This CQC guidance covers the fundamental standards under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, applying to all providers registered with CQC in England across health and social care. It sets requirements for provider fitness (Regs 4–7), person-centred care, dignity, consent, safe treatment, safeguarding, staffing, governance, and duty of candour (Regs 8–20A). Operators must ensure that individuals, partners, directors, nominated individuals, and registered managers meet character, qualification, health, and suitability standards, and that care is personalised, safe, and rights-respecting.
View official source[Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 4: Requirements where the service provider is an individual or partnership Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 4 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 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 (see the information and documents identified in Schedule 3 of the regulations). CQC cannot prosecute for a breach of this regulation or any of its parts but we can take regulatory action. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. The regulation in full 4.— This regulation applies where a service provider (P) is an individual or a partnership. P must not carry on a regulated activity unless P is fit to do so. P is not fit to carry on a regulated activity unless P is— an individual who carries on the regulated activity, otherwise than in partnership with others, and satisfies the requirements set out in— paragraph (4), and paragraph (5), or a partnership and— each of the partners satisfies the requirements set out in paragraph (4), and P satisfies the requirement set out in paragraph (6). The requirements referred to in paragraph (3)(a)(i) and (b)(i) are that, if P is an individual, that individual or, if P is a partnership, each of the partners— is of good character, is able by reason of their health, after reasonable adjustments are made, of properly performing tasks which are— where P is an individual, intrinsic to the carrying on of the regulated activity, or where P is a partnership, intrinsic to their role in the carrying on of the regulated activity, and is able to supply to the Commission, or arrange for the availability of, information relating to themselves specified in Schedule 3. The requirement referred to in paragraph (3)(a)(ii) is that P has the necessary qualifications, competence, skills and experience to carry on the regulated activity. The requirement referred to in paragraph (3)(b)(ii) is that, through the combination of the qualifications, competence, skills and experience of the partners, P has the necessary qualifications, competence, skills and experience to carry on the regulated activity. In assessing an individual's character for the purposes of paragraph (4)(a), the matters considered must include those listed in Part 2 Schedule 4. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 4 (1) This regulation applies where a service provider (P) is an individual or a partnership. 4(4) The requirements referred to in paragraph (3)(a)(i) and (b)(i) are that, if P is an individual, that individual or, if P is a partnership, each of the partners— 4(4)(a) be of good character; Guidance on 4(4)(a) When assessing whether an individual or partner is of good character, providers must follow robust processes to make sure that they gather all available information to confirm that the individual or partner is of good character, and must have regard to the matters outlined in Schedule 4, Part 2 of the regulations. It is not possible to outline every character trait an individual should have but we would expect to see that the processes followed take account of honesty, trustworthiness, reliability and respectfulness. If a provider discovers information that suggests an individual or partner is not of good character after they have been appointed to a role, they must take appropriate and timely action to investigate and rectify the matter. Where a provider considers the individual or partner to be suitable despite the existence of information relevant to issues identified in Schedule 4 Part 2, the provider's reasons should be recorded for future reference. 4(4)(b) is able by reason of their health, after reasonable adjustments are made, of properly performing tasks which are— (i) where P is an individual, intrinsic to the carrying on of the regulated activity, or (ii) where P is a partnership, intrinsic to their role in the carrying on of the regulated activity Guidance on 4(4)(b) This aspect of the regulation relates to the ability of individuals to carry out their role. This does not mean that people who have a long-term condition, a disability or mental illness cannot be appointed. When appointing relevant individuals, the provider must have processes for considering a person's physical and mental health in line with the requirements of the role. All reasonable steps must be made to make adjustments for individuals to enable them to carry out their role. These must be in line with requirements to make reasonable adjustments for employees under the Equality Act 2010. 4(5) The requirement referred to in paragraph (3)(a)(ii) is that P has the necessary qualifications, competence, skills and experience to carry on the regulated activity. Guidance on 4(5) Individuals must be appropriately skilled with the necessary qualifications, competence, knowledge and experience. They must be able to demonstrate the competency required to carry on the regulated activity and to manage it where there is no registered manager. Individuals must have appropriate knowledge of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Part 3), relevant best practice and guidance and understand the consequences of failing to take action on set requirements. The provider must have appropriate processes for assessing and checking that the individual holds the required qualifications and has the competence, skills and experience required to undertake the role. These processes must be followed in all cases and relevant records kept. 4(6) The requirement referred to in paragraph (3)(b)(ii) is that, through the combination of the qualification, competence, skills and experience of the partners, P has the necessary qualifications, competence, skills and experience to carry on the regulated activity Guidance on 4(6) Providers must ensure that the qualifications, competence, skills and experience of all the partners, taken together, will ensure that they are able to carry on the regulated activity in a satisfactory manner. The partnership should demonstrate that, together, they have appropriate knowledge of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Part 3) and understand the consequences of failing to take action on set requirements. The provider must have appropriate processes for assessing and checking that between them, the partners have the required qualifications and the competence, skills and experience to undertake the role. These processes must be followed in all cases and relevant records kept. [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 5: Fit and proper persons: directors Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 5 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. CQC cannot prosecute for a breach of this regulation or any of its parts, but we can take regulatory action. See the offences section of this guidance for more detail. The regulation in full 5.— This regulation applies where a service provider is a body other than a partnership. Unless the individual satisfies all the requirements set out in paragraph (3), a service provider must not appoint or have in place an individual— as a director of the service provider, or performing the functions of, or functions equivalent or similar to the functions of a director. The requirements referred to in paragraph (2) are that— the individual is of good character, the individual has the qualifications, competence, skills and experience which are necessary for the relevant office or position or the work for which they are employed, the individual is able by reason of their health, after reasonable adjustments are made, of properly performing tasks which are intrinsic to the office or position for which they are appointed or to the work for which they are employed, the individual has not been responsible for, been privy to, contributed to or facilitated any serious misconduct or mismanagement (whether unlawful or not) in the course of carrying on a regulated activity or providing a service elsewhere which, if provided in England, would be a regulated activity, and none of the grounds of unfitness specified in Part 1 of Schedule 4 apply to the individual. In assessing an individual's character for the purposes of paragraph (3)(a), the matters considered must include those listed in Part 2 of Schedule 4. The following information must be available to be supplied to the Commission in relation to each individual who holds an office or position referred to in paragraph (2)(a) or (b)— the information specified in Schedule 3, and such other information as is required to be kept by the service provider under any enactment which is relevant to that individual. Where an individual who holds an office or position referred to in paragraph (2)(a) or (b) no longer meets the requirements in paragraph (3), the service provider must— take such action as is necessary and proportionate to ensure that the office or position in question is held by an individual who meets such requirements, and if the individual is a health care professional, social worker or other professional registered with a health care or social care regulator, inform the regulator in question. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 5(1) This regulation applies where a service provider is a body other than a partnership Guidance on 5(1) This regulation applies to all providers that are not individuals or partnerships. 5(2) Unless the individual satisfies all the requirements set out in paragraph (3), a service provider must not appoint or have in place an individual— (a) as a director of the service provider, or (b) performing the functions of, or functions equivalent or similar to the functions of a director. Guidance on 5(2) For NHS bodies it applies to executive and non-executive, permanent, interim and associate positions, irrespective of their voting rights. The requirement will also apply to equivalent director posts in other providers, including trustees of charitable bodies and members of the governing bodies of unincorporated associations. Where a local authority is a provider, the regulations will not apply to elected members as they are accountable through a different route. 5(3)(a) the individual is of good character Guidance on 5(3)(a) When assessing whether a person is of good character, providers must follow robust processes to make sure that they gather all available information to confirm that the person is of good character, and they must have regard to the matters outlined in Schedule 4, Part 2 of the regulations. It is not possible to outline every character trait that a person should have, but we would expect to see that the processes followed take account of a person's honesty, trustworthiness, reliability and respectfulness. If a provider discovers information that suggests a person is not of good character after they have been appointed to a role, the provider must take appropriate and timely action to investigate and rectify the matter. Where a provider considers the individual to be suitable, despite existence of information relevant to issues identified in Schedule 4, Part 2, the provider's reasons should be recorded for future reference and made available. 5(3)(b) the individual has the qualifications, competence, skills and experience which are necessary for the relevant office or position or the work for which they are employed, Guidance on 5(3)(b) Where providers consider that a role requires specific qualifications, they must make this clear and should only appoint those candidates who meet the required specification, including any requirements to be registered with a professional regulator. Providers must have appropriate processes for assessing and checking that the candidate holds the required qualifications and has the competence, skills and experience required, (which may include appropriate communication and leadership skills and a caring and compassionate nature) to undertake the role. These must be followed in all cases and relevant records kept. We expect all providers to be aware of, and follow, the various guidelines that cover value-based recruitment, appraisal and development, and disciplinary action, including dismissal for chief executives, chairs and directors, and to have implemented procedures in line with the best practice. This includes the seven principles of public life (Nolan principles). 5(3)(c) the individual is able by reason of their health, after reasonable adjustments are made, of properly performing tasks which are intrinsic to the office or position for which they are appointed or to the work for which they are employed, Guidance on 5(3)(c) This aspect of the regulation relates to a person's ability to carry out their role. This does not mean that people who have a long-term condition, a disability or mental illness cannot be appointed. When appointing a person to a role, providers must have processes for considering their physical and mental health in line with the requirements of the role. All reasonable steps must be made to make adjustments for people to enable them to carry out their role. These must be in line with requirements to make reasonable adjustments for employees under the Equality Act 2010. 5(3)(d) the individual has not been responsible for, been privy to, contributed to or facilitated, any serious misconduct or mismanagement (whether unlawful or not) in the course of carrying on a regulated activity or providing a service elsewhere which, if provided in England, would be a regulated activity, and Guidance on 5(3)(d) Providers must have processes in place to assure themselves that a person has not been responsible for, privy to, contributed to, or facilitated any serious misconduct or mismanagement in the carrying on of a regulated activity. This includes investigating any allegation of such and making independent enquiries. Providers must not appoint any person who has been responsible for, privy to, contributed to, or facilitated any serious misconduct or mismanagement (whether lawful or not) in the carrying on of a regulated activity. A director may be implicated in a breach of a health and safety requirement or another statutory duty or contractual responsibility because of how the entire management team organised and managed its organisation's activities. In this case, providers must establish what role the director played in the breach so that they can judge whether it means they are unfit. If the evidence shows that the breach is attributable to the director's conduct, CQC would expect the provider to find that they are unfit. Although providers have information on when convictions, bankruptcies or similar matters are to be considered 'spent' there is no time limit for considering serious misconduct or responsibility for failure in a previous role. 5(3)(e) none of the grounds of unfitness specified in Part 1 of Schedule 4 apply to the individual. Guidance on 5(3)(e) A person who will be acting in a role that falls within the definition of a "regulated activity" as defined by the Safeguarding Vulnerable Groups Act 2006 must be subject to a check by the Disclosure and Barring Service (DBS). Providers must seek all available information to assure themselves that directors do not meet any of the elements of the unfit person test set out in Schedule 4 Part 1. Robust systems should be in place to assess directors in relation to bankruptcy, sequestration, insolvency and arrangements with creditors. In addition, where a director meets the eligibility criteria, providers should establish whether the person is on the children's and/or adults safeguarding barred list and whether they are prohibited from holding the office in question under other laws such as the Companies Act or Charities Act. If a provider discovers information that suggests an individual is unfit after they have been appointed to a role, the provider must take appropriate and timely action to investigate and rectify the matter. 5(6) Where an individual who holds an office or position referred to in paragraph (2)(a) or (b) no longer meets the requirements in paragraph (3), the service provider must— (a) take such action as is necessary and proportionate to ensure that the office or position in question is held by an individual who meets such requirements, and (b) if the individual is a health care professional, social worker or other professional registered with a health care or social care regulator, inform the regulator in question. Guidance on 5(6) Providers must assess and regularly review the fitness of directors to ensure that they remain fit for the role they are in. Providers must determine how often to review fitness based on the assessed risk to business delivery and/or to the people using the service posed by the individual and/or role. Providers must have arrangements in place to respond to concerns about a person's fitness in relation to Regulation 5(3) and (4) after they have been appointed to a role, which either they or others have identified, and providers must adhere to these arrangements. Providers must investigate, in a timely manner, any concerns about a person's fitness or ability to carry out their duties, and where concerns are substantiated, they must take proportionate, timely action. Where a person's fitness to carry out their role is being investigated, appropriate interim measures may be required to minimise any risk to people who use the service. Related guidance DBS checks and the fit and proper person requirement: frequently asked questions (pdf, 33.14kB, English) [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 6: Requirement where the service provider is a body other than a partnership Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 6 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. CQC cannot prosecute for a breach of this regulation or any of its parts but we can take regulatory action. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. The regulation in full 6.— This regulation applies where the service provider is a body other than a partnership. The body must give notice to the Commission of the name, address and position in the body of an individual (in these Regulations referred to as "the nominated individual") who is— employed as a director, manager or secretary of the body, and responsible for supervising the management of the carrying on of the regulated activity by the body. The registered person must take all reasonable steps to ensure that the nominated individual— is of good character, has the necessary qualifications, competence, skills and experience to properly supervise the management of the carrying on of the regulated activity, is able by reason of their health, after reasonable adjustments are made, of properly doing so, and is able to supply to the registered person, or arrange for the availability of, the information specified in Schedule 3. In assessing an individual's character for the purposes of paragraph (3)(a), the matters considered must include those listed in Part 2 of Schedule 4 Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 6 (1) This regulation applies where the service provider is a body other than a partnership. 