Module Two – Clinical Standards

Scope

The Cosmetic Practice Standards Authority (CPSA) Clinical and Practice Standards outline the clinical and practice requirements for non-surgical cosmetic procedures and hair restoration surgery (HRS).

Non-surgical cosmetic procedures include the use of:

• Botulinum toxin
•  Skin fillers
• Chemical peels and micro needling
• Laser, intense pulsed light, light emitting diode (LIPLED) and energy based treatmentsand
• HRS which includes Hair Transplant Surgery by both StripFollicular Unit Transplant (FUT) and Follicular Unit Extraction (FUE) donor hair harvesting techniques, and Prosthetic Hair Fibre Implantation (PHFI). HRS is recognised as Level 1b invasive cosmetic surgeryand
• Orphan treatments which do not clearly align with a modalitysubsetand
• Novel and untested treatments. Where potential risk isforeseen; CPSA will endeavour to produce a publicly available position statement on newer treatments and those without an evidence baseIn the future, CPSA will provide guidance based on procedure related data collection and the reporting of adverse events. The CPSA will use this data to identify trends in treatment modalities and

products, highlighting outlier practice; both poor and outstanding.

Standards for the individual modalities have been produced through stakeholder engagement, including: dermatologists, plastic, reconstructive and aesthetic surgeons, aesthetic doctors, dentists, nurses, aesthetic practitioner, the beauty sector, industry experts and professional bodies.

Practitioners must provisionally register with the JCCP and can only gain full JCCP registration once they can evidence the standards have been met. Provisional registrants will be evaluated at 18 months to ascertain whether standards have been met or further evidence is required. If standards are met full JCCP registration will occur at 2 years.

Definitions

Adverse event

An unintended, unexpected or unfavourable event which can result in temporary or permanent outcome. This may include serious injury, deformity, disability and/or death.

Assessor

An experienced practitioner that meets the recognised CPSA Assessor Standards. Their credentials have been scrutinised and benchmarked by a JCCP panel. Assessors will evaluate the competence of Supervisors (see definition).

Cosmetic procedure

A procedure, with the primary aim of changing physical appearance without direct medical benefit.

Competence

The practitioner’s ability to demonstrate appropriate qualifications, training, scientific knowledge, procedural skill, adequate experience and accountability to perform a procedure safely and effectively.

The ability to recognise and treat the complications associated with a treatment, including adverse events which may require resuscitation.

Complaint

Where a patient, member of the public or staff expresses dissatisfaction with: the outcome of a treatment, the encounters with practitioners or staff, the standard of the facility; the overall service provided; financial costs of the service.

Compliment

Where a patient, member of staff or member of the public expresses satisfaction and/or thanks for a treatment, the encounters with practitioners or staff, the standards of the facility; the overall service

provided; financial costs of the service.

Continuous Professional Development (CPD)

The additional relevant educational, training, managerial, leadership and reflective work a practitioner must engage with to ensure practice is professional, up-to-date and progressive. CPD must be presented to an appraiser on an annual basis.

“Cooling off” period

Is the time interval required between the consultation (where risks are explained, patient is appropriately counselled, detailed financial costs are explained) and the decision to proceed with this treatment

Facility (or premises)
The establishment and environment where a treatment is delivered.

General Sales List (GSL medicines)

These medicines can be purchased from any retail outlet without a prescription. There are limits on the quantity and strength of medicines that can be supplied.

Health Education England (HEE)

The government arms length body which delivers healthcare training. HEE produced the non-surgical cosmetic and HRS educational and training requirement framework.

Health

The physical, mental and social well-being of an individual.

Oversight

The supervision and responsibility for a known delegated practitioner.

Pharmacy Medicines (P medicines)

These medicines can only be purchased without a prescription but only from a registered pharmacy and are not available for self- selection.

Practitioner

A person who is offering and/or undertaking the procedure(s).

Prescriber

An independent prescriber of prescription only medicines (POMs). The presciber has vicarious liability for their the practitioner who administers the prescription.

Prescription Only Medicines (POMs)

These medicines can only be supplied in accordance with a prescription.

must be prepared to exclude themselves from decision making [7].

