Irmer Implications For Clinical Practice in Diagnostic Imaging Interventional Radiology and Nuclear Medicine

Institute of Physics and
Engineering in Medicine
IR(ME)R
Implications for
clinical practice in
diagnostic imaging,
interventional
radiology and
diagnostic nuclear
medicine
June 2020
Contents
Foreword3
1 Introduction5
2 Duty holder roles and responsibilities 7
3 Employer’s procedures, document control and audit 18
4 Training24
5 Entitlement30
6 Referral process 36
7 Justification and authorisation 40
8 Optimisation48
9 Diagnostic reference levels 51
10 Patient dose assessment and recording 55
11 Clinical evaluation 57
12 Identification of the individual to be exposed 59
13 Pregnancy and breastfeeding enquiries 61
14 Communicating benefits and risks 67
15 Children and young people 71
16 Carers and comforters 74
17 Health screening and individual health assessment 80
18 Non-medical imaging exposures (using medical
radiological equipment) 83
19 The role of the medical physics expert (MPE) 86
20 Equipment and quality assurance (QA) 89
21 Accidental or unintended exposures 95
22 Nuclear medicine licensing 102
23 Research104
References109
Appendix 1: Glossary114
Appendix 2: Abbreviations used in this document 118
Appendix 3: Key things to consider when writing
employer’s procedures 120
Appendix 4: Example template for a local training record 125
Appendix 5:
Example template for individual scope of practice 126
Appendix 6: Group entitlement 128
Appendix 7: Example pregnancy flow chart 129
Appendix 8: Working party membership 130
www.rcr.ac.uk IR(ME)R 3
Implications for clinical practice in diagnostic imaging, interventional radiology and
diagnostic nuclear medicine
Foreword Ionising radiation has been used for over 100 years in medical imaging, greatly
helping patient diagnosis and treatment. Continual advances in technology
have led to the increasing use of ionising radiation in many patient pathways.
The benefits of using ionising radiation for diagnosis and treatment need to be
weighed against the risks associated with the detrimental effects of the radiation
dose. Regulations provide a framework for the safe use of ionising radiation
in medical and non-medical imaging using medical radiological equipment.
Guidance is required to help interpret these regulations.
The Ionising Radiation (Medical Exposures) Regulations 2017 and Ionising
Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 came
into force on 6 February 2018 replacing IR(ME)R 2000 and the Medicines
(Administration of Radioactive Substances) Regulations 1978. The updated
regulations retain the four duty holders identified in IR(ME)R 2000: the employer,
referrer, practitioner and operator. The responsibilities of each duty holder
are defined in the regulations. The principles of justification, optimisation and
adequate training of practitioners and operators remain fundamental to the
updated regulations, with some new requirements included.
This guidance seeks to explain how the requirements of the regulations should
be interpreted and used in practice. It explains the principles and requirements
of IR(ME)R, providing clinical scenarios to enable practical interpretation of
the regulations. This document has been written in support of all staff groups
involved in medical and non-medical exposures within clinical settings, both
in the NHS and the independent sector, research laboratories, universities and
sports facilities, where appropriate. This guidance also applies to those services
using ionising radiation outside of radiology and nuclear medicine departments
such as cardiology and orthopaedics. Specific guidance is available for dental
exposures and therefore is not covered in this guidance.
The inclusion of diagnostic nuclear medicine into this document complements
the updated radiotherapy IR(ME)R guidance, which now includes molecular
radiotherapy. Every effort has been made to provide a consistent approach
across the two guidance documents with shared working across the disciplines
of diagnostic imaging, nuclear medicine and radiotherapy.
This guidance has been produced by a working party, which included
representatives from:
§ British Institute of Radiology
§ British Society of Paediatric Radiology
§ Institute of Physics and Engineering in Medicine
§ Medical Exposures Group, Public Health England
§ Royal College of Radiologists
§ Society and College of Radiographers
We would like to thank members of the working party (Appendix 8) for their time
and expertise in developing this document and acknowledge the radiotherapy
IR(ME)R working party for their contribution and shared working.
Particular thanks should go to Dr Peter Riley, who chaired the working party.
Sadly, Peter passed away during the later stages of the development of this
document. The radiology community owe him a great debt for this document.
In recognition of all his valuable work as an interventional radiologist and on
radiation safety the RCR has issued this document in memoriam to Dr Riley.
We hope this document will support the diagnostic and nuclear medicine
communities to implement IR(ME)R in their practice.
Stewart Redman
Radiation Protection Adviser to The Royal College of Radiologists
1. This guidance document is intended to provide a practical approach to implementing

Introduction the Ionising Radiation (Medical Exposure) Regulations 2017 (IR(ME)R) for all staff groups
delivering a range of diagnostic imaging, interventional radiology and diagnostic nuclear
medicine services.1 This guidance also applies to the implementation of the Ionising
Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 and any reference to
‘IR(ME)R’ can be taken to refer to these regulations also, unless specifically stated.2 Within
the UK responsibility for healthcare is devolved and different approaches may be taken in
each of the four nations.
Typical scenarios and examples have been included within text boxes to provide practical
advice on aspects of the regulations. These are taken from information provided to the
working party by several hospital trusts or health boards and are not intended to be
prescriptive. A glossary of terminology used in this guidance is included in Appendix 1.
The Regulations
IR(ME)R implements the medical exposure provisions from the European Council Basic
Safety Standards Directive 2013/59/Euratom (BSSD).3 The BSSD takes into account the
recommendations from the International Commission on Radiological Protection (ICRP)
publication 103.4
IR(ME)R includes new requirements relating to the following:
§ Reporting of accidental and unintended exposures (Chapter 21)

§ Introduction of non-medical imaging exposures using medical radiological equipment
which replaced and expanded upon medico-legal exposures (Chapter 18)
§ Introduction of a formal recognition scheme for medical physics experts (Chapter 19)
§ Introduction of licensing for employers and practitioners for the administration of
radioactive substances to persons for diagnosis, treatment or research (Chapter 22)
§ Existing equipment requirements moved from the Ionising Radiations Regulations 1999
and new equipment requirements from BSSD added (Chapter 20).5
IR(ME)R places obligations on specific duty holders and provides a framework intended to
protect individuals from the hazards associated with medical and non-medical exposures
involving ionising radiation. The responsibility for compliance with IR(ME)R lies with the
employer and each of the entitled duty holders. The roles and responsibilities of all duty
holders are explained in Chapter 2 (Duty holder roles and responsibilities).
IR(ME)R applies to medical exposures and specific types of non-medical exposures listed in
Table 1.1 [Regulation 3].
Table 1.1: Types of exposure

Exposure Examples
Medical exposures § Patients, as part of their medical § X-ray imaging, computed

diagnosis or treatment tomography (CT), fluoroscopy,
interventional radiology, dual-
energy X-ray absorptiometry (DXA),
mammography
§ Nuclear medicine imaging, positron
emission tomography/computed
tomography (PET-CT), non-imaging
nuclear medicine examinations
§ Individuals as part of health § Imaging a group or population for a

screening programmes disease (eg, NHS Breast Screening
Programme)
§ Individuals participating in research § Patients taking part in clinical trials

programmes
§ Carers and comforters § Individuals who provide support

and comfort to a patient within a
controlled or a supervised area
(where access is normally restricted,
or systems of work are in place to
exclude members of the public)
§ Asymptomatic individuals § Investigations to exclude disease on

individuals with no symptoms
Non-medical exposures § Individuals undergoing non-medical § Health assessment for employment,

imaging using medical radiological immigration or insurance purposes
equipment § Radiological age assessment
§ Identification of concealed objects
within the body
This document should be read in conjunction with IR(ME)R and other published guidance.6
2. Responsibility
Duty holder roles The responsibility for compliance with IR(ME)R lies with the employer, each of the entitled
and responsibilities duty holders and any other employees involved within the IR(ME)R pathway. The roles
and responsibilities of all duty holders are explained in this chapter. Each duty holder has
personal and professional responsibility for ensuring the regulations are complied with.
An individual duty holder’s legal responsibility is to act in the way the employer has set out
in the employer’s procedures.
An individual’s professional responsibility is to:
§ Have and express a professional view, where appropriate, as to whether those

procedures are adequately designed to ensure safe delivery of a medical or non-
medical exposure to an individual
§ Be able to challenge the actions and decisions, as appropriate, of others if their
performance is likely to result in ineffective or unsafe delivery of an exposure; it is the
valued professional role of any healthcare professional to look beyond their traditionally
defined boundaries to improve care for patients.
Professionally it is the responsibility of healthcare staff to challenge the decisions of others if

they feel patient safety is at risk. Doing so can avert serious adverse events.
An individual may be entitled to act as more than one duty holder (for example, referrer,
practitioner and operator for an orthopaedic procedure involving fluoroscopic control). In
these situations, the individual is responsible for the requirements of each of the duty holder
roles they undertake [Regulation 2(2)].
Responsibility cannot be delegated. A person can delegate a task to another individual (as
long as that individual is competent to undertake the task) but still retains the responsibility.
This means the work must be overseen, reviewed or checked and must be signed for by the
person responsible. Further detail on supervision can be found in Chapter 4 (Training).
Unnecessary delegation has been identified as a known cause of error and should be
avoided; for example, when initiating an exposure, it is best practice to identify the patient
yourself rather than delegate.
The medical care of a patient is generally led by staff of consultant status. The consultant
has a professional and general medico-legal responsibility for the medical management
of the patient. They are responsible under IR(ME)R for each task they undertake, such
as referral, but they cannot be held responsible for those tasks carried out by other duty
holders, such as justification.
A signature indicates the duty holder is taking responsibility for that specific task. It would
be inappropriate to sign for something outside your scope of practice for which you have
not been trained, are deemed competent and are entitled. Electronic signatures have
been adopted in many areas of radiological practice to replace handwritten signatures.7
Electronic signatures are only as secure as the business processes and technology used
to create them. Users should be made aware of local procedures governing the use of IT
and the General Data Protection Regulation (GDPR),8 including any potential for disciplinary
action if log-in details are shared.9
Regulation 19 provides a defence of due diligence. If a duty holder has, so far as reasonably
practicable, taken all steps to comply with the regulations, they may be able to offer a
defence of due diligence. Examples of practical ways of demonstrating that all reasonable
steps have been taken include documentation of:
§ Identification checks
§ Pregnancy and breastfeeding checks
§ Conversations and discussion with individuals exposed
§ Quality control (QC) records
§ Clear, accurate and up-to-date employer’s procedures.
Employer
In IR(ME)R the definition of employer relates to health and safety functions rather than
employment matters. The employer, as a duty holder under IR(ME)R, is responsible
for providing a framework within which professionals undertake their functions. This
framework is provided through written procedures, written protocols and quality assurance
(QA) programmes. The employer has a statutory duty to make sure these are in place
[Regulation 6]. The duties of the employer are set out in Table 2.1.
Table 2.1: Requirements for the employer
Regulation Requirement Things to consider
Regulation 5(1)(a) Licensing for the § Ensure appropriate, valid employer

administration licence is in place for scope of
of radioactive service at each site (Chapter 22)
substances
Regulation 6 General procedures, § Establish written employer’s

protocols and QA procedures required in Schedule 2
(Appendix 3)
§ Establish written protocols for
standard radiological practices
§ Establish referral guidelines
§ Have a QA programme in place for
documentation (Chapter 3)
§ Ensure practitioners and operators
are adequately trained and
engage in continuing professional
development (CPD) and education
after qualification (Chapter 4)
§ Establish dose constraints for
research exposures (Chapter 23)
and for carers and comforters
(Chapter 16)
Regulation 7 Clinical audit § Ensure the employer’s procedure

details how and when clinical audit
is carried out (Chapter 3)
Regulation 8 Accidental or § Ensure referrer, practitioner

unintended and individual exposed (or their
exposures representative) is informed of
clinically significant accidental or
unintended exposures (CSAUE)
and the outcome of analysis of the
exposure
§ Investigate, record and report
incidents where an accidental or
unintended exposure has occurred
(Chapter 21)
Regulation 12(9) Clinical evaluation § Ensure that a clinical evaluation is

recorded for every exposure except
for carers and comforters (Chapter
11)
Regulation 13 Population doses § Ensure dose estimates from

medical exposures for diagnostic
and interventional procedures are
collected (Chapter 10)
Regulation 14(1) Expert advice § Appoint a suitable medical physics

expert (MPE) (Chapter 19)
Regulations 15(1), Equipment § Implement and maintain an

15(3), 15(6) equipment QA programme
§ Maintain an equipment inventory
§ Implement measures to address
poorly performing equipment
(Chapter 20)
Regulations 17(4), Training records § Keep appropriate training records

17(5) and ensure they are available for
inspection (Chapter 4)
§ Share training records between
employers (Chapter 5)
Schedule 2 Written employer’s § A minimum requirement of 14

procedures employer’s procedures
§ Review and update periodically (eg,
1–3 years) (Chapter 3)
Under IR(ME)R, the employer is legally responsible, when establishing practices for the safe
delivery of diagnostic imaging, interventional or nuclear medicine services, for ensuring that
robust written procedures exist including those listed in Schedule 2 [Regulation (6(1)]. It is
essential that procedures are regularly reviewed and updated. Such procedures must be
documented and should describe the responsibilities of every duty holder involved in the
process, including the employer.
The organisation should designate an accountable representative to ensure the employer’s
duties are fulfilled. The individual undertaking this role must hold a senior position within
the organisation, usually at board level or as part of the executive team. In NHS services this
individual is generally the chief executive unless an alternative individual has been formally
designated. The individual’s role should relate to all those professional groups that provide
elements of the service and should ideally incorporate all other services using ionising
radiation.
The detailed implementation of IR(ME)R may be delegated to an appropriately trained and
experienced professional, such as a clinical lead for radiology or medical director. However,
the legal responsibility for compliance with IR(ME)R cannot be delegated and remains with
the employer. The employer must be aware of their responsibilities under IR(ME)R and
ensure the tasks they have delegated are appropriately discharged.
There should be clear governance structures describing how policies, procedures and
protocols are implemented. Ratification processes may be achieved through, for example,
a radiation protection committee (RPC) which provides a framework for the formal adoption
of documentation, DRLs, optimisation, and so on. The RPC should feed up through
the governance framework for providing assurance to the employer of organisational
compliance.
Referrer
The referrer must be a registered healthcare professional as defined in IR(ME)R.10 In
Northern Ireland, this also includes medical practitioners registered with the Medical
Council of Ireland.
Referrers are entitled, by the employer, to request that an individual is exposed to ionising
radiation as part of a diagnostic, interventional or nuclear medicine investigation. Referrals
are made taking into account the referral guidelines provided by the employer. Many
radiology departments will accept referrals from outside their organisation, for example
from a general practice or a chiropractor. In all situations, the employer’s procedures
must state from whom they will accept referrals and how the referrer will be provided with
the specified referral guidelines. Referrer awareness training is discussed in Chapters
4 (Training) and 6 (Referral process). Information on non-medical referrers is included in
Chapter 6 (Referral process).
The roles and responsibilities of the referrer are set out in Table 2.2.
Table 2.2: Requirements for the referrer
Regulation 6(2) Written procedures § Ensure referrals comply with

are complied with employer’s referral guidelines
by the referrer § Referrer awareness training
(Chapter 4) (eg, process for
amending or cancelling a referral)
Regulation 6(5)(a) Referral guidelines § Access to established guidelines

made available that can be used to make a referral
(eg, iRefer)
§ When and how to seek advice on
non-standard referrals
Regulation 8(1) Clinically § Ensure involvement in the process

significant for CSAUE
accidental or § Awareness of the need for the
unintended individual exposed (or their
exposures representative) to be informed
(CSAUE) are
§ Provide advice when the decision
communicated to
may be not to inform the individual
the referrer
§ Understand how the outcome of
analysis is shared
Regulation 10(5) Sufficient medical § Provide enough information to

data are supplied identify the individual
§ Provide information on relevant
clinical history to enable
justification by practitioner
§ Where relevant provide
information on pregnancy or
breastfeeding
Schedule 2(b) Individual § Understand specified scope of

entitlement practice
§ Adhere to limited referral rights
when they are applied
See Chapter 6 (Referral process) for further information on referral guidelines, referrer
training, entitlement and scope of practice.
Practitioner
The IR(ME)R practitioner’s primary role is the justification of exposures. The practitioner
must be a registered healthcare professional as defined in IR(ME)R and comply with the
employer’s procedures [Regulation 10(1)]. Practitioners who wish to justify exposures
involving the administration of radioactive substances must hold a valid practitioner licence
[Regulation 5(1)(b)]. Further information on licensing is available in Chapter 22 (Nuclear
medicine licensing).
The practitioner is entitled by the employer to justify and authorise the exposure of an
individual to ionising radiation. The process of justification and authorisation is described in
more detail in Chapter 7 (Justification and authorisation). To perform justification, the referral
is assessed against the clinical data supplied by the referrer. The practitioner must be
adequately trained and be competent to consider the potential detriment of the exposure
against the potential benefits for that individual. For certain exposures, the practitioner may
need to consider the benefits to society (for example, health screening or research).
Before justifying an exposure, the practitioner should review the results of any relevant
previous imaging and consider the suitability of alternative imaging techniques that do not
involve the use of ionising radiation. The roles and responsibilities of the practitioner are set
out in Table 2.3.
Table 2.3: Requirements for the practitioner
Regulation Requirement Things to conside
Regulation 10(1) Employer’s § Read and comply with employer’s

procedures procedures
Regulation 5(1)(b) Licence for § Hold a valid practitioner licence (Chapter 22)
administered § Understand what is specified in the licence
activity
§ Adhere to the terms of the licence
Regulation 10(2) Justification of § Weigh up benefit and risk

the exposure § Request further information if required
§ Authorise referrals that are justified
Regulation 10(6) Co-operate § Share relevant information

with other staff § Participate in multidisciplinary team
meetings
§ Get medical physics support and advice
§ Work together with other specialists and
duty holders
Regulations 11(2), Justification of § Evaluate the information provided

11(3), 11(4) exposure § Consider the data supplied to establish net
benefit
§ Consider the urgency of the exposure
Regulation Requirement Things to conside
§ Consider justification of exposures to

carers and comforters and asymptomatic
individuals
§ Take into account guidelines issued by
professional or relevant bodies
§ Choose a modality that best addresses the
clinical problem
§ Authorise referrals that are justified
Regulation 11(5) Task of § Issue authorisation guidelines to be used by

authorisation operators
§ Retain responsibility of justification for
referrals authorised under guidelines
Regulation 12(1) Optimisation § Ensure exposures are kept as low as

reasonably practicable
§ Use non-ionising radiation modalities where
appropriate
§ Be aware of and use local and national DRLs
Regulation 12(8) Pay particular § Optimisation of:

attention § Paediatric exposures (Chapter 15)
§ Health screening programme exposures
(Chapter 17)
§ High-dose exposures (Chapter 10)
§ Pregnancy status (Chapter 13)
§ Breastfeeding status (Chapter 13)
Regulation 17(1) Training § Adequate training as defined in Schedule 3