6(3) The registered person must take all reasonable steps to ensure that the nominated individual is— 6(3)(a) of good character; Guidance on 6(3)(a) When assessing whether a nominated individual is of good character, providers must follow robust processes to make sure that they gather all available information to confirm that the individual is of good character, and have regard to the matters outlined in Schedule 4, Part 2 of the regulations. It is not possible to outline every character trait an individual should have, but we would expect to see that the processes followed take account of honesty, trustworthiness, reliability and respectfulness. If a provider discovers information that suggests a nominated individual is not of good character after they have been appointed to a role, the provider must take appropriate and timely action to investigate and rectify the matter. Where a provider considers the nominated individual to be suitable despite the existence of information relevant to issues identified in Schedule 4, Part 2, the reasons should be recorded for future reference. 6(3)(b) has the necessary qualifications, competence, skills and experience to properly supervise the management of the carrying on of the regulated activity, Guidance on 6(3)(b) The nominated individual should be appropriately skilled with the necessary qualification(s), knowledge and experience, and demonstrates the competency required to supervise the management of the regulated activity. The nominated individual should demonstrate that they have appropriate knowledge of applicable legislation including the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, relevant best practice and guidance, and understand the consequences of failing to take action on set requirements. The provider must have appropriate processes for assessing and checking that the nominated individual holds the required qualifications and has the competence, skills and experience required to undertake the role. These processes must be followed in all cases and relevant records kept. 6(3)(c) is able by reason of their health, after reasonable adjustments are made, of properly doing so, and Guidance on 6(3)(c) This aspect of the regulation relates to the ability of nominated individuals to carry out their role. This does not mean that people who have a long-term condition or disability cannot hold such positions. The provider must have processes for considering the nominated individual's physical and mental health in line with the requirements of the role. All reasonable steps must be made to make adjustments for nominated individuals to enable them to carry out their role. These must be in line with requirements to make reasonable adjustments for employees under the Equality Act 2010. [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 7: Requirements relating to registered managers Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 7 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. CQC cannot prosecute for a breach of this regulation or any of its parts but we can take regulatory action. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. The regulation in full 7.— A person (M) shall not manage the carrying on of a regulated activity as a registered manager unless M is fit to do so. M is not fit to be a registered manager in respect of a regulated activity unless M is— of good character, has the necessary qualifications, competence, skills and experience to manage the carrying on of the regulated activity, able by reason of M's health, after reasonable adjustments are made, of doing so, and able to supply to the Commission, or arrange for the availability of, the information relating to themselves specified in Schedule 3. In assessing an individual's character for the purposes of paragraph (2)(a), the matters considered must include those listed in Part 2 of Schedule 4. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 7 (1) A person (M) shall not manage the carrying on of a regulated activity as a registered manager unless M is fit to do so 7(2) M is not fit to be a registered manager in respect of a regulated activity unless M is— 7(2)(a) of good character; Guidance on 7(2)(a) When assessing whether a registered manager is of good character, providers must follow robust processes to make sure that they gather all available information to confirm that the individual is of good character, and have regard to the matters outlined in Schedule 4, Part 2 of the regulations. It is not possible to outline every character trait an individual should have, but we would expect to see that the processes followed take account of honesty, trustworthiness, reliability and respectfulness. If a provider discovers information that suggests a registered manager is not of good character after they have been appointed to a role, they must take appropriate and timely action to investigate and rectify the matter. Where a provider considers the registered manager to be suitable despite the existence of information relevant to issues identified in Schedule 4, Part 2, the provider's reasons should be recorded for future reference. 7 (2)(b) has the necessary qualifications, competence , skills and experience to manage the carrying on of the regulated activity, Guidance on 7(2)(b) The registered manager should be appropriately skilled with the qualification(s), knowledge and experience and demonstrate the competency required to manage the regulated activity. The registered manager should demonstrate that they have appropriate knowledge of applicable legislation including the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Part 3), relevant best practice and guidance and understand the consequences of failing to take action on set requirements. The provider must have appropriate processes for assessing and checking that the individual holds the required qualifications and has the competence, skills and experience required to undertake the role. These processes must be followed in all cases and relevant records kept. 7(2)(c) able by reason of M's health, after reasonable adjustments are made, of doing so. Guidance on 7(2)(c) This aspect of the regulation relates to the ability of registered managers to carry out their role. This does not mean that people who have a long-term condition or disability cannot hold such positions. The provider must have processes for considering the person's physical and mental health in line with the requirements of the role. All reasonable steps must be made to make adjustments for registered managers to enable them to carry out their role. These must be in line with requirements to make reasonable adjustments for employees under the Equality Act 2010. [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 8: General Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 8 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 regulation in full 8.— A registered person must comply with regulations 9 to 20A in carrying on a regulated activity. But paragraph (1) does not require a person to do something to the extent that what is required to be done to comply with regulations 9 to 20A has already been done by another person who is a registered person in relation to the regulated activity concerned. For the purposes of determining under regulations 9 to 20A whether a service user who is 16 or over lacks capacity, sections 2 and 3 of the 2005 Act (people who lack capacity) apply as they apply for the purposes of that Act. [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 9: Person-centred care Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 9 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. Please see the glossary for important clarification of the terms "appropriate care and treatment"; "needs"; "preferences"; and "relevant person". CQC cannot prosecute for a breach of this regulation or any of its parts, but we can take regulatory action. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. The regulation in full 9.— The care and treatment of service users must— be appropriate, meet their needs, and reflect their preferences. But paragraph (1) does not apply to the extent that the provision of care or treatment would result in a breach of regulation 11. Without limiting paragraph (1), the things which a registered person must do to comply with that paragraph include— carrying out, collaboratively with the relevant person, an assessment of the needs and preferences for care and treatment of the service user; designing care or treatment with a view to achieving service users' preferences and ensuring their needs are met; enabling and supporting relevant persons to understand the care or treatment choices available to the service user and to discuss, with a competent health care professional or other competent person, the balance of risks and benefits involved in any particular course of treatment; enabling and supporting relevant persons to make, or participate in making, decisions relating to the service user's care or treatment to the maximum extent possible; providing opportunities for relevant persons to manage the service user's care or treatment; involving relevant persons in decisions relating to the way in which the regulated activity is carried on in so far as it relates to the service user's care or treatment; providing relevant persons with the information they would reasonably need for the purposes of sub-paragraphs (c) to (f); making reasonable adjustments to enable the service user to receive their care or treatment; where meeting a service user's nutritional and hydration needs, having regard to the service user's well-being. Paragraphs (1) and (3) apply subject to paragraphs (5) and (6). If the service user is 16 or over and lacks capacity in relation to a matter to which this regulation applies, paragraphs (1) to (3) are subject to any duty on the registered person under the 2005 Act in relation to that matter. But if Part 4 or 4A of the 1983 Act applies to a service user, care and treatment must be provided in accordance with the provisions of that Act. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 9(1) The care and treatment of service users must – (a) be appropriate, (b) meet their needs and (c) reflect their preferences Guidance on 9(1) Providers must do everything reasonably practicable to make sure that people who use the service receive person-centred care and treatment that is appropriate, meets their needs and reflects their personal preferences, whatever they might be. 9(2) But paragraph (1) does not apply to the extent that the provision of care or treatment would result in a breach of Regulation 11. Guidance on 9(2) Providers must make sure that they provide appropriate care and treatment that meets people's needs, but this does not mean that care and treatment should be given if it would act against the consent of the person using the service. In some cases, people's preferences for their care or treatment may not meet their needs. Where this is the case, and people lack mental capacity or are detained under mental health legislation, providers must act in accordance with the Mental Capacity Act 2005 and/or the Mental Health Act 1983. 9(3) Without limiting paragraph (1), the things which a registered person must do to comply with that paragraph include– 9(3)(a) carrying out, collaboratively with the relevant person, an assessment of the needs and preferences for care and treatment of the service user; Guidance on 9(3)(a) Each person using a service, and/or the person who is lawfully acting on their behalf, must be involved in an assessment of their needs and preferences as much or as little as they wish to be. Providers should give them relevant information and support when they need it to make sure they understand the choices available to them. Assessments must take into account current legislation and consider relevant nationally recognised evidence-based guidance. Where a person lacks the mental capacity to make specific decisions about their care and treatment, and no lawful representative has been appointed, their best interests must be established and acted on in accordance with the Mental Capacity Act 2005. Other forms of authority such as advance decisions must also be taken into account. Each person's care and treatment needs and preferences should be assessed by people with the required levels of skills and knowledge for the particular task. Assessments of people's care and treatment needs should include all their needs, including health, personal care, emotional, social, cultural, religious and spiritual needs. Assessments should take into account specific issues that are common in certain groups of people and can result in poor outcomes for them if not addressed. These include diseases or conditions such as continence support needs and dementia in older people, and diabetes in certain ethnic groups. Assessments should be reviewed regularly and whenever needed throughout the person's care and treatment. This includes when they transfer between services, use respite care or are re-admitted or discharged. Reviews should make sure that people's goals or plans are being met and are still relevant. Where providers share responsibility for providing care and treatment with other services through partnership working, integrated care and multidisciplinary assessments, they should also take into account information from all relevant teams, staff and services. 9(3)(b) designing care or treatment with a view to achieving service users' preferences and ensuring their needs are met Guidance on 9(3)(b) A person's care and treatment must be designed to make sure it meets all their needs. There may be times when a person's needs and preferences can not be met. In these instances, providers must explain the impact of this to them and explore alternatives so that the person can make informed decisions about their care and treatment. Providers must make every reasonable effort to meet people's preferences. When any preferences about the choice of care and treatment can not be met, providers must fully explain why so that people using the service understand the reasons. The explanation should show how the provider has considered the impact of this on the person. This is so that they can make further informed decisions about their care and treatment. This includes where preferences can not be met because of restrictions under the Mental Health Act 1983. When planning how to meet a person's preferences, providers should take into account, and make provision for, any impact this may have on other people using the service. A clear care and/or treatment plan, which includes agreed goals, must be developed and made available to all staff and others involved in providing the care. Where relevant, the plan should include ways in which the person can maintain their independence. Plans should include an agreed review date. Providers should use nationally recognised evidence-based guidance when designing, delivering and reviewing care. Staff providing care must be kept up to date with any changes to a person's needs and preferences. 9(3)(c) enabling and supporting relevant persons to understand the care or treatment choices available to the service user and to discuss, with a competent health care professional or other competent person, the balance of risks and benefits involved in any particular course of treatment; Guidance on 9(3)(c) Each person, and/or person lawfully acting on their behalf, must have all the necessary information about their care and treatment. This information should be provided in a way that the person understands. Health care professionals or people with the required level of skills and knowledge must discuss care and treatment choices with the person and/or person lawfully acting on their behalf. They must provide support to make sure the person understands all the risks and benefits associated with those choices and enable them to make informed decisions about their care and treatment. The person using the service must be able to discuss care and treatment choices continually and have support to make any changes to those choices if they wish. They should be given information about the risks and benefits of any changes in a way they can understand. Even when the person using the service does not raise the issues themselves, discussions should include all health, care, social and emotional needs. 9(3)(d) enabling and supporting relevant persons to make, or participate in making, decisions relating to the service user's care or treatment to the maximum extent possible; Guidance on 9(3)(d) Providers must make every reasonable effort to provide opportunities to involve people in making decisions about their care and treatment, and support them to do this. This includes physical, psychological or emotional support, or support to get information in an accessible format or to understand the content. It may include involving people in discussions, inviting them to meetings and encouraging them to ask questions and providing suggestions. People using the service and/or those lawfully acting on their behalf must be actively encouraged and supported to be involved in making decisions about their care or treatment as much or as little as they wish to be. This includes taking all steps to maximise a person's mental capacity in different ways to make as many of their own choices as possible. A record must be kept of all assessments, care and treatment plans, and decisions made by people who use the service and/or those acting on their behalf. See Regulation 17 (Good governance). 9(3)(e) providing opportunities for relevant persons to manage the service user's care or treatment; Guidance on 9(3)(e) People using the service and/or those lawfully acting on their behalf must be given opportunities to manage as much of their care and treatment as they wish and are able to, and should be actively encouraged to do so. 'Manage' in this context may mean being actively involved, overseeing or making decisions about their care or treatment depending on how much they need or want to be involved. This may include managing their medicines, managing or supporting their personal care including eating and drinking, or using appropriate equipment and technology. People using the service and/or those lawfully acting on their behalf should be given suitable information, advice, instruction and/or emotional support to help manage any care and treatment safely. 