1. Readthecodeonline.NMC.https://www.nmc.org.uk/standards/code/read-the-code-online/
2. Actwithhonestyandintegrity.GMC.http://www.gmc-uk.org/guidance/good_medical_practice/honesty_integrity.asp
3. PrincipleOne.Putpatients’interestsfirst.GDC.https://standards.gdc-uk.org/pages/principle1/principle1.aspx
4. http://www.hpc-uk.org/aboutregistration/standards/standardsofconductperformanceandethics/
5. Standards for Pharmacy Professionals 2017
6. Medicines Ethics and Practice – The Professional Guide forPharmacists 2017
7. Honesty in financial dealings. General Medical Council.http://www.gmc- uk.org/guidance/good_medical_practice/20466.asp

Duty of candour

Practitioners must be open and honest when something has gone wrong with the care, treatment or other services that they provide by:

Informing service users or, where appropriate, their carers, that something has gone wrong;

Apologising;
Taking action to put matters right; and
Making sure that service users or, where appropriate, their

carers, receive a full and prompt explanation of what has happened and any lasting effects.

References

1. Regulation 20: Duty of Candour. Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20. http://www.cqc.org.uk/guidance-providers/regulations- enforcement/regulation-20-duty-candour

Efficacy of treatments

• Practitioners must be open and honest about the efficacy of treatments. If little or no evidence is available, practitioners must have a frank discussion around the procedure.
• Practitioners must not make ill claims of efficacy to entice patients.
• Practitioners must provide effective treatments based on the best available evidence [1].
• When prescribing medications off-license practitioners must be assured and honest of its efficacy [1].References:

A provider should use the principles set out by the Association of Independent Healthcare Organisations Practising Privileges Principles [1].

The provider must be assured that the practitioner provides evidence adequate of:

1. UptodateCurriculumVitae(CV)
2. Valid degrees and qualifications
3. Atleasttworeferences(atleastonerefereemustberegulated by a PSRB)
4. Professional license (if applicable)
5. Evidence of professional good standing
6. AnysanctionsonPSRBlicense,whichimpactsuponpractiseor supervision (if applicable)
7. Valid appraisal (and revalidation where required)
8. HasbeenclearedbytheEnhancedDirectBarringServices(DBS) Check
9. Adequateindemnitytopracticeand/orsupervise

10.Adequate occupational health and immunisation history 11.The procedures performed are within scope of practise and

insurance
12.Is adequately trained and qualified to perform the procedures

stated

References

1. Association of Independent Healthcare Organisations Practising Privileges Principles. https://aiho.org.uk/689-aiho- practising-privileges-principles

Disclosure and Barring Services (DBS)

All practitioners must have a cleared contemporaneous Enhanced DBS check [1].

References

1. DBSchecks(PreviouslyCRBchecks)

https://www.gov.uk/disclosure-barring-service-check/overview

Good standing of practitioner

• A practitioner must be able to demonstrate they are of good standing
• The provider must ensure that their practitioners are of good standing.
• If a practitioner is regulated by a Professional Statutory Regulatory Body (PSRB), the provider must ensure there are no sanctions that would prevent the practitioner from working.
• A practitioner who has been ‘struck-off’ from their respective PSRB Register is by default, unable to meet the CPSA

• Control measures been identified and put in place as a result of the risk assessments
• Risks and control measures directly relate to the occupations and activities carried out in the workplace
• Systems in place to control general and clinical waste
• Risks and control measures explained to employees andothers
• Risk assessments are regularly reviewed

Accident, incidents and first aid

A provider and/or practitioner must be able to demonstrate:

• Adequate arrangements for first aid materials have been made
• Adequate arrangements for trained first aid persons have been made
• Accidents, incident and first aid episodes are recorded in a logbook
• Learning occurs after events
• All legally reportable accidents, incidents and ill-health bereported to the enforcing authority and will they be investigated to enable remedial action to be taken

Staff induction and training

Providers must demonstrate:

• Health and safety information, instruction and training given to all new employees
• Ongoing health and safety information, instruction and training provided
• Health and safety information, instruction and training recorded
• The effectiveness of health and safety information, instruction and training assessed, and is the assessment recorded

Personal protective equipment (PPE) and clothing (C)

Providers must demonstrate:

• PPE/C provided, free of charge, to employees/practitioners as determined through risk assessment
•  Training and information on the safe use of PPE/C provided to all employees/practitioners
• Proper use and storage of PPE/C enforced
• PPE/C maintained and replaced

Fire safety

Providers and practitioners must ensure the premises is safe from fire according to the Regulatory Reform (Fire Safety) Order 2005: a short guide to making your premises safe from fire [1].

