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{{org_field_name}}

Registration Number: {{org_field_registration_no}}

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Duty of Candour Policy

1. Purpose

The purpose of this policy is to ensure that {{org_field_name}} complies with the organisational Duty of Candour requirements contained in Part 2 of the Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016 and the Duty of Candour Procedure (Scotland) Regulations 2018.

The organisational Duty of Candour applies when an unintended or unexpected incident occurs in the provision of a care service and, in the reasonable opinion of a registered health professional who was not involved in the incident, the incident appears to have resulted in, or could result in, one of the outcomes specified in section 21(4) of the Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016, and that outcome relates directly to the incident rather than to the natural course of the person’s illness or underlying condition.

This policy sets out how {{org_field_name}} will:

• identify and respond to incidents which may activate the organisational Duty of Candour;
• obtain the required opinion from an appropriate registered health professional who was not involved in the incident;
• notify and communicate with the relevant person;
• offer and, where accepted, provide a written apology;
• offer and arrange a meeting with the relevant person;
• review the circumstances which led or contributed to the incident;
• involve the relevant person in that review;
• provide information and appropriate support to the relevant person and staff involved;
• keep the records required by legislation;
• identify learning and improvements arising from incidents; and
• prepare, publish and notify the Care Inspectorate of the organisation’s annual Duty of Candour report as required.

{{org_field_name}} will carry out the Duty of Candour procedure openly, honestly, compassionately and in a person-centred manner, while respecting confidentiality, data protection requirements and any legal restrictions on disclosure.

2. Scope

This policy applies to {{org_field_name}} as the responsible person providing a care service and to all employees, workers and other persons acting on behalf of the organisation who may be involved in identifying, reporting, managing, reviewing or responding to an unintended or unexpected incident.

This includes:

• Care Workers;
• Registered Managers and Supervisors;
• administrative and office staff where their role is relevant to the procedure;
• agency and temporary staff;
• volunteers and students; and
• any other person acting on behalf of {{org_field_name}} in connection with the provision of the care service.

Staff must report promptly any unintended or unexpected incident which may meet the statutory Duty of Candour threshold. The Duty of Candour procedure must be activated where an unintended or unexpected incident has occurred in the provision of the care service and, in the reasonable opinion of a registered health professional who was not involved in the incident:

• the incident appears to have resulted in, or could result in, the death of the person;
• the incident appears to have resulted in, or could result in, a permanent lessening of bodily, sensory, motor, physiological or intellectual functions, including brain damage or removal of the wrong limb or organ;
• the incident appears to have resulted in, or could result in, harm which is not severe harm but which results in:
  • an increase in the person’s treatment;
  • changes to the structure of the person’s body;
  • shortening of the person’s life expectancy;
  • impairment of the person’s sensory, motor or intellectual functions which has lasted, or is likely to last, for a continuous period of at least 28 days; or
  • pain or psychological harm which has been, or is likely to be, experienced for a continuous period of at least 28 days; or
• the person requires treatment by a registered health professional in order to prevent:
  • the person’s death; or
  • an injury which, if left untreated, would lead to one or more of the outcomes described above.

In every case, the qualifying outcome must relate directly to the unintended or unexpected incident rather than to the natural course of the person’s illness or underlying condition.

An incident must have occurred before the statutory organisational Duty of Candour procedure can be activated. A situation in which no incident occurred, although an incident theoretically could have occurred, does not by itself activate the organisational Duty of Candour procedure.

Where the person who received the care has died or lacks capacity to participate in the procedure, {{org_field_name}} will identify the appropriate person to act on their behalf in accordance with the applicable legislation and legal authority, including any welfare power of attorney or guardianship arrangements where relevant.

3. Related Policies

The Duty of Candour process is linked to several other policies within {{org_field_name}}. Staff should be familiar with these policies to ensure a consistent approach to managing incidents.

• Incident Reporting and Investigation Policy – outlines how to record and investigate adverse events.
• Complaints and Feedback Policy – ensures that concerns raised by people we support and their families are managed properly.
• Safeguarding Policy – provides guidance on protecting vulnerable individuals.
• Health and Safety Policy – sets out procedures for ensuring a safe care environment.
• Whistleblowing Policy – allows staff to raise concerns about unsafe practices without fear of retaliation.
• Confidentiality and Data Protection Policy – ensures that information is managed securely and in compliance with GDPR.