(Chapter 4)
§ Training on and competency in local
equipment and techniques
§ Training on new techniques and technology
Schedule 2(b) Individual § Understand specified scope of practice

entitlement (Chapter 5)
§ Ensure entitlement is reviewed and updated
when new skills are added
§ Remove entitlement of specific tasks when
no longer competent or required
The employer should specify the scope of practice for which an individual can act as a
practitioner. The scope of practice may be limited; for example, to justification of general
radiography, CT, interventional procedures, nuclear medicine, and so on. It is important to
define this in the employer’s procedures.
Operator
There is no requirement for the operator to be a registered healthcare professional. The
operator is any person who is trained and entitled, in accordance with the employer’s
procedures, to carry out practical aspects of an exposure [Regulations 10(3) and 17(1)]. The
operator is individually responsible for all practical aspects of a procedure they undertake.
Some examples of practical aspects include:
§ Patient identification
§ Checking pregnancy or breastfeeding status
§ Operating the imaging equipment
§ Optimisation
§ Initiating the exposure
§ Contrast administration
§ Dispensing/administration of a radiopharmaceutical
§ Image manipulation and archive
§ Clinical evaluation
§ Quality control checks.
Operator functions may also be carried out by the MPE or other trained medical physics
staff including medical physicists and clinical technologists.
Authorisation may be carried out by either a practitioner or an operator [Regulation 11(1)(c)].
Where the practitioner is not available and the authorisation process is carried out
by an operator they must follow authorisation guidelines issued by the practitioner
[Regulation 11(5)].
Third-party service engineers would not normally be entitled operators. In most
circumstances, third-party engineers, whether providing initial installation or servicing, are
responsible for presenting equipment in a safe condition and working to the manufacturer’s
specifications. They are not usually responsible for the equipment being in a state fit for
clinical use; further measurements and verification are needed before the equipment can
be used clinically. The roles and responsibilities of the operator are set out in Table 2.4.
Table 2.4: Requirements for the operator
Regulation 10(1) Employer’s § Read and comply with employer’s

procedures procedures
Regulations Practical aspects § Training required to carry out any

10(3), 10(4) practical aspects and/or authorisation
of exposures to guidelines provided by
practitioner
§ Allocation of responsibility to
appropriate specialist staff
Regulation 10(6) Co-operate with § Share relevant information

other staff § Liaise with other duty holders involved
in an individual exposure
§ Participate in multidisciplinary team
meetings
§ Get medical physics support and
advice
Regulation 12(1) Optimisation § Ensure exposures are kept as low as

reasonably practicable
§ Be aware of and use local and national
DRLs
Regulation 12(3) Selection of § Choose the most appropriate

equipment and equipment and method for the
methods individual being exposed
§ Ensure exposures are as low as
reasonably practicable (ALARP) by
using techniques such as screen
grabs, low pulse rate, prospective
gating
§ Assess and evaluate dose during and
after the procedure
Regulation 12(8) Pay particular § Paediatric exposures (Chapter 15)

attention § Health screening programme
exposures (Chapter 17)
§ High-dose exposures (eg, some CT
and interventional) (Chapter 10)
§ Pregnancy status (Chapter 13)
§ Breastfeeding status (Chapter 13)
Regulation 17(1) Training § Adequate training to carry out any

practical aspect of an exposure
(Chapter 4)
§ Training on and competency in local
equipment and techniques
Schedule 2(b) Individual entitlement § Understand specified scope of

practice (Chapter 5)
§ Ensure entitlement is reviewed and
updated when new skills are added
§ Remove entitlement of specific tasks
when no longer competent or required
The employer should specify the scope of practice and the tasks for which an individual can
act as an operator and be able to demonstrate that they are adequately trained to perform
these tasks. Individual training records for operators require regular review as individuals
develop and equipment and techniques change.
A medical exposure using ionising radiation must only be performed by an operator who
has been trained, is deemed competent and is entitled to perform these procedures by the
employer. The operator is responsible for checking patient demographics, as provided, to
ensure the correct individual is being examined, and for ensuring the appropriate imaging
protocol is used. Further information on training requirements is available in Chapter 4
(Training).
Non-statutory-registered operators
Some staff groups are not registered with a formal regulatory body such as the Health and
Care Professions Council (HCPC), for example clinical technologists and radiographic
assistant practitioners (APs). It is important to note that the term ‘practitioner’ in this context
is different from the term as defined by IR(ME)R.
Although not a requirement of IR(ME)R, radiographic assistant practitioners may be
accredited by the College of Radiographers (CoR) and entered onto the CoR public
voluntary register.11 APs who are not on the voluntary register but have completed an in-
house training programme may be assessed as competent and entitled as operators to
carry out specific practical aspects of an exposure.
Once an AP has been trained and deemed competent, they can be entitled as an operator
with a specific scope of practice. However, a radiographer should always be available to
provide supervision, support and advice on radiographic practice.
Another example of non-statutory-registered operators is healthcare science practitioners,
who are graduates with a healthcare science degree and who have completed a
Practitioner Training Programme, or individuals who have demonstrated equivalence with
that training programme (for example, clinical technologists) through accreditation by the
Academy for Healthcare Science (AHCS) or the Institute of Physics and Engineering in
Medicine (IPEM).
They are eligible to join an assured Register of Healthcare Science Practitioners through
the AHCS or the assured Register of Clinical Technologists through IPEM. The assured
registers are accredited by the Professional Standards Authority.
Before entitling a non-statutory-registered individual to act as an IR(ME)R operator, the
employer must ensure that the person is adequately trained and that the training meets
the requirements of Schedule 3 of the regulations. The scope of such entitlement must be
clearly documented, as for all staff groups. When these individuals are acting as entitled
IR(ME)R operators, they are legally responsible for their actions.
3. Procedures and protocols

Employer’s procedures, Regulation 6(1) requires the employer to have in place written procedures as specified in
document control Schedule 2 as a minimum. Within the radiation safety framework, the employer may choose
and audit to have additional employer’s procedures to cover the full range of service delivery.
When a practice is not carried out as part of a local service, for example non-medical
imaging or research exposures, an employer’s procedure is still required. This could include
a clear statement such as ‘No research exposures are carried out in this trust’.
Employer’s procedures must be documented and define the responsibilities of duty holders
involved in the process. They should include clear instructions on how and when a process
should be carried out and who is responsible. Appendix 3 details things to consider for
inclusion within employer’s procedures.
The employer must ensure written protocols are in place for every type of standard
radiological practice [Regulation 6(4)]. These protocols should be locally established, in
collaboration with the MPE, taking into account service delivery and available equipment.
Where possible, a local standard template should be considered for these protocols.
Quality assurance programmes for documentation

Regulation 6(5)(b) requires that the employer must have in place QA programmes for
written procedures and protocols. There is a requirement to have an employer’s procedure
to ensure the QA programmes for written procedures and written protocols are followed
[Schedule 2(d)].
An employer’s procedure in respect of QA programmes for radiological equipment is also
required. More detail can be found in Chapter 20 (Equipment and quality assurance).
Regulation 2 of IR(ME)R defines QA as ‘any planned and systematic action necessary to
provide adequate assurance that a structure, system, component or procedure will perform
satisfactorily in compliance with generally applicable standards and QC is part of quality
assurance’.
The benefits of using a robust QA programme include:
§ Supporting safer service delivery
§ Promoting a consistent approach to service delivery
§ Providing assurance of service quality to the employer
§ Ensuring up-to-date documents are accessible
§ Driving continual service improvement through review.
The employer is responsible for implementing IR(ME)R requirements across the range of
services using ionising radiation within the organisation. An organisation-wide document
may be established to achieve this (for example, within a radiation safety policy). Care
needs to be taken to ensure local, modality-specific procedures are consistent with any
organisation-wide documents. For example, where entitlement of practitioners differs
between radiology and nuclear medicine, this should be clearly stated.
A key component of a QA programme is the control and management of documentation.
Table 3.1 includes matters to consider when establishing a QA programme for
documentation.
Table 3.1: Considerations when establishing a QA programme for documentation
QA programme Things to consider
How are written procedures Process should include:

and protocols developed and § Standard template, consistent
established? terminology and page numbering
§ Engage appropriate subject experts
§ Clear governance arrangements
§ Clarify who is responsible for review
process and accuracy of content
§ Clearly identify the authors
§ Define document authorisation process
§ Potential use of quality management
software
§ Training for staff
How is assurance of service quality § Audit of compliance

provided to the employer? § Regular feedback to governance teams
How are procedures and protocols Process should:

reviewed? § Include clear governance
arrangements
§ Describe the review process to
incorporate staff feedback
§ State who is responsible for document
review
§ Describe version control
§ Document revision history, summary
of changes, signature, date of approval
and next review date
§ Include outcomes of internal audit,
nonconformities or observations from
external audit, inspection or incident
investigations
How frequently should reviews § Local decision: commonly completed

occur? every two to three years or following
change in service delivery, legislation
or similar, based on whichever is the
minimum
How and where can staff access § Read-only electronic documents

procedures and protocols? (intranet/shared network drive/quality
management system)
§ Paper documents (avoid multiple
uncontrolled copies or versions, and to
allow access in the event of a network
failure)
§ Consider access for staff based outside
the department (eg, referrers at external
clinics)
How are changes communicated to Formalised process and may include:

all relevant staff? § Staff meetings (minutes and attendance
list)
§ Email (with read receipt)
§ Newsletters, memos, etc
§ Electronic quality management
systems (QMS) software
§ Communication with others outside the
department (eg, referrers, cardiologists)
The management of written procedures should ensure that only the current version of any
document is available and used by staff. Where hard copies of procedures or protocols are
made available, a disclaimer should be included to say ‘uncontrolled when printed’. Old hard
copies must be removed from circulation.
Written protocols include descriptions of how an examination is carried out. They should be
evidence-based, reflect current practice and be ratified through the QA process.
Examination protocols, embedded in the radiological equipment, require additional
management to ensure they are locked and changes cannot be made by unauthorised
staff. Software updates may change agreed examination protocol settings, therefore copies
of protocols should be backed up. A system should be in place to communicate system
changes. Further detail on handover processes is included in Chapter 20 (Equipment and
quality assurance).
A robust management system is essential to ensure consistency between written protocols
and examination protocols embedded within the equipment. Where possible, embedded
protocols should be locked. Backup copies must be kept and maintained so that staff can
check the embedded protocols are correct.
External review and accreditation schemes for imaging services including QA programmes
are available, such as the Quality Standard for Imaging,12 but there is no requirement for this
in IR(ME)R.
IR(ME)R audit
The QA programme should cover all aspects of the diagnostic imaging process, including
practices involving non-medical imaging and non-imaging nuclear medicine examinations.
To ensure the QA programme is being followed and written procedures are complied with,
a system of regular IR(ME)R audit is essential. A schedule of IR(ME)R audit may be drawn up
on a rolling programme to check employer’s procedures are in place and being followed.
Some examples of IR(ME)R audits are included in Table 3.2, but this list is not exhaustive.
Table 3.2: Considerations when establishing an IR(ME)R audit programme
Audit Things to consider
Appropriateness of referrals § Does the referrer adhere to the

relevant referral guidelines and referral
process?
§ Is sufficient clinical and demographic
information provided to justify the
referral and identify the patient?
§ Appropriate feedback should be
provided to referrers, and corrective
actions should be taken where
nonconformance reoccurs.
Patient ID procedure § Is it possible to identify who performed

the ID check and confirm their
entitlement?
§ How and where is this recorded?
Are operators complying with the
procedure?
Patient pregnancy or breastfeeding § Are pregnancy or breastfeeding

status procedure enquiries carried out and documented
in accordance with the employer’s
procedure?
IR(ME)R operator/practitioner/referrer § Are records up to date and accurate?

entitlement § Do they reflect current scope of
practice?
§ Are all duty holders appropriately
entitled both within the department
and outside (eg, GPs)?
Operator training records § Are records available and up to date for

all operators?
§ Do competency records reflect
available equipment and processes?
Audit Things to consider
DRLs § Have DRLs been reviewed as per the

employer’s procedure?
§ Are doses or administered activities
accurately recorded?
§ What action is taken where DRLs are
consistently exceeded?
Justification and authorisation § Is it possible to identify the practitioner/

authorising operator?
§ Is the operator authorising
appropriately and within the
authorisation procedure?
Clinical evaluation § Is there evidence of a written clinical

evaluation of the exposure in a sample
of patient records?
Image quality and technique § Is there a process for reviewing reject

analysis?
Clinical audit
Regulation 7 requires the employer to have in place a programme for clinical audit. Audit is a
tool for reviewing and improving healthcare outcomes and ensuring patient care is provided
in line with best practice standards.13 Change should be implemented where practice
is deemed to fall short of the standard and, after a specified period of time, re-audited to
ensure the corrective action has had the desired positive effect.
The general objectives of clinical audit should be to:
§ Improve the quality of patient care
§ Identify areas for improvement
§ Promote the effective use of resources
§ Enhance the provision and organisation of clinical services
§ Further professional education and training.14
Audit will help identify:

§ How well a department is performing against pre-defined standards or benchmarks
§ Areas where performance or compliance is not meeting agreed standards and areas for
improvement
§ Compliance with existing evidence-based practice
§ Areas where training is needed
§ Areas where changes in practice are needed
§ Where new standards or benchmarks are required.
Clinical audit should be an established part of every radiology and nuclear medicine
department and a key component of the wider clinical governance framework. The
basis for audit should be to assess the quality improvement process by highlighting the
discrepancies between actual practice and standards.15 It should aim to enhance the
provision and organisation of clinical services through the promotion of effective use of
resources and identify the changes needed to improve the standard of practice.
A multidisciplinary team approach to establishing and carrying out an audit programme will
yield the most effective results. An example of this would be an image optimisation team
(IOT)who may jointly manage dose audits, optimisation and review of protocols.16
With increasingly complex equipment and techniques, maintaining quality in radiology
and nuclear medicine should be responsive and wide-ranging. It must be measured and
re-evaluated against best practice standards using peer-reviewed publications and from
the wider community, not solely through internal departmental audit.
Clinical audits should also be used in the engagement, education and training of staff to
create an environment of continuous development.
A clinical audit report should provide basic information about the audit, display the audit
results, provide a plan to implement change and a review date or timeline of when change
should happen. Results of clinical audit should be made available to the employer.
4. Regulation 17(1) prohibits any practitioner or operator from carrying out an exposure or any
Training practical aspect of an exposure without having been adequately trained. Regulation 17(2)
defines recognised evidence of training; for example, certificates for degrees, diplomas.
Schedule 3 lists the theoretical knowledge and practical experience required as adequate
training for practitioners and operators.
The employer’s responsibility

The employer has the responsibility to ensure all practitioners and operators are adequately
trained to perform the tasks defined within their scope of practice [Regulation 6(3)(a)].
This includes undertaking continuous education and training after qualification and when
new equipment or techniques are introduced [Regulation 6(3)(b)].
Employers should consider establishing an auditable process for the management
and delivery of training within their local governance framework. As individuals join a
department, there is often a period of induction into local practice. Time should be allowed
for the delivery, receipt and recording of effective training. Regulation 17(4) requires the
employer to keep training records for all practitioners and operators and make these
available at inspection. Training records should contain the date and the nature of training
and reflect an individual’s continuous development and local department-specific training,
as well as that achieved through pre- and post-registration qualifications. An example of a
local training record is included in Appendix 4.
Before operators use a new piece of equipment unsupervised, they must complete a
training programme and a record should be made of this training. This includes the use
of equipment at different sites, even though the same make and model may be installed
across many departments. While some equipment may appear familiar, there may be
differences in how, for example, the protocols on CT scanners have been constructed and
how these differences could affect both dose and image quality.
Training is also required in the communication of the benefits and risks from exposures with
patients or other individuals exposed, such as carers and comforters.
Training records of all staff entitled to act as practitioners and/or operators should be
reviewed and updated on a regular basis, perhaps as part of the appraisal process, or when
additional training has been successfully completed. This information may be collated in a
training matrix that cross-references the duty holder’s scope of practice and entitlement.
Regulation 17(5) requires employers to co-operate with regard to the training records for
locum and agency staff. The employing agency has the responsibility to check formal
qualifications and registration of the individual through its own recruitment processes. The
employer must be satisfied that the agency employer has systems in place to review and
maintain the training records. Training records must be made available to the employer
when requested. Local induction training requirements apply equally to locum and agency
staff as they do for permanent employees.
Adequate training
Schedule 3 of IR(ME)R outlines the areas of theory and practice necessary for the training
of practitioners and operators that would be considered adequate. It also sets out details of
the adequate training that practitioners and operators must have completed before they can
be entitled by the employer. Areas of training need only reflect the tasks that the duty holder
will undertake.
The subject areas in Schedule 3, Table 1, as relevant to a practitioner’s or operator’s role,
should be covered in adequate breadth and depth so that an individual may carry out their
duties.
Schedule 3, Table 2, refers to focused areas of knowledge and training relevant to specific
areas of practice (diagnostic radiology, radiotherapy and nuclear medicine). Although
formal training programmes will provide adequate education and practical training relevant
to each profession, there may be scope for further development in many of these areas
and a need for further training in others. For example, when upgrading an imaging room
from computed radiography (CR) to digital radiography (DR) all relevant staff will need to
be trained in the use of the new equipment. Practitioners and operators should consider
the need for further training prior to any extension to their scope of practice, especially
when that crosses the boundary between diagnostic radiography, radiotherapy and
nuclear medicine; for example, PET-CT or MR radiotherapy [Regulation 6(3)(b)]. A training
framework is particularly relevant where hybrid imaging techniques are introduced.
Training should not be limited to the operation and optimisation of the equipment but
should incorporate the elements of Schedule 3 that govern the particular patient pathway
and take into account any statutory and non-statutory requirements of the healthcare
practitioner. An example of a non-statutory requirement might be adapting communication
techniques for individuals who are anxious, vulnerable or have communication challenges.
Operators and practitioners should demonstrate compassion and, where appropriate, act
as the individual’s advocate.17,18
MPEs must be appropriately entitled as IR(ME)R operators for specific tasks and keep an
up-to-date record of their knowledge and training. An individual can only be entitled as an
MPE if they are recognised by the Secretary of State in Great Britain or the Department of
Health in Northern Ireland. The Department of Health and Social Care has established a
UK-wide MPE recognition scheme and has appointed RPA2000 as the assessing body.19,20
The employer must appoint a suitable MPE and ensure they are involved to the extent
required by Regulation 14 (Expert advice). MPEs will acquire a different set of knowledge
and skills relating to the operation of imaging equipment. More information on this can be
found in Chapter 19 (The role of the medical physics expert). The MPE’s unique skill set
must be utilised during the equipment procurement process and may involve, for example,
discussions with existing users or manufacturers’ product specialists.
MPEs are required to develop a large portfolio of skills to enable them to have a clear
understanding of the capabilities and relational factors of the equipment they look after.
The MPE should continue to develop their knowledge and understanding of equipment
performance, for example by working with engineers and applications specialists during
planned upgrades or installations.
MPEs may be expected to work across a wide range of sites using many different makes
and models of imaging equipment. At the point at which they become an entitled operator
under IR(ME)R, the employer must be assured that the MPE is adequately trained to
operate and work on the equipment. Where MPEs are contracted by a different employer
under a service-level agreement, training records should be made available.
Clinical technologists may similarly acquire ongoing knowledge and skills across a wide
range of equipment relevant to their area of expertise. They must keep an up-to-date
record of their training, which may include graded competencies related to the technical
level at which they are authorised to operate the equipment. At the point at which they
become an entitled operator under IR(ME)R, the employer must be satisfied that the clinical
technologist has evidenced adequate training for each piece of equipment.
MPEs and clinical technologists should be considered for inclusion with other operators
(eg, radiographers, radiologists and cardiologists) in the training provided by manufacturers’
applications specialists when new equipment is installed.
As for all IR(ME)R duty holders it is the responsibility of each individual, regardless of
their professional background, to recognise and work within the limitations of their own
knowledge and skills.
Practitioner training records

Professional qualifications in clinical radiology or nuclear medicine, for example Fellowship
of the RCR (FRCR) by examination and the subsequent award of a Certificate of Completion
of Specialist Training (CCT) by the General Medical Council (GMC), provide suitable
evidence of competence to act as a practitioner. Practitioners in nuclear medicine require
a valid licence issued by the Licensing Authority to be able to justify an exposure involving
the administration of radioactive substances [Regulation 5(1)(b)]. This is issued on the
basis of specialist training and experience. This may be further guided by recognition of
subspecialisation, and entitlement should be appropriate to the skills and level of training
and experience of the individual.21
Employer’s procedures should specify training requirements for IR(ME)R practitioners
who are not medically qualified, such as radiographers. The training records should
demonstrate appropriate skills, knowledge, experience and assessed competence within a
clearly defined scope of practice. The Society and College of Radiographers has provided
guidance on what should be included in IR(ME)R practitioner training.22
A radiographer is trained and entitled to justify and report musculoskeletal general

radiography images of the upper and lower extremities. Their additional training is
recorded. To justify these exposures, they are entitled as a practitioner, within a defined
scope of practice. To report these exposures, they are entitled as an operator, within a
separate, defined scope of practice. Both training and entitlement records will reflect
their additional learning and its application to the clinical setting.
Operator training records

