We carried out an announced comprehensive inspection on 4 February 2019 to ask the service the following key questions; Are services safe, effective, caring, responsive and well-led?

Our findings were:

Are services safe?

We found that this service was not providing safe care in accordance with the relevant regulations.

Are services effective?

We found that this service was providing effective care in accordance with the relevant regulations.

Are services caring?

We found that this service was providing caring services in accordance with the relevant regulations.

Are services responsive?

We found that this service was providing responsive care in accordance with the relevant regulations.

Are services well-led?

We found that this service was providing well-led care in accordance with the relevant regulations.

We carried out this inspection under Section 60 of the Health and Social Care Act 2008 as part of our regulatory functions. This inspection was planned to check whether the service was meeting the legal requirements and regulations associated with the Health and Social Care Act 2008.

The Bio-Rejuvenation Clinic Limited, trading as 23MD, provides a comprehensive range of medical, dermatological and aesthetic treatments to their patients.

This service is registered with CQC under the Health and Social Care Act 2008 in respect of some, but not all, of the services it provides. There are some exemptions from regulation by CQC which relate to particular types of regulated activities and services and these are set out in Schedule 1 and Schedule 2 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. 23MD provides a range of non-surgical cosmetic interventions, for example fat reduction therapy and non-surgical face lift which are not within CQC scope of registration. Therefore, we did not inspect or report on these services.

There are two lead clinicians, who are clinic directors, at 23MD. One of the lead clinicians is the registered manager. A registered manager is a person who is registered with the Care Quality Commission to manage the service. Like registered providers, they are ‘registered persons’. Registered persons have legal responsibility for meeting the requirements in the Health and Social Care Act 2008 and associated Regulations about how the service is run.

As part of our inspection, we asked for CQC comment cards to be completed by patients prior to our inspection. We received eight completed comment cards and patients said they were satisfied with the standard of care received and thought the doctors were approachable, committed and caring. We did not speak with patients directly at the inspection.

Our key findings were:

• The provider had specialised in individualised bioidentical hormone replacement therapy for women and men. Patients were treated with unlicensed medicines which followed evidence-based guidelines and systems were in place to ensure this was carried out safely.
• Some systems and processes were in place to keep people safe. However, some aspects were not operated effectively.
• Staff had the skills, knowledge and experience to deliver effective care and treatment, in most respects. However, some core training for staff had not been completed on a regular basis. Following the inspection, the provider has arranged for staff to undertake specific training and we will review at the next inspection.
• Not all staff in direct clinical contact had undertaken the requisite blood tests and vaccinations to keep staff and patients safe; and there was cross contamination in relation to cleaning equipment. Following the inspection, the provider has initiated measures to mitigate the risk of infection in relation to staff immunity and immunisations and we will review this at the next inspection.
• The clinicians reviewed the effectiveness and appropriateness of the care provided to ensure it was in line with current research and national guidance. Quality improvement and monitoring was achieved through engaging with local and international networks of physicians, clinical audit and patient feedback. However, it would be considered good practice to demonstrate quality assurance and improvement in relation to the regulated activity.
• Staff we spoke with were aware of their responsibility to respect people’s diversity and human rights.
• Patients were treated with compassion, kindness, dignity and respect and they were involved in their care and decisions about their treatment.
• Structures, processes and systems to support good governance and management were clearly set out, understood and effective.
• Some practice policies did not contain sufficient information.
• There were limited facilities and arrangements for those patients who are hard of hearing and whose first language is not English.
• There were systems to support improvement and innovation work.

We identified a regulation that was not being met and the provider must:

• Ensure care and treatment is provided in a safe way to patients.

You can see full details of the regulation not being met at the end of this report.

In addition, there were areas where the provider could make improvements and should:

• Consider implementing further clinical audit to measure and demonstrate improved health outcomes for patients receiving bio-identical hormone therapy.
• Review and update practice policies at an appropriate frequency and ensure they contain sufficient information.
• Review the safeguarding policy and consider broadening the definition of safeguarding and at-risk groups within it.
• Review employment processes to ensure appropriate information regarding references is documented during the staff recruitment process.
• Review processes to encourage quality improvement in clinical outcomes.
• Review the facilities and arrangements for those patients who are hard of hearing and whose first language is not English.

Dr Rosie Benneyworth BM BS BMedSci MRCGP

Chief Inspector of Primary Medical Services and Integrated Care