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

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Statutory Instruments

# 2014 No. 2936

National Health Service, England

Social Care, England

Public Health, England

# 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 F1.                        

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.                        

F12008 c. 14. Section 20 of the Health and Social Care Act 2008 (“the 2008 Act”) was amended by section 81 of the Care Act 2014 (c. 23). Section 161(3) of the 2008 Act was amended by section 294(4) of the Health and Social Care Act 2012 (c. 7).

## **PART 1**E+WGeneral

### Citation and commencementE+W

1.—(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.

[F2(6)These Regulations cease to have effect after 31st March 2022.]                  

F2Reg. 1(6) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **3**

### InterpretationE+W

2.—(1) In these Regulations—                  

“16 to 19 Academy” has the same meaning as in section 1B of the Academies Act 2010 F3;                  

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

“the 1983 Act” means the Mental Health Act 1983 F4;                  

“the 2005 Act” means the Mental Capacity Act 2005 F5;                  

“the 2006 Act” means the National Health Service Act 2006 F6;                  

“the 2001 Order” means the [F7Health Professions Order 2001];                  

“the 2010 Regulations” means the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 F8;                  

“employment” means—                  

employment under a contract of service, an apprenticeship, a contract for services or otherwise than under a contract, and

the 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 F9;                  

“equipment” includes—                  

a medical device (as defined in regulation 2(1) (interpretation) of the Medical Devices Regulations 2002) F10, and                           

materials 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 F11 (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, or

a Special Health Authority;

“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 F12;                  

“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, or

the 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, or

the 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), or                                    

the 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, or                           

a 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 F13;                  

“registered manager” means, in respect of a regulated activity, a person registered with the Commission F14 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 F15;                  

“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, and

supporting and monitoring placements[F16,                           

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 [F17the 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, and

the giving of vaccinations and immunisations;

“vulnerable adult” has the same meaning as in section 60(1) (interpretation) of the Safeguarding Vulnerable Groups Act 2006 F18.                  

(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)—

“agency worker” and “temporary work agency” have the same meaning as in the Agency Workers Regulations 2010 F19.                     

F32010 c. 32. Section 1B was inserted by section 53(7) of the Education Act 2011 (c. 21).

F41983 c. 20.

F52005 c. 9. Relevant amendments were made by the Mental Health Act 2007 (c. 12), **sections 50** and 55 and Part 10 of Schedule 11.

F62006 c. 41.

F7Words in reg. 2(1) substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, **Sch. 3 para. 34(a)**; S.I. 2019/1436, reg. 2(b)

F8S.I. 2010/781, as amended by S.I. 2011/2711, 2012/921, 2012/979, 2012/1479, 2012/1513, 2013/235 and 2013/472.

F91973 c. 35. Relevant amendments were made by the Employment Relations Act 1999 (c. 26), **section 31** and paragraphs 1 and 7 of Schedule7.

F10S.I. 2002/618. Relevant amendments were made by S.I. 2008/2986.

F111999 c. 21. Relevant amendments were made by the Health and Social Care Act 2008, sections 111 and 116, paragraph 1 of Schedule 8 and                              Part 2 of Schedule 15, the Health and Social Care Act 2012, sections 209 and 213, and S.I. 2002/253 and 2010/231.

F121992 c. 13. Relevant amendments were made by the Apprenticeships, Skills, Children and Learning Act 2009 (c. 22), **section 125** and paragraphs 1 and 13(1) and (2) of Schedule 8.

F132010 c. 15.

F14By section 1(1) of the 2008 Act, “the Commission” means the Care Quality Commission.

F151996 c. 56. Relevant amendments were made by the Education Act 1997 (c. 44), **sections 51** and 57, paragraph 10 of Schedule 7 and Schedule 8, the Education Act 2002 (c. 32), **section 215** and Part 3 of Schedule 22, the Childcare Act 2006 (c. 21), **section 95**, and the Education Act 2011 (c. 21), **section 54** and paragraph 9 of Schedule 13, and S.I. 2010/1080.

F16Words in reg. 2(1) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **4**

F17Words in reg. 2(1) substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, **Sch. 3 para. 34(b)**; S.I. 2019/1436, reg. 2(b)

F182006 c. 47. Relevant amendments were made by section 65(2) of the Protection of Freedoms Act 2012 (c. 9).

F19S.I. 2010/93. Relevant amendments were made by S.I. 2011/1941.

## **PART 2**E+WRegulated Activities

### Prescribed activitiesE+W

3.—(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**E+WRequirements in relation to Regulated Activities

### SECTION 1E+WRequirements relating to persons carrying on or managing a regulated activity

#### Requirements where the service provider is an individual or partnershipE+W

4.—(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 [F20, 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 [F21, competence], skills and experience of the partners, P has the necessary qualifications, skills and experience to carry on the regulated                     activity.                  

[F22(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.]                  

F20Word in reg. 4(5) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **5(a)**

F21Word in reg. 4(6) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **5(a)**

F22Reg. 4(7) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **5(b)**

#### Fit and proper persons: directorsE+W

5.—[F23(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), [F24a 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, F25... 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.                  

F23Reg. 5(1) substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **6(2)**

F24Words in reg. 5(2) substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **6(3)(a)**

F25Word in reg. 5(2)(b) omitted (1.4.2015) by virtue of The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **6(3)(b)**

#### Requirement where the service provider is a body other than a partnershipE+W

6.—(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 [F26, 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.                  

[F27(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.]                  

F26Word in reg. 6(3)(b) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **7(a)**

F27Reg. 6(4) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **7(b)**

#### Requirements relating to registered managersE+W

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.                  

(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 [F28, 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.                  

[F29(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.]                  

F28Word in reg. 7(2)(b) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **8(a)**

F29Reg. 7(3) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **8(b)**

### SECTION 2E+WFundamental Standards

#### GeneralE+W

8.—(1) A registered person must comply with regulations [F309 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 [F309 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 [F309 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.                  

F30Words in reg. 8 substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **9**

#### Person-centred careE+W

9.—(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;                  

(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;                  

(e)providing opportunities for relevant persons to manage the service user's care or treatment;                  

(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;                  

(g)providing relevant persons with the information they would reasonably need for the purposes of sub-paragraphs (c) to (f);                  

(h)making reasonable adjustments to enable the service user to receive their care or treatment;                  

(i)where meeting a service user's nutritional and hydration needs, having regard to the service user's well-being.                  

(4) Paragraphs (1) and (3) apply subject to paragraphs (5) and (6).

(5) 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.                  

(6) 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.                  

#### Dignity and respectE+W

10.—(1) Service users must be treated with dignity and respect.                  

(2) Without limiting paragraph (1), the things which a registered person is required to do to comply with paragraph (1) include                     in particular—                  

(a)ensuring the privacy of the service user;                  

(b)supporting the autonomy, independence and involvement in the community of the service user;                  

(c)having due regard to any relevant protected characteristics (as defined in section 149(7) of the Equality Act 2010) of the                        service user.                  

#### Need for consentE+W

11.—(1) Care and treatment of service users must only be provided with the consent of the relevant person.                  

(2) Paragraph (1) is subject to paragraphs (3) and (4).

(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.                  

(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.                  

(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).                  

#### Safe care and treatmentE+W

12.—(1) Care and treatment must be provided in a safe way for service users.                  

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

(a)assessing the risks to the health and safety of service users of receiving the care or treatment;                  

(b)doing all that is reasonably practicable to mitigate any such risks;                  

(c)ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience                        to do so safely;                  

(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;                  

(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 is used in a safe way;                  

(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;                  

(g)the proper and safe management of medicines;                  

(h)assessing the risk of, and preventing, detecting and controlling the spread of, infections, including those that are health                        care associated;                  

(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.                  

