Standard operating procedure

Duty of Candour Procedure

How [Organisation Name] recognises a notifiable safety incident and discharges the statutory and professional duty of candour: being open and honest with patients when something goes wrong, offering a genuine apology, and keeping a full written record of every step.

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What's inside

This standard operating procedure is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Purpose
  • 2. Scope
  • 3. Definitions and abbreviations
  • 4. Responsibilities
  • 5. Harm thresholds that trigger the statutory duty
  • 6. Procedure
  • 7. Documentation and records
  • 8. Related documents
  • 9. Review and version control
  • 10. Disclaimer

Legislation & standards it maps to

  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 - Regulation 20 (Duty of candour)
  • Care Quality Commission guidance - Regulation 20: Duty of candour
  • General Medical Council and Nursing and Midwifery Council, Openness and honesty when things go wrong: the professional duty of candour (2015)
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 - Regulation 18 (Notification of other incidents) and the Care Quality Commission statutory notification requirements
  • Compensation Act 2006, section 2 (apology, offer of treatment or other redress is not in itself an admission of liability)
  • Data Protection Act 2018 and the UK General Data Protection Regulation

Who it applies to

All staff at [Organisation Name], clinical and non-clinical, including the registered manager, registered nurses, doctors and other registered health professionals, healthcare assistants, and reception and administrative staff involved in the care of patients or in responding when something goes wrong.

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

Apology
An expression of sorrow or regret for harm or distress that has occurred; in law it is not, by itself, an admission of legal liability.
Best interests
A decision made for someone who cannot decide for themselves, choosing the option that is best for them.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Compensation Act 2006
The law which confirms, in section 2, that saying sorry or offering redress after something goes wrong is not in itself an admission of legal fault.
Contemporaneous record
A written record made at the time of an event, or as soon as possible afterwards, so it is accurate and reliable.
Data Protection Act 2018
The UK law that controls how organisations collect, store and use people's personal information.
Duty of candour
The duty to be open and honest with a patient and their family when something goes wrong with their care.
General Medical Council (GMC)
The body that registers and regulates doctors in the UK.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting out the fundamental standards that care providers must meet, including the duty of candour in Regulation 20.
Mental capacity
Whether a person can understand and make a particular decision for themselves at the time it needs to be made.
Moderate harm
Harm that needs a moderate increase in treatment and is significant but not permanent.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time.
Notifiable safety incident
An unintended or unexpected incident during care that a health professional reasonably thinks could have caused, or did cause, death or a defined level of harm, triggering the statutory duty of candour.
Notifiable event
An incident a provider is legally required to report to the regulator, such as a death or serious injury.
Nursing and Midwifery Council (NMC)
The body that registers and regulates nurses and midwives in the UK.
Professional duty of candour
The personal duty each registered health professional has to be open and honest with patients and their employer when something goes wrong.
Prolonged psychological harm
Psychological harm a patient has suffered, or is likely to suffer, for a continuous period of at least 28 days.
Regulated activity
A type of care or treatment the law requires a provider to register with the regulator to deliver.
Registered Manager
The person registered with the regulator as responsible for the day-to-day running of a service.
Relevant person
The patient, or where the patient has died, lacks capacity or is a child, the person lawfully acting on their behalf.
Safeguarding
Protecting people's health, wellbeing and rights and keeping them safe from abuse, harm or neglect.
Severe harm
A permanent reduction in a person's physical, sensory, movement, mental or psychological functions caused directly by an incident.
Standard Operating Procedure (SOP)
A written, step-by-step instruction setting out how a particular task or process should be carried out consistently.
Statutory (organisational) duty of candour
The legal duty owed by the provider organisation, as opposed to the separate duty owed by each individual professional.
UK General Data Protection Regulation (UK GDPR)
The UK's main data-protection law governing how personal information is collected and used.

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