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The Ultimate CQC FAQ: Everything Healthcare Providers Need to Know
Care Quality Commission (CQC) compliance is crucial for many healthcare service providers. Understanding their regulatory landscape is fundamental to satisfying CQC requirements. Since launching 8foldGovernance’s CQC support services, we have been approached by a number of existing and potential clients requiring more information. Whilst answers to almost all of the questions below are available on CQC’s website, they can be difficult to locate and require experience to interpret.
Below are the most common questions our team have answered over the last 24 months, combined with those answered over years of experience.
Table of Contents
Who are CQC?
CQC, or Care Quality Commission, is England’s independent health and adult social care regulator. It aims to ensure that health and social care services deliver safe, effective, compassionate, and high-quality care and to encourage service improvement. It does this by keeping a register of all health and social care providers and monitoring their performance.
Why do I need to register with CQC?
Registering with CQC is legally required before undertaking specific health and social care activities in England. Schedule 1 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 details which activities. The CQC’s website is the best starting point for an easier-to-understand guide. Under Section 10(1) of the Health and Social Care Act 2008, failure to register is a criminal offence that can result in an unlimited fine or a custodial prison sentence.
How do I know if my business is in the scope of CQC-regulated activities?
Your company or organisation must be based in England for the regulated activities to apply. Fourteen activities fall within the scope of the Regulated Activities.
The CQC’s website provides a full breakdown, a helpful explanation, and accompanying applicability flow diagrams. For technology companies, it is essential to consider who is carrying out, taking responsibility for, or overseeing the activities. Health technologies are increasingly offering CQC functionality that delivers a CQC-regulated activity. More details are discussed in this blog.
What happens if I am in scope for a regulated activity but don’t register with CQC?
Under Section 10(1) of the Health and Social Care Act 2008, failure to register is a criminal offence that can result in an unlimited fine or a custodial prison sentence. The CQC’s website sets out how it prosecutes the organisations and includes stories of successful prosecutions.
What if I provide services and I am based outside of England?
The CQC regulates health and social care in England. Each of the other home nations has independent health and social care regulators. The memorandum of understanding details how they interact.
Notably, regulators cannot regulate an organisation if it is not based in their legal jurisdiction—the deciding factor is not where the patient or service user is based; it is where the organisation is based. Understanding this is crucial for remote care providers, including health technology providers, diagnostic and screening services, and telemedicine companies.
I deliver services remotely to patients. Do I need to be CQC registered?
It depends on whether you are based in England and the type of service you provide. CQC-regulated activities cover remote services, so it is advisable to assess what you provide against CQC’s guidance on what is a regulated activity.
My company sells technology products to healthcare providers. Am I in scope for CQC-regulated activities?
It all depends on where you are based, what the technology does and who is “managing” or overseeing the regulated activity. We have previously written a blog on this, which may be helpful.
How do I register with CQC?
Registering with the CQC requires the following:
- Compile all the supporting evidence that the CQC require to demonstrate that you will able to run the planned activity safely.
- Recruit a registered manager for the planned activity – this person must have the right skillset to run the day to day registered activity Or
- Identify someone who has the right skillset to oversee the planned activity and then apply for them to be a registered manager – dopn’t forget to gain an enhanced DBS check through the CQC for the proposed registered manager
- Complete a registered provider application
- Submit all the documents mentioned above according to the latest CQC application process – this has changed a couple of times over the last two years so it is worth monitoring the CQC updates for the latest process.
What else do I need to consider as part of CQC registration?
Registering with the CQC requires a mindset shift within an organisation. Culture, Governance, and Leadership are the three pillars that support healthcare organisations – discussed in this blog.
Those registered with the CQC have additional legally mandated responsibilities beyond companies’ other legal duties. These are set out in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.
Governance arrangements must be adapted to account for the new regulated obligations. This may include appointing new directors, expanding the accountabilities of current directors and introducing new governance structures.
Effective leadership at all levels is crucial, and leaders must demonstrate knowledge of organisational policies, effective staff management, and the delivery of functional aspects of their roles.
An open and honest culture is vital for organisational learning, effective incident reporting and quality improvement. CQC will want to see a shared vision based on transparency, equity, equality, human rights, diversity, inclusion, and engagement.
What is the supporting evidence?
Each application requires supporting documentation. The CQC outlines the documentation requirements for different providers applying for registration. Policies and procedures must accurately demonstrate a provider’s ability to deliver safe, effective, and well-managed healthcare services.
