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{{org_field_name}}

Registration Number: {{org_field_registration_no}}

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Duty of Candour Policy

1. Purpose

{{org_field_name}} is committed to providing safe, person-centred and transparent care and support to people using our Supported Living service.

This policy sets out how {{org_field_name}} will comply with the statutory Duty of Candour under Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

The Duty of Candour requires registered persons to act in an open and transparent way with people using the service, or a person lawfully acting on their behalf, in relation to care and treatment provided in carrying on a regulated activity.

This includes:

• maintaining an open and transparent culture in relation to care and support generally;
• informing the relevant person as soon as reasonably practicable when a notifiable safety incident has occurred;
• providing a truthful account of the facts known at the time;
• explaining what further enquiries or investigations are considered appropriate;
• providing reasonable support;
• offering an apology;
• following the initial notification with the required written notification; and
• keeping appropriate records of the Duty of Candour process.

The specific statutory Duty of Candour procedure described in this policy applies where an incident meets the definition of a notifiable safety incident under Regulation 20.

Even where an incident does not meet the statutory threshold for a notifiable safety incident, {{org_field_name}} will continue to act openly and transparently with people using the service about their care and support.

{{org_field_name}} is registered with the Care Quality Commission to carry out the regulated activity of {{org_field_regulated_activity}} for {{org_field_service_users_bands}} in supported living settings.

2. Scope

This policy applies to:

• the registered provider;
• the Registered Manager;
• all employees;
• agency workers;
• contractors;
• volunteers; and
• any other person working on behalf of {{org_field_name}} who may become aware of an incident involving a person using the service.

The general requirement to act openly and transparently applies to care and treatment provided by {{org_field_name}} in carrying on its regulated activity.

The specific statutory Duty of Candour procedure applies where an unintended or unexpected incident occurs during the provision of the regulated activity and meets the definition of a notifiable safety incident applicable to a provider that is not a health service body, as set out in Regulation 20(9).

Staff must report all incidents and concerns promptly so that the Registered Manager or registered provider can determine whether the statutory Duty of Candour procedure is required.

Whether an incident constitutes a notifiable safety incident must be assessed against the legal criteria in Regulation 20 and must not be determined solely by whether the organisation considers itself to have been at fault.

3. Policy Statement

At {{org_field_name}}, we are committed to:

• Being open and honest when things go wrong.
• Acknowledging mistakes and learning from them to prevent future occurrences.
• Providing timely and transparent communication to those affected by incidents.
• Issuing a genuine apology and explaining what happened and why.
• Ensuring all staff understand and fulfil their responsibilities under the Duty of Candour.

We believe that honesty is fundamental in maintaining the confidence of those who use our services. We will ensure that any incidents that meet the criteria for a notifiable safety incident are handled with integrity, professionalism, and empathy.

4. Definitions

4.1 Duty of Candour

The statutory Duty of Candour requires {{org_field_name}}, as a registered provider, and the Registered Manager, as registered persons, to act in an open and transparent way with people using the service in relation to care and treatment provided in carrying on a regulated activity.

Where a notifiable safety incident occurs, Regulation 20 imposes additional specific requirements concerning notification, support, explanation, apology, written follow-up and record keeping.

The general duty to be open and transparent applies even where an event does not meet the statutory definition of a notifiable safety incident.

4.2 Notifiable Safety Incident

For {{org_field_name}}, which is not a health service body, the definition in Regulation 20(9) applies.

A notifiable safety incident is an unintended or unexpected incident that occurs in respect of a person using the service during the provision of a regulated activity and which, in the reasonable opinion of a healthcare professional:

• appears to have resulted in the death of the person, where the death relates directly to the incident rather than to the natural course of the person’s illness or underlying condition;
• appears to have resulted in an impairment of the person’s sensory, motor or intellectual functions that has lasted, or is likely to last, for a continuous period of at least 28 days;
• appears to have resulted in changes to the structure of the person’s body;
• appears to have resulted in the person experiencing prolonged pain;
• appears to have resulted in the person experiencing prolonged psychological harm;
• appears to have resulted in the shortening of the person’s life expectancy; or
• requires treatment by a healthcare professional in order to prevent the person’s death or prevent an injury that, if untreated, would be likely to result in one or more of the outcomes listed above.

