The statutory duty of candour – final version is published
11th July, 2014
The Department of Health has published its response to the consultation about the statutory duty of candour which includes a copy of the final version of the Regulations.
These will introduce the statutory duty of candour for NHS bodies from 1 October 2014 and will be extended to all CQC registered providers from April 2015.
What are the regulations?
The Regulations will be called the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 which, as well as the obligations placed on NHS organisations under the duty of candour, include provisions about fundamental standards and the fit and proper person requirement.
Further regulations will be produced to set out the duty of candour requirements for all other CQC registered providers.
Some changes have been made to the draft regulations which were issued as part of the consultation.
What are the changes?
The Regulations now distinguish between healthcare harm definitions which apply to only NHS bodies. Other providers will use the CQC notifiable safety incident definitions and this will be set out in separate regulations.
For NHS bodies, the statutory duty of candour will apply for all cases of significant harm to a patient. This is classified using the definitions in the National Reporting and Learning System (NRLS) reporting definitions and includes all harm classified as moderate or severe or in relation to the death of a patient where the death relates to the incident of harm.
The definition also includes prolonged psychological harm which is not in the NRLS definitions.
The regulations now make it clear that the statutory duty applies when it is in the reasonable opinion of a healthcare professional that significant harm has occurred.
The definition of relevant person who is the person who should be notified of any notifiable safety incident has been clarified to make it clearer and includes who to notify when the patient has died, lacks capacity or is under 16.
What are the penalties for flouting the regulations?
The Department of Health have decided that a failure to notify the relevant person will constitute a criminal offence by the NHS body with a maximum penalty of £2500.
The response to the consultation makes it clear that NHS Trusts and other provider organisations will be expected to implement the new duty across their organisation which will require the education and training of staff.
How can Ward Hadaway help?
If you need assistance with educating and training staff, we can provide comprehensive and practical training on all aspect of the duty of candour.
Please get in touch for more details.
Please note that this briefing is designed to be informative, not advisory and represents our understanding of English law and practice as at the date indicated. We would always recommend that you should seek specific guidance on any particular legal issue.
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