Key required documents include:
- Statement of Purpose
- Information Commissioner’s Office (ICO) registration certificate
- Public and employer liability insurance quote or certificate
- Financial viability statement
- DBS Checks
- Consent policy and procedure
- Equality, diversity and human rights policy
- Governance policy
- Infection control policy
- Medicines management policy
- Recruitment policy
- Safeguarding policy and procedures
Depending on the type of service, additional documents, such as business continuity plans, emergency plans, and staff training matrices, will be required.
How long will it take to register with the CQC?
The registration assessment process can take some time. Importantly, you cannot manage regulated activities until CQC confirms successful registration. This has been known to take between 3 and 6 months.
- Review the application and ask for more information if needed or potentially return the application depending on what information is missing
- Book a date to complete a site visit if needed
- Arrange an interview with the registered manager and nominated individual
Can I speed up the CQC registration process?
Yes. Firstly, you can submit an urgent registration application if you deliver critical services to create capacity within the NHS.
Secondly, if you don’t qualify for an urgent application, then there are other things you can do to speed up your application that are in your control. Importantly once you submit the submission timescale is completely dependent on CQC processes. Ensuring the below
- Have all the key documentation and supporting evidence ready before submission, and that it aligns to best practice.
- Ensure your application contains all the necessary information and that no fields are unanswered.
- Be aware and have the additional documents ready to reply to any request quickly.
- If you have premises that you will be delivering a regulated activity from, ensure you have done a thorough site audit before or during the application to ensure your site aligns with best practice guidance, such as health building notes, has accessibility arrangements, and complies with health and safety regulations.
What happens after I register with the CQC?
Following a successful application and confirmation that your organisation is registered with CQC, you must be able to demonstrate ongoing compliance with the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.
We have discussed the priorities an organisation needs to focus on in this blog.
The documents, policies and procedures submitted in the application phase now need to become a reality, with ongoing monitoring for compliance and adaptation as the organisation develops.
Will the CQC conduct one-off inspections?
Yes and no. If you register with CQC as a new provider, CQC states that they will normally aim to inspect within 12 months of registration. For services that are rated, the first inspection will be comprehensive, and you will receive your initial rating.
As part of the Single Assessment Framework, organisations that have already been inspected will receive more frequent information requests. Any on-site inspection will target evidence gathering against some of the Quality Statements that support the current CQC inspection methodology.
What is the CQC Single-Assessment Framework?
The single assessment framework is based on five key questions. CQC will ask if a provider is:
- Safe?
- Effective?
- Caring?
- Responsive to people’s needs?
- Well-led?
Quality statements outline what an organisation should be able to state in response to the above questions. Assessing the quality statements involves gathering on-site and off-site evidence across six evidence categories.
CQC uses a scoring system to produce ratings. This approach aims to be more flexible, transparent, and responsive, allowing for more frequent updates to judgments and ratings.
The framework is applied across all sectors with slight variations in evidence categories and types considered for each.
How will CQC gather evidence of compliance?
The CQC gathers on-site and off-site evidence across six categories:
People’s experience of health and care services:
- Includes feedback from service users, families, carers, and advocates.
- Gathered through various methods like phone calls, interviews, surveys, and community groups.
Feedback from staff and leaders:
- Includes staff surveys, interviews, focus groups, and whistleblowing.
- Covers both frontline staff and those in leadership positions.
Feedback from partners:
- Evidence from organisations that interact with the service being assessed.
- Includes commissioners, other providers, regulators, and professional bodies.
Observation:
- Direct observation of care and care environments.
- Mainly conducted on-site by CQC inspectors and Specialist Professional Advisors.
Processes:
- Focuses on the effectiveness of care delivery processes.
- Audits, safety incident findings, access times, and case note reviews are included.
Outcomes:
- Measures the impact of care on individuals’ physical, functional, or psychological status.
- Examples include mortality rates, admission rates, and infection control rates.
The extent and sources of evidence collected will depend on the type of services.
I represent a CQC-registered organisation that has subcontracted a service to a supplier based outside of England. What do I need to know?
When a subcontracted remote care provider is based outside the regulator’s jurisdiction, the CQC will hold the registered provider accountable. This is the provider who made the contract with the subcontractor. The registered provider retains responsibility for delivering the service, including ensuring appropriate arrangements are in place and implementing quality assurance measures. This accountability applies even though the subcontracted provider is outside CQC’s direct jurisdiction.
This information highlights the importance of due diligence and ongoing oversight when healthcare providers subcontract services, especially across jurisdictional boundaries. It emphasises that outsourcing does not absolve the primary provider of responsibility for quality and compliance.
I represent a non CQC-registered organisation that has subcontracted a service to a supplier based outside of England. What do I need to know?
This is slightly more grey, and where engagement with the CQC is needed. It will depend on who CQC classifies as carrying out the regulated activity. If they deem that you are managing the day-to-day regulated activity, you may well need to register.
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