#### Safeguarding service users from abuse and improper treatmentE+W

13.—(1) Service users must be protected from abuse and improper treatment in accordance with this regulation.                  

(2) Systems and processes must be established and operated effectively to prevent abuse of service users.

(3) Systems and processes must be established and operated effectively to investigate, immediately upon becoming aware of, any                     allegation or evidence of such abuse.                  

(4) Care or treatment for service users must not be provided in a way that—

(a)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,                  

(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,                  

(c)is degrading for the service user, or                  

(d)significantly disregards the needs of the service user for care or treatment.                  

(5) A service user must not be deprived of their liberty for the purpose of receiving care or treatment without lawful authority.

(6) For the purposes of this regulation—

“abuse” means—                     

any behaviour towards a service user that is an offence under the Sexual Offences Act 2003 F31,                              

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.

(7) For the purposes of this regulation, a person controls or restrains a service user if that person—

(a)uses, or threatens to use, force to secure the doing of an act which the service user resists, or                  

(b)restricts the service user's liberty of movement, whether or not the service user resists,                  

including by use of physical, mechanical or chemical means.

F312003 c. 42.

#### Meeting nutritional and hydration needsE+W

14.—(1) The nutritional and hydration needs of service users must be met.                  

(2) Paragraph (1) applies where—

(a)care or treatment involves—                  

(i)the provision of accommodation by the service provider, or                  

(ii)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.                  

(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.                  

(4) For the purposes of paragraph (1), “nutritional and hydration needs” means—                  

(a)receipt by a service user of suitable and nutritious food and hydration which is adequate to sustain life and good health,                  

(b)receipt by a service user of parenteral nutrition and dietary supplements when prescribed by a health care professional,                  

(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                  

(d)if necessary, support for a service user to eat or drink.                  

(5) 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.                  

#### Premises and equipmentE+W

15.—(1) All premises and equipment used by the service provider must be—                  

(a)clean,                  

(b)secure,                  

(c)suitable for the purpose for which they are being used,                  

(d)properly used                  

(e)properly maintained, and                  

(f)appropriately located for the purpose for which they are being used.                  

(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.                  

(3) For the purposes of paragraph (1)(b), (c), (e) and (f), “equipment” does not include equipment at the service user's accommodation if—                  

(a)such accommodation is not provided as part of the service user's care or treatment, and                  

(b)such equipment is not supplied by the service provider.                  

#### Receiving and acting on complaintsE+W

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.                  

(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.                  

(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.                  

#### Good governanceE+W

17.—(1) Systems or processes must be established and operated effectively to ensure compliance with the requirements in this Part.                  

(2) Without limiting paragraph (1), such systems or processes must enable the registered person, in particular, to—

(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);                  

(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;                  

(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;                  

(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;                  

(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;                  

(f)evaluate and improve their practice in respect of the processing of the information referred to in sub-paragraphs (a) to (e).                  

(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—                  

(a)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                  

(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.                  

#### StaffingE+W

18.—(1) Sufficient numbers of suitably qualified, competent, skilled and experienced persons must be deployed in order to meet the                     requirements of this Part.                  

(2) Persons employed by the service provider in the provision of a regulated activity must—

(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,                  

(b)be enabled where appropriate to obtain further qualifications appropriate to the work they perform, and                  

(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.                  

#### Fit and proper persons employedE+W

19.—(1) Persons employed for the purposes of carrying on a regulated activity must—                  

(a)be of good character,                  

(b)have the qualifications, competence, skills and experience which are necessary for the work to be performed by them, and                  

(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.                  

(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.                  

(3) The following information must be available in relation to each such person employed—

(a)the information specified in Schedule 3, and                  

(b)such other information as is required under any enactment to be kept by the registered person in relation to such persons                        employed.                  

(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.                  

(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.                  

(6) Paragraphs (1) and (3) of this regulation do not apply in a case to which regulation 5 applies.

#### Duty of candourE+W

20.—(1) [F32Registered persons] must act in an open and transparent way with relevant persons in relation to care and treatment provided to service users                     in carrying on a regulated activity.                  

(2) As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred a [F33registered person] must—                  

(a)notify the relevant person that the incident has occurred in accordance with paragraph (3), and                  

(b)provide reasonable support to the relevant person in relation to the incident, including when giving such notification.                  

(3) The notification to be given under paragraph (2)(a) must—

(a)be given in person by one or more representatives of the [F34registered person],                  

(b)provide an account, which to the best of the [F35registered person’s] knowledge is true, of all the facts the [F35registered person] knows about the incident as at the date of the notification,                  

(c)advise the relevant person what further enquiries into the incident the [F36registered person] believes are appropriate,                  

(d)include an apology, and                  

(e)be recorded in a written record which is kept securely by the [F37registered person].                  

(4) The notification given under paragraph (2)(a) must be followed by a written notification given or sent to the relevant person                     containing—                  

(a)the information provided under paragraph (3)(b),                  

(b)details of any enquiries to be undertaken in accordance with paragraph (3)(c),                  

(c)the results of any further enquiries into the incident, and                  

(d)an apology.                  

(5) But if the relevant person cannot be contacted in person or declines to speak to the representative of the [F38registered person]—                  

(a)paragraphs (2) to (4) are not to apply, and                  

(b)a written record is to be kept of attempts to contact or to speak to the relevant person.                  

(6) The [F39registered person] must keep a copy of all correspondence with the relevant person under paragraph (4).                  

(7) In this regulation—

“apology” means an expression of sorrow or regret in respect of a notifiable safety incident;                  

“moderate harm” means—                  

harm that requires a moderate increase in treatment, and

significant, but not permanent, harm;

“moderate increase in treatment” means an unplanned return to surgery, an unplanned re-admission, a prolonged episode of care, extra time in hospital or                     as an outpatient, cancelling of treatment, or transfer to another treatment area (such as intensive care);                  

[F40“notifiable safety incident” has the meaning given in paragraphs (8) and (9);]                   

[F41“prolonged pain” means pain which a service user has experienced, or is likely to experience, for a continuous period of at                        least 28 days;]                   

“prolonged psychological harm” means psychological harm which a service user has experienced, or is likely to experience, for a continuous period of at                     least 28 days;                  

“relevant person” means the service user or, in the following circumstances, a person lawfully acting on their behalf—                  

on the death of the service user,

where the service user is under 16 and not competent to make a decision in relation to their care or treatment, or

where the service user is 16 or over and lacks capacityF42... in relation to the matter;                           

“severe harm” means a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong                     limb or organ or brain damage, that is related directly to the incident and not related to the natural course of the service                     user's illness or underlying condition.                  

[F43(8)In relation to a health service body, “notifiable safety incident” means any unintended or unexpected incident that occurred                        in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care                        professional, could result in, or appears to have resulted in—                  

(a)the death of the service user, where the death relates directly to the incident rather than to the natural course of the service                           user’s illness or underlying condition, or                  

(b)severe harm, moderate harm or prolonged psychological harm to the service user.                  

(9)In relation to any other registered person, “notifiable safety incident” means any unintended or unexpected incident that                        occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health                        care professional—                  

(a)appears to have resulted in—                  

(i)the death of the service user, where the death relates directly to the incident rather than to the natural course of the service                           user’s illness or underlying condition,                  

(ii)an impairment of the sensory, motor or intellectual functions of the service user which has lasted, or is likely to last,                           for a continuous period of at least 28 days,                  

(iii)changes to the structure of the service user’s body,                  

(iv)the service user experiencing prolonged pain or prolonged psychological harm, or                  

(v)the shortening of the life expectancy of the service user; or                  

(b)requires treatment by a health care professional in order to prevent—                  

(i)the death of the service user, or                  

(ii)any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned in sub-paragraph                           (a).]                  

