Regulation 3
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) This paragraph does not apply where paragraph 2 (accommodation for persons who require nursing or personal care) or paragraph 4 (accommodation and nursing or personal care in the further education sector) applies.
(3) The following types of provision are excepted from sub-paragraph (1)—
(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;
[F1(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)[F2;
“related third party” means—
(a)an individual with parental responsibility (within the meaning of section 3 of the Children Act 1989) for a child to whom personal care services are to be provided;
(b)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;
(c)a group of individuals mentioned in either of paragraphs (a) and (b) making arrangements on behalf of one or more persons to whom personal care services are to be provided;
(d)a trust established for the purpose of providing services to meet the health or social care needs of a named individual.]
Textual Amendments
F1Sch. 1 para. 1(3)(c) substituted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(2)(a)
F2Words in Sch. 1 para. 1(4) inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(2)(b)
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 an adult placement carer under the terms of a carer agreement;
(b)in a school; or
(c)in an institution within the further education sector [F3or in a 16 to 19 Academy].
Textual Amendments
F3Words in Sch. 1 para. 2(2)(c) inserted (1.5.2012) by The Alternative Provision Academies and 16 to 19 Academies (Consequential Amendments to Subordinate Legislation) (England) Order 2012 (S.I. 2012/979), art. 1(b), Sch. para. 27
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.
Accommodation and nursing or personal care in the further education sectorE+W
4.—(1) Subject to sub-paragraph (2), the provision of residential accommodation together with nursing or personal care for persons in an institution within the further education sector.
(2) Sub-paragraph (1) only applies where the number of persons to whom nursing or personal care and accommodation are provided is more than one tenth of the number of students to whom both education and accommodation are provided.
Treatment of disease, disorder or injuryE+W
5.—(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 multi-disciplinary team which includes a health care professional; or
(b)a social worker, or a multi-disciplinary 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 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 14 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 M1 or regulation 8 or 12 of the Work in Compressed Air Regulations 1996 M2, 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 M3.
(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” mean persons registered as such with the Health Professions Council pursuant to article 5 of the 2001 Order M4;
(c)“dental practitioner” means a dentist registered as such with the General Dental Council pursuant to section 14 of the Dentists Act 1984 M5;
(d)“dental hygienist”, “dental therapist”, “dental nurse”, “dental technician” and “orthodontic therapist” mean persons registered as such with the General Dental Council in the dental care professionals register M6;
(e)“mental disorder” means any disorder or disability of the mind, including dependence on alcohol or drugs;
(f)“midwife” means a registered midwife;
(g)“social worker” means a person who is registered as such [F4in Part 16 of the register maintained by the Health and Care Professions Council under article 5 of the Health and Social Work Professions Order 2001.]
Textual Amendments
F4Words in Sch. 1 para. 5(4)(g) substituted (1.8.2012) by The Health and Social Care Act 2012 (Consequential ProvisionSocial Workers) Order 2012 (S.I. 2012/1479), art. 1(2), Sch. para. 88(3)
Marginal Citations
M31990 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.
M4“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.
M5Section 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.
M6The 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.
Assessment or medical treatment for persons detained under the 1983 ActE+W
6.—(1) [F5Subject to sub-paragraph (1A),] 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 M7);
(b)recalled to that hospital under section 17E of that Act M8; 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.
[F6(1A) 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) of that Act.]
(2) In this paragraph—
(a)“hospital” means a hospital within the meaning of Part 2 of that Act M9;
(b)“medical treatment” has the same meaning as in section 145 of that Act M10; and
(c)“mental disorder” has the same meaning as in section 1 of that Act M11.
Textual Amendments
F5Words in Sch. 1 para. 6(1) inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(3)(a)
F6Sch. 1 para. 6(1A) inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(3)(b)
Marginal Citations
M7Section 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).
M8Section 17E was inserted by section 32 of the 2007 Act.
M9See sections 34(2) and 145(1) of the 1983 Act; relevant amendments were made by the Care Standards Act 2000, Schedule 4, paragraph 9.
M10Section 145 was amended by section 7 of the 2007 Act.
M11Section 1 was amended by section 1(2) of the 2007 Act.
