IRMERThe Ionising Radiation (Medical Exposure) Regulations 2017

A compilation of Regulations and Guidance by John Saunderson of Hull University Teaching Hospitals

Notes (25/09/2019)

With amendments from the Ionising Radiation (Medical Exposure) (Amendment) Regulations 2018.

CQC 2019, Significant accidental and unintended exposures under IR(ME)R Guidance for employers and duty-holders. Care Quality Commission, Healthcare Inspectorate Wales, The Regulation and Quality Improvement Authority, and Healthcare Improvement Scotland. June 20191 added

DHSC 2018, Guidance to the Ionising Radiation (Medical Exposure) Regulations 20172, June 2018 added

(Text in this font and colour is added by John Saunderson to aid finding of section of interest)

1 https://www.cqc.org.uk/guidance-providers/ionising-radiation/definition-significant-accidental-or-unintended-exposures (accessed 2/6/2019)2 https://www.gov.uk/government/publications/ionising-radiation-medical-exposure-regulations-2017-guidance (accessed 4/10/2018)

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S T A T U T O R Y I N S T R U M E N T S

2017 No. 1322

HEALTH AND SAFETY

The Ionising Radiation (Medical Exposure) Regulations 2017

Made - - - - 20th December 2017

Laid before Parliament 22nd December 2017

Coming into force - - 6th February 2018

The Secretary of State, being the Minister designated(a) for the purposes of section 2(2) of the European Communities Act 1972(b) in relation to safety measures in regard to radioactive substances and the emission of ionising radiation, in exercise of the powers conferred by that section and by section 56 of the Finance Act 1973(c), makes the following Regulations. Regulation 4 and Schedule 1 (the Licensing Authority) are made with the consent of the Treasury.

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(a) S.I. 1977/1718; there are no relevant amendments.

(b) 1972 c. 68; section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c. 51), and by Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c. 7). In so far as these Regulations deal with matters that are within the devolved competence of Scottish Ministers, the power of the Secretary of State to make regulations in relation to those matters in or as regards Scotland is preserved by section 57(1) of the Scotland Act 1998 (c. 46).

(c) 1973 c. 51; amendments have been made to section 56 by S.I. 2011/1043; there are other amendments to that section which are not relevant for the purposes of these Regulations

DHSC 2018

1. Introduction

This document provides guidance to accompany the Ionising Radiation (Medical Exposure) Regulations 2017, ("the Regulations") and should therefore be read in conjunction with the Regulations. This Guidance document is not intended to be binding and cannot take the place of legal advice. It is a guide to help explain how certain provisions of the Regulations should be interpreted and may be used as a point of reference by the enforcement authorities when reaching decisions about enforcement. However, the ultimate arbiter in any case of doubt would be the Court: only it could make a definitive ruling on the interpretation of the legislation.

This Guidance is also applicable to the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 and any reference to "the Regulations" can be taken to refer to these also, unless otherwise stated. Any specific differences concerning the Regulations for Northern

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Ireland are noted in the text.

The Regulations implement for Great Britain (and Northern Ireland) in part, provisions of Council Directive 2013/59/Euratom of 5 December 2013 (the “Basic Safety Standards Directive”) laying down the basic safety standards for protection against the dangers from exposure to ionising radiation. The Regulations address the radiation protection of persons undergoing medical exposures whether as part of their own medical diagnosis or treatment, as part of research, as asymptomatic individuals, as those undergoing non-medical imaging using medical radiological equipment or as carers and comforters of persons undergoing medical exposures.

The Regulations impose duties on employers and those with responsibilities for undertaking activities covered by the legislation, including optimising and justifying medical exposures and administering ionising radiation. While overall the Regulations broadly reflect existing provisions, they also introduce additional requirements which act to enhance protection for those undergoing medical exposures:

• the Regulations expand requirements for reporting of accidental or unintended exposures to ionising radiation to include doses that are less than intended

• the Regulations formalise the recognition of medical physics experts (MPEs)

• the Regulations introduce requirements for licensing of the administration of radioactive substances to persons for diagnosis, treatment or research.

The Regulations revoke and replace:

• the Ionising Radiation (Medical Exposure) Regulations 2000 (in Northern Ireland the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2000)

• the Medicines (Administration of Radioactive Substances) Regulations 1978

• the Medicines (Radioactive Substances) Order 1978.

They provide consequential amendment of:

• the Justification of Practices Involving Ionising Radiation Regulations 2004

• the Human Medicines Regulations 2012

• the Ionising Radiations Regulations 2017.

The Basic Safety Standards Directive requires that all exposures to ionising radiation must be justified prior to the exposure being made. The Directive refers to two levels of justification: justification of types of practice for all categories of exposure; and justification of individual exposures for medical and non-medical imaging purposes, where medical radiological equipment is used.

The Regulations apply only to individual exposures. Justification of types of practice involving medical and non-medical imaging exposures is covered by the Justification of Practices Involving Ionising Radiation Regulations 2004.

Practice involving the use of ionising radiation in the NHS and the private sector of healthcare is broadly consistent and the Guidance applies to both the NHS and the private sector.

R.1 Citation and commencement

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1. These Regulations may be cited as the Ionising Radiation (Medical Exposure) Regulations 2017 and come into force on 6th February 2018.

R.2(1) Interpretation

2.—(1) In these Regulations—

“accidental exposure” means an exposure of an individual as a result of an accident;

CQC 2019

Accidental exposure: an individual has received an exposure in error, when no exposure of any kind was intended

“adequate training” means training which satisfies the requirements of Schedule 3 and the expression “adequately trained” is to be construed accordingly;

“assessment” means prior determination of amount, parameter or method;

“carers and comforters” means individuals knowingly and willingly incurring an exposure to ionising radiation by helping, other than as part of their occupation, in the support and comfort of individuals undergoing or having undergone an exposure;

DHSC 2018

2. Interpretation – Regulation 2

This regulation defines a number of terms used in the Regulations. Certain key definitions are discussed below:

“carers and comforters”

Carers and comforters are individuals who are knowingly and willingly exposed to ionising radiation through support and comfort of those undergoing exposure. The definition makes clear that individuals undertaking this role are not those doing so as part of their employment. Carers and comforters are commonly relatives or friends of those undergoing exposure.

R.2(1) “clinical audit” means a systematic examination or review of medical radiological procedures which seeks to improve the quality and outcome of patient care through structured review, whereby medical radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, with modification of practices, where indicated, and the application of new standards if necessary;

“diagnostic reference levels” means dose levels in medical radiodiagnostic or interventional radiology practices, or, in the case of radio-pharmaceuticals, levels of activity, for typical examinations for groups of standard-sized individuals or standard phantoms for broadly defined types of equipment;

“dose constraint” means a restriction set on the prospective doses of individuals which may result from a given radiation source;

“employer” means any person who, in the course of a trade, business or other undertaking, carries out (other than as an employee), or engages others to carry out, those exposures described in regulation 3 or practical aspects, at a given radiological installation;

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"employer”

The definition of the employer under these Regulations is someone other than an employee who, in the course of a trade or business carries out or engages others to carry out, medical exposures or practical aspects.

The legal duties of the employer under these Regulations cannot be delegated to another and the employer should be identified so that duties placed on the employer can be attributed and

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fulfilled for the relevant activities laid out in Regulations. In circumstances where more than one employer may exist for certain aspects of an exposure, cooperation between employers is recommended to agree the roles and responsibilities of each party. In practice, the designated employer for each aspect of the exposure would usually be the person best placed to undertake the functions and responsibilities required in the Regulations.

R.2(1) “employer’s procedures” means the procedures established by an employer pursuant to regulation 6(1);

“equipment” means equipment which—

(a) delivers ionising radiation to a person undergoing exposure; or

(b) which directly controls or influences the extent of such exposure;

“evaluation” means interpretation of the outcome and implications of, and of the information resulting from, an exposure;

“health screening” means a procedure for early diagnosis in population groups at risk; “interventional radiology” means the use of X-ray imaging techniques to facilitate the introduction and guidance of devices in the body for diagnostic or treatment purposes;

“ionising radiation” means the transfer of energy in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less or a frequency of 3 × 1015 hertz or more capable of producing ions directly or indirectly;

“Licensing Authority”—

(a) for the purpose of licensing any practitioner in respect of the administration of radioactive substances means the Secretary of State;

(b) for the purpose of licensing any employer in respect of the administration of radioactive substances means—

(i) in England, the Secretary of State;

(ii) in Scotland, the Scottish Ministers; and

(iii) in Wales, the Welsh Ministers;

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Under IR(ME)R, the term ‘equipment’ includes equipment that delivers radiation and ancillary equipment that directly influences the dose to the individual. This can include, but is not limited to:

• contrast injectors

• software

• picture archiving and communication systems (PACS) and radiology information systems (RIS) or similar

• radiotherapy planning systems

• treatment verification systems

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"Licensing Authority”

The Licensing Authority for the Regulations applies only to the administration of radioactive substances.

For practitioners in Great Britain, the Licensing Authority will be the Secretary of State, in Northern Ireland this will be the Department of Health for Northern Ireland. Only one licence is

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required regardless of where the practitioner is entitled as a duty holder.

For employers, there will be different Licensing Authorities for England, Scotland, Wales and Northern Ireland. Employer licences are specific to each medical radiological installation.

R.2(1) “medical exposure” means an exposure coming within any of paragraphs (a) to (e) of regulation 3;

“medical physics expert” means an individual or a group of individuals, having the knowledge, training and experience to act or give advice on matters relating to radiation physics applied to exposure, whose competence in this respect is recognised by the Secretary of State;

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“medical physics expert”

The Regulations require medical physics experts (MPEs) to be appropriately educated and trained, and to be recognised by the Secretary of State. Further details on the MPE recognition scheme can be found on the GOV.UK website3.

The functions of the MPE role are different to that of the radiation protection adviser or radioactive waste adviser, as defined under other radiation protection regulations, although, in practice, it is possible that the same person may undertake more than one role.

R.2(1) “medical radiological” means pertaining to radiodiagnostic and radiotherapeutic procedures, and interventional radiology or other medical uses of ionising radiation for planning, guiding and verification purposes;

“medical radiological procedure” means any procedure giving rise to a medical exposure;

“non-medical imaging exposure” means any deliberate exposure of humans for imaging purposes where the primary intention of the exposure is not to bring a health benefit to the individual being exposed;

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"non-medical imaging exposure”

Non-medical imaging exposures within these Regulations are those deliberately undertaken using medical radiological equipment which do not confer a health benefit to the individual exposed. They are carried out for purposes other than those described in regulation 3 (a) – (e). Examples of non-medical imaging using medical radiological equipment include, but are not limited to:

(i) health assessment for employment purposes

(ii) health assessment for immigration purposes

(iii) health assessment for insurance purposes

(iv) radiological age assessment

(v) identification of concealed objects within the body.

“operator” means any person who is entitled, in accordance with the employer’s procedures, to carry out practical aspects including those to whom practical aspects have been allocated, medical physics experts and, except where they do so under the direct supervision of a person who is adequately trained, persons participating in practical aspects as part of practical training;

3 https://www.gov.uk/government/publications/medical-physics-experts-recognition-scheme . RPA2000 recognition scheme at http://www.rpa2000.org.uk/mpe-recognition-scheme/

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DHSC 2018

“operator”

An operator is anyone who is entitled by the employer to carry out a practical aspect (see "practical aspect" below).

An operator usually will carry out a range of functions as part of their employment and Schedule 2(1)(b) requires entitlement and the scope of practice of operators to be clearly defined within the employer’s written procedures.

R.2(1) “patient dose” means the dose concerning patients or other individuals undergoing exposures to which these Regulations apply;

“practical aspect” means the physical conduct of a medical exposure and any supporting aspects, including handling and use of medical radiological equipment, the assessment of technical and physical parameters (including radiation doses), calibration and maintenance of equipment, preparation and administration of radio-pharmaceuticals, clinical evaluation and image processing;

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"practical aspect”

Practical aspects are defined as the physical conduct of medical exposures. The range of functions covered by this term is extensive and includes the supporting functions prior to the exposure taking place, such as routine performance testing of equipment as required by regulation 15(3), the preparation of radiopharmaceuticals, treatment planning and calculation of monitor units to be delivered in radiotherapy, as well as performing the exposure itself. The term also includes activities undertaken after the exposure has taken place, image processing and archiving.

R.2(1) “practitioner” means a registered health care professional who is entitled in accordance with the employer’s procedures to take responsibility for an individual exposure;

“quality assurance” means all those planned and systematic actions necessary to provide adequate assurance that a structure, system, component or procedure will perform satisfactorily in compliance with generally applicable standards and quality control is a part of quality assurance;

“quality control” means the set of operations (programming, coordinating, implementing) intended to maintain or to improve quality and includes monitoring, evaluation and maintenance at required levels of all characteristics of performance of equipment that can be defined, measured, and controlled;

“radioactive substance” means any substance that contains one or more radionuclides the activity or activity concentration of which cannot be disregarded from a radiation protection point of view;

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“radioactive substance”

Radioactive substances are substances containing one or more radionuclides that cannot be disregarded from a radiation protection point of view. Due to variations in the way different radioactive substances are metabolised and concentrated in the body, an absolute level of radioactivity is not more closely defined. In practice, substances containing only naturally occurring radionuclides in normal concentrations, e.g. naturally occurring potassium, would not normally be included in this definition for the purposes of licensing.