F32Words in reg. 20(1) substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **10(2)**

F33Words in reg. 20(2) substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **10(3)(a)**

F34Words in reg. 20(3)(a) substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **10(3)(b)**

F35Words in reg. 20(3)(b) substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **10(3)(b)**

F36Words in reg. 20(3)(c) substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **10(3)(b)**

F37Words in reg. 20(3)(e) substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **10(3)(b)**

F38Words in reg. 20(5) substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **10(3)(c)**

F39Words in reg. 20(6) substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **10(3)(d)**

F40Words in reg. 20(7) substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **10(4)(a)**

F41Words in reg. 20(7) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **10(4)(b)**

F42Words in reg. 20(7) omitted (1.4.2015) by virtue of The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **10(4)(c)**

F43Reg. 20(8)(9) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **10(5)**

#### [F44Requirement as to display of performance assessmentsE+W

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).                  

(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, and                  

(c)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.                  

(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 that relates to the service provider’s performance at those premises.                  

(4)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.                  

(5)There must be displayed at the service provider’s principal place of business at least one sign showing the most recent rating                        of—                  

(a)the service provider’s overall performance, and                  

(b)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.                  

(6)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).                  

(7)Any sign displayed, or anything shown on a website, under this regulation must—                  

(a)be legible,                  

(b)be displayed conspicuously in a place which is accessible to service users, and                  

(c)for each rating shown, show the date on which it was given by the Commission.                  

(8)This regulation does not apply to any premises that are—                  

(a)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                  

(b)a service user’s accommodation where such accommodation is not provided as part of the service user’s care or treatment.]                  

F44Reg. 20A inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **11**

## **PART 4**E+WCompliance and Offences

### Guidance and CodeE+W

21.  For the purposes of compliance with the requirements set out in these Regulations, the registered person must have regard                     to—                  

(a)guidance issued by the Commission under section 23 of the Act in relation to the requirements set out in Part 3 (with the                        exception of regulation 12 in so far as it applies to health care associated infections); and                  

(b)in relation to regulation 12, in so far as it applies to health care associated infections, any code of practice issued by                        the Secretary of State under section 21 of the Act in relation to the prevention or control of health care associated infections.                  

### OffencesE+W

22.—(1) It is an offence for a registered person to fail to comply with any of the requirements in the following regulations, as read                     with regulation 8—                  

(a)regulation 11,                  

(b)regulation 16(3), F45...                  

(c)regulation 17(3).                  

[F46(d)regulation 20(2)(a) and (3), or                  

(e)regulation 20A.]                  

(2) A registered person commits an offence if the registered person fails to comply with a requirement of regulation 12, 13(1)                     to (4) or 14, as read with regulation 8, and such failure results in—                  

(a)avoidable harm (whether of a physical or psychological nature) to a service user,                  

(b)a service user being exposed to a significant risk of such harm occurring, or                  

(c)in a case of theft, misuse or misappropriation of money or property, any loss by a service user of the money or property concerned.                  

F47(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .                  

(4) But it is a defence for a registered personF48... to prove that they took all reasonable steps and exercised all due diligence to prevent the breach of any of those regulations                     that has occurred.                  

F45Word in reg. 22(1)(b) omitted (1.4.2015) by virtue of The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **12(2)(a)**

F46Reg. 22(1)(d)(e) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **12(2)(b)**

F47Reg. 22(3) omitted (1.4.2015) by virtue of The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **12(3)**

F48Words in reg. 22(4) omitted (1.4.2015) by virtue of The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **12(4)**

### Offences: penaltiesE+W

23.—F49(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .                  

F49(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .                  

F49(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .                  

(4) A person guilty of an offence under regulation 22(1) for breach of regulation 11 or an offence under regulation 22(2) is liable                     on summary conviction to [F50a fine] .                  

(5) A person guilty of an offence under regulation 22(1) for breach of regulation [F5116(3), 17(3) or 20(2)(a) and (3] is liable, on summary conviction, to a fine not exceeding level 4 on the standard scale.                  

[F52(5A)A person guilty of an offence under regulation 22(1) for breach of regulation 20A is liable, on summary conviction, to a fine                        not exceeding level 2 on the standard scale.]                  

F53(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .                  

F49Reg. 23(1)(2)(3) omitted (12.3.2015) by virtue of The Legal Aid, Sentencing and Punishment of Offenders Act 2012 (Fines on Summary Conviction) Regulations 2015 (S.I. 2015/664), reg. 1(1), **Sch. 4 para. 85(2)** (with reg. 5(1))

F50Words in reg. 23(4) substituted (12.3.2015) by The Legal Aid, Sentencing and Punishment of Offenders Act 2012 (Fines on Summary Conviction) Regulations 2015 (S.I. 2015/664), reg. 1(1), **Sch. 4 para. 85(3)** (with reg. 5(1))

F51Words in reg. 23(5) substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **13(2)**

F52Reg. 23(5A) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **13(3)**

F53Reg. 23(6) omitted (1.4.2015) by virtue of The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **13(4)**

## **PART 5**E+WPenalty Notices

### Penalty noticesE+W

24.—(1) The offences under the provisions listed in the first column of Schedule 5 are prescribed as fixed penalty offences for the                     purposes of section 86 of the Act.                  

(2) The monetary amount of a penalty for each fixed penalty offence is prescribed in the third column of Schedule 5.

(3) The time by which the penalty specified in a penalty notice is to be paid is the end of the period of 28 days beginning with                     the date of receipt of the notice.                  

(4) Subject to paragraph (5), the methods by which a penalty notice may be paid are by cash, cheque, credit or debit card, postal                     order or electronic transfer of funds to the Commission's bank account.                  

(5) A penalty may only be paid by credit card from the date on which the Commission has in place arrangements to accept such payments.

(6) Where a person is given a penalty notice, proceedings for the offence to which the notice relates may not be instituted before                     the end of the period of 28 days beginning with the date of receipt of the notice.                  

(7) Section 93 of the Act applies to a penalty notice as it applies to a notice required to be given under Part 1 of the Act.

(8) If a penalty notice is given by being sent by an electronic communication, in accordance with section 94 of the Act, the notice                     is, unless the contrary is proved, to be taken to have been received on the next working day after the day on which it is                     sent.                  

(9) A penalty notice must give such particulars of the circumstances alleged to constitute the offence as seem to the Commission                     to be reasonably required to provide the person to whom the notice is given with information about it.                  

(10) A penalty notice must state—

(a)the name and address of the person to whom the notice is given,                  

(b)the amount of the penalty,                  

(c)the period during which proceedings will not be taken for the offence,                  

(d)that payment within that period will discharge any liability for the offence,                  

(e)the consequences of the penalty not being paid before the expiration of the period for paying it,                  

(f)the person to whom and the address at which the penalty may be paid and to which any correspondence about the penalty may                        be sent, and                  

(g)the means by which payment of the penalty may be made.                  

(11) The Commission may withdraw a penalty notice by giving written notice of the withdrawal to the person to whom the notice was                     given if—                  

(a)the Commission determines that it ought not to have been given or it ought not to have been given to the person to whom it                        was addressed, or                  

(b)it appears to the Commission that the notice contains material errors.                  

(12) A penalty notice may be withdrawn in accordance with paragraph (11) whether or not the period for payment referred to in paragraph                     (3) has expired, and whether or not the penalty has been paid.                  