Training records for operators should be detailed and up to date, reflecting training and
competency achieved for learned skills. All healthcare staff professionals (including doctors,
assistant practitioners and MPEs) acting as operators must have regularly updated training
records that reflect their scope of practice for each piece of equipment and for similar
equipment across different sites.
Staff who have not had specific training on working with ionising radiation as part of their
professional qualification (for example, orthopaedic surgeons) may undertake operator
roles after appropriate theoretical and practical training.
Trainees (for example, medical students) must be supervised by an appropriately trained

and entitled operator. Further detail can be found in the ‘Supervision including students and
trainees’ section, below.
A department has a new fluoroscopy room installed. Following satisfactory completion

of medical physics acceptance testing, a core team of radiographers and radiologists
who will use the equipment are scheduled to have training on using the new unit by the
manufacturer’s application specialist. One of the MPEs responsible for the equipment
QC and optimisation is invited to attend the training.
The core team then cascade the training using theoretical and practical sessions
to others in the department, and a competency checklist and training record are
developed by the service lead. The checklist and record are completed by every
operator prior to working unsupervised and being entitled by the employer. Training
records for this equipment are reviewed, in line with the standards described in the
employer’s procedures and following software updates.
A radiology registrar transfers to a new hospital as part of a rotational educational

programme and is scheduled to perform a barium screening list. As part of an earlier
placement at a different hospital, the registrar received equipment training on a
similar fluoroscopy unit and was entitled as an operator at that site for screening
lists. The registrar has an up-to-date training record reflecting this training. Before
the first screening list a training session is completed with the lead radiographer
in the fluoroscopy suite. The lead radiographer highlights the specific set-up of
the fluoroscopy units and identifies the differences between the similar pieces of
equipment and protocols. The lead radiographer supervises the registrar throughout
their first fluoroscopy session and then completes and updates the registrar’s training
record. They are entitled as an operator by the employer at this site.
Supervision including students and trainees

Regulation 2 defines an operator as any person who is adequately trained to carry out
practical aspects of an exposure and differentiates this from anyone who acts under the
direct supervision of a person who is adequately trained.
Where an individual is not considered adequately trained, and therefore cannot be entitled
as an operator, they must be supervised by someone who is entitled to undertake the task.
An operator who supervises a trainee may provide evidence that the trainee has
successfully completed training, including theoretical knowledge and practical experience,
to be deemed adequately trained and competent to carry out an exposure. However, it is
for the employer to decide whether or not an individual is consequently entitled to act as an
operator. For further information see Chapter 5 (Entitlement).
A trainee (for example, a student radiographer or trainee assistant practitioner) is unlikely
to meet the requirements of Schedule 3, adequate training, to be entitled as an operator
until they have completed a full programme of assessment. Until this time, Regulation
17(3) applies, which permits trainees to perform any practical aspect of an exposure
under supervision. In this situation, the supervising operator retains full responsibility
for each task. It is essential that the supervisor has agreed to oversee a particular task
before it commences, and that the trainee is clear who is supervising them. There is
guidance available from professional bodies on what constitutes adequate supervision of
trainees.23–27 Inappropriate supervision arrangements may put the patient/individual at risk.
The same level of care and supervision should apply throughout normal working hours and
out of hours.
Where a person carrying out a task is considered fully trained and competent to do so, it is
normally appropriate that they should be entitled to act as an operator in their own right.
An employer may entitle a trainee undergoing practical training as an operator within a
clearly defined and limited scope of practice. An agreed level of competence should be
recorded and assessment should be undertaken in collaboration with the associated
educational institution.
For trainee radiologists, who will already be medically qualified but who may not necessarily
be trained in radiation protection, the scope of their entitlement, as both practitioner and
operator, should be commensurate with their knowledge and experience. There should be
clarity as to which aspects of their role require supervision.
Training for referrers

While not explicitly required under IR(ME)R, it is considered best practice that, where
practicable, referrers complete some form of local awareness training. The scope of training
may include:
§ Use of the electronic referral system
§ How to request, cancel or change a referral (electronic and/or paper)
§ Local procedures governing the use of IT and the GDPR, including any potential for
disciplinary action if log-in details are shared
§ How to access referral guidelines, including information on radiation dose
§ The specific examinations included in a non-medical referrer’s entitled scope of practice
§ Professional and legal responsibilities.
Referrer training may reduce the number of errors (inappropriate or repeat examinations)
caused by incorrect patient identification at the time of the referral. The Society and College
of Radiographers (SCoR) has published an IR(ME)R referrers’ checklist for referring a
patient for a diagnostic imaging examination.28
An organisation may deem it appropriate to entitle some referrers, for a limited scope of
practice, to specific areas of anatomy or clinical indications.
Joint professional body guidance is available for referrers who are not medically qualified,
such as nurse practitioners, physiotherapists and chiropractors and further information is
given in Chapter 6 (Referral process).29,30
Employers should ensure that all referrals for examinations involving the use of ionising
radiation are appropriate through regular audit. This should be part of an overarching
radiation protection governance and assurance programme which promotes education
and service improvement.
Training for non-IR(ME)R duty holders involved in the referral process

Some of the initial receipt and processing of referrals may fall to non-IR(ME)R duty holders
such as administrative staff. Consideration should be given to the training of these staff to
ensure referrals are actioned in a timely and consistent manner. This should include, for
example, familiarisation of the procedure to:
§ Alert the referrer that additional information is required
§ Alert the referrer that an exposure has not been justified
§ Alert the referrer that the department has been unable to contact the individual for
whom the exposure is intended
§ Ensure referrals are appropriately prioritised and expedited as required
§ Manage future appointments at specific time intervals (for example, follow-up scans)
§ Address patient queries regarding their examination.
Paper systems and radiology information systems (RIS) should be fit for purpose, and users
should receive training as appropriate to their role in the referral to diagnosis pathway.
Referral processes are discussed in Chapter 6 (Referral process).
5 Entitlement is the term used to describe the process of endorsement by an appropriate and
Entitlement specified individual within the organisation. They must have the knowledge and experience
to authorise, on behalf of the employer, that a duty holder or a group of duty holders have
been adequately trained and deemed competent in their specific IR(ME)R duty holder roles.
The employer has the responsibility to ensure that all practitioners and operators are
adequately trained to perform the tasks defined within their scope of practice [Regulation
6(3)(a)]. Training requirements are described in further detail in Chapter 4 (Training).
There is a requirement to have an employer’s procedure to identify individuals entitled to act
as IR(ME)R duty holders [Schedule 2(b)]. Table 5.1 includes matters to consider for inclusion
within the employer’s procedure required under Schedule 2(b).
Table 5.1: Points to consider for inclusion in employer’s procedure Schedule 2(b)
Entitlement procedure Things to consider
Who has responsibility for § Statement to identify responsibility

compliance with IR(ME)R in
the organisation?
Lines of IR(ME)R § Clear governance structure

accountability and § Those using ionising radiation outside the
delegation of tasks imaging department
throughout the organisation
Responsibilities of IR(ME)R § Reading and complying with the relevant

duty holders employer’s procedures [Regulation 6(2)]
§ Do staff understand what duty holder roles they
are performing and when?
Initial qualification § Relevant qualifications (eg, FRCR Part 1 for

requirements for each radiologists, BSc (Hons) or equivalent for
duty holder/group of duty radiographers, MSc for clinical scientists)
holders
Confirmation of registration § Process for checking individuals are registered

for referrers and healthcare professionals as defined in the
practitioners National Health Service Reform and Healthcare
Professions Act 200210
Confirmation of practitioner § Records of valid licences, and process for

licence for administration of renewal before expiry
radioactive substances
Entitlement procedure Things to consider
How individuals/groups § Entitlement letter or documents showing scope

demonstrate their of practice
entitlement and scope of
practice
How entitlement/scope § Process for reviewing and updating

of practice is updated and entitlement/scope of practice
reviewed § Specified timeframe (eg, at appraisal or when
scope of practice changes)
§ Who is responsible for auditing and reviewing
entitlement/scope of practice
The organisation should designate an accountable representative to ensure the employer’s

duties are fulfilled. A statement should be included to clearly define this responsibility, such
as: ‘The overall responsibility for ensuring that the Ionising Radiation (Medical Exposure)
Regulations are complied with lies with …’.
The employer’s procedure should unambiguously describe who has been delegated the
task of ensuring duty holders, throughout the organisation, are appropriately trained, are
competent and entitled to perform their roles and how this is achieved. It should describe
the governance arrangements for approving entitlement, detailing how entitlement is
managed and the roles and responsibilities of those involved. A description of IR(ME)R lines
of accountability can be evidenced through supplementary organisational charts within the
employer’s procedure.
Where staff are entitled as a group, the employer must be able to identify each individual
in that group. The individuals should be trained, assessed competent and entitled before
performing the task and have a means of demonstrating their entitlement and scope of
practice. This may be demonstrated through a letter from the employer.
It is important to emphasise that, while the task of training, assessing and entitling may be
delegated, the legal responsibility always remains with the IR(ME)R employer.
The procedure must also incorporate those duty holders and areas outside the imaging
department where ionising radiation is in use, such as cardiology, orthopaedics or
rheumatology services. There may be different management structures and lines of
accountability in these departments.
Regulation 5(1)(b) requires practitioners who justify exposures involving the administration
of radioactive substances to hold a licence. When entitling practitioners for nuclear
medicine or PET-CT examinations, the employer should ensure that the individual’s licence
is valid. Further information on licensing is included in Chapter 22 (Nuclear medicine
licensing).
Each duty holder, or group of duty holders, will have a defined scope of practice that clearly
describes the extent of the tasks they may undertake (See example scope of practice,
Appendix 5).
Scope of practice
A scope of practice describes a range of skills and tasks based on professional registration,
education, training, knowledge and experience. A scope of practice encompasses the
competencies and training required to perform specific tasks to ensure safe and effective
practice.
Each duty holder should have a scope of practice outlining the tasks they are entitled to
perform, and they should be clear about what they are permitted to undertake. This scope
of practice should be updated when, for example, there is a new service requirement, an
installation or upgrade of equipment, or when a scope of practice has been extended in
some way. This also applies when a duty holder is no longer involved in a task or has had
a significant period of absence and where refresher training is required. As part of the
appraisal process, the scope of practice and associated training records of all staff entitled
to act as practitioners and/or operators should be reviewed and updated.
The scope of practice may be very limited and specific. For example, a nurse working in
a clinic may be entitled to refer specific groups of patients for pre-treatment chest X-rays,
or orthopaedic consultants may be entitled as IR(ME)R operators to clinically evaluate
extremity images.
There should be a process to sign off training records at each stage to confirm assessment
of competence by the assessor and the employee. A competency assessor should
be familiar with, and experienced in, the tasks and requirements of the duties they are
assessing.
The CT clinical lead radiologist in a radiology department is keen to develop staff

and improve efficiency within the department. The radiologist spends time training
and supervising the CT clinical lead radiographer in the justification of a range of CT
examination referrals. Once the radiographer is deemed competent by the supervising
radiologist, the entitlement records are updated with the radiographer’s new scope of
practice. The competency documentation relating to this training is signed off by the
supervising radiologist and is added to the radiographer’s training records. Once this
has been completed the CT radiographer may then be entitled, by the employer, to act
as a practitioner justifying and authorising these specific CT examinations.
Table 5.2 includes further matters to be considered when establishing employer’s

procedures on entitlement.
Table 5.2: Considerations for entitlement
Professional roles and duty holders Things to consider
Assistant practitioner trained to perform § Training programme and records

general radiography for a defined scope of § Audit of practice
practice
Entitle as an operator
Professional roles and duty holders Things to consider
Medical physics expert/medical physicist/ § Where MPE advice is provided

clinical technologist under contract, the MPE must be
Entitle as an operator entitled by each employer
Orthopaedic surgeon/podiatrist using mini § Training programme including

C-arm without a radiographer present specific IR(ME)R/radiation
Entitle as a referrer, practitioner and protection and equipment
operator training
§ Up-to-date records
§ Appropriate registration
for referrer and practitioner
entitlement
§ Audit of practice
Group entitlement, such as nurse practitioners § Training programme including

in emergency departments who refer and specific IR(ME)R/radiation
clinically evaluate images within a defined protection training
scope of practice § Up-to-date records
Entitle as a referrer and operator § Appropriate registration for
referrer entitlement
Third-party provider undertaking justification § Qualifications, registration and

and clinical evaluation appropriate training checked, and
Entitle as a practitioner and operator records available (maintained by
third-party employer)
§ Appropriate registration for
practitioner entitlement
§ Training records should be made
available by third-party provider to
the employer on request
Agency radiographer § Qualifications, training and

Entitle as an operator, referrer and/or registration checked
practitioner depending on professional § Induction programme including
background, within a defined scope of records for locally delivered
practice training (eg, equipment)
§ Agency should provide training
records on request
Third-party providers
The employer’s procedure should consider the entitlement and scope of practice of
IR(ME)R duty holders from a third-party provider.
Staff employed by third-party providers need to be entitled as practitioners in the employer’s
procedures if they are carrying out the justification process and as operators if they
are performing clinical evaluation or other practical aspects. This can either be on an
individually named basis or as a group entitlement. For group entitlement, the employer
must be able to identify each individual in the group and be assured that they are registered,
trained and competent to perform the tasks.
Operators carrying out examinations need to be aware who the practitioner is for each
exposure before it is performed.
For situations where there is more than one employer involved in a care pathway, it is
important from a governance perspective that each employer understands and identifies
who has IR(ME)R responsibility at each point in the pathway. This detail could be included
in the employer’s procedures or in the contract between the two employers, but it should be
clear for all individuals involved.
When individuals work across multiple sites with multiple employers, they are required to be
appropriately entitled at each site by each employer.
Two NHS trusts work together to provide specialist podiatry services, including use of
a mini C-arm in theatre. The consultant podiatrist is employed by Trust A and is entitled
as referrer, practitioner and operator. The consultant podiatrist also provides similar
services at Trust B, using their mini C-arm, to reduce distance and travel time for the
patients. The consultant podiatrist is entitled by Trust B as a referrer, practitioner and
operator, is following the employer’s procedure at Trust B when working there and has
had a formal induction including training on processes and equipment.
Two NHS trusts work together as a consortium to provide PET-CT services. Trust A
holds an employer licence and employs three licensed practitioners. Trust B holds an
employer licence and employs six licensed practitioners. To meet waiting time targets,
patients may be booked into available scan slots at either Trust A or B. Where patients
transfer from one trust to another, the entitlement of duty holders and the process for
justification and authorisation of referrals is clear.
Trust A entitles practitioners and operators at Trust A only. Trust B entitles practitioners
and operators at Trust B only.
A referral is received at Trust B and justified and authorised by one of the six licensed
practitioners. There are no available scanning slots at Trust B within the waiting time
target, so the referral is transferred to Trust A.
At Trust A, one of the three licensed practitioners has issued authorisation guidelines
to allow operators at Trust A to authorise referrals. The authorisation guidelines include
criteria that any PET-CT referrals that have been justified by any of the six licensed
practitioners at Trust B may be authorised. The licensed practitioner at Trust A who
issued the authorisation guidelines is the IR(ME)R practitioner for these referrals.
Reciprocal authorisation guidelines are in place at Trust B.
The process of entitlement involves:

§ Training supported by training records
§ Assessment of competence by an appropriate individual – this must be
documented
§ Entitlement – this may be for an individual or by staff group (when practicable)
§ Duty holders performing their functions and undertaking continuous professional
development.
6. A referral is a request for an exposure to be performed, not a direction to undertake an

Referral process exposure. A referral must be made by an appropriately entitled registered healthcare
professional as defined by IR(ME)R.
Duty holders have responsibilities under IR(ME)R at each step of a patient pathway. These
are included in Table 6.1.
Table 6.1: Considerations for the requirements of the employer and duty holders
Regulation Things to consider
Employer must establish referral § Use iRefer as a basis for the development
guidelines, including radiation of referral guidelines31
doses, and make these available to § Include radiation dose information
referrers
§ Process to ensure all referrers have
Regulation 6(5)(a) access to referral guidelines (including
new referrers)
§ Process to ensure referrers understand
their responsibilities under IR(ME)R within
their individual scope of practice
§ Audit quality of referrals (including shared
learning)
Referrer must supply sufficient Include on a referral:

medical data for practitioner to Essential information:
enable justification
§ Accurate, up-to-date patient identification
Regulation 10(5) information
§ Relevant clinical history
§ Clinical diagnosis
§ Requested examination
§ Information related to research trials
(where relevant)
§ Information related to pregnancy and
breastfeeding (where relevant)
§ Signature of referrer
§ Referrer name and contact details
Expected information:
§ Clinical findings on examination
§ Mobility status (eg, requires hoist)
§ Co-morbidities (where relevant)
§ Medication (where relevant)
Desirable information:
§ Carer or comforter requirements or other
relevant radiation protection information
Practitioner must consider § Process for contacting referrer

information supplied by referrer to § Documentation of discussions with
justify each individual exposure and referrer
avoid unnecessary exposures
§ Process for returning referrals
Regulation 11(4)
The referrer must supply sufficient medical data (for example, previous diagnostic
information or medical records) for the practitioner to be able to weigh up the benefit of
the exposure against the risks [Regulation 10(5)]. Further information on the justification
process is included in Chapter 7 (Justification and authorisation).
The referrer must also supply accurate, up-to-date information to enable the operator to
correctly identify the individual to be exposed.
Referral guidelines
The employer has responsibility for putting referral guidelines in place and making sure
these are available to referrers [Regulation 6(5)(a)]. Referral guidelines set out the conditions
in which an individual would typically be referred for a specific type of exposure and must
include an estimate or indication of the radiation dose associated with that exposure.
In diagnostic imaging and interventional radiology, iRefer is often used as the basis for
developing or updating an organisation’s referral guidelines. Healthcare professionals
outside the radiology department may use documented pathways in a particular specialty,
which may include the most appropriate imaging tests. Where local specific examinations
are undertaken, not included in iRefer, referral guidelines need to be written.
In nuclear medicine and PET-CT, BNMS guidelines, EANM guidelines and the PET-CT
evidence-based guidelines are often used.32–34
MDT referrals should include the name of the individual making the referral.
Referrer training
While not explicitly required under IR(ME)R, it is considered best practice that, where
practicable, referrers complete some form of local awareness training. A resource to
encourage referrers to pause and check prior to making a referral was introduced in 2017.28
Some of the initial receipt and processing of referrals may also fall to non-IR(ME)R duty
holders such as administrative staff. Consideration should be given to the training of these
staff to ensure referrals are actioned in a timely and consistent manner. More details on
referrer and administrative staff training can be found in Chapter 4 (Training).
Referral systems
The use of electronic referral systems is widespread and increasing, though some
employers still accept handwritten referrals from a number of specified sources and
therefore run a dual electronic and paper referral system. These different processes should
be clearly described in the employer’s procedures.
Electronic referral systems require the referrer to log in using a unique identifier. RCR
guidance suggests that an employer’s procedure should ensure it is a disciplinary offence
to use someone else’s log-in to initiate a referral.9 The employer’s procedure should address
potential safety risks when using paper referral forms; for example, prohibiting the use of
blank pre-signed paper referral forms.
The increased efficiency that may be seen from using an electronic referral system must
be balanced with the potential for requesting exposures for the incorrect patient. Audit is
an effective tool to evaluate the quality and accuracy of referrals and can help to identify
referrer training needs. Published audit tools are available for referrals.35
The CQC has reported that the most commonly notified error was the ‘wrong patient’ being
referred for imaging.36 As part of a constructive safety culture, the referrer should be notified
and given the opportunity to contribute to any error, near miss or investigation involving an
incorrect or inaccurate referral they are involved in.
Electronic referral systems and paper-based systems should be fit for purpose to ensure
those tasked with the administration, justification, authorisation and practical aspects of the
referral to diagnosis pathway can fulfil their responsibilities.
There are a number of different processes involved with referrals for an examination
involving ionising radiation. These must be clearly described in written procedures and
employers should consider providing training for everyone involved in the referral process.
Non-medical referrers
There are several groups of non-medical-registered healthcare professional referrers
(NMRs) who, as part of their extended role, may request to be considered to refer. The
process may start with a formal request that describes the reason, scope of practice and
service delivery improvement this individual will provide for the organisation. The process
may also describe the training programme, competency sign-off and self-audit processes
to be completed before entitlement would be granted. The criteria for entitlement will be
agreed locally by the service accepting referrals and entitling the NMRs. A clinician who
is an entitled referrer should take responsibility for providing mentorship, guidance and
governance to individual NMRs or teams of NMRs.
The entitlement of NMRs is the responsibility of the IR(ME)R employer; however, the task
of entitlement is often delegated to an appropriate individual within the organisation, such
as the clinical director for radiology. It is anticipated those tasked with entitling NMRs will
have set the standards and evidence of training required, and that until the NMR provides all
documentation, entitlement will not be granted. If it is reported, or audit demonstrates, that
an NMR is repeatedly acting outside of their agreed scope of practice the decision may be
made to remove their entitlement.
A list of entitled NMRs must be available to all practitioners and operators, along with their
scope of practice. This list should be reviewed on a regular basis, enabling new NMRs to
commence practice while removing those who are no longer entitled to refer.
All the referrer duty holder requirements of IR(ME)R apply to NMRs. At present, physicians’
associates cannot be entitled as referrers under IR(ME)R as they are not registered
healthcare professionals. However, this may change in the future and this may also apply to
other staff groups.37
NMRs may be:29

