NHS trusts and the duty of candour

The Care Quality Commission (CQC) recently decided not to pursue a duty of candour case against an NHS trust due to a lack of evidence. Sarah Knight looks at the lessons to be learned.

It will be a considerable relief to United Lincolnshire Hospitals Trust (ULHT) that the CQC has confirmed its decision not to pursue a prosecution for alleged breach of the statutory duty of candour under Regulation 20 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

This duty became a statutory requirement after recommendations made by Sir Robert Francis in the Mid Staffs inquiry in 2013. It imposes a legal duty to be open and honest with patients (or service users), or their families, when something goes wrong that appears to have caused or could lead to significant harm in the future. It applies to all health and social care organisations registered with the CQC and the CQC can move directly to a prosecution without issuing a warning notice if it has sufficient evidence. 

Regulation 20 of the Health and Social Care Act 2008 (Regulations) 2014 provides:

Reg (1) - Registered persons 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.

Reg (2) - As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred a registered person must:

• Notify the relevant person that the incident has occurred, and
• Provide reasonable support to the relevant person in relation to the incident, including when giving such notification (there are strict requirements for how the notification must be undertaken).

Reg (3) - The notification to be given under paragraph (2)(a) must (inter alia):

• Provide an account, which to the best of the registered person's knowledge is true, of all the facts the registered person knows 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 by the registered person.

The CQC issued its first fine to an NHS trust for failure under this regulation in February 2019 when it imposed a fixed penalty notice of £1,250 to Bradford Teaching Hospitals NHS Foundation Trust. The trust had failed to issue a timely apology to the family of a baby boy in relation to missed opportunities and delay in his care. The duty of candour had been triggered when the trust had correctly recorded the issues surrounding the baby’s care as a notifiable safety incident, but failed to let the family know until three months after the notification. 

The maximum fine a court can impose is £2,500. This is comparatively small but the very negative publicity and reputational damage that such allegations have on an organisation are far reaching and to be avoided at all costs. The adverse stress that such investigations can cause families at a time when they are already distressed is also clearly not acceptable.

It is worth noting that the allegations could have been avoided if ULHT had engaged effectively with Nottingham Assistant Coroner Heidi Connor, when she conducted an investigation into the death of Elaine Bradbrook. The inquest was concluded in February 2018 and the coroner issued a report for the Prevention of Future Deaths (PFD) in which she expressed her concerns that UHLT had failed to appreciate the significance of issues that had arisen in relation to the care of Mrs Bradbrook. The PFD stated:

• It [ULHT] has not carried out any internal investigation, nor contacted Elaine’s family in line with its duty of candour. I am concerned that there has been no opportunity for learning within the trust, following these serious failures.
• The trust’s procedure for carrying out High Level Investigations and Serious Untoward Incident Investigations should be reviewed.
• The trust legal services team did not send the witness (doctor) responsible for reviewing Elaine shortly before transfer, as requested. It sent no representative or supporter with the witness, despite the trust being an Interested Person. There was no representative in attendance to hear the conclusions which raised serious concerns.

The CQC has dropped the proposed prosecution due to lack of evidence. It would seem from the coroner’s comments that the allegation may very well have been avoided if ULHT had provided robust evidence and representation at the inquest.

Whilst the prosecution has not been pursued, it is clear that the CQC does not consider these issues in isolation. It is inevitable that the CQC will remain concerned about ULHT’s compliance with the fundamental standards in terms of governance systems and its compliance with the fit and proper persons obligations under Regulation 5 – another current area of focus for CQC.

This case is a timely reminder of the importance of getting things right from the outset when engaging with the family when things go wrong and to ensure that the significance of the coroner’s inquiry is not overlooked. Even when not given interested person (IP) status in an inquest, we would suggest taking early legal advice regarding disclosure, the provision of witness evidence, requests for IP status and the proper presentation of “PFD” evidence to assist all those participating in the coroner’s inquiry.

Sarah Knight is a Principal Associate at Weightmans. She can be contacted on 0121 200 7288 or This email address is being protected from spambots. You need JavaScript enabled to view it..