(13) Where a penalty notice has been withdrawn in accordance with paragraph (11), the Commission must—

(a)repay any amount paid by way of penalty in pursuance of that notice to the person who paid it, within 14 days beginning with                        the day on which written notice of the withdrawal was given, and                  

(b)remove from publication any information about the payment of the penalty which has been published in accordance with regulations                        made under section 89 of the Act, within 7 days beginning with the day on which written notice of the withdrawal was given.                  

(14) Except as provided in paragraph (15), no proceedings may be instituted or continued against the person to whom a penalty notice                     was given for the offence to which the penalty notice relates where that notice has been withdrawn in accordance with paragraph                     (11).                  

(15) Where a penalty notice has been withdrawn under paragraph (11)(b), proceedings may be instituted or continued for the offence                     in connection with which that penalty notice was issued if a further penalty notice in respect of the offence has been given                     and the penalty has not been paid before the expiration of the period for payment referred to in paragraph (3).                  

(16) In this regulation—

“debit card” means a card the use of which by its holder to make a payment results in a current account of the holder at a bank, or at                     any other institution providing banking services, being debited with the payment;                  

“credit card” means a card which is a credit-token within the meaning of section 14 of the Consumer Credit Act 1974 F54;                  

“electronic communication” has the same meaning as in the Electronic Communications Act 2000 F55;                  

“working day” means any day other than—                  

a Saturday or Sunday,

Christmas Day or Good Friday, or

a day which is a bank holiday in England and Wales under the Banking and Financial Dealings Act 1971 F56.                           

F541974 c. 39.

F552000 c. 7. *See* section 15(1) (general interpretation), as amended by the Communications Act 2003 (c. 21), **section 406(1)** and paragraph 158 of Schedule 17.

F561971 c. 80. *See* section 1 and paragraph 1 of Schedule 1.

## **PART 6**E+WMiscellaneous

### RevocationsE+W

25.—[F57(1)] The following are revoked—                  

(a)the 2010 Regulations,                  

(b)the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2011 F58,                  

(c)regulation 11 of the Care Quality Commission (Registration) and (Additional Functions) and Health and Social Care Act 2008                        (Regulated Activities) (Amendment) Regulations 2012 F59, and                  

(d)the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 F60.                  

[F61(2)Despite the revocation in paragraph (1)(a), the definitions of “nursing care” and “personal care” in regulation 2 of the 2010 Regulations (interpretation) are to continue to have effect so far as necessary for the purposes of section 73 of the Care Act 2014 (Human                        Rights Act 1998: provision of regulated care or support etc a public function).]                  

F57Reg. 25 renumbered as reg. 25(1) (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **14(2)**

F58S.I. 2011/2711.

F59S.I. 2012/921.

F60S.I. 2012/1513.

F61Reg. 25(2) inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **14(3)**

### Transitional and transitory provisionE+W

26.—(1) No proceedings for an offence under regulation 22 may be brought against a person for a failure to comply with any of regulations                     11, 12, 13(1) to (4), 14, 16(3), 17(3) or 20(2)(a) and (3) in so far as such failure was a continuing failure which—                  

(a)was the subject of a warning notice given by the Commission in accordance with regulation 27(2)(a) of the 2010 Regulations                        (offences), and                  

(b)occurred during the period ending with the time specified in that notice within which the registered person must take action                        to secure compliance in accordance with section 29(2)(c)(ii) of the Act.                  

F62(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .                  

F62Reg. 26(2) omitted (1.4.2015) by virtue of The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **15**

### ReviewE+W

27.—(1) Before [F631st April 2020], the Secretary of State must—                  

(a)carry out a review of these Regulations,                  

(b)set out the conclusions of the review in a report, and                  

(c)publish the report.                  

(2) The report must in particular—

(a)set out the objectives intended to be achieved by the regulatory system established by these Regulations,                  

(b)assess the extent to which those objectives are achieved, and                  

(c)assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that                        imposes less regulation.                  

F64(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .                  

F64(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .                  

F63Words in reg. 27(1) substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **16(2)**

F64Reg. 27(3)(4) omitted (1.4.2015) by virtue of The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **16(3)**

Signed by the authority of the Secretary of State for Health.

Norman Lamb

 Minister of State,

 Department of Health

 Regulation 3(1)

## SCHEDULE 1E+WRegulated Activities

### Personal careE+W

1.—(1) Subject to sub-paragraphs (2) and (3), the provision of personal care for persons who, by reason of old age, illness or disability                     are unable to provide it for themselves, and which is provided in a place where those persons are living at the time the care                     is provided.                  

(2) Sub–paragraph (1) does not apply where paragraph 2 (accommodation for persons who require nursing or personal care) applies.

(3) Sub-paragraph (1) does not apply to—

(a)the supply of carers to a service provider by an undertaking acting as an employment agency or employment business for the                        purposes of that provider carrying on a regulated activity,                  

(b)the introduction of carers to an individual (other than a service provider) by a person (including an employment agency or                        an employment business) having no ongoing role in the direction or control of the service provided to that individual,                  

(c)the services of a carer employed by an individual or related third party, without the involvement of an undertaking acting                        as an employment agency or employment business, and working wholly under the direction and control of that individual or related                        third party in order to meet the individual's own care requirements, and                  

(d)the provision of personal care by a person managing a prison or other similar custodial establishment (other than a hospital                        within the meaning of Part 2 of the 1983 Act).                  

(4) In sub-paragraph (3)—

“carer” means an individual who provides personal care to a person referred to in sub-paragraph (1);                  

“related third party” means—                  

an individual with parental responsibility (within the meaning of section 3 of the Children Act 1989 F65) for a child to whom personal care services are to be provided;                           

an individual with power of attorney or other lawful authority to make arrangements on behalf of the person to whom personal                              care services are to be provided;                           

a group of individuals mentioned in either of paragraphs (a) or (b) making arrangements on behalf of one or more persons to                              whom personal care services are to be provided;                           

a trust established for the purpose of providing services to meet the health or social care needs of a named individual.

F651989 c. 41.

### Accommodation for persons who require nursing or personal careE+W

2.—(1) The provision of residential accommodation together with nursing or personal care.                  

(2) Sub-paragraph (1) does not apply to the provision of accommodation—

(a)to an individual by a shared lives carer under the terms of a shared lives agreement,                  

(b)in a school,                  

(c)in an institution within the further education sector or in a 16 to 19 Academy, or                  

(d)in an institution within the further education sector where the number of persons to whom nursing or personal care and accommodation                        are provided is not more than one-tenth of the number of students to whom both education and accommodation are provided                  

### Accommodation for persons who require treatment for substance misuseE+W

3.  The provision of residential accommodation for a person together with treatment for drug or alcohol misuse, where acceptance                     by the person of such treatment is a condition of the provision of the accommodation.                  

### Treatment of disease, disorder or injuryE+W

4.—(1) Subject to sub-paragraph (2), the provision of treatment for a disease, disorder or injury by or under the supervision of—                  

(a)a health care professional, or a team which includes a health care professional, or                  

(b)a social worker, or a team which includes a social worker, where the treatment is for a mental disorder.                  

(2) The activities set out in sub-paragraph (3) are excepted from sub-paragraph (1).

