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National Health Service, England
Social Care, England
Public Health, England
12th June 2012
Coming into force in accordance with regulation 1(2)
The Secretary of State for Health, in exercise of the powers conferred by sections 8(1), 20, 35 and 161(3) and (4) of the Health and Social Care Act 2008(1), makes the following Regulations:
In accordance with section 20(8) of the Health and Social Care Act 2008, 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 approved by a resolution of each House.
1.—(1) These Regulations may be cited as the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012.
(2) These Regulations shall come into force—
(a)on 18th June 2012 for all provisions except regulations 8(4) and 9(2) and (3);
(b)on 1st October 2012 for regulation 8(4);
(c)on 1st October 2013 for regulation 9(2) and (3).
2. The Health and Social Care Act 2008 (Regulated Activities) Regulations 2010(2) are amended as follows.
3. In regulation 4 (requirements where the service provider is an individual or partnership)—
(a)for paragraph (3)(b), substitute—
“(b)a partnership and—
(i)each of the partners satisfies the requirements set out in paragraph (5); and
(ii)P satisfies the requirement set out in paragraph (6).”;
(b)in paragraph (4), for “are that P or, where applicable, each of the partners” substitute “in paragraph 3(a) are that P”; and
(c)after paragraph (4), insert—
“(5) The requirements referred to in paragraph 3(b)(i) are that each of the partners is—
(a)of good character;
(b)physically and mentally fit to carry on the regulated activity; and
(c)able to supply to the Commission, or arrange for the availability of, information relating to themselves specified in Schedule 3.
(6) The requirement referred to in paragraph 3(b)(ii) is that, through the combination of the qualifications, skills and experience of the partners, P has the necessary qualifications, skills and experience to carry on the regulated activity.”.
4. In regulation 12 (cleanliness and infection control), after paragraph (2), insert—
“(3) In this regulation, “medical device” has the same meaning as in regulation 2 (interpretation) of the Medical Devices Regulations 2002(3).”.
5. For regulation 18 (consent to care and treatment) substitute—
“18.—(1) In relation to the care and treatment provided for the service user, the registered person must have suitable arrangements in place for—
(a)obtaining, and acting in accordance with, the consent of service users, or the consent of another person who is able lawfully to consent to care and treatment on that service user’s behalf; or
(b)where (a) does not apply, establishing, and acting in accordance with, the best interests of the service user.
(2) Section 4 of the Mental Capacity Act 2005(4) (best interests) applies for the purposes of this regulation as it applies for the purposes of that Act.”.
6. In regulation 27(4) (offences), for “took all reasonable steps or exercised all due diligence” substitute “took all reasonable steps and exercised all due diligence”.
7. After Part 7 (revocation) insert—
30.—(1) Before 1st October 2017, 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.”.
8.—(1) Schedule 1 (regulated activities) is amended as follows.
(2) In paragraph 1 (personal care)—
(a)for sub-paragraph (3)(c) substitute—
“(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”; and
(b)in sub-paragraph (4), after the definition of “carer” insert—
“related third party” means—
an individual with parental responsibility (within the meaning of section 3 of the Children Act 1989(5)) 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) and (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.”.
(3) In paragraph 6 (assessment or medical treatment for persons detained under the 1983 Act)—
(a)at the beginning of sub-paragraph (1), insert “Subject to sub-paragraph (1A),”;
(b)after sub-paragraph (1), insert—
“(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(6).”
(4) In paragraph 7 (surgical procedures), after sub-paragraph (1)(a), insert—
“(aa)the purpose of sterilisation or reversal of sterilisation;”.
