This guidance describes how providers and managers can meet the regulations. These include the fundamental standards – the standards below which care must never fall.
It was first published on 1 April 2015. It sets out our guidance for providers on meeting two groups of regulations:
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Part 3)
- Care Quality Commission (Registration) Regulations 2009 (Part 4)
Section 23 of the Health and Social Care Act 2008 (HSCA 2008) says that CQC must produce guidance to help providers to comply with the regulations made under this Act. We therefore developed this guidance with the help of people who use services, organisations that represent them, health and adult social care providers, other regulators and professional bodies.
The regulations set out in this guidance apply to all registered persons (providers and managers) registered with the Care Quality Commission (CQC) that carry on regulated activities. There are many different types of services that are governed by the regulations.
The guidance does not attempt to describe in detail how the regulations apply to each type of service registered with CQC, but we will be proportionate in how we apply the regulations to different types of services. We will consider the size and type of services and the relevance of the regulation to the regulated activity provided. For example, when inspecting providers of personal care to people in their own home we would not assess Regulation 15: Premises and equipment, or when inspecting dentists we would not assess Regulation 14: Meeting nutrition and hydration needs, as they would not apply to these types of regulated activity.
Terminology
The regulations refer to 'the service user' or 'relevant person'. Where we quote a regulation directly, we use the term 'service user', but elsewhere in the guidance, we use the phrase 'people who use services' or 'people', as our engagement work has shown that this is the term people prefer.
The regulations lay down fundamental standards to be met by registered persons, that is, registered providers and registered managers. This guidance is called Guidance for providers and we use that terminology throughout, but it applies equally to registered managers.
Using this guidance
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.
The regulations
This guidance covers two groups of regulations.
1. Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Part 3)
These regulations introduce the new fundamental standards, which describe requirements that reflect the recommendations made by Sir Robert Francis following his inquiry into care at Mid Staffordshire NHS Foundation Trust. They will enable us to pinpoint more clearly the fundamental standards below which the provision of regulated activities and the care provided to people must not fall, and to take appropriate enforcement action where we find it does.
Part 3 of these regulations has two sections: Section 1 describes the requirements relating to persons carrying on or managing a regulated activity. Section 2 introduces the fundamental standards below which the provision of regulated activities and the care people receive must never fall. They came into force for all health and adult social care services on 1 April 2015.
The requirements in Section 1 (relating to persons carrying on or managing a regulated activity) include a regulation about fit and proper person requirements for directors (Regulation 5). This regulation was introduced to ensure that directors are fit to hold their position. Directors must meet certain criteria, including that they are "of good character"; have the qualifications, competence, skills and experience necessary for the relevant position; and are capable of undertaking the relevant position after any reasonable adjustments have been made. They must also not have been responsible for any serious misconduct or mismanagement in the course of carrying on a regulated activity.
The requirements in Section 2 (fundamental standards) include a statutory duty of candour (Regulation 20) and a requirement for providers to display their CQC rating (Regulation 20A).
The aim of Regulation 20, statutory duty of candour, requires registered persons to be open and honest with the people who use their service when something goes wrong with their care or treatment. When a specified safety incident has occurred in respect of care provided, the regulation sets out a clear set of legal duties on registered providers about how and when to notify people using their service (or their relevant representatives) about those safety incidents. The regulation also describes when notifications about safety incidents need to be made to CQC.
The aim of Regulation 20A, the requirement to display performance assessments, is to require providers who have received a CQC rating to display it conspicuously at their premises and on their website.
2. Care Quality Commission (Registration) Regulations 2009 (Part 4)
The Care Quality Commission (Registration) Regulations 2009 set out requirements that providers must have regard to in relation to their registration, including their financial position, fees, statement of purpose, the circumstances when the need to make notifications to CQC and requirements in relation to termination of pregnancies.
Our operating model
The regulations and this guidance are an essential component of CQC's new approach, as set out in our strategy Raising standards, putting people first. The diagram of our operating model summarises how we register, monitor, inspect and award ratings to providers, take enforcement action and provide an independent voice on the quality of care.
The law says that we must take into account our guidance on meeting the regulations:
- When we make regulatory decisions about a registered provider or manager's registration. That is, granting a registration, refusing an application for registration, cancelling or suspending a registration, or varying, removing or imposing conditions on a registration.
- In our regulatory decisions when a registered provider or manager may have breached regulations, conditions of registration and in decisions relating to criminal offences.
- In any proceedings for the urgent cancellation of a registration, or for appeals relating to an urgent cancellation.
- In any proceedings for a failure to comply with conditions of registration or for breaches of regulations.
Our guidance on meeting the regulations is therefore central to:
1. Registration. We have strengthened CQC's registration process – particularly for how we assess applications for registration. To be registered with CQC, applicants must demonstrate that they will be able to meet the requirements set out in the regulations. When considering new applications for registration, and variation or cancellation of existing registrations, we now also take account of the duty of candour and the fit and proper person requirement for directors. To help us do this, we draw on the detail included in this guidance.
2. Inspection and ratings. To get to the heart of people's experiences of care and support, the focus of our inspections is on the quality and safety of services, based on the things that matter to people. We therefore ask five key questions about the service, are they:
- Safe?
- Effective?
- Caring?
- Responsive to people's needs?
- Well-led?
To help our inspection teams direct the focus of their inspections, they use a standard set of 'key lines of enquiry' (KLOEs) and prompts. KLOEs help them to form a judgement about the quality of the service, determine a rating for each of the five key questions, and where relevant, produce an overall rating for the service. Ratings are an important part of our inspection process and use a four-point scale: outstanding, good, requires improvement, or inadequate.
Our provider handbooks describe how we carry out inspections, make judgements and, where appropriate, award ratings to providers. They list the KLOEs, which also provide additional information that may help providers to meet the requirements of these regulations. The KLOEs and prompts are specific to each sector and focus on the detail relevant to the sector.
For each of the five key questions we have developed characteristics to describe what care for each of those four rating levels looks like. These characteristics provide a framework, which, together with professional judgement, guide our inspection teams when they make a judgement about a rating.
Our use of ratings and the focus on looking for 'good' are an important part of our model for assessing the overall quality of the care people received. The characteristics of good and outstanding care that we look for in our inspections, as set out in our handbooks, go beyond the fundamental standards as set out in the regulations.
However, our inspections also assess whether the requirements set out in the regulations are met.
3. Enforcement. The regulations set in law a clear minimum standard that registered providers and managers must meet. CQC will be able to take enforcement action against registered providers and managers that do not meet them (the law calls this a breach of regulation(s)).