Before you get started
Do I need to be CQC registered?
Before creating an application to register your service with the CQC, first check whether you actually need to be registered.
The criteria for this is fairly simple: If you carry out a ‘regulated activity’ in England, then you must register with the CQC.
It is your responsibility to check which regulated activity (or activities) you are looking to provide, and apply to register for this in advance of providing the service.
Even if you won't be providing this service on a permanent or regular basis, it is an offence to carry out a regulated activity without being registered - so check carefully!
You will also need to establish:
- Who will be responsible for carrying out the regulated activity?
- Will any exceptions apply?
- From which location(s) will the regulated activity be carried out?
- Is a ‘Registered Manager’ required at the location(s)?
- If providing services with children, is registration required with the CQC, Ofsted, or both?
Who is responsible for registering with the CQC?
Applicants registering with the CQC are known as ‘service providers’. A service provider is the legal entity who will be carrying out the regulated activity, and may be:
- An individual
- A partnership
- An organisation
Individuals, referred to as 'sole traders,' need to register if they carry out regulated activities themselves.
Partnerships need to register as a single entity, listing the names of individual partners. Corporate groups and franchise holders register individually, with distinctions made between the registered provider and the brand. Joint ventures, primary care collaborations, and Section 75 agreements may require separate registration, depending on the structure and arrangements.
Organisations, such as local authorities, NHS trusts, registered companies, charities, and limited liability partnerships, must register at an organisational level, with the responsibility falling on the entity rather than its controllers.
For subcontracted services, the legal entity directly responsible for carrying out the regulated activity should register, even if the service is part of a broader pathway of care.
For example, if Provider A (a clinic) subcontracts to Provider B for the provision of radiology service delivery including staffing, while it may be a seamless care pathway for patients of Provider A, both providers will need to be registered individually with the CQC.
In the case of services with children, the same regulated activities cannot be dual registered with both CQC and Ofsted. If a provider must register with Ofsted, the parts of its service that Ofsted regulates are exempt from registration with CQC, and vice versa.
Which countries do the CQC regulate?
The CQC only regulates providers inside England, who provide services to patients in England. For the other UK countries - Scotland, Wales and Northern Ireland - there are separate local arrangements. Please check with the respective regulatory body in your local country for more information on this.
Are there any exceptions to registering with the CQC?
There are a number of exceptions and exemptions to registering with the CQC:
Medical practitioners in independent practice:
Medical practitioners providing the regulated activity - classed as ‘treatment of disease, disorder or injury’ (TDDI) - in a surgery or consulting room, may have an exception for providing this independently.
If you are an individual or a group of doctors providing this activity in a surgery or consulting room; are a service provider registered for TDDI, or employed by one that is; and are either on the medical performers list of a designated body or employed by a service provider that is a designated body, you could have an exception and should explore this further.
However, several procedures listed in Schedule 2, paragraph 4 are not covered by the exception, such as certain treatments under anaesthesia, cosmetic surgery or endoscopy, to name a few.
Individual budgets, self-funded nursing care, and personal care:
If a registered nurse works directly for an individual without agency involvement, the nurse may not need separate CQC registration. Similar exceptions apply to personal care arrangements made directly by individuals.
Introductory or employment agencies:
Employment agencies are exempt if they assist in finding registered nurses, nursing associates, or care workers without having a role in managing or directing the care provided.
Third-party exceptions:
This refers to services organised through third parties, such as occupational health schemes, medical or dental services by government departments, and assessments related to insurance claims..
Other exceptions:
Various other exceptions exist, including activities carried out by a carer for a family member or someone in a personal relationship, primary ophthalmic and pharmacy services, treatment by registered nurses in schools, first aid in specific circumstances, and activities related to testing for COVID-19.
These exceptions should hopefully clarify situations where registration with the CQC may not be required, providing a nuanced understanding of scenarios exempt from regulatory oversight.
How do I apply for CQC registration?
Application is online via the Portal which is accessed from the CQC website.
The application form is a 21-page document which requests the following information:
- Proof of identity
- Your contact details
- Your personal address
- Details of the business you’re applying for
- Applicable regulated activities
- Confirmation of DBS checks
- Recent photographs
- Full employment history with the dates of your employment, the role and your reason for leaving the job
- Your past medical history and its potential impact on your ability to act as a registered Manager
- Any professional registered bodies that you might be a member of
- Whether you are the subject of any investigations relating to health and social care
How long does the application take to complete?
The application completion time may vary based on the number of regulated activities you’re registering, and the complexity of your service. It's advised to allow up to eight hours to complete this.
Application terms you need to know
What is a ‘Regulated Activity’?
A ‘regulated activity’ is described as “an activity involving, or connected with, the provision of health or social care” under Section 8(1) of the Health and Social Care Act 2008. Review this document carefully - with particular attention to Schedule 1 - before starting your application.
The following list is a summary of the 14 currently regulated activities:
- Personal care for people who are unable to provide it for themselves because of old age, illness or disability
- Accommodation for people who require nursing or personal care
- Accommodation for people who require treatment for substance misuse
- Treatment of disease, disorder or injury.