(3) The activities referred to in sub-paragraph (2) are—

(a)assessment or medical treatment for persons detained under the 1983 Act,                  

(b)the provision of treatment by means of surgical procedures,                  

(c)diagnostic and screening procedures,                  

(d)services in slimming clinics,                  

(e)the practice of alternative and complementary medicine, with the exception of the practice of osteopathy or chiropractic,                  

(f)the provision of treatment in a sports ground or gymnasium (including associated premises) where it is provided for the sole                        benefit of persons taking part in, or attending, sporting activities and events,                  

(g)the provision of treatment (not being first aid for the purposes of paragraph 9 of Schedule 2) under temporary arrangements                        to deliver health care to those taking part in, or attending, sporting or cultural events,                  

(h)the provision of hyperbaric therapy, being the administration of oxygen (whether or not combined with one or more other gases)                        to a person who is in a sealed chamber which is gradually pressurised with compressed air, where the primary use of that chamber                        is—                  

(i)pursuant to regulation 6(3)(b) of the Diving at Work Regulations 1997 F66 or regulation 8 or 12 of the Work in Compressed Air Regulations 1996 F67, or                  

(ii)otherwise for the treatment of workers in connection with the work which they perform, and                  

(i)the carrying on of any of the activities authorised by a licence granted by the Human Fertilisation and Embryology Authority                        under paragraph 1 of Schedule 2 to the Human Fertilisation and Embryology Act 1990 F68.                  

(4) In this paragraph—

(a)“health care professional” means a person who is—                  

(i)a medical practitioner,                  

(ii)a dental practitioner,                  

(iii)a dental hygienist,                  

(iv)a dental therapist,                  

(v)a dental nurse,                  

(vi)a dental technician,                  

(vii)an orthodontic therapist,                  

(viii)a nurse,                  

(ix)a midwife,                  

(x)a biomedical scientist,                  

(xi)a clinical scientist,                  

(xii)an operating department practitioner,                  

(xiii)a paramedic, or                  

(xiv)a radiographer;                  

(b)“biomedical scientist”, “clinical scientist”, “operating department practitioner”, “paramedic” and “radiographer” means persons registered as such with the Health and Care Professions Council pursuant to article 5 of the 2001 Order;                  

(c)“dental practitioner” means a dentist registered as such with the General Dental Council pursuant to section 14 of the Dentists Act 1984 F69;                  

(d)“dental hygienist”, “dental therapist”, “dental nurse”, “dental technician” and “orthodontic therapist” means persons registered as such with the General Dental Council in the dental care professionals register;                  

(e)“mental disorder” means any disorder or disability of the mind, including dependence on alcohol or drugs;                  

(f)“midwife” means a registered midwife.                  

F66S.I. 1997/2776.

F67S.I. 1996/1656.

F681990 c. 37. Relevant amendments were made by: the Human Fertilisation and Embryology Act 2008 (c. 22), **sections 11** and 66, Paragraphs 1 and 2 of Schedule 2, and Schedule 8, Part 1; and S.I. 2007/1522.

F691984 c. 24. Section 14 was substituted by S.I. 2005/2011 and amended by S.I. 2007/3101.

### Assessment or medical treatment for persons detained under the 1983 ActE+W

5.—(1) Subject to sub-paragraph (2), the assessment of, or medical treatment (other than surgical procedures) for, a mental disorder                     affecting a person in a hospital where that person is—                  

(a)detained in that hospital pursuant to the provisions of the 1983 Act (with the exception of section 135 or 136),                  

(b)recalled to that hospital under section 17E of that Act F70, or                  

(c)detained in that hospital pursuant to an order or direction made under another enactment, where that detention takes effect                        as if the order or direction were made pursuant to the provisions of the 1983 Act.                  

(2) Sub-paragraph (1) does not apply to the assessment or treatment by a registered medical practitioner appointed for the purposes                     of Part 4 of the 1983 Act in giving a certificate under sections 57 (treatment requiring consent and a second opinion), 58                     (treatment requiring consent or a second opinion) or 58A (electro-convulsive therapy, etc) of that Act.                  

(3) In this paragraph—

“hospital” means a hospital within the meaning of Part 2 of the 1983 Act;                  

“medical treatment” has the same meaning as in section 145 (interpretation) of that Act;                  

“mental disorder” has the same meaning as in section 1 of that Act.                  

F70Section 17E was inserted into the Mental Health Act 1983 (c. 20) by section 32(1) and (2) of the Mental Health Act 2007 (c. 12).

### Surgical proceduresE+W

6.—(1) Subject to sub-paragraphs (2) to (4), surgical procedures (including all pre-operative and post-operative care associated                     with such procedures) carried on by a health care professional for—                  

(a)the purpose of treating disease, disorder or injury,                  

(b)the purpose of sterilisation or reversal of sterilisation,                  

(c)cosmetic purposes, where the procedure involves the use of instruments or equipment which are inserted into the body, or                  

(d)the purpose of religious observance.                  

(2) Subject to sub-paragraph (3), the following procedures are excepted from sub-paragraph (1)—

(a)nail surgery and nail bed procedures carried out by a health care professional on any area of the foot, and                  

(b)surgical procedures involving the curettage, cautery or cryocautery of warts, verrucae or other skin lesions carried out by—                  

(i)a medical practitioner, or                  

(ii)another health care professional on any area of the foot.                  

(3) Sub-paragraph (2) only applies where the procedures are carried out—

(a)without anaesthesia, or                  

(b)using local anaesthesia.                  

(4) The following cosmetic procedures are excepted from sub-paragraph (1)(c)—

(a)the piercing of any part of the human body,                  

(b)tattooing,                  

(c)the subcutaneous injection of a substance or substances for the purpose of enhancing a person's appearance, and                  

(d)the removal of hair roots or small blemishes on the skin by the application of heat using an electric current.                  

### Diagnostic and screening proceduresE+W

7.—(1) Subject to sub-paragraphs (3), (5) and (7), diagnostic and screening procedures involving—                  

(a)the use of X-rays and other methods in order to examine the body by the use of radiation, ultrasound or magnetic resonance                        imaging,                  

(b)the use of instruments or equipment which are inserted into the body to—                  

(i)view its internal parts, or                  

(ii)gather physiological data,                  

(c)the removal of tissues, cells or fluids from the body for the purposes of discovering the presence, cause or extent of disease,                        disorder or injury,                  

(d)the use of equipment in order to examine cells, tissues and other bodily fluids for the purposes of obtaining information                        on the causes and extent of a disease, disorder or injury, and                  

(e)for the purposes of obtaining information on the causes and extent of a disease, disorder or injury, or the response to a                        therapeutic intervention, where such information is needed for the purposes of the planning and delivery of care or treatment,                        the use of equipment to measure or monitor physiological data in relation to the—                  

(i)audio-vestibular system,                  

(ii)vision system,                  

(iii)neurological system,                  

(iv)cardiovascular system,                  

(v)respiratory system,                  

(vi)gastro-intestinal system, or                  

(vii)urinary system.                  

(2) Subject to sub-paragraphs (3), (5) and (7), the analysis and reporting of the results of the procedures referred to in sub-paragraph                     (1).                  

(3) The procedures specified in sub-paragraph (4), and the analysis and reporting of the results of those procedures, are excepted                     from sub-paragraphs (1) and (2).                  