Providers must demonstrate:

•  A named person(s) for emergencies
•  A fire log/record book kept
•  A means of raising the alarm and fire detection in place
•  Appropriate means of fighting fire in place
•  Effective means of escape in place including unobstructedroutes and exits
• Fire-fighting equipment, preventive measures and emergencyarrangements maintained, including through tests andpractise drills
• Evidence of risk assessment complete which identifies risks,hazards and control measuresReferences

1. Regulatory Reform (Fire Safety) Order 2005: a short guide to making your premises safe from fire. https://www.gov.uk/government/publications/making-your- premises-safe-from-fire

Safe and healthy working environment

Providers must demonstrate:

•  The premises (structure, fabric, fixtures and fittings) safe and healthy (suitable, maintained and kept clean)
•  The working environment (temperature, lighting, space, ventilation, noise) an appropriate safe and healthy one
•  welfare facilities (toilets, washing, drinking, eating, changing) provided as appropriate and maintained
•  There is access to a dedicated hand wash sink that must be for hand washing only. The sink must not be dual purpose e.g. a kitchen or bathroom sink
•  Multiple use equipment and devices cleaned or decontaminated between use
•  Single use and single person devices are not re-used or shared
•  There are appropriate laundry facilities and supplies of clean linen/towels sufficient for each treatment/procedure and for additional use for modesty reasons as required
•  Substances which fall under the Control of Substances Hazardous to Health Regulations 2002 in a suitable storage with safety data sheet [1]
•  Exposure to hazards from physical, chemical and biological agents adequately controlled
•  Facilities are provided to ensure modesty and privacy appropriate to the treatment/procedure

References

1. Control of Substances Hazardous to Health Regulations 2002. www.hse.gov.uk/cossh

Employer liability and insurance

Providers must demonstrate:

•  Professional Indemnity and Public Liability insurance current and other relevant insurances in place as appropriate to the business undertaking
•  Employers liability insurance current if appropriate to the business
•  They can account for practitioners when they work away from the employer’s own premises or when employees are placed with another employer / site

Annual reviews

Providers must demonstrate:

•  Health, Safety and Welfare annual review
•  An annual review of practitioner competencies and scope ofpractice
•  Employed practitioners have undergone an annual review ofCPD and formal appraisal

Workplace violence

Providers must safeguard staff against workplace violence and follow the World Health Organisation Framework Guidelines for Addressing Workplace Violence in the Health Sector [1].

References

1. World Health Organisation Framework Guidelines for Addressing Workplace Violence in the Health Sectorhttp://www.who.int/violence_injury_prevention/violence/activities/ workplace/en/

Security

Providers must demonstrate:

•  A security policy
•  Ensure patients are safe
•  Locks and alarms should be available to safeguard againstintruders and to keep patients and staff safe.
•  The premises are risk assessed for potential securitybreaches
•  Security breaches are reported and learnt from

For larger providers of concern security personnel may be required

Medical device storage

Providers must demonstrate:

• They meet the regulatory standards for particular medical devices
• Hazardous chemicals shall be labelled and stored in accordance with recognized standards.

Compressed gases

Compressed gas cylinders must be stored and handled in a safe manner according to the British Compressed Gas Association Medical Gases guidance.

References

1. British Compressed Gas Association Medical Gases guidance.

http://www.bcga.co.uk/pages/index.cfm?page_id=29

Electricity at work

A practitioner must comply with Electricity at Work Regulations [1] and electrical appliances should undergo Portable Appliance Testing [2].

References

1. TheElectricityatWorkRegulations1989.

http://www.hse.gov.uk/pubns/priced/hsr25.pdf
2. PortableApplianceTesting(PAT).https://www.pat.org.uk/

Needlestick injuries

Body fluid or blood exposure

The practitioner and/or provider must adhere to the Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 [1] which provides advice on:

• Safe use and disposal of sharps
• Training requirements
• Procedures for responding to a sharps injuryTraining courses

Safe sharps handling must be formally trained on the accredited courses

Preventative measures

External Defibrillator (AED). BLS must be refreshed on an annual basis.