- Assessment or medical treatment for persons detained under the Mental Health Act 1983
- Surgical procedures
- Diagnostic and screening procedures
- Management of supply of blood and blood-derived products
- Transport services, triage and medical advice provided remotely
- Maternity and midwifery services
- Termination of pregnancies
- Services in slimming clinics
- Nursing care
- Family planning services
These guidelines are subject to change; check them regularly to ensure you have the most up-to-date information.
You must register for each and every proposed regulated activity. For example, many clinics commonly register for both Regulated Activity 7, ‘Diagnostic and screening procedures’ and Regulated Activity 4, ‘Treatment of disease, disorder or injury’.
What is a ‘Registered Manager’?
The Registered Manager plays a crucial role in ensuring adherence to regulations and maintaining the quality of care provided.
All types of providers, including partnerships, organisations, and sole-traders, must appoint a Registered Manager who oversees the daily operation of regulated activities. This manager must demonstrate capacity, capability, and essential skills, ensuring they can effectively manage the regulated activity.
The focus is on the day-to-day manager, rather than a more senior manager. Job share arrangements allow for multiple managers to be appointed at the same location.
How do I apply to be a ‘Registered Manager’?
If you’ve never previously been a Registered Manager for a CQC-regulated service, you will need to apply for this prior to the organisational application. You must demonstrate that you have the skills and experience necessary to manage the relevant regulated activities.
The application can be done online via the Provider Portal, or by completing the relevant documents and emailing them to the CQC. It’s the CQC’s decision as to whether they think you are fit for the role, so its worth ensuring you take time to complete the required information accurately.
What is a ‘Nominated Individual’?
When seeking registration, regulations will instruct you to nominate an individual as the primary contact - this is your ‘Nominated Individual’. This will preferably be a senior figure (a director, manager, or secretary) with authority and responsibility for supervising the regulated activity.
There is flexibility in the nomination, meaning you can choose the same person for multiple activities, or different individuals for each. However, only one person can be nominated for each activity.
In small organisations, the same person might serve as both the Registered Manager and Nominated Individual, although separation is encouraged. Registering as an individual or partnership eliminates the need for a Nominated Individual.
What is a ‘Statement of Purpose’?
A Statement of Purpose is a business's mission statement that outlines its activities, locations, and target audience. In your application, this statement must encompass your goals, services, catered demographics, contact information, legal identity, and service locations.
What is considered a ‘location’?
Physical locations may include:
- Places where the delivery of regulated activities take place, such as hospitals, dental surgeries.
- A location where operations are managed, but the regulated activities take place elsewhere, such as domiciliary care agencies.
For mobile or online services, location can be classed as a head office or regional base overseeing day-to-day activity.
If regulated activities are provided from multiple locations, include all of these in your application.
Documents you need to provide
Criminal Record Checks
If you are a registered healthcare professional you need to provide an enhanced DBS check that is less than 12 months only. If you are not a healthcare professional, you’ll need to apply for a CQC-enhanced DBS check. This involves verification of your identity, which can be completed at certain Post Offices. It's worth noting this can take up to 60 working days.
Policies & Procedures
You will be required to submit a number of policies and procedure documents for review along with your application. These are formal documents in your organisation which are written in line with current legislation and guidance. These should be shared amongst your staff and underpin the framework in which they operate.
References
You will also need to provide details of your employment history and contact details for your NHS GP.
What happens next?
How long does the registration process take?
You can’t start providing any regulated activities for this particular unregistered service whilst awaiting your registration interview. The CQC website advises it takes at least 10 weeks to progress from submission to interview - however in some cases this has taken significantly longer, even around six to nine months, so prepare to be patient.
Registration Interview
The CQC Registration team conducts a 30-60 minute interview with the Registered Manager. This is likely to be virtual, via Teams or Zoom.
For the interview, it's advisable to have a copy of your application form with you, a copy of the essential standards, and a copy of the company’s Statement of Purpose. The inspector will ask questions to assess your understanding of the essential standards and the regulatory framework.
Questions you may be asked include:
- How do you define your job role at this business?
- How long have you worked for this business and how many days per week do you work there?
- What is your understanding of your legal responsibilities as a Registered Manager?
- What notifications do you have to send to the CQC and when?
- How does your company approach equality, diversity and inclusion?
- How do you ensure you gather valid consent for each patient?
- What is your process to recruit suitable and qualified staff for the job?
- How would you investigate an allegation of abuse within the practice?
- Explain your whistleblowing policy.
- Explain your infection control processes.
- Where would you look up the CQC requirements?
As with all interviews, the key to getting this part right is all in the preparation, so make sure you can answer these questions and demonstrate your understanding of the essential standards.
Then, you'll be ready for your inspection...
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About Dr Jonathan Andrews
Jonathon is an experienced NHS and private doctor, freelance CQC advisor and a medical advisor for early-stage healthcare start-ups. He has advised on several health tech startups & scale-ups on CQC registrations, as well as private clinics. He was awarded Most Pioneering Health Tech Chief Medical Officer 2023 by C-Suite Awards.
Click here to connect with Jonathan
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