It is a criminal offence to carry out a regulated activity without being registered with the CQC under Section 10(1) of the Health and Social Care Act 2008. If found guilty of an offence under Section 10, the court can impose an unlimited fine and/or a sentence of up to 12 months imprisonment.
The various regulated activities and the definitions of those activities are contained in Schedule 1 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. These include:
- Personal care
- Accommodation for persons who require nursing or personal care
- Accommodation for persons who require treatment for substance misuse
- Treatment of disease, disorder or injury
- Assessment or medical treatment for persons detained under the 1983 Act
- Surgical procedures
- Diagnostic and screening procedures
- Management of supply of blood and blood derived products etc
- Transport services, triage and medical advice provided remotely
- Maternity and midwifery services
- Termination of pregnancies
- Services in slimming clinics
- Nursing care
- Family planning services.
It was reported by the CQC on 18th February 2022 that a company operating an online doctor’s service had been prosecuted by the CQC for carrying out the regulated activity of ‘treatment of disease, disorder or injury’. The court imposed a fine of £3,500 and ordered the company to pay the CQC’s prosecution costs of £10,000 plus a victim surcharge of £170. This demonstrates that the costs of a prosecution are often higher than the fine itself and overall, can make the total financial penalty imposed on an unregistered provider very significant.
The consequences of failing to properly identify the correct registration position can therefore be devastating, both financially and reputationally. It is therefore essential to establish the correct legal position in respect of any registration requirements for your individual set of circumstances and prior to setting up a new business.
What should I do if I am carrying out a regulated activity without registration?
The key to minimising any potential criminal enforcement action or prosecution by the CQC is by ensuring that early and prompt action is taken to rectify any genuine error as quickly as possible. The submission of an application to register with the CQC as soon as you become aware of your need to register will serve as valuable mitigation in any prosecution, and may encourage the CQC to take no further action.
If you are unsure whether you require CQC registration, you should seek specialist legal advice as soon as possible. It is ultimately your responsibility to establish whether you need to be registered with the CQC. This is not something which the CQC will advise you on and in our experience, the CQC will only direct you to the relevant legislation and registration guidance. Failing to make sufficient and appropriate enquiries to determine the correct registration position is not a suitable defence and this will only increase the likelihood of criminal enforcement action, particularly if you fail to take prompt action to remedy any previous failure to register where required.
Where registration is required, an application for registration should be submitted to the CQC without delay. You should also bear in mind that if you continue to carry out any regulated activities without registration during the registration process, you will be continuing to commit a criminal offence until your CQC registration is granted. It is therefore important that you take the appropriate legal advice and action to avoid aggravating any criminal offence that has been committed.
Where regulated activities have been undertaken for some time without registration, it is important that any responses you make to the CQC are carefully drafted and considered to protect your position and that proactive steps are taken to rectify this in a reasonable and timely manner. However, in the event of criminal enforcement action or a prosecution by the CQC, specialist legal advice should be sought as soon as possible in order to mitigate the potential impact of such action on the relevant individual(s) and business.
Case Studies
Our specialist CQC lawyers regularly advise a range of different services on the scope of CQC registration and have represented numerous unregistered providers in criminal investigations and prosecutions by the CQC. Some of our recent case are set out below:
Personal assistant accused of carrying out ‘personal care’
Our CQC lawyers acted for a self-employed carer (‘personal assistant’) who was being investigated by the CQC for carrying out the regulated activity of ‘personal care’. The CQC wrote to our client and requested a written response under caution, providing three options:
- Apply to CQC for registration
- Stop carrying on the regulated activity
- Make written representations about why you do not need to be registered.
Our CQC lawyers advised on their registration position and subsequently made detailed written representations to the CQC explaining why they fell outside the scope of CQC registration. After considering our representations, the CQC confirmed that they would be taking no further action.
Consultant surgeon accused of carrying out ‘treatment of disease, disorder or injury’ and ‘surgical procedures’ at a private aesthetic clinic
Our specialist CQC lawyers acted for a consultant surgeon who ran a private clinic providing non-surgical aesthetic treatments and interventions. The CQC had been informed that the clinic was providing a number of surgical procedures, botox and mole removal and requested a written response under caution.
Following our advice on their registration position, we submitted a detailed response to the CQC explaining why their current treatments and interventions did not fall within the scope of CQC registration for either regulated activity. In light of our response, the CQC confirmed that they would not be taking any criminal enforcement action.
Dentist accused of carrying out ‘treatment of disease, disorder or injury’ and ‘diagnostic and screening procedures’ at a teeth straightening service
Our specialist CQC lawyers acted for a company, owned by a dentist, which operated a teeth straightening service. The service operated as a direct to consumer (DTC) platform. The company was being investigated by the CQC for carrying out the regulated activities of ‘treatment of disease, disorder or injury’ and ‘diagnostic and screening procedures’ following a number of complaints from patients.
The CQC invited the company to make written representations in lieu of attending an interview under caution and provided them with a PACE Pre-Interview Disclosure Notice consisting of numerous questions. We made a detailed response under caution and put forward detailed mitigation on behalf of the company outlining why they should not be prosecuted, including the steps they had taken to clarify their registration position and the details of their subsequent registration application. After considering our representations, the CQC decided to issue a fixed penalty notice of £4,000 instead of a prosecution, which would have left the company open to an unlimited fine and costs.
Specialist CQC lawyers
If you require specialist legal advice on whether you fall within the scope of CQC registration, or you have received notification from the CQC that they are investigating or prosecuting you for an offence under Section 10 of the Health and Social Care Act 2008, we have a dedicated team of specialist CQC solicitors who would be happy to help you. Call our specialist CQC solicitors now on 0161 696 6250 or contact us via our online enquiry form.
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