If an AED is not immediately available on the premises, practitioners must know where the nearest available AED is located. AED locations can be found by entering a postcode at www.heartsafe.org.uk [2].

Anaphylaxis

The recognition and treatment of anaphylaxis must be integrated into all modality training pathways.

Emergency medicine and equipment must be regularly checked and recorded to be functioning and in-date. A practitioner must have access to:

• Maintained oxygen supply and a mask
• Adrenaline auto injector for intramuscular injection
• The anaphylaxis treatment algorithm (Resus Council orequivalent)
• Any other emergency medicine deemed appropriate basedon risk assessmentAll practitioners must be able to recognise and treat anaphylactic shock. Practitioners must be able to:

• Position patient appropriately
• Administer intramuscular injection (using an auto injector) ofadrenaline 500 micrograms 1:1000 concentration
• Administer oxygenSedation

• If administering sedation, practitioners must assure that the appropriate numbers of skilled staff are available
• Practitioners must follow the Royal College of Anaesthetists Guidelines for the Provision of Anaesthesia Services (GPAS) Guidance on the Provision of Sedation Services 2016 [4] and the Academy of Medical Royal Colleges, Safe sedation practice for healthcare procedures [5]References

1. Adult basic life support and automated external defibrillationhttps://www.resus.org.uk/resuscitation-guidelines/adult-basic-life-support-and-automated-external-defibrillation/
2. Heartsafe®.http://www.heartsafe.org.uk/
3. Resus Council – Emergency Treatment of AnaphylacticReaction. https://www.resus.org.uk/anaphylaxis/emergency- treatment-of-anaphylactic-reactions/

Society “A Competency Framework for all Prescribers” [3].

Administration

POMs must only be administered against a valid prescription written by a:

(a) a doctor;
(b) a dentist;
(c) a supplementary prescriber;
(d) a nurse independent prescriber; or
(e) a pharmacist independent prescriber.
It is good practice for all medicines, including P and GSL medicines,

to be prescribed in order to maintain clear records.

Following administration appropriate records should be made in the patients notes.

Stock

Where medicines are held as stock they must be:

1. Procuredthroughrecognisedwholesalers
2. Administeredagainstavalidprescription
3. Storedsecurelyandinthecorrectenvironmentasrecommended by the manufacturer
4. Audited at regular intervals
5. Recordedappropriatelywhenadministered

Disposal

Medicines waste should be stored securely until disposal.

Suitable arrangements for the disposal of medicines and medical devices must be in place. The Department of Health ‘Management and disposal of healthcare waste (HTM 07-01)’ guidance should be followed [4].

Emergency Medicines
Those medicines listed in Schedule 19 of the Human Medicines Regulations may be administered without a prescription for the purpose of saving life in an emergency [1].

Medicines stocked for the purpose of emergency use must be risk assessed. The practitioner must be competent to administer the medicines.

See “Resuscitation Requirements” above.

Controlled Drugs (CDs)

64/

2. Infection Protection Society. Process Improvement Tools (PIT) Hand hygienehttp://www.ips.uk.net/index.php/download_file/view/585/264/2 64/
3. Infection Protection Society. Process Improvement Tools (PIT). Hand hygiene Observation Tool. http://www.ips.uk.net/index.php/download_file/view/614/264/2 64/
4. Infection Protection Society. Process Improvement Tools (PIT). Theatre asepsis.http://www.ips.uk.net/index.php/download_file/view/704/264/2 64/ .
5. Infection Protection Society. Process Improvement Tools (PIT). Scrub procedures. http://www.ips.uk.net/index.php/download_file/view/590/264/2 64/
6. OneTogether Infection Assessment Toolkit. Infection Prevention Practice across the Surgical Pathwayhttp://www.ips.uk.net/index.php/download_file/view/4168/290 3/
7. Decontamination of Surgical Equipment (Healthcare Technical Memorandum 01-01). https://www.gov.uk/government/publications/management- and-decontamination-of-surgical-instruments-used-in-acute- care

Infection control – procedure room

Clinical hand wash sink [1]

