Duty of Candour

Morgannwg LDC has been asked by Swansea Bay UHB to ensure that colleagues in General Dental Practice, both Providers, Performers and Practice Staff understand the Duty of Candour Statutory Guidance in Wales. The regulations further information are contained in two long documents published by Welsh Government, intended for all NHS organisations and Providers and their staff. This includes Medical, Dental, Pharmaceutical and Optical providers and their staff. The content of this page is an attempt to summarise the contents of all the documents to save time for GDPs and their staff and the LDC has produced this summary in response to the request by Swansea Bay UHB. We include links to the Welsh Government documentation for those that wish to download and keep all the relevant information as published.

The Duty of Candour documentation referred to on this page is about the Duty of Candour Statutory Guidance in Wales, which outlines the responsibilities of health care providers to be open and honest with service users about unexpected harm.

Duty of Candour is defined by the General Dental Council as follows:

Every healthcare professional must be open and honest with patients when something goes wrong with their treatment or care which causes, or has the potential to cause, harm or distress. This means that healthcare professionals must:

tell the patient (or, where appropriate, the patient’s advocate, carer or family) when something has gone wrong;
apologise to the patient (or, where appropriate, the patient’s advocate, carer or family);
offer an appropriate remedy or support to put matters right (if possible); and
explain fully to the patient (or, where appropriate, the patient’s advocate, carer or family) the short and long term effects of what has happened.

Healthcare professionals must also be open and honest with their colleagues, employers and relevant organisations, and take part in reviews and investigations when requested. Health and care professionals must also be open and honest with their regulators, raising concerns where appropriate. They must support and encourage each other to be open and honest and not stop someone from raising concerns.

The relevant GDC page can be found here.

Introductory Letter to the Welsh Regulations

Access the Introductory Letter HERE

The introductory letter is from the deputy CMO and can be summarised as follows;

The Duty of Candour and Duty of Quality came into force on 1st April 2023 in Wales, with the Duty of Candour directly applying to primary care providers.
Health boards are responsible for ensuring improvements in the quality of health services, including primary care services, even though the Duty of Quality does not directly apply to primary care providers.
The legislation aims to enhance the quality of services for patients and improve their overall experience within the healthcare system.
Training sessions and materials are available to assist primary care providers and their staff in understanding and implementing the new duties.
The new duties align with the priorities of A Healthier Wales and aim to make the NHS in Wales more responsive, person-centred, and effective, with the involvement of the service users’ voice through the organisation Llais.

The Regulations

Access the Statutory Regulations HERE

To summarise the document, the purpose of the Candour Procedure Regulations is to outline the requirements for training and support for NHS staff involved in providing healthcare, investigating adverse outcomes, and managing the duty of candour procedure. These regulations aim to ensure that healthcare providers comply with the duty of candour, promote honesty, transparency, and openness in healthcare settings, and improve the quality of care provided to service users. The regulations provide a structured process for notifying service users about adverse outcomes, offering apologies, conducting investigations, and maintaining open communication, ultimately fostering a culture of learning and improvement within healthcare organisations.

The duty of candour in the Act primarily focuses on ensuring that service users are informed and supported in case of unexpected harm during healthcare provision, emphasising openness, transparency, accountability, honesty, and learning. It aims to empower service users, drive improvements in care quality, promote a culture of honesty, and enhance overall healthcare experiences and outcomes.

Duty of candour in healthcare is triggered by specific events or circumstances such as moderate harm, severe harm, death, harm that is unintended or unexpected, harm that occurs while waiting for diagnostics or care, and harm that is more than minimal. It is also triggered when a service user suffers an adverse outcome linked to the provision of healthcare, requiring healthcare providers to be open, honest, provide explanations, offer apologies, and maintain transparency and communication throughout the investigation process.

Annexes to the Documents

Access the Annexes HERE

There are several annexes to in the document. The annexes important to GDS practice are highlighted in bold in the list below and need to be observed by all practice staff.

Annex A – Duty of Candour Trigger Review Process (p1 – Very Important):
- Outlines the process for determining if the Duty of Candour applies based on adverse outcomes and healthcare provision’s role.
Annex A1 – Trigger Review Process Where services are commissioned:
- Focuses on situations where healthcare is delivered in Wales as part of the NHS in Wales.
Annex B – Levels of Harm Framework (pp3-7 – Very Important):
- Categorizes levels of harm in healthcare incidents and specifies which incidents trigger the Duty of Candour procedure.
Annex C – Duty of Candour Procedure (p8 – Very Important):
- Describes the process for incidents triggering the Duty of Candour, including notification requirements.
Annex D – Support for the service user/person acting on their behalf (p9):
- Emphasizes the importance of providing support to service users and individuals acting on their behalf.
Annex D1 – Support for Staff involved in the Duty of Candour Procedure(p10):
- Focuses on the support needed for staff involved in adverse outcomes or incidents.
Annex E – Making a Meaningful Apology (p11,12):
- Outlines elements of a sincere apology to be given to the service user or person acting on their behalf.
Annex F – Duty of Candour Review process and record keeping (p13):
- Details the review process to prevent recurrence and record-keeping requirements.
Annex F1 – Duty of Candour Review Process and Record Keeping (p14):
- Provides a guide on handling incidents where harm has occurred.
Annex G – Duty of Candour Reporting, publication and monitoring (p15):
- Specifies reporting obligations of Primary Care Providers regarding the Duty of Candour.
Annex G1 – Duty of Candour Reporting, publication and monitoring:
- Requires annual reports on the Duty of Candour, with specific content and publication requirements.
Annex H – Case Study Examples (Case 15 on p30 will be of interest):
- Provides case studies illustrating how the Duty of Candour checklist questions are used to determine if the duty is triggered.

Once again knowledge of Annexes B and C is very important, together with the information in Annex A.

Examples of Possible Triggers in Dental Practice

Patients swallowing or inhaling an object
Mismanagement of a medical emergency
Hypochlorite exclusion
Perforation
Damage to other teeth
Iatrogenic soft tissue damage
Incorrect tooth notation leading to inappropriate treatment
Facial palsy after LA administration
Extraction/filling of the wrong tooth
Prolonged anaesthesia/paraesthesia
Inappropriate prescription leading to complications or severe allergic reaction
Overdose of Midazolam in a sedation patient
Reaction to Latex Allergy
Mis management of anti-coagulants
Incorrect implant placement causing iatrogenic damage
Inappropriate diagnosis and management of an Urgent referral for USC

It is important to realise that not every example here is necessarily a trigger. The decision as to whether a possible trigger is appropriate is made following consideration of the guidance in annexes A and B referred to above. If this suggests that a trigger is appropriate then follow the guidance in Annex C.