Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Part 3)
Scope of this chapter
This chapter provides a summary of each regulation under the Health and Care Act 2008 (Regulated Activities) Regulations 2014 (Part 3).
Regulations 4-7 relate to requirements of the person/s carrying on or managing regulated activities.
Regulations 8-20A are known as the Fundamental Standards. These are the standards below which care must never fall.
Where applicable, the chapter provides links to related chapters in the Handbook that can be used to help demonstrate during an inspection how the service meets a particular regulation.
Note: Service providers are responsible for meeting the regulations and deciding how to do this. It is not the intention or purpose of this chapter to tell providers or managers what they must do to deliver their services.
Related Chapters and Guidance
- CQC: Regulations for service providers and managers
- Offences: The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
Amendment
Section 7, Regulation 9A. Visiting and accompanying in care homes, hospitals and hospices was updated in May 2024 to include a link to the newly published CQC guidance.
The intention of this regulation is to ensure that people who use services have their needs met because the service is provided by an appropriate person.
To meet the requirements of this regulation, providers must register with the CQC under Section 10 of the Health and Social Care Act 2008.
The registered provider or partners of the registered provider must:
- Be of good character;
- Be able to properly perform tasks that are intrinsic to their role;
- Have the necessary qualifications, competence, skills and experience to carry on the regulated; activity or supervise its management;
- • Be able to supply CQC with documents that confirm their suitability.
The CQC cannot prosecute for a breach of this regulation but can take regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 4: Requirements where the service provider is an individual or partnership.
The intention of this regulation is to ensure that people who have director level responsibility for the quality and safety of care, and for meeting the fundamental standards are fit and proper to carry out this important role.
The CQC cannot prosecute for a breach of this regulation but can take regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
For guidance on meeting this regulation see Regulation 5: Fit and proper persons: directors.
The intention of this regulation is to ensure that the provider is represented by an appropriate person nominated by the organisation to carry out this role on their behalf (nominated individual).
The nominated individual is responsible for supervising the management of the regulated activity provided. This is because providers who comply with this regulation will have appointed as a nominated individual a director, manager or secretary who:
- Is of good character;
- Is able to properly perform tasks that are intrinsic to their role;
- Has the necessary qualifications, competence, skills and experience to supervise the management of the regulated activity;
- Has supplied them with documents that confirm their suitability.
The CQC cannot prosecute for a breach of this regulation but can take regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 6: Requirement where the service provider is a body other than a partnership.
The intention of this regulation is to ensure that people who use services have their needs met because the regulated activity is managed by an appropriate person.
This is because providers who comply with the regulations will have a registered manager who:
- Is of good character;
- Is able to properly perform tasks that are intrinsic to their role;
- Has the necessary qualifications, competence, skills and experience to manage the regulated activity;
- Has supplied them with documents that confirm their suitability.
The CQC cannot prosecute for a breach of this regulation but can take regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 7: Requirements relating to registered managers.
This regulation aims to make it clear that if a provider has more than one registered person (for example, a registered provider as well as a registered manager) they do not all individually need to take the same action to meet every regulation. However, they must make sure that they meet every regulation for each regulated activity they provide, and that all the registered people must comply with the requirements of the regulations.
It also states that for Regulations 9 to 20A, sections 2 and 3 of the Mental Capacity Act 2005 must be considered for people who use the service who are aged 16 or over to determine whether they lack the mental capacity to consent.
The intention of this regulation is to make sure that people using a service have care or treatment that is personalised specifically for them.
This regulation describes the action that providers must take to make sure that each person receives appropriate person-centred care and treatment that is based on an assessment of their needs and preferences.
Providers must work in partnership with the person, make any reasonable adjustments and provide support to help them understand and make informed decisions about their care and treatment options, including the extent to which they may wish to manage these options themselves.
Providers must make sure that they take into account people’s capacity and ability to consent, and that either they, or a person lawfully acting on their behalf, must be involved in the planning, management and review of their care and treatment.
Providers must make sure that decisions are made by those with the legal authority or responsibility to do so, but they must work within the requirements of the Mental Capacity Act 2005, which includes the duty to consult others such as carers, families and/or advocates where appropriate.
The CQC cannot prosecute for a breach of this regulation but can take regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 9: Person-centred care.
This regulation aims to make sure:
- People staying in a care home, hospital or hospice can receive visits from people they want to see;
- People living in a care home are not discouraged from taking visits outside the home;
- People attending appointments in a hospital or hospice, that do not require an overnight stay, can be accompanied by a family member, friend or advocate if they want someone with them.
The regulation explains what providers must do to make sure they respect the right of each person to receive visits and to be accompanied, following an assessment of their needs and preferences.
CQC cannot prosecute for a breach of this regulation or any of its parts, but they can take regulatory action, including civil enforcement action where this is appropriate.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices.