• Dedicated for hand washing only (not instrumentdecontamination or body fluid discharge)
• Plug must not be used to allow for hand washing underrunning water
• Integral back outlet the sink surround e.g. grout/splashbackmust be intact and easy to clean
• Situated near patient/service user i.e. in the room if invasiveprocedures performed or in adjacent room
• Hand washing sinks must be supplied with liquid soap from aclean dispenser, disposable paper towels and a black bag waste bin. Alcohol rub must be available for staff in the clinic room (but not at sink)
• Sinks ideally should be operated by lever action (e.g. elbow) or sensor taps (with single self-draining spout). If elbow taps are not available disposable towels can be used to switch of the taps
• A clinical hand wash sink must be accessible and should not be sited behind curtain rails TMV3-approved thermostatic mixing valve (either fitted directly to tap or integral within it, in accordance with Health Technical Memorandum 04-01)

Visitor/service user hand wash sink [1]

• Must be present in the toilet areas
• As above except hand drying may be by air drier ordisposable paper towels (not fabric towel)Flooring [1]
• No carpet in any area where clinical procedures areperformed or where there is a risk of body fluid spillage

• The floor must be easily cleaned (a wooden floor isacceptable if sealed)
• Place an absorbent pad on the floor if the wound is oozingheavilyFurniture and horizontal work surfaces [1]

• All surfaces and furniture including chairs must be smooth (nodeep chips and scratches), easy to clean. Surfaces that can be contaminated with body fluid must be able to tolerate chlorine releasing solution (10,000ppm of av.chlorine)
• Work surfaces must be free from extraneous items and clutter Clinical waste

The practitioner must comply with the Department of Health Healthcare Technical Memorandum 07-01: safe management of healthcare waste [2]

Sharps [1]

• Sharps Boxes – Boxes for the disposal of scalpels, needlesor any other sharps must comply with BS 7320 andUN3291.The sharps box lid colour code is:
• Purple – for sharps contaminated with cytotoxic or cytostaticdrugs
• Orange- sharps waste not contaminated with anydrugs/chemicals
• Yellow- sharps waste contaminated with any drugs/chemicalsClinical waste – bags [1]

• Waste bags- Black – for non-hazardous waste
• Orange – infectious waste with no chemical contaminationinclude all blood soiled waste
• Yellow – infectious waste with chemical contamination
• Tiger stripe waste – offensive waste but not known to beinfection risk Decontamination [1]

Couch and seating for examining patients must be easy to clean (fluid impermeable material, no splits or tears). Fresh

blue disposable roll must be placed on the couch for each patient. At the start and end of each clinic, wipe the couch with sanitizing wipes. Also clean with detergent if visibly soiled or used by a known infected patient. It must also tolerate disinfectants to decontaminate blood stained fluids

• Dignity blanket – provide a single use disposable dignity blanket or machine launder reusable linen after each patient.
• Pillows must be covered to make them impermeable to fluids. Wipe pillow with sanitising wipe at the start and end of each clinic and wash with detergent if visibly soiled. Disposable pillow cases rather than linen cases should be used if a pillow case is required
• IT equipment in procedure room – a wipeable keyboard should be used. The keyboard should tolerate wiping with a sanitizing wipe at the beginning and end of each clinic and if obviously soiled
• Blood pressure cuffs – wipe with a sanitizing wipe after each use and protect from body fluid contactBuckets [1]

• Must be lined with a single use disposable liner (e.g. single use waste bag) before filling with water, to prevent contamination of the bucket
• Do not fill the bucket directly from a hand washing sink or kitchen sink. If no other clean water source is available fill the bucket in these areas using a clean jug filled from the kitchen tap/hand washing sink)
• After use, discard the bucket fluid into a sluice type out let (ie not hand wash sink). A sluice type outlet includes a slop hopper, toilet in a non-inpatient area or cleaners sink
• If a toilet has to be used it must be cleaned with a sanitising wipe after each bucket emptying
• Staff must wear disposable gloves, aprons and face protection when decanting body fluids, followed by hand washing
• The lid must be closed when flushing the toilet to reduce aerosol spread. If more than one toilet available in the clinic then limit the discarding of fluid to one toilet and keep it out of action for the duration of the clinic. To clean out the bucket with a sanitising wipe, store bucket dryPrivacy screens [1]
• Must be wipeable with a sanitizing wipe or detergent and hot water

