The statutory duty of candour has been hailed the greatest reform in patient rights in the modern era. It was brought in under the Health & Social Care Act 2008 (Regulated Activities) Regulations 2014 as amended, in response to the Mid Staffordshire Inquiry.
The regulation 20 duty of candour requirements are detailed and specific. There is an overriding obligation to be open and transparent, coupled with clear requirements to notify patients and/or their families where there is any unintended or unexpected incident, whether this amounts to an error or not. This notification must be prompt. Whilst the requirements are dependent upon the level of harm sustained, the underlying principles governing the provisions are focussed on ensuring that patients are kept properly informed and that errors and/or other unintended consequences are not ‘brushed under the carpet’.
Duty of candour is a particularly difficult area for health and social care providers, partly due to the strict requirements, and also because it often results in providers having to disclose sensitive information before they have the opportunity to fully consider the ramifications of any such disclosure, with initial notification being required as soon as practicable (and provision for further information to be shared following investigation). This initial notification must provide an account “of all the facts the registered person knows about the incident, as at the date of the notification.” This puts pressure on the provider from the outset.
The above being said, the CQC has been slow to prosecute in relation to breaches of regulation 20 (and other breaches). The CQC has been criticised for this, and, in response, has historically stated that their focus has been on increasing awareness and working with organisations, rather than the ‘blame game’.
The AVMA Chief Executive has previously declared that he is “deeply disappointed” in the failure of the CQC to enforce the duty of candour requirements effectively. In a time of crisis for NHS and social care provision, there is much debate over the extent to which prosecutions fix the problem, and the CQC does appear to be alive to these concerns, and, for example, has previously stopped inspections during the winter period to enable services to focus on the provision of care.
However, in the last few years, there has been extensive media coverage of shocking statistics in health and social care, such as the meteoric rise in reports of abuse received by the CQC, increasing from 37,060 in 2014 to 67,590 in 2018. Whilst this does open the age old debate of whether this reflects more effective reporting of these incidents, or an increase in real terms, the figures are clearly of great public concern. As a result the CQC is under mounting pressure to take punitive action against providers.
Following the current Chief Executive (Mr Trenholm) taking his position in July 2018, there appears to have been a change of approach. Mr Trenholm has stated that health and social care organisations will be held to account: the CQC must uphold standards and this will inevitably result in prosecutions. Ex-military and civil police officers have recently been recruited for the specific purpose of reviewing evidence in relation to potential prosecutions, and we are seeing an increase in prosecutions in all areas, including duty of candour. A report in August 2019 confirmed that CQC criminal prosecutions were up one third this year.
The first duty of candour prosecution was brought against Bradford Teaching Hospital in January 2019. The Trust was fined £1,250 for failing to apologise to the family within a reasonable period of time, following the death of their baby boy in July 2016. There had been delays in diagnosis and admission, and the Trust recorded the care as a notifiable safety incident, but the family were not informed. The parents did not receive an apology or explanation until October 2016.
The maximum fine a court can impose amounts to £2,500, but for most providers the reputational damage far outweighs the financial penalty.
On 9 October 2019, we saw the second duty of candour prosecution, resulting in the Royal Cornwall Hospitals NHS Trust being fined £16,250. The CQC issued 13 fixed penalty notices of £1,250 each, for failing to comply with the duty of candour. This resulted from a routine review of serious incident investigations at the trust. There were seven separate safety incidents where the trust had failed to apply the duty of candour regulation. These related to a variety of issues including medication errors, delays in diagnosis and missed opportunities.
In stark contrast to the announced increase in regulatory action, on 16 October 2019, the CQC dropped a prosecution for failing to comply with the statutory duty of candour against United Lincolnshire Hospital Trust (ULHT) due to a lack of evidence. The allegation arose following an inquest into the death of Elaine Bradbrook. The Assistant Coroner for Nottingham issued a Prevention of Future Deaths Report in which she criticised the ULHT’s failure to contact the family, failure to carry out any internal investigations and their failure to engage with the Coroner and attend the inquest.
In a response to the report, Neill Hepburn, ULHT’s medical director, accepted that the trust’s care of Ms Bradbrook fell below the standard one would expect and that some of the trust’s processes around duty of candour were inadequate at the time of Elaine’s death. Nevertheless, he reported that the trust has now remedied these inadequacies and a medical examiner service has been introduced to contact families and that this service will be extended to include all deaths.
This case serves as a reminder that, whilst a failure to comply with the duty of candour could result in a prosecution, robust evidence of non-compliance with the specific statutory duty is required for a prosecution to succeed. For CQC registrants it is important to ensure that investigations are undertaken and remedial action taken as soon as an incident arises so as to reduce the prospect of a prosecution and to demonstrate compliance with the regulations.
Our experience at BLM reflects the CQC approach referred to above, with there being an increase in investigations, prosecutions and enforcement notices across the board.
Written by Ella Partner, associate at BLM