Aesthetic procedure safety policy (private clinic)

1. What the regulation says

Care and treatment must be provided in a safe way for service users. (Reg 12(1) (the headline duty))

assessing the risks to the health and safety of service users of receiving the care or treatment, (Reg 12(2)(a) (risk assessment))

doing all that is reasonably practicable to mitigate any such risks, (Reg 12(2)(b) (risk mitigation))

ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely, (Reg 12(2)(c) (staff competence))

where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs, (Reg 12(2)(f) (sufficient equipment + medicines supply))

the proper and safe management of medicines, (Reg 12(2)(g) (medicines management))

The full text is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/12. Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

Care and treatment must be provided in a safe way. The regulation lists the areas a provider must address, including risk assessment, risk mitigation, staff competence, safe premises, safe equipment, sufficient equipment and medicines, medicines safety, infection prevention and shared-care planning. Regulation 12 is central to CQC's safety expectations.

3. Purpose

This policy sets out how the Clinic manages safety for non-surgical aesthetic procedures.

It covers botulinum toxin, dermal fillers, product traceability, prescribing routes, anatomical risk review, complication response, Yellow Card reporting and patient selection.

4. Sources to verify before adoption

• GMC, Guidance for doctors who offer cosmetic interventions: https://www.gmc-uk.org/professional-standards/the-professional-standards/cosmetic-interventions
• GMC, Good practice in prescribing and managing medicines and devices: https://www.gmc-uk.org/professional-standards/professional-standards-for-doctors/good-practice-in-prescribing-and-managing-medicines-and-devices
• Botulinum Toxin and Cosmetic Fillers (Children) Act 2021: https://www.legislation.gov.uk/ukpga/2021/19/contents
• Human Medicines Regulations 2012: https://www.legislation.gov.uk/uksi/2012/1916/contents
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12: https://www.legislation.gov.uk/uksi/2014/2936/regulation/12
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 17: https://www.legislation.gov.uk/uksi/2014/2936/regulation/17
• MHRA Yellow Card scheme: https://yellowcard.mhra.gov.uk/
• General Pharmaceutical Council: https://www.pharmacyregulation.org/
• Joint Council for Cosmetic Practitioners: https://www.jccp.org.uk/
• Cosmetic Practice Standards Authority: https://www.cosmeticstandards.org.uk/

5. Scope

This policy applies to:

• botulinum toxin treatment
• dermal filler treatment
• other injectable aesthetic treatments
• prescription-only medicines used for aesthetic procedures
• aesthetic medical devices and products
• patient selection for aesthetic procedures
• complication recognition and escalation
• emergency reversal or rescue arrangements where relevant
• post-procedure review
• adverse-event reporting

The Clinic does not allow a product, device or medicine to be used unless the Consultant has approved it for the Clinic's service, scope and staff competence.

Before adoption, the Clinic names its clinical and prescribing leads, approved procedures and products, complication and out-of-hours routes, emergency stock locations, photography system, recall owner, referral partners and the records used for treatment, stock, incidents and improvement actions.

6. Aesthetic procedure process

The Clinic follows a documented process for every aesthetic procedure.

6.1 Patient selection

The Aesthetic Practitioner or Consultant assesses:

• reason for treatment
• expected outcome
• previous aesthetic procedures
• current medicines
• allergy and adverse reaction history
• pregnancy or breastfeeding status where relevant
• medical contraindications
• signs of coercion or pressure
• unrealistic expectations
• body image concern or mental-health concern
• aftercare ability

Where the assessment raises concern, the procedure is paused and the Consultant reviews the patient.

6.2 Product and prescribing checks

The Clinic records the lawful route for each product or medicine.

The check covers:

• whether the product is a prescription-only medicine
• prescriber identity where required
• patient-specific assessment
• product name
• batch number
• expiry date
• supplier
• storage condition
• recall route
• who may administer it
• training required

Staff do not use stock supplied by the patient or by an unapproved supplier.

6.3 Anatomical safety review

Before injection or treatment, the clinician reviews anatomical risks for the treatment area.

The local procedure covers:

• treatment area marking where relevant
• vascular occlusion risk for fillers
• glabella, nose, forehead and periorbital caution where relevant
• aspiration or cannula technique where local protocol requires it
• dose or volume limit
• product placement depth
• patient positioning
• escalation route if unexpected pain, blanching, visual symptoms or skin change occurs

The Clinic verifies technique and anatomical protocols against current professional source material before adoption.

7. Complication response

The Clinic keeps a written complication-response pathway.

7.1 Immediate complications

If Staff identify an immediate complication, they:

• stop the procedure
• make the patient safe
• call the Consultant or senior clinician
• follow the product-specific complication pathway
• call 999 where urgent transfer is required
• record symptoms, timing, product, dose, area and action taken
• preserve product and batch information
• arrange follow-up

The Clinic does not treat a complication as a cosmetic dissatisfaction complaint until clinical harm has been excluded.

7.2 Dermal filler vascular concern

The Clinic keeps a filler vascular-event response pathway where it provides dermal fillers.

