Duty of Candour Policy

1. Purpose

This policy sets out how Highland Wellness and Weight Management Clinic (“the Clinic”) will meet its organisational duty of candour obligations when an unintended or unexpected incident occurs in the course of providing weight-loss injections and wellness services that appears to have caused (or could cause) harm, in accordance with Scottish law and regulatory guidance.
The aims are to ensure openness and transparency with service users (and, where appropriate, their families/carers), to promote a culture of learning and improvement, and to maintain trust and safety in the services we provide.

2. Scope

This policy applies to:

• All clinical and wellness services delivered by the Clinic (including but not limited to weight-loss injection programmes, wellness assessments, follow-up care, ancillary services).
• All employees, contractors, locums, and those working under the Clinic’s governance or supervision.
• All incidents that may meet the threshold for the duty of candour (see Section 4).
• Service users (patients) and, where relevant, their nominated representatives or carers.

3. Legal & Regulatory Framework

• The Clinic is subject to the organisational duty of candour under the Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016.
• The Duty of Candour Procedure (Scotland) Regulations 2018 set out the procedure to follow when the duty is activated.
• Guidance issued by the Scottish Government on the organisational duty of candour (March 2025) identifies key thresholds, roles, timing, and responsibilities.
• The Clinic is committed to meeting the standards of openness, transparency, apology and improvement as set out in the guidance.

4. When does the Duty of Candour apply? (Thresholds)

The duty of candour procedure must be activated as soon as reasonably practicable when the Clinic becomes aware that:

• An unintended or unexpected incident occurred in the course of providing a health service (i.e., our weight-loss/wellness service).
• In the reasonable opinion of a registered health professional not involved in the incident, that incident appears to have resulted in, or could result in, one or more of the following outcomes (where the outcome relates directly to the incident, and not to the natural course of an underlying condition):
  • The death of the person.
  • Permanent lessening of bodily, sensory, motor, physiologic or intellectual functions.
  • An injury, disease or requiring treatment by a registered health professional which:
    • increases the person’s treatment;
    • changes the structure of the person’s body;
    • shortens life expectancy;
    • impairs sensory/motor/intellectual function for at least 28 days;
    • causes pain or psychological harm for at least 28 days.
  • The incident is not simply due to the natural course of the person’s illness or underlying condition.
  • Examples relevant to our clinic might include (but are not limited to): an adverse reaction to an injection that leads to hospitalisation; a serious error in dosing or administration with significant harm; a wellness treatment error causing significant and sustained psychological distress.

If the incident is a near-miss (i.e., did not cause harm and was unlikely to do so) then the duty of candour procedure does not need to be activated.

5. Key Roles & Responsibilities

• Responsible Person: The Clinic’s nominated senior lead, Dr Alison Brooks, is the “responsible person” for activating and overseeing the duty of candour procedure.
• Registered Health Professional (RHP) Review: An RHP not involved in the incident shall provide an independent opinion on whether the thresholds are met. (E.g., a consultant external to the case or another senior clinician)
• Staff: All staff must be aware of this policy, their role in incident reporting, cooperating with reviews, supporting service users, and undergoing training.
• Service User/Patient: The person who received the service (or in certain circumstances their representative) is the “relevant person”. The Clinic must engage with them meaningfully when the duty is activated.

6. Procedure for Activation & Response

6.1 Incident identification and initial action

• On becoming aware of an unintended or unexpected incident, staff must immediately secure the safety of the service user, provide appropriate clinical care, and escalate the incident according to the Clinic’s incident/investigation policy.
• The responsible person will ensure an RHP not involved in the case is engaged to provide a view on whether the duty of candour threshold is met.
• If the RHP considers the threshold is met, the duty of candour procedure must be activated without undue delay. The date the decision to activate is taken shall be recorded as the “Procedure Start Date”.