§ Referring as part of a clinical team where they will act on a radiology report rather than
clinically evaluate the images themselves. An example is an orthopaedic specialist
physiotherapist.
§ Referring as part of a clinical team where a clinician will undertake the clinical
evaluation. An example is a radiographer referring for SPECT-CT imaging following
completion of a planar bone scan.
§ Referring as an autonomous healthcare professional, clinically evaluating the images
and treating the patient prior to a radiology report being issued. An example is an
advanced nurse practitioner in a minor injuries unit.
While training for referrers is not a requirement of IR(ME)R it is expected that all NMRs will
have had appropriate training in order for them to be entitled. Training may be delivered via
an educational institution, in-house or eLearning, or by a combination of all approaches.
Medical specialists in the appropriate clinical area may provide relevant clinical in-house
training, while radiology staff and MPEs may also be involved with the training of NMRs.
Table 6.2: Examples of theoretical and practical training for NMRs
Training Examples of training to be undertaken
Theoretical § Principles of radiation protection

§ Legal and professional responsibilities
§ Responsibilities in relation to patient safety and
clinical governance
§ Benefits and risks of examinations within their scope
of practice
§ Referral guidelines for scope of practice
Practical § Face-to-face learning, including time spent in relevant

imaging modalities
§ Local referral pathways
§ Training on electronic referral systems including
cancellation process
§ Employer’s procedures that must be read and
followed
It is considered good practice when employers include NMRs in their audit programme.
Newly entitled NMRs may be audited at more regular intervals initially, enabling
departments to be assured of their compliance with IR(ME)R and that the NMR is acting
within their agreed scope of practice.
NMRs should complete update training on a regular basis (for example, at least every three
years).
7. Justification is the process of weighing up the expected benefits of an exposure against

Justification and the possible detriment of the associated radiation dose. The benefit may not only be to
authorisation the individual exposed but to society as a whole. An example of this may be emigration/
immigration chest X-rays, which may also safeguard the community the individual joins.
Justification is an intellectual activity and is the primary role of the practitioner. Justification
must be completed for each individual exposure that applies under IR(ME)R:
§ Patients as part of their own medical diagnosis or treatment
§ Individuals as part of health screening programmes
§ Patients or persons voluntarily involved in research programmes
§ Carers and comforters
§ Asymptomatic individuals
§ Individuals undergoing non-medical imaging using medical radiological equipment.
Regulation 11(1)(b) says that an exposure may not be carried out unless it has been
justified, prior to the exposure, by a practitioner who must ensure there is a net benefit from
the exposure. Where the exposure involves the administration of radioactive substances,
Regulation 11(1)(a) says that this may not be carried out unless the employer and
practitioner hold an appropriate licence.
When justifying an exposure, there are a number of considerations for practitioners to take
into account. Some examples are:
§ Will the exposure contribute to, or change, the individual’s healthcare management?
§ Has the referrer provided enough relevant clinical information to be able to justify the
exposure?
§ Has the referrer provided enough information to be able to definitively identify the
patient?
§ Is the exposure likely to answer the clinical question being asked?
§ What relevant previous imaging is available?
§ Are there alternative techniques that will answer the question but do not involve ionising
radiation?
Specific matters that must be considered by the practitioner when justifying an exposure
are outlined in Table 7.1.
Regulation 11(4) requires the practitioner to take note of all the data provided by the referrer
to ensure that the exposure is appropriate for that individual and to safeguard against
unnecessary exposures. In accordance with local referral processes, if the referral has
insufficient detail, the practitioner may request further information.
When justifying an exposure, the urgency of the examination should also be taken into
account [Regulation 11(3)(d)(i)]. For example, if pregnancy cannot be excluded, especially
if the abdominal and pelvic areas are to be exposed, or where the exposure involves the
administration of radiopharmaceuticals, then the practitioner must consider both the
individual concerned and their unborn child. The practitioner should consider whether the
exposure could be delayed until it is confirmed whether the individual is pregnant or indeed
consider if the exposure can wait until the baby is born. The clinical risk of delaying the
exposure should be weighed up against the risk of the exposure.
When justifying an exposure to an individual who is breastfeeding, the urgency of a

nuclear medicine examination should also be taken into account [Regulation 11(3)(d)(ii)].
Consideration should be given, where appropriate, to delaying the test until the individual is
no longer breastfeeding, choosing an alternative radiopharmaceutical that is not secreted
in breast milk and ensuring the purity of the radiopharmaceutical. Further guidance is
available in Chapter 13 (Pregnancy and breastfeeding enquiries).
Table 7.1: Considerations for justification of an exposure to ionising radiation
IR(ME)R Regulation 11(2) Consider
(a) The specific objectives § What is to be gained by carrying out the

of the exposure and the exposure?
characteristics of the § How may the outcome affect the care
individual involved pathway/management of the individual?
§ Previous imaging, medical history, age,
pregnancy or breastfeeding status, body
habitus
§ For nuclear medicine exposures, any
medication the patient is taking and
whether this will affect the result of the
investigation; medication may need to be
stopped prior to the investigation
(b) The total potential § What is the expected benefit of the

diagnostic or exposure?
therapeutic benefits § Is the exposure likely to answer the clinical
to the individual and question?
society from the
§ Will the individual’s treatment be altered?
exposure
(c) The detriment the § What is the likely dose from the exposure?
exposure may cause § What is the risk to the individual from that
dose?
§ Nuclear medicine patients with caring
responsibilities, those who are hospital
inpatients and those who may have
close contact with other people after
the investigation may require additional
radiation protection advice
§ Potential exposure to carers and
comforters
IR(ME)R Regulation 11(2) Consider
(d) What other alternative § How effective are any alternative

imaging modalities are techniques compared with the planned
available that could exposure?
answer the diagnostic § Is the alternative available locally in a
question but involve clinically acceptable timeframe?
less or no radiation?
Authorisation
Authorisation is a process separate to justification and is the documentation confirming
that the intellectual activity of justification has taken place. Authorisation may be carried
out by either a practitioner or an operator [Regulation 11(1)(c)]. Where the practitioner is
not available and the authorisation process is carried out by an operator, they must follow
authorisation guidelines issued by the practitioner [Regulation 11(5)]. When the justification
process is carried out the practitioner must demonstrate this has been completed by
authorising the exposure. Authorisation may be demonstrated by, for example, signing or
initialling the referral in a predetermined place or by entering an electronic password. The
employer’s procedures should describe clearly how authorisation is to be demonstrated.
A third-party provider radiologist is telephoned to discuss an urgent referral for an out-

of-hours CT scan. As the radiologist has no access to the RIS, they cannot authorise the
scan, so they follow the employer’s procedure and contact the on-call CT radiographer.
The CT radiographer checks the radiologist is included on the list of the third-party
radiologists entitled as practitioners by the employer. The radiologist justifies the scan,
confirms the protocol to be used and verbally authorises it. The radiographer completes
the RIS record and, in doing so, verifies the verbal authorisation and includes the details
of the radiologist as the justifying practitioner.
Where the practitioner justifying an examination does have access to the RIS, it is expected
they will carry out the process of authorisation following on directly from the justification
process.
It is not always possible for a practitioner (for example, a radiologist) to review every imaging
referral, so the regulations allow for an appropriately entitled operator to authorise an
exposure following written authorisation guidelines issued by a practitioner.
It is recommended that the practitioner’s guidelines are referred to as authorisation
guidelines rather than justification guidelines, so the purpose of the document is clear.
The practitioner is responsible for the justification of any exposure that is authorised
by an operator following the authorisation guidelines. The operator is responsible for
authorisation and for following the authorisation guidelines accurately. Where the details
within a referral, or the patient’s condition, fall outside the criteria listed in the authorisation
guidelines, the operator cannot authorise the exposure and justification and authorisation
by a practitioner are required.
In many departments and clinics, radiographers and other healthcare professionals (for
example, orthopaedic surgeons and speech and language therapists) are entitled as
practitioners for a specific range of diagnostic procedures. These individuals must be
registered healthcare professionals, appropriately trained, deemed competent and entitled
as a practitioner as specified in the employer’s procedures.
Authorisation guidelines
Authorisation guidelines must be issued by one named practitioner (often, but not always,
the lead radiologist for that area or lead licensed practitioner for nuclear medicine). The
practitioner who produces the authorisation guidelines takes responsibility for justification
of each individual exposure authorised by operators following these guidelines. If this
person leaves the organisation’s employment, the guidelines must be reviewed and
updated by another practitioner, who then takes the responsibility for the exposures
authorised under their guidelines. The author and review/revision dates should be clearly
stated. Published criteria such as the iRefer or PET-CT guidelines may be used to form
the basis of local authorisation guidelines.32,34 The authorisation guidelines should reflect
current best practice and take into account local service provision. Authorisation guidelines
should be clearly written using precise statements that are unambiguous in order to allow
the operator to confirm whether the referral can be authorised.
While referral guidelines such as those produced by the RCR (for example, iRefer) are not
sufficiently detailed for use as local authorisation guidelines, they could be considered to be
a suitable starting point for their development.
In a hospital that has a number of subspecialty areas such as paediatric radiology,
neuroradiology or cardiology, there may be a set of authorisation guidelines for individual
areas, each produced by a different practitioner. In some imaging departments,
authorisation guidelines may be used in one area (for example, CT) but not in others
(such as general radiography or nuclear medicine). However, where they are issued, the
operator responsible for authorising, following the guidelines, must be clearly identified
and appropriately entitled as specified in the employer’s procedures. It must be possible to
identify who the practitioner is for each exposure performed and who has authorised the
exposure.
In general radiography, a referral is received by a radiographer, who reviews the clinical

information provided by the referrer in the context of the clinical question the referrer
is asking. The radiographer, acting as the practitioner, considers the benefit of the
exposure as well as any potential risk associated with the use of ionising radiation. They
consider the age of the individual, any relevant previous imaging and associated clinical
evaluation, and other imaging modalities using less or no radiation, and they review
pregnancy status, where appropriate. If the radiographer considers the procedure to be
justified, they authorise the exposure, which can then be carried out.
The radiographer in this scenario must be appropriately entitled by the employer as a

practitioner, and will need to be trained, deemed competent and act within their defined
scope of practice.22 Training and competency records must be completed before being
entitled by the employer as a practitioner. It is the employer’s responsibility to keep up-to-
date training records; however, this task is often delegated to others, such as a radiology
services manager. This should be clearly described in the employer’s procedures.
A CT scanning unit receives a referral, which is reviewed by a radiographer, who

assesses the clinical information provided by the referrer. The radiographer will
consider this information against a set of authorisation guidelines produced by the lead
consultant radiologist. If the information is covered by the authorisation guidelines, the
radiographer documents that the examination is authorised, and the medical exposure
can then be carried out.
In this scenario, the lead consultant radiologist is the practitioner justifying the exposure.
The radiographer is acting as an operator authorising the exposure following the
authorisation guidelines. The radiographer may or may not be the same operator who then
carries out the exposure. Both the radiologist and the radiographer must be appropriately
entitled in their respective IR(ME)R duty holder roles by the employer to act within a defined
scope of practice.
Where authorisation guidelines are issued, if operators do not follow these guidelines,
they are acting outside their entitlement and may be in breach of IR(ME)R. Healthcare
professionals can only legally function as practitioners if they are entitled to do so.
Entitlement by the employer offers a level of protection for both the employer and employee;
the employer is assured that staff members are working within a defined and agreed scope
of practice, and the individual staff members cannot be expected to do anything for which
they are not entitled or trained.
Vetting
This term is commonly confused with justification; however, vetting may be separate
activities that occur at different stages in the imaging pathway. The term vetting is not
referred to in IR(ME)R and is not synonymous with the process of justification. Vetting is a
term often used for those procedures that require a patient appointment, such as PET-CT
scanning or fluoroscopic examinations, and is linked to the scheduling of an examination;
however, this does not mean that the examination has been justified. It should be noted
that, irrespective of the process used, all exposures must be justified by an appropriately
trained and entitled practitioner before the exposure takes place. Vetting describes
different activities for different imaging departments. It can describe, for example, booking/
scheduling, setting protocols, justifying/authorising or reviewing previous imaging. If the
term vetting is to be used it is important to clarify whether this refers to the justification,
authorisation or protocolling of a referral. This should be clearly described in the employer’s
procedures.
It may be that more than one practitioner is responsible for the justification of different
elements of an examination.
A referral for a CT scan of the head is reviewed by Radiologist A, who simultaneously

justifies, authorises and protocols the scan. The patient is then booked onto a session
supervised by a different radiologist (B). On attendance, the patient undergoes the CT
scan as indicated by Radiologist A. On assessing the images acquired, Radiologist
B, supervising the CT list, decides that a post-contrast CT scan of the same area is
required, and this is justified and authorised by the supervising Radiologist B.
In this scenario, the reviewing radiologist (A) is the practitioner responsible for the
justification of the pre-contrast scan. The supervising radiologist (B) is the practitioner
responsible for the post-contrast scan. A clear record must be made of each practitioner’s
involvement in the justification of these scans.
A referral for a bone scintigram is justified and authorised by the licensed practitioner
and protocolled for a planar acquisition. At imaging, an area is identified by the
radiographer that would benefit from a SPECT-CT. The radiographer contacts the
practitioner, who justifies and authorises the additional CT exposure.
Justification by practitioners working for third-party providers

Where an employer has contracted a third-party provider to deliver services (for example,
justification and clinical evaluation), they should scrutinise and entitle a specified group
of appropriately qualified and experienced individuals to act as practitioners to justify a
predetermined group of examinations and operators for clinical evaluation.
The operator performing the examination must be able to identify the named individual who
is the practitioner for each examination, prior to the exposure, and this information should
be clearly documented.
The employer needs to be satisfied that all practitioners contracted to perform justification
for its organisation are registered healthcare professionals and are trained and competent
prior to entitling them as IR(ME)R practitioners.10
Justification of exposures to comforters and carers

Exposures to carers and comforters also require individual justification [Regulation 11(1)(b)].
Justification and authorisation may be carried out by a practitioner or these exposures may
be authorised by an operator following authorisation guidelines.
Regulation 11(3)(b) specifies additional considerations that must be applied to the
justification of exposures to carers or comforters. Where authorisation guidelines for carers
and comforters are issued, the additional requirements of Regulation 11(3)(b) should be
included as detailed in Table 7.2.
The requirements in both Tables 7.1 and 7.2 must be considered when justifying exposures
to carers or comforters.
Table 7.2: Additional considerations for exposures to carers or comforters
IR(ME)R Regulation 11(3)(b) Things to consider
(i) Any likely health benefits to the § Possibility of having a diagnosis,

patient being examined treatment or knowing there is no
underlying medical issue
(ii) Any possible benefits to the carer § Reassurance that a family

or comforter member, partner, friend or
dependant is receiving medical
attention, and will be able to
have the examination with their
support
(iii) The detriment the exposure may § What is the likely dose to the
cause carer or comforter from the
exposure?
§ What is the risk to the individual
from that dose?
Justification for asymptomatic individuals (including health screening and

individual health assessment)
Exposures may be performed for early detection of disease in a specific group of apparently
healthy individuals who are considered to be at risk (for example, NHS Breast Screening
Programme (NHSBSP)), or as part of an individual health assessment (IHA).38 IHAs involve
asymptomatic individuals who may consider they are at risk from disease and wish to
exclude any unknown underlying health issues. IHAs are directed at individuals rather than
groups or populations.
IR(ME)R [Regulation 11(3) (c)(i–iii)] has a number of requirements (in addition to those
listed in Table 7.1) that must be considered when justifying exposures to asymptomatic
individuals for early detection of disease. These include exposures undertaken as part
of health screening programmes and IHAs. An example of good practice is where local
procedures stipulate exposures to asymptomatic individuals are individually justified by the
practitioner, rather than including this criteria in authorisation guidelines. The practitioner
must take into account recommendations and guidance from relevant bodies. Examples
include, but are not limited to, the NHSBSP and the Committee on Medical Aspects of
Radiation in the Environment (COMARE).39,40
Justification for research exposures

All research exposures must be clearly identified, and each research trial must have ethics
committee approval as described in Chapter 23 (Research). Each research exposure still
requires individual justification and authorisation.
Justification for non-medical imaging exposures

An employer’s procedure [Schedule 2(m)] is required for non-medical imaging exposures.
Regulation 11(1)(e) requires that non-medical imaging exposures must comply with the
employer’s procedures for this group of exposures. The employer’s procedure should
specify which non-medical imaging exposures, if any, are undertaken by the organisation
and how each group of non-medical exposures is identified and managed. Each non-
medical exposure requires justification and authorisation taking into account the
considerations detailed in Table 7.1. For example, it may be decided that only practitioners
can justify non-medical referrals for legal purposes. Further information on non-medical
imaging exposures can be found in Chapter 18 (Non-medical imaging exposures).
8. Optimisation is a key principle of the radiation protection framework within IR(ME)R. The
Optimisation optimisation process is the joint responsibility of the practitioner, operator and MPE.
Requirements for optimisation of exposures are described in Regulation 12.
Regulation 12(1) states that ‘the practitioner and operator … must ensure that doses … are
kept ALARP consistent with the intended purpose’.
Regulation 14(3) requires the MPE to contribute to optimisation of exposures to individuals.
Optimisation requires a multidisciplinary team including MPEs, radiographers and
radiologists. Optimisation is not limited to dose reduction; it requires an understanding of
image quality, equipment parameters and their intercorrelation. The aim of optimisation is
to achieve the image quality required to answer the clinical question using the lowest dose
possible. Efficient working practices are important to ensure the team works effectively
towards optimisation.
Review of optimisation should be carried out on a regular basis and when practice changes
or when equipment is updated. The optimisation process should be considered and
included in staff training. Table 8.1 describes areas for consideration when optimising
exposures, but this list is not exhaustive.
Table 8.1: Things to consider when optimising exposures
Optimisation Things to consider
Training § There is a robust training programme

