Whilst social care providers have been more than used to issuing notifications of serious incidents that occur to service users to CQC under regulation 18 of The Care Quality Commission (Registration) Regulations 2009 (‘the 2009 Regulations’) there is a danger that the more recent Duty of candour notification requirements can be overlooked.

If you, as a care provider, fall into this trap it could result in CQC taking enforcement action against you and it may also have a bearing on any claim a service user may seek to pursue against you.

What is the Duty of candour?

The duty of candour in regulation 20 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (‘the 2014 Regulations’) as amended by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (‘the 2015 Regulations’) specifically places a duty on a registered provider to act in an open and transparent way and to notify the service user or, where the adult service user has died or lacks capacity, a person lawfully acting on their behalf if a ‘notifiable safety incident’ has occurred.

What is a ‘notifiable safety incident’?

The 2015 Regulations contain the following definition of ‘notifiable safety incident’ which is not identical to, but mostly reflects, those notifiable incidents in Regulation 18(2)(a)of the 2009 Regulations:

(9) In relation to any other registered person, “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—

(a) appears to have resulted in—

(i) 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,

(ii) 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,

(iii) changes to the structure of the service user’s body,

(iv) the service user experiencing prolonged pain or prolonged psychological harm, or

(v) the shortening of the life expectancy of the service user; or

(b) requires treatment by a health care professional in order to prevent—

(i) the death of the service user, or

(ii) any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned in sub-paragraph (a).”

If you conclude that such an incident has occurred then, in addition to the Regulation 18 obligation to notify CQC ‘without delay’, you must:

  1. act in an open and transparent way;
  2. as soon as you reasonably can after a notifiable safety incident has occurred:
    1. notify the service user or their lawful representative that the incident has occurred; and
    2. provide reasonable support to the service user or their lawful representative in relation to the incident;
  3. ensure that the notification:
    1. is given personally by you or your representative;
    2. gives as true an account as you can of all the facts you know about the incident at the time of notification;
    3. advises what further enquiries into the incident you believe are appropriate;
    4. includes an apology (defined in the 2015 Regulations as an expression of sorrow or regret in respect of the incident); and
    5. is recorded in a written record which you keep securely.
  4. follow up the initial verbal notification with written confirmation of:
    1. the account of the facts known to you;
    2. the further enquiries to be made into the incident and the results of those enquiries; and
    3. the apology.

If you cannot contact the person to notify or they refuse to speak to you the verbal and written notification requirements in Regulation 20 do not apply but you must keep a written record of attempts to contact or speak with them.

Regard must be had to the CQC guidance for providers on meeting the regulations a copy of which is available via the CQC website at www.cqc.org.uk. In relation to regulation 20 see pages 79 onwards of the guidance and as to regulation 18 see pages 97 onwards.

Where appropriate, you should also comply with the duty as to dealing with complaints in regulation 16 of the 2014 Regulations.

What are the consequences of not complying with the Duty of candour?

If you do not give the initial notification strictly in accordance with the requirements of Regulation 20 CQC can prosecute the breach without first serving a Warning Notice on you. A defence is available where you can show that you took all reasonable steps and acted with all due diligence, though clearly it would be best not to find yourself in this position at all!

Any breach of Regulation 20 is a criminal offence.

Great care should, therefore, be taken to ensure not only that the content of any notification meets the regulatory requirement but also that it does not prejudice your position in relation to any claim that may be brought against you in connection with the incident, nor result in any insurances you may have in place for legal expenses insurance or to meet any claims to be negated.

Specialist legal advice should be sought at as early a stage as possible, especially where there is any possibility of your facing a claim in connection with the incident.

Giving an apology in each such case may not come entirely naturally, though this is a strict requirement. It is not an admission of guilt as long as it is expressed in the right way.

It is essential that you and your staff are aware of these obligations and your staff trained to identify and report such incidents and respond to them in an appropriate way.


If you need advice regarding the Duty of candour or other regulatory obligations, contact Giles Gillingham at rhw Solicitors LLP, specialist legal advisers to care providers, who will be pleased to help.

Email: giles.gillingham@rhw.co.uk

Tel: 01483 302000