These policies work together to create a safe and accountable care environment.

4. What is the Duty of Candour?

The organisational Duty of Candour is a statutory procedure applying to organisations which provide health services, care services and social work services in Scotland. As a provider of a registered care service, {{org_field_name}} is a responsible person for the purposes of the Duty of Candour legislation.

The statutory procedure is activated following an unintended or unexpected incident in the provision of the care service where a registered health professional who was not involved in the incident gives the reasonable opinion that the incident appears to have resulted in, or could result in, one of the outcomes specified in section 21(4) of the Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016 and the outcome relates directly to the incident rather than to the natural course of the person’s illness or underlying condition.

Once the statutory threshold has been met, {{org_field_name}} must follow the Duty of Candour procedure as soon as reasonably practicable. This includes:

• notifying the relevant person;
• providing the required information about the incident and the procedure;
• offering and, where accepted, providing a written apology;
• inviting the relevant person to a meeting and giving them an opportunity to ask questions and express their views;
• providing a note of the meeting and a named contact following the meeting;
• reviewing the circumstances which led or contributed to the incident;
• seeking and taking account of the relevant person’s views during the review;
• offering information about appropriate support;
• preparing a written report of the review;
• offering to provide the relevant person with the review report and the required further information;
• supporting employees involved in the incident and the Duty of Candour procedure; and
• maintaining the statutory written record of the procedure.

An apology or another step taken in accordance with the Duty of Candour procedure does not, of itself, amount to an admission of negligence or breach of a statutory duty.

The purpose of the organisational Duty of Candour is to promote openness, honesty, learning and improvement following unintended or unexpected incidents and not to apportion blame.

5. Principles of the Duty of Candour

To ensure we uphold the Duty of Candour effectively, {{org_field_name}} follows these core principles:

1. Openness and Honesty – Ensuring that all communication with people we support, families, and staff is transparent.
2. Respect and Compassion – Approaching every incident with sensitivity, ensuring that individuals feel supported.
3. Accountability – Taking responsibility for errors and ensuring corrective actions are taken.
4. Apology and Explanation – Providing a meaningful and sincere apology to those affected.
5. Investigation and Learning – Using incidents as learning opportunities to improve care practices.
6. Staff Support – Ensuring that employees are not unfairly blamed and receive necessary emotional and professional support.
7. Compliance with Regulations – Meeting all Care Inspectorate and SSSC requirements to ensure legal compliance.

6. Managing the Duty of Candour Procedure

6.1 Identification, Reporting and Statutory Assessment

All staff must report immediately, through {{org_field_name}}’s incident reporting arrangements, any unintended or unexpected incident which they believe has caused, may have caused or could result in harm meeting the statutory Duty of Candour threshold.

The Registered Manager, or another person formally authorised by {{org_field_name}}, will coordinate the organisational response and ensure that immediate safety, safeguarding, medical and regulatory actions are taken.

The Registered Manager does not determine the statutory Duty of Candour threshold solely on their own assessment. {{org_field_name}} must obtain the reasonable opinion of a registered health professional who was not involved in the incident.

The registered health professional must consider:

• the nature of the unintended or unexpected incident;
• whether the incident appears to have resulted in, or could result in, one of the statutory outcomes;
• whether that outcome relates directly to the incident; and
• whether the outcome instead relates to the natural course of the person’s illness or underlying condition.

Where {{org_field_name}} does not employ a suitable registered health professional, it will seek the opinion of an appropriate registered health professional who was not involved in the incident. Where appropriate, this may include a registered health professional already involved in the person’s care or familiar with their clinical history, such as their GP.

The date on which {{org_field_name}} receives confirmation of the registered health professional’s opinion that the statutory criteria are met will be recorded as the procedure start date.

Where the statutory criteria are met, {{org_field_name}} will activate the Duty of Candour procedure as soon as reasonably practicable.