For the purposes of Regulation 20:

• prolonged pain means pain experienced, or likely to be experienced, continuously for at least 28 days; and
• prolonged psychological harm means psychological harm experienced, or likely to be experienced, continuously for at least 28 days.

All three of the following elements must therefore be considered:

• the incident was unintended or unexpected;
• it occurred during the provision of a regulated activity; and
• the applicable harm threshold in Regulation 20(9) is met in the reasonable opinion of a healthcare professional.

The existence or absence of fault does not determine whether an incident is a notifiable safety incident.

Where staff are uncertain whether the threshold has been met, the matter must be escalated promptly to the Registered Manager, who will obtain appropriate healthcare professional advice where required.

4.3 Relevant Person

For the purposes of this policy, the relevant person will normally be the person using the service.

A person may lawfully act on their behalf where:

• the person using the service has died;
• the person lacks capacity in relation to the matter; or
• another lawful basis exists for that person to act on their behalf.

Where the person using the service lacks capacity in relation to the matter, {{org_field_name}} will identify the appropriate person lawfully acting on their behalf in accordance with the Mental Capacity Act 2005 and any other applicable legal authority.

A relative, friend or next of kin must not automatically be treated as having legal authority to act on behalf of the person solely because of their relationship.

Where the person using the service has capacity, they remain the relevant person unless another person is lawfully authorised to act on their behalf.

5. Responsibilities

5.1 Responsibilities of the Registered Manager

The Registered Manager, together with the registered provider, is responsible for ensuring compliance with Regulation 20.

The Registered Manager will:

• ensure that incidents are identified, reported and reviewed promptly;
• determine whether an incident may meet the definition of a notifiable safety incident;
• obtain the reasonable opinion of an appropriate healthcare professional where required to determine whether the statutory harm threshold has been met;
• ensure that the relevant person is notified as soon as reasonably practicable;
• ensure that reasonable support is provided to the relevant person;
• ensure that the relevant person receives a truthful account of all facts known at the time;
• explain what further enquiries or investigations are considered appropriate;
• ensure that an appropriate apology is provided;
• ensure that the initial notification is followed by the required written notification;
• ensure that the relevant person is informed of the results of further enquiries or investigations;
• ensure that all Duty of Candour discussions, correspondence, attempts to make contact and actions are properly recorded;
• retain copies of written correspondence with the relevant person;
• consider separately whether the incident is subject to a statutory CQC notification or notification to another authority;
• ensure staff receive appropriate Duty of Candour training; and
• review incidents and resulting learning to improve the quality and safety of the service.

The Registered Manager may delegate individual actions to an appropriately competent senior member of staff, but overall accountability for ensuring that the Duty of Candour requirements are met remains with the registered person.

5.2 Responsibilities of All Staff

All staff have a duty to:

• Report incidents, errors, and concerns immediately to their manager.
• Where to report:
  • Verbally to the Registered Manager or Safeguarding Lead
  • Inform the Registered Manager by email: {{org_field_registered_manager_email}}
  • Call the office and inform the Registered Manager or Safeguarding Lead: {{org_field_phone_no}}
  • Out of hours phone number: {{out_of_hours}}
• Engage in open and honest communication with individuals and families.
• Support those affected by an incident with compassion and understanding.
• Participate in training and development related to the Duty of Candour.

Failure to comply with this policy may result in disciplinary action, as transparency and honesty are fundamental values of our organisation.

6. Procedure for Managing a Notifiable Safety Incident

When an incident may meet the definition of a notifiable safety incident, {{org_field_name}} will follow the procedure below.

Step 1 – Immediate Safety and Internal Escalation

The immediate safety, health and welfare of the person using the service will take priority.

Staff must:

• take any immediate action necessary to protect the person from further harm;
• obtain emergency or other healthcare assistance where required;
• report the incident immediately to the Registered Manager or designated senior person;
• record the incident in accordance with the organisation’s incident-reporting procedure; and
• preserve relevant information and evidence where necessary.

The Registered Manager will review the circumstances promptly and determine whether the incident may fall within Regulation 20.

Where necessary, an appropriate healthcare professional will be consulted to establish whether the applicable harm threshold is met.