9(3)(f) involving relevant persons in decisions relating to the way in which the regulated activity is carried on in so far as it relates to the service user's care or treatment; Guidance on 9(3)(f) Providers must actively seek the views of people who use their service and those lawfully acting on their behalf, about how care and treatment meets their needs. Providers must be able to demonstrate that they took action in response to any feedback. 9(3)(g) providing relevant persons with the information they would reasonably need for the purposes of sub-paragraphs (c) to (f); Guidance on 9(3)(g) People using services and those lawfully acting on their behalf must be given relevant information in the most suitable way for them and in a way that they can understand. This includes information that describes: The condition or conditions affecting the person using the service. All possible relevant or appropriate care and treatment options. The risks and benefits of each option. The implications of not undertaking any, or only undertaking a part, of the care and treatment options. Costs/fees/tariffs associated with care and treatment. Reasonable expectations of the outcome of each care and treatment option. 9(3)(i) where meeting a service user's nutritional and hydration needs, having regard to the service user's well being Guidance on 9(3)(i) Where food and/or drink are provided for people who use services, they must have a choice that meets their needs and preferences as far as is reasonably practical. Providers must make sure that they assess each person's nutritional and hydration needs to support their wellbeing and quality of life. This includes when there is no expected cure for an illness. [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 9A 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. Everyone should work on the assumption that in-person visiting and accompaniment to appointments are possible. Providers must put in place any measures or precautions necessary and proportionate to ensure that visiting and accompaniment can continue to happen safely. These must be the least restrictive options and must be decided with the person using the service, and their family, friends or advocates where appropriate. The provider must help people to understand their options and make informed decisions, making reasonable adjustments where necessary. The provider, in partnership with people involved in the decision, should regularly review any precautions that have been implemented and should remove them as soon as possible. It is important that information is communicated clearly to the person using the service and those restricted from visiting throughout the process. The provider should also be clear with those involved who they can contact within the service if they have questions or concerns about any restrictions in place. Very occasionally, there may be exceptional circumstances where, despite any precautions put in place, a visit or accompaniment may still pose a significant risk to the health, safety or welfare of a person using the service or on the premises. This risk will mean that, despite considering all possible actions and precautions, an in-person visit or accompaniment cannot be safely facilitated and there is no alternative but to restrict visiting or accompaniment at that time. If this is the case, the provider should put in place the necessary restriction and review arrangements regularly. As soon as circumstances change, the provider should remove the restriction and allow in-person visiting or accompaniment again. A human rights-based approach to decision making can support providers in enabling visiting and accompaniment and when considering restrictions in complex situations. This includes considering the appropriate balance between a person's right to private and family life, independence, choice and control, risk and safety. Providers must consider whether restrictions are lawful, legitimate and proportionate. Providers must make sure they take people's mental capacity into account. They must make sure that either the person, or someone lawfully acting on their behalf, is involved in planning, managing and reviewing their care and treatment. This includes their right to having visitors and being accompanied to appointments. Providers must make sure decisions are made by those with the legal authority or responsibility to do so. They must work within the requirements of the Mental Capacity Act 2005. The Act includes a duty to consult others, such as families, unpaid carers and advocates, where practicable and appropriate. Providers must also work within the requirements of the Human Rights Act 1998 and the Equality Act 2010, including the Public Sector Equality Duty, where applicable, and make reasonable adjustments. See the glossary for clarification of the terms 'needs' and 'preferences'. CQC cannot prosecute for a breach of this regulation or any of its parts, but we can take regulatory action, including civil enforcement action where this is appropriate. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. Registered persons maintain overall responsibility for ensuring that all regulations are met. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 9A(1) This regulation applies to a registered person in respect of a relevant regulated activity carried on in a care home, hospital or hospice. Guidance on 9A(1) Regulation 9A(6)(a) defines 'regulated activity' for these purposes as all regulated activities except : personal care accommodation for persons who require treatment for substance misuse, and any detoxification services for substance misuse management of supply of blood and blood derived products transport services, triage and medical advice provided remotely This regulation does not apply to anyone who is detained in a prison or similar institution to which the Prison Act applies. This regulation also does not apply to anyone detained under the Immigration Acts. However, the requirements of this regulation do apply if someone detained in a prison or under the Immigration Acts is transferred to hospital and detained in that hospital under the Mental Health Act 1983. 'Care home' and 'hospice' are as defined in Regulation 9A(6). Hospital is defined in Regulation 2. 9A(2 ) Unless there are exceptional circumstances, service users— (a) whose care or treatment involves an overnight stay or the provision of accommodation in a care home, hospital or hospice, must be facilitated to receive visits at those premises; (b) who are provided with accommodation in a care home, must not be discouraged from taking visits out of that care home; (c) who attend a hospital or hospice for the provision of care or treatment which does not involve an overnight stay, must be enabled to be accompanied at those premises by a family member, friend or a person who is otherwise providing support to the service user. Guidance on 9A(2)(a) Providers must support people who use their service to receive visits in person from people they want to see, when they want to see them, unless there are exceptional circumstances that prevent this from being possible. Staff should do all they can to make this possible and easy to arrange. This might look different for different people using different types of service, and providers may need to consider different issues depending on their individual situation and environment. This is why individual risk assessments are important. Guidance on 9A(2)(b) This part of the regulation aims to support people's social contact, to maintain community connections and help them have different experiences. Providers must not discourage visits out of the care home or impose unreasonable rules that could effectively act as a restriction when people return after leaving the care home premises for any reason, unless there are exceptional circumstances. For example, unreasonably long periods of isolation which may discourage a resident from deciding to go out. Providers should not make the process for taking a visit out difficult by, for example, requiring people to complete lengthy administrative processes before and after visits out. Providers should monitor and review visiting policies/arrangements to ensure they are working well for everyone. If providers already have contractual arrangements that involve paying for additional staff to support care home residents to go out, this regulation does not change these arrangements. Discussions and decisions about visits out should be supported by individual risk assessments and good care planning. This regulation is not about the provider resourcing visits out but ensuring these discussions and decisions do not inhibit or discourage people from going out with their family, friends or advocates. Guidance on 9A(2)(c) If someone attends a hospital or hospice for care or treatment that does not need them to stay in overnight, that service must let the person bring someone with them to those premises and support them. This includes day care treatment and outpatient appointments. This is so people do not have to attend the appointment alone and can help them feel more comfortable and safer when they attend their appointment. It may also help with communication and sharing information where this might otherwise be difficult. This regulation does not create any new requirements on transport or other services to physically take friends, family or advocates to an appointment with the person, over or beyond arrangements that may already be in place. Guidance on 9A(2)(a)(b)(c) Providers must (unless there are exceptional circumstances): support people using their service to receive visits not discourage people from taking visits outside the care home support people using their service to be accompanied at the premises when attending appointments. 'Visit' means seeing someone in person. The provider should assume visits and accompaniment are possible unless they are confident there are exceptional circumstances. Where a risk has been identified we expect providers to implement appropriate precautions to enable a visit to happen safely, rather than prevent visiting altogether. For example, this may include a visit where the visitors wear a face mask if there is a significant risk of infection. If providers are considering taking any precautions or making restrictions to visiting or accompaniment they should continue to apply human rights-based decision making and risk assessment to the individual situation. This should always follow the preferences of the person using the service, wherever possible, and their assessed needs. Providers must consider that any restriction to a person's right to receive visitors is lawful, has a legitimate aim and is proportionate. Proportionate means that there is the least restriction possible to achieve the aim. Providers must work in partnership with the person using the service, and should involve those who wish to visit or accompany them, to determine if there is an exceptional circumstance that justifies restricting visiting, discouraging visits out, or restricting accompaniment to an appointment. This could be to protect the person using the service, other people using the service, staff or people visiting, where there is a significant risk to their health, safety or welfare. When determining whether there are exceptional circumstances, providers should base their assessment on the health, safety and welfare of people using the service or other people involved. This should include giving consideration to the appropriate balance of a person's rights, the needs of people using their service and any identified risks, including the risk to the person's health and wellbeing resulting from restricting visiting. If there is a need for additional precautions or a restriction to be put in place, the provider should apply the most proportionate and least restrictive option. This should be the option least likely to interfere with the person's right to see their visitors when and how they want. For example, if there is a legitimate reason for restricting visits in person because of a significant risk to people's health, safety or welfare, providers should consider ways to mitigate those risks. This could be by implementing additional health and safety measures, or using technology such as video or phone calls to maintain contact until visits in person can be resumed. Options such as these should not be used as alternatives to in-person visiting, where the person wants in-person visits. Providers should consider every individual decision as a separate case. Providers should not apply blanket decisions or long-term restrictions. They should review decisions to restrict visiting regularly by working together with the people involved. They should also review these decisions when the circumstances change. Providers must keep a record of any assessment and decisions on visiting. They should be able to demonstrate: what are the stated preferences of the person how they have made these decisions and who has been involved how the balance of the person's rights has been considered whether restrictions are lawful, legitimate and proportionate whether they have implemented any mitigations to make sure they have used the least restrictive, most reasonable option when they have reviewed the restrictions. As part of this, providers should consider any requirements under Regulation 17: Good governance . Providers should always support visits in person to someone who is receiving care at the end of their life. This applies to all types of premises covered by this regulation, including care homes, hospitals and hospices. This guidance is based on the NHS definition of 'end of life care'. "People are considered to be approaching the end of life when they are likely to die within the next 12 months, although this is not always possible to predict. This includes people whose death is imminent, as well as people who: have an advanced incurable condition, such as cancer, dementia or motor neurone disease are generally frail and have co-existing conditions that mean they are expected to die within 12 months have existing conditions if they are at risk of dying from a sudden crisis in their condition have a life-threatening acute condition caused by a sudden catastrophic event, such as an accident or stroke." 9A(3) Without limiting paragraph (2), the things which a registered person must do to comply with that paragraph include— (a) in relation to paragraph (2)(a), securing that service users are facilitated to receive visits in a way that is appropriate, meets the service user's needs and, so far as reasonably practicable, reflects their preferences; (b) in relation to paragraph (2)(a) and (c), taking such action, or putting in place such precautions, as is necessary and proportionate to ensure that service users may receive visits or be accompanied safely; (c) securing that, when making arrangements or decisions in respect of a service user for the purposes of paragraph (2), regard is given to any care or treatment plan for the service user; (d) involving relevant persons when making any arrangements or decisions in respect of a service user for the purposes of paragraph (2). Guidance on 9A(3)(a) Providers should enable a person using their service to receive visitors in a way that meets their preferences, so far as reasonably practicable. Guidance on 9A(3)(b) Providers must put in place any measures or precautions necessary and proportionate to ensure that visiting and accompaniment can continue to happen safely. Guidance on 9A(3)(c) Any existing care or treatment plans should be considered when making an assessment or decision about visits or accompaniment to appointments. Guidance on 9A(3)(d) If providers cannot meet the person's preferences for a visit, they should consult with the person and their family, friends or advocates and offer them as many options as possible. This is so the person can have as much control as possible over the arrangements. 9A(4) Nothing in this regulation— (a) requires a service user to receive a visit, take a visit out of a care home or be accompanied— (i) without the relevant person's consent, or (ii) where the service user lacks the capacity to give consent, where it would not be in the service user's best interests; (b) requires or enables a registered person to do anything which would not be in accordance with any court or tribunal order or with any provision (including any direction, power or authorisation) contained in, or made by virtue of, any of the legislation listed in paragraph (5) (including by virtue of any instrument made under that legislation). Guidance on 9A(4) Providers should take all reasonable steps to support people using their service to receive visits, go on visits or to be accompanied when attending appointments that do not require an overnight stay, unless this is against the person's wishes or, if they lack mental capacity to make the relevant decision, it is not in their best interests. There may be times when the wishes of the person with the relevant capacity using the service are not the same as those of people who want to visit them. In those circumstances, providers should always give priority to the wishes of people using their service. Where a person lacks the relevant capacity, it is important to be aware of legal considerations for that particular circumstance and it may be appropriate to take legal advice. Providers registered with CQC should also be mindful of any considerations under Regulation 11: need for consent 9A(5) The legislation referred to in paragraph (4) is - (a) the 1983 Act; (b) the 2005 Act; (c) so far as relating to high security psychiatric services, the 2006 Act. Guidance on 9A(5) (a) is the Mental Health Act 1983 (b) is the Mental Capacity Act 2005 (c) is the National Health Services Act 2006 9A(6) (a) In this regulation— "care home" has the meaning given in section 3 (care homes in England) of the Care Standards Act 2000 "hospice" means an establishment other than a hospital whose primary function is the provision of palliative care to persons who attend or are resident there, who are suffering from a progressive disease in its final stages; "relevant regulated activity" means an activity prescribed in regulation 3 as a regulated activity for the purposes of section 8(1) of the Act, except it does not include - (i) the regulated activities in paragraphs 1, 3, 8 and 9 of Schedule 1 (ii) any detoxification services for substance misuse provided in the course of carrying on a regulated activity; (iii) any services provided to a service user (other than a service user who is in receipt of services provided in the carrying on of a regulated activity in paragraph 5 of Schedule 1) who - (aa) is, or is required to be, detained in a prison or other institution to which the Prison Act 1952 applies, (bb) is detained under the Immigration Acts, (cc) is required to be detained in a prison or other institution to which equivalent legislation to that referred to in sub-paragraph (aa) applies in Scotland and Northern Ireland; "visit", (except in the context of the taking of a visit out of a care home), means a visit from— (i) a family member of the service user, (ii) a friend of the service user, (iii) a person visiting to provide support or companionship to the service user; (b) in the definition of 'relevant regulated activity' in sub-paragraph (a), "prison" has the same meaning as in section 53(1) of the Prison Act 1952; (c) a reference to having or lacking capacity, or to a person's best interests, in this regulation is to be interpreted in accordance with the 2005 Act. [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 10: Dignity and respect Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 10 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. CQC cannot prosecute providers for a breach of this regulation or of its parts, but we can take regulatory action. