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The Health and Social Care Act 2008 (Regulated Activities) Regulations 2010

Draft Legislation:

This is a draft item of legislation. This draft has since been made as a UK Statutory Instrument: The Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 (revoked) No. 781

Diagnostic and screening procedures

This section has no associated Explanatory Memorandum

8.—(1) Subject to sub-paragraph (3), 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 sub-paragraph (3), 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, 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

(g)the use of an auroscope.

(5) For the purposes of this paragraph—

(a)“chiropractor” means a person registered with the General Chiropractic Council pursuant to section 3, 4, 5 or 5A of the Chiropractors Act 1994(1); and

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

(1)

1994 c. 17. Section 5A was inserted by S.I. 2007/3101, regulation 219.

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