University Hospitals Plymouth NHS Trust yesterday became the first NHS Trust in England successfully prosecuted by the Care Quality Commission (CQC) for failing to comply with its statutory duty of candour.

The prosecution arose from an incident in December 2017 where a patient suffered a perforated oesophagus during an endoscopy procedure and later died.

Under Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, all CQC registered providers must act in an open and transparent way in relation to the care and treatment provided to patients and, where a notifiable safety incident has occurred, must notify the patient or their representative about the incident.  The specific requirements of Regulation 20 are that the notification must:

  1. be given in person by a representative of the provider;
  2. provide a true account of all the facts the provider knows about the incident;
  3. advise the patient or their representative as to what further enquiries into the incident will be undertaken;
  4. include an apology; and
  5. be recorded in a written format which is then securely stored by the provider.

CQC has the power to pursue criminal prosecutions in respect of Regulation 20 breaches.  In this case, the NHS Trust did not inform the patient’s family of the oesophageal perforation over a long period of time and despite active enquiries by her next of kin.  As a result, CQC ultimately decided to exercise its most significant power and prosecute. 

The Trust pleaded guilty at Court and was ordered to pay a fine of £1,600, a victim surcharge of £120 and legal costs of £10,845.43. 

Duty of candour regulations came into force in November 2014 for NHS bodies and in April 2015 for all other organisations, yet are still applied inconsistently in our experience.  For assistance in relation to any CQC related matter, please don't hesitate to contact Andrea James or another member of Brabners' Regulatory Group.