• Non-wipeable screens must be able to be laundered in awashing machine. Wipe/launder screens if visibly soiled, if used for patients with a known infection and at least 6

monthly

Storage [1]

• Store clean supplies in a clean, dust protected area (e.g. box,covered trolley or cupboard)
• Clean supplies and used supplies must be stored andtransported in separate containers
• Clean and dirty areas should be kept separate and theworkflow patterns of each area should be clearly defined.
• The design and finish of ancillary areas should facilitate goodcleaning
• They should have facilities for hand-hygiene and sufficientstorage for supplies and equipmentCleaning schedule [1][3]

• Immediately: All spills and body fluid contamination must becleaned immediately with a 1% chlorine releasing solution
• Daily: Floors, chairs, tables, hand wash containers, wastereceptacles, toys, toilets, sinks, examination couch, low surfaces, treatment area – may need additional cleaning if clinics run ‘back to back’
• Weekly: door handles, switches, internal glazing, high surfaces
• Monthly: Dust walls and ceilings, radiators, ventilation grilles
• 6 monthly: external glazing, curtains/blinds
• Yearly: Wash walls and ceilingReferences1. Appendix 7.4: Generic treatment room standard. Aseptic Technique and Clean Technique

2. HealthcareTechnicalMemorandum07-01:safemanagement of healthcare waste.https://www.gov.uk/government/uploads/system/uploads/attac hment_data/file/167976/HTM_07-01_Final.pdf
3. National Standards of Cleanliness in the NHS 2007

Clinical waste

The practitioner must comply with the Department of Health Healthcare Technical Memorandum 07-01: safe management of healthcare waste [1].

References

1. HealthcareTechnicalMemorandum07-01:safemanagement of healthcare waste.https://www.gov.uk/government/uploads/system/uploads/attac hment_data/file/167976/HTM_07-01_Final.pdf

Procedure room size, layout and equipment

The clinical area should be organised so that dirty and clean procedures and processes are clearly separated to reduce the cross contamination.

Size

• The room should be greater than 12m2
• Sufficient size that ensures required staff (are able to movefreely and there is access to three sides of the operating couch.Hand wash basin

• Designated clinical hand wash basin must be available.
• Large enough to contain splashing and enables the correcthand wash technique to be performed
• Ideally the clinical hand wash basin should be fitted withelbow or sensor operated taps
• Wall mounted liquid soap dispenser
• Wall mounted alcohol rub dispenser
• Wall mounted and paper towel dispenser
• Surgical hand scrub must be available in a pump operateddispenser. It is preferable to have this wall mounted
• Foot operated waste bin for disposal of paper towels
• Nailbrushes if used for completing a surgical hand washingtechnique at the beginning of the session must be single useand disposed of immediately after use
• Splash backs should be impermeable and smooth.Furniture, fixtures and fittingsFurniture, fixtures and fittings must be clean, intact and constructed of an impermeable material that allows easy and frequent cleaning and able to withstand chlorine base solution

Couch

• Free standing adjustable couch
• Covering intact and made of impervious material to allowcleaning.
• Step-stool availableSharps bins

Sharps bins must be immediately available in the room and preferably wall mounted.

Storage

• The room should contain the minimum amount of equipment to reduce the accumulation of dust and allow easy cleaning.
• Equipment and consumables should be stored off the floor.
• Equipment should be stored in a cupboard to reduce risk ofenvironmental contamination.

Flooring

• Must be impervious to moisture and withstand cleaning
• Intact washable floor covering (non-slip)Walls
• Must be impervious to moisture and withstand cleaning.
• Intact washable walls.
• Posters laminated to facilitate cleaning.Windows/Blinds/Curtains

• Ideally have obscured glass
• Blinds if used must be impervious to moisture and withstandcleaningVentilation

Mechanical or natural ventilation Lighting

Moveable spot lighting that is easy to clean

Privacy

• Room with solid partitions and a door that offers privacy.
• Doors lockable without vision panelsEmergency equipment