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. The regulation in full 10.— Service users must be treated with dignity and respect. Without limiting paragraph (1), the things which a registered person is required to do to comply with paragraph (1) include in particular— ensuring the privacy of the service user; supporting the autonomy, independence and involvement in the community of the service user; having due regard to any relevant protected characteristics (as defined in section 149(7) of the Equality Act 2010) of the service user. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 10(1) Service users must be treated with dignity and respect. Guidance on 10(1) When people receive care and treatment, all staff must treat them with dignity and respect at all times. This includes staff treating them in a caring and compassionate way. All communication with people using services must be respectful. This includes using or facilitating the most suitable means of communication and respecting a person's right to engage or not to engage in communication. Staff must respect people's personal preferences, lifestyle and care choices. When providing intimate or personal care, provider must make every reasonable effort to make sure that they respect people's preferences about who delivers their care and treatment, such as requesting staff of a specified gender/sex People using the service should be addressed in the way they prefer. People using the service must not be neglected or left in undignified situations such as those described in the guidance for Regulation 13(4) below. 10(2) Without limiting paragraph (1), the things which a registered person is required to do to comply with paragraph (1) include in particular— Guidance on 10(2) Providers must make sure that they treat people using services with dignity and respect. In particular this includes the things listed in 10(2) (a)-(c) but these things are not exhaustive and providers must demonstrate that they take all reasonable steps to make sure that people using their service are always treated with dignity and respect. 10(2)(a) ensuring the privacy of the service user; Guidance on 10(2)(a) Each person's privacy must be maintained at all times including when they are asleep, unconscious or lack capacity. All reasonable efforts should be made to make sure that discussions about care treatment and support only take place where they cannot be overheard. Staff must make sure that people have privacy when they receive treatment and that they are supported to wash, bath, use the toilet and hold private conversations. Each person's privacy needs and expectations should be identified, recorded, and met as far as is reasonably possible. People's relationships with their visitors, carer, friends, family or relevant other persons should be respected and privacy maintained as far as reasonably practicable during visits. People using services should not have to share sleeping accommodation with others of the opposite sex, and should have access to segregated bathroom and toilet facilities without passing through opposite-sex areas to reach their own facilities. Where appropriate, such as in mental health units, women should have access to women-only day spaces. If any form of surveillance is used for any purpose, providers must make sure this is in the best interests of people using the service, while remaining mindful of their responsibilities for the safety of their staff. Any surveillance should be operated in line with current guidance. Detailed guidance on the use of surveillance is available on CQC's website. 10(2)(b) supporting the autonomy, independence and involvement in the community of the service user; Guidance on 10(2)(b) People who use services must be offered support to maintain their autonomy and independence in line with their needs and stated preferences. When offering support, staff should respect people's expressed wishes to act independently but also identify and mitigate risks in order to support their continued independence as safely as possible. (See Regulation 12(2)(a) & (b) for more detail). People must be supported to maintain relationships that are important to them while they are receiving care and treatment. People must be supported to be involved in their community as much or as little as they wish. Providers must actively work with people who wish to maintain their involvement in their local community as soon as they begin to use a service. The provider must make sure that people are not left unnecessarily isolated. Note: Where people are detained in high security settings, 'the community' relates to the facility where they are detained and their level of involvement in it will depend on their care and treatment needs. 10(2)(c) having due regard to any relevant protected characteristics (as defined in section 149(7) of the Equality Act 2010) of the service user . Guidance on 10(2)(c) People using services must not be discriminated against in any way and the provider must take account of protected characteristics, set out in the Equality Act 2010. The protected characteristics are age, disability, sex, gender reassignment, pregnancy and maternity status, race, religion or belief and sexual orientation. This means that providers must not discriminate, harass or victimise people because of these protected characteristics. This includes direct and indirect discrimination, which is described in the Equality Act 2010. Providers must also make sure that they have due regard to people's protected characteristics in the way in which they meet all other regulatory requirements. For example, in relation to care and treatment reflecting the person's preferences in Regulation 9(1)(c) or in relation to community involvement in relation to Regulation 10(2)(b). [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 11: Need for consent Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 11 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. See the glossary for the definition of 'relevant person' in relation to Regulation 11. 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, CQC may also take other regulatory action. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. The regulation in full 11.— Care and treatment of service users must only be provided with the consent of the relevant person. Paragraph (1) is subject to paragraphs (3) and (4). If the service user is 16 or over and is unable to give such consent because they lack capacity to do so, the registered person must act in accordance with the 2005 Act*. But if Part 4 or 4A of the 1983 Act** applies to a service user, the registered person must act in accordance with the provisions of that Act. Nothing in this regulation affects the operation of section 5 of the 2005 Act*, as read with section 6 of that Act (acts in connection with care or treatment). * Mental Capacity Act 2005 ** Mental Health Act 1983 Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 11(1) Care and treatment of service users must only be provided with the consent of the relevant person. Guidance on 11(1) When a person is asked for their consent, information about the proposed care and treatment must be provided in a way that they can understand. This should include information about the risks, complications and any alternatives. A person with the necessary knowledge and understanding of the care and treatment should provide this information so that they can answer any questions about it to help the person consent to it. Discussions about consent must be held in a way that meets people's communication needs. This may include the use of different formats or languages and may involve others such as a speech language therapist or independent advocate. Consent may be implied and include non-verbal communication such as sign language or by someone rolling up their sleeve to have their blood pressure taken or offering their hand when asked if they would like help to move. Consent must be treated as a process that continues throughout the duration of care and treatment, recognising that it may be withheld and/or withdrawn at any time. When a person using a service or a person acting lawfully on their behalf refuses to give consent or withdraws it, all people providing care and treatment must respect this. Where a person lacks mental capacity to make an informed decision, or give consent, staff must act in accordance with the requirements of the Mental Capacity Act 2005 and associated code of practice. Consent procedures must make sure that people are not pressured into giving consent and, where possible, plans must be made well in advance to allow time to respond to people's questions and provide adequate information. Policies and procedures for obtaining consent to care and treatment must reflect current legislation and guidance, and staff must follow them at all times. 11(2) Paragraph (1) is subject to paragraphs (3) and (4). 11(3) If the service user is 16 or over and is unable to give such consent because they lack capacity to do so, the registered person must act in accordance with the 2005 Act. 11(4) But if Part 4 or 4A of the 1983 Act applies to a service user, the registered person must act in accordance with the provisions of that Act. 11(5) Nothing in this regulation affects the operation of section 5 of the 2005 Act, as read with section 6 of that Act (acts in connection with care or treatment). Guidance on 11(2), 11(3), 11(4) and 11(5) Providers must make sure that staff who obtain the consent of people who use the service are familiar with the principles and codes of conduct associated with the Mental Capacity Act 2005, and are able to apply those when appropriate, for any of the people they are caring for. [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 12: Safe care and treatment Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 12 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 we 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. 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. We do not have to serve a Warning Notice before prosecution. Additionally, CQC may also take other regulatory action. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. Note: The regulation does not apply to the person's accommodation if this is not provided as part of their care and treatment. The regulation in full 12.— Care and treatment must be provided in a safe way for service users. Without limiting paragraph (1), the things which a registered person must do to comply with that paragraph include— assessing the risks to the health and safety of service users of receiving the care or treatment; doing all that is reasonably practicable to mitigate any such risks; ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely; ensuring that the premises used by the service provider are safe to use for their intended purpose and are used in a safe way; ensuring that the equipment used by the service provider for providing care or treatment to a service user is safe for such use and is used in a safe way; where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs; the proper and safe management of medicines; assessing the risk of, and preventing, detecting and controlling the spread of, infections, including those that are health care associated; where responsibility for the care and treatment of service users is shared with, or transferred to, other persons, working with such other persons, service users and other appropriate persons to ensure that timely care planning takes place to ensure the health, safety and welfare of the service users. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 12(1) Care and treatment must be provided in a safe way for service users. Guidance on 12(1) Providers must provide care and treatment in a safe way. In particular, this includes the areas listed in 12(2) (a) – (i). However, 12(2) is not exhaustive and providers must demonstrate that they have done everything reasonably practicable to provide safe care and treatment. Providers should consult nationally recognised guidance about delivering safe care and treatment and implement this as appropriate. 12(2) without limiting paragraph (1), the things which a registered person must do to comply with that paragraph include– 12(2)(a) assessing the risks to the health and safety of service users of receiving the care or treatment; Guidance on 12(2)(a) Risk assessments relating to the health, safety and welfare of people using services must be completed and reviewed regularly by people with the qualifications, skills, competence and experience to do so. Risk assessments should include plans for managing risks. Assessments, planning and delivery of care and treatment should: be based on risk assessments that balance the needs and safety of people using the service with their rights and preferences include arrangements to respond appropriately and in good time to people's changing needs be carried out in accordance with the Mental Capacity Act 2005. This includes best interest decision making; lawful restraint; and, where required, application for authorisation for deprivation of liberty through the Mental Capacity Act 2005 Deprivation of Liberty Safeguards or the Court of Protection. All this applies when people use a service. This includes when they are admitted, discharged, transferred or move between services. 12(2)(b) doing all that is reasonably practicable to mitigate any such risks; Guidance on 12(2)(b) Providers must do all that is reasonably practicable to mitigate risks. They should follow good practice guidance and must adopt control measures to make sure the risk is as low as is reasonably possible. They should review methods and measures and amended them to address changing practice. Providers should use risk assessments about the health, safety and welfare of people using their service to make required adjustments. These adjustments may be to premises, equipment, staff training, processes, and practices and can affect any aspect of care and treatment. Relevant health and safety concerns should be included in people's care and treatment plans/pathways. This includes allergies, contraindications and other limitations relating to the person's needs and abilities. Staff must follow plans and pathways. Medication reviews must be part of, and align with, people's care and treatment assessments, plans or pathways and should be completed and reviewed regularly when their medication changes. Providers must comply with relevant Patient Safety Alerts, recalls and rapid response reports issued from the Medicines and Healthcare products Regulatory Agency (MHRA) and through the Central Alerting System (CAS). Incidents that affect the health, safety and welfare of people using services must be reported internally and to relevant external authorities/bodies. They must be reviewed and thoroughly investigated by competent staff, and monitored to make sure that action is taken to remedy the situation, prevent further occurrences and make sure that improvements are made as a result. Staff who were involved in incidents should receive information about them and this should be shared with others to promote learning. Incidents include those that have potential for harm. Outcomes of investigations into incidents must be shared with the person concerned and, where relevant, their families, carers and advocates. This is in keeping with Regulation 20, Duty of candour. There must be policies and procedures in place for anyone to raise concerns about their own care and treatment or the care and treatment of people they care for or represent. The policies and procedures must be in line with current legislation and guidance, and staff must follow them. The provider must have arrangements to take appropriate action if there is a clinical or medical emergency. Medicines must be administered accurately, in accordance with any prescriber instructions and at suitable times to make sure that people who use the service are not placed at risk. When it is agreed to be in a person's best interests, the arrangements for giving medicines covertly must be in accordance with the Mental Capacity Act 2005. There must be arrangements to request a second opinion in relation to medicines for people who are detained under the Mental Health Act 1983. 12(2)(c) ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely; Guidance on 12(2)(c) Staff must only work within the scope of their qualifications, competence, skills and experience and should be encouraged to seek help when they feel they are being asked to do something that they are not prepared or trained for. Staff should be appropriately supervised when they are learning new skills, but are not yet competent. Only relevant regulated professionals with the appropriate qualifications must plan and prescribe care and treatment, including medicines. Only relevant regulated professionals or suitably skilled and competent staff must deliver care and treatment. 12(2)(d) ensuring that the premises used by the service provider are safe to use for their intended purpose and are used in a safe way; 12(2)(e) ensuring that the equipment used by the service provider for providing care or treatment to a service user is safe for such use and used in a safe way; Guidance on 12(2)(d) and 12(2)(e) Providers must ensure the safety of their premises and the equipment within it. They should have systems and processes that assure compliance with statutory requirements, national guidance and safety alerts. 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 these regulations are adhered to as responsibility for any shortfall rests with the provider. Providers should have and implement up to date induction and training plans for the safe operation of premises and equipment, including incident reporting and emergency and contingency planning. Providers should include in their financial planning the capital and revenue costs of maintaining safety. Providers must make sure that equipment is suitable for its purpose, properly maintained and used correctly and safely. This includes making sure that staff using the equipment have the training, competency and skills needed. 12(2)(f) where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs; Guidance on 12(2)(f) People's medicines must be available in the necessary quantities at all times to prevent the risks associated with medicines that are not administered as prescribed. This includes when people manage their own medicines. Sufficient medication should be available in case of emergencies. Sufficient equipment and/or medical devices that are necessary to meet people's needs should be available at all times and devices should be kept in full working order. They should be available when needed and within a reasonable time without posing a risk. The equipment, medicines and/or medical devices that are necessary to meet people's needs should be available when they are transferred between services or providers. 