The intention of this regulation is to make sure that people using the service are treated with respect and dignity at all times while they are receiving care and treatment.
To meet this regulation, providers must make sure that they provide care and treatment in a way that ensures people’s dignity and treats them with respect at all times. This includes making sure that people have privacy when they need and want it, treating them as equals and providing any support they might need to be autonomous, independent and involved in their local community.
Providers must have due regard to the protected characteristics as defined in the Equality Act 2010.
The CQC cannot prosecute for a breach of this regulation but can take regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 10: Dignity and respect.
The intention of this regulation is to make sure that all people using the service, and those lawfully acting on their behalf, have given consent before any care or treatment is provided.
Providers must make sure that they obtain the consent lawfully and that the person who obtains the consent has the necessary knowledge and understanding of the care and/or treatment that they are asking consent for.
Consent is an important aspect of providing care and treatment, but in some cases, acting strictly in accordance with consent will mean that some of the other regulations cannot be met. For example, this might apply with regard to nutrition and person-centred care. However, providers must not provide unsafe or inappropriate care just because someone has consented to care or treatment that would be unsafe.
The CQC can prosecute for a breach of this regulation or a breach of part of the regulation and can move directly to prosecution without first serving a Warning Notice. Additionally, they can also take additional regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 11: Need for consent.
The intention of this regulation is to prevent people from receiving unsafe care and treatment and prevent avoidable harm or risk of harm.
Providers must assess the risks to people’s health and safety during any care or treatment and make sure that staff have the qualifications, competence, skills and experience to keep people safe.
Providers must make sure that the premises and any equipment used is safe and where applicable, available in sufficient quantities.
Medicines must be supplied in sufficient quantities, managed safely and administered appropriately to make sure people are safe.
Providers must prevent and control the spread of infection.
Where the responsibility for care and treatment is shared, care planning must be timely to maintain people’s health, safety and welfare.
CQC understands that there may be inherent risks in carrying out care and treatment, and will not consider it to be unsafe if providers can demonstrate that they have taken all reasonable steps to ensure the health and safety of people using their services and to manage risks that may arise during care and treatment.
Note: The regulation does not apply to the person’s accommodation if this is not provided as part of their care and treatment.
The CQC can prosecute for a breach of this regulation or a breach of part of the regulation if a failure to meet the regulation results in avoidable harm to a person using the service or if a person using the service is exposed to significant risk of harm. They can move directly to prosecution without first serving a Warning Notice. Additionally, they can also take additional regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 12: Safe care and treatment.
Accidents, Injury and Incidents
Assessing and Monitoring Health and Safety Risk
Disclosure and Raising a Concern
Emergencies and Unplanned Events
Health and Safety Policy and Responsibilities
Infection Prevention and Control
Information and Guidance for Specific Safeguarding issues
Learning from Safeguarding Enquiries, Safety Incidents and Complaints
Promoting Individual Wellbeing
Reducing the Risk of a Closed Culture
Risk Assessment (person-centred)
Supporting People with Complex Needs and Specific Conditions
The intention of this regulation is to safeguard people who use services from suffering any form of abuse or improper treatment while receiving care and treatment. Improper treatment includes discrimination or unlawful restraint, which includes inappropriate deprivation of liberty under the terms of the Mental Capacity Act 2005.
To meet the requirements of this regulation, providers must have a zero tolerance approach to abuse, unlawful discrimination and restraint. This includes:
- Neglect;
- Subjecting people to degrading treatment;
- Unnecessary or disproportionate restraint;
- Deprivation of liberty.
Providers must have robust procedures and processes to prevent people using the service from being abused by staff or other people they may have contact with when using the service, including visitors.
Abuse and improper treatment includes care or treatment that is degrading for people and care or treatment that significantly disregards their needs or that involves inappropriate recourse to restraint. For these purposes, ‘restraint’ includes the use or threat of force, and physical, chemical or mechanical methods of restricting liberty to overcome a person’s resistance to the treatment in question.
Where any form of abuse is suspected, occurs, is discovered, or reported by a third party, the provider must take appropriate action without delay. The action they must take includes investigation and/or referral to the appropriate body. This applies whether the third party reporting an occurrence is internal or external to the provider.