(4) The procedures referred to in sub-paragraph (3) are—

(a)the taking of blood samples where—                  

(i)the procedure is carried out by means of a pin prick or from a vein, and                  

(ii)it is not necessary to send such samples for analysis to a place which is established for the purposes of carrying out tests                        or research in relation to samples of bodily cells, tissues or fluids;                  

(b)where part of neither the planning and delivery of care or treatment nor a national screening programme, other than for cancer,                        the taking and analysis of samples of bodily tissues, cells or fluids in order to ascertain—                  

(i)the existence of a genetically inherited disease or disorder, or                  

(ii)the influence of an individual's genetic variation on drug response;                  

(c)the carrying out of procedures as part of a national cancer screening programme by a body established solely for the purpose                        of such a programme;                  

(d)fitness screening procedures carried out in a gymnasium in order to ascertain that a person is sufficiently healthy to use                        fitness equipment or take part in fitness routines safely;                  

(e)the taking of X-rays by chiropractors;                  

(f)the use of ultrasound equipment by physiotherapists;                  

(g)the carrying out of a hearing needs assessment or the supply and fitting of a hearing aid carried out by a hearing aid dispenser                        or a person acting under the direction or supervision of a hearing aid dispenser where—                  

(i)the patient is aged 19 or over, or                  

(ii)the patient is under 19 years old and the procedure is carried out in, or arranged by, a school or 16 to 19 Academy;                  

(h)the taking of urine samples where it is not necessary to send such samples for analysis to a place which is established for                        the purposes of carrying out tests or research in relation to samples of bodily cells, tissues or fluids;                  

(i)the taking and analysing of wound swabs, hair samples or nail clippings;                  

(j)the non-ambulatory recording of blood pressure;                  

(k)the use of 12-lead electrocardiography;                  

(l)the use of a peak flow meter to measure peak expiratory flow;                  

(m)pulse oximetry when used for the purpose of spot recording;                  

(n)spirometry when carried out for screening, non-diagnostic or monitoring purposes;                  

(o)diagnostic and screening procedures carried out by a person in connection with any of the activities listed in Schedule 2                        (activities for which licences may be granted) to the Human Fertilisation and Embryology Act 1990 F71 for which a licence has been granted to that person under section 16 (grant of licence) of that Act.                  

(5) Where a service provider is registered in respect of an activity listed in any other paragraph of this Schedule, the procedures                     specified in sub-paragraph (6), and the analysis and reporting of the results of those procedures, are excepted from sub-paragraphs                     (1) and (2) of this paragraph.                  

(6) The procedures referred to in sub-paragraph (5) are—

(a)the taking of blood or urine samples,                  

(b)the analysis of urine or stool samples by means of dip stick or other reagent, and                  

(c)the taking of tissue samples by means of—                  

(i)a swab specimen from any external part of the body or from the mouth, ear, nose or throat, or                  

(ii)skin scrapings.                  

(7) The carrying out of diagnostic and screening procedures mentioned in sub-paragraph (1) or analysis and reporting of such procedures                     for research is excepted from sub-paragraphs (1) and (2) where those procedures, or that analysis and reporting, do not form                     any part of an individual's care or treatment.                  

(8) For the purposes of this paragraph—

“chiropractor” means a person registered with the General Chiropractic Council under section 3, 4, 5 or 5A of the Chiropractors Act 1994                     F72;                  

“hearing aid dispenser” means a person registered as such with the Health and Care Professions Council pursuant to article 5 of the 2001 Order;                  

“physiotherapist” means a person registered as such with the Health and Care Professions Council pursuant to article 5 of the 2001 Order.                  

F71Relevant amendments were made by: the Human Fertilisation and Embryology Act 2008 (c. 22), **sections 11** and 66, Schedule 2, and Schedule 8, Part 1; and S.I. 2007/1522 and 2009/2232.

F721994 c.17. Relevant amendments were made by S.I. 2007/3101 and 2008/1774.

### Management of supply of blood and blood derived products etcE+W

8.—(1) Subject to sub-paragraph (2), the management of—                  

(a)the supply of blood, blood components and blood derived products intended for transfusion,                  

(b)the supply of tissues and tissue derived products intended for transplant, grafting or use in a surgical procedure, and                  

(c)the matching and allocation of donor organs intended for transplant, and of stem cells and bone marrow intended for transfusion.                  

(2) Sub-paragraph (1) does not apply to the management of the supply of blood, blood components, tissues and products mentioned                     in sub-paragraph (1)(a) and (b) where that management does not involve direct physical contact with patients or donors.                  

(3) For the purposes of this paragraph—

“donor” means a person from whom anything mentioned in sub-paragraph (1)(a) or (b) is derived;                  

“patient” means a person to whom anything mentioned in sub-paragraph (1)(a) or (b) is administered.                  

### Transport services, triage and medical advice provided remotelyE+W

9.—(1) Subject to sub-paragraphs (3) and (4), transport services provided by means of a vehicle which is designed for the primary                     purpose of carrying a person who requires treatment.                  

(2) Medical advice in cases where immediate action or attention is needed, or triage provided, over the telephone or by electronic                     mail by a body established for that purpose.                  

(3) Transport services which are provided within the confines of the site or venue being used for an activity or event mentioned                     in paragraph 4(3)(f) or (g) are excepted from sub-paragraph (1).                  

(4) The provision of an air ambulance is excepted from sub-paragraph (1) where—

(a)the aircraft is registered with the Civil Aviation Authority pursuant to [F73article 27 (application for the registration of an aircraft) of the Air Navigation Order 2016], and                  

(b)the person providing the air ambulance does not provide treatment to a patient.                  

(5) For the purposes of this paragraph—

“triage” means the assignment of degrees of urgency to diseases, disorders or injuries in order to decide the order and place of                     treatment of service users;                  

“vehicle” includes an air or water ambulance.                  

F73Words in Sch. 1 para. 9(4)(a) substituted (25.8.2016) by The Air Navigation Order 2016 (S.I. 2016/765), art. 1, **Sch. 14 Pt. 2 para. 7** (with arts. 17-23, 274(2)-(4))

### Maternity and midwifery servicesE+W

10.—(1) Subject to sub-paragraph (2), maternity and midwifery services carried on by, or under the supervision of, a health care professional.                  

(2) The following services are excepted from sub-paragraph (1)—

(a)midwifery services, where the provision of those services is carried on by an individual—                  

(i)acting on their own behalf,                  

(ii)otherwise than in pursuance of the 2006 Act, and                  

(iii)who provides such services only to service users in their own homes;                  

(b)the provision of advice, information and support in relation to pregnancy, childbirth or the acquisition of parenting skills,                        where provided by a body whose primary purpose or function is not the provision of health care (other than that advice, information                        and support);                  

(c)services provided under arrangements relating to the care of pregnant women and women who are breast feeding made [F74under Part 1 of the Care Act 2014 (care and support)].                  

F74Words in Sch. 1 para. 10(2)(c) substituted (1.4.2015) by The Care Act 2014 (Consequential Amendments) (Secondary Legislation) Order 2015 (S.I. 2015/643), art. 1(2), **Sch. para. 48** (with art. 4)

### Termination of pregnanciesE+W

11.  The termination of pregnancies.                  

### Services in slimming clinicsE+W

12.  Services provided in a slimming clinic consisting of the provision of advice or treatment by, or under the supervision of,                     a medical practitioner, including the prescribing of medicines for the purposes of weight reduction.                  

### Nursing careE+W

13.—(1) Subject to sub-paragraph (2), the provision of nursing care, including nursing care provided in a person's own home which                     is not—                  

(a)provided as part of any other regulated activity, and                  

(b)exempted from being a regulated activity under any other paragraph in this Schedule.                  

(2) The following types of provision are excepted from sub-paragraph (1)—

(a)the supply of nurses to a service provider by an undertaking acting as an employment agency or employment business for the                        purposes of that provider carrying on a regulated activity,                  

(b)the introduction of nurses to an individual (other than a service provider) by a person (including an employment agency or                        an employment business) having no ongoing role in the direction or control of the service provided to that individual, and                  

(c)the services of a nurse employed by an individual, without the involvement of an undertaking acting as an employment agency                        or an employment business, and working wholly under the direction and control of that individual in order to meet that individual's                        own nursing requirements.                  

### Family planning servicesE+W

14.  The insertion or removal of an intrauterine contraceptive device carried out by, or under the supervision of, a health care                     professional.                  

 Regulation 3(4)

## SCHEDULE 2E+WRegulated Activities: General Exceptions

1.—(1) Any activity which is carried on—E+W

(a)in the course of a family or personal relationship, and

(b)for no commercial consideration.

(2) A family relationship includes a relationship between two persons who—

(a)live in the same household, and

(b)treat each other as though they were members of the same family.