6.2 Notification to the Service User / Relevant Person

• The Clinic will notify the relevant person as soon as reasonably practicable that:
  • an incident has occurred which appears to meet the duty of candour threshold;
  • we will conduct a review of what happened;
  • they will be kept informed of outcomes and any proposed remedial action.
• The initial notification should normally be face to face or by telephone, followed by written communication. The communication will include:
  • an apology (“I am sorry that this has happened”).
  • an explanation of what is known at that time.
  • what the Clinic will do to review and address the incident.
  • confirmation of the person receiving the service will be involved in the review, asked if they have questions or concerns, and given regular updates.
• The Clinic must make clear the person’s rights, including how to raise concerns, and remind them of independent bodies if relevant.

6.3 Investigation / Review

• A full review will be carried out to understand what happened, why, and what actions are required to prevent recurrence. This will be done in line with the Clinic’s incident/investigation policy.
• The review will consider contributions from clinical staff, technical/supply systems (injections, devices, process), follow-up care, the service user’s experience, and organisational factors.
• The relevant person will be offered the opportunity to be involved (to ask questions, contribute information) and will be kept updated about progress and findings.
• At the conclusion of the review, the Clinic will prepare a report which includes: what happened, root causes (where identified), what actions will be taken, timescales for completion, who is responsible for each action, and how learning will be disseminated.

6.4 Communication of Findings and Remedial Actions

• After the review, the Clinic will provide the relevant person with a written summary of the findings (written in plain language) and apologise again. The summary will include:
  • what happened;
  • the findings of the review;
  • what has been or will be done to address the issues;
  • timescales and how progress will be shared;
  • how the Clinic will monitor effectiveness of actions.
• The Clinic will commit to learning and continuous improvement, and that the findings will feed into clinical governance, staff training, process changes, audit and improvement plans.

6.5 Record Keeping

• The Clinic will maintain a clear log of incidents, decisions about activation of duty of candour, dates of notifications, communications with relevant persons, review reports, actions taken, and their completion.
• Records will be kept securely, in line with data protection legislation, and will be used for internal learning and external regulatory/inspection purposes if required.

6.6 Governance and Reporting

An annual duty of candour report must be prepared and published at the end of each financial year, providing information about when and where the duty of candour procedure has been applied. See appendix 1.

7. Training and Support

• All clinical and support staff will receive training on the duty of candour: what it is, when it applies, how to respond if an incident occurs, and how to communicate with service users. The Clinic will maintain records of training completed.
• The Clinic will provide support for staff involved in incidents (which can be distressing) including access to counselling or peer support as needed.
• The Clinic’s governance lead will review and update this policy, and ensure staff awareness through induction, refresher training and periodic audits.

8. Confidentiality and Apology

• An apology given under the duty of candour is not an admission of legal liability. It is an expression of regret that the incident occurred and is part of the openness requirement. The Royal College of Anaesthetists
• Communications with the relevant person shall respect confidentiality, data protection legislation, and the service user’s preferences for who should be involved.

9. Integration with Other Policies

This duty of candour policy should be read in conjunction with:

• Data Protection & Confidentiality Policy
• Patient Complaints Policy
• Safeguarding Policy
• Consent and Treatment Policy (particularly relevant for weight-loss injections and wellness services)

10. Specific Considerations for Weight-loss Injections & Wellness Services

• Given the nature of our services (weight-loss injections, wellness care), the Clinic recognises additional risk areas such as: medication/injection errors, off-licence use, adverse reactions, psychological distress about outcomes, follow-up care failures, patient expectations and consent issues.
• The Clinic will ensure that any incident within this service area is evaluated with these risk considerations in mind, and thresholds for activation are considered in context (e.g., if an injection error leads to increased treatment, prolonged harm or psychological harm, the duty of candour may apply).
• The relevant person will be provided with additional support, as wellness clients may have heightened anxiety or may regard the incident differently than a standard hospital-based patient. Thus, clear communication, emotional support and review of expectations are particularly important.

11. Monitoring and Review

• The Clinic will monitor compliance with this policy, including timeliness of notifications, quality of communication with relevant persons, completion of actions, and dissemination of learning.
• Key metrics will include: number of incidents, number of duty of candour activations, timescales from incident to notification, timescales for review and closure, staff training completion, and recurrence of similar incidents.
• The Clinic will review the policy every two years (or sooner if legislation/guidance changes) and will audit the effectiveness of implementation at least annually.

Appendix 1