The CQC can prosecute for a breach of the following parts of this regulation if a failure to meet those parts results in avoidable harm to a person using the service or if a person using the service is exposed to significant risk of harm. They can move directly to prosecution without first serving a Warning Notice. Additionally, they can also take additional regulatory action:
| Part | Requirement |
|---|---|
|
13 (1) |
Service users must be protected from abuse and improper treatment in accordance with this regulation. |
|
13 (4) (a) |
Care or treatment for service users must not be provided in a way that includes discrimination against a service user on grounds of any protected characteristics (as defined in Section 4 of the Equality Act 2010) of the service user. |
|
13 (4) (b) |
Care or treatment for service users must not be provided in a way that includes acts intended to control or restrain a service user that are not necessary to prevent, or not a proportionate response to, a risk of harm posed to the service user or another individual if the service user was not subject to control or restraint. |
|
13 (4) (c) |
Care or treatment for service users must not be provided in a way that is degrading for the service user. |
|
13 (4) (d) |
Care or treatment for service users must not be provided in a way that significantly disregards the needs of the service user for care or treatment. |
The CQC cannot prosecute for a breach of other parts of this regulation but can take regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 13: Safeguarding service users from abuse and improper treatment.
Accidents, Injury and Incidents
Culturally Appropriate Care and Support
Emergencies and Unplanned Events
Equality, Diversity and Human Rights
Promoting Individual Wellbeing
Safeguarding and Deprivation of Liberty chapters
Overarching Aims, Duties, and Principles
Disclosure and Raising a Concern
Contributing to Safeguarding Discussions and Meetings
Information and Guidance for Specific Safeguarding issues
Learning from Safeguarding Enquiries, Safety Incidents and Complaints
Reducing the Risk of a Closed Culture
Recognising a Deprivation of Liberty
Responding to a Deprivation of Liberty
The intention of this regulation is to make sure that people who use services have adequate nutrition and hydration to sustain life and good health and reduce the risks of malnutrition and dehydration while they receive care and treatment.
To meet this regulation, where it is part of their role, providers must make sure that people have enough to eat and drink to meet their nutrition and hydration needs and receive the support they need to do so.
People must have their nutritional needs assessed and food must be provided to meet those needs. This includes where people are prescribed nutritional supplements and/or parenteral nutrition. People’s preferences, religious and cultural backgrounds must be taken into account when providing food and drink.
The CQC can prosecute for a breach of this regulation or a breach of part of the regulation if a failure to meet the regulation results in avoidable harm to a person using the service or if a person using the service is exposed to significant risk of harm. They can move directly to prosecution without first serving a Warning Notice. Additionally, they can also take additional regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 14: Meeting nutritional and hydration needs.
The intention of this regulation is to make sure that the premises where care and treatment are delivered are clean, suitable for the intended purpose, maintained and where required, appropriately located, and that the equipment that is used to deliver care and treatment is clean, suitable for the intended purpose, maintained, stored securely and used properly.
Providers retain legal responsibility under these regulations when they delegate responsibility through contracts or legal agreements to a third party, independent suppliers, professionals, supply chains or contractors. They must therefore make sure that they meet the regulation, as responsibility for any shortfall rests with the provider.
Where the person using the service owns the equipment needed to deliver their care and treatment, or the provider does not provide it, the provider should make every effort to make sure that it is clean, safe and suitable for use.
Note: The term ‘premises’ does not apply to the person’s own accommodation where accommodation is not provided as part of their care and treatment. In addition, ‘equipment’ does not include equipment at the person’s own accommodation, where it is not provided as part of their care or treatment.
The CQC cannot prosecute for a breach of this regulation but can take regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 15: Premises and equipment.
If the guidance is being implemented in practice, all the following chapters of the Handbook can be used to demonstrate how the service meets this regulation:
The intention of this regulation is to make sure that people can make a complaint about their care and treatment.
To meet this regulation providers must have an effective and accessible system for identifying, receiving, handling and responding to complaints from people using the service, people acting on their behalf or other stakeholders.
All complaints must be investigated thoroughly and any necessary action taken where failures have been identified.
The CQC can prosecute for a breach of part 16 (3) of this regulation. They can move directly to prosecution without first serving a Warning Notice. Additionally, they can also take additional regulatory action.
| Part | Requirement |
|---|---|
|
16 (3) |
The registered person must provide to the Commission, when requested to do so and by no later than 28 days beginning on the day after receipt of the request, a summary of:
|
The CQC cannot prosecute for a breach of other parts of this regulation but can take regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 16: Receiving and acting on complaints.
The intention of this regulation is to make sure that providers have systems and processes that ensure that they are able to meet other requirements in this part of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Regulations 4 to 20A).
To meet this regulation; providers must have effective governance, including assurance and auditing systems or processes. These must assess, monitor and drive improvement in the quality and safety of the services provided, including the quality of the experience for people using the service.
The systems and processes must also assess, monitor and mitigate any risks relating the health, safety and welfare of people using services and others.
Providers must continually evaluate and seek to improve their governance and auditing practice.
In addition, providers must securely maintain accurate, complete and detailed records in respect of each person using the service and records relating the employment of staff and the overall management of the regulated activity.
As part of their governance, providers must seek and act on feedback from people using the service, those acting on their behalf, staff and other stakeholders, so that they can continually evaluate the service and drive improvement.