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R.2(1) “radiodiagnostic” means pertaining to in-vivo diagnostic nuclear medicine, medical diagnostic radiology using ionising radiation, and dental radiology;

“radiological installation” means a facility where exposures to which these Regulations apply are performed;

“radiotherapeutic” means pertaining to radiotherapy, including nuclear medicine for therapeutic purposes;

“referrer” means a registered health care professional who is entitled in accordance with the employer’s procedures to refer individuals for exposure to a practitioner;

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“referrer”

A referrer must be a registered health care professional. Referrers are responsible for referring individuals to the practitioner for specific exposures to be undertaken in accordance with the employer's recommendations for referral criteria in regulation 6(5)(a). Schedule 2(1)(b) requires entitlement and the scope of practice to be clearly defined within the employer’s written procedures.

For Northern Ireland, the definition of referrer has been broadened slightly to allow for situations where medical practitioners in the Republic of Ireland (registered with the Medical Council of Ireland) could be entitled in line with employers procedures and agreements between healthcare bodies to refer individuals for exposures in Northern Ireland.

R.2(1) “registered health care professional” means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002(a)4;

“relevant enforcing authority” means—

(a) in England, the Care Quality Commission(b)5;

(b) in Scotland, the Scottish Ministers; and

(c) in Wales, the Welsh Ministers;

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“relevant enforcing authority”

The enforcing authority for the Regulations is appropriate to each of the countries to which the Regulations apply. As stated in the Regulations, for England the Care Quality Commission is the enforcing authority. For Scotland this is Healthcare Improvement Scotland and for Wales this is Healthcare Inspectorate Wales, as specified by the relevant Ministers. In Northern Ireland the Regulation and Quality Improvement Authority has been specified by the Department of Health to provide enforcement and inspection activities.

R.2(1) “unintended exposure” means any exposure to ionising radiation which is significantly different from the exposure intended for a given purpose.

4 (a) 2002 c. 17. Section 25 has been amended by paragraph 17 of Schedule 10 and Part 2 of Schedule 15 the Health and Social Care Act 2008 (c. 14), sections 220, 222 and 224 of and paragraphs 56 and 62 of Schedule 15 to the Health and Social Care act 2012 (c. 7), section 5(1) of the Health and Social Care (Safety and Quality) Act 2015 (c. 28), paragraph 1 and 2 of Schedule 4 to the Children and Social Work Act 2017 (c. 16).5 (b) Established by section 1 of the Health and Social Care Act 2008 (c. 14)

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DHSC 2018

"unintended exposure”

An unintended exposure is one that was not intended per se or which is significantly different from that intended by the practitioner (taking into account appropriate variation in accordance with the need to optimise exposures). Such exposures might include but are not limited to circumstances where an individual receives the wrong exposure (including circumstances where the referral was made for the wrong individual), an exposure involving inappropriate exposure factors or administered activity, where the wrong part of the body is exposed, or where the exposure is not delivered within accepted tolerances.

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Unintended exposure: although the exposure of an individual was intended, the exposure they received was significantly greater or different to that intended. For example, in the dose received, the modality or technique carried out, anatomy, radiopharmaceutical or timing of exposure. These can happen for many reasons including procedural, systematic or human error

R.2(2) (2) In these Regulations, where an individual is—

(a) an employer;

(b) a referrer;

(c) an operator; or

(d) a practitioner,

and is also an individual coming within at least one other of sub-paragraphs (a) to (d), that individual is subject to each of the duties applying to every person described in a sub-paragraph which also describes that individual.

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Regulation 2(2)

In some cases, a single individual may act as more than one duty holder (for example, some dental practitioners). Such individuals should be clear on their responsibilities as each of these duty holders under the Regulations and comply with all regulatory requirements. Where an employer carries out other duty holder tasks, the employer is still required to establish the procedures required by this regulation and to comply with them.

CQC For England - CQC’s enforcement policy for the Ionising Radiation (Medical Exposure) Regulations 2017, v3, Care Quality Commission, Feb 2018

https://www.cqc.org.uk/sites/default/files/20180307_IRMER_2000_enforcementpolicy_2017v2.pdf (accessed on 18/6/2018)

R.3 Application

3. --(1) These Regulations apply to the exposure of ionising radiation in England and Wales and Scotland—

(a) to patients as part of their own medical diagnosis or treatment;

(b) to individuals as part of health screening programmes;

(c) to patients or other persons voluntarily participating in medical or biomedical, diagnostic or therapeutic, research programmes;

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(d) to carers and comforters;

(e) to asymptomatic individuals;

(f) to individuals undergoing non-medical imaging using medical radiological equipment.

(2) Regulation 21 and paragraphs 1 and 2 of Schedule 4 apply to the exposure of ionising radiation in Northern Ireland6

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3. Application – Regulation 3

This regulation lists the range of exposures to ionising radiation to which the Regulations apply, introducing exposures to carers and comforters, asymptomatic individuals and individuals undergoing non-medical imaging using medical radiological equipment.

R.4 The Licensing Authority

4.—(1) The Licensing Authority may upon payment of a fee (where required) issue a licence to a person required by these Regulations to hold a licence.

(2) A licence described in paragraph (1) may be—

(a) issued for such period as the Licensing Authority considers appropriate;

(b) subject to such conditions as the Licensing Authority may consider appropriate; and

(c) varied or revoked at any time.

(3) Schedule 1 makes further provision relating to the application for, and the issue of, a licence described in paragraph (1).

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4. The Licensing Authority – Regulation 4

This regulation establishes the basis by which the Licensing Authority may issue a licence to those required to hold one, as detailed in regulation 5. Licences may be issued for a set period of time and may be subject to conditions. The Licencing Authority may vary or revoke licenses at any time. Some licences may require a fee to be paid before they can be issued and further information on fees is provided in Schedule 1.

Operational aspects of licensing will be carried out by Public Health England (PHE) on behalf of the Licensing Authorities, advised where appropriate by the Administration of Radioactive Substances Advisory Committee (ARSAC).

R.5 Requirement to hold a licence

5.—(1) A person must hold a valid licence issued by the Licensing Authority if that person—

(a) is an employer, in which case that person must hold a licence in respect of each radiological installation at which radioactive substances are to be administered for such purposes as may be specified in that licence; or

(b) is a practitioner, in which case that person must hold a licence in order to justify, within the meaning of regulation 11 an exposure involving the administration of radioactive substances for such purposes as may be specified in that licence.

(2) In this regulation, “purpose” when describing the purpose for which a licence is issued, means diagnosis, treatment or research.

6 Ionising Radiation (Medical Exposure) (Amendment) Regulations 201810

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5. Requirement to hold a licence – Regulation 5

This regulation establishes the requirement for certain persons to hold a valid licence:

1. A separate licence is required by the Employer, at each installation where the administration of radioactive substances will take place for a specified purpose.

2. A licence is required by a practitioner in order to administer radioactive substances for a specified purpose.

Purpose is defined as being either for diagnosis, treatment or research and will be specified on the licence.

This regulation replaces previous requirements for practitioners to hold a certificate under the Medicines (Administration of Radioactive Substances) Regulations 1978 and the Medicines (Radioactive Substances) Order 1978.

Further information relating to applications for licences and the review processes is given in Schedule 1.

ARSAC

See ARSAC Notes for guidance on the clinical administration of radiopharmaceuticals and use of sealed radioactive sources, Administration of Radioactive Substances Advisory Committee

https://www.gov.uk/government/organisations/administration-of-radioactive-substances-advisory-committee (Accessed 18/06/2018)

R.6(1) Employer’s duties: establishment of general procedures, protocols and quality assurance programmes

6.—(1) The employer must ensure that written procedures are in place in respect of—

(a) those matters described in Schedule 2; and

(b) any other matter in relation to which these Regulations mandate the establishment of procedures.

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Regulation 6(1) (Employer’s procedures)

This regulation requires the employer to establish written procedures. These are intended to provide a framework under which professionals can practice. It is recommended that the employer seek advice from professional colleagues from relevant specialties in establishing the procedures.

Procedures listed in Schedule 2 of the Regulations are not exhaustive. It is recommended that written procedures should be considered controlled documents: reviewed at regular intervals according to the procedure in Schedule 2(1)(d) and as required in regulation 6(5)(b); approved according to agreed practice; and archived appropriately.

R.6(2)

R.6(3)

(2) The employer must take steps to ensure that any written procedures are complied with by the referrer, practitioner and operator.

(3) The employer must take steps to ensure that every practitioner or operator engaged by the

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employer to carry out exposures or any practical aspect—

(a) complies with the provisions of regulation 17(1)7; and

(b) undertakes continuing education and training after qualification including, in the case of clinical use of new techniques, training related to those techniques and the relevant radiation protection requirements.

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Regulation 6(3) (Practitioner & Operator training + CPD)

This regulation requires the employer to ensure that practitioners and operators are both adequately trained and undertake continuing education and training.

However, it is to be noted that the duty is not on the employer to provide continuing education and training but to take steps to ensure that the practitioner and operator undertake education and training. In accordance with regulation 2(2), where the employer is also the practitioner or operator (or both), the employer must ensure that appropriate continuing education and training is undertaken.

In cases where the employer engages and entitles individuals as practitioners and operators, other than those who are employees, it is recommended that it is agreed, for example in the contract, that the practitioner or operator to be engaged must have been adequately trained and undertakes continuing education and training.

It is recommended that, where practicable, all practitioners and operators engaged to carry out exposures are trained locally on the equipment they use.

R.6(4) (4) The employer must ensure, where appropriate, that written protocols are in place for every type of standard radiological practice coming within these Regulations, including practices involving non-medical imaging.

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Regulation 6(4) (Written Protocols)

It is the responsibility of the employer to ensure, where appropriate, that written protocols are in place for every type of standard radiological practice covered by the Regulations. The protocols required under this regulation should not be confused with employer’s written procedures required by regulation 6(1).

Protocols might include, for example, the exposure factors used, dose to be delivered or specific techniques used to deliver ionising radiation. It is recommended that protocols are developed by appropriate, experienced professionals and that consideration is given to healthcare pathways. A multi-disciplinary team approach may be appropriate.

In practice, it may not always be possible to produce detailed and rigid protocols for every medical and non-medical imaging exposure, but it is recommended that where possible, protocols should be evidence based, specific to each examination and machine, and that any deviations are recorded. For example, in radiotherapy, written protocols might refer to standard dose regimes, energies and beam projection. Such protocols do not negate the need for individual planning to produce the intended therapeutic effect.

Protocols must be written down and it is recommended that they are maintained, accessible and their status as controlled documents understood. Regulation 6(5)(b) requires the employer to establish quality assurance programmes for written protocols.

7 i.e. does not carry out any exposure or practical aspect unless adequately trained.

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R.6(5) (5) The employer must—

(a) establish recommendations concerning referral guidelines for medical exposures, including radiation doses, and ensure that these are available to the referrer;

(b) establish quality assurance programmes for written procedures and written protocols;

(c) regularly review and make available to an operator, diagnostic reference levels in respect of an exposure falling within—

(i) regulation 3(a)—

(aa) where the exposure involves interventional radiology procedures, in which case, diagnostic references levels are to be provided where appropriate; and

(bb) where the exposure does not involve interventional radiology procedures, in which cases regard must be had to European and national diagnostic reference levels where available;

(ii) regulation 3(b) or (e) in which cases regard must be had to European and national diagnostic reference levels where available;

(iii) regulation 3(f) where practicable;

(d) establish dose constraints—

(i) for biomedical and medical research programmes falling within regulation 3(c) where no direct medical benefit for the individual is expected from the exposure; and

(ii) with regard to the protection of carers and comforters falling within regulation 3(d).

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Regulation 6(5)(a) (Referral Guidelines)

The employer must ensure the referral guidelines for medical exposures required under this regulation are available to all entitled referrers to that department. There is an obligation to have these guidelines in place regardless of the size or type of the department or types of examinations performed.

In establishing the referral guidelines, it is recommended to consult and agree these with professionals involved in medical exposures. Many departments may already have guidelines in place and information supplied by professional medical bodies may be useful, for example the Royal College of Radiologists has produced recommendations for diagnostic practice which include dose information8.

Referral guidelines are required for concomitant exposures in radiotherapy that are included as an adjunct to treatment, where these are not included within the radiotherapy protocol or where separate justification is required. It is recommended that referral guidelines for therapy and planning exposures include requirements for confirming disease by specific criteria such as imaging or histopathology.

Regulation 6(5)(b) (QA of Procedures, etc.)

This regulation requires the employer to establish quality assurance programmes for written procedures and protocols. Quality assurance programmes for equipment are dealt with under regulation 15.

In practice, each of the employer’s written procedures and protocols in a quality assurance programme of this type could be in the form of a controlled document which may include:

8 https://www.irefer.org.uk/ 13

• who is responsible for authorising the document, on behalf of the employer

• who is responsible to the authorising person for the accuracy of the document content, for document review, and for ensuring the document is up to date

• a formal process for making changes

• the version number

• the date of the last and next scheduled review

• page numbering.

Regulation 6(5)(c) (Diagnostic Reference Levels - DRLs)

This regulation requires the employer to regularly review and make available local diagnostic reference levels for exposures identified in regulations 3(a), (b), (e) and (f). It is important to note the definition of diagnostic reference levels refers to typical examinations for standard sized patients or phantoms for broadly defined types of equipment. Examples of national diagnostic reference levels include those produced by ARSAC9 and PHE10.

National or European diagnostic reference levels must be taken into account where available for standard diagnostic exposures, and where appropriate, diagnostic reference levels for interventional radiology examinations should be provided; acknowledging, for example, that there may be limited data for certain exposures. Diagnostic reference levels for non-medical imaging must be established where practicable, for example this may include such exposures which are undertaken on a routine basis.