Step 2 – Identify the Relevant Person

The Registered Manager will establish who is the relevant person for the purposes of Regulation 20.

This will normally be the person using the service.

Where the person has died or lacks capacity in relation to the matter, the organisation will identify the person lawfully acting on their behalf.

The person’s communication and accessibility needs will also be identified so that the Duty of Candour process can be carried out in a way they can understand.

Step 3 – Notify the Relevant Person as Soon as Reasonably Practicable

As soon as reasonably practicable after {{org_field_name}} becomes aware that a notifiable safety incident has occurred, the relevant person must be notified.

The notification must normally be given in person by the Registered Manager or another appropriate representative of the registered provider.

During that discussion, the representative must:

• explain that a notifiable safety incident has occurred;
• provide an account which, to the best of the organisation’s knowledge, is true and includes all facts known at that time;
• avoid speculation or unsupported conclusions;
• explain what further enquiries or investigations the organisation believes are appropriate;
• answer questions as openly as possible based on the information currently available;
• provide an apology; and
• explain how the person will be supported and kept informed.

A written record of the discussion must be made and stored securely.

Step 4 – Provide Reasonable Support

{{org_field_name}} will provide reasonable support to the relevant person in relation to the incident, including when the initial notification is given.

Support will be appropriate to the person’s individual circumstances and may include:

• arranging a suitable private environment for discussions;
• providing information in an accessible format;
• arranging communication support or an interpreter where required;
• allowing the person to have an advocate, relative, friend or other appropriate person present;
• explaining what will happen next;
• providing appropriate emotional or practical support;
• signposting to independent advocacy or other support services where appropriate; and
• providing a named contact for further questions or updates.

The support offered and provided will be recorded.

Step 5 – Provide an Apology

An apology must be provided to the relevant person.

For the purposes of Regulation 20, an apology is an expression of sorrow or regret in relation to the notifiable safety incident.

The apology will be:

• sincere;
• clear;
• appropriate to the circumstances; and
• provided as part of the initial notification and again in the written follow-up.

Providing an apology does not constitute an admission of legal liability.

Step 6 – Written Follow-Up Notification

The initial notification must be followed by a written notification given or sent to the relevant person.

The written notification will include:

• the factual information provided during the initial discussion;
• details of any further enquiries or investigations that are to be undertaken;
• the results of any further enquiries that have been completed;
• an apology; and
• appropriate contact information for further questions.

Where enquiries are ongoing when the first written notification is sent, further written communication will be provided when material findings or outcomes become available.

Copies of all correspondence with the relevant person will be retained securely.

Step 7 – Where the Relevant Person Cannot Be Contacted or Declines to Speak

If the relevant person cannot be contacted in person or declines to speak with the organisation’s representative, the Registered Manager will ensure that reasonable attempts are made to make contact.

A written record will be maintained of:

• each attempt to contact the relevant person;
• the date and time of the attempt;
• the method used;
• the outcome; and
• any indication that the person declined to engage.

The organisation will follow the requirements of Regulation 20 concerning situations where the relevant person cannot be contacted or declines to speak.

Step 8 – Investigation and Ongoing Communication

Appropriate enquiries or investigation will be undertaken to establish what happened, why it happened and what action is required.

The investigation will be proportionate to the incident and may include:

• reviewing care records;
• speaking with staff and relevant professionals;
• reviewing risk assessments and care plans;
• examining policies and procedures;
• identifying contributory factors and root causes;
• considering whether safeguarding action is required; and
• identifying improvements needed to reduce the risk of recurrence.

The relevant person will be kept appropriately informed of significant findings and the outcome.

Step 9 – CQC and Other Statutory Notifications

The Registered Manager will separately consider whether the incident must be notified to CQC under the Care Quality Commission (Registration) Regulations 2009 or reported to any other statutory or safeguarding authority.

The fact that an incident is a notifiable safety incident for the purposes of Regulation 20 does not, by itself, determine whether a separate CQC statutory notification is required.

Where a statutory notification is required, it will be submitted without delay and in accordance with the applicable notification requirements.

Depending on the circumstances, the organisation will also consider whether notification or referral is required to:

• the Local Authority Safeguarding Adults Team;
• the police;
• a commissioner;
• the Disclosure and Barring Service;
• a professional regulator; or
• another appropriate statutory body.

