The new aesthetic licensing clause included in the Health and Care Act will give the secretary of state power to introduce a licensing regime for aesthetic non-surgical cosmetic procedures and will make it an offence for someone to practise without a licence or to work from unlicensed premises. The list of procedures, detailed conditions and practitioner education and training requirements to be included in the scope of the licence will be set out in regulations after national consultation with relevant stakeholders. It is anticipated that a requirement of the licensing scheme will be to introduce consistent standards that individuals carrying out certain non-surgical cosmetic procedures will have to meet, such as hygiene and safety standards for premises.
Currently, the JCCP premises standards require registrants of the JCCP to self-certify through the use of self-audit, where practitioners deliver non-surgical treatments and/or provide an education/training environment. The authors are currently reviewing existing premises standards that are in place, alongside the Chartered Institute of Environmental Health (CIEH) advising the JCCP on recommended changes required in preparation for the new licence. The purpose of the review is to ensure that the standards comply with any new laws and regulations, reflect best practice and act as a guide to the policymakers for the new national licensing scheme.
Self-certification
The original task and finish group for the premise standards agreed that self-certification of environments is not sufficient to ensure a safe clinical environment and premises should be regularly checked and assessed by appropriately qualified people to ensure they are, and continue to be, fit for purpose. The group recommended a situation where self-certification is implemented in the early phases of registration with consideration given for inspections later. Given the forthcoming licensing scheme, the JCCP recommends that self-certification continues alongside the additional evidential requirements to which JCCP registrants may be periodically subject to, until such time premises standards are written into law.
Self-certification tool
The current self-certification tool requires JCCP registrants to self-certify that they meet premises standards 001 (minimum requirements), with additional requirements depending on the treatment modality delivered. These requirements are in addition to those set down by the Cosmetic Practice Standards Authority (CPSA), including, for example, processes of audit, which should be implemented in parallel to premises-specific standards.
The authors have recommended that revised premises standards mirror the work of the CIEH and its toolkit for tattooing and body piercing as the minimum requirements (CIEH, 2013). This toolkit was prepared by a panel of health protection and practitioner representatives and comprises consensus expert advice from a multi-agency steering group with representatives from the CIEH, Health and Safety Laboratory, Public Health England (formerly Health Protection Agency), Tattoo and Piercing Industry Union and also individuals with practical experience of working in this area as expert advisors, practitioners or regulators. The guidance is supported by extensive documentary evidence of scientific knowledge, reported research and published literature encompassing expert advice.
As the non-surgical field of practice develops, orphan or emerging treatments will come on to the market and, therefore, the self-certification tool should cover all modalities. It is recognised that surgical procedures, such as thread lifts, may be out of scope; however, these would be covered by the Care Quality Commission (CQC) regulatory framework.
» The JCCP recognises that current premises where non-surgical procedures are delivered vary from practitioner/patients’ home to CQC-registered premises, and the scope is not to exclude businesses or individuals from attaining registration «
As a minimum, the premises standards should include:
- Health and safety standards
- Risk assessment, risk management and control
- Accident, incidents, reporting, first aid and medical emergency arrangements
- Infection prevention control
- Consent
- Management of medicines and storage of medicines
- Waste management and disposal
- Maintaining a safe and healthy working environment.
The CIEH is currently reviewing the JCCP's revised premises standards and is due to submit feedback shortly, prior to submission to the JCCP board for ratification.
Treatment modalities
The authors recognise existing specific criteria that are already in place for currently ‘in scope modalities’ and note these should be considered alongside any new standards for clinic environments. For example, all lasers and intense pulsed lights (IPL) must comply with current standards (for example, BS EN 60601-2-22:2013 for medical lasers and BS 60601-2-57:2011 for IPL). They are also regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) and, in some instances, the system regulator and local authority. Other existing criteria include:
- The London Local Authorities Act 1991, standard conditions
- National Occupational Standards
- Quality Assurance Agency (QAA) (2012) UK quality code for higher education part B: assuring and enhancing academic quality chapter 10: managing higher education provision with others
- CQC regulation 15 premises and equipment or an equivalent system regulator in the devolved administrations
- MHRA lasers, intense light source systems and LEDs—guidance for safe use in medical, surgical, dental and aesthetic practices (2015).
The JCCP recognises that a range of additional aesthetic procedures will be added to the JCCP's list of recognised modalities as the result of the Government's anticipated consultation exercise, which is expected to commence later this year. Accordingly, the JCCP premises standards will be designed in such a way to accommodate such changes/additions.
Different working environments
The JCCP recognises that current premises where non-surgical procedures are delivered vary from practitioner/patients’ home to CQC-registered premises, and the scope is not to exclude businesses or individuals from attaining registration. However, we feel strongly that more invasive procedures need a separate set of criteria that are performed in a clinical environment. Given that Health Education England (HEE) separated the modalities by risk categories, the JCCP considers this an appropriate way forward. The following are recommended as minimum requirements:
- If the practitioner is working from their home address and meets the audit guidelines, this is acceptable
- If the practitioner is moving between houses/premises, they take the responsibility to ensure every premises meets the audit guidelines
- Any other mobile working (for example, working from a hotel or patient rooms on a temporary basis) would not be permitted.
Health Improvement Scotland has produced guidance for independent clinics where services are provided in a service user's home that could be used as part of the JCCP's work.
Environments: conferences and exhibitions
Cosmetic injectable procedures should be performed in clinical environments, given that it is known that biofilm can develop after inoculation of 40 bacteria. Therefore, injections in carpeted environments are not appropriate. Appropriate emergency medicines should be available to treat the patient immediately in the event of an adverse reaction, and there may be an issue relating to confidentiality and consent, as many attendees of conferences use social media, such as Twitter and Instagram, and send photographs of volunteers having treatment performed.
Procedures should be performed in a clinical room with minimal essential personnel to reduce the risk of cross-contamination. Given the current age of virtual meetings and conferences, live demonstrations can easily be delivered virtually with live commentary being delivered to large groups. The JCCP continues to recommend that live demonstrations do not take place at conferences and exhibitions.
Further work development
The authors have engaged with representatives from the CIEH before submitting the revised premises standards to the Clinical Advisory Group (CAG) and JCCP for review and ratification, with the intention that the final version will be used as part of the public consultation for the national licensing regime.
Further comment from manufacturers is being sought in relation to carrying out live demonstrations at conferences and how they intend to demonstrate procedures to large groups.
Statements will be required on how premises will be managed for those practitioners who currently hold CQC registration and work under an existing regulated premises framework.