In the first criminal prosecution of its kind to reach court, the University Hospitals Plymouth NHS Trust has pleaded guilty to breaching its 'duty of candour' under Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. The NHS Trust has been fined and ordered to pay legal costs totalling £12,565 after the Care Quality Commission (CQC) took them to court.
The case was concerned the death of Elise Woodfield, 91, after she suffered a perforated oesophagus during an endoscopy procedure in December 2017. The Trust were prosecuted for of its duty of candour for filing to be transparent or open with the patients’ family with regards to the surgical error and of failing to apologise to them in a timely way.
The Trust pleaded guilty, admitting breach of the duty of candour, and issued a “wholehearted apology” to the family after the hearing.
All registered providers must demonstrate that they are meeting regulatory requirements in order to register with CQC and then continue to deliver regulated services. The aim of Regulation 20 is to ensure that registered providers are open and transparent with people who use services and other ‘relevant persons’ (people acting lawfully on their behalf) in relation to care and treatment.
The duty of candour
The duty of candour requires providers to promote 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. When a notifiable safety incident has occurred, the person and other relevant persons must be informed as soon as reasonably practicable after the incident has been identified. Providers subject to the NHS Standard Contract should be aware that the standard contract requires that the notification must be within at most 10 working days of the incident being reported to local systems, and sooner where possible.
The Regulations set out specific requirements that providers must follow when things go wrong, including informing people about the incident, providing reasonable support, providing truthful information and an apology when things go wrong.
Regulation 20 also defines what constitutes a notifiable safety incident for health service bodies and all other providers (such as primary medical and dental practices, adult social care and independent healthcare providers). This includes incidents that, in the reasonable opinion of a healthcare professional, could result in, or appear to have resulted in, the death of the person using the service or severe harm, moderate harm, or prolonged psychological harm.
Be open and transparent
This case highlights the duty on all care providers to be open and transparent with patients and their families when things go wrong during care and treatment. CQC can prosecute for a breach of Regulation 20(2)(a) and 20(3) and can move directly to prosecution without first serving a Warning Notice. Nigel Acheson, CQC’s Deputy Chief Inspector of hospitals reflected that this case noted sends a clear messages that CQC will take action to prosecute providers when that does not happen.
For further advice about your duties under Regulation 20 contact Claire Rawle.
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