The Health and Social Care Act 2008 (Regulated Activities) Regulations 2010
Made: 15th March 2010
Coming into force: 1st April 2010
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 1 — GENERAL
Citation and commencement
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interpretation
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 2 — REGULATED ACTIVITIES
Prescribed activities
3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 3 — REQUIREMENTS RELATING TO PERSONS CARRYING ON OR MANAGING A REGULATED ACTIVITY
Requirements where the service provider is an individual or partnership
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Requirement where the service provider is a body other than a partnership
5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Requirements relating to registered managers
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Registered person: training
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 4 — QUALITY AND SAFETY OF SERVICE PROVISION IN RELATION TO REGULATED ACTIVITY
General
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Care and welfare of service users
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Assessing and monitoring the quality of service provision
10
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safeguarding service users from abuse
11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cleanliness and infection control
12
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Management of medicines
13
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Meeting nutritional needs
14
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety and suitability of premises
15
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety, availability and suitability of equipment
16
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Respecting and involving service users
17
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consent to care and treatment
18
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Complaints
19
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records
20
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Requirements relating to workers
21
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Staffing
22
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supporting workers
23
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cooperating with other providers
24
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 5 — COMPLIANCE AND OFFENCES
Compliance with regulations
25
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Guidance and Code
26
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Offences
27
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 6 — PENALTY NOTICES
28
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 7 — REVOCATION
Revocation
29
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 1 — Regulated Activities
Personal care
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accommodation for persons who require nursing or personal care
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accommodation for persons who require treatment for substance misuse
3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accommodation and nursing or personal care in the further education sector
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treatment of disease, disorder or injury
5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Assessment or medical treatment for persons detained under the 1983 Act
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Surgical procedures
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diagnostic and screening procedures
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Management of supply of blood and blood derived products etc.
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transport services, triage and medical advice provided remotely
10
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maternity and midwifery services
11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Termination of pregnancies
12
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Services in slimming clinics
13
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Nursing care
14
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Family planning services
15
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 2 — Regulated Activities: General exceptions
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
17
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 3 — Information Required In Respect Of Persons Seeking To Carry On, Manage Or Work For The Purposes Of Carrying On, A Regulated Activity
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 4 — Fixed Penalty Offences
| Provision creating offence | General nature of offence | Monetary amount of penalty |
|---|---|---|
| Regulation 27 of these Regulations | Contravention of, or failure to comply with, requirements relating to quality and safety of service provision in relation to a regulated activity | £4,000 in the case of an offence committed by a service provider; £2,000 in the case of an offence committed by a registered manager |
| Section 10(1) of the Act | Carrying on a regulated activity without being registered | £4,000 |
| Section 33 of the Act | Failure to comply with conditions | £4,000 in the case of an offence committed by a service provider; £2,000 in the case of an offence committed by a registered manager |
| Section 34(1) of the Act | Carrying on a regulated activity whilst registration is suspended | £4,000 |
| Section 34(2), (3) or (4) of the Act | Managing a regulated activity whilst registration is cancelled or suspended | £2,000 |
| Section 63(7) of the Act | Obstructing entry and inspection | £300 |
| Section 64(4) of the Act | Failure to provide documents and information | £300 |
| Section 65(4) of the Act | Failure to provide an explanation | £300 |
Signed
Signed by authority of the Secretary of State for Health.
Mike O'Brien — Minister of State, — 2010-03-15
Explanatory note
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Footnotes
[^f00001]: 2008 c. 14. “Prescribed” and “regulations” are defined in section 97(1) of the Act.
[^f00002]: 1983 c.20.
[^f00003]: 2006 c.41.
[^f00004]: S.I. 2002/254.
[^f00005]: See the definition of “relevant professions” in Schedule 3, paragraph 1 of the 2001 Order as amended by S.I. 2004/2033, article 10(5)(b)(i).
[^f00006]: 1973 c.35. See section 13(2) and (3). Section 13(2) was amended by the Employment Relations Act 1999 (c.26), Schedule 7, paragraphs 1 and 7.
[^f00007]: 1999 c.8. Section 60(2) was amended by the Health and Social Care Act 2008, Schedule 8, paragraph 1(3) and Schedule 15, Part 2 and by S.I. 2002/253 and the 2001 Order.
[^f00008]: 1992 c.13.
[^f00009]: The definition of “registered medical practitioner” in Schedule 1 to the Interpretation Act 1978 (c.30) has been substituted by S.I. 2002/3135, Schedule 1, paragraph 10 with effect from 16th November 2009.