Regulation 17(1) in place to ensure all practitioners and
operators are competent and aware of how
to use existing, new or updated equipment
Protocols § Written protocols are in place for all

Regulation 6(4) standard examinations, including non-
medical imaging using medical radiological
equipment
Quality assurance (QA) § There are established QA programmes for

Regulations 6(5), 12(3) and 15(1) both written procedures and equipment or
methods.
Equipment § Existing equipment is appropriate for

Regulation 12(3) the individual examination and due
consideration is given to ensuring each
exposure is ALARP
§ Review of DRLs
MPE advice § MPE to be consulted on optimisation,

Regulations 14(2)(c) and 14(3)(a) including patient dose assessment,
radiation protection of patients and other
individuals, and DRLs (Chapter 19)
Optimisation Things to consider
Clinical audit § How image quality, technique, protocols,

Regulation 7 doses or reject analysis may be audited and
practice changed based on evidence
Carers and comforters § Adherence to dose constraints specified in

Regulation 6(6) employer’s procedures
Regulation 12(8) requires the practitioner and operator to pay particular attention to the
optimisation of the areas listed in Table 8.2.
Table 8.2: Areas requiring particular attention when optimising exposures
Particular attention Examples of things to consider

when optimising
Exposures of children § Pre-programmed equipment settings (eg,

based on a range of ages and weights)
§ Specific paediatric imaging protocols for
nuclear medicine, administered activity
scaling and specify minimum activity
Exposures in a health screening § Specific inclusion criteria for health

programme screening programmes approved by the
UK National Screening Committee (UK
NSC) approved, robust QA programme,
regular image quality audit, and so on to
meet population screening programme
standards
Exposures involving high doses § Specialist training for staff involved in

(eg, fetal doses >10 mGy), high-dose examinations
examinations exceeding minimum § Use of pre-programmed dose limit
threshold for tissue reactions (eg, warnings
cataracts, erythema), some hybrid
§ Regular review of protocols
imaging (eg, 18FDG PET-CT), some
CT interventional procedures § Audit of image quality
§ Dose surveys
Individuals where pregnancy § Minimise scan area to keep dose ALARP

cannot be excluded § Referral pathway (eg, consultant to
consultant)
§ Administer a lower activity and increase
image acquisition time
Particular attention Examples of things to consider

when optimising
Individuals who are breastfeeding § Consider delaying examination;

alternative radiopharmaceuticals;
interruption of breast feeding
While standard protocols should be determined through an optimisation process, it is the

responsibility of the operator to ensure exposure parameters are always appropriate for the
individual. Technique and exposure parameters may require further optimisation from the
planned protocol according to patient age, size or other pertinent clinical information.
Procedures with the potential to deliver high doses must be undertaken, or closely
supervised, by operators who have specific training in those techniques. Dose limit
warnings should be programmed into the equipment to ensure operators are aware that
a high dose is being delivered. Dose limit warnings should be set in collaboration with the
MPE and with consideration of average doses for different procedures.
Continuous review of optimisation of nuclear medicine protocols is considered good
practice. Technologies such as resolution recovery should be considered and may be
employed to reduce patient dose, improve image quality or improve patient experience
through shorter acquisition times. A multidisciplinary approach should be taken in the
optimisation process in order to produce diagnostic images at the lowest practicable dose.
9. Diagnostic reference levels (DRLs) are radiation dose levels, or for nuclear medicine the
Diagnostic administered activity, for typical diagnostic examinations on standard size adults and
reference levels children for broadly defined types of equipment (for example, CT, fluoroscopy or general
radiography) [Regulation 2(1)].
DRLs are benchmarks of patient radiation dose, based on dose indices and where certain
variables, such as equipment type, examination and patient size, are standardised to
minimise uncertainty. DRLs are often considered the first step in the optimisation process.
DRLs should not be consistently exceeded when good and normal practice is applied.
DRLs should be used with professional judgement. All operators should be familiar with
and trained in the appropriate use of DRLs.
In diagnostic imaging and interventional radiology, DRLs are generally set as a result of
national and local surveys (referred to respectively as national DRLs or local DRLs). DRLs
apply to a population, and individual patients should not be compared with the DRL, nor
should DRLs be used as dose limits. Instead, DRLs are an essential tool in the optimisation
process.41 They can help to identify issues relating to equipment or practice by highlighting
unusually high or low radiation doses.
DRLs are given as dose indices, in units relevant for the imaging modality. Appropriate dose
parameters for DRLs are adopted for each imaging modality, as shown in Table 9.1.
Table 9.1: Examples of DRL dose indices
Modality DRL Example units
General radiography Dose area product (DAP) Gy.cm2

(digital radiography,
computed radiography)
Fluoroscopy, including Fluoroscopy DAP Gy.cm2

interventional Acquisition DAP Gy.cm2
CT Computed tomography mGy

dose index (CTDIvol) mGy.cm
Dose length product
(DLP)
Mammography Mean glandular dose mGy

(MGD)
Nuclear medicine Administered activity MBq
DRLs are applicable for standard size individuals, unless stated otherwise, and relate to the
imaged body region and the specific diagnostic question or clinical indication. If comparing
DRLs from different populations, variations in standard size should be taken into account.
However, for ease of data collection, and to minimise uncertainties where the number of
contributions is small, a default approach is to use 70 kg for adults (+/− 5 kg when presented
as a mean or median value, or +/− 20 kg for individual contributions to a mean or median
value), even though this does not account for current, regional or clinical demographics.
Paediatric populations vary and DRLs will need to take into account a range of ages
and weights. Weight is generally considered as the easiest approach for establishing
paediatric body DRLs, although age is sufficient for paediatric heads.42 Further guidance on
establishing paediatric DRLs is available from this reference.
In nuclear medicine, the DRL is the administered activity. Nuclear medicine protocols
should specify a tolerance on the activity to be administered (for example, +/−10%) for each
examination. For some nuclear medicine examinations (for example, myocardial perfusion
scanning or PET-CT), local DRLs may use weight-based activity schedules; this should be
included in the protocols.
Regulation 6(5)(c)(i–iii) says that the employer must establish DRLs for exposures for typical
examinations carried out as part of medical diagnosis or treatment at that centre. This
includes procedures as part of health screening programmes, for asymptomatic individuals
and, where practicable, for non-medical imaging using medical radiological equipment. If a
department performs an adequate number of standard interventional procedures, a DRL for
those procedures should be established. Local DRLs should be set with regard to national
and European DRLs where available.
National DRLs (NDRLs)

While European DRLs are available, national DRLs better reflect UK practice. All UK NDRLs
are adopted and published through a process established by the Public Health England
(PHE) NDRL Working Party.
NDRLs in computed tomography (including CT in hybrid imaging), planar diagnostic X-ray,
non-complex interventional and dental radiography, fluoroscopy and mammography are
set using data submitted by hospitals to national dose surveys. These national dose surveys
or audits may be undertaken by PHE, professional bodies or other suitable organisations.43
Resultant data, suitable as NDRLs, are presented to the NDRL Working Party for their
consideration.
The NDRL for the majority of these modalities is set as the third quartile of the national
survey, meaning that three-quarters of submissions have values below the NDRL, and one
quarter above. The exception is the NDRL for screening mammography, which is set as an
upper limit from a national survey.
NDRLs for administered radioactivity in nuclear medicine examinations are set by the
Administration of Radioactive Substances Advisory Committee (ARSAC).21 These are the
recommended administered activities for standard size patients.
Local DRLs (LDRLs)

Regulation 14(3)(a) requires the MPE to contribute to the application and use of DRLs.
Regular dose audits should be carried out under a local governance programme,
when new equipment is installed and if clinical practice changes, as advised in IPEM
guidance.44 This is most effective when undertaken with advice from the MPE working
as part of a multidisciplinary team including radiographers, radiologists, interventionists
and cardiologists. LDRLs should reflect local practice, equipment and patient cohorts.
Consideration should be given to setting LDRLs for children for commonly requested
examinations. The employer’s procedure [Schedule 2(f)] should detail actions required
where LDRLs are consistently exceeded [Regulation 6(7)].
An employer, with advice from their MPE and a multidisciplinary team, may decide to
adopt NDRLs as their own LDRLs or, following local dose audits, choose to set their own
LDRLs. An LDRL should be appropriately set using values from a local dose audit, with an
appropriate action level identified.44 Where an LDRL is set higher than the NDRL, based
on a local dose audit, this should be justified by the employer.44 Efforts should be made to
optimise further, or consideration given to replacement of equipment. Having the LDRLs
displayed in the work area is considered good practice.
A radiology department has recently installed a new CR chest X-ray room. As part of the
dose audit schedule, the lead radiographer and MPE work together to analyse dose
information recorded on the RIS system from this room over a six-month period. The
data is used to establish an LDRL for both adult and paediatric chest X-ray examinations
using the employer’s agreed method. Once the LDRLs are established, they are
compared with NDRLs before being ratified by the radiation protection committee. The
room DRL chart is updated to reflect the newly agreed values and staff are informed of
the change.
In nuclear medicine, it may be possible to set an LDRL at a lower administered activity than
the NDRL. These LDRLs may be exceeded in exceptional circumstances, such as with a
bariatric patient or a patient who is unable to tolerate standard acquisition times. Where
administered activity is increased based on an individual’s clinical circumstances, this must
be justified and recorded by the licensed practitioner. Further guidance is available from
ARSAC.21
A nuclear cardiology department has set an LDRL of 600MBq +/− 10% for a two-
day myocardial perfusion imaging protocol using 99mTc tetrofosmin. An audit of
administered activities from the last six months shows that the distribution is skewed
towards the upper limit of the tolerance range with the average activity administered
635MBq. The MPE is contacted and further analysis of the administered activity is
carried out including assessment of residual activity, correlation with patient weight and
assessment of image quality. Following this analysis, a weight-based activity schedule
is proposed and ratified by the radiation protection committee.
LDRLs should be established for the CT component of hybrid imaging. LDRLs will vary
depending on how the CT component is used, and the purpose of the exposure should be
clear. If localisation is the aim rather than requiring diagnostic information, a low dose DRL
should be established. Where diagnostic information is required (for example, in parathyroid
imaging), a high-dose exposure is likely to be used to provide detailed diagnostic images of
the parathyroid glands. When setting LDRLs it is important to engage MPEs in both CT and
nuclear medicine to ensure both elements of the exposure are optimised.
Image optimisation teams (IOT)

DRLs should be reviewed systematically, preferably by a multidisciplinary team consisting
of radiographers, radiologists, interventionists and MPEs. This function may be undertaken
by the IOT where doses, protocols and processes can be reviewed in a structured way. A
formal record of IOT meetings will ensure any actions are expedited and followed up.16
An X-ray department has a dedicated cardiology interventional suite where many

specialist cardiac examinations are undertaken each year. There are no NDRLs
for these particular specialist procedures as there is a lack of available data. The
department, however, has analysed and reviewed dose data for the procedures they
have carried out and established LDRLs for their typical examinations and patient
sizes at this department. Future reviews of patient doses can be undertaken which
compare doses with the LDRLs to inform optimisation. This review of doses involves a
multidisciplinary team including radiographers, interventionists and MPEs.
10. IR(ME)R may require individual doses to be reviewed and assessed when:
Patient dose § Establishing local diagnostic reference levels (LDRLs)
assessment and § Undertaking incident analysis following, for example, equipment malfunction
recording
§ Comparing and standardising protocols between equipment
§ Performing clinical audit
§ Collecting dose estimates as required under Regulation 13
§ Optimising protocols
§ Establishing dose constraints.
The best method by which this can be achieved is to record parameters relevant to each
exposure. The parameters to be recorded can be found in Chapter 9 (DRLs).
There are many methods by which dose data can be recorded, such as dose management
systems, RIS, patient information systems, local data files such as Microsoft Excel, or by
maintaining paper records. If the data are recorded in a single place, subsequent review
of the data is much easier as it avoids having to convert data from paper files or individual
patient records.
There is a requirement for an employer’s procedure for the assessment of patient dose
[Schedule 2(e)]. The employer’s procedure should specify what information needs to be
recorded as this may be different for each modality and can vary from one manufacturer
to another. The employer’s procedure should also specify where the dose indicators are
recorded. Operators must be aware of the dose indicator units of each system and ensure
they are recorded according to the employer’s procedures. The employer must seek advice
from the MPE about the most appropriate methods for recording and assessing the patient
dose taking into account the systems in place. Regulation 14(2)(d) requires the MPE to give
advice on patient dosimetry.
Where high-dose examinations are conducted, the employer’s procedure should describe
the process for recording and investigating cases where doses exceed a threshold trigger
level, above which deterministic effects could occur. This trigger level could be based on an
appropriate dose indicator such as dose area product (DAP) or dose length product (DLP).
Facilities for dose mapping significantly improve the ability to identify such cases and may
be available on new equipment. The departmental procedure should include a process
for the clinical follow-up of cases where the patient has received a dose that could lead
to potential tissue reactions. As part of the consent process, the operator should discuss
the benefits and risks of the exposure, including the radiation effects that may occur. More
information is included in Chapter 14 (Communicating benefits and risks).
Regulation 15(5) requires that any interventional radiology and CT equipment must be able
to provide the appropriate information to make an assessment of the dose at the end of an
exposure. Further details are included in Chapter 20 (Equipment and quality assurance).
Table 10.1 describes the dose recording requirements in Regulation 16 for equipment
installed after 6 February 2018.
Table 10.1: IR(ME)R requirements for equipment installed after 6 February 2018
Equipment installed Requirement
Interventional radiology equipment Device to inform those staff involved of the

Regulation 16(3) amount of radiation produced during the
exposure
Interventional and CT equipment Must be able to transfer dose information to

Regulation 16(5) the individual’s record, such as the radiology
information system (RIS) or picture archiving
and communications system (PACS)
Any other equipment producing Have a device to enable an assessment of

ionising radiation for medical or patient dose to be made, for each exposure,
non-medical purposes or where appropriate have the capacity to
Regulations 16(6)(a), 16(6)(b) transfer this information to the individual’s
record
Generally, equipment will display a dose indicator, which is dependent on the modality; this
must be recorded on the patient record or referral and is also available within the digital
imaging and communications in medicine (DICOM) header of the image when stored
on the PACS. To facilitate dose and DRL data collection, individual doses should also be
recorded on the RIS. In paediatric examinations, it may be helpful to record the weight of
the individual for inclusion in dose audits. Dose management software may be used for
optimisation purposes.
11. Regulation 12(9) says that the employer must ensure that a clinical evaluation of the
Clinical evaluation outcome is recorded for each exposure. Clinical evaluation involves the assessment of an
image and the documentation by suitably trained and entitled operators. Clinical evaluation
is most commonly considered to be a documented radiology report, which is usually
recorded on the RIS. Other methods of clinical evaluation include written records in the
patient notes or quantification data from non-imaging nuclear medicine examinations.
Any assessment of an image that has an impact on patient management should also be
considered a clinical evaluation. There are a number of areas within an organisation where
clinical evaluation is performed and recorded. For example, radiographers alerting referrers
to a significant finding,45 orthopaedic surgeons using fluoroscopic guidance in theatre,
cardiologists performing interventional procedures or clinical technologists processing
dynamic images in nuclear medicine. In some of these instances, the outcome of the
clinical evaluation may be recorded directly in the patient’s clinical notes.
The different processes for recording clinical evaluation should be clearly described
in the employer’s procedure [Schedule 2(j)]. The procedure should explain how and
where each clinical evaluation is recorded and describe when, or if, exposure factors
should be included. Exposure factors do not always form part of the formal report but are
routinely recorded on the RIS or dose management software, either by the operator or
by being automatically transferred. The procedure should also apply to those exposures
that take place outside of the diagnostic imaging, interventional radiology and nuclear
medicine departments. All staff undertaking clinical evaluation, including those working
in departments remote from radiology, must be trained and entitled and must follow the
employer’s procedure.
A clinical evaluation is not required for individuals who are exposed while being a carer or
comforter.
Clinical evaluation is an operator function. Each individual or group of individuals who
undertake this task must be entitled in accordance with the relevant employer’s procedure
[Schedule 2(b)] following adequate training and assessment of competency.
The process of clinical evaluation, and adherence to the employer’s procedure, should
be assessed by audit (see Chapter 3 (Audit)).46 Clinical evaluation is the final step in the
justification process. Exposures that are not clinically evaluated are not justified.
A mobile chest X-ray is performed on a patient in an intensive care unit (ICU) following
insertion of a central venous pressure (CVP) line. To effectively manage patient
treatment the image is clinically evaluated, on the unit, by a suitably trained and entitled
ICU clinician. The evaluation confirms the line is appropriately positioned for immediate
use. This evaluation is documented in the patient’s notes by the clinician.
An orthopaedic surgeon performing a hip-pinning procedure in theatre uses

fluoroscopic guidance to accurately position the pins. Following completion of the
operation, the surgeon records the clinical evaluation in the patient’s postoperative
notes. The radiographer present during the procedure records dose-related factors on
the RIS. The radiology department performs a regular audit of patient notes to monitor
whether the clinical evaluation process is completed in accordance with the employer’s
procedure.
The RCR has produced standards for the reporting of imaging investigations by non-
radiologist medically qualified practitioners.47
Where an employer contracts with a third party to provide a clinical evaluation service it
should consider the following:
§ Evidence that staff providing any clinical evaluation are trained, competent and entitled
to do so
§ Evidence required to ensure robust data confidentiality systems are in place (for
example, GDPR)
§ Communication system for discussion of findings, including an escalation procedure
for urgent clinical findings
§ Audit programme.
Guidance is available from the RCR on standards for the provision of teleradiology, including
specific standards for reporting and communication of results.48
12. IR(ME)R Schedule 2(a) requires the employer to establish ‘procedures to identify correctly
Identification of the individual to be exposed to ionising radiation’. The procedure should specify how and
the individual to when an individual is to be identified.
be exposed Correct identification (ID) of the patient or individual to be exposed is an operator task and
must be undertaken prior to any exposure. Correct identification always starts with the
referrer. There is evidence to show that incidents involving referral of the wrong patient are
among the largest percentage of all diagnostic errors notified to the IR(ME)R regulators.36
Further information on accidental and unintended exposures is included in Chapter 21
(Accidental or unintended exposures).
Robust employer’s procedures should be in place to ensure the individual can be
correctly identified in any clinical scenario. These should be supported by fit-for-purpose
standardised information technology systems and infrastructure.
For the majority of requested examinations, the most appropriate and adequate means of
positively confirming the identification of the individual is by direct questioning requiring an
active response. A minimum of three questions should be asked, typically:
§ What is your name?
§ What is your date of birth?
§ What is your address?
All responses must match the information provided on the referral. The employer’s
procedure must describe the process to follow where there are discrepancies.
Professional body guidance and resources are available to assist organisations to
implement robust policies for the process of identification.49 There are a number of
additional checking processes suggested by professional bodies such as, but not limited
to, checking previous imaging and confirming laterality/anatomy.50,51 The introduction of the
WHO checklist in 2008 has been shown to reduce the number of deaths related to surgical
processes and is endorsed by the RCR in its guidance on implementing safety checklists for
radiological procedures.51–53
The operator undertaking the individual identification check must be identifiable by their
signature on the referral or electronically on the RIS. The employer’s procedure should state
where this should be recorded and define the responsibilities of each operator involved.
Where possible, the same operator performing the exposure should confirm the individual’s
identification. Where there are multiple operators involved in the exposure, the operator
performing the identification should clearly communicate and cross-check the individual’s
identification with the operator undertaking the exposure. The employer’s procedure must
describe the responsibilities of the duty holders in this two-stage process.
There may be circumstances where verbal communication is difficult or not possible. It is
important that the employer’s procedure identifies alternative means of establishing the
correct identity of the individual. Some examples of how this could be achieved are included
in Table 12.1.
Table 12.1: Alternative methods of identification
Scenario Things to consider
Unconscious individual/ § Use hospital wristband as part of ID check

