Regulation 21 of the HSCA 2008 (Regulated Activity) Regulations 2014 (as amended) says that registered persons "must have regard" to this guidance.
If you are a prospective provider or manager applying for registration, this means you must demonstrate that you will be able to meet the requirements set out in these regulations and, once registered, that you will continue to meet them.
Section 25(1) of the HSCA 2008 says that CQC must take this guidance into account when we make our regulatory decisions. We will therefore use this guidance when deciding whether a provider or manager meets the requirements of the regulations when we consider an application for registration. If a prospective provider is not able to demonstrate that they will meet the requirements of the regulations from their first day of business, we may refuse the application.
If you are already registered with CQC as a provider or manager, it is important that you read and consider this guidance in relation to the regulated activities you provide, as it will help you to understand what you need to do to meet the regulations.
You are responsible for meeting the regulations and deciding how to do this. It is not CQC's role to tell providers or managers what they must do to deliver their services. When registered providers and managers do not follow this guidance, we will ask them to provide evidence that their approach enables them to meet the requirements of the regulations.
For each regulation in this guidance, we provide:
- A copy of the actual text of the regulation. It is important to use the text of each regulation as the first source of information about how to meet its requirement. We only provide further guidance on how to meet the individual components of each regulation where we think it needs further clarification and definition. Where we think that the text of the regulation itself is self-explanatory, we do not give any further guidance. There have been a number of amendments to the original regulations on which this guidance is based, but we have used the amended regulations in this guidance.
- A summary of the intention of the regulation.
- Guidance on the requirements of specific components of the regulation. The guidance on specific components of each regulation should not be considered exhaustive as there may be other ways that providers can show that they meet each component of the regulation.
The following pages provide information that supports the guidance.
Web links to legislation. The legislation is relevant for all registered providers and managers whatever regulated activity they provide.
Web links to guidance. Links to guidance include guidance specific to the different types of activities and services provided and recognised quality standards. We expect registered providers and managers to take account of other nationally recognised guidance that might be specific to the services they deliver. This includes guidance produced by the Department of Health, National Institute for Health and Care Excellence, Public Health England, the former National Patient Safety Agency, NHS England, Skills for Health, Skills for Care and relevant clinical and professional bodies. This section also includes guidance from other national organisations that publish guidelines or are recognised by health and social care professionals as producers of high-quality guidance.
The legislation and related guidance in the annexes are listed alphabetically and say which regulation they apply to. The online version enables you to search by specific regulation, sector type (NHS trusts, primary medical services, mental health services and adult social care) and by specific themes.
Glossary of terms used in the guidance.
List of service types. This sets out the many different types of services that are governed by the regulations and to which the provider guidance applies. Some providers' activities will cover more than one service type.
Quick reference chart of offences. This shows which regulations CQC can prosecute against.