• Equipment, emergency packs and sterile swabs should be available to tamponade bleeding
• Resuscitation trolley should be available with access to an AED (if no direct access providers/practitioners must know where the nearest AED is available). Necessary emergency drugs and adjuncts required for CPR immediately available
• For sharp local anaesthetic and sedation cases, cardiovascular monitoring equipment should be available during and after the treatment. Oxygen should be availablePatient safety

• The practitioner and/or provider should ensure the safety of the patient during treatment
• No patient should be left unattended during or immediately after treatment. The staff member left with a patient must be adequately trained to deal with unexpected events

Waiting room

• There should be a designated waiting room with seating available
• The area should be uncluttered, clean and well lit
• If there is a designated area for administrative tasks, thisshould maintain patient confidentiality and be safe for

If there is a noticeable language barrier, arrangements for a translator should be made

Initial consultation

• Must be in person, face to face with an appropriately trained practitioner
• Must not be with an industry representative selling a product.
• The consultation should not be delegated to unqualified staffwho are unable to perform the procedure and cannot carryout the consent process
• Practitioners may need to offer a 2nd (and more if required)consultation prior to embarking upon treatment, especially for more invasive proceduresHistory and examination

1. Confirmation of patients identify including: name, date of birth, sex, address and next of kin
2. Contact details should be recorded
3. A unique patient identifying number should be generated.
4. Assessment and documentation of a patient’s general healthstatus to check feasibility of treatment
5. Assess and document specific aesthetic concerns
6. Assess and document past medical history
7. Assess and document past psychological/psychiatric history
8. Assess and document aesthetic history
9. Assess and document assess and document allergies

10.Assess and document any evidence of body dysmorphia 11.Assess and document patient expectations
12.Assess and document skin quality, type and local condition 13.Assess and document skin disease
14.Use diagrams and annotate discussion
15.Assess and refer for /request relevant blood tests, if

necessary
16.Assess and refer for /request other relevant investigations 17.If in any doubt with capacity and consent process, get further

opinion from a medical colleague/supervisor
18.If the patient is diagnosed with dysmorphia no aesthetic

medical treatments shall be performed
19.Inform the patient of and document the financial implications. 20.The consultation is the start of the consent process and

counselling must be documented; highlighting risks and benefits

Follow up consultations

• Follow up must be offered to all patients.
• Face to face is recommended
• If video consultation is used it must be deemed safe to do soby the supervisor.
• A mechanism must be in place to identify those patients who

need an emergency face-to-face review and make this available at short notice.

Patient information

• Information should be provided after initial consultation and read during the cooling off period, with ample opportunity to ask questions before the procedure.
• The practitioner should provide information to the patient who is up to date, accurate, understandable, realistic, truthful and not misleading.
• Practitioners should counsel patients on the aims of treatments, benefits, risks, potential adverse effects, alternativesEfficacy of treatment

• The practitioner must provide background information and the evidence of treatments and devices on request
• If there is no evidence available or it is weak; the practitioner must relay this information honestly to the patientManaging expectations

• The practitioner must inform the patient of the expectations of a treatment and devices used, ensuring they are aligned with the patient’s.
• These must be compared to alternative options, including other modalities of treatments, techniques, drugs, agents and devices.
• The practitioner must articulate the comparable result of doing nothing and present this in a balanced wayCooling off

The practitioner must offer the patient time to digest information, weigh up the risks and benefits of treatment, reflect and ask additional questions before embarking upontreatment (refer to ‘cooling off’).

Photographs

• Photos are recommended pre and post procedure
• The patient must give written consent to have photos takenand stored
• At least two views must be taken
• Enhanced before and after photos must not be used asadvertising material
• Intended outcomes must be realistic and photos must not beused as an enticing marketing tool
• Honest and realistic limitations of the treatment must beexplained to the patient

Psychological/ Psychiatric concerns

The practitioner must be aware of and be able to screen for psychological concerns and/or psychiatric illness. For such patients a referral for a psychological/psychiatric professional is advised prior to commencing cosmetic treatment. This includes training and awareness of Body dysmorphia disorder (BDD). If you are unable to refer directly to these services the patient should be referred to see their GP.

Cooling off

The cooling off period is a minimum time frame that should be used between consultation and treatment. The time frame depends on the level of invasion and risk of a procedure. This is specified for each modality and must be offered to every patient.

Practitioners must offer patients time to think before agreeing to go ahead with treatment [1].