[^f00010]: 1996 c.56; seesection 4 for the meaning of “school”. Section 4 has been amended by the Education Act 1997 (c. 44), sections 51, 57(1) and (4) and Schedule 7, paragraphs 10(a) and (b) and Schedule 8, by the Education Act 2002 (c. 32), section 215(2) and Schedule 22, Part 3, and by the Childcare Act 2006 (c. 21), section 95(1), (2) and (3).
[^f00011]: 2006 c. 47. Section 59 was amended by S.I. 2008/912, Schedule 1, paragraph 21 and by the Education and Skills Act 2008 (c. 25), section 147(8).
[^f00012]: See section 97(1) of the Act for the definition of “English NHS body”.
[^f00013]: 2000 c. 14.
[^f00014]: S.I. 2002/618; the relevant amending instrument is S.I. 2008/2936.
[^f00015]: The General Social Care Council is established under Part 5 of the Care Standards Act 2000 (c.14). See section 55 of that Act for the definition of “social care worker”, and S.I. 2004/561.
[^f00016]: 2000 c.7; seesection 15 as amended by the Communications Act 2003 (c.21), Schedule 17, paragraph 158.
[^f00017]: 1971 c. 80.
[^f00018]: 1974 c. 39.
[^f00019]: S.I. 2009/660.
[^f00020]: S.I. 1997/2776.
[^f00021]: S.I. 1996/1656.
[^f00022]: 1990 c. 37. Paragraph 1 of Schedule 2 was amended by the Human Fertilisation and Embryology Act 2008 (c. 22), Schedule 2, paragraph 2 and Schedule 8, Part I and by S.I. 2007/1522.
[^f00023]: “Relevant professions” are set out in Schedule 3, paragraph 1 of the 2001 Order. See S.I. 2004/2033, articles 3(4)(c) and 10(5)(b)(ii) and S.I. 2007/3101, Part 21, for relevant amendments.
[^f00024]: Section 14 of the Dentists Act 1984 (c.24) (“the 1984 Act”) was substituted by the Dentists Act 1984 (Amendment) Order 2005 (S.I. 2005/2011) (“the 2005 Order”), article 2(6) and amended by S.I. 2007/3101, regulation 111.
[^f00025]: The dental care professionals register was established by section 36B of the 1984 Act as inserted by article 29 of the 2005 Order and amended by S.I. 2001/3101, regulation 122.
[^f00026]: 2000 c.14. See also S.I. 2007/3101, regulations 230 and 232(a) for relevant amendments.
[^f00027]: Section 135 was amended by the Mental Health (Scotland) Act 1984 (c.36) Schedule 3, paragraph 56, the Police and Criminal Evidence Act 1984 (c.60) Schedule 6, Part 1 and Schedule 7, Part 1, the National Health Service and Community Care Act 1990 (c.19) Schedule 10, the Care Standards Act 2000 (c.14) Schedule 4, paragraph 9, the Mental Health Act 2007 (“the 2007 Act”) (c.12) section 44 and Schedule 2, paragraph 10(a) and S.I. 2005/2078, Schedule 1, paragraph 2(9). Section 136 was amended by the 2007 Act, section 44 and Schedule 2, paragraph 10(b).
[^f00028]: Section 17E was inserted by section 32 of the 2007 Act.
[^f00029]: Seesections 34(2) and 145(1) of the 1983 Act; relevant amendments were made by the Care Standards Act 2000, Schedule 4, paragraph 9.
[^f00030]: Section 145 was amended by section 7 of the 2007 Act.
[^f00031]: Section 1 was amended by section 1(2) of the 2007 Act.
[^f00032]: 1994 c. 17. Section 5A was inserted by S.I. 2007/3101, regulation 219.
[^f00033]: See section 97(1) of the Act for the definition of “English NHS provider”. See regulation 3(6) which provides that the words “by an English NHS provider” cease to have effect on 1st April 2011.
[^f00034]: 2000 c.14.
[^f00035]: This paragraph will cease to have effect on 1st April 2012: see regulation 3(8)(a).
[^f00036]: This paragraph will cease to have effect on 1st April 2012: see regulation 3(8)(a).
[^f00037]: This paragraph will cease to have effect on 1st April 2012: see regulation 3(8)(a).
[^f00038]: This paragraph will cease to have effect on 1st April 2011: see regulation 3(8)(b).
[^f00039]: 1996 c.16. The definition of police authority in section 101 was amended by the Greater London Authority Act 1999 (c. 29), section 312(2).
[^f00040]: This paragraph will cease to have effect on 1st April 2011: see regulation 3(8)(b).
Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.