Surgical proceduresE+W
7.—(1) Subject to sub-paragraphs (2) to (5), 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;
[F7(aa)the purpose of sterilisation or reversal of sterilisation;]
(b)cosmetic purposes, where the procedure involves the use of instruments or equipment which are inserted into the body; or
(c)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)(b)—
(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.
Textual Amendments
F7Sch. 1 para. 7(1)(aa) inserted (1.10.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(b), 8(4)
Diagnostic and screening proceduresE+W
8.—(1) Subject to [F8sub-paragraphs (3), (4A) and (4C)], 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)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,
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.
(2) Subject to [F8sub-paragraphs (3), (4A) and (4C)], 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 [F9or 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)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,
where such procedures are part of neither the planning and delivery of care or treatment nor a national screening programme, other than for cancer;
(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; and
[F10(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; and
(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 for which a licence has been granted to that person under section 16 (grant of licence) of that Act.]
[F11(4A) 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 (4B), and the analysis and reporting of the results of those procedures, are excepted from sub-paragraphs (1) and (2) of this paragraph.
(4B) The procedures referred to in sub-paragraph (4A) 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.
(4C) 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.]
(5) For the purposes of this paragraph—
(za)[F12“16 to 19 Academy” has the same meaning as in section 1B of the Academies Act 2010;]
(a)“chiropractor” means a person registered with the General Chiropractic Council pursuant to section 3, 4, 5 or 5A of the Chiropractors Act 1994 M12; and
(aa)[F13“hearing aid dispenser” means a person registered as such with the Health Professions Council pursuant to article 5 of the 2001 Order;]
(b)“physiotherapist” means a person registered as such with the Health Professions Council pursuant to article 5 of the 2001 Order.
Textual Amendments
F8Words in Sch. 1 para. 8(1)(2) substituted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(5)(a)
F9Words in Sch. 1 para. 8(4)(a)(i) inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(5)(b)(i)
F10Sch. 1 para. 8(4)(g)-(o) substituted (18.6.2012) for Sch. 1 para. 8(4)(g) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(5)(b)(ii)
F11Sch. 1 para. 8(4A)-(4C) inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(5)(c)
F12Sch. 1 para. 8(5)(za) inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(5)(d)(i)
F13Sch. 1 para. 8(5)(aa) inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(5)(d)(ii)
Marginal Citations
M121994 c. 17. Section 5A was inserted by S.I. 2007/3101, regulation 219.
Management of supply of blood and blood derived products etc.E+W
9.— [F14(1)] [F15Subject 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.
[F16(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.]
Textual Amendments
F14Sch. 1 para. 9 renumbered as Sch. 1 para. 9(1) (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(6)(a)
F15Words in Sch. 1 para. 9(1) inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(6)(b)
F16Sch. 1 para. 9(2)(3) inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(6)(c)
Transport services, triage and medical advice provided remotelyE+W
10.—(1) [F17Subject to sub-paragraphs (2A) and (2B),] transport services provided F18... 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.
[F19(2A) Transport services which are provided within the confines of the site or venue being used for an activity or event mentioned in paragraph 5(3)(f) or (g) are excepted from sub-paragraph (1).
(2B) 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 article 6 (aircraft to be registered) of the Air Navigation Order 2009; and
(b)the person providing the air ambulance does not provide treatment to a patient.]
(3) For the purposes of this paragraph—
(a)“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; and
(b)“vehicle” includes an air or water ambulance.
Textual Amendments
F17Words in Sch. 1 para. 10(1) inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(7)(a)
F18Words in Sch. 1 para. 10(1) omitted (30.11.2011) by virtue of The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2011 (S.I. 2011/2711), regs. 1, 2(5)
F19Sch. 1 para. 10(2A)(2B) inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 8(7)(b)
Maternity and midwifery servicesE+W
11.—(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 pursuant to section 254 of, and Schedule 20 to, the 2006 Act (local social services authorities).
Termination of pregnanciesE+W
12. The termination of pregnancies.
Services in slimming clinicsE+W
13. 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
14.—(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
15. The insertion or removal of an intrauterine contraceptive device carried out by, or under the supervision of, a health care professional.