For exposures where diagnostic reference levels are not available, the exposures must still be optimised, as under regulation 12, taking into account the exposure used for similar procedures if appropriate. Adherence to diagnostic reference levels below national or European values alone may not necessarily be sufficient to meet all requirements for optimisation.

Regulation 6(5)(d)(i) (Dose Constraints for Research)

This regulation requires dose constraints to be established by the employer for research protocols involving standard radiodiagnostic procedures, where no health benefit is expected for the individual exposed. Such research should be subject to a dose constraint based on the total dose from all radiodiagnostic procedures included in the protocol.

Regulation 6(5)(d)(ii) (Dose Constraints for C & Cs)

This regulation requires dose constraints to be established for carers and comforters, which should be set locally. It is suggested that a dose constraint of 5mSv can be considered appropriate for most circumstances. However, it is accepted that there will be a wide variety of circumstances involving exposure to carers and comforters which may arise, and this regulation allows the employer flexibility in setting dose constraints for carers and comforters locally. It is recommended that on occasions when a higher value may be appropriate, such as where the carer or comforter is supporting the treatment of a vulnerable individual, dose constraints should be assessed and agreed on a case-by-case basis, making clear to the carer and comforter the risks involved.

R.6(6) (6) A dose constraint must be established by the employer in terms of individual effective or

9 https://www.gov.uk/government/publications/arsac-notes-for-guidance 10 https://www.gov.uk/government/publications/diagnostic-radiology-national-diagnostic-reference-levels-ndrls

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R.6(7)

equivalent doses over a defined appropriate time period.

(7) The employer must ensure appropriate reviews are undertaken whenever diagnostic reference levels are consistently exceeded and ensure that corrective action is taken where appropriate.

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Regulation 6(7) (Review when DRL exceeded)

Under this regulation the employer is required to ensure reviews are undertaken at a local level, to evaluate the reasons why diagnostic reference levels have been consistently exceeded. To comply with this regulation, corrective action might include setting new values for local diagnostic reference levels (see regulation 6(5)(c) and accompanying notes) or retraining an individual.

This regulation is not intended to replace or diminish the need for regular reviews of diagnostic reference levels.

R.6(8) (8) The employer must take measures to raise awareness of the effects of ionising radiation amongst individuals capable of childbearing or breastfeeding.

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Regulation 6(8) (Enquiries of pregnancy)

This regulation requires the employer to take steps to raise awareness of the effects of ionising radiation amongst individuals capable of childbearing or breastfeeding. It is advised that this should not be restricted to enquiries by operators prior to exposure and might include measures such as signs in waiting rooms or inclusion of relevant information in appointment letters, where appropriate.

R.7 Employer’s duties: clinical audit

7. The employer’s procedures must include provision for the carrying out of clinical audit as appropriate.

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7. Employer’s duties: clinical audit – Regulation 7

This regulation requires the employer’s procedures to provide for the carrying out of clinical audit as appropriate. In doing so, the employer may wish to take account of existing professional guidance specific to the subject.

Clinical audit activities relating to healthcare involving exposures to ionising radiation may be carried out by a range of professionals, but in all cases consideration should be given to radiation protection aspects. For example, audit of a healthcare pathway might include consideration of the role of imaging within the pathway and its benefits in relation to overall outcome. Clinical audit can result in better optimisation of exposures, both individually and collectively as part of a pathway as a whole and it is recommended that results of clinical audit should be made available to the employer.

R.8 Employer’s duties: accidental11 or unintended12 exposure

11 R.2(1) “accidental exposure” means an exposure of an individual as a result of an accident;15

8.—(1) The employer’s procedures must provide that the referrer, the practitioner, and the individual exposed or their representative (if there is one) are informed of the occurrence of a clinically significant unintended or accidental exposure and of the outcome of the analysis of this exposure.

DHSC 2018

8. Employer’s duties: accidental or unintended exposure – Regulation 8

This regulation provides a comprehensive system for analysis, recording and reporting of accidental or unintended exposures. It includes events which are the consequence of equipment or procedural failure. The term “accidental or unintended exposure” does not in itself define when an event is considered significant and should be notified to the appropriate enforcing authority. This is considered under regulation 8(4).

The requirements are consistent with duty of candour.

Documentation relating to potential and actual incidents should be retained in line with relevant guidance, including that published by the enforcing authorities.

Regulation 8(1) (Clinically significant incidents)

It is important that where accidental or unintended exposures are clinically significant, the appropriate professionals involved with the care of a patient are aware that such an incident has taken place and that details are shared with them, to provide for the patient being informed and to ensure that appropriate care can be provided for the patient in the future. Clinically significant exposures are not defined by the relevant enforcing authorities. It is intended that guidance on these will be issued jointly by appropriate clinical and medical professional bodies in collaboration with the Health Departments.

The regulation allows for circumstances where it is not in the best interests of the patient to be informed of such an exposure. For example, delivery of radiotherapy to a patient undergoing palliative treatment, where the effects of an unintended or accidental exposure are unlikely to become apparent in the remaining life of the individual, but being informed of the incident may have a detrimental effect on the patient’s well-being. Such circumstances will be exceptional and in practice the practitioner and the referrer should be involved in this decision and the basis for the decision recorded in the patient’s notes. In such cases however, it is recommended that a representative of the patient is informed wherever possible.

The requirements of this regulation are consistent with the general need to conduct clinical practice in an open and transparent environment.

R.8(2) (2) The employer’s quality assurance programme must, in respect of radiotherapeutic practices, include a study of the risk of accidental or unintended exposures.

DHSC 2018

Regulation 8(2) (Study of risk for radiotherapy incidents)

This regulation recognises that radiotherapy exposures tend to have the potential for the greatest detriment in cases of accidental or unintended exposures (either to an individual or to a group of patients undergoing similar treatment) and requires employers to include a study of risk within associated quality assurance programmes. Quality assurance programmes relating to all exposures to which the Regulations apply are required generally, as addressed in regulation 6(5)(b) and 15.

12 R.2(1) “unintended exposure” means any exposure to ionising radiation which is significantly different from the exposure intended for a given purpose.

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R.8(3) (3) The employer must establish a system for recording analyses of events involving or potentially involving accidental or unintended exposures proportionate to the radiological risk posed by the practice.

DHSC 2018

Regulation 8(3) (Recording analysis of incidents)

This regulation requires that systems for recording analyses of events are put in place, commensurate with the risk of the practice. Therefore, in practice, those relating to radiotherapy will tend to be more rigorous than those for general diagnostic radiography.

Such systems must address both near misses and errors. Applicable events are additional to those notifiable to the relevant enforcing authority in regulation 8(4)(b)(iv). In practice, this is a requirement of administrative processes already in place.

R.8(4) (4) Where the employer knows or has reason to believe that an accidental or unintended exposure has or may have occurred in which a person, while undergoing—

(a) any exposure, was or could have been exposed to levels of ionising radiation significantly greater than those generally considered to be proportionate in the circumstances;

(b) a radiotherapeutic exposure was or could have been exposed to levels of ionising radiation significantly lower than those generally considered to be proportionate in the circumstances,

the employer must—

(i) undertake an immediate preliminary investigation of the incident;

(ii) unless that investigation shows beyond a reasonable doubt that no such exposure has occurred, immediately notify the relevant enforcing authority;

(iii) conduct or arrange for a detailed investigation of the circumstances of the exposure and an assessment of the dose received; and

(iv) notify the relevant enforcing authority, within the time period specified by the relevant enforcing authority, of the outcome of the investigation and any corrective measures adopted.

DHSC 2018

Regulation 8(4) (Significantly greater than intended, or RT significantly less)

This regulation requires the employer to carry out immediate preliminary investigations of accidental or unintended exposures.

This regulation applies to any exposure which has or may have involved significantly greater levels of ionising radiation than considered proportionate in the circumstances; as well as radiotherapeutic exposures which have or may have involved significantly lower levels of ionising radiation than considered proportionate in the circumstances. Unless the preliminary investigation shows beyond a reasonable doubt that such an exposure has not occurred, the relevant enforcing authority must be immediately notified and the employer must arrange for a detailed investigation of the exposure, which should include:

• establishing what happened

• identifying the causes and contributory factors of the failure

• remedial action to minimise the chance of a similar failure

• estimating the doses involved.

The employer must inform the relevant enforcing authority of the outcome of the detailed

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investigation and any corrective action taken, within the time frame specified by the relevant enforcing authority.

Notification is required to be made directly to the relevant enforcing authority appointed for these Regulations. Further guidance will be provided by the relevant enforcing authorities.

CQC

et al

See Significant accidental and unintended exposures under IR(ME)R Guidance for employers and duty-holders; Care Quality Commission, Healthcare Inspectorate Wales, The Regulation and Quality Improvement Authority & Healthcare Improvement Scotland. June 2019.

https://www.cqc.org.uk/guidance-providers/ionising-radiation/definition-significant-accidental-or-unintended-exposures

https://www.cqc.org.uk/sites/default/files/20190603_significant_accidental_and_unintended_exposures_guidance.pdf

(Accessed 4/06/2019)

CQC 2019

IR(ME)R 17: Guidance on significant accidental and unintended exposures (June 2019)

Introduction

The Ionising Radiation (Medical Exposure) Regulations 2017 and the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 are designed to protect people while undergoing examinations and treatment using ionising radiation. When there is an accidental or unintended exposure to ionising radiation, and the IR(ME)R employer knows or thinks that it is significant, they must investigate the incident and report it to the appropriate UK IR(ME)R enforcing authority (under Regulation 8(4)). This guidance tells you which incidents you need to report. It replaces the previous guidance on investigation and notification of medical exposures much greater than intended (MGTI) under IR(ME)R 2000, and is jointly agreed by the English, Welsh, Scottish and Northern Ireland enforcement authorities.

Definition of significant accidental or unintended exposures

Regulation 2 of IR(ME)R defines accidental and unintended exposures. When accidental and unintended exposures are judged to be ‘significant’ (or SAUE), they need to be notified to the enforcement authority under Regulation 8(4). To help you make notifications, we categorise SAUE as:

Accidental exposure: an individual has received an exposure in error, when no exposure of any kind was intended.

Unintended exposure: although the exposure of an individual was intended, the exposure they received was significantly greater or different to that intended. For example, in the dose received, the modality or technique carried out, anatomy, radiopharmaceutical or timing of exposure. These can happen for many reasons including procedural, systematic or human error. Unintended exposures can also include exposures to individuals resulting from an equipment malfunction. Under IR(ME)R, the term ‘equipment’ includes equipment that delivers radiation and ancillary equipment that directly influences the dose to the individual. This can include, but is not limited to:

contrast injectors

software

picture archiving and communication systems (PACS) and radiology information systems (RIS) or similar

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radiotherapy planning systems

treatment verification systems

Regulation 8(1) refers to the employer’s responsibilities when an incident is considered as ‘clinically significant’, which must be notified to the appropriate enforcing authority under Regulation 8(4). See the table on page 8 for notification codes and criteria.

When to investigate and notify the enforcement authority

The employer’s responsibilities are set out in Regulation 8(4). As the employer, if you suspect, or are informed, that a SAUE has, or may have occurred, you must first carry out a preliminary investigation as soon as possible.

If the preliminary investigation shows beyond reasonable doubt that the incident meets the specified criteria for a SAUE, you must notify the appropriate enforcing authority as soon as possible.

This means that, depending on the circumstances, employers need to make the notification no later than 2 weeks after discovering the incident. You must then carry out a detailed investigation of the circumstances of the exposure or arrange for this to happen.

Keeping records of investigations

There must be a record of the investigations and what they found. You need to keep these records in accordance with your local procedures and with Regulation 8(3). You must do this regardless of whether an incident needs to be notified to the appropriate enforcing authority or not.

For SAUE incidents, you must send a report on the outcome of the investigation to the appropriate enforcing authority. The report should include:

what happened

an estimate of the dose(s) received by the exposed individual(s)

a detailed account of the root causes and contributory factors

whether any similar previous incidents have occurred where individuals might have been over or under exposed, or if there are any trends that show a possible systematic failure

whether local duty of candour requirements have been met

whether local procedure, required under Regulation 8(1), schedule 2(l), has been applied

any learning from the investigation and how this has been shared

the corrective measures adopted and/or remedial actions implemented to reduce the likelihood or prevent this type of incident from happening again.

The appropriate enforcing authority needs to receive the investigation report as soon as possible, regardless of the severity of the incident or any complications. Employers need to submit the report no later than 12 weeks after the incident was discovered. This is irrespective of any timeframes of a health board or an employer’s own timeframes for reporting serious incidents.

If you cannot submit the report within the expected timeframe, you need to discuss with an inspector from the appropriate enforcing authority as early as possible.

Criteria for making a notification

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The table shows the criteria for a significant accidental or unintended exposure (SAUE) that must be notified to the appropriate enforcing authority.

We use the ‘effective dose’ as the principal dose parameter, including for radiotherapy planning and verification imaging. However, where it is difficult to assess the effective dose or where alternative dose units are more relevant, the notification form allows you to add this information in the relevant section.

Interventional radiology and cardiology

Determining the extent of any ‘unintended’ dose across a range of examinations and treatments in interventional radiology and cardiology is complex.

Where there is a local diagnostic reference level (DRL), enforcing authorities have determined that a dose greater than or equal to 10 times the local DRL will help you to determine what incidents are notifiable. This applies even when there has been no procedural failure.

