When does your business need CQC registration?

The recent shocking BBC Panorama documentary, ‘Botched: The Brazilian Butt Lift Nightmare’, has highlighted the dangers of an inherently risky procedure known as a ‘liquid Brazilian butt-lift’, or a ‘BBL’. The technique involves injecting dermal filler into the buttocks to give a lifted and larger appearance. The potential complications are significant and include sepsis, tissue necrosis and infection.  Tragically, it is a procedure that has resulted in the death of some patients.

The Joint Council for Cosmetic Practitioners states, ‘Recent years have seen a growing prevalence and normalisation of non-surgical cosmetic procedures, associated with the rise of social media, the increasing accessibility and affordability of providers and the advancement of technologies and products in this field’. Campaigners and medical associations have long been campaigning for better oversight and regulation of such procedures. They highlight statistics which suggest that an alarming percentage of BBLs and other aesthetic procedures are undertaken by providers who are not registered with the Care Quality Commission (CQC), not medically qualified and who operate from non-clinical premises.

Despite the dangers and apparent invasive nature of liquid BBLs, surprisingly the CQC does not regulate this type of cosmetic treatment. The CQC’s role, as the independent regulator of health and social care services in England, is to ensure that care services are safe, effective and high-quality. As part of its oversight, the CQC does regulate cosmetic treatments which involve surgical procedures carried out by a healthcare professional, which captures, for example, a buttock lift by use of an implant. The liquid BBL involves the injection of dermal filler, however, rather than the insertion of an implant. For this reason, it falls outside of the scope of CQC regulation because it is considered to be a cosmetic treatment which does not amount to a ‘surgical procedure’.

When is CQC registration required?

Service providers must register with the CQC if they provide any health or social care in England which amounts to a ‘regulated activity’ under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (as amended). Once registered, they will fall within the CQC’s regulatory remit and be subject to the CQC’s regulatory requirements, including the need to undergo regular inspection. The above example demonstrates that the requirement for CQC registration can be nuanced and require careful consideration. In some instances, it will be fairly clear that registration with the CQC will be required. In others, the position is more complex and it can leave healthcare or social care providers and professionals unsure of their regulatory obligations.

Take the example of a service provider that uses the results of sample testing to provide tailored advice to customers. The question as to whether the service amounts to a regulated activity attracting CQC registration will require a careful consideration of a number of factors, including:

• What type of sample is being taken;
• Who is responsible for taking and analysing the samples;
• What type of advice is being provided to customers;
• What is the professional status of those that are providing the advice to customers.

On one hand, it is unsurprising that a medically qualified professional taking blood samples directly from a patient and using the blood analysis results to diagnose and treat a clinical disorder must operate under a CQC registration. On the other, a service provider that uses urine sample results to advise a customer about nutrition via a non-medically qualified individual is likely to fall outside the scope of CQC registration. There is, of course, a whole range of scenarios in-between which may or may not attract CQC registration, according to the specific situation.

Other nebulous examples include:

• Where a qualified healthcare professional is providing an activity which would not amount to a regulated activity but for the fact that the person providing the treatment holds a professional healthcare qualification;
• Where a service can be carried out for aesthetic purposes as well as for clinical treatment purposes;
• Where some parts of a service are outsourced to healthcare professionals whereas some parts are retained in-house.

What are the consequences of failing to correctly register with the CQC?

It is crucially important for service providers to ensure that they are properly registered with the CQC where required. Failure to hold the correct registration with the CQC can attract serious sanctions.  The CQC can restrict the activities of a service provider or prevent them from operating completely.  The CQC also has the power to bring criminal prosecutions against service providers who are practising illegally without holding CQC registration, which can attract an unlimited fine and up to 12 months’ imprisonment in some circumstances.

What can services providers do to ensure compliance?

It can be incredibly difficult to ascertain whether CQC registration is required.  Subtle differences in business models can sometimes be the difference between a service provider being captured by the CQC’s regulatory remit or falling outside of it entirely.  Unfortunately, the experience of many service providers who find themselves in this position is that the CQC is unwilling to provide tailored and clear guidance to confirm whether or not registration is required.

Where a service provider is unsure, it is important that they seek specialist legal advice before undertaking any potential regulated activity.  Where a service provider is already in operation and has attracted the scrutiny of the CQC, obtaining such advice at an early stage and prior to any response being made to the CQC is key.  Seeking specialist input early on can be pivotal in preventing CQC regulatory action and fostering a positive working relationship with the CQC.

If you require specialist advice about CQC matters, including whether you need to obtain or amend existing CQC registration, please contact Natasha Ricioppo.