6.2 Immediate Actions

Following an unintended or unexpected incident, staff must:

• take immediate action to protect the safety, health and wellbeing of the person;
• obtain emergency or other medical assistance where required;
• report the incident promptly in accordance with the organisation’s incident reporting procedure;
• preserve relevant records and other evidence;
• notify the Registered Manager or designated senior person without delay;
• make any safeguarding or protection referral required by law or local procedure; and
• ensure that any separate statutory or regulatory notification required in relation to the incident is made.

The Duty of Candour procedure does not replace safeguarding, Care Inspectorate notification, complaints, disciplinary, criminal, professional regulatory or other statutory processes. Where another process applies, it may operate alongside the Duty of Candour procedure.

6.3 Notification and Communication with the Relevant Person

Once the Duty of Candour procedure has been activated, {{org_field_name}} must notify the relevant person as soon as reasonably practicable.

The notification must include:

• an account of the incident to the extent that the facts are known at the date of notification;
• an explanation of the actions that {{org_field_name}} will take as part of the Duty of Candour procedure; and
• where the procedure start date is more than one month after the date of the incident, an explanation of the reason for the delay in starting the procedure.

{{org_field_name}} will take reasonable steps to establish the relevant person’s preferred method of communication and, where reasonably practicable, will communicate by that method and in a manner which the person can understand.

Where appropriate, reasonable adjustments, accessible information, interpreting or communication support will be provided.

Where attempts to contact the relevant person are unsuccessful, {{org_field_name}} will continue to take reasonable steps to establish contact and will maintain a written record of all attempts.

Where a relevant person indicates that they do not wish to receive information about the Duty of Candour procedure, their wishes will be respected and recorded.

Information must not be disclosed where doing so would prejudice a criminal investigation or prosecution or would breach a legal restriction on disclosure.

6.4 Apology

In addition to any apology made at the time of the incident, {{org_field_name}} must offer the relevant person a written apology and, where the relevant person wishes to receive it, provide that written apology.

The apology will be personal, sincere and appropriate to the circumstances and will express sorrow or regret in respect of the unintended or unexpected incident.

An apology, or any other step taken in accordance with the Duty of Candour procedure, does not of itself amount to an admission of negligence or breach of a statutory duty.

A record of the apology offered and, where applicable, provided will be retained as part of the Duty of Candour record.

6.5 Meeting with the Relevant Person

{{org_field_name}} must invite the relevant person to attend a meeting and give them the opportunity to submit questions in advance.

Reasonable steps must be taken to make the meeting accessible and suitable for the relevant person’s circumstances and communication needs. The relevant person may be supported by another person, including an advocate, interpreter or other person of their choosing where appropriate.

The meeting must include:

• an account of the incident;
• an explanation of any further steps {{org_field_name}} intends to take to investigate the circumstances which led or contributed to the incident;
• an opportunity for the relevant person to ask questions about the incident;
• an opportunity for the relevant person to express their views about the incident; and
• information about any other legal or review procedures being followed in relation to the incident in addition to the Duty of Candour procedure.

Following the meeting, {{org_field_name}} must provide the relevant person with:

• a note of the meeting; and
• contact details for an individual member of staff acting on behalf of {{org_field_name}} whom the relevant person may contact.

Where the relevant person does not wish to attend or is unable to attend a meeting, the information required by the Duty of Candour Regulations will nevertheless be offered or provided as applicable.

6.6 Review, Learning and Written Report

{{org_field_name}} must carry out a review of the circumstances which it considers led or contributed to the unintended or unexpected incident.

As part of the review, {{org_field_name}} must seek the views of the relevant person and take account of any views expressed.

The review will identify, where applicable:

• what happened;
• the circumstances and factors which led or contributed to the incident;
• what can be learned from the incident;
• any action required to improve the quality and safety of the service; and
• how relevant learning should be shared to support continuous improvement.

Where the review has not been completed within three months beginning with the procedure start date, {{org_field_name}} must provide the relevant person with an explanation of the reason for the delay.

Following the review, {{org_field_name}} must prepare a written report which includes:

• a description of how the review was carried out;
• a statement of any actions to be taken by {{org_field_name}} to improve the quality of the service and to share learning with other persons or organisations where appropriate; and
• a list of the actions taken as part of the Duty of Candour procedure and the date on which each action took place.