Where local DRLs are not available, you should compare the dose with the estimated intended exposure if it is quantifiable.

You may also consider submitting a notification if it will lead to wider learning. This is at the discretion of the employer.

We also include deterministic effects (excluding transient erythema) in the criteria for making notifications of interventional radiology and cardiology exposures. We will keep these criteria under review.

In England only, there are now age-related dose thresholds for notifications of accidental exposures

.

Under-exposures

Regulation 8(4)(b) requires employers to make notifications of radiotherapeutic exposures that are significantly lower than intended. This includes molecular radiotherapy, brachytherapy and intraoperative therapy.

You do not need to make a notification of exposures lower than intended for non-radiotherapeutic modalities.

Complementary notification codes

As well as notification codes 1-8, the table includes complementary codes that help to identify specific types of incident:

Voluntary: incidents that do not necessarily meet the criteria for statutory notification but, because of other significant or unusual circumstances, may be submitted for wider learning.

Clinically significant: incidents involving ‘clinically significant’ exposure(s). The criteria for these are developed and published by professional bodies.

Multiple individuals (more than one): incidents where a theme has been identified over a number of incidents or where a single incident has involved multiple individuals.

Equipment: refers to incidents where equipment failures are the direct cause.

Where a notification specifies a complementary notification code as the basis for an incident, it must also be accompanied by a notification code 1-8, to indicate the most relevant exposure category for the incident.

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Incidents that do not meet the notification criteria

You do not need to make a statutory notification for:

Repeat exposures involving no procedural, human, systematic or equipment errors. These are not included in the definition of SAUE. For example, where original images are undiagnostic and need a technical repeat or are not diagnostic due to contrast extravasation or movement.

Foetal exposures where there has been no procedural failure

Incidents involving medical and non-medical ionising radiation that do not meet the dose threshold and notification criteria for SAUE still need to be investigated and analysed locally under Regulation 8(3). Employers must record the analyses of these events, which should consider any thematic reviews and trend analyses.

You should also consider coding all incidents to understand total numbers of similar incidents irrespective of whether they are notified or below the relevant notification threshold.

This is particularly important for incidents that were previously reported as MGTI under IR(ME)R 2000. Examples included referral errors, the wrong individual or wrong anatomy, timing errors, use of wrong radiopharmaceutical, and radiotherapy partial geographical misses.

The appropriate enforcing authority will review these analyses through regulatory monitoring activity and will collect data from employers periodically. This type of evidence, together with SAUE notifications and knowledge of local governance processes for managing radiation incidents, may be used to assess compliance with Regulation 8 more generally.

This guidance will be reviewed periodically and revised as necessary, based on analyses of notifications received by enforcing authorities. This is to ensure consistent notification practice among employers and to share wider learning of SAUE incidents.

Appropriate UK enforcement authorities

To submit a notification, the appropriate IR(ME)R enforcement authorities are:

England: The Care Quality Commission www.cqc.org.uk/irmer-notification

Wales: Healthcare Inspectorate Wales www.hiw.org.uk email: IRMERIncidents@Wales.GSI.Gov.uk

Northern Ireland: The Regulation and Quality Improvement Authority www.rqia.org.uk

Scotland: Healthcare Improvement Scotland www.healthcareimprovementscotland.org email: hcis.irmer@nhs.net

Reporting device-related incidents

Where there are risks to individuals relating to medical devices, employers should consider reporting all device and medicine-related incidents to other agencies including:

England and Wales: The Medicines and Healthcare Products Regulatory Agency (MHRA) http://www.gov.uk/report-problem-medicine-medical-device

Scotland: Health Facilities Scotland http://www.hfs.scot.nhs.uk/services/incident-reporting-and-investigation-centre-iric-1/how-to-report-an-adverse-incident/

Northern Ireland: the Northern Ireland Adverse Incident Centre https://www.health-ni.gov.uk/articles/reporting-adverse-incident

It is good practice for employers to report such incidents (even if they have not resulted in

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SAUE). This enables the UK Competent Authority for the Medicines and Medical Device Regulations (MHRA) to take appropriate action with the manufacturer.

Public or occupational exposures

Where members of the public or workers receive over-exposures to ionising radiation, these need to be reported to the Health and Safety Executive under Regulation 26 of The Ionising Radiation Regulations 2017.

http://www.hse.gov.uk/radiation/ionising/index.htm

Health and Safety Executive Northern Ireland https://www.hseni.gov.uk/articles/ionising-radiation#toc-3

Over-exposures resulting from equipment faults before the equipment is put into clinical use, for example, for critical examination, should also be reported to the Health and Safety Executive.

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Notification codes, categories and criteria

Notes to the tablea. Criteria apply to the total exposure from the incident, including any intended component plus over-exposure and/or necessary repeat exposures. Where a multiplication factor is specified this is defined as the total dose from the incident divided by the intended dose.b. This column of the table defines the various notification criteria. Where the exposure is not easily estimated in mSv or the dose unit specified, an alternative recognised unit may be applied and specified in the notification.c. In England, Wales and Northern Ireland, a child is someone who has not yet reached their 18 th birthday. In Scotland, this is someone who has not yet reached their 16th birthday.d. Excluding where there has been no breakdown in protocol and repeat verification imaging has facilitated correction of a ‘setup’ error so preventing a geographical miss in treatment.

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Notes to the tablee. Excluding where the under-exposure to the target volume is a result of a geographical miss, which is reportable under 8.1 or 8.2.f. A surrogate for the locally defined error margin might be a displacement of 2.5 times the local imaging action level for specific anatomical site and treatment intent.

Published by: Care Quality Commission www.cqc.org.uk enquiries@cqc.org.uk Tel: 03000 616161, June 2019

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R.9 Relevant enforcing authority’s duties: accidental or unintended exposure

9. The relevant enforcing authority must put in place mechanisms enabling the timely dissemination of information, relevant to radiation protection in respect of medical exposures, regarding lessons learned from significant events.

DHSC 2018

9. Relevant enforcing authority’s duties: accidental or unintended exposure – Regulation 9

This regulation requires the relevant enforcing authorities to put in place mechanisms to provide information on significant events, to enable learning from experience and implementation of preventative measures, so that the probability of similar events is minimised. This may be provided through annual reports or specific case studies, as deemed appropriate by the relevant enforcing authority.

R.10 Duties of the practitioner, operator and referrer

10.—(1) The practitioner and the operator must comply with the employer’s procedures.

DHSC 2018

10. Duties of the practitioner, operator and referrer – Regulation 10

Regulation 10 sets out the respective responsibilities of practitioners, operators and referrers.

Regulation 10(1)

The practitioner and the operator must comply with the employer’s procedures, including those listed in Schedule 2.

R.10 (2) The practitioner is responsible for the justification of an exposure and such other aspects of an exposure as is provided for in these Regulations.

(3) Practical aspects of an exposure or part of it may be allocated in accordance with the employer’s procedures by the employer or the practitioner, as appropriate, to one or more individuals entitled to act in this respect in a recognised field of specialisation.

DHSC 2018

Regulation 10(3)

This regulation deals with the allocation of responsibility for practical aspects of an

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exposure to specific individuals entitled to act in this respect, in accordance with the employer's procedures (see Schedule 2(1)(b)). The person to whom a practical aspect has been allocated, the operator as defined in regulation 2, is responsible for that aspect (see regulation 10(4)).

R.10 (4) The operator is responsible for each practical aspect which the operator carries out as well as for any authorisation given pursuant to regulation 11(5).

(5) The referrer must supply the practitioner with sufficient medical data (such as previous diagnostic information or medical records) relevant to the exposure requested by the referrer to enable the practitioner to decide whether there is a sufficient net benefit as required by regulation 11(1)(b).

DHSC 2018

Regulation 10(5)

Regulation 10(5) specifies that the referrer plays a role in the justification process by providing relevant medical data to the practitioner, but the referrer does not undertake justification itself.

In order for the data to be sufficient for the purposes of justification, it may be necessary to include previous diagnostic information or medical records such as the clinical question being addressed, which is particularly relevant in the case of diagnostic exposures, or information relating to pregnancy and breastfeeding, where known. It may also be helpful to include information relating to clinical conditions which mean pregnancy and breastfeeding are not possible, to prevent inappropriate questioning of such individuals prior to an exposure taking place when this would normally be considered appropriate.

R.10(6) (6) The practitioner and the operator must cooperate, regarding practical aspects, with other specialists and staff involved in an exposure, as appropriate

R.11 Justification of individual exposures

11.—(1) A person must not carry out an exposure unless—

DHSC 2018

11. Justification of individual exposures – Regulation 11

This regulation deals with the justification and authorisation of individual exposures and provides that no one may carry out an exposure unless the matters set out in regulation 11(1)(a)-(f), where applicable, have been complied with. Points to draw attention to under this regulation are as follows:

Regulation 11(1)

In this regulation, the phrase "carry out an exposure" refers to the actual process of exposure to ionising radiation itself, and not to other practical aspects of the exposure, such as calibration, which can be carried out irrespective of the justification of individual exposures.

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R.11(1)(a) (a) in the case of the administration of radioactive substances, the practitioner and employer are licensed to undertake the intended exposure;

DHSC 2018

Regulation 11(1)(a)

For exposures involving the administration of radioactive substances, the justification and authorisation of exposures must only take place when both employer and practitioner licences have been issued. Regulation 20 provides guidance on transitional arrangements. These licences must include the specific radioactive substance to be administered and the purpose of the exposure.

R.11(1)(b) (b) it has been justified by the practitioner as showing a sufficient net benefit giving appropriate weight to the matters set out in paragraph (2);

DHSC 2018

Regulation 11(1)(b)

This regulation requires that any exposure must be justified before the exposure can take place. The practitioner is responsible for the justification of each individual exposure. In practice, this should be based on evidence where available, for example, knowledge of the hazard associated with the exposure and the clinical information supplied by the referrer.

Regulation 11(1)(b) requires a practitioner to give appropriate weight to the matters set out in regulation 11(2) in determining whether an exposure shows a sufficient net benefit and can be justified. This means that the practitioner needs to consider and balance as appropriate the elements set out in regulation 11(2).

R.11(1)(c) (c) it has been authorised by the practitioner or, where paragraph (5) applies, the operator;

DHSC 2018

Regulation 11(1)(c)

Authorisation is a process separate to justification and is the means by which it can be demonstrated that justification has been carried out. The method of authorisation may depend on local circumstances; in practice this may include an electronic signature or a signature on a request card. It is recommended that the employer specify a method of authorisation to be used locally to ensure a consistent approach.

The Regulations require that authorisation is carried out before the exposure takes place. In most circumstances, this does not present problems, particularly if opportunities provided by role extension and by regulation 11(5) are utilised.

R.11(1)(d) (d) in the case of an exposure taking place in the course of a research programme under regulation 3(c), that programme has been approved by an ethics committee and,

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in the case of the administration of radioactive substances, approved by an expert committee who can advise on the administration of radioactive substances to humans;

DHSC 2018

Regulation 11(1)(d)

The definition of an ethics committee is given in regulation 11(6).

Research involving the administration of radioactive substances must additionally be approved by the expert advisory committee ARSAC. ARSAC approval of a study does not replace the requirement for justification of exposures on an individual level.

R.11(1)(e) (e) in the case of an exposure falling within regulation 3(f) (non-medical imaging), it complies with the employer’s procedures for such exposures; and

DHSC 2018

Regulation 11(1)(e)

These Regulations introduce justification of non-medical imaging exposures using medical radiological equipment. In such cases, the benefits may be financial or social rather than for the health of the individual being exposed.

R.11 (f) in the case of an individual of childbearing potential, the person has enquired whether that individual is pregnant or breastfeeding, if relevant.

(2) The matters referred to in paragraph (1)(b) are—

(a) the specific objectives of the exposure and the characteristics of the individual involved;

(b) the total potential diagnostic or therapeutic benefits, including the direct health benefits to the individual and the benefits to society, of the exposure;

(c) the individual detriment that the exposure may cause; and

(d) the efficacy, benefits and risk of available alternative techniques having the same objective but involving no or less exposure to ionising radiation.

DHSC 2018

Regulation 11(2)

In the process of justification under regulation 11(1)(b) appropriate weight is to be given to the factors specified in regulation 11(2).

R.11(3)(a) (3) In considering the weight to be given to the matters referred to in paragraph (2), the practitioner justifying an exposure in accordance with paragraph (1)(b) must have regard, in particular to—

(a) recommendations from appropriate medical scientific societies or relevant bodies where a procedure is to be performed as part of any health screening programme;

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Regulation 11(3)(a) (Justification – health screening)

In justifying an exposure which is to an individual as part of a health screening programme, the practitioner must justify the exposure under regulation 11(1)(b) and appropriate weight must be given to the matters set out in regulation 11(2). In doing so, the practitioner is required by this regulation to have particular regard to recommendations from appropriate medical scientific societies or relevant bodies.

R.11(3)(b) (b) whether in circumstances where there is to be an exposure to a carer or comforter such an exposure would show a sufficient net benefit taking into account—

(i) the likely direct health benefits to a patient;

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(ii) the possible benefits to the carer or comforter; and

(iii) the detriment that the exposure might cause;

DHSC 2018

Regulation 11(3)(b) (Justification – C&Cs)

Where there is to be an exposure to a carer or comforter, the practitioner is required to justify the exposure under regulation 11(1)(b) and appropriate weight must be given to the matters set out in regulation 11(2). In doing so, the practitioner must have particular regard to the matters set out in regulation 11(3)(b).