patient § Cross-reference hospital ‘unknown patient’
number and major incident policies
§ Use national unique patient identification
number
§ Can a relative, carer or staff member confirm
the individual’s ID?
A patient undergoing an § Who confirms the identification of the patient

interventional diagnostic or (eg, anaesthetist, nurse in charge, surgeon)?
surgical procedure § Use of the WHO surgical checklist51
An individual who is § Use hospital wristband to confirm ID

lacking capacity to identify § Can a relative, carer or staff member confirm
themselves the individual’s ID?
An individual with sensory § Confirm ID using written cards, braille or sign

impairment (eg, deaf or blind) language to assist active process
§ Could other forms of ID be used (eg, photo ID
driving licence)?
An individual who speaks an § Local policy for the provision of a translation

alternative language service
§ Hospitals may require their own interpreter to
be present and not just a family member
Paediatric cases § If the child is unable to answer all of the

questions, ID could be completed with a
parent, guardian, accompanying nurse or other
healthcare professional who knows the child
Immigration cases § May be more complex identifying the individual

and may require completion of additional
documentation according to local procedure
IR(ME)R Schedule 3 (Adequate Training) includes the identification of the individual being
exposed as a requirement, and training on this topic must be completed before operators
are entitled.
In nuclear medicine, the employer’s procedure should specify how the correct
radiopharmaceutical is identified, including labelling requirements.
13. IR(ME)R provides a framework designed to protect individuals from the harmful effects of
Pregnancy and ionising radiation. This includes the radiation protection of the fetus and those individuals
breastfeeding enquiries who are breastfeeding. IR(ME)R includes the requirement to make enquiries of individuals
of childbearing potential, and this should accurately reflect the diversity of the gender
spectrum in the population.
There is an increased risk of detrimental effects from radiation exposure upon the rapidly
growing and dividing cells of a fetus compared with an adult. Employers must have a
procedure to establish pregnancy and breastfeeding status [Schedule 2(c)]. Table 13.1
describes the regulatory requirements relating to pregnancy and breastfeeding and
highlights some considerations for inclusion in the employer’s procedure.
Table 13.1: Considerations for inclusion in the employer’s procedure
Procedure to § Examinations where pregnancy enquiries are relevant

establish pregnancy (eg, primary beam between diaphragm and knees,
and breastfeeding and all nuclear medicine examinations)
status § Age range based on local demographics
Schedule 2(c) § High-dose and low-dose examinations
§ Process if more than one operator is involved in an
exposure
§ Process for patients in theatres
§ Unconscious patients and emergency situations
§ Individuals lacking capacity and those with sensory
impairment (eg, deaf or blind)
§ Process for the exposure of pregnant individuals
§ Process when pregnancy is disclosed in individuals
aged under 16 (including support and safeguarding
where appropriate*)
§ Process to follow if pregnancy testing is part of the
local decision-making process
§ Exceptions where pregnancy checking is not required
Measures to raise § Posters in waiting areas

awareness § Information in appointment letters and
Regulation 6(8) documentation for wards
§ Adequate training for those involved with patient
communication
Justification § Alternative examination involving less or no ionising

Regulation 11 radiation
§ Urgency of the examination and whether it could be
delayed
§ Consultant-to-consultant referral
Optimisation § Optimised protocols for pregnant individuals

Regulation 12 § Reduce administered activity and image for longer
where possible
§ Adequate operator training (how to adjust technique/
protocols)
* Children under 13 are legally unable to give consent to sexual activity and therefore, if the
possibility of pregnancy is reported, follow local safeguarding procedures.54,55
Making pregnancy or breastfeeding enquiries in advance of an exposure is an operator

task; however, the referrer is responsible for providing sufficient medical data to enable the
practitioner to justify the exposure [Regulation (10)(5)]. This data should include previous
diagnostic information and the pregnancy status of the individual. Where there is no
possibility of pregnancy, local referral guidelines should make it explicit for the referrer
to provide the relevant clinical information (such as total abdominal hysterectomy (TAH),
bilateral salpingo-oophorectomy, sterilisation). Regulation 11(1)(f) requires operators
to enquire about pregnancy status where relevant. Therefore, the process for checking
pregnancy and breastfeeding status must be explicitly described in the employer’s
procedure and any exceptions clearly defined.
The definition of ‘where relevant’ should be stated clearly in the employer’s procedure. For
example:
§ It may be considered relevant for the operator to ask all individuals who have recently
given birth if they are breastfeeding prior to administration of a radioactive substance
and to provide them with information and time to discuss the benefits and risks of the
procedure.
§ Enquiries about the possibility of pregnancy may be considered relevant for all
individuals aged between the locally agreed age range who are undergoing exposures
of the abdomen and pelvis or any high-dose or interventional exposures.
§ It may be considered not relevant to ask an individual who is known to have had a TAH
or who is undergoing medical treatment resulting in infertility or arrested ovulation
about any possibility of pregnancy.
Wherever possible, any appointment information sent out prior to the examination
should explain why the department needs to be aware of the individual’s pregnancy or
breastfeeding status. The use of waiting room information leaflets and posters highlighting
the importance of disclosure of pregnancy, or possible pregnancy or breastfeeding status
(where appropriate), is essential [Regulation 6(8)].
Employer’s procedure
Age range
In many departments, pregnancy enquiries are made for examinations on individuals of
childbearing potential within the age range 12–55 years. However, some departments
have liaised with their trust/health board obstetrics team to set an age range that more
accurately reflects local patient demographics (for example, 11–55 years).
Establishing pregnancy status can be a sensitive matter, especially, for example, when
asking those under the age of 16 years accompanied by a parent. The privacy and dignity
of the individual should be respected when considering where and how these personal
conversations occur and with whom the information is shared.
Further information that may be of assistance when developing an employer’s procedure
is available from the Society and College of Radiographers and the Royal College of
Paediatrics and Child Health.56,57
Unconscious, anaesthetised or sedated patients and emergency situations

The employer’s procedure must specify whose responsibility it is to confirm pregnancy
status prior to the patient being anaesthetised or sedated. Interventional procedures may
include the use of additional documentation such as the WHO checklist.58
NICE clinical guideline 45 ‘Routine preoperative tests for elective surgery’ recommends
enquiring about the possibility of pregnancy, providing information relating to the risks to
the fetus, documenting conversations and carrying out a pregnancy test, with consent, if
there is any doubt.59
Emergency examinations do not preclude the necessity to check for the possibility
of pregnancy, unless the individual’s care would be put at risk by doing so. These
situations should be anticipated and clearly described in the employer’s procedure. The
procedure should clearly define the mechanism for justification of the exposure in these
circumstances.
Trans male or gender-nonconforming individuals

A trans person is someone whose gender differs from that assigned to them at birth. A trans
male is a man who was assigned female at birth and therefore may have the capacity to
become pregnant.
The legal process for gender change is in the Gender Recognition Act 2004 (GRA 2004).60
The Equality Act 2010 (EA 2010) safeguards individuals with a protected characteristic from
discrimination and harassment.61 Gender reassignment is a protected characteristic and
a person who is proposing to undergo or is undergoing gender reassignment is protected
from discrimination.
Consideration should be given to the employer’s procedure to ensure it reflects the
diversity of the gender spectrum in the population when making pregnancy enquiries.
The employer’s procedure should be in keeping with the wider trust/health board policy
on patient dignity and privacy.56 Tools such as information leaflets, posters and patient
questionnaires can be used to facilitate effective communication. The Sex Identity Gender
and Expression (SIGE) form may be adapted for use in the UK with minor modifications to
some of the terminology; for example, ‘Your doctor has referred you for an X-ray’.62,63
The GRA 2004 prohibits the disclosure without consent of protected information about a
person who has changed their gender. The referrer may not be able to provide information
on pregnancy status when there is a need to protect the confidentiality of a person’s
transitional status. The individual must consent to this information being shared.
Where a referrer, practitioner or operator is unaware of the possibility of pregnancy due to
the individual being unidentified/undeclared as a trans male, or where the individual has
not consented to the sharing of their gender identity or their childbearing potential, the
individual to be exposed has the sole responsibility for safeguarding the fetus. It is therefore
essential to provide every individual with adequate information relating to the benefits
and risks associated with the radiation dose prior to the procedure, as this gives them the
opportunity to ask questions and to declare any possibility of pregnancy. Table 13.2 includes
additional challenges that operators may encounter when making pregnancy enquiries.
Table 13.2: Challenges and additional considerations when making pregnancy

enquiries
Scenario Additional things to consider
Referrer § May not have asked the individual prior to

referral, or has not provided the information
Individual § May not be aware they are pregnant
Specific communication needs § Individuals lacking capacity

§ Individuals with sensory impairment (eg, deaf
or blind)
§ Individuals who speak an alternative
language
§ Sensitivity for individuals undergoing
treatment for cancer that may affect fertility
Variable cycle menstrual periods Menstrual cycle may not be regular:

§ Affected by illness (eg, anorexia or
hyperthyroidism)
§ Affected by chemotherapy treatment
§ Affected by other medical therapies that can
disrupt menstruation
Parent/guardian(s) present § Individual unwilling or afraid to answer

truthfully
Underage sexual activity § Legal consequences for those under 16

years (safeguarding process)
Concealed pregnancy § Vulnerable individuals (eg, possibility of

sexual abuse)
Scenario Additional things to consider
Religious or cultural beliefs § Individual unwilling or afraid to answer

truthfully (eg, unmarried individual)
Trans male or gender- § Using tools such as the SIGE form

nonconforming individuals
Breastfeeding
Individuals who are breastfeeding and require a nuclear medicine study need to be
advised of the risks to themselves and their baby. If they decide to proceed with the study,
consideration should be given to:
§ Delaying the test until they are no longer breastfeeding
§ Choosing an alternative radiopharmaceutical that is not secreted in breast milk
§ Ensuring the purity of the radiotracer.
Where the administration goes ahead, ARSAC guidance on breastfeeding interruption

times should be consulted with the aim of keeping the dose to the baby below 1mSv.21
Practical application
Individuals should be asked whether they might be pregnant. They are likely to respond with
‘No’, ‘Yes’ or ‘Not sure’. Table 13.3 includes possible actions to take following each response.
Examinations considered to be high dose, resulting in fetal doses of more than about 10mGy,
should be scheduled within the first ten days of the individual’s menstrual cycle (ten-day
rule). It is unlikely that an individual will become pregnant within the first ten days following
the start of a period. The employer’s procedures should clearly define the examinations
classed as high dose, where the ten-day rule should be used. Further information has been
produced jointly by the Health Protection Agency, the RCR and the SCoR.64
An example of a pregnancy enquiries flow chart can be found in Appendix 7.
The response to pregnancy enquiries must be documented as evidence that the
appropriate questions have been asked. If the individual chooses not to answer questions
relating to the possibility of pregnancy, this should be documented and local procedures for
unknown pregnancy status followed. The operator should inform the practitioner, who may
reconsider justification.
It should be noted that where there is no appropriate imaging alternative, an exposure may
be justified even when it is known the individual is or may be pregnant. A possible example
of this is in the case of major trauma. However, in all cases there is a requirement to follow
procedures. A specific procedure should be considered for the justification of exposures
during pregnancy, for example consultant-to-consultant referral.
Table 13.3: Possible actions to consider
Response Possible action
No § Proceed with the examination
Yes § Consider deferring the examination if not urgent

§ Consider another examination that involves less or no
ionising radiation
§ Operator to discuss the examination with a practitioner
and possibly an MPE to agree whether the exposure
could be further optimised, taking into consideration the
potential exposure of the fetus
§ Confirm the exposure is still justified and discuss with the
referrer if it can be deferred
Not sure § Determine whether the individual’s period is overdue

§ Consider deferring the examination if not urgent
§ If their period is not overdue then continue with the
examination unless it is a high-dose examination (see
below)
§ If their period is overdue, or they report a missed period,
they should be considered pregnant
§ Consider another examination that involves less or no
ionising radiation
§ Consider the use of an appropriate pregnancy test taking
into account the radiation risk to the fetus; the individual
must consent to pregnancy testing
§ If pregnancy testing is undertaken, the employer’s
procedure should include who does this, the training
required to perform the test and deliver the results, and
the facilities (including time) required to do so; guidance
is available on the use and accuracy of pregnancy
testing57,59,65,66
If the possibility of pregnancy is discovered before the exposure takes place, the operator
should alert the practitioner, who should reconsider justification of the exposure. The
practitioner may recommend delaying the exposure or suggest an alternative imaging
pathway.
All duty holders have a responsibility for the radiation protection of the fetus or
breastfeeding individual. Employers should develop procedures to mitigate accidental or
unintended exposures. If an unintended fetal exposure occurs, this may require notification
to the relevant enforcing authority in accordance with published guidance.67 IR(ME)R
applies to all individuals of childbearing potential.
14. Communicating the benefits and risks associated with an ionising radiation exposure has
Communicating always been recognised as a fundamental principle of diagnostic imaging, interventional
benefits and risks radiology and nuclear medicine services. In normal daily practice, duty holders have
conversations with patients with the intention of improving understanding of the benefits of
having the examination and providing information on the associated risks. The introduction
of Schedule 2(i), requiring an employer’s procedure for providing adequate information
relating to the benefits and risk associated with the exposure, formalises this recognised
practice. Information should be given, where practicable, to the individual being exposed or
their representative prior to the exposure.
Schedule 3 includes the requirement for IR(ME)R duty holders to have adequate training
on the benefits and risks of radiation and risk communication. It is recognised that
communication of the benefits and risk from radiation exposure can be quite challenging.
Individuals and/or their representatives may have difficulty processing information due to
an array of emotions, stress, confusion and worry. They may give greater weight to negative
information than to positive information being provided.68 Therefore, it is important to
ensure that the benefits of the exposure are clearly described along with the implications
of not having the examination. IR(ME)R duty holders may wish to reference the justification
process, emphasising that the examination is the most appropriate option to answer the
clinical question posed, has been tailored to the individual and that radiation doses are
optimised.
Information may be provided by a combination of IR(ME)R duty holders, such as referrer,
practitioner or operator, or it may fall to only one duty holder. The employer’s procedure
should specify how this information is delivered to ensure a consistent message is provided
across the patient pathway. This information will support the individual being exposed to
make an informed decision about the examination they are being offered.
The way in which this information is delivered will vary depending on the type of
examination, the individual being exposed, the diverse delivery of service provision, and so
on. The information can take various forms, such as posters,69 leaflets, verbal discussions
and appointment letters, or be part of written consent.
The employer’s procedure should outline a range of scenarios where different types of
information are provided. The method of communication and level of information provided
may vary depending on the complexity of the examination and the level of risk.70
Within Wales employers should ensure any information is made available in Welsh and
English to comply with the requirements of the Welsh Language Act 1993 and the Welsh
Language (Wales) Measure 2011.71,72 Table 14.1 lists examples of different communication
methods and things to consider when establishing an employer’s procedure.
Table 14.1: Examples of different communication methods when establishing an

employer’s procedure
Type of communication Things to consider
Verbal discussion § Staff training

§ Use of standard phrases to ensure consistent
message
§ Patient dignity, when choosing the location for
discussion
§ Sufficient time for questions
§ Availability of additional advice (eg, MPE)
Poster § Content of information

§ Placement and visibility of poster
§ Size of poster
§ Alternative languages
§ Invitation to discuss any concerns or request more
information
Appointment letter/ § Use of standard phrases to ensure consistent

information leaflet message
§ Invitation to discuss any concerns or request more
information
Written consent § Incorporation into the consent process for the

examination (eg, interventional/cardiology, theatres,
CT colonography)
The use of risk bands and ranges in Table 14.2 may help explain to the individual the level
of risk of cancer induction associated with the examination.73 It may be helpful for the
employer’s procedure to include simple phrases as examples for communicating this
information to the individual. Comparisons to natural background radiation exposure may
be considered as part of the approach to understanding risks.74 However, this concept
may not be familiar to everyone and may result in further questions. Natural background
radiation involves whole-body exposure, while diagnostic imaging exposures are more
localised.
Table 14.2: Examples of X-ray examinations divided into four broad risk bands for
cancer induction patients aged 30–60 years73
Risk band Risk range Typical type of X-ray examination
Negligible <1 in a million Radiography of chest, limbs and

teeth
Minimal 1 in a million to 1 in 100,000 Radiography of head, neck and

joints
Very low 1 in 100,000 to 1 in 10,000 Radiography of spine, abdomen

and pelvis
Low 1 in 10,000 to 1 in 1,000 CT, angiography studies of the

alimentary, biliary and urinary
tracts, and interventional radiology
Perceptions of radiation can vary widely among individuals, carers and comforters or their
representatives. It is the role of the duty holder to assess each individual and tailor the
information to their needs. It is important to translate medical terms into understandable
concepts, avoid medical jargon, speak in a concise manner and make sure the information
being given is understood. The individuals should be given the opportunity to ask questions
if they have concerns about the information being provided.
The employer’s procedure should be clear as to when to keep a record of any additional
information delivered. For example, this could be a verbal conversation with a concerned
patient, or involvement of the MPE where specific radiation protection information is
required based on the individual’s circumstances. The procedure should specify where this
is recorded (for example, on the referral form, the RIS, a consent form or the medical notes).
A pregnant woman arrives in the CT unit from the emergency department with a
suspected pulmonary embolism. The referring consultant discusses the patient with
the CT radiologist and they agree that the most appropriate examination due to the
level of urgency is a CT pulmonary angiogram. The referring consultant explains to the
patient the benefits of having the examination and associated low risk to both her and
her unborn child.
The patient is very unwell but is also distressed and worried about the risk from the
radiation to her unborn child and requests further information.
The radiologist justifying the referral explains in detail to the patient the benefits of
having the examination, the associated low risk from the exposure to her and her
unborn child, how the examination is optimised and the risk of not performing the
examination. The patient agrees to undergo the examination and signs the appropriate
documentation. The radiologist makes a record of the discussions on the RIS.
Table 14.3 includes additional situations for inclusion in the employer’s procedure.
Table 14.3: Additional situations for inclusion in employer’s procedure
Example situations for inclusion Things to consider

in employer’s procedure
Emergency trauma unconscious § No information provided to the

patient individual
Paediatric patients § Information provided to parent/

guardian
Additional advice is required § Contact details for support

(eg, radiologist or MPE)
Patient lacks capacity § Information provided to

representative
Patient with sensory impairment § Additional tools
Communication in alternative § Information leaflets in different

languages for local population languages
demographics § How to contact an interpreter
Regulation 12(6) requires, where appropriate, written instructions and information to