{{org_field_name}} must offer to provide the relevant person with:

• a copy of the written review report;
• details of further information about actions taken to improve the quality of the service provided by {{org_field_name}} or other health, care or social work services; and
• details of services or support which may be able to assist the relevant person, taking account of their needs.

6.7 Records, Regulatory Notifications, Training and Staff Support

{{org_field_name}} must keep a written record for every incident in respect of which the Duty of Candour procedure is followed.

The record must include a copy of every document and item of correspondence relating to the application of the Duty of Candour procedure to the incident.

Duty of Candour records will be retained securely in accordance with the organisation’s records management, confidentiality and data protection arrangements.

Activation of the Duty of Candour procedure does not remove or replace any requirement to notify the Care Inspectorate or another statutory or professional body. The Registered Manager will ensure that all separate regulatory notifications required in relation to the incident are submitted in accordance with the applicable requirements and timescales.

{{org_field_name}} will ensure that employees who carry out the Duty of Candour procedure on its behalf receive relevant training, guidance and support concerning the procedure and information about services and support available to relevant persons.

Employees involved in an incident must also be provided with details of any services or support of which {{org_field_name}} is aware that may provide assistance or support to them, taking account of the circumstances of the incident and the employee’s needs.

Staff must cooperate honestly and openly with investigations and reviews and must maintain clear and accurate records.

7. Duty of Candour Annual Report

As a responsible person providing a care service, {{org_field_name}} must prepare an annual Duty of Candour report as soon as reasonably practicable after the end of each financial year.

The report must contain, in relation to that financial year:

• information about the number and nature of incidents to which the organisational Duty of Candour procedure applied;
• where a single incident affected more than one person, appropriate information about the number of people affected;
• an assessment of the extent to which {{org_field_name}} carried out the required Duty of Candour procedure;
• information about {{org_field_name}}’s policies and procedures relating to the Duty of Candour, including:
  • procedures for identifying and reporting incidents;
  • support available to staff; and
  • support available to persons affected by incidents;
• information about any changes made to {{org_field_name}}’s policies and procedures as a result of incidents to which the Duty of Candour procedure applied; and
• any other information that {{org_field_name}} considers appropriate.

The annual report must not name any individual or contain information from which an individual could be identified.

{{org_field_name}} will publish its annual Duty of Candour report in an appropriate publicly accessible manner.

Following publication, {{org_field_name}} will notify the Care Inspectorate as required. For a registered care service, information about whether the annual Duty of Candour report has been published will be provided through the Care Inspectorate’s applicable Annual Return process or any replacement process specified by the Care Inspectorate.

The annual Duty of Candour report is separate from individual Care Inspectorate incident notifications and does not remove the requirement to submit any notification required by the Care Inspectorate in relation to a particular incident.

8. Compliance and Monitoring

{{org_field_name}} will monitor compliance with this policy and the statutory organisational Duty of Candour procedure.

The Registered Manager, or another person formally authorised by {{org_field_name}}, will ensure that:

• potential Duty of Candour incidents are identified and escalated promptly;
• the opinion of a registered health professional who was not involved in the incident is obtained where required;
• each activated Duty of Candour procedure is documented and the statutory steps are completed;
• the relevant person is appropriately involved, informed and supported;
• staff involved in incidents and in carrying out the procedure receive the required support, training and guidance;
• all records required by the Duty of Candour legislation are maintained;
• learning and improvement actions arising from reviews are implemented and monitored;
• notifications required by the Care Inspectorate or another relevant authority are made separately in accordance with the applicable notification requirements and timescales; and
• the annual Duty of Candour report is prepared, published and notified to the Care Inspectorate as required.

Compliance with this policy will be reviewed through the organisation’s governance, incident review and quality assurance arrangements.

9. Policy Review

This policy will be reviewed annually or sooner if:

• There are legislative changes impacting Duty of Candour requirements.
• A significant Duty of Candour incident highlights the need for policy updates.
• The Care Inspectorate provides new guidance.

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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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