Policy

Adverse Event Management Policy

Identification, reporting, investigation and learning from adverse events, complications and near misses in aesthetic practice

For Aesthetic ClinicRef BS-AES-POL-001See a sample (PDF) →
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  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
  • Optional 3-monthly updates

What's inside

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

  • 1. Purpose
  • 2. Scope
  • 3. Policy statement
  • 4. Definitions
  • 5. Recognising adverse events in aesthetic practice
  • 6. Immediate clinical management and escalation
  • 7. Reporting and notification duties
  • 8. Duty of candour
  • 9. Investigation and analysis
  • 10. Roles and responsibilities
  • 11. Training and competence
  • 12. Records, monitoring and audit
  • 13. Related documents
  • 14. Version control and review
  • 15. Appendix A - Adverse event initial response checklist
  • 16. Appendix B - Internal adverse event report form (core fields)
  • 17. Disclaimer

Legislation & standards it maps to

  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 - in particular Regulation 12 (Safe care and treatment), Regulation 16 (Receiving and acting on complaints), Regulation 17 (Good governance), Regulation 18 (Staffing) and Regulation 20 (Duty of candour)
  • Care Quality Commission (Registration) Regulations 2009 - in particular Regulation 18 (Notification of other incidents) and Regulation 16 (Notification of death of a service user)
  • Human Medicines Regulations 2012 (as amended) - including the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme and pharmacovigilance requirements
  • Medical Devices Regulations 2002 (SI 2002/618, as amended) - Medicines and Healthcare products Regulatory Agency (MHRA) reporting of device-related adverse incidents
  • Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 (RIDDOR)
  • Data Protection Act 2018 and the UK General Data Protection Regulation (UK GDPR)
  • Human Medicines Regulations 2012, Regulation 214 (prescribing requirements) - as applied to local anaesthetics, botulinum toxin and other prescription-only medicines

Who it applies to

All registered managers, prescribers, practitioners (medical, nursing, dental and non-medical injectors), clinical support staff, locums, students and contractors of [Organisation Name]

