The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014

Made: 6th November 2014

Coming into force in accordance with regulation 1

The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 8, 20(1) to (5A), 35, 86(2) and (4), 87(1) and (2) and 161(3) and (4) of the Health and Social Care Act 2008 .

In accordance with section 20(8) of that Act, the Secretary of State has consulted such persons as the Secretary of State considers appropriate.

A draft of these Regulations was laid before Parliament in accordance with section 162(3) of the Health and Social Care Act 2008, and was approved by a resolution of each House of Parliament.

PART 1 — General

Citation and commencement

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• (1) These Regulations may be cited as the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

• (2) This regulation and regulation 2 come into force on the day after the day on which these Regulations are made.

• (3) The provisions to which this paragraph applies come into force at the end of the period of 21 days beginning with the day on which these Regulations are made.

• (4) Paragraph (3) applies to—

• (a) regulation 5, and Schedule 3 insofar as it relates to regulation 5;

• (b) regulation 20;

• (c) regulation 21, only insofar as it relates to regulations 5 and 20;

• (d) regulation 22(3);

• (e) regulation 22(4), only insofar as it relates to a breach of regulation 20(2)(a) and (3);

• (f) regulation 23(6);

• (g) regulation 24 and Schedule 5, only insofar as they relate to a contravention of, or a failure to comply with, requirements in regulation 20(2)(a) and (3);

• (h) regulation 26(2);

• (i) Schedule 4.

• (5) All other provisions of these Regulations come into force on 1st April 2015.

• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Interpretation

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• (1) In these Regulations—

• “16 to 19 Academy” has the same meaning as in section 1B of the Academies Act 2010 ;

• “the Act” means the Health and Social Care Act 2008;

• “the 1983 Act” means the Mental Health Act 1983 ;

• “the 2005 Act” means the Mental Capacity Act 2005 ;

• “the 2006 Act” means the National Health Service Act 2006 ;

• “the 2001 Order” means the Health Professions Order 2001;

• “the 2010 Regulations” means the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 ;

• “employment” means—employment under a contract of service, an apprenticeship, a contract for services or otherwise than under a contract, andthe grant of practising privileges by a service provider to a medical practitioner, giving permission to practice as a medical practitioner in a hospital managed by the service provider,and “employed” and “employer” is to be construed accordingly;

• “employment agency” and “employment business” have the same meaning as in section 13 (interpretation) of the Employment Agencies Act 1973 ;

• “equipment” includes—a medical device (as defined in regulation 2(1) (interpretation) of the Medical Devices Regulations 2002) , andmaterials used in, or used by persons employed in, the carrying on of a regulated activity;

• “health care professional”, except in paragraph 4 of Schedule 1, means a person who is registered as a member of any profession to which section 60(2) of the Health Act 1999 (regulation of health professions, social workers, other care workers, etc) applies;

• “health service body” means—an NHS trust established under section 25 of the 2006 Act,an NHS foundation trust,...a Special Health Authority , or NHS England;

• “hospital”, except in paragraphs 1(3)(d) and 5 of Schedule 1, has the same meaning as in section 275 (interpretation) of the 2006 Act;

• “institution within the further education sector” has the same meaning as in section 91 (interpretation of Education Acts) of the Further and Higher Education Act 1992 ;

• “local anaesthesia” means any anaesthesia other than general, spinal or epidural anaesthesia, and also excludes the administration of a regional nerve block;

• “medical practitioner” means a registered medical practitioner;

• “nominated individual” must be construed in accordance with regulation 6(2);

• “nurse” means a registered nurse;

• “nursing care” means any services provided by a nurse and involving—the provision of care, orthe planning, supervision or delegation of the provision of care,

other than any services which, having regard to their nature and the circumstances in which they are provided, do not need to be provided by a nurse;

• “partnership” does not include a limited liability partnership;

• “personal care” means—physical assistance given to a person in connection with—eating or drinking (including the maintenance of established parenteral nutrition),toileting (including in relation to the process of menstruation),washing or bathing,dressing,oral care, orthe care of skin, hair and nails (with the exception of nail care provided by a person registered with the Health and Care Professions Council as a chiropodist or podiatrist pursuant to article 5 of the 2001 Order), orthe prompting, together with supervision, of a person, in relation to the performance of any of the activities listed in paragraph (a), where that person is unable to make a decision for themselves in relation to performing such an activity without such prompting and supervision;

• “premises” means—any building or other structure, including any machinery, engineering systems or other objects which are physically affixed and integral to such building or structure, and any surrounding grounds, ora vehicle,

but in regulations 12, 14 and 15 does not include the service user's accommodation where such accommodation is not provided as part of the service user's care or treatment ...;

• ...