Regulation 11(3)(b)(ii) refers to the possible benefits to the carer or comforter. These benefits are likely to be psychological rather than physical.

Individual justification of exposures to carers and comforters is required in addition to the justification required for the associated patient or non-medical imaging exposure. The appropriate matters in regulations 11(2) and 11(3) should have been considered separately with regard to the associated patient or the individual undergoing non-medical imaging exposure as part of the justification process for those individuals.

R.11(3)(c) (c) in the case of asymptomatic individuals where a medical radiological procedure—

(i) is to be performed for the early detection of disease;

(ii) is to be performed as part of a health screening programme; or

(iii) requires specific documented justification for that individual by the practitioner, in consultation with the referrer,

any guidelines issued by appropriate medical scientific societies, relevant bodies or published by the Secretary of State;

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Regulation 11(3)(c) (Justification – asymptomatic)

When justifying an exposure in the case of asymptomatic individuals, the practitioner must justify the exposure under regulation 11(1)(b) and appropriate weight must be given to the matters set out in regulation 11(2). In doing so, the practitioner is required by this regulation to take into account guidelines issued by appropriate medical scientific societies, relevant bodies or the Secretary of State. This applies to exposures of all asymptomatic individuals, including exposures for individual health assessment.

R.11(3)(d) (d) the urgency of the exposure, where appropriate, in cases involving—

(i) an individual where pregnancy cannot be excluded, in particular if abdominal and pelvic regions are involved, taking into account the exposure of both the person concerned and any unborn child; and

(ii) an individual who is breastfeeding and who undergoes an exposure involving the administration of radioactive substances, taking into account the exposure of both the individual and the child.

DHSC 2018

Regulation 11(3)(d) (Justification – potential pregnancy and breastfeeding)

This regulation applies in cases where the practitioner is justifying an exposure to an individual where pregnancy cannot be excluded, particularly if abdominal or pelvic regions are involved; or in cases involving administration of radioactive substances to an individual who is breastfeeding.

The practitioner must justify the exposure under regulation 11(1)(b) and appropriate weight must be given to the matters set out in regulation 11(2). In doing so, the practitioner is required by this regulation to have particular regard to the urgency of the exposure.

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R.11(4) (4) In deciding whether to justify an exposure under paragraph (1)(b) the practitioner must take account of any data supplied by the referrer pursuant to regulation 10(5) and must consider such data in order to avoid unnecessary exposure.

DHSC 2018

Regulation 11(4)

This regulation is linked to regulation 10(5) which requires the referrer to supply the practitioner with sufficient medical data relevant to the exposure requested, to enable the practitioner to decide whether the exposure can be justified. Regulation 11(4) requires the practitioner to consider the data provided by the referrer before justification, to avoid any unnecessary exposure.

R.11 (5) Where it is not practicable for the practitioner to authorise an exposure as required by paragraph (1)(c), the operator must do so in accordance with guidelines issued by the practitioner.

(6) In this regulation—

“ethics committee” means—

(a) an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004(a)13;

(b) the Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000(b)14; or

(c) any other committee established to advise on the ethics of research investigations in human beings, and recognised for that purpose by or on behalf of the Secretary of State, the Scottish Ministers or the Welsh Ministers; and

“individual detriment” means clinically observable deleterious effects in individuals or their descendants, the appearance of which is either immediate or delayed and, in the latter case, implies a probability rather than a certainty of appearance.

DHSC 2018

12. Optimisation – Regulation 12

Regulation 12 provides for the optimisation process which involves ensuring that doses arising from exposures are kept as low as reasonably practicable, but consistent with the intended purpose. In practice, optimisation is a process which relies heavily on professional competence and skill.

R.12 Optimisation

12.—(1) In relation to all exposures to which these Regulations apply except radiotherapeutic exposures, the practitioner and the operator, to the extent of their respective involvement in an exposure, must ensure that doses arising from the exposure are kept as low as reasonably practicable consistent with the intended purpose.

DHSC 2018

Regulation 12(1)

Under this regulation, doses arising from all exposures to which the Regulations apply, other than those intended for radiotherapy, must be kept as low as reasonably practicable. For example, diagnostic imaging exposures need to be of sufficient quality to answer the clinical question posed, but the individual should not be exposed to doses beyond this. In practice, decisions on the use of devices or techniques designed to optimise exposures will

13 (a) S.I. 2004/1031.14 (b) 2000 asp 4

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rest with the practitioner and operator and may depend on factors such as availability or clinical circumstance.

R.12(2) (2) In relation to all radiotherapeutic exposures the practitioner must ensure that exposures of target volumes are individually planned and their delivery appropriately verified taking into account that doses to non-target volumes and tissues must be as low as reasonably practicable and consistent with the intended radiotherapeutic purpose of the exposure.

DHSC 2018

Regulation 12(2)

This regulation requires individual planning of target volumes for all radiotherapeutic exposures. It also applies therefore, to therapeutic research exposures. Doses to non-target volumes and tissues must be kept as low as reasonably practicable and consistent with the intended purpose of the exposure. The practitioner should use the best means available and decisions on optimisation should be taken to ensure the most appropriate care for each individual patient. For individual planning regarding therapy with unsealed sources, the practitioner is recommended to carry out an assessment of the individual patient, taking into account any established dosimetry techniques, relevant professional guidance and the patient’s overall medical condition. Use of standard activities of radiopharmaceuticals may be appropriate in some cases, where this is consistent with professional guidelines.

R.12(3) (3) Without prejudice to paragraphs (1) and (2), the operator must select equipment and methods to ensure that for each exposure the dose of ionising radiation to the individual undergoing the exposure is as low as reasonably practicable and consistent with the intended diagnostic or therapeutic purpose and in doing so must have regard, in particular to—

(a) quality assurance;

(b) assessment and evaluation of patient dose or administered activity; and

(c) adherence to such diagnostic reference levels for radiodiagnostic examinations falling within regulation 3(a), (b), (e) and (f) as the employer may have established,

as set out in the employer’s procedures.

DHSC 2018

Regulation 12(3)(c)

In practice, the requirement to adhere to diagnostic reference levels is with respect to the typical values for a procedure and should not be applied to individual patient procedures, where diagnostic requirements should be applied.

R.12(4) (4) For each medical or biomedical research programme falling within regulation 3(c), t he employer’s procedures must provide that—

(a) the individuals concerned participate voluntarily in the research programme;

(b) the individuals concerned are informed in advance about the risks of the exposure;

(c) the dose constraint set down in the employer’s procedures for individuals for whom no direct medical benefit is expected from the exposure is adhered to; and

(d) individual target levels of doses are planned by the practitioner, either alone or with the input of the referrer, for patients who voluntarily undergo an experimental diagnostic or therapeutic practice from which the patients are expected to receive a diagnostic or therapeutic benefit.

31

DHSC 2018

Regulation 12(4)

This regulation requires the employer’s procedures to provide certain safeguards for medical and biomedical research programmes.

Regulation 12 (4)(c)

This regulation requires that dose constraints for research exposures where no direct medical benefit for the individual is expected, must be adhered to. The constraint must be set by the employer in procedures, as per Schedule 2(1)(g), and it is recommended that this should be set at a level to facilitate the research, consistent with the research protocol.

Regulation 12(4)(d)

This regulation requires the planning of individual target levels of doses for patients who voluntarily undergo experimental diagnostic or therapeutic practices in cases where some benefit to the patient is expected. It is recommended that the practitioner in such circumstances is identified as the person most able to set these target levels, with respect to knowledge of ionising radiation and its potential risks. In practice the practitioner may wish to seek advice from others to clarify the doses involved.

In practice, the planned target level of dose should be set so the benefit outweighs the detriment, so as to avoid excessive doses to non-target volumes or organs at risk. For example, where interventional techniques are employed, a radiation dose target level should be set below that which might produce unacceptable levels of skin damage.

R.12(5) (5) In the case of regulation 3(d), the employer’s procedures must provide that appropriate guidance is established for the exposure of carers and comforters.

DHSC 2018

Regulation 12(5)

This regulation requires that the employer establishes guidance for carers and comforters. It is recommended that this guidance should provide practical information regarding dose optimisation such that the dose constraint is not exceeded.

R.12(6) (6) In the case of patients undergoing treatment or diagnosis with radioactive substances, the employer’s procedures must provide that, where appropriate, written instructions and information are provided to—

(a) the patient, where the patient has capacity to consent to the treatment or diagnostic procedure;

(b) where the patient is a child who lacks capacity (within the meaning of the Mental Capacity Act 2005(a)15 in the case of a child aged sixteen or seventeen) so to consent, a person with parental responsibility (within the meaning of the Children Act 1989(b)16) for the child; or

(c) where the patient is an adult who lacks capacity (within the meaning of the Mental Capacity Act 2005) so to consent, the person who appears to the practitioner to be the most appropriate person.

DHSC 2018

Regulation 12(6)

This regulation requires the employer’s procedures to provide for the giving of written instructions and information in cases where radioactive substances are administered, if appropriate. The regulation sets out the persons to whom such instructions and information must be given.

15 (a) 2005 c. 9; see section 2 as to the meaning of “capacity”.16 (b) 1989 c. 41; see section 3 as to the meaning of “parental responsibility”.

32

Regulation 12(6)(a) refers to the patients themselves where they are adults or children who have capacity to consent to the treatment or diagnostic procedure. It is recommended that in cases where children are subject to exposures it may also be appropriate to give the information or advice to the person(s) with parental responsibility.

Regulation 12(6)(b) deals with circumstances where the patient is a child who lacks capacity to consent. This should be based on the ability of the child to understand information provided rather than age. The regulation requires that the information be given to the person(s) with parental responsibility.

Regulation 12(6)(c) deals with adults that lack capacity and requires that written instructions and information is provided to the person considered most appropriate by the practitioner. In selecting who to give the information to, it may be useful to consider paragraph 7 of Section 4 of the Mental Capacity Act 2005, although it is likely that circumstances will differ considerably for each individual.

R.12(7) (7) The instructions and information referred to in paragraph (6) must

(a) specify how doses resulting from the patient’s exposure can be restricted as far as reasonably possible so as to protect persons in contact with the patient;

(b) set out the risks associated with ionising radiation; and

(c) be provided to the patient or other person specified in paragraph (6) as appropriate prior to the patient leaving the radiological installation where the exposure was carried out.

DHSC 2018

Regulation 12(7)

This regulation sets out some of the matters to be addressed in the information to be provided pursuant to regulation 12(6) and when they should be given. In practice, the level of administered activity and resulting dose to others will determine what, if any, advice needs to be given. For example, it will usually be appropriate to give advice in most therapy exposures.

R.12(8) (8) In complying with the obligations under this regulation, the practitioner and the operator must pay particular attention in relation to—

(a) medical exposures of children;

(b) medical exposures as part of a health screening programme;

(c) medical exposures involving high doses to the individual being exposed;

(d) where appropriate, individuals in whom pregnancy cannot be excluded and who are undergoing a medical exposure, in particular if abdominal and pelvic regions are involved, taking into account the exposure of both the individual and any unborn child; and

(e) where appropriate, individuals who are breastfeeding and who are undergoing a medical exposure involving the administration of radioactive substances, taking into account the exposure of both the individual and the child.

33

DHSC 2018

Regulation 12(8)

This regulation requires the practitioner and the operator to have regard to certain factors in the optimisation process. One such factor, in regulation 12(8)(c), is high dose to the individual being exposed. This will be relevant to procedures including, but not limited to, interventional radiology, radiotherapy and some CT scanning, which deliver an increased radiation dose compared to most routine diagnostic examinations.

Another factor, as per regulation 12(8)(d), is potential pregnancy, in particular if abdominal and pelvic regions are involved. In practice, the dose to the uterus, and, where pregnancy is confirmed, to the unborn child, is likely to vary with the anatomical site exposed and magnitude of the exposure in radiology or administered activity and radiopharmaceutical in nuclear medicine.

Under regulation 12(8)(e), nuclear medicine exposures to individuals who are breast feeding must also be given due regard. Further guidance is available at https://www.gov.uk/government/publications/arsac-notes-for-guidance

R.12(9) (9) The employer must take steps to ensure that a clinical evaluation of the outcome of each exposure, other than where the person subject to the exposure is a carer or a comforter, is recorded in accordance with the employer’s procedures including, where appropriate, factors relevant to patient dose.

DHSC 2018

Regulation 12(9)

This regulation requires the employer to ensure that a clinical evaluation of the outcome of each exposure, other than exposures to carers and comforters, is recorded, as set out in the employer's procedures. It is recommended that such an evaluation should be accurate and timely, such that it contributes appropriately to the care of the exposed person. In practice clinical evaluation might include the resulting diagnostic findings or therapeutic implications, as appropriate or, in the case of therapy exposures, a clear record that the exposures delivered are consistent with those prescribed, or where these have deviated, the basis for this.

Factors relevant to the patient dose should be included in the record of clinical evaluation, where appropriate, as such information might enable estimation of the effective dose to the individual to be made at a later date, if necessary.

R.13 Estimates of population doses

13. The employer must collect dose estimates from medical exposures for radiodiagnostic and interventional procedures, taking into consideration the distribution by age and gender of the exposed population and, when so requested, must provide the dose estimates to the Secretary of State.

34

DHSC 2018

This regulation requires the employer to collect dose estimates from medical exposures, and to provide these to the Secretary of State when requested. Information relating to dose estimates from medical diagnostic and interventional procedures, but not therapeutic procedures, is used to estimate population doses.

