First Published: August 2019

Last Reviewed: July 2025

Next Review: July 2026

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Policy Statement

 

Hart Skin & Wellness Centre is committed to being open, honest, and transparent with service users when something goes wrong with their treatment or care. Duty of Candour is a legal requirement under the Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016 and a core component of safe, person‑centred practice.

 

We aim to:

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• Communicate openly and compassionately

• Acknowledge when things go wrong

• Offer a meaningful apology

• Explain what happened and why

• Support the patient throughout

• Learn from incidents to prevent recurrence

 

This policy aligns with:

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• Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016

• HIS Duty of Candour Guidance

• NMC Code (2018)

• GMC Good Medical Practice

• UK GDPR & Data Protection Act 2018

• Hart Skin & Wellness Centre Complaints Policy

• Hart Skin & Wellness Centre Grievance Policy

 

Purpose

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This policy ensures:

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• A consistent, compassionate approach when harm occurs

• Clear communication with service users

• Accurate documentation and reporting

• Timely escalation to the Clinical Director

• Integration with the Complaints Policy and Complaints Handling SOP

• Learning and improvement following incidents

• Compliance with statutory Duty of Candour requirements

 

ScopeThis policy applies to:

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• All employees

• Self‑employed clinicians

• Practising‑privilege clinicians

• Administrative staff

• Anyone acting on behalf of the clinic

 

It covers:

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• Incidents resulting in harm

• Near misses requiring learning

• Complaints that trigger Duty of Candour

• Communication with service users

• Documentation and reporting

• Learning and improvement

 

Definition of Harm (Duty of Candour Threshold/Triggers)

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Duty of Candour applies when a patient experiences:

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• Unintended or unexpected harm, AND

• The harm is more than minimal, AND

• The harm results in:

• Additional treatment

• Prolonged recovery

• Psychological harm

• Permanent or temporary impairment

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This threshold is assessed through the Risk Assessment and Root Cause Analysis (Link)

 

If Duty of Candour is triggered then the situation is immediately escalated to the Clinical Director.

 

Preventing Harm Through Informed Consent

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To minimise the risk of harm, clinicians must:

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• Conduct a thorough consultation

• Explain proposed treatment clearly

• Discuss risks, benefits, and alternatives

• Provide realistic expectations

• Document consent accurately

• Offer alternative treatments where appropriate

 

This ensures patients make informed decisions and understand potential outcomes.

 

When Something Goes Wrong

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If an incident occurs during or after treatment, the treating practitioner must:

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1. Recognise and acknowledge the incident

2. Inform the service user as soon as possible

3. Explain what has happened, why, and what it means

4. Offer a sincere apology

5. Provide clear, understandable information

6. Ensure the conversation is private and sensitive

7. Escalate immediately to the Clinical Director If the treating practitioner is not the Clinical Director, escalation is mandatory.

 

Risk Assessment & Escalation

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All incidents and complaints must undergo a Complaints, Risk Assessment & Root Cause Analysis (Link). This must be completed within 48 hours. This includes:

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• Severity level (Low / Moderate / High / Extreme)

• Safeguarding considerations

• Duty of Candour trigger check

• Clinical risk

• Reputitional /operational risk

 

Communication With the Service User

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The practitioner or Clinical Director must:

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• Explain the short‑ and long‑term implications

• Discuss what will happen next

• Offer appropriate follow‑up care

• Provide reassurance and emotional support

• Allow time for questions

• Provide written information if needed

• Refer to another professional if required

 

Communication must be:

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• Honest

• Compassionate

• Non‑defensive

• Clear and jargon‑free

 

Reporting and Documentation

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All Duty of Candour incidents must be:

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• Reported to the Clinical Director immediately

• Documented factually in Clinical Notes

• Logged in the Incident Log 

• Clinic management team monitor Incident Log Daily for reports

• Recorded in the Duty of Candour Annual Report

• Reviewed at governance meetings

 

Documentation must include:

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• Date and time of incident

• What happened

• Who was involved

• Actions taken

• Patient communication

• Follow‑up arrangementsIf the incident involves a medical device or adverse drug reaction, it must be reported to the MHRA Yellow Card Scheme.

 

Complaints, Risk Assessment & Root Cause Analysis (Link)

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All Duty of Candour events require a Complaints, Risk Assessment & Root Cause Analysis, conducted in accordance with the Root Cause Analysis (RCA) SOP.

 

RCA includes:

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• Evidence gathering

• Timeline creation

• Identification of contributing factors

• Identification of root cause(s)

• Development of corrective actions

• Integration into the Quality Improvement Plan

 

Learning and Improvement

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Every Duty of Candour event is an opportunity for:

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• Reflection

• Review of practice

• Identification of system factors

• Updating SOPs or policies

• Additional staff training

• Improving patient information or consent processes

 

Learning outcomes are fed into:

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• Governance meetings

• Quality Improvement Plan

• Staff training and development

 

Support for Staff

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We recognise that incidents can be distressing. Staff involved will be offered:

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• Support from the Clinical Director

• Time to reflect

• Guidance on communication

• Additional training if required

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We promote a learning culture, not a blame culture.

 

Annual Duty of Candour Report

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The clinic must publish an annual Duty of Candour report including:

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• Number of Duty of Candour events

• Nature of incidents

• Actions taken

• Learning outcomes

• Improvements made

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This report is reviewed at governance meetings and made available to service users.

 

Review of Policy

 

This policy will be reviewed:

• Annually

• After any significant incident

• Following changes in legislation or HIS guidance

• Following audit findings