(3) A personal relationship is a relationship between or among friends.

(4) A friend of a person (A) includes a person who is a friend of a member of A's family.

2.  Any activity which involved the carrying on of an establishment or agency within the meaning of the Care Standards Act 2000                     F75 for which Her Majesty's Chief Inspector of Education, Children's Services and Skills is the registration authority under                     that Act.E+W

F752000 c. 14. *See* section 5 (registration authorities), as amended by the Adoption and Children Act 2002 (c. 38), **section 139(1)** and paragraphs 103 and 105 of Schedule 3, the Health and Social Care Act 2008, section 95 and paragraphs 1 and 6 of Schedule                              5, and section 4(2)(b) of the Children and Young Persons Act 2008 (c. 23).

3.—(1) Subject to paragraph 4, the provision of treatment in a surgery or consulting room by a medical practitioner who is (or a                     group of medical practitioners who are)—E+W

(a)a service provider in respect of a regulated activity specified in paragraph 4 of Schedule 1 (treatment of disease, disorder                        or injury) or employed by such a service provider, and

(b)either on the medical performers list for a designated body or employed by a service provider that is a designated body.

(2) In this paragraph, “designated body” means a body prescribed by regulation 4 of the Medical Profession (Responsible Officers) Regulations 2010 F76.                  

F76S.I. 2010/2841. Relevant amendments were made by S.I. 2011/2581 and 2013/391.

4.  Paragraph 3 does not apply in relation to—E+W

(a)treatment carried out under anaesthesia (other than local anaesthesia for the purposes of a procedure mentioned in paragraph                        6(2) of Schedule 1) or intravenously administered sedation,

(b)medical services provided in connection with childbirth,

(c)the termination of pregnancies,

(d)cosmetic surgery, with the exception of the procedures referred to in paragraph 6(4) of Schedule 1,

(e)haemodialysis or peritoneal dialysis,

(f)endoscopy other than using a device which does not have a lumen or other channel for the purpose or design of passing fluid                        or instruments through, or removing body tissue or fluid or any other item from, a person's body,

(g)the provision of hyperbaric therapy, being the administration of oxygen (whether or not combined with one or more other gases)                        to a person who is in a sealed chamber which is gradually pressurised with compressed air, where such therapy is carried out                        by or under the supervision or direction of a medical practitioner,

(h)intravenous, intrathecal or epidural administration of medicines or diagnostic agents,

(i)the therapeutic or diagnostic use of x-rays, radiation, protons or magnetic resonance imaging, or

(j)invasive cardiac physiology tests.

5.—(1) Medical or dental services provided (otherwise than in conjunction with the provision of accommodation in a hospital) only                     under arrangements made on behalf of service users by—E+W

(a)their employer,

(b)a government department, or

(c)an insurance provider with whom the service users hold an insurance policy, other than an insurance policy which is solely                        or primarily intended to provide benefits in connection with the diagnosis or treatment of physical or mental illness, disability                        or infirmity.

(2) In this paragraph, “insurance provider” means—                  

(a)a person regulated by the Financial Conduct Authority or the Prudential Regulation Authority who sells insurance, or underwrites                        the risk of such insurance, or

(b)the agent of such a person.

6.  Forensic medicine or dental services provided under arrangements made with a local policing body as defined in section 101                     of the Police Act 1996 F77 (interpretation).E+W

F771996 c. 16. Relevant amendments were made by section 96(2)(a) of the Police Reform and Social Responsibility Act 2011 (c. 13).

7.  Primary ophthalmic services provided under Part 6 of the 2006 Act and services of a kind which, if provided in pursuance of                     that Act, would be provided as primary ophthalmic services under that Part.E+W

8.  Services which are provided at or from premises that are a registered pharmacy (within the meaning given by section 74 of                     the Medicines Act 1968 F78) and which are—E+W

(a)pharmaceutical services and local pharmaceutical services provided under Part 7 of the 2006 Act, or

(b)services of a kind which, if provided in pursuance of that Act, would be provided as pharmaceutical services or local pharmaceutical                        services under that Part or services provided in pursuance of that Act.

F781968 c. 67. Section 74 was amended by the Statute Law (Repeals) Act 1993 (c. 50) and S.I. 2010/231.

9.  The provision of first aid by—E+W

(a)health care professionals where it is provided in unexpected or potentially dangerous situations requiring immediate action,

(b)organisations established for that purpose, or

(c)non-health care professionals trained to deliver such treatment.

10.—(1) Defence medical and dental services being—E+W

(a)health or dental care provided by the armed services,

(b)education and training provided by the armed services to service and other personnel in connection with the provision of health                        or dental care, including the maintenance of the clinical skills of such personnel, and

(c)any service or facility falling within sub-paragraph (a) or (b) provided on behalf of the armed services under any agreement                        or arrangement made with the armed services.

(2) In sub-paragraph (1), “armed services” means the naval, military and air forces of the Crown and includes the reserve forces.                  

11.  Treatment provided in a school to the pupils of that school by a nurse who is engaged and directed by the school.E+W

 Regulations 4 to 7 and 19(3)

## SCHEDULE 3E+WInformation Required in Respect of Persons Employed or Appointed for the Purposes of a Regulated Activity

1.  Proof of identity including a recent photograph.E+W

2.  Where required for the purposes of an exempted question in accordance with section 113A(2)(b) of the Police Act 1997 F79, a copy of a criminal record certificate issued under section 113A of that Act together with, after the appointed day and                     where applicable, the information mentioned in section 30A(3) of the Safeguarding Vulnerable Groups Act 2006 (provision of                     barring information on request) F80.E+W

F791997 c. 50. Sections 113A and 113B were inserted by section 163(2) of the Serious Crime and Police Act 2005 (c. 15) and amended by: the Safeguarding Vulnerable Groups Act 2006, section 63(1) and Schedule 9, Part 2, paragraph 14; the Armed Forces Act 2006 (c. 52), **section 378(1)** and paragraph 149 of Schedule 16; the Criminal Justice and Immigration Act 2008 (c. 4), **section 50**; the Policing and Crime Act 2009 (c. 26), **sections 97(2)** and 112(2) and Part 8 of Schedule 8; the Protection of Freedoms Act 2012, sections 79(2), 80(1), 82 and 115, paragraphs 35                              to 37 and 135 of Schedule 9, and Parts 5 and 6 of Schedule 10; the Crime and Courts Act 2013 (c. 22), **section 15(3)** and Schedule 8, Part 2, paragraphs 55 and 60; and S.I. 2009/203, 2010/1146, 2012/3006 and 2013/1200.

F80Section 30A was inserted by section 72(1) of the Protection of Freedoms Act 2012 and amended by S.I. 2012/3006.

3.  Where required for the purposes of an exempted question asked for a prescribed purpose under section 113B(2)(b) of the Police                     Act 1997, a copy of an enhanced criminal record certificate issued under section 113B of that Act together with, where applicable,                     suitability information relating to children or vulnerable adults.E+W

4.  Satisfactory evidence of conduct in previous employment concerned with the provision of services relating to—E+W

(a)health or social care, or

(b)children or vulnerable adults.

5.  Where a person (P) has been previously employed in a position whose duties involved work with children or vulnerable adults,                     satisfactory verification, so far as reasonably practicable, of the reason why P's employment in that position ended.E+W

6.  In so far as it is reasonably practicable to obtain, satisfactory documentary evidence of any qualification relevant to the                     duties for which the person is employed or appointed to perform.E+W

7.  A full employment history, together with a satisfactory written explanation of any gaps in employment.E+W

8.  Satisfactory information about any physical or mental health conditions which are relevant to the person's capability, after                     reasonable adjustments are made, to properly perform tasks which are intrinsic to their employment or appointment for the                     purposes of the regulated activity.E+W

9.  For the purposes of this Schedule—E+W

(a)“the appointed day” means the day on which section 30A of the Safeguarding Vulnerable Groups Act 2006 comes into force;

(b)“satisfactory” means satisfactory in the opinion of the Commission;

(c)“suitability information relating to children or vulnerable adults” means the information specified in sections 113BA and 113BB respectively of the Police Act 1997.