be given to patients (or their representatives) who are administered with radioactive
substances. An employer’s procedure on providing this written information is also required
[Schedule 2(h)]. A risk assessment will be needed, under both IR(ME)R and IRR2017, to
consider the risks to other persons who will be exposed. This should consider typical
scenarios and exposures to relatives, members of the public, other medical professionals,
care home staff, and so on, and should be used to inform the advice and written information
given to patients.
The written information should:
§ Provide advice on precautions to observe after the exposure to restrict the dose to
others the patient may come into contact with
§ Describe the risks from the exposure to other people
§ Be provided before the patient leaves the hospital
§ Include contact details for obtaining further information, such as the MPE.
In practice, written information leaflets are often sent to patients with their appointment
letters, including details of how to get further information.
15. While not defined in IR(ME)R a child is generally identified as a person under the age of
Children and 18. Different services may have different age cut-off points at an operational or service
young people level. Children, teenagers and young adults (defined as ages 0 to 24 years old) are often
considered together as a special group of patients in healthcare guidance.75
The IR(ME)R processes of referral, justification, optimisation and clinical evaluation are
the same for children and adults, as are the roles and responsibilities of the employer,
referrer, practitioner and operator. However, Regulation 12(8)(a) says that the practitioner
and operator must pay particular attention to the optimisation of exposures performed on
children.
Children carry greater risk of radiation-induced injury than adults, especially younger
children and girls. The benefits of a diagnosis should be considered in conjunction with the
increased risk to the child from ionising radiation, due to the rapidly growing and dividing
cells of children.
Regulation 11(1)(b) describes how all exposures must be justified to give sufficient net
benefit. Regulation 11(2)(a) requires that the specific objectives of the exposure and the
characteristics of the individual must be taken into consideration by the practitioner when
justifying any exposure. Practitioners must be aware of the normal variations of growth
and development and where conditions are restricted to childhood or present themselves
differently to that of adults.76
Consideration should also be given to alternative techniques that do not use ionising
radiation, such as the use of ultrasound as a primary imaging modality for children to
answer the clinical question of abdominal pain.
Therefore, specific medical conditions in childhood are not necessarily investigated and
managed in the same way as for adults. Some examples are:
§ The investigation of developmental dysplasia of the hip (DDH)77
§ Suspected physical abuse (SPA), previously referred to as non-accidental injury (NAI)78
§ Imaging of the chest for suspected infection; there are fewer indications for initial
imaging and follow-up in children (due to the different course and pattern of risk for the
child with chest infections)
§ Imaging trauma in children.79
When considering referrals for paediatric imaging, the justification process and protocols
used for adults may not necessarily be appropriate. Paediatric referral guidelines are
available.31 Where a practitioner issues authorisation guidelines, they should include
specific paediatric criteria to enable operators to authorise these referrals.
Imaging children poses distinct challenges.80 In certain circumstances, paediatric
examinations may have a better outcome if the child is supported by someone they know.
These individuals should be designated as a carer and comforter, and further information
is available in Chapter 16 (Carers and comforters). When providing an effective and quality
paediatric imaging service, consideration should be given to offering specific child-friendly
X-ray rooms. The room should be equipped with the necessary accessory equipment such
as immobilisation devices and, where possible, items for distracting the child during the
examination, such as toys, colourful lights or electronic devices.
It is important when imaging children that equipment used has the full range of dose
reduction features and, where possible, a broad selection of pre-programmed exposure
factors based on a range of ages or weights.16 Advice from MPEs should be sought to assist
in optimising protocols to ensure doses are kept ALARP. LDRLs should be established
for routine paediatric examinations, and where this is not possible, national or European
paediatric DRLs should be made available to staff.43
While patient anxiety, fear, lack of co-operation and inability to keep still are not exclusive to
childhood, the likelihood of practical difficulties in obtaining a radiological examination is
much greater.81 Experience and expertise are required when imaging the young.82 Gaining
the trust and co-operation of the child, with clear communication between the operator and
both the child and parent/guardian, will improve the probability of getting successful and
adequate diagnostic images first time.
To minimise the need for sedation, distraction strategies should be considered and, where
available, the involvement of play specialists. Additional considerations for optimising
paediatric exposures are included in Table 15.1.
Table 15.1: Things to consider when optimising paediatric exposures
Requirements Things to consider
Attention to optimisation of paediatric § Effective immobilisation

exposures § Collimation (rather than post-process
Regulation 12(8) image cropping)
§ Appropriate use of grids, focal spot
selection, AEC, and so on
§ Pre-programmed exposure factors
on all X-ray equipment
§ Use and development of paediatric
exposure charts (age and size
specific)
Adequate training § Specialist training programmes for

Regulation 17(1) operators and practitioners
Co-operation with other specialists § MPE involvement in paediatric

involved protocol development
Regulation 10(6) § Sharing of relevant information
§ Multidisciplinary team meetings
Carers and comforters § Adherence to dose constraints

Regulation 6(6) specified in employer’s procedures
Having specific paediatric protocols will support the operator in limiting the number of
views/phases; for example, a single AP projection for the investigation of DDH or single-
phase scanning for body imaging in CT. Consideration should also be given to image
quality and possible acceptance of noisier images if they will provide sufficient diagnostic
information for a lower dose of radiation.
Professional bodies and employers should continue to provide opportunities for staff
to receive continuous professional development and specialist training in paediatric
imaging.82
Emphasis should be placed on the appropriate use of high-dose examinations for children
such as CT or PET-CT, with a multidisciplinary approach to optimisation though groups
such as IOTs.16
Concerning nuclear medicine studies, it is important to liaise with parents/guardians
in advance of the scan to provide information and understand the child’s needs and
requirements. There should be consideration of whether sedation is required and whether
there are appropriate facilities for this locally.83 It is best practice to have a paediatric
cannulation service to enhance patient experience. Nuclear medicine and PET-CT
departments designed for adults often provide a poor environment for children, but a
few simple modifications and the involvement of play specialists can make a marked
improvement. Separate imaging protocols should be established for paediatric imaging;
these should be optimised and administered activity calculated according to the employer’s
procedures. Minimum administered activity values should be established. Paediatric
hybrid imaging protocols should also consider optimisation of the CT imaging. Guidance is
available from ARSAC and European Association of Nuclear Medicine (EANM).21,84
16. Carers and comforters are those who are knowingly and willingly exposed to ionising
Carers and comforters radiation while supporting an individual undergoing an exposure. Where radioactive
substances are administered, this will include exposure from support provided after the
administration. Typically, carers and comforters will be relatives or friends of the individual
exposed who help or give additional care to them. Not all relatives or friends of the patient
need to be designated as carers and comforters; many can be considered as members of
the public.
The definition of carers and comforters specifies that these individuals are not providing
support or care as part of their employment [Regulation 2(1)]. Exposures to professional
carers (for example, residential care home assistants or Macmillan nurses) should be
considered under the Ionising Radiations Regulations 2017.85
There is a requirement to have an employer’s procedure for the exposure of carers and
comforters [Schedule 2(n)]. The employer’s procedure should define when individuals may
be designated as carers and comforters, include relevant dose constraints and outline the
steps to be taken by IR(ME)R duty holders to identify such individuals.
There is no lower dose threshold to designate individuals as carers and comforters.
The radiation risk assessment for the examination should be used to identify standard
radiation protection precautions and any potential restrictions for nuclear medicine
procedures. Typical dose estimates and radiation protection precautions may be based on
published data.86 Where, due to the level of support and care provided, individuals cannot
comply with any precautions identified by the radiation risk assessment, they may need to
be designated as a carer and comforter. For clarity, it may be helpful to include guidance
on when relatives or friends of the patient do not need to be designated as carers and
comforters (for example, a friend driving a nuclear medicine patient home from hospital).
A person may be designated as a carer and comforter where they attend with an individual
and can therefore knowingly and willingly be exposed. The criteria in Table 16.1 should be
used to identify such individuals.
Table 16.1: Suggested criteria for carers and comforters
Criteria Examples
Individuals who provide During an exposure:

support and comfort to a § Being with a patient in an X-ray room, gamma
patient within a controlled camera room or PET-CT scanner room
or supervised area (where
§ Being present in the injection room during
access is normally restricted,
the administration of radioactive substances
or systems of work are in place
or staying with the patient during the uptake
to exclude members of the
phase of a PET-CT scan
public)
Schedule 2(n)
Criteria Examples
Individuals who provide Those who provide additional care:

support or care to those who § Help with standard daily tasks including
have been administered dressing, bathing and toileting
radioactive substances and
§ Parents who care for a child after returning
are not able or willing to
home from hospital
follow the usual instructions
regarding prolonged close
contact Those who are not able to follow usual radiation
Regulations 12(6) and 12(7), protection precautions:
Schedule 2(h) § Particularly relevant for molecular
radiotherapy where restrictions such as
sleeping apart for a period of time are often
given; a radiation risk assessment must be
carried out
The employer’s procedure may consider scenarios where the justification of the dose to the
carer and comforter may require particular attention, additional radiation protection advice
from the MPE and a lower dose constraint. Examples include:
§ Individuals who are pregnant would not normally be designated as carers and
comforters. It is preferable for a non-pregnant relative or friend to offer support instead,
but this may not always be practicable. The practitioner may seek the advice of the MPE,
who can undertake an appropriate risk assessment and evaluation of potential dose. If
the pregnant individual agrees to the exposure, this may be justified by the practitioner.
A reduced dose constraint may be appropriate for pregnant carers and comforters.
§ Children who act in a caring role would not normally be designated as carers and
comforters. Trust/health board procedures for consent should be followed to determine
whether children under the age of 18 years (or 16 years in Scotland) can ‘knowingly and
willingly’ consent to an exposure as a carer and comforter. The employer’s procedure
may require the exposure to these children to be individually justified by the practitioner
(rather than including these criteria in authorisation guidelines).
Normally, individuals who do not attend with the patient cannot ‘knowingly and willingly’
incur an exposure and therefore should be treated as members of the public. Guidance
is available on dose limits and setting dose constraints for members of the public.87
However, there are certain exposures, such as those arising from nuclear medicine or PET
procedures, where it may be possible to get prior written agreement from an individual to
be a carer and comforter, without attending with the patient. This type of situation is rare for
diagnostic administrations but may be more common for molecular radiotherapy, where
close contact restrictions are often given. Where this situation is anticipated, the process
should be described in the employer’s procedure and appropriately documented.
Regulation 19 provides a defence of due diligence. If a practitioner or authorising operator
has followed the employer’s procedure, and taken reasonable steps prior to the exposure of
the patient to identify any potential carers or comforters, then no employee has any duties
under the regulations or can be deemed to have been negligent, even if a carer or comforter
is identified after the exposure of the patient.
A two-year-old child requires a dimercaptosuccinic acid (DMSA) examination. The child

is accompanied by their father to the hospital. Prior to the exposure taking place, the
clinical technologist explains the procedure and discusses the exposure that the father
will receive in supporting his child during the examination. The child’s father is happy to
go ahead, and the clinical technologist authorises the exposure to the father as a carer
and comforter following authorisation guidelines.
On departure from hospital, the father is given written information to observe careful
hygiene when changing the child’s nappies. On return home, the child is cared for
by the mother for the rest of the day. The mother cannot be designated as a carer
and comforter as she has not been given the opportunity to ‘knowingly and willingly’
consent to the exposure. In this situation, the mother will receive a very low exposure,
and for radiation protection purposes, she is considered to be a member of the public.
The written information given under Regulation 12(6) provides advice for keeping the
dose to the child’s mother ALARP.
Exposures to carers and comforters require individual justification [Regulation 11(1)(b)]. The
justification and authorisation may be carried out by a practitioner; however, where this is
not practicable, these exposures may be authorised by an operator following authorisation
guidelines, as seen in Chapter 7 (Justification and authorisation). The person who acts as
practitioner or authorising operator for an exposure to a carer and comforter is the person
best placed to do this. This might not be the person who initially justifies and authorises
the exposure. A practitioner justifying exposures to carers and comforters does not need to
hold a practitioner licence as required under Regulation 5(1)(b). The practitioner must be a
registered healthcare professional and must be appropriately trained and entitled.
Specific matters that must be considered by the practitioner when justifying any exposure
(to the individual or to the carer and comforter) are outlined in Table 16.2 [Regulation
11(2)]. Additional considerations must be applied to the justification of exposures to
carers or comforters as detailed in Table 16.3 [Regulation 11(3)(b)]. Where authorisation
guidelines for carers and comforters are issued, the additional requirements of Regulation
11(3)(b) should be included. The requirements in both Table 16.2 and Table 16.3 must be
considered when justifying exposures to carers or comforters.
Table 16.2: Considerations for justification of an exposure
IR(ME)R Regulation 11(2) Things to consider
(a) The specific objectives § What is to be gained by carrying out the

of the exposure and the exposure?
characteristics of the § How may the outcome affect the care pathway/
individual involved management of the individual?
§ Previous imaging, medical history, age,
pregnancy or breastfeeding status, body habitus
§ For nuclear medicine exposures, any medication
the patient is taking and whether this will affect
the result of the investigation; medication may
need to be stopped prior to the investigation
(b) The total potential § What is the expected benefit of the exposure?
diagnostic or § Is the exposure likely to answer the clinical
therapeutic benefits question?
to the individual and
§ Will the individual’s treatment be altered?
society from the
exposure
(c) The detriment the § What is the likely dose from the exposure?
exposure may cause § What is the risk to the individual from that dose?
§ Nuclear medicine patients with caring
responsibilities, those who are hospital inpatients
and those who may have close contact with
other people after the investigation may require
additional radiation protection advice
§ Potential exposure to carers and comforters
(d) What alternative § How effective are any alternative techniques

imaging modalities are compared with the planned exposure?
available that could § Is the alternative available locally in a clinically
answer the diagnostic acceptable timeframe?
question but involve
less or no radiation?
Table 16.3: Additional considerations for justification of exposures to carers or

comforters
Regulation 11(3)(b) Things to consider
(i) Any likely health § Possibility of having a diagnosis or

benefits to the patient treatment, or knowing there is no underlying
being examined medical issue
(ii) Any possible benefits § Knowledge that a family member, partner,

to the carer or friend or dependant is receiving medical
comforter attention and will be able to have the
examination, with their support
(iii) The detriment the § What is the likely dose to the carer or
exposure may cause comforter from the exposure?
§ What is the risk to the individual from that
dose?
The employer’s procedure for providing information on the benefits and risks of exposures
should include information for carers and comforters [Schedule 2(i)]. Providing adequate
information prior to the exposure will allow carers and comforters to understand the
benefits and risks involved so that they may ‘knowingly and willingly’ incur the exposure
to themselves. This information should also include advice on precautions or measures to
keep the dose to the carer and comforter ALARP.
The way in which information is delivered will vary depending on the type of exposure
and can take different forms including verbal discussions, posters, information leaflets or
appointment letters. Further detail is provided in Chapter 14 (Communicating benefits and
risks). Local arrangements may include the use of a form or other documentation to record
the information given to or received from the carer and comforter, such as pregnancy status,
name and relationship to the individual exposed.
The employer must establish dose constraints for carers and comforters [Regulation
6(5)(d)(ii)]. The employer’s procedure should allow flexibility in setting appropriate dose
constraints to encompass the variety of circumstances involving exposure to carers and
comforters that may arise. Different dose constraints can be set for each modality. The
advice of the MPE should be sought when setting appropriate dose constraints.
The employer must establish guidance for the exposure of carers and comforters
[Regulation 12(5)]. The MPE should be involved in developing this guidance to provide
practical information to keep the exposure to the carer and comforter ALARP within the
dose constraint. This may include appropriate use of personal protective equipment (PPE),
advice on positioning within the room and guidance to be given to the carer and comforter,
including restrictions on close contact time or measures to minimise contamination for
patients administered with radioactive substances.
The requirements of Schedule 2(a) to have an employer’s procedure to correctly identify
the individual to be exposed does not apply to carers and comforters as there is no referrer
for an exposure to a carer and comforter and therefore no referral to check identification
against.
Table 16.4 summarises the requirements for carers and comforters and associated matters
to consider.
Table 16.4: Regulatory requirement for carers and comforters
Regulatory requirement Things to consider
Employer’s procedure § Process for designating individuals as

Schedule 2(n) carers and comforters
§ Documentation/records
§ Involvement of the MPE
Entitlement § Identifying appropriate individuals entitled

Schedule 2 (b) to act as practitioner for justification of
exposure to carers and comforters
Individual justification § Benefits and risks from the exposure to the

Regulation 11(1)(b) carer and comforter
§ Use of authorisation guidelines
§ Criteria for individual justification by
practitioner
Communicating benefits and § Information leaflets and posters for carers

risks and comforters
Schedule 2(i) § Non-standard situations where additional
written information for carers and
comforters is required
Establishing dose constraints § Dose constraints for standard scenarios

Regulation 6(5)(d)(ii) and risk assessments
§ Flexibility to set appropriate dose
constraints that cover non-standard
circumstances, where an individual risk
assessment is required
Guidance § Practical information to keep exposure

Regulation 12(5) below the dose constraint
17. The investigation of asymptomatic individuals falls into two distinct categories, and IR(ME)R
Health screening applies to both:
and individual health § Health screening [Regulation 3(b)]
assessment § Individual health assessments (IHAs) [Regulation 3(e)].
Those invited to participate in health screening programmes are asymptomatic (having no

clinical signs or symptoms of a disease) but are part of an apparently healthy target group or
populations who are deemed to be at increased risk from a specific condition or disease.
IHAs are used for those asymptomatic individuals who, based on their own personal
circumstances, may wish to seek reassurance by excluding unknown underlying disease. In
general, IHAs are not provided by NHS services.
National screening programmes

The UK National Screening Committee (UK NSC) advises ministers in the four UK countries
about national screening programmes. Their remit is to assess the evidence and decide if
the implementation of a national screening programme will result in more benefit than harm
at a societal and individual level. They do this by using strictly defined criteria and review
processes.88
National screening programmes are proactive, evidence-based, planned, resourced and
nationally co-ordinated. National screening programmes select participants from a local
population who may be considered to be at risk of a particular condition or disease. Those
selected receive an invitation to attend for a diagnostic test rather than seeking a referral
from their doctor.
National screening programmes provide clearly defined care pathways, which include
further investigation and treatment when required. An example of a national screening
programme involving exposures to ionising radiation is the NHS Breast Screening
Programme (NHSBSP).38
National screening programmes must follow all the requirements for IR(ME)R, including
justification, optimisation and training. There are some specific requirements for health
screening programmes and these are listed in Table 17.1.
Table 17.1: Requirements for health screening programmes
Justification for health screening § UK NSC recommendations

programmes must consider § Clear justification process
recommendations or guidelines from described in employer’s
‘medical scientific societies or relevant procedure
bodies’
Regulations 11(3)(a) and 11(3)(c)
Practitioner and operator must pay § National QA programmes are set

attention to optimisation for health and must be adhered to
screening programmes § Establish specific screening
Regulation 12(8)(b) protocols
A 52-year-old woman receives an invitation to attend the NHS Breast Screening

Programme for a mammogram. The woman is provided with an information leaflet
relating to the benefits and risks of the exposure prior to the appointment.89
During the identification and information process the operator discovers the patient
has breast implants. The local authorisation guidelines include criteria that individuals
with breast implants require additional views. The radiographer on the mobile unit is not
trained to perform these additional views. This is explained to the individual and another
appointment is arranged at the breast screening centre for the following week.
In this scenario, it was not possible for the operator (radiographer) to authorise and perform
the exposure on the individual. It is possible to screen women with implants on a mobile
unit, but on this occasion the operator was not trained to carry out these additional views.
Imaging of women with breast implants should only be undertaken by a trained and entitled
registered radiographer.90
Individual health assessment (IHA)

IHAs are directed at individuals rather than groups or populations. An IHA is defined as any
investigation involving exposure to ionising radiation on an asymptomatic individual wishing
to exclude any unknown underlying health issues.
In its 12th report, COMARE stated that services providing whole-body CT scanning
of asymptomatic individuals should stop doing so immediately.40 It went on to provide
recommendations that should be followed for CT scanning of asymptomatic individuals for
specified areas/conditions.
Any exposure made as part of an IHA must follow all the requirements for IR(ME)R,
including compliance with the employer’s procedures for referral, justification, optimisation
and evaluation, in the same way as any other medical or non-medical exposures.
A 45-year-old man is concerned that he may develop dementia as his brother has
recently been diagnosed with early onset dementia. He has no symptoms but is keen
to take preventative measures and wants to be sure there are no signs of the disease in
his brain. He enquires with an independent healthcare provider about the possibility of
a CT scan of his head for reassurance. He is asked to complete a comprehensive health
questionnaire, which is reviewed by a consultant neuroradiologist entitled as a referrer
and practitioner for this healthcare provider. The practitioner assesses the benefit to
this individual of identifying early structural signs of dementia against the risk of the
ionising radiation and recommends an MRI scan is done instead.
A 60-year-old male smoker who has no symptoms, but does have a strong family history
of coronary artery disease, wishes to check his health status. He carries out an online
search and finds a company offering coronary health assessments. The individual
organises an appointment and meets with a consultant cardiologist.
An extensive health questionnaire is completed and reviewed. The cardiologist who
is entitled as a referrer and practitioner for this company completes a referral for a
calcium-scoring CT scan. The same cardiologist also justifies the exposure after
weighing up the benefits and risk associated with the exposure. This information is
shared with the individual and the scan is scheduled for later that same day.
In the IHA scenarios described, the practitioner must consider all the requirements of
Regulation 11(2). This will include the characteristics of the individual, such as age, gender
and clinical history, the benefits and risks to the individual from an exposure and any
available alternative techniques that do not involve ionising radiation.
Justification of exposures for asymptomatic individuals