References

1. Guidance for doctors who offer cosmetic interventions.

www.gmc-uk.org/guidance/ethical_guidance.28687.asp

Consent

A patient must give permission before they receive any type of medical treatment, test or examination. This must be done on the basis of an explanation by the practitioner [1].

Consent should be an ongoing process from first consultation to the day of the treatment. Written consent must be gained prior to the treatment taking place.

For consent to be valid:

• The patient must be competent.
• The patient must have sufficient information to make achoice.
• The patient must be able to give their consent freely [2].Consent process should include

1. Details of intended outcomes
2. Limitations, risks, alternative treatments and result of doingnothing
3. Commonly occurring and serious but rare complicationsshould be fully explained and understood
4. Recovery period, time required off work, what to avoid and forhow long (off-work, keeping dry etc.)
5. Confirmthepatientisabletoretain,understandandexplainthe planned treatment, benefits, risks and alternativeoutcomes
6. Claiming below average or low rate of complication should

not be used to entice patients

7. Known rates of complications should be documented if knownas a whole number i.e.1 in 100
8. Writteninformationshallbeinadditionto,andnotreplacedan informative discussion
9. Bothpartiesmustsigntheinformedconsentform

10.The practitioner should ensure that the patient is informed of

the limitation, implications and potential complications of the

aesthetic medical treatment before booking
11.No money should be exchanged for the procedure until the

patient has gone through the first aspect of consent which includes fully understands the limitation, implications and potential complications of the treatment, with the exception of previously declared non-refundable deposit

12.No treatment should occur without completion of consent 13.Treatment for patients under the age of 18 years should be

only in exceptional circumstances with a documented medical

assessment
14.The consent form signed by both parties, understandable and

legible

References

1. Consenttotreatment.www.nhs.uk/conditions/consent-to- treatment/pages/introduction.aspx
2. Consent–thebasics.www.medicalprotection.org/uk/resources/facstsheets/england -factsheets/uk-eng-consent-the-basics

Safe timing of treatments

Practitioners should advise on lifestyle modification around the time of a procedure. If the risk of a procedure could be reduced by losing weight, smoking cessation, or improving a concurrent medical/skin condition including psychological state this should be made explicitly clear to the patient.

Practitioners should consider age, skin quality, patient expectations and realistic achievable outcomes when counselling a patient for a procedure.

Practitioners should consider the patient’s psychological state when considering treatment, and not proceed with a procedure if concerns are uncovered.

Patient correspondence

The patient is entitled to view their notes and should receive correspondence relating to a treatment. The practitioner must provide access to patient records according to The Freedom of Information Act 2000 request [1].

Access to written information about a condition and procedure should be given to the patient. The information given should be clear and honest; and must not involve any marketing tactics to entice the patient

The identification, speciality, affiliation and qualification of a practitioner who performs the treatment must appear clearly and accurately on all formal communications with the patient.

Cancellation policies should be clear to the patient before they embark upon treatment and before any payment is made. A full refund of treatment fees shall be given if any pre-payment is made when the cancellation is within the “cooling off” period. Further arrangements are at the practitioner/clinics discretion but shall be clearly explained and set out in writing to patients.

References

1. Howtomakeafreedomofinformation(FOI)request.

www.gov.uk/make-a-freedom-of-information_request/the- freedome-of-information-act

Out of hours and emergency cover

Patients should be given an emergency contact number for the provider or practitioner in the case of emergency.

Emergency out of hours care should be provided by the practitioner involved in the treatment, unless there are clear arrangements made with a nominated covering practitioner.

Cross cover should be provided by a practitioner who is appropriately trained and of a similar level of expertise. For higher risk treatments a formal handover of the patient is required.

Discharge, follow-up and patient satisfaction

• Patients must receive a discharge document after a procedure outlining aftercare and follow-up if required
• A guidance document outlining the treatment performed, the aftercare required and how to recognise complications should be issued
• Dressing advice (if required) should be issued
• An emergency contact number must be provided
• When and where to seek emergency care should be outlined.
• It is best practice for the practitioner to follow up their ownpatients
• If patient has late concerns about the result, the patient isentitled to see the practitioner who performed the treatment
• A patient feedback survey should be carried out beforedischarge and/or on follow up (also see complaints and