12(2)(g) the proper and safe management of medicines; Guidance on 12(2)(g) Staff responsible for the management and administration of medication must be suitably trained and competent and this should be kept under review. Staff must follow policies and procedures about managing medicines, including those related to infection control. These policies and procedures should be in line with current legislation and guidance and address: supply and ordering storage, dispensing and preparation administration disposal recording. 12(2)(h) assessing the risk of, and preventing, detecting and controlling the spread of, infections, including those that are health care associated; Guidance on 12(2)(h) The Department of Health has issued a Code of Practice about the prevention and control of healthcare associated infections Health and Social Care Act 2008: Code of Practice for health and adult social care on the prevention and control of infections and related guidance . The law says that CQC must take the Code into account when making decisions about registration and by any court during legal proceedings about registration. By following the Code, providers will be able to show how they meet this regulation but they do not have to comply with the Code by law. A provider may be able to demonstrate that they meet this regulation in a different way (equivalent or better) from that described in the Code. When assessing risk, providers should consider the link between infection prevention and control, antimicrobial stewardship, how medicines are managed and cleanliness. 12(2)(i) where responsibility for the care and treatment of service users is shared with, or transferred to, other persons, working with such other persons, service users and other appropriate persons to ensure that timely care planning takes place to ensure the health, safety and welfare of the service users. Guidance on 12(2)(i) The provider must actively work with others, both internally and externally, to make sure that care and treatment remains safe for people using services. When care is shared between two or more providers or where there are integrated services, there should be appropriate arrangements to share relevant information promptly and in line with current legislation and guidance, and to plan and deliver care in partnership. When more than one provider is responsible for the safety of a person using services, the responsibility for providing safe care rests with the principal care provider at the time it is given. Arrangements should be in place to support people who are in a transition phase between services and/or other providers. When people move between services or providers, appropriate risk assessments must be undertaken to make sure their safety is not compromised. This includes when they move between or with other bodies who may not be registered with CQC, such as the police. Decisions about a move between services or providers relating to people who may lack mental capacity to make that decision for themselves must be made in accordance with the Mental Capacity Act 2005. To make sure that people who use services are safe and any risks to their care and treatment are minimised, providers must be able to respond to and manage major incidents and emergency situations. This includes having plans with other providers or bodies in case of events such as fires, floods, major road traffic accidents or major incidents, and natural disasters such as earth quakes or landslides (see the legislation page for link to the Civil Contingencies Act 2004). [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 13: Safeguarding service users from abuse and improper treatment Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 13 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. CQC can prosecute for a breach of some parts of this regulation (13(1) to 13(4)) 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. We do not have to serve a Warning Notice before prosecution. Additionally, CQC may also take any other regulatory action. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. The regulation in full 13.— Service users must be protected from abuse and improper treatment in accordance with this regulation. Systems and processes must be established and operated effectively to prevent abuse of service users. Systems and processes must be established and operated effectively to investigate, immediately upon becoming aware of, any allegation or evidence of such abuse. 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 characteristic (as defined in section 4 of the Equality Act 2010) of the service user, 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, is degrading for the service user, or significantly disregards the needs of the service user for care or treatment. A service user must not be deprived of their liberty for the purpose of receiving care or treatment without lawful authority. For the purposes of this regulation— 'abuse' means— any behaviour towards a service user that is an offence under the Sexual Offences Act 2003(a), ill-treatment (whether of a physical or psychological nature) of a service user, theft, misuse or misappropriation of money or property belonging to a service user, or neglect of a service user. For the purposes of this regulation, a person controls or restrains a service user if that person— uses, or threatens to use, force to secure the doing of an act which the service user resists, or restricts the service user's liberty of movement, whether or not the service user resists, including by use of physical, mechanical or chemical means. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 13.—(1) Service users must be protected from abuse and improper treatment in accordance with this regulation. Guidance on 13.—(1) All providers must make sure that they have, and implement, robust procedures and processes that make sure that people are protected. Safeguarding must have the right level of scrutiny and oversight, with overall responsibility held at board level or equivalent. 13(2) Systems and processes must be established and operated effectively to prevent abuse of service users. Guidance on 13(2) As part of their induction, staff must receive safeguarding training that is relevant, and at a suitable level for their role. Training should be updated at appropriate intervals and should keep staff up to date and enable them to recognise different types of abuse and the ways they can report concerns. Staff must be aware of their individual responsibilities to prevent, identify and report abuse when providing care and treatment. This includes referral to other providers. Staff must understand their roles and associated responsibilities in relation to any of the provider's policies, procedures or guidance to prevent abuse. Information about current procedures and guidance about raising concerns about abuse should be accessible to people who use the service, advocates, those lawfully acting on their behalf, those close to them and staff. Providers should use incidents and complaints to identify potential abuse and should take preventative actions, including escalation, where appropriate. Providers should work in partnership with other relevant bodies to contribute to individual risk assessments, developing plans for safeguarding children and safeguarding adults at risk, and when implementing these plans. This includes regularly reviewing outcomes for people using the service. Providers and their staff must understand and work within the requirements of the Mental Capacity Act 2005 whenever they work with people who may lack the mental capacity to make some decisions. 13(3) Systems and processes must be established and operated effectively to investigate, immediately upon becoming aware of, any allegation or evidence of such abuse. Guidance on 13(3) Providers must take action as soon as they are alerted to suspected, alleged or actual abuse, or the risk of abuse. Where appropriate, this action should be in line with the procedures agreed by local Safeguarding Adults or Children Boards. Providers and staff must know and understand the local safeguarding policy and procedures, and the actions they need to take in response to suspicions and allegations of abuse, no matter who raises the concern or who the alleged abuser may be. These include timescales for action and the local arrangements for investigation. Staff must be aware of, and have access to, current procedures and guidance for raising and responding to concerns of abuse. Staff should have access to support from line management when considering how to respond to concerns of abuse. Managers and staff must understand their individual responsibilities to respond to concerns about abuse when providing care and treatment, including investigating concerns. Staff must understand their roles and associated responsibilities in supporting the actions the provider takes in responding to allegations and concerns about abuse. Providers should make sure that staff are kept up to date about changes to national and local safeguarding arrangements. Where appropriate, staff must follow local safeguarding arrangements to make sure that allegations are investigated internally or externally. Providers must make sure that they respond without delay to the findings of any investigations. When people who use services make allegations of abuse, or actually experience abuse, they must receive the support they need. Where allegations of abuse are substantiated, providers must take action to redress the abuse and take the necessary steps to ensure the abuse is not repeated. This may involve seeking specialist advice or support. When required to, providers must participate in serious case reviews. Any changes to practice and/or recommendations relating to the provider must be implemented. 13(4) Care or treatment for service users must not be provided in a way that– Guidance on 13(4) 13(4)(a) 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) 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, Staff must understand their individual responsibilities in preventing discrimination in relation to the protected characteristics set out in s.4 of the Equality Act 2010. These are: age; disability; gender reassignment; pregnancy and maternity; race; religion or belief; sex; and sexual orientation. Providers should have systems for dealing with allegations and acts of discrimination regardless of who raises the concern or who the allegation is against. This includes policies and procedures that describe the required actions and the timescales in which to take action. Providers must support people who use services when they make allegations of discrimination or actually experience discrimination. They must not unlawfully victimise people who use services for making a complaint about discrimination. When allegations of discrimination are substantiated, providers must take corrective action and make changes to prevent it happening again. This may involve seeking specialist advice or support. See Regulation 13(7) for the meaning of restraint in relation to this regulation. As part of their induction, staff must receive training that is relevant to their role and at a suitable level to make sure any control, restraint or restrictive practices are only used when absolutely necessary, in line with current national guidance and good practice, and as a last resort. The provider should make arrangements to keep staff up to date at appropriate intervals. If using restraint, providers must make sure that restraint: Is only used when absolutely necessary. Is proportionate in relation to the risk of harm and the seriousness of that harm to the person using the service or another person. Takes account of the assessment of the person's needs and their capacity to consent to such treatment. Follows current legislation and guidance. Providers and staff should regularly monitor and review the approach to, and use of, restraint and restrictive practices. Where a person lacks mental capacity to consent to the arrangements for their care or treatment, including depriving them of their liberty, providers must follow a best interest process in accordance with the Mental Capacity Act 2005, including the use of the Mental Capacity Act 2005 Deprivation of Liberty Safeguards, where appropriate. 13(4)(c) is degrading for the service user, or Guidance on 13(4)(c) Providers and staff must take all reasonable steps to make sure that people who use services are not subjected to any form of degradation or treated in a manner that may reasonably be viewed as degrading, such as: not providing help and aids so that people can be supported to attend to their continence needs, and making sure people are not: left in soiled sheets for long periods left on the toilet for long periods and without the means to call for help left naked or partially or inappropriately covered made to carry out demeaning tasks or social activities ridiculed in any way by staff. This list is not exhaustive. Providers should consult and consider the views of people using their service when defining the meaning of 'degrading'. 13(4)(d) significantly disregards the needs of the service user for care or treatment. Guidance on 13(4)(d) Care and treatment must be planned and delivered in a way that enables all a person's needs to be met. This includes making sure that enough time is allocated to allow staff to provide care and treatment in accordance with the person's assessed needs and preferences. There should be policies and procedures that support staff to deliver care and treatment in accordance with the requirements detailed in the plan(s) of care. When a person lacks the mental capacity to consent to care and treatment, a best interests process must be followed in accordance with the Mental Capacity Act 2005. Other forms of authority such as advance decisions must also be taken into account. Staff should raise any concerns with the provider about their ability to provide planned care. When concerns are raised, the provider should respond appropriately and without delay. 13(5) A service user must not be deprived of their liberty for the purpose of receiving care or treatment without lawful authority. Guidance on 13(5) Providers must act at all times in accordance with the Mental Capacity Act 2005 Deprivation of Liberty Safeguards: Code of Practice and the Mental Capacity Act 2005 Code of Practice. Hospitals and care homes must follow the Deprivation of Liberty Safeguards. Other types of services must ensure that any deprivation of the liberty of a person who lacks mental capacity is authorised by the Court of Protection. [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 14: Meeting nutritional and hydration needs Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 14 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. 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 a person using the service is exposed to significant risk of harm. In these instances, CQC can move directly to prosecution without first serving a warning notice. Additionally, CQC may also take any other regulatory action. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. The regulation in full 14.— The nutritional and hydration needs of service users must be met. Paragraph (1) applies where— care or treatment involves— the provision of accommodation by the service provider, or an overnight stay for the service user on premises used by the service for the purposes of carrying on a regulated activity, or the meeting of the nutritional or hydration needs of service users is part of the arrangements made for the provision of care or treatment by the service provider. But paragraph (1) does not apply to the extent that the meeting of such nutritional or hydration needs would— result in a breach of regulation 11, or not be in the service user's best interests. For the purposes of paragraph (1), "nutritional and hydration needs" means— receipt by a service user of suitable and nutritious food and hydration which is adequate to sustain life and good health, receipt by a service user of parenteral nutrition and dietary supplements when prescribed by a health care professional, the meeting of any reasonable requirements of a service user for food and hydration arising from the service user's preferences or their religious or cultural background, and if necessary, support for a service user to eat or drink. Section 4 of the 2005 Act (best interests) applies for the purposes of determining the best interests of a service user who is 16 or over under this regulation as it applies for the purposes of that Act. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 14(1) The nutritional and hydration needs of service users must be met. Guidance on 14(1) Providers must include people's nutrition and hydration needs when they make an initial assessment of their care, treatment and support needs and in the ongoing review of these. The assessment and review should include risks related to people's nutritional and hydration needs. Providers should have a food and drink strategy that addresses the nutritional needs of people using the service. 14(2) Paragraph 1 applies where— (a) care or treatment involves— the provision of accommodation by the service provider, or an overnight stay for the service user on premises used by the service for the purposes of carrying on a regulated activity, or (b) the meeting of the nutritional or hydration needs of service users is part of the arrangements made for the provision of care or treatment by the service provider. Guidance on 14(2) Providers must meet people's nutrition or hydration needs wherever an overnight stay is provided as part of the regulated activity or where nutrition or hydration are provided as part of the arrangements made for the person using the service. 14(3) But paragraph (1) does not apply to the extent that the meeting of such nutritional or hydration needs would— (a) result in a breach of regulation 11, or (b) not be in the service user's best interests Guidance on 14(3) Providers must follow people's consent wishes if they refuse nutrition and hydration unless a best interests decision has been made under the Mental Capacity Act 2005. Other forms of authority such as advance decisions should also be taken into account. CQC recognises that some services may vary the way they apply this regulation to take account of people's assessed needs and wishes. This includes specialist eating disorder services and some palliative care or end of life situations. 