Standard operating procedure

Adverse Incident & Near Miss Reporting Procedure

Step-by-step process for making the patient safe, reporting any adverse incident or near miss within 24 hours, grading harm, investigating proportionately and discharging external reporting duties.

For Aesthetic ClinicRef BS-AES-SOP-013See a sample (PDF) →
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  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
  • Optional 3-monthly updates

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. What to report
  • 6. Procedure
  • 7. External reporting duties
  • 8. Records and learning
  • 9. Related documents
  • 10. Review and version control
  • 11. Disclaimer

Legislation & standards it maps to

  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12 (Safe care and treatment)
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 17 (Good governance)
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 20 (Duty of candour)
  • Care Quality Commission (Registration) Regulations 2009, Regulation 18 (Notification of other incidents)
  • Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013
  • Health and Safety at Work etc. Act 1974
  • Data Protection Act 2018 and the UK General Data Protection Regulation
  • Medicines and Healthcare products Regulatory Agency Yellow Card scheme for suspected adverse drug reactions and medical device adverse incidents

Who it applies to

All staff at [Organisation Name] - practitioners, prescribers, registered nurses, clinical support staff, reception and administrative staff, and anyone working on the premises - who witnesses, is involved in or is told about an adverse incident or near miss.

Glossary

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

Adverse event
Any unexpected or unwanted occurrence linked to a treatment that harms, or could harm, a patient.
Adverse incident
Any event that caused, or could have caused, harm to a patient, member of staff, visitor or the public, or loss or damage to the organisation.
Anaphylaxis
A severe, life-threatening allergic reaction needing immediate emergency treatment.
Blood-borne virus
An infection such as hepatitis B, hepatitis C or HIV that can be passed on through blood.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Care Quality Commission (Registration) Regulations 2009
The rules that set out the events a registered provider must formally notify to the Care Quality Commission, such as a death or serious injury.
Contemporaneous
Written down at the time something happens, or as soon as possible afterwards, so the record is accurate.
Duty of candour
The legal duty to be open and honest with a person and their family when something goes wrong with their care.
Harm grading
Rating both the actual harm an incident caused and the worst harm it could realistically have caused, to decide how thoroughly to investigate.
Health and Safety Executive (HSE)
The national body responsible for regulating and enforcing workplace health and safety in Great Britain.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting the fundamental standards that providers of regulated care must meet, including safe care, good governance and the duty of candour.
Medicines and Healthcare products Regulatory Agency (MHRA)
The body that regulates medicines and medical devices in the United Kingdom and runs the Yellow Card scheme.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time. Also called a 'good catch'.
Nominated Individual
The senior person responsible to the regulator for supervising how a service is provided.
Notifiable safety incident
An unintended incident during care that results in moderate or greater harm, prolonged psychological harm or death, which triggers the duty of candour.
Patient safety incident
Any unintended or unexpected event in care that did, or could have, harmed one or more patients.
PECR
The Privacy and Electronic Communications (EC Directive) Regulations 2003, the rules covering marketing by phone, email and text and the use of cookies.
Quarantine (of equipment or products)
Setting an item aside and out of use so it cannot be touched, cleaned or repaired until it has been investigated.
Registered Manager
The person registered with the regulator as responsible for the day-to-day running of a service.
Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 (RIDDOR)
The law requiring certain workplace injuries, diseases and dangerous events to be reported to the Health and Safety Executive.
Risk register
A central record of the risks a service faces, who owns each one and what is being done to control it.
Root cause analysis (RCA)
A structured investigation of a serious event that looks for the underlying causes, not just the immediate one.
Safeguarding
Protecting people's health, wellbeing and rights and keeping them safe from abuse, harm or neglect.
Second victim
A member of staff who is themselves distressed or affected after being involved in a patient safety incident or error.
Sharps
Needles, blades and other items that can cut or puncture the skin.
Special category data
Sensitive personal information, such as health records, that data-protection law gives extra protection.
Standard Operating Procedure (SOP)
A document setting out the agreed step-by-step way to carry out a specific task safely and consistently.
UK General Data Protection Regulation (UK GDPR)
The United Kingdom's main data-protection law governing how personal information is collected and used.
Vascular occlusion
A blockage of a blood vessel, a serious complication that can occur with certain aesthetic injectable treatments.
Yellow Card scheme
The Medicines and Healthcare products Regulatory Agency's system for reporting suspected side effects of medicines and problems with medical devices.

How it works

  1. Buy securely with Stripe - instant, no VAT, no account needed.
  2. Download your editable Word file from the link we email you straight away.
  3. Complete the placeholders for your service, then have it approved before use.
  4. Add the optional updates subscription and we keep it current as guidance changes.

Related documents

PolicyAdverse Event Management Policy£54.99
PolicySafeguarding Policy£54.99
PolicyComplaints Policy£54.99
PolicyConsent & Risk Disclosure Policy£54.99

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