Background to the guidance
A new system of registration
As the regulator of health and adult social care in England, we make sure that the care people receive meets essential standards of quality and safety and we encourage ongoing improvements by those who provide or commission care.
The new registration system for health and adult social care will make sure that people can expect services to meet essential standards of quality and safety that respect their dignity and protect their rights. The new system is focused on outcomes rather than systems and processes, and places the views and experiences of people who use services at its centre.
We will continuously monitor compliance with essential standards as part of a new, more dynamic, responsive and robust system of regulation. Our assessors and inspectors will frequently review all available information and intelligence we hold about a provider. We will seek information from patients and public representative groups, and from organisations such as other regulators and the National Patient Safety Agency.
If we have concerns that a provider is not meeting essential standards of quality and safety, we will act quickly, working closely with commissioners and others, and using our new enforcement powers if necessary.
In addition to the assurance about compliance with essential standards that registration will provide, we have an important function in promoting improvement by providing independent, reliable and timely information about the quality of care in providers above essential standards, and about the quality of care secured by commissioners for their local communities, which we describe as assessments of quality.
These assessments include: our periodic reviews of the performance of all health and adult social care providers, and of councils and primary care trusts as commissioners of care; and our special reviews and studies of particular aspects of care, on economy, efficiency and effectiveness, and information issues.
Why we produced the guidance
Section 23(1) of the Health and Social Care Act 2008 requires the Care Quality Commission to produce guidance for providers of health and adult social care, to help them comply with the regulations within the Act that govern their activities.
The Act, the regulations and this guidance are part of a wider regulatory framework that includes regulation of professionals such as nurses, doctors and social workers. The framework is designed to ensure that people who use services are protected and receive the care, treatment and support they need.
We will use the guidance when deciding whether to register individual providers, and also when monitoring their services afterwards to check that they are continuing to comply with the regulations. We will also refer to it when using our powers of enforcement to bring about improvement in poor services or to prevent a provider from carrying out regulated activities.
Who the guidance is for
The guidance is for providers of health or social care services who carry out the “regulated activities” shown in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010.
Many of our own staff will also use the guidance in their work. In addition, courts and tribunals will take account of it when making decisions about our enforcement activities.
Other groups with an interest in the quality of health and social care may find the guidance helpful – for example, people who use services, other regulators, MPs and the general public.
The guidance does not apply to:
- Commissioners of care services: our guidance does not apply directly to councils and primary care trusts when they commission (buy) care services, as commissioning is not a regulated activity. However, because of its emphasis on outcomes for people, we hope that the guidance will help them to make decisions about which providers to buy services from.
- Individual professionals: The standards for individual professionals are set and enforced by their professional registration bodies. For example, the General Medical Council and the Nursing and Midwifery Council provide guidance about their standards for doctors and nurses.
How we developed the guidance
When developing our guidance about compliance for providers of health or social care, we carried out a large-scale public consultation. We sought the views of people who use care services and those who provide them, other regulators, and organisations that represent people who use services or providers, or that work in the wider system of health and social care.
When producing the final version of the guidance, we have
- Continued to focus on the outcomes, experiences and human rights of people who use health and social care services.
- Used plain English wherever we can.
- Stayed within the scope of the regulations.
- Applied common standards across both health and adult social care services wherever possible.
- Provided additional prompts for certain types of providers to help them comply with aspects of the regulations that relate only to them.
- Taken account of relevant legislation and standards set by other regulators.
- Set out the standards against which we will take enforcement action to protect people from poor standards of care, treatment and support.
- Built on the progress made under the existing laws and standards governing health and social care in England.
- Applied the Government’s principles for better regulation.
How the guidance is structured
We have grouped the regulations and their associated outcomes into six key areas.
- Involvement and information.
- Personalised care, treatment and support.
- Safeguarding and safety.
- Suitability of staffing.
- Quality and management.
- Suitability of management.
The guidance for each area is made up of a summary of the area and the regulations that it covers, and then for each regulation:
- The text of the regulation
- What we think people who use services should experience when providers comply with the regulation (the definition of the outcome)
This is what we will focus on when we check that providers are meeting essential standards.
- Detailed prompts to help providers achieve the outcome. We do not expect providers to use these prompts as a checklist, but they can help providers to identify if they are meeting the outcome.
The detailed prompts are divided into:
- Prompts that apply to all providers irrespective of the types of services they provide.
- Prompts that only apply to providers of certain types of services.
Do I need to read all of the outcomes?
We strongly recommend that you read all of the guidance that applies to you for all of the outcomes in the six key areas. This is because our expectations for one outcome may sometimes apply to a number of other outcomes. For example, Outcome 14 about supporting workers is the main part of the guidance that addresses staff training. But for providers to achieve the outcomes needed for, say, nutrition or safeguarding, they may need to meet staff training requirements in these areas.
Do providers have to follow the guidance?
The detailed outcomes and prompts that we provide for each regulation indicate what providers should be doing to meet the requirements of the regulations. However, providers are not legally bound to use these and, although we must take it into account when deciding whether a provider is complying with the regulations, and in tribunals and courts, our guidance is not legally enforceable in its own right.
However, if you decide to follow other arrangements for demonstrating compliance with the regulations, Regulation 26 of the Health and Social Care Act (Regulated Activities) Regulations 2010 requires you to be able to show that you have taken account of our outcomes and prompts when judging your compliance.
If you choose not to use the prompts, you will still need to be able to show us that you are meeting the needs of people using your services, and to the standards that the regulations require. If you do not do so, we will ask you to explain why.
But if you feel you cannot follow our prompts because your services are particularly innovative and the evidence you will want to provide will be different from that which the prompts indicates, we will work with you to confirm that your services are reaching the essential standards of quality and safety.
More about the underlying regulations
The regulations that govern your registration by the Care Quality Commission are the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 and the Care Quality Commission (Registration) Regulations 2009.
Section 23 of the Act requires us to produce guidance about some of these regulations. These are called Section 20 Regulations and this guidance only relates to them.
When we refer to “the Act”, we mean the Health and Social Care Act 2008.
Regulation of the requirement to prevent or control healthcare associated infections
The Care Quality Commission is not required by the Act to produce guidance about legislation governing the prevention or control of healthcare-associated infections [regulation 12 of the Health & Social Care Act 2008 (Regulated Activities) Regulations 2010]. This guidance is available in the Department of Health’s publication: The Code of Practice for health and adult social care on the prevention and control of infections and related guidance.
Other relevant legislation
The Act allows us to take account of a provider’s compliance with any other legislation that we believe is relevant to registration. In the prompts we have referred to legislation that we consider to be of particular importance, but we have not included all relevant legislation.
As a provider of care, you are responsible for knowing what other legislation is relevant to your service and making sure that you comply with it. We may consider your compliance with such legislation when monitoring and checking your services.
Schedule of applicable publications by other organisations
In addition to following our guidance about compliance with the regulations, and other relevant legislation, please make sure that you read the schedule of applicable publications that we have drawn up for providers. The list will be updated from time to time, with the latest version available at www.cqc.org.uk/