On the 23 September 2020 the University Hospital Plymouth NHS Trust pleaded guilty at Plymouth Magistrates' Court to failing to comply with its duty of Candour in a prosecution brought by the Care Quality Commission (CQC). There had been several previous prosecutions against NHS Trusts for failing to comply with their duty of Candour however they ended in fixed penalty fines. This was the first prosecution to go to Court for sentence.
The Trust was fined £1,600.00, a victim surcharge of £126.00 and ordered to pay the costs of the CQC in full of £10,845.43.
The case concerned the death of an elderly patient who was undergoing an endoscopy. The procedure was abandoned when the patient suffered a perforated oesophagus. The patient was transferred to a ward for observations where she collapsed and later died. The hospital initially failed to identify the death was a serious incident and share information with the family and subsequently failed to provide a full account of the facts in response to a complaint from the patient's family.
After the prosecution Nigel Acheson Deputy Chief Inspector of Hospitals gave the following statement:
"All care providers have a duty to be open and transparent with patients and their loved ones, particularly where something goes wrong and this case sends a clear message that we will not hesitate to take action when that does not happen. Sadly, the family received neither a prompt apology nor a full explanation regarding the tragic events that took place prior to the patient's death. University Hospitals Plymouth NHS Trust was not transparent or open with regard to what happened and it did not apologise to Mrs Woodfield's family in a timely way. Patients and their families are entitled to the truth and a formal written apology as soon as is practical after a serious incident, and the University Hospitals Plymouth NHS Trust's failure to fulfil this duty is why CQC took this action. This is the first time CQC has prosecuted an NHS Trust for failure to comply with the regulation concerning duty of candour, and we welcome the outcome of today's hearing".
The prosecution brings into sharp focus the expectations of the CQC in relation to the duty of candour to patients and their families to be exercised by care providers when things go wrong with the provision of care.
The statutory requirement to exercise the duty of candour is set out at Regulation 20 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 as amended by the Amendment Regulations in 2015 which extended the duty from health service bodies to registered persons which widens the scope on NHS providers to all providers of care and treatment carrying on a regulated activity including those in the private sector.
Here is a link to the CQC's own guidance on the duty of candour. In brief terms the duty requires the care provider to notify the service user or in appropriate circumstances the service user's family that a notifiable safety incident has occurred and provide the support to the service user or the service user's family.
The notification must be given in person, provide an account of the facts of the incident as known to the care provider, or advise what further enquiries are appropriate including apology and record notification securely. The failures of the NHS Trust centred around failing to identify the death of Mrs Woodside as a notifiable safety incident which led to the Trust failing to communicate what had happened to the family in an open and transparent way and subsequently failure to apologise in a timely way.
It is clear from the statement of Nigel Acheson of the CQC that the CQC will use its regulatory enforcement powers to move directly to prosecute offenders who fail to adhere to the statutory duty of candour without using other enforcement powers of cautions or penalty notices.
Avoiding enforcement action - ensuring notification, engagement and reporting
Identification of relevant incidents
The recent prosecution highlights the need for providers to ensure that their staff are absolutely clear on their Duty of Candour and what constitutes a notifiable safety incident requiring notification to the service user or their family.
Regulation 20 sets out detailed definitions as to what constitutes a notifiable safety incident for both health service bodies (r20 paragraph 8) and other providers (r20 paragraph 9). The differences reflect the different reporting criteria for health service bodies via the National Reporting and Learning System (NRLS) and the other providers to the CQC.
The amended regulation 20 sets out detailed definitions as to what constitutes a notifiable safety incident for both health service bodies (paragraph 8) and other providers (paragraph 9).
The differences reflect the different reporting criteria for health service bodies via the National Reporting and Learning System (NRLS) and the other providers to the CQC.
Providers also need to ensure that they have the systems and personnel in place to:
- support staff record and investigate incidents
- engage and record engagement with service users and their families
- report to appropriate regulatory bodies
- reach findings and conclusions from investigations
- identify an action plan and carry it out.
Inquests - consequences of failing to properly investigate
It is vital that a provider can evidence its own thorough investigation into a fatal incident and identification of an action plan to reduce the risk of future similar incidents to the Coroner so that the Coroner can be satisfied that risks have been identified and addressed.
If the Coroner has concerns at the end of an inquest there is a continuing risk of harm to the public the Coroner must act and make a prevention of future deaths report which will almost certainly be addressed at the very least to the provider.