Step 10 – Recording, Learning and Improvement

A complete Duty of Candour record will be maintained.

The record will include:

• details of the incident;
• the assessment of whether the Regulation 20 threshold was met;
• any healthcare professional opinion obtained;
• details of the relevant person;
• the date and method of the initial notification;
• the factual account provided;
• the apology provided;
• details of reasonable support offered and provided;
• details of further enquiries or investigations;
• copies of written notifications and correspondence;
• attempts to contact the relevant person where applicable;
• investigation findings;
• statutory notifications or referrals;
• improvement actions; and
• evidence that agreed actions have been completed.

Learning from incidents will be used to improve care, staff practice, risk management, training, policies and organisational systems.

7. Training and Awareness

All relevant staff will receive training and information appropriate to their role so that they understand the statutory Duty of Candour and the organisation’s procedures.

Training will include:

• the general duty to act openly and transparently;
• Regulation 20 and its application to the Supported Living service;
• how to recognise and report incidents that may meet the definition of a notifiable safety incident;
• the harm thresholds applicable to providers that are not health service bodies;
• the requirement for the reasonable opinion of a healthcare professional when determining whether the statutory threshold is met;
• how to report incidents promptly;
• the meaning of the relevant person;
• how and when the relevant person must be notified;
• providing a truthful factual account;
• explaining further enquiries or investigations;
• providing reasonable support;
• making an appropriate apology;
• written follow-up requirements;
• record keeping;
• the distinction between the Duty of Candour process and separate CQC statutory notification requirements; and
• learning from incidents.

Registered Managers and other staff responsible for carrying out Duty of Candour notifications will receive additional training appropriate to their responsibilities.

Staff understanding will be monitored through supervision, incident review, competency discussions, audits or other appropriate quality-assurance arrangements.

Where gaps in knowledge or practice are identified, additional training or support will be provided.

8. Compliance and Monitoring

The Registered Manager will monitor compliance with this policy and Regulation 20 through the organisation’s governance arrangements.

This will include reviewing:

• incidents that may have met the Duty of Candour threshold;
• whether the Regulation 20 threshold was assessed correctly;
• whether appropriate healthcare professional opinion was obtained where required;
• whether the relevant person was identified correctly;
• whether notification took place as soon as reasonably practicable;
• whether the initial notification was given in accordance with Regulation 20;
• whether a truthful factual account was provided;
• whether appropriate further enquiries were explained;
• whether an apology was provided;
• whether reasonable support was offered and provided;
• whether written follow-up was completed;
• whether correspondence and attempts to contact the relevant person were retained;
• whether separate statutory CQC notifications or safeguarding referrals were made where required;
• whether investigation findings were communicated appropriately;
• whether improvement actions were completed; and
• whether staff demonstrate an appropriate understanding of the Duty of Candour.

Any identified non-compliance will be addressed promptly through corrective action, training, supervision, changes to procedures or other appropriate management action.

Significant learning and themes will be reviewed through the organisation’s governance arrangements and used to improve the safety and quality of the service.

9. References

This policy should be read in conjunction with:

• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 – Regulation 20: Duty of Candour
• Care Quality Commission – Regulation 20: Duty of Candour guidance
• Care Quality Commission – Notifiable safety incidents guidance
• Care Quality Commission – What you must do when you discover a notifiable safety incident
• Care Quality Commission (Registration) Regulations 2009, including statutory notification requirements where applicable
• Mental Capacity Act 2005
• Incident Reporting Policy
• Safeguarding Adults Policy
• Complaints Policy
• Consent Policy
•  Governance and Quality Assurance Policy

Official CQC Regulation 20 guidance:
https://www.cqc.org.uk/guidance-regulation/providers/regulations-service-providers-and-managers/health-social-care-act/regulation-20

CQC guidance on notifiable safety incidents:
https://www.cqc.org.uk/guidance-regulation/providers/regulations-service-providers-and-managers/health-social-care-act/regulation-20/incidents

10. Review Date

This policy will be reviewed annually or sooner if regulatory updates or best practices change.

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Responsible Person: {{org_field_registered_manager_first_name}}{{org_field_registered_manager_last_name}}
Reviewed on: {{last_update_date}}
Next Review Date: {{next_review_date}}
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