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

Diagnostic and screening procedures E+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 M1 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 M2 ;

“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.

Marginal Citations

M1 Relevant 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.

M2 1994 c.17. Relevant amendments were made by S.I. 2007/3101 and 2008/1774.