R.14 Expert advice

14.—(1) The employer must ensure that a suitable medical physics expert is appointed and involved, in accordance with paragraph (2), in relation to every type of exposure to which these Regulations apply.

(2) A medical physics expert must –

(a) be closely involved in every radiotherapeutic practice other than standardised therapeutic nuclear medicine practices;

(b) be involved in practices including standardised therapeutic nuclear medicine practices, diagnostic nuclear medicine practices and high dose interventional radiology and high dose computed tomography;

(c) be involved as appropriate for consultation on optimisation, in all other radiological practices not mentioned in sub-paragraphs (a) and (b)17; and

(d) give advice on—

(i) dosimetry and quality assurance matters relating to radiation protection concerning exposures;

(ii) physical measurements for the evaluation of dose delivered;

(iii) medical radiological equipment.

(3) A medical physics expert must also contribute to the following matters—

(a) optimisation of the radiation protection of patients and other individuals subject to exposures, including the application and use of diagnostic reference levels;

(b) the definition and performance of quality assurance of the equipment;

(c) acceptance testing of equipment;

(d) the preparation of technical specifications for equipment and installation design;

(e) the surveillance of the medical radiological installations;

(f) the analysis of events involving, or potentially involving, accidental or unintended exposures;

(g) the selection of equipment required to perform radiation protection measurements;

(h) the training of practitioners and other staff in relevant aspects of radiation protection;

(i) the provision of advice to an employer relating to compliance with these

17 Ionising Radiation (Medical Exposure) (Amendment) Regulations 201835

Regulations.

(4) The medical physics expert must, where appropriate, liaise with a radiation protection adviser and a radioactive waste adviser.

(5) In this regulation—

(a) “radiation protection adviser” means an individual who, or a body which is competent to advise on radiation protection in relation to occupational and public exposures;

(b) “radioactive waste adviser” means an individual who, or a body which is competent to provide expert advice on radioactive waste management and environmental radiation protection.

DHSC 2018

This regulation explicitly requires the employer to appoint, and entitle as an operator, a medical physics expert (MPE). The MPE should be involved, to varying degrees, in every type of exposure. This is consistent with established good practice and previous regulatory requirements.

In practice, the level of involvement of the MPE should be determined by the level of hazard and risk associated with the type of exposure and the amount of benefit expected from the MPE’s advice. It is recommended that an MPE is consulted when a new clinical technique involving exposure to ionising radiation is to be introduced, for example to assess potential impact of doses to those subject to exposure.

Regulation 14(3) provides further information on the advice and activities to be provided by the MPE under these Regulations, including to provide advice on compliance with these Regulations, as in regulation 14(3)(i).

An employer may require more than one MPE, depending on the extent of the activities of the radiological installation. The definition of operator includes the MPE and, as such, the scope of practice of each MPE should be defined in the employer's procedures, as in Schedule 2(1)(b).

RPA2000

DHSC guidance on Medical physics experts recognition scheme at https://www.gov.uk/government/publications/medical-physics-experts-recognition-scheme .

RPA2000 recognition scheme at http://www.rpa2000.org.uk/mpe-recognition-scheme/

R.15(1)-(2)

Equipment: general duties of the employer

15.—(1) An employer who has control over any equipment must—

(a) implement and maintain a quality assurance programme in respect of that equipment which must as a minimum permit—

(i) the assessment of the dose of ionising radiation that a person may be exposed to from an exposure to which these Regulations apply, by way of

36

the ordinary operation of that equipment; and

(ii) the administered activity to be verified;

(b) draw up, keep up-to-date and preserve at each radiological installation an inventory of equipment at that installation and, when so requested, must provide it to the relevant enforcing authority.

(2) The inventory referred to in paragraph (1)(b) must contain the following information—

(a) name of manufacturer;

(b) model number;

(c) serial number or other unique identifier;

(d) year of manufacture; and

(e) year of installation.

DHSC 2018

Regulation 15 sets out general requirements in respect of all equipment, regardless of when it was installed and brought into clinical service.

Regulation 15(1)(b) and 15(2)

These regulations require the employer to keep and make available for inspection an up to date inventory of equipment and specifies what information the inventory must contain. The inventory must be made available, on request, to the relevant enforcing authority.

R.15(3) (3) An employer must undertake adequate—

(a) testing of any equipment before it is first used for a medical radiological purpose;

(b) performance testing at regular intervals;

(c) performance testing following a maintenance procedure which is capable of affecting the equipment’s performance.

DHSC 2018

Regulation 15(3)

This regulation outlines duties on the employer regarding testing of equipment. It is recommended that testing of equipment before clinical use should be undertaken by staff designated and entitled by an appropriate employer for this purpose, and such staff should be considered as operators. In practice, this activity should not be undertaken by individuals acting purely as service engineers of the company installing or maintaining equipment.

R.15(4)-(6)

(4) A person must not use fluoroscopy equipment unless that equipment features—

(a) a device to control automatically the dose rate; or

(b) an image intensifier or equivalent device.

(5) Equipment used for interventional radiology and computed tomography must have a device or other feature capable of informing the practitioner, at the end of an exposure of relevant parameters for assessing the patient dose.

(6) An employer must –

(a) put in place any measures necessary to improve inadequate or defective performance of equipment;

(b) specify acceptable performance criteria for equipment; and

(c) specify what corrective action is necessary when, following the application of any criteria specified under paragraph (b), equipment is ascertained to be defective; such corrective action may include taking the equipment out of service.

37

DHSC 2018

Regulation 15(6)

This regulation outlines requirements relating to equipment performance. Guidelines on acceptable performance criteria for equipment, intended to ensure patient safety, have been produced by scientific professional bodies. The employer may adopt these or similar appropriate criteria. Corrective action should be taken at the earliest opportunity if equipment performance does not meet specified criteria. In some cases where equipment is considered defective, it may be necessary to remove the equipment from service, for example where patient safety could be compromised.

R.16 Equipment installed on or after 6th February 2018

16.—(1) This regulation only applies in respect of—

(a) equipment installed on or after 6th February 2018; and

(b) an employer who has control of any such equipment.

(2) Equipment used for external beam radiotherapy with a nominal beam energy exceeding 1 MeV must have a device or other feature, the purpose of which is, to verify key treatment parameters.

(3) Equipment used for interventional radiology must have a device or other feature capable of informing any person involved in the conduct of an exposure of the amount of radiation produced by the equipment during such an exposure.

(4) Equipment used for planning, guiding and verification purposes must have a device or other feature capable of informing the practitioner, at the end of an exposure, of relevant parameters for assessing the dose.

(5) Equipment used for interventional radiology and computed tomography must have the capacity to transfer, to the record of a person’s exposure, information relating to relevant parameters for assessing the dose.

(6) Insofar as not already provided in this regulation, any equipment producing ionising radiation must—

(a) have a device, or other feature, capable of informing the practitioner of relevant parameters for assessing the patient dose; and

(b) where appropriate, have the capacity to transfer this information to the record of a person’s exposure.

DHSC 2018

This regulation is additional to the general requirements for all equipment that are specified in regulation 15 but applies only to equipment installed after these Regulations came into force.

Regulations 16(3) – (6)

These regulations require certain equipment to have various features or devices for the

38

provision or transfer of specific information.

Regulation 16(5) introduces requirements relating to transfer of information to a record of a person's exposure. In practice, this should enable an estimate of the dose to be made for the exposure, from stored data, should it be required.

R.17(1)-(3)

Training

17.—(1) Subject to the following provisions of this regulation a practitioner or operator must not carry out any exposure or any practical aspect without having been adequately trained.

(2) A certificate issued by an institute or person competent to award degrees or diplomas or to provide other evidence of adequate training is, if such certificate so attests, sufficient proof that the person to whom it has been issued has been adequately trained.

(3) Nothing in paragraph (1) above prevents a person from participating in practical aspects of the procedure as part of practical training if this is done under the supervision of a person who is adequately trained.

DHSC 2018

This regulation prohibits any practitioner or operator from carrying out an exposure or any practical aspect without having been adequately trained. Adequate training is that which satisfies the requirements of Schedule 3.

Regulation 17(3)

This regulation allows trainees to participate in practical aspects of an exposure as part of their training, as long as they are appropriately supervised by a person who has been adequately trained. In practice, the nature and extent of the supervision required will depend on the task in question and the level of pre-existing training and experience. The definition of operator in regulation 2 makes it clear that an individual undertaking practical aspects as part of practical training would be considered an operator, unless under the direct supervision of somebody who is adequately trained.

R.17(4) (4) The employer must keep and have available for inspection by the relevant enforcing authority an up-to-date record of all relevant training undertaken by all practitioners and operators engaged by the employer to carry out any exposures or any practical aspect of such exposures showing the date or dates on which training qualifying as adequate training was completed and the nature of the training.

DHSC 2018

Regulation 17(4)

This regulation requires the employer to keep and have available for inspection an up-to-date record of all practitioners and operators engaged, showing the date on which training was completed and the nature of the training. It is recommended that this should include practical training relating to specific equipment or equipment functionality, such as dose saving devices, where this varies significantly from established functionality or where the practice is not consistent with routine activities associated with a professional role.

39

Induction programmes might be considered as part of training, for example those elements that relate to the employer’s procedures and protocols.

In accordance with regulation 2(2), where the employer is concurrently practitioner or operator, the employer must still keep training records.

In practice, training records should be stored in a manner which enables them to be made available for inspections, for example separately from employee's personnel files.

R.17(5) (5) Where the employer (“employer A”) enters into a contract with another employer (“employer B”) to engage a practitioner or operator otherwise employed by that employer B, employer B is responsible for keeping the records required by paragraph (4) and must supply such records to employer A immediately upon request.

DHSC 2018

Regulation 17(5)

This regulation makes clear that, where an employer entitles individuals to act as practitioners or operators but those individuals remain employed by another body, for example agency staff, then the second party (in this example, the agency) are responsible for keeping and maintaining up to date records of previous and continuing education and training (which may include local training, as necessary) of the staff supplied by the agency. These must be made available to the entitling employer upon request.

R.17(6) (6) Schedule 3 makes further provision about the training of practitioners and operators.

R.18 Enforcement

18. These Regulations are to be enforced by the relevant enforcing authority as if they were health and safety regulations made under section 15 of the Health and Safety at Work etc. Act 1974(a)18 and the provisions of that Act, as regards enforcement and offences, are to apply for the purposes of these Regulations.

DHSC 2018

This regulation provides for the Regulations to be enforced by the relevant enforcing authority as if they were made under section 15 of the Health and Safety at Work etc. Act 1974 (in Northern Ireland, Article 17 of the Health and Safety at Work (Northern Ireland) Order 1978) and the provisions of the 1974 Act (the 1978 Order in Northern Ireland) regarding enforcement and offences also apply . As explained in the definitions, the enforcing authority is specific to each of the administrations.

R.19 Defence of due diligence

19. In any proceedings against any person for an offence consisting of the contravention of these Regulations it is a defence for that person to show that the person took all reasonable steps and exercised all due diligence to avoid committing the offence.

18 (a) 1974 c. 37; section 15(1) was substituted by paragraph 6 of Schedule 15 to the Employment Protection Act 1975 (c. 71) and amended by S.I. 2002/794. There are other amendments to section 15 not relevant for the purposes of these Regulations.

40

R.20 Revocation and transitional provision

20.—(1) The Ionising Radiation (Medical Exposure) Regulations 2000(b19) are revoked.

(2) Subject to the transitional provisions in paragraph (3), the Medicines (Administration of Radioactive Substances) Regulations 1978(c)20 and the Medicines (Radioactive Substances) Order 1978(d)21 are also revoked to the extent that they apply in England and Wales and Scotland.

(3) Any certificate issued to a person under the Medicines (Administration of Radioactive Substances) Regulations 1978 which is valid on 6th February 2018 is deemed—

(a) to be a licence issued under these Regulations for as long as that certificate remains valid; and

(b) to license the employer responsible for the medical radiological installation for the matters specified in that certificate.

(4) Nothing in paragraph (3) prevents a person from applying for a licence under these Regulations on or after the date that they come into force.

DHSC 2018

Regulation 20 of these Regulations revokes the Ionising Radiation (Medical Exposure) Regulations 2000 and associated amendment regulations in Great Britain. In Northern Ireland, Regulation 20 of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 revokes the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2000 and associated amendment regulations. The Medicines (Administration of Radioactive Substances) Regulations 1978 and associated amendments and the Medicines (Radioactive Substances) Order 1978 are also revoked.

Transitional provisions specify that existing certificates held under the Medicines (Administration of Radioactive Substances) Regulations 1978 that are valid on the 6th February are considered to:

• Be a licence until the expiry date specified

• Licence the employer at the installation specified for the purposes and scope detailed on the certificate

• Licence the practitioner at the installation specified for the purposes and scope detailed on the certificate.

After the Regulations are in force this does not prohibit employers and practitioners from applying for licenses under the Regulations at any time.

R.21 Consequential amendments

21. Schedule 4 sets out amendments consequential on the making of these Regulations

19 (b) S.I. 2000/1059; amended by paragraph (1) of Schedule 8 to the Care Act 2014 (c. 23), S.I. 2004/1031, S.I. 2006/2523, S.I. 2006/2806, S.I. 2007/1898, S.I. 2009/462, S.I. 2011/1567 and S.I. 2012/191620 (c) S.I. 1978/1006, amended by S.I. 1995/2147, 2005/2754 and 2006/2407.21 (d) S.I. 1978/1004, amended by S.I. 2006/2407.

