In November 2014, regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 introduced the duty of candour for NHS bodies. From 1 April 2015, the duty will be extended to apply to other CQC registered providers, when the Health and Social Care Act 2008 (Regulated Activities)(Amendment) Regulations 2015 come into force.
What does the duty require?
The duty of candour requires all CQC registered providers to act in an open and transparent way in relation to care and treatment provided to service users.
When will it apply?
Upon becoming aware of a ‘notifiable safety incident’, registered providers must notify the relevant person that the incident has occurred, provide reasonable support, and:
a. provide an account, which is true to the best of the body’s knowledge, of all the facts known about the incident at the time of notification;
b. advise about other relevant enquiries;
c. include an apology (defined as an expression of sorrow or regret);
d. record the account in writing and keep it securely.
Are the requirements the same for health service bodies and other registered providers?
The amendment regulations introduce into regulation 20 a subtly different definition of a ‘notifiable safety incident’ for other registered providers, compared to that which applies to health service bodies.
The “notifiable safety incident” of which a health service body must notify a relevant person (service user or person lawfully acting on their behalf) remains as previously defined:
“any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in: -
- The death of the service user, where the death relates directly to the incident rather than to the natural course of the service user’s illness or underlying condition; or
- Severe harm, moderate harm or prolonged psychological harm to the service user.” (Regulation 20(8))
Regulation 20(9) states however:
“In relation to a registered person who is not a health service body, “notifiable safety incident” means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional –
- Appears to have resulted in –
- The death of the service user, where the death relates directly to the incident rather than to the natural course of the service user’s illness or underlying condition,
- An impairment of the sensory, motor or intellectual functions of the service user which has lasted, or is likely to last, for a continuous period of at least 28 days,
- Changes to the structure of the service user’s body,
- The service user experiencing prolonged pain or prolonged psychological harm, or
- The shortening of the life expectancy of the service user; or
- Requires treatment by a health care professional in order to prevent –
- The death of the service user, or
- Any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned in sub-paragraph (a).”
“Moderate harm” is defined as a) harm that requires a moderate increase in treatment, and b) significant, but not permanent, harm.
Furthermore, the duty on the health service body will be applicable when an incident either did result in harm (of the type specified) or, in the opinion of a reasonable health care professional, could have resulted in harm (of the type specified). The duty on other registered providers will be applicable when an incident did result in harm (of the type specified) or would have resulted, without the intervention of a health care professional. The difference may seem subtle, but it appears that the health service body’s duty to be candid about near misses is broader than that of other registered providers.
What happens if we do not comply with the duty of candour?
The CQC has the power to issue fixed penalty notices and prosecute registered providers for a breach. Non-compliance could also affect a provider’s continued registration with the CQC.
What can we do to enable compliance?
BLM previously recommended that registered providers took the following practical steps to enable compliance with the duty of candour from 1 April 2015:
- Preparation of guidance documents for staff on the definition of a ‘notifiable safety incident’ and the steps to be taken when a notifiable safety incident occurs. Registered providers will be expected to implement the new duty through front line staff and will ultimately be accountable for any failures.
- Preparation of a template notification letter.
- Some NHS Trusts have prepared policy documents setting out their commitment to openness and candour. Registered providers should be proactive in preparing policies and procedures ready for implementation of the duty.
- Training/education to support new guidance/policies. Most staff will already be aware of how to report incidents which have resulted in serious harm but will need to be aware of the definition of a notifiable safety incident and the steps that should be taken.
- Identification of staff to whom notifiable safety incidents should be reported and the mechanism by which this reporting should take place.
- Identify individuals who are able to provide reasonable support to the service user (this could also be referenced in the letter to the service user). It will be important for the service user/representative to feel that they are involved in the process and are kept updated as the investigation progresses.
BLM would be happy to provide training, advice on steps to be taken and the drafting of policies, template notifications and general procedures relating to the implementation of the duty of candour.