows:
- The general position is that registered providers must ‘act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity’.
- ‘Relevant persons’ in the context of adult care services are defined as the service user or a person lawfully acting on their behalf if the service user has died or lacks capacity in relation to the matter.
- Once a provider is aware that a notifiable safety incident has occurred, they must notify the relevant person of that incident and provide reasonable support to them, including when giving the notification.
- The definition of ‘notifiable safety incident’ provided in regulation 20 is ‘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 health care professional, could result 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.’
- ‘Severe harm’ is defined as ‘a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong limb or organ or brain damage, that is related directly to the incident and not related to the natural course of the service user’s illness or underlying condition’.
- ‘Moderate harm’ is defined as harm that requires a moderate increase in treatment, and significant, but not permanent, harm.
- ‘Moderate increase in treatment’ means an unplanned return to surgery, an unplanned re-admission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, or transfer to another treatment area (such as intensive care).
- ‘Prolonged psychological harm’ means ‘psychological harm which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days’.
- The notification must be given in person. It must provide an account of the incident that to the best of the provider’s knowledge is true of all the facts they are aware of at the time of notification. It should also advise the relevant person what further enquiries the provider believes are appropriate and include an apology. It should be recorded in a written record.
- Following the notification, a written notification should follow, and it should include the information discussed above and provide an update on any further enquiries, as well as an apology.
- If the relevant person cannot be contacted in person then a written record of all communication should be kept of the attempts to contact the relevant person.
The provider must keep a copy of all correspondence.
CQC has been taking a firmer stance when it comes to enforcement of this duty recently. While we have not seen evidence of any prosecutions in relation to adult social care providers yet, it is certainly worth noting. Back in January 2019, Bradford Teaching Hospitals NHS Foundation Trust was issued a fixed penalty notice and fined £1,250 as it had failed to comply with the duty of candour. Sadly, a baby had passed away due to delays in diagnosing his condition and missed opportunities to admit him to hospital. The family was not informed and did not receive an apology until three months after the notifiable safety incident. Then, in October 2019, Royal Cornwall Hospitals NHS Trust was issued with 13 fixed penalty notices, with fines totalling £16,250, for failing to comply with the duty of candour. It had failed to notify patients or families as soon as reasonably possible.
Most recently, on 23 September 2020, University Hospitals Plymouth NHS Trust was prosecuted and ordered to pay £12,565. As far as the author is aware, this is the first time that CQC has prosecuted a provider for failure to comply with regulation 20. CQC brought the prosecution because the trust failed to share details of what had happened to a 91-year-old woman before her death following an unsuccessful endoscopy procedure. The trust did not communicate with her family about what had happened in an open and transparent way. It also failed to apologise to her family within a ‘reasonable timeframe’. It had to pay a £1,600 fine, £120 victim surcharge and £10,845 in court costs. It is likely that, buoyed by this successful prosecution, CQC will be placing a greater emphasis on enforcement in this area in the future.
Recently, it has become clear that CQC has taken a greater interest in leadership in its inspections and ensuring that the statutory duty of care is complied with. While the specific key line of enquiry regarding the duty of candour, usually found at W1, is not in the new guidance Monitoring questions for adult social care providers (see https://tinyurl.com/CQCMonitoringW), it is apparent that it would fall under question W2 for ‘Well-led’: ‘How does the governance framework ensure that responsibilities are clear and that quality performance, risks and regulatory requirements are understood and managed?’ CQC will be asking ‘How are you meeting all the relevant legal requirements, including CQC registration requirements, safety and public health obligations and sending notifications?’ Compliance with regulation 20 would fall within the scope of this question.
There was a great deal of discussion about the duty of candour when it was first introduced, but it is important that providers and managers are attentive to the detailed statutory provisions. Providers must comply with this obligation in any event. Should you require further convincing of the importance of compliance, in accordance with the ratings principle, if the inspectors find a single occasion when the duty of candour has not been complied with, this will constitute a breach. If a breach is found, the overall rating for an adult social care service can be no better than requires improvement, no matter how excellent your service is otherwise.
- Regulation 20, The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: https://tinyurl.com/HSCAReg20
- Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry Executive summary, Chaired by Robert Francis QC, London: The Stationery Office, February 2013: https://tinyurl.com/MidStaffSummary
Use the following item in the Toolkit to put the ideas in this article into practice:
About the author
Lucy Bowker is a trainee solicitor at Gordons LLP and works with Neil Grant.