14(4) For the purposes of paragraph (1), "nutritional and hydration needs" means— 14(4)(a) receipt by a service user of suitable and nutritious food and hydration which is adequate to sustain life and good health, Guidance on 14(4)(a) Nutrition and hydration assessments must be carried out by people with the required skills and knowledge. The assessments should follow nationally recognised guidance and identify, as a minimum: requirements to sustain life, support the agreed care and treatment, and support ongoing good health dietary intolerances, allergies, medication contraindications how to support people's good health including the level of support needed, timing of meals, and the provision of appropriate and sufficient quantities of food and drink. Nutrition and hydration needs should be regularly reviewed during the course of care and treatment and any changes in people's needs should be responded to in good time. A variety of nutritious, appetising food should be available to meet people's needs and be served at an appropriate temperature. When the person lacks capacity, they must have prompts, encouragement and help to eat as appropriate. Where a person is assessed as needing a specific diet, this must be provided in line with that assessment. Nutritional and hydration intake should be monitored and recorded to prevent unnecessary dehydration, weight loss or weight gain. Action must be taken without delay to address any concerns. Staff must follow the most up-to-date nutrition and hydration assessment for each person and take appropriate action if people are not eating and drinking in line with their assessed needs. Staff should know how to determine whether specialist nutritional advice is required and how to access and follow it. Water must be available and accessible to people at all times. Other drinks should be made available periodically throughout the day and night and people should be encouraged and supported to drink. Arrangements should be made for people to receive their meals at a different time if they are absent or asleep when their meals are served. Snacks or other food should be available between meals for those who prefer to eat 'little and often'. 14(4)(b) receipt by a service user of parenteral nutrition and dietary supplements when prescribed by a health care professional, Guidance on 14(4)(b) Providers must have systems to make sure that people using the service receive their prescribed parenteral nutrition and dietary supplements at the specified times. Parenteral nutrition and dietary supplements must only be administered by appropriately qualified, skilled, competent and experienced staff. 14(4)(c) the meeting of any reasonable requirements of a service user for food and hydration arising from the service user's preferences or their religious or cultural background, and Guidance on 14(4)(c) People should be able to make choices about their diet. People's religious and cultural needs must be identified in their nutrition and hydration assessment, and these needs must be met. If there are any clinical contraindications or risks posed because of any of these requirements, these should be discussed with the person, to allow them to make informed choices about their requirements. When a person has specific dietary requirements relating to moral or ethical beliefs, such as vegetarianism, these requirements must be fully considered and met. Every effort should be made to meet people's preferences, including preference about what time meals are served, where they are served and the quantity. 14(4)(d) if necessary, support for a service user to eat or drink Guidance on 14(4)(d) People's food must be placed within their reach and presented in a way that is easy to eat, such as liquidised or finger foods where appropriate. Food must be served and maintained at the right temperature for the whole mealtime. People should be encouraged to eat and drink independently. They should receive appropriate support, which may include encouragement as well as physical support, when they need it. People must have appropriate equipment or tools to help them eat and drink independently. Each person who requires support should have enough time to enable them to take adequate nutrition and hydration to sustain life and good health. [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 15: Premises and equipment Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 15 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. CQC cannot prosecute for a breach of this regulation or any of its parts, but we can take regulatory action. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. Note: 'Premises' and 'equipment' are defined in the regulations. The definitions make sure that 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 regulation in full 15.— All premises and equipment used by the service provider must be— clean, secure, suitable for the purpose for which they are being used, properly used properly maintained, and appropriately located for the purpose for which they are being used. The registered person must, in relation to such premises and equipment, maintain standards of hygiene appropriate for the purposes for which they are being used. For the purposes of paragraph (1)(b), (c), (e) and (f), "equipment" does not include equipment at the service user's accommodation if— such accommodation is not provided as part of the service user's care or treatment, and such equipment is not supplied by the service provider. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 15(1) All premises and equipment used by the service provider must be— 15(1)(a) clean, Guidance on 15(1)(a) Premises and equipment must be kept clean and cleaning must be done in line with current legislation and guidance. Premises and equipment should be visibly clean and free from odours that are offensive or unpleasant. Providers should: use appropriate cleaning methods and agents, operate a cleaning schedule appropriate to the care and treatment being delivered from the premises or by the equipment monitor the level of cleanliness take action without delay when any shortfalls are identified. make sure that staff with responsibility for cleaning have appropriate training. Domestic, clinical and hazardous waste and materials must be managed in line with current legislation and guidance. 15(1)(b) secure, Guidance on 15(1)(b) Security arrangements must make sure that people are safe while receiving care, including: Protecting personal safety, which includes restrictive protection required in relation to the Mental Capacity Act 2005 and Mental Health Act 1983. This includes the use of window restrictors or locks on doors, which are used in a way that protects people using the service when lawful and necessary, but which does not restrict the liberty of other people using the service. Protecting personal property and/or money. Providing appropriate access to and exit from protected or controlled areas. Not inadvertently restricting people's movements. Providing appropriate information about access and entry when people who use the service are unable to come and go freely and when people using a service move from the premises as part of their care and treatment. Using the appropriate level of security needed in relation to the services being delivered. If any form of surveillance is used for any purpose, the provider must make sure that this is done in the best interests of people using the service, while remaining mindful of their responsibilities for the safety of their staff. Any surveillance should be operated in line with current guidance. Detailed guidance on the use of surveillance is available on CQC's website. 15(1)(c) suitable for the purpose for which they are being used, Guidance on 15(1)(c) Premises must be fit for purpose in line with statutory requirements and should take account of national best practice. Premises must be suitable for the service provided, including the layout, and be big enough to accommodate the potential number of people using the service at any one time. There must be sufficient equipment to provide the service. Adequate support facilities and amenities must be provided where relevant to the service being provided. This includes sufficient toilets and bathrooms for the number of people using the service, adequate storage space, adequate seating and waiting space. People's needs must be taken into account when premises are designed, built, maintained, renovated or adapted. Their views should also be taken into account when possible. People should be able to easily enter and exit premises and find their way around easily and independently. If they can't, providers must make reasonable adjustments in accordance with the Equality Act 2010 and other current legislation and guidance. Any alterations to the premises or the equipment that is used to deliver care and treatment must be made in line with current legislation and guidance. Where the guidance cannot be met, the provider should have appropriate contingency plans and arrangements to mitigate the risks to people using the service. The premises and equipment used to deliver care and treatment must meet people's needs and, where possible, their preferences. This includes making sure that privacy, dignity and confidentiality are not compromised. Reasonable adjustments must be made when providing equipment to meet the needs of people with disabilities, in line with requirements of the Equality Act 2010. 15(1)(d) properly used, 15(1)(e) properly maintained, and Guidance on 15(1)(d) and 15(1)(e) Providers must make sure that they meet the requirements of relevant legislation so that premises and equipment are properly used and maintained. See the relevant legislation . The provider's Statement of Purpose and operational policies and procedures for the delivery of care and treatment should specify how the premises and equipment will be used. Any change of use of premises and/or equipment should be informed by a risk assessment and providers must make appropriate alterations to premises and equipment where reasonably practical. Where this is not possible, providers should have appropriate contingency plans and arrangements to mitigate the risks to people using the service. Alterations must be in line with current legislation and guidance. There should be regular health and safety risk assessments of the premises (including grounds) and equipment. The findings of the assessments must be acted on without delay if improvements are required. There should be suitable arrangements for the purchase, service, maintenance, renewal and replacement of premises (including grounds) and equipment. These arrangements must make sure that they meet the requirements of current legislation and guidance, manufacturers' instructions and the provider's policies or procedures. Providers must have operational policies and procedures and maintenance budgets to maintain their equipment, buildings and mechanical engineering and electrical systems so that they are sound, operationally safe and exhibiting only minor deterioration. All equipment must be used, stored and maintained in line with manufacturers' instructions. It should only be used for its intended purpose and by the person for whom is it provided. Providers must make sure that staff and others who operate the equipment are trained to use it appropriately. 15(1)(f) appropriately located for the purpose for which they are being used. Guidance on 15(1)(f) When planning the location of premises, providers must take into account the anticipated needs of the people who will use the service and they should ensure easy access to other relevant facilities and the local community. Facilities should be appropriately located to suit the accommodation that is being used. This includes short distances between linked facilities, sufficient car parking that is clearly marked and reasonably close, and good access to public transport. Equipment must be accessible at all times to meet the needs of people using the service. This means it must be available when needed, or obtained in a reasonable time so as not to pose a risk to the person using the service. Equipment includes chairs, beds, clinical equipment, and moving and handling equipment. 15(2) The registered person must, in relation to such premises and equipment, maintain standards of hygiene appropriate for the purposes for which they are being used. Guidance on 15(2) Providers must comply with guidance from the Department of Health about the prevention and control of infections: Health and Social Care Act 2008: The Code of Practice for health and adult social care on the prevention and control of infections and related guidance . Where applicable, premises must be cleaned or decontaminated in line with current legislation and guidance, and equipment must be cleaned, decontaminated and/or sterilised in line with current legislation and guidance and manufacturers' instructions. Equipment must be cleaned or decontaminated after each use and between use by different people who use the service. Ancillary services belonging to the provider, such as kitchens and laundry rooms, which are used for or by people who use the service, must be used and maintained in line with current legislation and guidance. People using the service and staff using the equipment should be trained to use it or supervised/risk assessed as necessary. Multiple use equipment and devices must be cleaned or decontaminated between use. Single use and single person devices must not be re-used or shared. All staff must understand the risk to people who use services if they do not adhere to this. [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 16: Receiving and acting on complaints Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 16 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. When requested to do so, providers must provide CQC with a summary of complaints, responses and other related correspondence or information. CQC can prosecute providers for a breach of the part of this regulation that relates to the provision of information to CQC about a complaint within 28 days when requested to do so. CQC can move directly to prosecution without first serving a Warning Notice. In addition, CQC may take any other regulatory action in response to breaches of this regulation. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. The regulation in full 16.— Any complaint received must be investigated and necessary and proportionate action must be taken in response to any failure identified by the complaint or investigation. The registered person must establish and operate effectively an accessible system for identifying, receiving, recording, handling and responding to complaints by service users and other persons in relation to the carrying on of the regulated activity. 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— complaints made under such complaints system, responses made by the registered person to such complaints and any further correspondence with the complainants in relation to such complaints, and any other relevant information in relation to such complaints as the Commission may request. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 16(1) Any complaint received must be investigated and necessary and proportionate action must be taken in response to any failure identified by the complaint or investigation. Guidance on 16(1) People must be able to make a complaint to any member of staff, either verbally or in writing. All staff must know how to respond when they receive a complaint. Unless they are anonymous, all complaints should be acknowledged whether they are written or verbal. Complainants must not be discriminated against or victimised. In particular, people's care and treatment must not be affected if they make a complaint, or if somebody complains on their behalf. Appropriate action must be taken without delay to respond to any failures identified by a complaint or the investigation of a complaint. Information must be available to a complainant about how to take action if they are not satisfied with how the provider manages and/or responds to their complaint. Information should include the internal procedures that the provider must follow and should explain when complaints should/will be escalated to other appropriate bodies. Providers that do not have independent review stages should regularly review their complaints resolution processes to ensure they are not disadvantaging complainants as a consequence. Where complainants escalate their complaint externally because they are dissatisfied with the local outcome, the provider should cooperate with any independent review or process. 16(2) The registered person must establish and operate effectively an accessible system for identifying, receiving, recording, handling and responding to complaints by service users and other persons in relation to the carrying on of the regulated activity. Guidance on 16(2) Information and guidance about how to complain must be available and accessible to everyone who uses the service. It should be available in appropriate languages and formats to meet the needs of the people using the service. Providers must tell people how to complain, offer support and provide the level of support needed to help them make a complaint. This may be through advocates, interpreter services and any other support identified or requested. When complainants do not wish to identify themselves, the provider must still follow its complaints process as far as possible. Providers must have effective systems to make sure that all complaints are investigated without delay. This includes: Undertaking a review to establish the level of investigation and immediate action required, including referral to appropriate authorities for investigation. This may include professional regulators or local authority safeguarding teams. Making sure appropriate investigations are carried out to identify what might have caused the complaint and the actions required to prevent similar complaints. When the complainant has identified themselves, investigating and responding to them and where relevant their family and carers without delay. Providers should monitor complaints over time, looking for trends and areas of risk that may be addressed. This includes considering whether the process needs to be revised, including adding an independent review stage if it is not part of the existing process. Staff and others who are involved in the assessment and investigation of complaints must have the right level of knowledge and skill. They should understand the provider's complaints process and be knowledgeable about current related guidance. Consent and confidentiality must not be compromised during the complaints process unless there are professional or statutory obligations that make this necessary, such as safeguarding. Complainants, and those about whom complaints are made, must be kept informed of the status of their complaint and its investigation, and be advised of any changes made as a result. Providers must maintain a record of all complaints, outcomes and actions taken in response to complaints. Where no action is taken, the reasons for this should be recorded. Providers must act in accordance with Regulation 20: Duty of Candour in respect of complaints about care and treatment that have resulted in a notifiable safety incident. 