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Duty of candour – first prosecution brought by the CQC for breach

University Hospitals Plymouth NHS Trust has been fined £1600, and ordered to pay £10,845.83 in costs and a victim surcharge of £120 following the first prosecution brought by the Care Quality Commission (the ‘CQC’) in respect of a breach of the duty of candour. The matter was heard at Plymouth Magistrates Court on 23 September 2020 and concerned the Trust’s failure to be transparent with the family of Elsie Woodfield, a 91 year old woman who sadly died following complications which occurred during an endoscopy procedure in 2017. The trust admitted its failings and was given credit for an early guilty plea.

Regulation 20

Pursuant to Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 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.

Regulation 20(3) requires a provider to provide a notification of notifiable safety incidents to the relevant person as soon as it is reasonably practicable to do so. Reasonable support must also be provided to the relevant person in relation to the incident, including the point at which they receive the notification. For completeness, the notification must:

  1. be given in person by one or more representatives
  2. provide an account, which to the best of the registered person’s knowledge is true, of all the facts known about the incident as at the date of the notification
  3. advise the relevant person what further enquiries into the incident the registered person believes are appropriate
  4. include an apology, and
  5. be recorded in a written record which is kept securely

The notification must be followed up in writing with details of the further enquires to be undertaken amongst other matters.

Detailed guidance for providers can be accessed via the CQC’s website.

As is explained in the CQC’s guidance, the introduction of this statutory duty represented an important step towards ensuring the open, honest and transparent culture that was found to be lacking at Mid Staffordshire NHS Foundation Trust. In addition it is noted that the failures at Winterbourne View revealed that there were no levers within the system to hold the “controlling mind” of organisations to account.

Fixed Penalty Notices

By way of reminder, our previous briefings on this topic have highlighted the issue and acceptance of fixed penalty notices in respect of breaches of Regulation 20.

It is important for providers to note that the CQC can move directly to prosecution for breach (of parts Regulation 20(2)(a) and 20(3)) without first serving a Warning Notice and may also take other regulatory action. As the CQC’s Deputy Chief Inspector for Hospitals, Nigel Acheson, commented the case represents a clear message that the CQC will not hesitate to take action when providers are not open and transparent with patients or loved ones when something goes wrong.


This would appear to be an opportune moment for providers to consider the extent to which services are currently complying with their obligations, review any relevant policy and remind staff of their duty. It would be sensible for providers to keep records of any action taken in this regard which would serve as useful evidence in mitigation should issues arise in the future.

  • keep copies of any relevant memos and minutes of meetings at which the issue is discussed
  • record updates to training materials and policy
  • keep copies of any resulting read and sign documentation as appropriate.

Should you require any assistance in relation to the matters discussed above please do not hesitate to contact us.


This briefing is for guidance purposes only. RadcliffesLeBrasseur LLP accepts no responsibility or liability whatsoever for any action taken or not taken in relation to this note and recommends that appropriate legal advice be taken having regard to a client's own particular circumstances.

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