The pathway covers:

• recognition of severe pain, blanching, livedo, visual symptoms or delayed skin change
• immediate senior clinical review
• hyaluronidase availability where the Clinic provides hyaluronic acid fillers
• emergency referral route
• patient follow-up
• incident recording
• product and batch traceability

The Clinic verifies hyaluronidase storage, prescribing, dosing and training against current clinical source material before adoption.

7.3 Botulinum toxin adverse event

If a botulinum toxin adverse event occurs, the Clinic records:

• indication and treatment area
• product and batch number
• dose
• dilution where relevant
• symptoms and timing
• treatment or advice given
• follow-up arrangements
• MHRA Yellow Card decision

The Consultant reviews repeated asymmetry, ptosis, systemic reaction or patient harm trends.

8. Product traceability and recall

The Clinic keeps traceability records for aesthetic products.

Records allow the Clinic to identify every patient treated with a specific product or batch where there is a recall, safety concern or regulatory enquiry.

If a recall or safety alert is received, Staff:

• identify affected stock
• quarantine stock
• identify affected patients where required
• contact the Consultant
• record the action taken
• consider external reporting
• assign improvement action where governance changes are needed

9. Responsibilities

• Registered Manager: owns this policy, ensures governance oversight and signs off annual review.
• Consultant: approves products, prescribing routes, complication pathways and clinical escalation.
• Aesthetic Practitioner: completes patient selection, procedure records, traceability records and complication escalation within competence.
• Clinic Nurse: supports stock checks, product quarantine, observations and patient follow-up where within role.
• Administration staff: support recall contact and appointment scheduling but do not give clinical advice.
• All staff: report product defects, adverse events, recall notices and unsafe practice immediately.

10. Records and evidence fields

For each procedure, the clinical record includes, as applicable:

• patient identifiers, procedure requested and patient-selection assessment
• practitioner and prescriber identity, professional registration and role
• consultation, capacity, consent, material risks, alternatives, expected outcome and time allowed for reflection
• prescription or lawful supply route and product approval status
• manufacturer, supplier, product name, batch or lot number and expiry date
• procedure date and time, anatomical site, treatment map, dose or volume, technique and equipment or device used
• before-and-after images where used, with separate lawful consent and purpose recorded
• immediate observations, aftercare, warning signs, emergency and out-of-hours contact information
• complication or adverse-event onset, symptoms, timing, advice, treatment, escalation and outcome
• planned and completed follow-up, including non-attendance and attempts to contact
• MHRA Yellow Card, safeguarding, professional-regulator, incident or other external-reporting decision and reference
• recall or quarantine notice, affected stock, patient trace, contact attempts and product disposition

Product approval, stock, recall, staff competence, audit and improvement-action records form the wider evidence set. The treatment record is cross-linked to these records where needed and is retained under the Clinic's records-management procedure.

11. Audit cadence

The Clinic uses the following Verivius default audit rhythm unless current source material requires a different rhythm:

• Monthly: the Clinic Nurse checks aesthetic product stock, expiry dates, storage and recall notices.
• Quarterly: the Consultant audits consent, product traceability, complication records and patient selection concerns.
• Annually: the Registered Manager reviews this policy against current GMC, MHRA, JCCP, CPSA and CQC source material.

Audit findings are recorded as improvement actions with an owner and review date.

12. Version control and review date

The Clinic keeps a controlled copy of this policy. The footer or document-control table records:

• policy owner
• version number
• date approved
• next review date
• changes made since the last version
• source material checked during the review

13. Related records

• Cosmetic consent and cooling-off period policy
• Product approval list
• Prescribing record
• Treatment map
• Product traceability log
• Recall log
• Incident register
• MHRA Yellow Card record
• Training matrix
• Improvement action register

Review cadence: annual or on regulatory change, whichever sooner. Owner: Registered Manager.

14. Related policies and tools

• Cosmetic Consent and Cooling-Off Period Policy
• Minor Surgical Procedure and Infection Prevention Policy
• Before-and-After Photography and Data Protection Policy
• Medicines Management Policy
• Incident Reporting, Investigation and Learning Policy
• Medical Emergencies and Deteriorating Patient Policy
• Private clinic compliance guide

15. Sources and further reading

This template is based on CQC's guidance for providers and managers, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and other topic-specific legislation and guidance listed below. It is a starting point for adaptation, not a substitute for legal, clinical, HR, safeguarding or specialist professional advice.

• CQC Regulation 12: Safe care and treatment
• CQC Regulation 17: Good governance
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/12)
• GMC cosmetic interventions guidance
• CQC Regulation 11 (consent)
• Advertising Standards Authority / CAP Code
• Safeguarding adults and children procedures
• BNF
• Resuscitation Council UK
• Procedure-specific emergency guidance
• MHRA safety alerts and the Yellow Card scheme
• Human Medicines Regulations 2012
• Joint Council for Cosmetic Practitioners
• Cosmetic Practice Standards Authority

16. When to seek further advice

Seek specialist advice where the issue involves serious harm, safeguarding, deprivation of liberty, restraint, children, professional misconduct, controlled drugs, radiation, termination of pregnancy, infection outbreak, water safety, employment dismissal, DBS barring referral, or regulatory enforcement.

17. Document control

This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the provider's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.