(5) In paragraph 8 (diagnostic and screening procedures)—
(a)in sub-paragraphs (1) and (2), for “sub-paragraph (3)” substitute “sub-paragraphs (3), (4A) and (4C)”;
(b)in sub-paragraph (4)—
(i)in paragraph (a)(i), after “pin prick” insert “or from a vein”;
(ii)for paragraph (g) substitute—
“(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(7) for which a licence has been granted to that person under section 16 (grant of licence) of that Act.”;
(c)after sub-paragraph (4), insert—
“(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
(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.”; and
(d)in sub-paragraph (5)—
(i)before paragraph (a), insert—
“(za)“16 to 19 Academy” has the same meaning as in section 1B of the Academies Act 2010(8);”; and
(ii)after paragraph (a), insert—
“(aa)“hearing aid dispenser” means a person registered as such with the Health Professions Council pursuant to article 5 of the 2001 Order(9);”.
(6) In paragraph 9 (management of supply of blood and blood derived products etc.)—
(a)insert “(1)” at the beginning of the existing paragraph;
(b)insert at the beginning of sub-paragraph (1), “Subject to sub-paragraph (2),”; and
(c)after sub-paragraph (1), insert—
“(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.”.
(7) In paragraph 10 (transport services, triage and medical advice provided remotely)—
(a)in sub-paragraph (1), at the beginning, insert “Subject to sub-paragraphs (2A) and (2B),”; and
(b)after sub-paragraph (2), insert—
“(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(10); and
(b)the person providing the air ambulance does not provide treatment to a patient.”.
9.—(1) Schedule 2 (regulated activities: general exceptions) is amended as follows.
(2) For paragraph 4 substitute—
“4.—(1) Subject to paragraph 5, and except where paragraph 3 applies(11), the provision of treatment in a surgery or consulting room by a medical practitioner who is (or group of medical practitioners who are)—
(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(12).”.
(3) In paragraph 5—
(a)in sub-paragraph (a), after “anaesthesia” insert “(other than local anaesthesia for the purposes of a procedure mentioned in paragraph 7(2) of Schedule 1)”;
(b)omit sub-paragraph (b);
(c)for sub-paragraph (c) substitute “medical services provided in connection with childbirth;”;
(d)for sub-paragraph (g) substitute—
“(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; ”; and
(e)after sub-paragraph (h), insert—
“(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.”.
(4) In paragraph 8—
(a)after “Medical” insert “or dental”;
(b)after “otherwise than” insert “in conjunction with the provision of accommodation”.
(5) In paragraph 10, after “medical”, insert “or dental”.
(6) After paragraph 17, insert—
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(13).”.
Signed by authority of the Secretary of State for Health.
Minister of State,
Department of Health
12th June 2012
(This note is not part of the Regulations)
These Regulations amend the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 (“the Regulated Activities Regulations”) which prescribe the kinds of activities that are regulated activities for the purposes of registration in respect of the provision of health or social care.
Regulation 3 allows service providers which are partnerships to meet the fitness requirements collectively rather than individually.
The definition of “medical device” is inserted into the Regulated Activities Regulations by regulation 4 to ensure the use of the terms “medical” and “dental” is consistent.
Regulation 5 ensures service providers have suitable arrangements in place where the service user lacks capacity to consent to care and treatment provided for them and Regulation 6 amends the defence of due diligence for an offence under the Regulated Activities Regulations.
Regulation 7 requires the Secretary of State to review the operation and effect of the Regulated Activities Regulations and publish a report.
Regulations 8 and 9 amend Schedules 1 and 2 to the Regulated Activities Regulations which respectively set out the activities that will be regulated activities for the purposes of the Health and Social Care Act 2008 and those which are exempt.
An impact assessment of the effect that this instrument will have on the costs and benefits to the service providers in question is available on the Department of Health’s web site at http://www.dh.gov.uk/en/Publicationsandstatistics/Legislation/index.htm and is published with the Explanatory Memorandum alongside the instrument at http://www.legislation.gov.uk.
2008 c.14. “Prescribed” and “regulations” are defined in section 97(1).
Paragraph 3 of Schedule 2 of S.I. 2010/781 ceases to have effect on 1st April 2012 in relation to all activities carried on by providers of out of hours services and on 1st April 2013 for all other purposes: see Regulation 3(8) of S.I. 2010/781 as inserted by Regulation 2(3) of S.I. 2011/2711.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
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