Regulations 3(7) and (8)
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 involves the carrying on of an establishment or agency within the meaning of the Care Standards Act 2000 M13 for which Her Majesty's Chief Inspector of Education, Children's Services and Skills is the registration authority under that Act.E+W
3. The provision of all medical services (including medical services provided otherwise than under the 2006 Act) by a provider whose sole or main purpose is the provision of primary medical services—E+W
(a)under arrangements made pursuant to the following sections of the 2006 Act—
[F20(i)section 3A (power of clinical commissioning groups as to commissioning certain health services),]
(ii)section 83(2)(b) (primary medical services),
(iii)section 92 (arrangements by [F21the Board] for the provision of primary medical services); or
(b)under a contract entered into pursuant to section 84 of that Act (general medical services contracts: introductory) M14.
Textual Amendments
F20Sch. 2 para. 3(a)(i) substituted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 150(2)(a)
F21Words in Sch. 2 para. 3(a)(iii) substituted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 150(2)(b)
Marginal Citations
M14This paragraph will cease to have effect on 1st April 2012: see regulation 3(8)(a).
[F224.—(1) Subject to paragraph 5, and except where paragraph 3 applies, the provision of treatment in a surgery or consulting room by a medical practitioner who is (or group of medical practitioners who are)—E+W
(a)a service provider in respect of a regulated activity specified in paragraph 5 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.]
Textual Amendments
5. Paragraph 4 does not apply in relation to—E+W
(a)treatment carried out under anaesthesia [F23(other than local anaesthesia for the purposes of a procedure mentioned in paragraph 7(2) of Schedule 1)] or intravenously administered sedation;
F24(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[F25(c)medical services provided in connection with childbirth;]
(d)the termination of pregnancies;
(e)cosmetic surgery, with the exception of the procedures referred to in paragraph 7(4) of Schedule 1;
(f)haemodialysis or peritoneal dialysis;
[F26(g)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; ]
(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 such therapy is carried out by or under the supervision or direction of a medical practitioner.
[F27(i)intravenous, intrathecal or epidural administration of medicines or diagnostic agents;
(j)the therapeutic or diagnostic use of x-rays, radiation, protons or magnetic resonance imaging; or
(k)invasive cardiac physiology tests.]
Textual Amendments
F23Words in Sch. 2 para. 5(a) inserted (1.10.2013) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(c), 9(3)(a)
F24Sch. 2 para. 5(b) omitted (1.10.2013) by virtue of The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(c), 9(3)(b)
F25Words in Sch. 2 para. 5(c) substituted (1.10.2013) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(c), 9(3)(c)
F26Sch. 2 para. 5(g) substituted (1.10.2013) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(c), 9(3)(d)
F27Sch. 2 para. 5(i)-(k) inserted (1.10.2013) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(c), 9(3)(e)
6. The provision by a general medical practitioner (other than one who is a provider for the purposes of paragraph 3) of—E+W
(a)primary medical services under arrangements made pursuant to the sections of the 2006 Act referred to in paragraph 3(a) and (b); or
(b)any of the services listed in paragraph 5 in premises which are the premises used by that practitioner for the purpose of the provision of primary medical services under the 2006 Act M15.
Marginal Citations
M15This paragraph will cease to have effect on 1st April 2012: see regulation 3(8)(a).
7. The provision of services (other than in a surgery, consulting room or hospital) involving treatment by medical practitioners working for the purposes of an undertaking which also provides such services in pursuance of the 2006 Act M16.E+W
Marginal Citations
M16This paragraph will cease to have effect on 1st April 2012: see regulation 3(8)(a).
8. Medical [F28or dental] services provided (otherwise than [F29in 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.
Textual Amendments
F28Words in Sch. 2 para. 8 inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 9(4)(a)
F29Words in Sch. 2 para. 8 inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 9(4)(b)
F309. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E+W
Textual Amendments
F30Sch. 2 para. 9 omitted (30.11.2011) by virtue of The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2011 (S.I. 2011/2711), regs. 1, 2(6)
10. Forensic medical [F31or dental] services provided under arrangements made with a police authority as defined in section 101 (interpretation) of the Police Act 1996 M17.E+W
Textual Amendments
F31Words in Sch. 2 para. 10 inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 9(5)
Marginal Citations
M171996 c.16. The definition of police authority in section 101 was amended by the Greater London Authority Act 1999 (c. 29), section 312(2).