 Regulation 5

## SCHEDULE 4E+WGood character and unfit person tests

### **PART 1**E+WUnfit person test

1.  The person is an undischarged bankrupt or a person whose estate has had sequestration awarded in respect of it and who has                     not been discharged.E+W

2.  The person is the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order or an order to like                     effect made in Scotland or Northern Ireland.E+W

3.  The person is a person to whom a moratorium period under a debt relief order applies under Part VIIA (debt relief orders)                     of the Insolvency Act 1986 F81.E+W

F811986 c. 45. Part VIIA was inserted by section 108 of, and Schedule 17 to, the Tribunals, Courts and Enforcement Act 2007 (c. 15).

4.  The person has made a composition or arrangement with, or granted a trust deed for, creditors and not been discharged in respect                     of it.E+W

5.  The person is included in the children's barred list or the adults' barred list maintained under section 2 of the Safeguarding                     Vulnerable Groups Act 2006, or in any corresponding list maintained under an equivalent enactment in force in Scotland or                     Northern Ireland.E+W

6.  The person is prohibited from holding the relevant office or position, or in the case of an individual from carrying on the                     regulated activity, by or under any enactment.E+W

### **PART 2**E+WGood character

7.  Whether the person has been convicted in the United Kingdom of any offence or been convicted elsewhere of any offence which,                     if committed in any part of the United Kingdom, would constitute an offence.E+W

8.  Whether the person has been erased, removed or struck-off a register of professionals maintained by a regulator of health                     care or social work professionals.E+W

 Regulation 24

## SCHEDULE 5E+WFixed Penalty Offences

F82S.I. 2009/3112, as amended by S.I. 2010/49, 2012/921, 2012/1641 and 2013/235.

F83Words in Sch. 5 Table substituted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **17(2)**

F84Words in Sch. 5 Table inserted (1.4.2015) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (S.I. 2015/64), regs. 1, **17(3)**

## Explanatory Note

(This note is not part of the Regulations)

These Regulations prescribe the kinds of activities that are regulated activities for the purposes of Part 1 of the Health                        and Social Care Act 2008 (“the Act”) and requirements that apply in relation to the way in which those activities are carried on.                     

Regulation 3 deals with the activities that are regulated activities for the purposes of section 8(1) of the Act. The activities                        are set out in Schedule 1 to the Regulations together with certain activity specific exemptions. An activity is only a regulated                        activity if it is carried on in England (regulation 3(3)). Regulation 3(4) provides that the activities listed in Schedule                        2 (general exceptions) are not to be regulated activities for the purposes of section 8(1) of the Act and these Regulations.                     

In Part 3, regulations 4 to 7, and Schedules 3 and 4, contain requirements in relation to persons registered in respect of                        the carrying on or management of a regulated activity (“registered persons”), and require certain information to be available                        in relation to those persons. Where a regulated activity is carried on by a body other than a partnership, that body must                        nominate an individual (“the nominated individual”) who must meet certain requirements (regulation 6). Regulation 7 lays down                        requirements in relation to registered managers.                     

Regulation 5 lays down a new fit and proper person requirement that must be met by directors of an NHS trust, an NHS foundation                        trust or a Special Health Authority that carries on a regulated activity. The requirement lays down criteria to be met by                        such directors, including that they are of good character and that none of the grounds of unfitness specified in Part 1 of                        Schedule 4 apply. A person must not perform the relevant role if they fail the fit and proper person requirement. A health                        service body that fails to comply with this requirement could have a condition imposed on its registration with the Care Quality                        Commission, requiring it to comply with the requirement, under section 12(5)(b) of the Act.                     

Regulations 8 to 19 lay down fundamental standards to be met by registered persons. Regulation 20 lays down a further fundamental                        standard to be met by health service bodies. The fundamental standards provide that:                     

care and treatment must be appropriate and reflect service users needs and preferences (regulation 9);

service users must be treated with dignity and respect (regulation 10);

care and treatment must only be provided with consent (regulation 11)

care and treatment must be provided in a safe way (regulation 12);

service users must be protected from abuse and improper treatment (regulation 13);

service users' nutritional and hydration needs must be met (regulation 14);

all premises and equipment used must be clean, secure, suitable and used properly (regulation 15);

complaints must be appropriately investigated and appropriate action taken in response (regulation 16);

systems and processes must be established to ensure compliance with the fundamental standards (regulation 17);

sufficient numbers of suitably qualified, competent, skilled and experienced staff must be deployed (regulation 18);

persons employed must be of good character, have the necessary qualifications, skills and experience, and be able to perform                                 the work for which they are employed (regulation 19);                              

health service bodies must be open and transparent with service users about their care and treatment (regulation 20).

Regulation 8(2) deals with who is responsible for complying with the Regulations in circumstances where there is more than                        one registered person in respect of a regulated activity.                     

Regulation 21 states that, for the purposes of compliance with the Regulations, a registered person must take account of guidance                        issued by the Care Quality Commission under section 23 of the Act and the code of practice issued by the Secretary of State                        under section 21 of the Act in relation to the prevention or control of health care associated infections. The guidance issued                        by the Care Quality Commission is available from the Care Quality Commission, Citygate, Gallowgate, Newcastle upon Tyne, NE1                        4PA (www.cqc.org.uk). The code of practice issued by the Secretary of State is available from the Department of Health, Richmond                        House, 79 Whitehall, London SW1A 2NS (www.gov.uk/government/organisations/department-of-health).                     

Regulation 22 creates offences in relation to breaches of requirements in regulation 11, 12, 13(1) to (4), 14, 16(3), 17(3)                        or 20(2)(a) and (3) and also includes a due diligence defence relating to any proceedings for such a breach. Regulation 23                        imposes penalties for those who commit such offences.                     

Regulation 24 and Schedule 5 prescribe fixed penalty offences for the purposes of section 86 of the Act and the amount of                        the penalty, and make provision about the time by which a fixed penalty must be paid and the method by which the payment may                        be made, the period during which proceedings cannot be instituted for the offence to which the penalty notice relates, the                        content of the penalty notice and when a penalty notice can be withdrawn.                     

Regulation 25 revokes the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 (“the 2010 Regulations”), together with other enactments which amended those Regulations.                     

Regulation 26 makes transitional and transitory provision in consequence of these Regulations coming into force. It provides                        that where enforcement action has been taken in relation to a continuing breach of the 2010 Regulations, and the person or                        body concerned has been given a specified time by which it must secure compliance with the 2010 Regulations, no criminal proceedings                        may be taken under these Regulations in relation to the breach in so far as it occurred before that specified time.                     

Regulation 27 requires the Secretary of State to review the operation and effect of these Regulations and lay a report before                        Parliament within five years after 1st April 2015 and within every five years after that. Following a review it will fall                        to the Secretary of State to consider whether the Regulations should remain as they are, or be revoked or be amended. A further                        instrument would be needed to revoke the Regulations or to amend them.                     

A full impact assessment of the costs and benefits of this instrument is available from the Department of Health, Richmond                        House, 79 Whitehall, London SW1A 2NS (www.gov.uk/government/organisations/department-of-health) and is published alongside                        this instrument and its Explanatory Memorandum at www.legislation.gov.uk.