Glossary

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

A-E assessment (Airway, Breathing, Circulation, Disability, Exposure)
A structured order for checking and treating a seriously unwell patient, dealing with the most life-threatening problems first.
Adrenaline
An emergency medicine injected into the muscle to treat a severe allergic reaction (anaphylaxis).
Adverse event
Any unexpected or unwanted occurrence linked to a treatment that harms, or could harm, a patient.
Anaphylaxis
A severe, life-threatening allergic reaction needing immediate emergency treatment.
Angioedema
Rapid swelling beneath the skin, often around the face, lips or throat, which can be part of a serious allergic reaction.
Best interests
A decision made for someone who cannot decide for themselves, choosing the option that is best for them.
Biofilm
A thin, stubborn layer of bacteria that can form around a filler or implant and cause persistent infection or inflammation.
Blood-borne virus (BBV)
An infection such as hepatitis B, hepatitis C or HIV that can be passed on through blood.
Botulinum toxin
A prescription-only medicine injected to relax muscles, commonly used to soften facial lines.
Bronchospasm
Sudden tightening of the airways that makes breathing difficult, which can occur in a severe allergic reaction.
Caldicott Guardian
The senior person responsible for protecting the confidentiality of people's health and care information.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Cellulitis
A spreading bacterial infection of the skin and the tissue beneath it that usually needs antibiotics.
Clinical governance
The system through which an organisation monitors and improves the quality and safety of the care it provides.
Complication
An unwanted clinical outcome of a procedure that can happen even when it is carried out correctly.
Dermal filler
A gel-like substance injected under the skin to smooth lines or add volume.
Diplopia
Double vision; seeing two images of a single object.
Disclosure and Barring Service (DBS) check
A criminal-records check showing whether a person is suitable to work with patients or vulnerable people.
Duty of candour
The legal duty to be open and honest with a person and their family when something goes wrong with their care.
Dysphagia
Difficulty or discomfort in swallowing.
Energy-based device
A machine that treats the skin using energy such as laser light, radiofrequency or ultrasound.
Fundamental standards
The minimum standards of safety and quality below which care must never fall.
General Dental Council (GDC)
The body that registers and regulates dental professionals in the United Kingdom.
General Medical Council (GMC)
The body that registers and regulates doctors in the United Kingdom.
General Pharmaceutical Council (GPhC)
The body that registers and regulates pharmacists and pharmacy technicians in Great Britain.
General practitioner (GP)
A doctor who provides everyday medical care in the community, often a patient's family doctor.
Granuloma
A small lump of inflamed tissue the body forms in reaction to a substance such as a filler.
Health and Safety Executive (HSE)
The national body responsible for regulating and enforcing workplace health and safety in Great Britain.
High-intensity focused ultrasound (HIFU)
A device that uses focused sound waves to heat and tighten tissue beneath the skin.
Hyaluronidase
A medicine that dissolves dermal filler, used urgently if a blood vessel becomes blocked.
Infection prevention and control (IPC)
The measures used to stop infection spreading between patients, staff and visitors.
Information governance
The framework for handling people's personal and health information legally, securely and appropriately.
Informed consent
Agreement to treatment given freely after the risks, benefits and alternatives have been clearly explained.
Intense pulsed light (IPL)
A skin treatment that uses broad-spectrum light, for example to treat pigmentation or unwanted hair.
Intramuscular
Given by injection directly into a muscle.
Just culture
A workplace approach that focuses on learning from mistakes and system failures rather than simply blaming individuals.
Local anaesthetic
A medicine that numbs a small area of the body so a procedure can be carried out without pain.
Medicines and Healthcare products Regulatory Agency (MHRA)
The United Kingdom body that regulates medicines and medical devices and runs the Yellow Card reporting scheme.
Mental capacity
Whether a person can understand and make a particular decision for themselves at the time it needs to be made.
Microneedling
A treatment that uses fine needles to make tiny punctures in the skin to encourage repair and renewal.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time.
Necrosis
The death of body tissue, for example when its blood supply is cut off.
Never event
A serious, largely preventable safety incident that should not happen if the right precautions are in place.
Nominated Individual
The senior person responsible to the regulator for supervising how a service is provided.
Notifiable safety incident
An incident causing certain levels of harm that, by law, a provider must be open about with the patient under the duty of candour.
Nursing and Midwifery Council (NMC)
The body that registers and regulates nurses and midwives in the United Kingdom.
Ophthalmology
The branch of medicine dealing with the eyes and their disorders.
Ophthalmoplegia
Weakness or paralysis of the muscles that move the eye.
Patient Group Direction (PGD)
A written instruction letting named staff supply or give a medicine without an individual prescription.
Personal protective equipment (PPE)
Items such as gloves, aprons and masks worn to protect against harm or infection.
Pharmacovigilance
The ongoing monitoring of medicines to detect, assess and prevent harmful side effects.
Polynucleotides
Injectable substances used in aesthetic treatments to support skin repair and quality.
Prescriber
A healthcare professional legally authorised to decide on and order medicines for a patient.
Prescription-only medicine (POM)
A medicine that may lawfully be supplied only on the instruction of an appropriate prescriber.
Ptosis
Drooping of an upper eyelid.
Radiofrequency
A device that uses radio-wave energy to heat the skin or deeper tissue, often to tighten or remodel it.
Registered Manager
The person registered with the regulator as responsible for the day-to-day running of a service.
Regulated activity
A type of care or treatment the law requires a provider to register with the regulator to deliver.
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 assessment
A structured check identifying what could cause harm and what is being done to prevent it.
Root cause analysis (RCA)
A structured investigation that looks beyond the immediate event to find the underlying reasons it happened.
Safeguarding
Protecting people's health, wellbeing and rights and keeping them safe from abuse, harm or neglect.
Secondary care
Specialist medical care, usually provided in a hospital after referral.
Serious adverse event
An adverse event causing death, lasting or major harm, or needing emergency treatment or hospital admission.
Sharps
Needles, blades and other items that can cut or puncture the skin.
Single assessment framework
The structure the regulator uses to judge a service, built around quality statements and five key questions (safe, effective, caring, responsive, well-led).
SMART action plan
An improvement plan whose actions are specific, measurable, achievable, relevant and time-bound.
Statement of Purpose
A required document describing who a service is, what it does and where, shared with the regulator.
Subject Access Request (SAR)
A person's legal right to ask for a copy of the personal information an organisation holds about them.
Triage
Sorting and prioritising cases according to how urgent or serious they are.
UK General Data Protection Regulation (UK GDPR)
The UK's main data-protection law governing how personal information is collected and used.
Urticaria
An itchy raised rash (hives) that can appear as part of an allergic reaction.
Vascular occlusion
A blockage of a blood vessel, for example by filler, which can starve tissue of blood and become an emergency.
Yellow Card scheme
The United Kingdom system for reporting suspected side effects of medicines and problems with medical devices to the regulator.

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