41

R.22 Review

22.—(1) The Secretary of State must from time to time—

(a) carry out a review of the regulatory provision contained in these Regulations; and

(b) publish a report setting out the conclusions of the review.

(2) The first report must be published before the end of the period of five years beginning with the coming into force of these Regulations.

(3) Subsequent reports must be published at intervals not exceeding 5 years.

(4) Section 30(3) of the Small Business, Enterprise and Employment Act 2015(e)22 requires that a review carried out under this regulation must, so far as is reasonable, have regard to how the Articles of Council Directive 2013/59/Euratom(f)23 implemented by these Regulations are implemented in other member States.

(5) Section 30(4) of the Small Business, Enterprise and Employment Act 2015 requires that a report published under this regulation must, in particular

(a) set out the objectives intended to be achieved by the regulatory provision referred to in paragraph (1)(a);

(b) assess the extent to which those objectives are achieved;

(c) assess whether those objectives remain appropriate; and

(d) if those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision.

(6) In this regulation, “regulatory provision” has the same meaning as in sections 28 to 32 of the Small Business, Enterprise and Employment Act 2015 (see section 32 of that Act).

Signed by authority of the Secretary of State for Health.

Stephen Brine

Parliamentary Under-Secretary of State,

20th December 2017

Department of Health

We consent

Mark Spencer

Heather Wheeler

20th December 2017

Two of the Lords Commissioners of Her Majesty’s Treasury

22 (e) 2015 c. 26. Section 30(3) was amended by the Enterprise Act 2016 (c. 12), section 1923 (f) OJ No L13,17.1.2041, p1

42

Schedule 1 SCHEDULE 1 Regulation 4

Licensing

Licence applications: general

1.—(1) A person required by regulation 5 to hold a licence must make an application to the Licensing Authority in the form specified from time to time by the Licensing Authority.

(2) A person applying for a licence under sub-paragraph (1) must provide to the Licensing

Authority—

(a) such of the information described in paragraph 2 as the Licensing Authority may from time to time specify necessary to determine the licence application;

(b) upon request in writing, any other information which the Licensing Authority requires for the purpose of considering the licence application; and

(c) the fee specified in paragraph 4.

(3) A person issued a licence under these Regulations (“the licensee”) must apply to the Licensing Authority if the licensee seeks a material change to the licence in respect of any matter dealt with by that licence.

Licence applications: indicative list of information

2. The information referred to in paragraph 1(2) is information relating to—

(a) responsibilities and organisational arrangements for protection and safety;

(b) staff competences, including information and training;

(c) design features of the radiological installation and of radiation sources;

(d) anticipated occupational and public exposures in normal operation;

(e) safety assessment of the activities and the facility in order to—

(i) identify ways in which potential exposures or accidental and unintended medical exposures could occur;

(ii) estimate, to the extent practicable, the probabilities and magnitude of potential exposures;

(iii) assess the quality and extent of protection and safety provisions, including engineering features, as well as administrative procedures;

(iv) define the operational limits and conditions of operation;

(f) emergency procedures;

(g) maintenance, testing, inspection and servicing so as to ensure that the radiation source and the facility continue to meet the design requirements, operational limits and conditions of operation throughout their lifetime;

(h) management of radioactive waste and arrangements for the disposal of such waste, in accordance with applicable regulatory requirements;

(i) management of disused sources;

(j) quality assurance

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Licence applications: urgent cases

3. The licensing authority may, on a case by case basis, relax any of the requirements relating to the making of an application for a licence in respect of a proposed urgent medical radiological exposure

Licence applications: employer fees

4.—(1) The fee payable by a person described in column 1 of Table 1 in respect of an application type specified in column 2 of that table is the corresponding amount in column 3.

(2) No fee is payable where the amount specified in column 2 is “0”.

Table 1

Licence type (1) Application type (2) Fee (£) (3)

Employer New 250

Amendment of an existing

licence

200

Renewal of an existing licence 200

Notification 0

Practitioner New 0

Amendment of an existing

licence

0

Renewal of an existing licence 0

Particular patient request 0

Review

5.—(1) A person who is aggrieved (“an aggrieved person”) by—

(a) a decision of the Licensing Authority—

(i) refusing to issue a licence;

(ii) imposing a limit of time upon a licence; or

(iii) revoking a licence; or

(b) the terms of any conditions attached to a licence by the Licensing Authority, may ask the Licensing Authority for a review.

(2) Any aggrieved person seeking a review must—

(a) within 28 days of the date that the person was notified of the decision, or the terms, which caused them to become an aggrieved person request the Licensing Authority to undertake a review described in paragraph (1) ; and

(b) must particularise in writing the reasons for seeking the review

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(3) The Licensing Authority must undertake a review, and provide the results of that review in writing to the aggrieved person.

Destination of fees

6. A fee payable under these Regulations is payable to the Secretary of State

DHSC 2018 This Schedule provides general information of the requirements for applications for licences. Applications will be managed by PHE on behalf of the Licensing Authority. Further details of the application process and requirements can be found in guidance published by ARSAC24. For urgent cases, the Regulations allow for the Licensing Authority to follow an alternative process.

Employer applications for licences are subject to a fee. Details of fees are specified in the Schedule.

24 https://www.gov.uk/government/publications/arsac-application-forms 45

Schedule 2 SCHEDULE 2Regulation 6

Employer’s Procedures

1. The employer’s written procedures for exposures must include procedures—

DHSC 2018 Schedule 2 sets out a list of matters that must be covered in the employer’s procedures. The list is not exhaustive but all those matters identified in Schedule 2 are binding.

Some of the matters listed in Schedule 2 require further comment. These are as follows:

(a) to identify correctly the individual to be exposed to ionising radiation;

DHSC 2018 The procedure should specify how an individual is to be identified before an exposure is made and it is recommended that this be positive and active, for example, "what is your name?"

In practice the procedure should state by whom the individual should be identified, for instance by the operator carrying out the exposure.

Schedule 2 (b) to identify individuals entitled to act as referrer or practitioner or operator within a specified scope of practice;

DHSC 2018 Entitlement of a referrer, a practitioner and an operator will be determined by the employer and will include their scope of practice (that is, the range of tasks that may be undertaken by them).

Those who are entitled under these Regulations as referrer, practitioner or operator could be identified in a variety of ways in the employer’s procedures, for example by profession, grade, or individual name. In practice, decisions on who is entitled to act as a referrer, practitioner or operator, and the scope of practice, should be taken at local level and may involve agreement between the employer and the healthcare professionals involved in exposures.

Entitlement and scope of practice should be supported by education and training. In some cases it may be necessary for the scope of practice of an individual to be restricted, for example to act as practitioner for radiographic procedures for extremities, or for exposures of carers and comforters, but not for complex examinations such as interventional procedures. Where one individual takes on more than one role under regulation 2(2), this must be documented in the employer's written procedures and scope of practice specified.

Schedule 2 (c) for making enquiries of individuals of childbearing potential to establish whether the individual is or may be pregnant or breastfeeding;

DHSC 2018 It is recommended that such procedures include the location of the primary beam in relation to the abdomen and the age range of individuals who should be asked about pregnancy or breast feeding. In setting this age range, consideration should be given to the increased period of reproductive capacity due to earlier maturity and advances in technology.

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Schedule 2 (d) to ensure that quality assurance programmes in respect of written procedures, written protocols, and equipment are followed;

(e) for the assessment of patient dose and administered activity;

(f) for the use and review of such diagnostic reference levels as the employer may have established for radiodiagnostic examinations falling within regulation 3(a), (b), (e) and (f)25;

(g) for determining whether the practitioner or operator is required to effect one or more of the matters set out in regulation 12(4)26 including criteria on how to effect those matters and in particular procedures for the use of dose constraints established by the employer for biomedical and medical research programmes falling within regulation 3(c) where no direct medical benefit for the individual is expected from the exposure;

(h) for the giving of information and written instructions as referred to in regulation 12(6);27

(i) providing that wherever practicable, and prior to an exposure taking place, the individual to be exposed or their representative is provided with adequate information relating to the benefits and risks associated with the radiation dose from the exposure;

DHSC 2018 The amount of information and the methods of conveying information should be commensurate with the associated risk. Posters, leaflets and information provided directly by a professional can all be useful in fulfilling this requirement.

Providing information regarding benefits and risks of an exposure can be difficult and patients and others may respond to information in different ways. It is recommended that information is provided in a simple, succinct and qualitative, rather than quantitative manner, and where possible, includes the clinical context. For example, "we believe the risks of the procedure are small and the procedure will help us to address your suspected clinical condition through diagnosis and treatment, where appropriate”.

In some cases, such as interventional radiology, procedures carry other risks, which are not related to ionising radiation. While these Regulations do not address these risks, it may be appropriate to discuss benefits and risks in a comprehensive manner, explained in a clear way so that the patient is aware of the risks associated with each element of the procedure.

In practice, the person who provides information about benefits and risks may differ depending on the clinical scenario. As such, it is recommended that the employer’s procedures indicate who should be available to provide this information in a range of scenarios, and that the provision of information should be clearly recorded.

It is not expected however, that this requirement will extend or replace any separate requirements for informed consent processes. Informed consent is not addressed in these Regulations.

Schedule 2 (j) for the carrying out and recording of an evaluation for each exposure including, where appropriate, factors relevant to patient dose;

(k) to ensure that the probability and magnitude of accidental or unintended exposure

25 i.e. for diagnosis, health screening, asymptomatic or non-medical imaging exposures (but not therapy, research or carer & comforter exposures)26 i.e. for research exposures27 i.e. nuclear medicine or brachytherapy

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to individuals from radiological practices are reduced so far as reasonably practicable;

(l) to ensure that the referrer, the practitioner, and the individual exposed or their representative are informed of the occurrence of any relevant clinically significant unintended or accidental exposure, and of the outcome of the analysis of this exposure;

(m) to be observed in the case of non-medical imaging exposures;

(n) to establish appropriate dose constraints and guidance for the exposure of carers and comforters.

DHSC 2018 It is recommended that such guidance includes, for example, information to identify when carers and comforters should be used to support exposures and how doses can be minimised.

Schedule 3 SCHEDULE 3Regulation 17

Adequate Training

1. Practitioners and operators must have successfully completed training, including theoretical knowledge and practical experience, in—

(a) such of the subjects detailed in Table 1 as are relevant to their functions as practitioner or operator; and

(b) such of the subjects detailed in Table 2 as are relevant to their specific area of practice.

DHSC 2018 Schedule 3 sets out details of the training which a practitioner or operator must have successfully completed, as relevant to their functions or area of practice, in order to be permitted to carry out medical exposures or practical aspects under the Regulations:

• Table 1 sets out subjects relevant to an individual’s functions as practitioner or operator

• Table 2 details subjects relevant to specific areas of practice.

Not all the subjects listed in Schedule 3 have to be covered. The subjects of Schedule 3 that would need to be covered will depend on the range of exposures the practitioner or operator intends carrying out.

The Regulations do not require the referrer to be adequately trained. Nevertheless, there is a requirement for referrers to understand their duties as specified under regulation 10 and to comply with employers' procedures as in regulation 6(2).

Schedule 3 Table 1

Radiation production, radiation protection and statutory obligations relating to ionising radiations

Fundamental Physics of Radiation

Properties of Radiation

Excitation and ionisation

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Attenuation of ionising radiation

Scattering and absorption

Radiation Hazards and Dosimetry

Biological effects of radiation – stochastic and deterministic

Risks and benefits of radiation

Absorbed dose, equivalent dose, effective dose, other dose indicators and their units

Management and Radiation Protection of the individual being exposed

Special Attention Areas

Pregnancy and potential pregnancy Asymptomatic individuals Breastfeeding

Infants and children

Medical and biomedical research

Health screening

Non-medical imaging Carers and comforters High dose techniques

Justification

Justification of the individual exposure Use of existing appropriate radiological information

Alternative techniques

Radiation Protection

Diagnostic reference levels

Dose Constraints

Dose Optimisation

Dose reduction devices and techniques

Dose recording and dose audit

General radiation protection

Quality Assurance and Quality Control including routine inspection and testing of equipment

Risk communication

Use of radiation protection devices

Statutory Requirements and Non-Statutory Regulations

Regulations

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Non-statutory guidance

Local procedures and protocols

Individual responsibilities relating to exposures

Responsibility for radiation safety

Clinical audit

Table 2

Diagnostic radiology, radiotherapy and nuclear medicine

All Modalities

General

Fundamentals of radiological anatomy Factors affecting radiation dose Dosimetry

Fundamentals of clinical evaluation

Identification of the individual being exposed

Diagnostic radiology

General

Principles of radiological techniques

Production of X-rays

Equipment selection and use

Specialised Techniques

Computed Tomography: advanced applications

Interventional procedures

Cone Beam Computed Tomography

Hybrid imaging

Fundamentals of Image Acquisition etc.