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— (a) complaints made under such complaints system, (b) responses made by the registered person to such complaints and any further correspondence with the complainants in relation to such complaints, and (c) any other relevant information in relation to such complaints as the Commission may request. Guidance on 16(3) CQC can ask providers for information about a complaint; if this is not provided within 28 days of our request, it may be seen as preventing CQC from taking appropriate action in relation to a complaint or putting people who use the service at risk of harm, or of receiving care and treatment that has, or is, causing harm. This can include requests for details on how the process is administered and reviewed, including whether it has an independent review stage. The 28-day period starts the day after the request is received. [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 17: Good governance Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 17 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 to 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. When requested, providers must provide a written report to CQC setting out how they assess, monitor, and where required, improve the quality and safety of their services. CQC can prosecute for a breach of part of this regulation (17(3)) if a provider fails to submit such a report when requested. CQC may consider that this failure could prevent the provider from taking appropriate, timely action. CQC could therefore move directly to prosecution for a breach of this part of the regulation without first serving a Warning Notice. Regulatory action can be taken for other parts of the regulation. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. The regulation in full 17.— Systems or processes must be established and operated effectively to ensure compliance with the requirements in this Part. Without limiting paragraph (1), such systems or processes must enable the registered person, in particular, 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); 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; maintain securely an accurate, complete and contemporaneous record in respect of each service user, including a record of the care and treatment provided to the service user and of decisions taken in relation to the care and treatment provided; maintain securely such other records as are necessary to be kept in relation to— persons employed in the carrying on of the regulated activity, and the management of the regulated activity; seek and act on feedback from relevant persons and other persons on the services provided in the carrying on of the regulated activity, for the purposes of continually evaluating and improving such services; evaluate and improve their practice in respect of the processing of the information referred to in sub-paragraphs (a) to (e). 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, and any plans that the registered person has for improving the standard of the services provided to service users with a view to ensuring their health and welfare. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 17(1) Systems or processes must be established and operated effectively to ensure compliance with the requirements in this Part. Guidance on 17(1) Providers must operate effective systems and processes to make sure they assess and monitor their service against Regulations 4 to 20A of Part 3 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (as amended). The provider must have a process in place to make sure this happens at all times and in response to the changing needs of people who use the service. The system must include scrutiny and overall responsibility at board level or equivalent. 17(2) Without limiting paragraph (1), such systems or processes must enable the registered person, in particular, to— 17(2)(a) 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); Guidance on 17(2)(a) Providers must have systems and processes such as regular audits of the service provided and must assess, monitor and improve the quality and safety of the service. The audits should be baselined against Regulations 4 to 20A of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and should, where possible, include the experiences people who use the service. The systems and processes should be continually reviewed to make sure they remain fit for purpose. Fit for purpose means that: systems and processes enable the provider to identify where quality and/or safety are being compromised and to respond appropriately and without delay. providers have access to all necessary information. Information should be up to date, accurate and properly analysed and reviewed by people with the appropriate skills and competence to understand its significance. When required, results should be escalated and appropriate action taken. Providers should have effective communication systems to ensure that people who use the service, those who need to know within the service and, where appropriate, those external to the service, know the results of reviews about the quality and safety of the service and any actions required following the review. Providers should actively seek the views of a wide range of stakeholders, including people who use the service, staff, visiting professionals, professional bodies, commissioners, local groups, members of the public and other bodies, about their experience of, and the quality of care and treatment delivered by the service. Providers must be able to show how they have: analysed and responded to the information gathered, including taking action to address issues where they are raised, and used the information to make improvements and demonstrate that they have been made Providers must seek professional/expert advice as needed and without delay to help them to identify and make improvements. Providers must monitor progress against plans to improve the quality and safety of services, and take appropriate action without delay where progress is not achieved as expected. Subject to statutory consent and applicable confidentiality requirements, providers must share relevant information, such as information about incidents or risks, with other relevant individuals or bodies. These bodies include safeguarding boards, coroners, and regulators. Where they identify that improvements are needed these must be made without delay. Providers should read and implement relevant nationally recognised guidance and be aware that quality and safety standards change over time when new practices are introduced, or because of technological development or other factors. 17(2)(b) 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; Guidance on 17(2)(b) Providers must have systems and processes that enable them to identify and assess risks to the health, safety and/or welfare of people who use the service. Where risks are identified, providers must introduce measures to reduce or remove the risks within a timescale that reflects the level of risk and impact on people using the service. Providers must have processes to minimise the likelihood of risks and to minimise the impact of risks on people who use services. Risks to the health, safety and/or welfare of people who use services must be escalated within the organisation or to a relevant external body as appropriate. Identified risks to people who use services and others must be continually monitored and appropriate action taken where a risk has increased. Note: In this regulation, 'others' includes anyone who may be put at risk through the carrying on of a regulated activity, such as staff, visitors, tradespeople or students. 17(2)(c) maintain securely an accurate, complete and contemporaneous record in respect of each service user, including a record of the care and treatment provided to the service user and of decisions taken in relation to the care and treatment provided; Guidance on 17(2)(c) Records relating to the care and treatment of each person using the service must be kept and be fit for purpose. Fit for purpose means they must: Be complete, legible, indelible, accurate and up to date, with no undue delays in adding and filing information, as far as is reasonable. This includes results of diagnostic tests, correspondence and changes to care plans following medical advice. Include an accurate record of all decisions taken in relation to care and treatment and make reference to discussions with people who use the service, their carers and those lawfully acting on their behalf. This includes consent records and advance decisions to refuse treatment. Consent records include when consent changes, why the person changed consent and alternatives offered. Be accessible to authorised people as necessary in order to deliver people's care and treatment in a way that meets their needs and keeps them safe. This applies both internally and externally to other organisations. Be created, amended, stored and destroyed in line with current legislation and nationally recognised guidance. Be kept secure at all times and only accessed, amended, or securely destroyed by authorised people. Both paper and electronic records can be held securely providing they meet the requirements of the Data Protection Act 2018. Decisions made on behalf of a person who lacks capacity must be recorded and provide evidence that these have been taken in line with the requirements of the Mental Capacity Act 2005 or, where relevant, the Mental Health Act 1983, and their associated Codes of Practice. Information in all formats must be managed in line with current legislation and guidance. Systems and processes must support the confidentiality of people using the service and not contravene the Data Protection Act 2018. 17(2)(d) maintain securely such other records as are necessary to be kept in relation to— (i) persons employed in the carrying on of the regulated activity, and (ii) the management of the regulated activity; Guidance on 17(2)(d) Records relating to people employed and the management of regulated activities must be created, amended, stored and destroyed in accordance with current legislation and guidance. Records relating to people employed must include information relevant to their employment in the role including information relating to the requirements under Regulations 4 to 7 and Regulation 19 of this part (part 3) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. This applies to all staff, not just newly appointed staff. Providers must observe data protection legislation about the retention of confidential personal information. Records relating to the management of regulated activities means anything relevant to the planning and delivery of care and treatment. This may include governance arrangements such as policies and procedures, service and maintenance records, audits and reviews, purchasing, action plans in response to risk and incidents. Records must be kept secure at all times and only accessed, amended or destroyed by people who are authorised to do so. Information in all formats must be managed in line with current legislation and guidance. Systems and processes must support the confidentiality of people using the service and not contravene the Data Protection Act 2018. 17(2)(e) seek and act on feedback from relevant persons and other persons on the services provided in the carrying on of the regulated activity, for the purposes of continually evaluating and improving such services; Guidance on 17(2)(e) Providers should actively encourage feedback about the quality of care and overall involvement with them. The feedback may be informal or formal, written or verbal. It may be from people using the service, those lawfully acting on their behalf, their carers and others such as staff or other relevant bodies. All feedback should be listened to, recorded and responded to as appropriate. It should be analysed and used to drive improvements to the quality and safety of services and the experience of engaging with the provider. Improvements should be made without delay once they are identified, and the provider should have systems in place to communicate how feedback has led to improvements. Where relevant, the provider should also seek and act on the views of external bodies such as fire, environmental health, royal colleges and other bodies who provide best practice guidance relevant to the service provided. 17(2)(f) evaluate and improve their practice in respect of the processing of the information referred to in sub-paragraphs (a) to (e). Guidance on 17(2)(f) Providers must ensure that their audit and governance systems remain effective. 17(3) 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—- 17(3)(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, and 17(3)(b) any plans that the registered person has for improving the standard of the services provided to service users with a view to ensuring their health and welfare. Guidance on 17(3)(a) and 17(3)(b) This information could include a request for an action plan or a Provider Information Return for adult social care services. [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 18: Staffing Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 18 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. CQC cannot prosecute for a breach of this regulation or any of its parts, but we can take regulatory action. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. The regulation in full 18.— Sufficient numbers of suitably qualified, competent, skilled and experienced persons must be deployed in order to meet the requirements of this Part. Persons employed by the service provider in the provision of a regulated activity must— receive such appropriate support, training, professional development, supervision and appraisal as is necessary to enable them to carry out the duties they are employed to perform, be enabled where appropriate to obtain further qualifications appropriate to the work they perform, and where such persons are health care professionals, social workers or other professionals registered with a health care or social care regulator, be enabled to provide evidence to the regulator in question demonstrating, where it is possible to do so, that they continue to meet the professional standards which are a condition of their ability to practise or a requirement of their role. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 18(1) Sufficient numbers of suitably qualified, competent, skilled and experienced persons must be deployed in order to meet the requirements of this Part. Guidance on 18(1) Providers must deploy sufficient numbers of suitably qualified, competent, skilled and experienced staff to make sure that they can meet people's care and treatment needs and therefore meet the requirements of Section 2 of these regulations (the fundamental standards). Providers should have a systematic approach to determine the number of staff and range of skills required in order to meet the needs of people using the service and keep them safe at all times. The approach they use must reflect current legislation and guidance where it is available. In determining the number of staff and range of skills required to meet people's needs, they should consider the different levels of skills and competence required to meet those needs, the registered professional and support workers needed, supervision needs and leadership requirements. Staffing levels and skill mix must be reviewed continuously and adapted to respond to the changing needs and circumstances of people using the service. There should be procedures to follow in an emergency that make sure sufficient and suitable people are deployed to cover both the emergency and the routine work of the service. 18(2) Persons employed by the service provider in the provision of a regulated activity must— 18(2)(a) receive such appropriate support, training, professional development, supervision and appraisal as is necessary to enable them to carry out the duties they are employed to perform, Guidance on 18(2)(a) Providers must ensure that they have an induction programme that prepares staff for their role. Training, learning and development needs of individual staff members must be carried out at the start of employment and reviewed at appropriate intervals during the course of employment. Staff must be supported to undertake training, learning and development to enable them to fulfil the requirements of their role. Where appropriate, staff must be supervised until they can demonstrate required/acceptable levels of competence to carry out their role unsupervised. Staff should receive appropriate ongoing or periodic supervision in their role to make sure competence is maintained. Providers must ensure that all staff receive training in how to interact appropriately with people with a learning disability and autistic people, at a level appropriate to their role. Staff should be supported to make sure they are can participate in: Statutory training. Other mandatory training, as defined by the provider for their role. Any additional training identified as necessary to carry out regulated activities as part of their job duties and, in particular, to maintain necessary skills to meet the needs of the people they care for and support. Other learning and development opportunities required to enable them to fulfil their role. This includes first aid training for people working in the adult social care sector. All learning and development and required training completed should be monitored and appropriate action taken quickly when training requirements are not being met. Staff should receive regular appraisal of their performance in their role from an appropriately skilled and experienced person and any training, learning and development needs should be identified, planned for and supported. Staff must receive appropriate supervision in their role to ensure they demonstrate and maintain competence in understanding the needs of people with a learning disability and autistic people, including knowing how to support them in the best way. Health, social and other care professionals must have access to clinical or professional supervision as required, in line with the requirements of the relevant professional regulator. 