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1.5 Duty of Candour Guidance

This chapter was added to the manual in April 2016.


  1. Background
  2. The Regulation
  3. Our Commitment
  4. Candour
  5. Meeting the Regulations
  6. Definition of Notifiable Safety Incidents
  7. Process of Investigation
  8. Notifying CQC

    Appendix 1: CQC KLOE - Guidance on prompts and sources of evidence on “Safe”

    Appendix 2: CQC Regulation 20

1. Background

The introduction of the regulation is a direct response to recommendation 181 of the Francis Inquiry report into the failings of Mid Staffordshire NHS Foundation Trust.

This report recommended that a statutory Duty of Candour be introduced for health and social care providers. In interpreting the regulation on the Duty of Candour, CQC use the definitions of openness, transparency and candour used by Robert Francis in his report:

  • Openness – enabling concerns and complaints to be raised freely without fear and questions asked to be answered;
  • Transparency – allowing information about the truth about performance and outcomes to be shared with staff, patients, the public and regulators;
  • Candour – any patient harmed by the provision of a healthcare service is informed of the fact and an appropriate remedy offered, regardless of whether a complaint has been made or a question asked about it.

The Duty of Candour aims to help service users/ patients receive accurate, truthful information from health and social care providers.

All health and social care providers registered with the Care Quality Commission have to comply with the new statutory Duty of Candour regulation. This is a new regulation under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. This Act sets out the requirements that all providers must meet in order to be registered with CQC.

2. The Regulation

The Health and Social Care Act was updated in November 2014 to include the Duty of Candour regulation (regulation 20), which fully commenced for providers on 1st April 2015.

The CQC describe the intention of Duty of the Candour regulation as:

“The intention of this regulation is to ensure that providers are open and transparent with people who use services and other 'relevant persons' (people acting lawfully on their behalf) in general in relation to care and treatment. It also sets out some specific requirements that providers must follow when things go wrong with care and treatment, including informing people about the incident, providing reasonable support, providing truthful information and an apology when things go wrong”.

The Duty of Candour is a legal duty which came into effect on 1st April 2015 for Social Care providers. We have a legal duty to inform and apologise to service users / patients if there has been mistakes in their care that has led to significant harm.

As a service, even prior to the Duty of Candour being introduced in April 2015, we had a responsibility to inform CQC of any notifiable incidents which occurred. Although Duty of Candour only applies to notifiable incidents, it is good practice to follow its principles for any incident that occurs within the service.

3. Our Commitment

As a Provider Service that strives to deliver a quality service we are fully committed to the principle of Candour. It has long been a foundation value which is rooted in best practice and respect for service users.   

Openness, transparency and candour should be embodied in how we support and work with Service Users and their families every day, and also in our relationships with other professionals. We do, however, recognise that there can be times when aspects of care and support go wrong.  At these times it is vital to acknowledge this, be honest, open and transparent about what has happened, apologise for mistakes made and most importantly to learn and develop as a result.  

This policy and the new duty to notify the CQC provides a means to explicitly reflect on and improve our practice.

4. Candour

What is Candour:

Candour can be described as:

  • Recognising when an incident occurs that impacts on a service user in terms of harm;
  • Notifying the service user (or family if applicable) that something has occurred. An example of this could be a medication error;
  • Apologising to the service user/ and or their family;
  • Continuing to support the service user in the best way possible;
  • Following up and keeping the service user informed as the investigation continues/evolves;
  • Keeping clear records /documentation of the discussions and steps taken and the outcomes of the investigation.

What do the behaviours of Candour look like:

There are many ways in which Candour can be demonstrated. In Provider services we demonstrate Candour in a number of ways:

  • Having open discussions with the service user and/or family when things go wrong;
  • Being open to feedback;
  • Learning from mistakes made;
  • Discussing and sharing feedback and lessons learnt with staff;
  • Engaging the service user and/or family as regards the outcome of the investigation;
  • To give a sincere apology in relation to the incident;
  • A commitment to rebuilding relationships;
  • Notifications to CQC within timescales;
  • Carry out incident reporting, and timely investigations;
  • The recording of complaints and plaudits;
  • Provided accessible information regarding making a complaint;
  • Undertake feedback questionnaires;
  • Ensure services have service improvement plans;
  • Regular audits undertaken.

