The results of Department of Health consultation on duty of candour and fundamental standards of care were published 7th July 2014.
From April 2015, subject to parliamentary approval of the Draft Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, health and social providers will be required to meet fundamental standards of care as a condition of their registration with the Care Quality Commission. There will be criminal penalties for failing to meet some of the standards, including £50,000 fines for breaches of duties in relation to consent, safe provision of care and treatment, protection from abuse, and nutritional and hydration needs.
The Duty Of Candour (AvMA’s ‘Robbie’s Law’) will apply to NHS bodies from October 2014, and will be extended to all CQC-registered providers in April 2015.
Under the proposed Regulation 20, a health service body must notify a service user (or person legally acting on behalf if they are under 16, lack capacity or have died) as soon as reasonably practicable after any unintended or unexpected incident that occurs during the provision of care or treatment that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in death, severe harm, moderate harm or prolonged psychological harm. The DOH has not provided further guidance on the harm thresholds as it has adopted existing definitions, but it accepts that CQC guidance will be needed to assist providers in their understanding of the harm definitions. It remains to be seen how these will be interpreted in practice.
The notification must be first in person by a representative of the health service body and then followed up in writing. It must contain the following information:
- an account of all the facts the heath service body knows about the incident;
- what further enquires into the incident the health service body believes are appropriate; and
- an apology.
Failure to notify is an offence for a health service body, subject to a £2,500 fine.