18(2)(b) be enabled where appropriate to obtain further qualifications appropriate to the work they perform, and Guidance on 18(2)(b) Providers must support staff to obtain appropriate further qualifications that would enable them to continue to perform their role. Providers must not act in a way that prevents or limits staff from obtaining further qualifications that are appropriate to their role. 18(2)(c) where such persons are health care professionals, social workers or other professionals registered with a health care or social care regulator, be enabled to provide evidence to the regulator in question demonstrating, where it is possible to do so, that they continue to meet the professional standards which are a condition of their ability to practise or a requirement of their role. Guidance on 18(2)(c) Where registration with a professional body is a requirement of the role, providers must make sure that staff are able to meet the requirements of the relevant professional regulator throughout their employment, such as requirements for continuing professional development. Staff should be supported to join Accredited Voluntary Registers if they wish. Providers must have appropriate systems in place to support this, such as revalidation and meeting codes of practice. Providers must not act in a way that prevents, limits or would result in staff not meeting requirements required by professional regulators. [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 19: Fit and proper persons employed Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 19 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. It is important to note that "person employed" will include any member of staff who currently works in the service as a volunteer or a contractor, as well as agency or bank staff. This is based on the broad meaning of “employment” set out in Regulation 2, which extends the scope to those engaged who are not under a contract. Employing unfit people, or continuing to allow unfit people to stay in a role, may lead CQC to question the fitness of a provider. If CQC considers that a breach of this regulation is also a breach of another regulation(s) that carries offence clauses, then we 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. CQC cannot prosecute for a breach of this regulation or any of its parts, but we can take regulatory action. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. The regulation in full 19.— Persons employed for the purposes of carrying on a regulated activity must— be of good character, have the qualifications, competence, skills and experience which are necessary for the work to be performed by them, and be able by reason of their health, after reasonable adjustments are made, of properly performing tasks which are intrinsic to the work for which they are employed. Recruitment procedures must be established and operated effectively to ensure that persons employed meet the conditions in— paragraph (1), or in a case to which regulation 5 applies, paragraph (3) of that regulation. The following information must be available in relation to each such person employed— the information specified in Schedule 3, and such other information as is required under any enactment to be kept by the registered person in relation to such persons employed. Persons employed must be registered with the relevant professional body where such registration is required by, or under, any enactment in relation to— the work that the person is to perform, or the title that the person takes or uses. Where a person employed by the registered person no longer meets the criteria in paragraph (1), the registered person must— take such action as is necessary and proportionate to ensure that the requirement in that paragraph is complied with, and if the person is a health care professional, social worker or other professional registered with a health care or social care regulator, inform the regulator in question. Paragraphs (1) and (3) of this regulation do not apply in a case to which regulation 5 applies. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 19(1) Persons employed for the purposes of carrying on a regulated activity must– 19(1)(a) be of good character, 19(1)(a) When assessing whether an applicant is of good character, providers must have robust processes and make every effort to gather all available information to confirm that the person is of good character, and have regard to the matters outlined in Schedule 4, Part 2 of the regulations. It is not possible to outline every character trait that a person should have, but we would expect to see that the processes followed take account of honesty, trust, reliability and respect. If a provider discovers information that suggests a person is not of good character after they have been employed, they must take appropriate and timely action to meet this regulation. If a provider considers that an applicant is suitable, despite them having information about anything set out in Schedule 3 , the provider's reasons should be recorded for future reference. 19(1)(b) have the qualifications, competence, skills and experience which are necessary for the work to be performed by them, and 19(1)(b) Where a qualification is required for a role, either by law or by a provider, providers should have the means to enable them to check that employees hold the appropriate qualification(s). Providers must have appropriate processes for assessing and checking that people have the competence, skills and experience required to undertake the role. These processes must be followed in all cases and relevant records kept. Providers should have systems in place to assess the competence of employees before they work unsupervised in a role. They must provide appropriate direct or indirect supervision until the person is assessed as competent to carry out the role. Competence may include the demonstration of a caring and compassionate approach. It is expected that providers that employ healthcare assistants and social care support workers should follow the Care Certificate standards to assess their competence. Providers may consider that a person can be engaged in a role based on their qualifications, skills and experience with the expectation that they will become competent within a specified timeframe once in the role. This means that they may work for the provider and undergo training at the same time in order to become competent. 19(1)(c) be able by reason of their health, after reasonable adjustments are made, of properly performing tasks which are intrinsic to the work for which they are employed. 19(1)(c) All reasonable steps must be made to make adjustments to enable people to carry out their role. These must be in line with requirements to make reasonable adjustments for employees under the Equality Act 2010. This may include offering alternative roles. This aspect of the regulation relates to the ability of individuals to carry out their role. This does not mean that people who have a long-term condition or a disability cannot be appointed. When appointing an employee, providers must have processes for considering their physical and mental health in line with the requirements of the role. 19(2) Recruitment procedures must be established and operated effectively to ensure that persons employed meet the conditions in– (a) paragraph (1), or (b) in a case to which regulation 5 applies, paragraph (3) of that regulation. 19(2) Providers must have effective recruitment and selection procedures that comply with the requirements of this regulation and ensure that they make appropriate checks for both employees and directors. Information about candidates set out in Schedule 3 of the regulations must be confirmed before they are employed. The Schedule 3 requirement for a full employment history does not apply to volunteers except where they are service providers, directors or registered managers. This is on the basis that those roles hold a level of responsibility where it is necessary to have a full employment history to ensure a person’s suitability and appropriateness of the role. Providers may request employment history for volunteers where they consider this is necessary to the role. Other checks deemed appropriate by the providers may also be undertaken. Selection and interview processes should assess the accuracy of applications and be designed to demonstrate candidates' suitability for the role, while meeting the requirements of the Equality Act 2010 in relation to pre-employment health checks. Recruitment and/or checks on candidates may be carried out by a party other than the provider. In this case, providers must assure themselves that all checks are complete and satisfactory. 19(4) Persons employed must be registered with the relevant professional body where such registration is required by, or under, any enactment in relation to– (a) the work that the person is to perform, or (b) the title that the person takes or uses. 19(4) Providers must have a process to check that staff have appropriate and current registration with a professional regulator or, where applicable, an accredited voluntary register. 19(5) Where a person employed by the registered person no longer meets the criteria in paragraph (1), the registered person must– (a) take such action as is necessary and proportionate to ensure that the requirement in that paragraph is complied with, and (b) if the person is a health care professional, social worker or other professional registered with a health care or social care regulator, inform the regulator in question. 19(5) Providers must regularly review the fitness of employees. Providers must follow robust systems to respond to concerns about a person's fitness after they are appointed to a role. This applies whether the concerns are raised by the provider or others. Providers should respond without delay to concerns about a person's fitness or ability to carry out their duties. This includes responding immediately if there is an imminent risk to people working in and using the service. The response taken to concerns about a person's fitness should be fair to the person and follow correct procedures. Where a person's fitness to carry out their role is being investigated, appropriate interim measures must be taken to minimise any risk to people using the service. Providers must inform others as appropriate about concerns or findings relating to a person's fitness and must support any related enquiries and investigations that others have carried out. They may inform bodies such as professional regulators, police, and safeguarding authorities about concerns. Meeting our requirements of employment for Regulation 19: frequently asked questions (pdf, 286.70kB, English) [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Background to the duty of candour Notifiable safety incidents Examples of notifiable safety incidents What you must do when you discover a notifiable safety incident How we regulate the duty of candour Regulation 20: Duty of candour (regulation in full) Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 20: Duty of candour Information for patients AvMA has published a leaflet about the duty of candour for patients and families. Download AvMA's Duty of Candour leaflet. For providers Joint statement on definitions and recording guidance - FutureNHS (requires login) The duty of candour is a general duty to be open and transparent with people receiving care from you. It applies to every health and social care provider that CQC regulates. The duty of candour requires registered providers and registered managers (known as ‘registered persons’) to act in an open and transparent way with people receiving care or treatment from them. The regulation also defines ‘ notifiable safety incidents ’ and specifies how registered persons must apply the duty of candour if these incidents occur. Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Statutory and professional duties of candour There are two types of duty of candour, statutory and professional. Both the statutory duty of candour and professional duty of candour have similar aims – to make sure that those providing care are open and transparent with the people using their services, whether or not something has gone wrong. This guidance is about the statutory duty of candour. We regulate the statutory duty, while the professional duty is overseen by regulators of specific healthcare professions such as the General Medical Council (GMC), Nursing and Midwifery Council (NMC) and the General Dental Council (GDC). The statutory duty also includes specific requirements for certain situations known as ‘ notifiable safety incidents ’. If something qualifies as a notifiable safety incident, carrying out the professional duty alone will not be enough to meet the requirements of the statutory duty. Saying sorry is not admitting fault A crucial part of the duty of candour is the apology. Apologising is not an admission of liability. This is the case, regardless of whether you are in the health or social care, or public or private sectors. In many cases it is the lack of timely apology that pushes people to take legal action. To fulfil the duty of candour, you must apologise for the harm caused, regardless of fault, as well as being open and transparent about what has happened. NHS Resolution is the organisation that manages clinical negligence claims against the NHS. Their ‘ Saying Sorry ’ leaflet confirms that apologising will not affect indemnity cover: “Saying sorry is: always the right thing to do not an admission of liability acknowledges that something could have gone better the first step to learning from what happened and preventing it recurring.” [Regulations for service providers and managers] Regulations for service providers and managers Introduction Health and Social Care Act 2008 (Regulated Activities) Regulations Regulation 4: Requirements where the service provider is an individual or partnership Regulation 5: Fit and proper persons: directors Regulation 6: Requirement where the service provider is a body other than a partnership Regulation 7: Requirements relating to registered managers Regulation 8: General Regulation 9: Person-centred care Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices Regulation 10: Dignity and respect Regulation 11: Need for consent Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments Care Quality Commission (Registration) Regulations Related legislation Related guidance Glossary of terms used in the guidance for providers and managers Service types Regulation 20A: Requirement as to display of performance assessments We've also published more detailed guidance on the requirement to display ratings , which includes details about how to use our widget and download posters from our site. Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20A 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 has developed 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. 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, CQC may also take other regulatory action. See the offences section for more detail. CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation. The regulation in full 20A.— This regulation applies where, and to the extent that, a service provider has received a rating of its performance by the Commission following an assessment of its performance under section 46(1) of the Act (reviews and performance assessments)*. There must be shown on every website maintained by or on behalf of any service provider— the Commission's website address, the place on the Commission's website where the most recent assessment of the service provider's overall performance and of its performance in relation to particular premises or activities may be accessed, and the most recent rating by the Commission of the service provider's overall performance and of its performance in relation to particular premises or activities, in a way which makes it clear to which activities or premises a particular rating relates. There must be displayed at each premises from which the service provider provides regulated activities at least one sign showing the most recent rating by the Commission that relates to the service provider's performance at those premises. For the purposes of paragraph (3), where the service provider has not received a rating of its performance at those premises, the rating to be shown is the rating of the service provider's overall performance. There must be displayed at the service provider's principal place of business at least one sign showing the most recent rating of— the service provider's overall performance, and its performance in relation to particular premises or activities, in a way which makes it clear to which activities or premises a particular rating relates. But paragraph (5) does not apply where the service provider's performance at its principal place of business, or at the premises of which it is part, is itself subject to a separate performance rating given by the Commission (in which case paragraphs (3) and (4) apply). Any sign displayed, or anything shown on a website, under this regulation must— be legible, be displayed conspicuously in a place which is accessible to service users, and for each rating shown, show the date on which it was given by the Commission. This regulation does not apply to any premises that are— the service provider's own home, except where service users have access to it for the purposes of receiving services provided in the carrying on of a regulated activity, or a service user's accommodation where such accommodation is not provided as part of the service user's care or treatment. *Section 46 of the 2008 Act was substituted by section 91(2) of the Care Act 2014. Guidance This sets out the guidance providers must have regard to against the relevant component of the regulation. 20A(1) This regulation applies — 20A(1) This regulation applies where, and to the extent that, a service provider has received a rating of its performance by the Commission following an assessment of its performance under section 46(1) of the Act (reviews and performance assessments). Guidance on 20A(1) This regulation applies where an organisation has received a CQC rating (Outstanding, Good, Requires improvement or Inadequate). This includes those organisations rated before 1 April 2015. In all instances, the most recent CQC rating is the one that should be displayed. 20A(2) There must be shown on every website maintained by or on behalf of any service provider — ( a) the Commission's website address (b) the place on the Commission's website where the most recent assessment of the service provider's overall performance and of its performance in relation to particular premises or activities may be accessed. Guidance on 20A(2) Providers must display their ratings on their websites. CQC has provided digital products to enable providers to do this. Using these will ensure that they display all the information required under this regulation. We have published more detailed guidance on what must be displayed on each website. 20A(3) There must be displayed at each premises from which the service provider provides regulated activities at least one sign showing the most recent rating by the Commission of the service provider's performance that relates to those premises. Guidance on 20A(3) If a regulated activity is provided at a premises, and the service provider has been rated by CQC, then the rating must be displayed. CQC has developed posters to help providers ensure that all the relevant information is included in an appropriate way. Using these will ensure that providers display all the information required under this regulation. We have published more detailed guidance on what must be displayed in each premises. 20A(7) Any sign displayed, or anything shown on a website, under this regulation must— (b) be displayed conspicuously in a place which is accessible to service users. Guidance on 20A(7) Whether something is conspicuous will depend on the setting. We have therefore published more detailed guidance on where and how to display.