• “reasonable adjustments” means such reasonable adjustments as would be required under the Equality Act 2010 ;

• “registered manager” means, in respect of a regulated activity, a person registered with the Commission under Chapter 2 of Part 1 of the Act as a manager in respect of that activity;

• “registered person” means, in respect of a regulated activity, a person who is the service provider or registered manager in respect of that activity;

• “relevant person”, except in regulation 20, means the service user or, where the service user is under 16 and not competent to make a decision in relation to their care or treatment, a person lawfully acting on their behalf;

• “school” has the same meaning as in section 4 of the Education Act 1996 ;

• “service provider” means, in respect of a regulated activity, a person registered with the Commission under Chapter 2 of Part 1 of the Act as a service provider in respect of that activity;

• “service user” means a person who receives services provided in the carrying on of a regulated activity;

• “shared lives agreement” means an agreement entered into between a person carrying on a shared lives scheme and an individual for the provision, by that individual, of personal care to a service user together with, where necessary, accommodation in the individual's home;

• “shared lives carer” means an individual who, under the terms of a shared lives agreement, provides, or intends to provide, personal care for service users together with, where necessary, accommodation in the individual's home;

• “shared lives scheme” means a scheme carried on (whether or not for profit) by a local authority or other person for the purposes of—recruiting and training shared lives carers,making arrangements for the placing of service users with shared lives carers, andsupporting and monitoring placements ,and for the purposes of section 20A of the Act (functions relating to processing of information by registered persons) “adult placement scheme” has the same meaning as “shared lives scheme”

• “social worker” means a person who is registered as such in the register of social workers in England maintained under section 39(1) of the Children and Social Work Act 2017;

• “treatment”, except in paragraph 5 of Schedule 1, includes—a diagnostic or screening procedure carried out for medical purposes,the ongoing assessment of a service user's mental or physical state,nursing, personal and palliative care, andthe giving of vaccinations and immunisations;

• “vulnerable adult” has the same meaning as in section 60(1) (interpretation) of the Safeguarding Vulnerable Groups Act 2006 .

• (2) In the definition of “employment” in paragraph (1), the reference to otherwise than under a contract includes—

• (a) under a shared lives agreement;

• (b) under an agreement between the service provider and a temporary work agency for the supply of an agency worker to the service provider;

• (c) under arrangements for persons to provide their services voluntarily.

• (3) In paragraph (2)—

PART 2 — Regulated Activities

Prescribed activities

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• (1) Subject to paragraphs (3) and (4), the activities specified in Schedule 1 are prescribed as regulated activities for the purposes of section 8(1) of the Act.

• (2) An activity which is ancillary to, or is carried on wholly or mainly in relation to, a regulated activity shall be treated as part of that activity.

• (3) An activity is only a regulated activity if it is carried on in England.

• (4) The activities specified in Schedule 2 are not regulated activities.

PART 3 — Requirements in relation to Regulated Activities

SECTION 1 — Requirements relating to persons carrying on or managing a regulated activity

Requirements where the service provider is an individual or partnership

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• (1) This regulation applies where a service provider (P) is an individual or a partnership.

• (2) P must not carry on a regulated activity unless P is fit to do so.

• (3) P is not fit to carry on a regulated activity unless P is—

• (a) an individual who carries on the regulated activity, otherwise than in partnership with others, and satisfies the requirements set out in—

• (i) paragraph (4), and

• (ii) paragraph (5), or

• (b) a partnership and—

• (i) each of the partners satisfies the requirements set out in paragraph (4), and

• (ii) P satisfies the requirement set out in paragraph (6).

• (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—

• (a) is of good character,

• (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, and

• (c) is able to supply to the Commission, or arrange for the availability of, information relating to themselves specified in Schedule 3.

• (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.

• (6) 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, skills and experience to carry on the regulated activity.

• (7) In assessing an individual’s character for the purposes of paragraph (4)(a), the matters considered must include those listed in Part 2 of Schedule 4.

Fit and proper persons: directors

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• (1) This regulation applies where the service provider is a body other than a partnership.

• (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.

• (3) The requirements referred to in paragraph (2) are that—

• (a) the individual is of good character,

• (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,

• (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,

• (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

• (e) none of the grounds of unfitness specified in Part 1 of Schedule 4 apply to the individual.

• (4) 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.

• (5) 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)—

• (a) the information specified in Schedule 3, and

• (b) such other information as is required to be kept by the service provider under any enactment which is relevant to that individual.

• (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.

Requirement where the service provider is a body other than a partnership

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• (1) This regulation applies where the service provider is a body other than a partnership.

• (2) 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—

• (a) employed as a director, manager or secretary of the body, and

• (b) responsible for supervising the management of the carrying on of the regulated activity by the body.

• (3) The registered person must take all reasonable steps to ensure that the nominated individual—

• (a) is of good character,

• (b) has the necessary qualifications , competence, skills and experience to properly supervise the management of the carrying on of the regulated activity,

• (c) is able by reason of their health, after reasonable adjustments are made, of properly doing so, and

• (d) is able to supply to the registered person, or arrange for the availability of, the information specified in Schedule 3.

• (4) 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.

Requirements relating to registered managers

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• (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.

• (2) M is not fit to be a registered manager in respect of a regulated activity unless M is—

• (a) of good character,

• (b) has the necessary qualifications , competence, skills and experience to manage the carrying on of the regulated activity,

• (c) able by reason of M's health, after reasonable adjustments are made, of doing so, and

• (d) able to supply to the Commission, or arrange for the availability of, the information specified in Schedule 3.

• (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.

SECTION 2 — Fundamental Standards

General

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• (1) A registered person must comply with regulations 9 to 20A in carrying on a regulated activity.

• (2) 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.

• (3) 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.

Person-centred care

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• (1) The care and treatment of service users must—

• (a) be appropriate,

• (b) meet their needs, and

• (c) reflect their preferences.

• (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.

• (3) Without limiting paragraph (1), the things which a registered person must do to comply with that paragraph include—

• (a) carrying out, collaboratively with the relevant person, an assessment of the needs and preferences for care and treatment of the service user;

• (b) designing care or treatment with a view to achieving service users' preferences and ensuring their needs are met;

• (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;