Optimisation of image quality and radiation dose

Image formats, acquisition, processing, display and storage

Contrast Media

Use and preparation

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Contraindications

Use of contrast injection systems

Radiotherapy

General

Production of ionising radiation

Treatment of malignant disease

Treatment of benign disease

Principles of external beam radiotherapy

Principles of brachytherapy

Specialised techniques

Intra-operative radiotherapy

Stereotactic radiotherapy and radiosurgery

Stereotactic ablative radiotherapy

Proton therapy

MR Linac therapy

Radiobiological Aspects for Radiotherapy

Fractionation

Dose rate

Radiosensitisation

Target volumes

Practical Aspects for Radiotherapy

Localisation equipment selection

Therapy equipment selection

Verification techniques including on-treatment imaging

Treatment planning systems

Radiation Protection Specific to Radiotherapy

Side effects—early and late

Toxicity

Assessment of efficacy

Nuclear Medicine

General

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Atomic structure and radioactivity

Radioactive decay

Principles of molecular imaging and non- imaging exposures

Principles of molecular radiotherapy

Molecular Radiotherapy

Dose rate

Fractionation

Radiobiology aspects

Radiosensitisation

Specialised techniques

Quantitative imaging – advanced applications

Hybrid imaging – advanced applications

Selective Internal Radiation Therapy

Principles of Radiation Detection, Instrumentation and Equipment

Types of detection systems

Optimisation of image quality and radiation dose

Image acquisition, artefacts, processing, display and storage

Radiopharmaceuticals

Calibration

Working practices in the radiopharmacy

Preparation of individual doses

Radiation Protection Specific to Nuclear Medicine

Conception, pregnancy and breastfeeding

Arrangements for radioactive individuals

Schedule 4 SCHEDULE 4 Regulation 21

Consequential amendments

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DHSC 2018 The Regulations include consequential amendments to existing regulations addressing the justification of types or classes of practice, human medicines and occupational exposure to ionising radiations. Schedule 4 sets these out.

The Justification of Practices Involving Ionising Radiation Regulations 2004 address the justification of types or classes of practices and were intended to implement a previous Basic Safety Standards Directive (96/29/Euratom). Regulation 21 ensures that the provisions, relating to a new class or type of practice involving ionising radiation or a class or type of practice which is no longer justified, do not prevent individual exposures which have been justified in accordance with regulation 11 of the Ionising Radiation (Medical Exposure) Regulations 2017.

The Human Medicines Regulations 2012 consolidate instruments concerning medicinal products for human use. Regulation 214 allows operators to administer prescription only medicines which are administered in connection with a medical exposure, if certain conditions are met. The amendments provide that the conditions which must be met relate to adherence to procedures and protocols in regulation 6(1) and (4) of the Ionising Radiation (Medical Exposure) Regulations 2017 and licenced practitioners, as described in regulation 5 of these Regulations.

The Ionising Radiations Regulations 2017 (in Northern Ireland the Ionising Radiations Regulations (Northern Ireland) 2017) address occupational exposures to ionising radiation and include requirements relating to carers and comforters and to equipment used in medical exposures. This amendment removes these requirements from the Ionising Radiations Regulations 2017 as they are now addressed in these Regulations.

Schedule 4 Amendment of the Justification of Practices Involving Ionising Radiation Regulations 2004

1.—(1) The Justification of Practices Involving Ionising Radiation Regulations 2004(a) are amended as follows.

(2) For regulation 21 (saving for medical practices) substitute—

“21. Nothing in regulation 4(5) of 5(3) shall prevent anything permitted under regulation

11 of the Ionising Radiation (Medical Exposure) Regulations 2017 or

regulation 11 of the Ionising Radiation (Medical Exposure) Regulations (Northern

Ireland) 2018(b).”.

Amendment of the Human Medicines Regulations 2012

2.—(1) The Human Medicines Regulations 2012(b) are amended as follows.

(2) In regulation 173 (exemption for certain radiopharmaceuticals), for paragraph (d) substitute—

“(d) for administration—

(i) in England and Wales and Scotland in accordance with a licence issued under the Ionising Radiation (Medical Exposure) Regulations 2017;

(ii) in Northern Ireland in accordance with a licence issued under the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.”.

(3) For regulation 240 (radioactive medicinal products), substitute—

“Radioactive medicinal products

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240.—(1) Regulation 214(2) does not apply to—

(a) a radioactive substance, administration of which results in a medical exposure; or

(b) any other prescription only medicine if it is being administered in connection with a medical exposure,

if Conditions A to E are met.

(2) Condition A is that the prescription only medicine is administered by an operator acting in accordance with the procedures and protocols referred to—

(a) in England and Wales and Scotland, in regulation 6(1) and (4) of the Ionising Radiation (Medical Exposure) Regulations 2017 which apply to the exposure;

(b) in Northern Ireland, in regulation 6(1) and (4) of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 which apply to the exposure.

(3) Condition B is that the medical exposure has been authorised by—

(a) an IRME practitioner; or

(b) where it is not practical for an IRME practitioner to authorise the exposure,

an operator acting in accordance with written guidelines issued by an IRME practitioner.

(4) Condition C is that—

(a) in England and Wales and Scotland, the IRME practitioner mentioned in sub-paragraph (a) or (b) of paragraph (3) is the holder of a licence issued under the Ionising Radiation (Medical Exposure) Regulations 2017;

(b) in Northern Ireland, the IRME practitioner mentioned in sub-paragraph (a) or (b) of paragraph (3) is the holder of a licence issued under the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.

(5) Condition D is that the prescription only medicine is not a product subject to special medical prescription.

(6) Condition E is that, in the case of a prescription only medicine that is not a radioactive substance, it is specified in the protocols referred to in paragraph (2).

(7) In this regulation—

“IRME practitioner” means—

(a) in relation to a medical exposure in England and Wales and Scotland, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2017;

(b) in relation to a medical exposure in Northern Ireland, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018;

“medical exposure” has the same meaning—

(a) in England and Wales and Scotland as in the Ionising Radiation (Medical Exposure) Regulations 2017;

(b) in Northern Ireland as in the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018;

“radioactive substance” has the same meaning—

(a) in England and Wales and Scotland as in the Ionising Radiation (Medical

54

Exposure) Regulations 2017;

(b) in Northern Ireland as in the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.”.”.28

Amendment of the Ionising Radiations Regulations 2017

3.—(1) The Ionising Radiations Regulations 2017(a)29 are amended as follows. (2) In regulation 2(1) (interpretation)—

(a) omit the definition of “carers and comforters”;

(b) insert after the definition of “calendar year”—

`““carers and comforters” means individuals knowingly and willingly incurring an exposure to ionising radiation by helping, other than as part of their occupation, in the support and comfort of individuals undergoing or having undergone a medical exposure

(other than as a carer and comforter);”;

(c) in the definition of “medical exposure”, after paragraph (d), insert—

“(e) carers and comforters;”.

(3) In regulation 3 (application)—

(a) in paragraph (2), omit “33”;

(b) omit paragraph (4).

(4) Omit regulation 33 (equipment used for medical exposure).

(5) In regulation 35(6) (duties of employees)—

(a) in sub-paragraph (a), after “overexposure;” insert “or”;

(b) in sub-paragraph (b), omit “or” the second time it appears;

(c) omit sub-paragraph (c).

(6) In regulation 38(2)(d) (exemption certificates)—

(a) before “25(2)” insert “and”;

(b) omit “and 33(1)”.

EXPLANATORY NOTE

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations implement, as respects Great Britain, some of the provisions of Council Directive 2013/59/Euratom (OJ No L13,17.1.2014, p1) laying down basic safety standards for protection against the dangers from exposure to ionising radiation. The Directive repeals Directives 89/618/Euratom, 90/641/Euratom, 96/26/Euratom, 97/43/Euratom and 20013/122/Euratom.

In particular, these Regulations transpose Directive requirements relating to dangers arising from ionising radiation in relation to medical exposure. They impose duties on

28 Ionising Radiation (Medical Exposure) (Amendment) Regulations 201829 (a) S.I. 2017/1075

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employers and those with responsibilities for administering ionising radiation to protect persons undergoing medical exposures whether as part of their own medical diagnosis or treatment, as part of research, as asymptomatic individuals, as those undergoing non-medical imaging using medical radiological equipment or as carers and comforters of persons undergoing medical exposures.

These Regulations revoke other Regulations relating to medical exposures and prior-authorisation for the administration of radioactive substances for the purposes of diagnosis, treatment and research.

Regulation 2 is an interpretation provision. Regulation 3 sets out the medical exposures to which the Regulations apply.

Regulation 4 sets out conditions under which the Licensing Authority may issue a licence for the administration of radioactive substances. Further provisions relating to the application for and the issuing of such licences are contained in Schedule 1.

Regulation 5 requires the employer and the practitioner who wish to administer radioactive substances to hold a valid licence issued by the Licensing Authority. Such licences will specify the radiological installation and purposes as appropriate.

Regulation 6 requires the employer to establish a framework of general procedures, protocols and quality assurance programmes. The procedures must cover the matters set out in Schedule 2 as a minimum. Written protocols, where appropriate, must be in place for standard radiological practices. The employer must establish recommendations regarding referral guidelines, establish quality assurance programmes for standard operating procedures, review and make available diagnostic reference levels, establish dose constraints where appropriate and raise awareness of the effects of ionising radiation amongst individuals capable of childbearing or breastfeeding.

Regulation 7 requires the employer’s procedures to include provision for clinical audit to be carried out.

Regulation 8 sets out the duties of the employer in relation to accidental or unintended medical exposures including provisions for providing information about clinically significant exposures, quality assurance programmes for radiotherapy, analysis and recording of events involving or potentially involving accidental or unintended exposures and processes for investigating and notifying the relevant enforcing authority when significant events have occurred.

Regulation 9 sets out the duties of the enforcing authority with regard to timely dissemination of information relating to significant accidental or unintended exposures.

Regulation 10 sets out the respective responsibilities of practitioners, operators and referrers. Practitioners and operators are required to follow the framework of procedures provided by the employer. The practitioner is responsible for the justification of a medical exposure. Authorisation of exposures is addressed here and in regulation 11. The operator is responsible for each practical aspect he or she carries out. The referrer must provide medical data as required by the practitioner in order that appropriate justification can take place.

Regulation 11 prohibits any medical exposure which has not been justified and authorised and sets out matters to be taken into account for justification. These include requirements relating to licensing and approval by an expert advisory committee, in the case of research, for exposures involving administration of radioactive substances. Justification of the exposure of carers and comforters is also required and recommendations or guidelines should be considered as part of justification of the exposure of asymptomatic individuals.

Regulation 12 provides for the optimisation process, and specifies the elements that are the responsibilities of the operator and the practitioner, depending on their involvement. Specific requirements are included for exposures in research, for carers and comforters and for exposures involving radioactive substances. Particular regard should be given to the exposures of children, exposures involving high doses, exposures of individuals involved

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in health screening programmes and pregnant or potentially pregnant or breastfeeding individuals. Regulation 12 also requires the employer to take steps to ensure that a clinical evaluation is recorded of each medical exposure.

Regulation 13 requires employers to provide when requested, to the Secretary of State data relating to dose estimates from diagnostic and interventional medical exposures.

Regulation 14 provides for suitable medical physics experts to be appointed and involved in relation to medical exposures.

Regulation 15 sets out general duties of the employer with respect to medical radiological equipment. These include requirements for quality assurance programmes, appropriate testing of equipment, performance criteria and actions to be taken when equipment does not perform appropriately.

Regulation 16 sets out additional requirements for equipment installed when the Regulations come into force including the transfer of information relating to patient dose where appropriate.

Regulation 17 prohibits a practitioner or operator from carrying out a medical exposure without having been adequately trained, except if supervised appropriately for practical aspects when undergoing training. The employer must keep and make available training records during inspections undertaken by the relevant enforcing authority. Further information regarding adequate training is set out in Schedule

Regulation 18 provides that the Regulations are made enforceable as health and safety regulations under the Health and Safety at Work etc. Act 1974 (c. 37).

Regulation 19 provides there is a defence of due diligence to proceedings for an offence under the

Regulations that all reasonable steps were taken and due diligence exercised.

Regulation 20 revokes the Ionising Radiation (Medical Exposure) Regulations 2000 (SI 2000/1059) and, subject to transitional provisions relating to existing certificates, the Medicines (Administration of Radioactive Substances) Regulations 1978 (S.I. 1978/1006) and the Medicines (Radioactive Substances) Order 1978 (S.I. 1978/1004).

Regulation 21 and Schedule 4 make provision consequential on the coming into force of these Regulations.

Regulation 22 makes provision for the review of these Regulations at the end of the period of 5 years beginning with the date on which they coming into force.

A full impact assessment has not been prepared to accompany this instrument as it has a low cost to business. However, a regulatory triage assessment accompanies this instrument.

EXPLANATORY NOTE (Amendment 2018/121)

(This note is not part of the Regulations)

These Regulations amend the Ionising Radiation (Medical Exposure) Regulations 2017 (S.I. 2017/1322) (“the 2017 Regulations”). In order to give full effect to the policy intention and to correct errors in the 2017 Regulations, these Regulations come into force immediately after the coming into force of the 2017 Regulations.

Regulation 2 amends the 2017 Regulations by:

inserting appropriate references to territorial extent and application correcting an erroneous cross-reference amending the Justification of Practices Involving Ionising Radiation Regulations

57

2004 (S.I. 2004/1769) to provide that the restriction of practices resulting in exposure to ionising radiation in certain cases does not prevent anything done under regulation 11 of the 2017 Regulations or regulation 11 of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 (which deal with justifications for individual exposures to such radiation)

amending the Human Medicines Regulations 2012 (S.I. 2012/1916)— so that the requirement for an authorisation under regulation 46 of those

Regulations does not apply where a radiopharmaceutical is prepared in accordance with a licence issued under the 2017 Regulations or the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018

to disapply, where specified conditions are met, the prohibition in section 214(2) of those Regulations on a person parenterally administering (save in specified circumstances) a prescription only medicine.

A full impact assessment has not been prepared for this instrument as it has a low cost to business.

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