5. Meeting the Regulations

To meet the requirements of Regulation 20, the CQC state that a registered provider has to:

  • Tell the relevant person, in person, as soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred, and provide support to them in relation to the incident, including when giving the notification;
  • Provide an account of the incident which, to the best of the provider’s knowledge, is true of all the facts the body knows about the incident as at the date of the notification;
  • Advise the relevant person what further enquiries the provider believes are appropriate;
  • Offer an apology;
  • Follow up the apology by giving the same information in writing, and providing an update on the enquiries;
  • Keep a written record of all communication with the relevant person.

6. Definition of Notifiable Safety Incidents

Regulation 20 defines what constitutes a notifiable safety incident for all providers and harm thresholds. The notifiable incidents that trigger the duty of candour for all providers are consistent with existing definitions of notifiable incidents.

The care provided to a service user has resulted in harm with the following thresholds:

  • The death of a service user related to an incident;
  • Moderate harm;
  • Severe harm;
  • Prolonged pain;
  • Prolonged psychological harm.

See the regulation for examples of incidents that would trigger the duty of candour.

The notification forms that could apply are:

  • Death of persons using the service;
  • Serious injury to a person who uses the service;
  • Abuse or allegations of abuse concerning a person who uses a service;
  • Incidents reported to or investigate by the police.

All of which must be submitted without delay.

7. Process of Investigation

Any incident within the service which causes distress or harm to a service user or their families must be investigated.

All staff need to remember that reporting of an incident can be very distressing for the person themselves, the staff member and other people involved in their care.

  • We need to be open and honest and to say sorry when things have not been done correctly/where mistakes have been made;
  • We need to do this in a way that is not defensive to ensure that we are able to work in a none blame culture, to enable us to be able to investigate incidents fully and feedback the outcome of these investigations;
  • It is important that all our staff are fully aware of this, to ensure that they do report incidents as they occur to ensure the safety of the service users;
  • At the time the incident is reported, the first thing we should do is minimise any ongoing risk by acting quickly and by calling for medical support or advice. For example, if incorrect medication is given, we must contact the pharmacy or GP for advice on what actions need to be taken. If the situation is an emergency then call for an ambulance;
  • We must explain to the service user and their families what has happened and explain the process for investigation;
  • When we become aware of an incident of harm or potential harm, we need to ensure that this is reported to a manager immediately so initial discussions can take place as soon as possible after recognising that something has gone wrong;
  • As a service we need to ensure that the correct level of support is given to the service user and families and that they are given one point of contact;
  • Additional support to the service user may be required. Depending upon the service provided this may involve additional direct care visits, visits/phone calls by the manager to explain what is happening, meetings with an advocate and at times a change of staff support/care provider. Each person will have different needs and it is important that we listen to the person and work with them to alleviate upset, anxiety and build confidence and reassurance;
  • Regular updates on investigation should be given to service users and their families and the full outcome of the investigation communicated openly and honestly within the confounds of confidentiality;
  • Managers need to support staff members involved in the incident and recognise that they themselves may be upset or traumatised by the situation they have been directly involved in or witnessed. Additional support and the Counselling service should be discussed with individuals concerned.

As part of inspections CQC will check that service have robust systems in place to meet the duty of candour and notification of safety incidents.

8. Notifying CQC

Any safety incident that requires notification under CQC regulations must be notified to CQC. This should be done via the correct notification form, found on the CQC website within the required timeframe. For notifications relating to Duty of Candour this is without delay.

If alongside the notification itself there is a need to provide further information to CQC under the Duty of Candour regulation this should be additional to the notification form and also provided without delay.

There is not a specific form in which to notify CQC under the Duty of Candour regulation. To provide this information to CQC Managers should undertake the following:

  • Complete required notification/s;
  • E-mail CQC on the notifications E-mail address making it clear that this is under the Duty of Candour regulation;
  • Provide additional information as required in relation to the Duty of Candour regulation itself.

The regulation in full can be found on the CQC website.


Click here to view Appendix 1: CQC KLOE - Guidance on prompts and sources of evidence on “Safe”

Click here to view Appendix 2: CQC Regulation 20