The CQC can prosecute for a breach of part 17 (3) of this regulation. They can move directly to prosecution without first serving a Warning Notice. Additionally, they can also take additional regulatory action.
| Part | Requirement |
|---|---|
|
17 (3) (a) |
The registered person must send to the Commission, when requested to do so and by no later than 28 days beginning on the day after receipt of the request a written report setting out how, and the extent to which, in the opinion of the registered person, the requirements of paragraph (2) (a) and (b) are being complied with. 17 (2) (a); Systems or processes must enable the registered person to assess, monitor and improve the quality and safety of the services provided in the carrying on of the regulated activity (including the quality of the experience of service users in receiving those services) 17 (2) (b); Systems or processes must enable the registered person to assess, monitor and mitigate the risks relating to the health, safety and welfare of service users and others who may be at risk which arise from the carrying on of the regulated activity |
|
17 (3) (b) |
In addition to the written report in 17 (3) (a) the registered person must also send to the Commission any plans that they have for improving the standard of the services provided to service users with a view to ensuring their health and welfare. |
The CQC cannot prosecute for a breach of other parts of this regulation but can take regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 17: Good governance.
The intention of this regulation is to make sure that providers deploy enough suitably qualified, competent and experienced staff to enable them to meet all other regulatory requirements described in this part of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.
To meet the regulation, providers must provide sufficient numbers of suitably qualified, competent, skilled and experienced staff to meet the needs of the people using the service at all times and the other regulatory requirements set out in this part of the above regulations.
Staff must receive the support, training, professional development, supervision and appraisals that are necessary for them to carry out their role and responsibilities. They should be supported to obtain further qualifications and provide evidence, where required, to the appropriate regulator to show that they meet the professional standards needed to continue to practise.
The CQC cannot prosecute for a breach of this regulation but can take regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 18: Staffing.
The intention of this regulation is to make sure that providers only employ ‘fit and proper’ staff who are able to provide care and treatment appropriate to their role and to enable them to provide the regulated activity.
To meet this regulation, providers must operate robust recruitment procedures, including undertaking any relevant checks.
They must have a procedure for ongoing monitoring of staff to make sure they remain able to meet the requirements, and they must have appropriate arrangements in place to deal with staff who are no longer fit to carry out the duties required of them.
Employing unfit people, or continuing to allow unfit people to stay in a role, may lead CQC to question the fitness of a provider.
The CQC cannot prosecute for a breach of this regulation but can take regulatory action. However, if the CQC considers that a breach of this regulation is also a breach of another regulation(s) that carries offence clauses, then they can move directly to prosecution without serving a Warning Notice. For example, in situations where the care and treatment is provided without the consent of a person using the service or someone lawfully acting on their behalf, and where it is unsafe, does not meet the person’s nutritional needs, results in abuse, or puts the person at risk of abuse.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 19: Fit and proper persons employed.
The intention of this regulation is to ensure that providers are open and transparent with people who use services and other ‘relevant persons’ (people acting lawfully on their behalf) in general in relation to care and treatment. It also sets out some specific requirements that providers must follow when things go wrong with care and treatment, including informing people about the incident, providing reasonable support, providing truthful information and an apology when things go wrong.
The regulation applies to registered persons when they are carrying on a regulated activity.
The CQC can prosecute for a breach of parts 20 (2) (a) and 20 (3) of this regulation. They can move directly to prosecution without first serving a Warning Notice. Additionally, they can also take additional regulatory action.
| Part | Requirement |
|---|---|
|
20 (2) (a) |
As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred a registered person must notify the relevant person that the incident has occurred in accordance with paragraph (3) |
|
20 (3) |
The notification to be given under paragraph (2)(a) must:
|
The CQC cannot prosecute for a breach of other parts of this regulation but can take regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
For guidance on meeting this regulation see Regulation 20: Duty of candour.
This regulation will apply to all providers when they have received a CQC performance assessment for their regulated activities.
Providers must ensure that their rating(s) are displayed conspicuously and legibly at each location delivering a regulated service and on their website (if they have one).
The regulation outlines the information that must be included.
CQC will develop posters for providers and digital products to use on websites. Using these will help providers to make sure that they display all the information required under this regulation.
The CQC can prosecute for a breach of this regulation or a breach of part of the regulation. They can move directly to prosecution without first serving a Warning Notice. Additionally, they can also take additional regulatory action.
Whether or not a provider can comply with this regulation is assessed as part of the registration process, as part of any service inspection and whenever the CQC receives information that suggests it is not being met.
At any point, if a provider does not comply with this regulation the CQC must legally refuse or withdraw registration.
For guidance on meeting this regulation see Regulation 20A: Requirement as to display of performance assessments.
Last Updated: April 17, 2024
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