F3211. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E+W
Textual Amendments
F32Sch. 2 para. 11 omitted (30.11.2011) by virtue of The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2011 (S.I. 2011/2711), regs. 1, 2(6)
12. 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
13. Pharmaceutical services and local pharmaceutical services provided under Part 7 of the 2006 Act[F33, 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, at or from premises that are a registered pharmacy (within the meaning given by section 74 of the Medicines Act 1968).] E+W
Textual Amendments
F33Words in Sch. 2 para. 13 substituted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 150(3)
14. 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.
15. 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.
16. Treatment provided in a school to the pupils of that school by a nurse who is engaged and directed by the school.E+W
17. In this Schedule—E+W
(a)“insurance provider” means—
(i)a person regulated by the [F34Financial Conduct Authority or the Prudential Regulation Authority] who sells insurance, or underwrites the risk of such insurance, or
(ii)the agent of such a person; and
(b)“primary dental services” includes the provision of dental implants.
Textual Amendments
F34Words in Sch. 2 para. 17 substituted (1.4.2013) by The Financial Services Act 2012 (Consequential Amendments and Transitional Provisions) Order 2013 (S.I. 2013/472), Sch. 2 para. 186
[F35Exemption for the Olympics and ParalympicsE+W
18.—(1) Any activity which is carried on under temporary arrangements in relation to those persons taking part in, or attending, a London Olympic event during the London Olympics period.
(2) In this paragraph, “London Olympic event” and “London Olympics period” have the meanings given by section 1 (interpretation of principal terms) of the London Olympic Games and Paralympic Games Act 2006.]
Textual Amendments
F35Sch. 2 para. 18 inserted (18.6.2012) by The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/1513), regs. 1(2)(a), 9(6)
Regulations 4, 5, 6 and 21
SCHEDULE 3E+WInformation Required In Respect Of Persons Seeking To Carry On, Manage Or Work For The Purposes Of Carrying On, A Regulated Activity
1. Proof of identity including a recent photograph.E+W
2. Where the certificate is required for a purpose referred to in—E+W
(a)section 113A(2)(b) of the Police Act 1997 M18, a criminal record certificate issued under section 113A of that Act together with, after the appointed day and where applicable, relevant information relating to children or vulnerable adults; or
(b)section 113B(2)(b) of the Police Act 1997, an enhanced criminal record certificate issued under section 113B of that Act together with, where applicable, suitability information relating to children or vulnerable adults.
Marginal Citations
M181997 c. 50. Sections 113A and 113B were inserted by the Serious Organised Crime and Police Act 2005 (c. 15), section 163(2), and amended by the Safeguarding Vulnerable Groups Act 2006 (c. 47), Schedule 9, Part 2, paragraphs 14(1), (2) and (3).
3. 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.
4. 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
5. Satisfactory documentary evidence of any relevant qualification.E+W
6. A full employment history, together with a satisfactory written explanation of any gaps in employment.E+W
7. Satisfactory information about any physical or mental health conditions which are relevant to the person's ability to carry on, manage or work for the purposes of, the regulated activity.E+W
8. For the purposes of this Schedule—E+W
(a)“the appointed day” means the day on which section 30 of the Safeguarding Vulnerable Groups Act 2006 M19 comes into force;
(b)“relevant information relating to children or vulnerable adults” has the same meaning as in section 31(2) and (3) of that Act;
(c)“satisfactory” means satisfactory in the opinion of the Commission; and
(d)“suitability information relating to children or vulnerable adults” means the information specified in sections 113BA and 113BB respectively of the Police Act 1997 M20.
Marginal Citations
M20Sections 113BA and 113BB were inserted into the Police Act 1997 by the Safeguarding Vulnerable Groups Act 2006, section 63(1), Schedule 9, Part 2, paragraph 14(1) and (4).
Regulation 28
SCHEDULE 4E+WFixed Penalty Offences
Provision creating offence | General nature of offence | Monetary amount of penalty |
---|---|---|
[F36Regulation 25 of the Care Quality Commission (Registration) Regulations 2009 | Contravention of, or failure to comply with, any of the provisions of regulations 12 and 14 to 20 of the Care Quality Commission (Registration) Regulations 2009 | £1250 in the case of an offence committed by a service provider £625 in the case of an offence committed by a registered manager] |
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 |
Textual Amendments