Justification of an exposure for an IHA may consider risk factors rather than symptoms.
Regulation 11(3)(c) states that the practitioner must justify the exposure as having shown
sufficient net benefit and must have regard in particular to any guidelines issued by
appropriate medical scientific societies, relevant bodies or the Secretary of State. This
applies to all asymptomatic individuals, including exposures for IHAs.6
Health screening programmes for an identified healthy population at increased risk of
a specific disease and individual health screening of asymptomatic individuals require
exposures to be justified and optimised in the same way as for other medical and non-
medical exposures. Health screening programmes are likely to come under the governance
of the NHS and have strict compliance criteria.
18. Non-medical imaging (NMI) exposures are defined as exposures that do not give a direct
Non-medical imaging health benefit to the individual undergoing the exposure. IR(ME)R applies to NMI exposures
exposures (using performed using medical radiological equipment designed and installed with the intention
of being used for medical diagnosis, treatment or screening of individuals.
medical radiological
equipment) Examples of NMI using medical radiological equipment are:
§ Assessment for employment purposes (occupational health checks)
§ Assessment for immigration/emigration purposes (visa application process)
§ Assessment for insurance purposes (medico-legal claims)
§ Assessment of radiological age (bone age hand X-rays)
§ Identification of concealed objects within the body (drug smuggling).
NMI exposures that use non-medical equipment, such as security screening at airports
and ports, are not covered by IR(ME)R. IR(ME)R does not apply to security screening within
prisons where this is carried out using non-medical equipment. However, IR(ME)R does
apply to any security screening using medical radiological equipment.
Where NMI exposures are performed, there must be an employer’s procedure
[Schedule 2(m)] describing the process to be followed by the duty holders involved with
these exposures. If NMI exposures are not performed by the organisation, the employer’s
procedure should clearly state this.
NMI exposures using medical radiological equipment must follow the IR(ME)R framework,
requiring referral by a registered healthcare professional, justification and authorisation.
Exposures need to be optimised taking into account the specific objectives of the
examination, such as a reduction in the number of views required. The availability of
previous imaging should be considered as part of the justification process.
Regulation 6(5)(c)(iii) says that the employer, where it is practicable (there are enough of
these examinations performed) must establish LDRLs for standard NMI exposures.
Regulation 6(4) requires the employer to ensure that written protocols are in place for every
type of standard NMI exposure carried out by the organisation. Consideration should also
be given to including a description of how NMI exposures may be identified by the operator
(for example, using a specific code on the RIS).
Table 18.1 provides some examples of practices involving NMI exposures, but this list is not
exhaustive.
Table18.1: Examples of non-medical imaging exposures
Non-medical imaging exposures Examples
Employment § Commercial pilots and air crew

Examinations may form part of pre- § Divers
employment medical assessments or § Miners
planned review to evaluate and monitor
§ Oil rig workers
individuals91,92
§ Heavy goods vehicle (HGV)
drivers
Immigration/emigration § TB screening
Many countries require individuals to
undergo chest radiography as part of the visa
application process
Insurance § Cervical spine X-ray for whiplash

Previously known as medico-legal exposures injury
Radiological assessment for age § Individuals seeking asylum in

Used in specific circumstances to determine the UK
the age of an individual who may be lacking
legal documentation
When justifying the examination, the
practitioner should consider the possibility
that the individual may be a child
Identification of concealed objects within § Individuals entering the UK

the body § Individuals in prison or custody
The individual may not have any clinical
symptoms and the purpose of the
examination is to identify internally concealed
drugs or objects
A solicitor sends a letter to the imaging department requesting a cervical spine X-ray
on a patient who is putting in a claim for whiplash injury following a car crash. The letter
is reviewed by a radiologist, who then arranges for the appropriate examination to be
undertaken. A referral is provided by the radiologist (as the referrer), who also justifies
and authorises the examination (as the practitioner). The operator performs the X-ray in
accordance with the written standard protocol for this NMI examination.
In this scenario, while it is the solicitor who has requested the exposure, they cannot be the
referrer under IR(ME)R as they are not a registered healthcare professional. The radiologist
who receives the letter completes a referral for the appropriate examination and will,
therefore, be the referrer and practitioner justifying the exposure.
A request for a CT scan of the abdomen and pelvis arrives in the radiology department.
It is initiated by a Border Force officer and is for an individual suspected of swallowing
packages containing drugs. The request is directed to a radiologist, who checks the
information complies with an agreed protocol, provides a referral and acts as referrer
and practitioner for this examination. The radiologist justifies and authorises the
examination and specifies the most appropriate scanning protocol to optimise the
individual’s radiation exposure.
In this scenario, if the individual was suffering symptoms that could be related to the
possible concealment of drugs within the body, this exposure would be for medical
purposes and not classed as a non-medical exposure. IR(ME)R applies to both types of
exposures.
19. An MPE has the knowledge, experience and training to provide advice on matters relating
The role of the medical to the physics of radiation exposures to patients and other individuals (such as carers and
physics expert (MPE) comforters or asymptomatic individuals). While the role of the MPE has existed for many
years, IR(ME)R formalises the requirements for MPE recognition, clarifies the role of the
MPE and requires the employer to appoint suitable MPEs to cover the type of work being
carried out. MPEs should be entitled as an operator in accordance with the employer’s
procedure.
MPEs are required to gain certification through a designated system; further details on this
process can be found on the RPA2000 website.19
Regulations 14(2) and 14(3) describe the role of the MPE and their required level of
involvement in service provision. Table 19.1 shows the different levels of MPE involvement,
which are determined by the hazard and risk associated with each type of practice. There is
guidance available for the employer to establish the required whole-time equivalent staffing
level for MPEs based on the services being provided.93
Table 19.1: Level of MPE involvement in each type of practice
Level of involvement
Closely Involved Involved as

involved appropriate
Radiotherapeutic practices
Standardised therapeutic
nuclear medicine (NM)
Type of practice
practices
Diagnostic NM practices
High-dose interventional
radiology and CT
All other radiological practices
The availability and proximity of the MPE should bear direct relation to the radiation risk
involved with the service provision. For example, an MPE for a non-standard nuclear
medicine therapy service should be readily available and normally employed at the site. An
MPE for a service providing only low-dose exposures (for example, general radiography
in a community hospital or low-dose nuclear medicine exposures in a research lab) could
be offsite. The MPE should have a greater level of involvement in high-dose diagnostic
radiology, such as interventional radiology, cardiology and high-dose CT. Arrangements
should be established and be well communicated between the MPE and staff in the
department, so that advice can be provided in a timely manner where necessary. These
arrangements should consider situations such as:
§ High-dose examinations on individuals requiring special consideration prior to the
exposure (for example, pregnant individuals)
§ Investigation and dose assessment following high-dose procedures (for example, skin
dose calculations following long and complex interventional or cardiac procedures)
§ When a fault is suspected with the equipment.
The MPE should be satisfied with the local control arrangements for the sites where they
are entitled.94 Staff need to be aware of how and when to contact their MPE. The MPE has
a wide remit, which can be broadly categorised as shown in Table 19.2. It should be noted
that the examples provided in this table are not exhaustive and that the role of the MPE will
vary depending on local requirements. Service agreements should clearly describe the
responsibilities of the MPE to ensure that all aspects of work are covered, and that work is
not duplicated.
Table 19.2: Examples of the roles of an MPE
Area Role examples
Equipment procurement and § Preparation of technical specifications and

commissioning installation design
§ Advice and input on equipment selection
Equipment management § Acceptance testing

§ Definition and performance of QA
§ Provision of advice following QA
§ Undertaking in-depth QA
Optimisation § Protocol development

§ Introduction of new and developing
techniques
§ Use of technological features and
reconstruction or image presentation
Dosimetry § Dose audits

§ Establishment of LDRLs
§ Radiation incident analysis including dosimetry
calculations
Regulatory compliance § Input to employer’s procedures and policies

§ Compliance audits
Area Role examples
Training § Local user QA

§ Radiation protection training for new staff
§ Update training for existing staff
The MPE should have knowledge and competence in all the above aspects of the role
relating to their own area of practice. The MPE must work collaboratively with IR(ME)R duty
holders, for example to ensure that exposures are optimised and image quality is adequate
to answer the clinical question.
There may be occasions when further advice from different experts is required to ensure
comprehensive radiation protection [Regulation 14(4)]. For example, a radiation protection
adviser (RPA) will advise on room design for a new installation and may perform a critical
examination on newly installed equipment. The MPE would also be able to offer advice
about features of the new equipment and perform commissioning and acceptance tests.
In nuclear medicine, the roles of MPE, RPA and radioactive waste adviser (RWA) are
required. For example, for the introduction of a sentinel node service in a theatre where
gamma probe QC is required, local rules need to be written and waste protocols developed
for theatres.
20. Regulatory requirements for medical radiological equipment were previously divided
Equipment and quality between the Ionising Radiations Regulations 1999 and IR(ME)R 2000.5,95 The equipment
assurance (QA) requirements in IRR2017 were revoked when IR(ME)R 2017 and IR(ME)R(NI) 2018 came
into force.
Regulation 15 in IR(ME)R sets out the requirements in relation to all equipment regardless
of when it was installed or brought into clinical service. Regulation 16 in IR(ME)R sets out
additional requirements for all equipment installed after 6 February 2018.
Equipment and the employer’s responsibilities

IR(ME)R details the duties of the employer in relation to any equipment that delivers ionising
radiation to an individual undergoing an exposure, as well as any ancillary devices that
can directly control or influence the exposure. This ancillary equipment may include, for
example:
§ CT contrast injector pump
§ Equipment used for gated examinations (for example, cardiac ECG leads)
§ Gamma cameras
§ Gamma probes
§ Radionuclide dose calibrators.
Equipment used for clinical evaluation (for example, reporting monitors) is not included as
ancillary equipment but should be included in the QA programme to ensure consistency
of set-up and image quality. Table 20.1 describes the employer’s duties in relation to
equipment.
Equipment QA refers to the planned system required to ensure that equipment performs
satisfactorily and in compliance with the regulations. This includes the actions necessary
to ensure that the QA system is working as it should, such as audit. Quality control (QC) is
one of the components of a QA programme and refers to operations carried out to improve
equipment quality such as testing, monitoring, evaluation and maintenance of equipment.
Table 20.1: Employer’s duties regarding equipment
Regulation 15 Things to consider
Implement and maintain an Arrangements for equipment QA including:

equipment QA programme § Types of tests
Regulation 15(1) § Frequency
§ Who is responsible for carrying out test
handover arrangements?
§ MPE involvement
Keep an up-to-date inventory of § Include all ancillary equipment that can

equipment directly influence the exposure
Regulation 15(2) § Remove equipment no longer in use
Regulation 15 Things to consider
Carry out testing of equipment prior § Programme for acceptance testing

to use for any medical purpose
Regulation 15(3)(a)
Carry out regular performance testing § Agreed programme for local routine QC
Regulation 15(3)(b) § Monthly, quarterly or annual medical
physics testing
Carry out testing following any § Procedure for informing of and

maintenance that may affect the co-ordinating testing with medical
equipment’s performance physics team
Regulation 15(3)(c) § Handover arrangements
Specify acceptable equipment § Record QC results

performance criteria, ensure § Define action levels
measures are in place to improve
§ Procedure to take equipment out of
inadequate or defective equipment
service
performance, and specify corrective
action to be taken in the case of § MPE involvement
defective equipment § Risk register
Regulations 15(6)(a), 15(6)(b) and § Image optimisation team
15(6)(c)
Equipment must have a device § MPE involvement in specification for

capable of automatically controlling fluoroscopy equipment
the radiation dose rate, such as an
image intensifier
Regulation 15(4)
Equipment must be capable of § MPE involvement in specification

providing an indication of radiation for interventional radiology and CT
dose delivered to the patient during equipment
any procedure
Regulation 15(5)
Regulation 16 includes the following additional requirements for equipment installed on or

after 6 February 2018:
§ All equipment that produces ionising radiation must be able to inform the practitioner
of parameters required for assessment of patient dose, such as an indication of DAP or
DLP [Regulation 16(6)(a)]. Where appropriate, such equipment must have the capability
to transfer this information to the person’s exposure record [Regulation 16(6)(b)].
§ All interventional radiology equipment must have a means of informing those
performing the examination, post exposure, of the amount of radiation produced during
that exposure [Regulation 16(3)].
§ All interventional radiology and CT equipment must be able to transfer dose information
to a person’s exposure record [Regulation 16(5)].
A multidisciplinary team approach to equipment management is essential. Table 20.2

describes things to consider throughout the life cycle of medical radiological equipment.
Table 20.2: Matters to consider throughout the equipment life cycle
Stage in the equipment life cycle Things to consider
Selection of equipment § MPE involvement

§ Procurement phase of equipment
selection
§ Assessment of dose optimisation
features on tendered equipment
§ Choice of the most appropriate
equipment to meet the service
requirements
Critical examinations § After initial installation

§ After major service or maintenance
where there may be radiation
protection implications (eg,
replacement X-ray tube or automatic
exposure controls (AECs))
Acceptance testing and baseline § Testing of equipment before clinical

performance testing use [Regulation 15(3)(a)]
Commissioning § Testing equipment before it is first

used
§ Setting up protocols and optimisation
of doses
§ Working with application specialists,
clinical leads and other relevant staff
Stage in the equipment life cycle Things to consider
QA programme § Testing equipment performance at

specified intervals and after major
maintenance
§ Extent of the QA programme
depending on the nature and range of
equipment in use
§ Definition of acceptable performance
criteria [Regulation 15(6)(b)]
§ Reporting processes (eg, equipment
faults, incidents)
Maintenance § Performance testing on a regular basis

[Regulation 15(3)(b)]
§ Employer’s procedures for accepting
equipment back into clinical use
following service or maintenance
[Regulation 15(3)(c)]
Inadequate or defective equipment § Assessment of aging equipment

resulting in the doses from medical
exposures being significantly greater
than local or national DRLs or
degradation of image quality
§ Escalation process for dealing with
inadequate or defective equipment
[Regulations 15(6)(a) and (c)]
Equipment QA programme
Regulation 15(1)(a) and Schedule 2(d) require the employer to have employer’s procedures
in place to ensure that equipment QA is implemented and maintained. Regulation 14(3)(b)
states that an MPE must contribute to defining the equipment QA programme. How this is
achieved will depend on the type of equipment and local agreements regarding who will
be responsible for specific tests.96 The advice of an MPE should be sought when reviewing
results of such QC testing that are out of tolerance. More detail can be found on the
involvement of the MPE in QA programmes in Chapter 19 (The role of the medical physics
expert).
Information and guidance on ionising radiation equipment QA and QC testing can be found
in the report series published by IPEM.97
The operator has a specific responsibility to consider QA and QC when ensuring that
exposures are ALARP [Regulation 12(3)(a)]. Table 20.3 provides examples of what should be
considered for inclusion in an equipment QA programme.
Table 20.3: Examples for inclusion in an equipment QA programme
When to test § Frequency of standard testing (eg, annually,

monthly)
§ Following an engineer’s visit (unless no impact on
dose or image quality)
§ Following fitting of a new part
Who will test? § Radiographer or clinical technologist (eg, daily or

monthly tests, post engineer visit)
§ Medical physics
Prior to external testing § Equipment handover (eg, the Association of

(eg, faults, servicing) Healthcare Technology Providers for Imaging,
Radiotherapy and Care (AXREM) form98)
§ Examine equipment log for known issues and
previous engineers’ reports
During testing § Specific tests for each equipment type

§ How to set up specific tests, including distances,
exposure parameters and position of phantoms
§ Record results
§ Ensure tolerances available
§ Record of assessment of results against tolerances
After testing § Report any issues verbally and/or in writing to

appropriate person (eg, MPE, lead radiographer,
QA lead)
§ Detail actions required (eg, seek MPE advice,
repeat test, remove equipment from service)
§ Record any actions taken and return to service
§ Equipment handover (eg, AXREM form)
Review and improvement § Review results to demonstrate performance over

time
§ Record of faults and corrective actions
§ Training records of those performing QC
Equipment inventory
The employer must keep an up-to-date inventory of all medical radiological equipment,
including ancillary devices, that can directly control or influence the exposure [Regulation
15(1)(b)] at each site. This inventory must be readily available on request by the enforcing
authority and must include [Regulation 15(2)]:
§ Name of manufacturer
§ Equipment model number
§ Serial number or another unique identifier
§ Year of manufacture
§ Year of installation.
This information is often stored electronically (for example, by the medical equipment
management department if there is one). The equipment inventory should be reviewed on
a regular basis and updated when new equipment is installed or when equipment is no
longer in use or is decommissioned. Consideration could be given to making some of this
information (for example, age of equipment) available to the public upon request.
21. The use of consistent terminology when discussing radiation errors and incidents is
Accidental or essential to assist reporting and analysis.99,100 Within this chapter, the following terms are
unintended exposures used:
§ Event: Something that happens to or involves a patient or individual.
§ Error: A failure to carry out a planned action as intended or an application of an
incorrect plan. Not all errors lead to radiation incidents (for example, where the error is
detected before the individual is exposed).
§ Radiation incident: An error where the delivery of radiation is different to that intended
and which could result in unnecessary harm to the patient.
§ Near miss: A potential radiation incident that was detected and prevented at any point
before an exposure takes place.
Errors, radiation incidents and near misses should be locally reported through incident
management systems (for example, Datix, Ulysses). Significant radiation incidents that meet
criteria established by the IR(ME)R enforcing authorities must be notified to the relevant
enforcing authority.
Accidental or unintended exposures

IR(ME)R defines the terms accidental exposure and unintended exposure in Regulation 2.
The Regulations require the employer to provide a system for analysis, recording and
reporting of accidental or unintended exposures [Regulation 8(3)]. The regulations
differentiate between significant accidental or unintended exposures (SAUE) and clinically
significant accidental or unintended exposures (CSAUE). Regulation 8(1) requires the
referrer, practitioner and individual exposed or their representative to be informed of a
CSAUE. Exposures that are CSAUE and those that are SAUE must be notified to the relevant
enforcing authorities. IR(ME)R applies to radiation incidents that involve either equipment or
procedural failures.
Significant accidental or unintended exposures (SAUE)

These exposures are significantly greater than intended. The relevant enforcing authorities
have published joint guidance on notification thresholds and requirements for SAUE.67 The
regulations require that SAUEs are notified to the relevant enforcing authorities.
Clinically significant accidental or unintended exposures (CSAUE)

The Department of Health and Social Care (DHSC) guidance to IR(ME)R does not define
CSAUE and the DHSC has asked the clinical and medical professional bodies to provide
further guidance on this topic.6The following guidance aims to fulfil this request.
The requirements of IR(ME)R are consistent with the duty of candour and the need to
conduct clinical practice in an open and transparent manner.101 The definition of moderate
harm required to trigger the duty of candour has been used as the basis for the following
guidance.102 For stochastic effects, a pragmatic definition in terms of the probability of
radiation-induced cancer has been employed as it is not possible to directly align these
effects with a definition given in terms of severity of harm.
The National Reporting and Learning System (NRLS) (now part of NHS Improvement
(NHSI)) defines events that cause moderate harm as:
Any unexpected or unintended incident that resulted in a moderate increase in
treatment, possible surgical intervention, cancelling of treatment, or transfer to another
area, and which caused significant but not permanent harm, to one or more persons
receiving NHS-funded care.103
It is important to note that justified exposures, where it is known in advance (or becomes
apparent during an exposure) that an adverse outcome may occur, are not CSAUE under
IR(ME)R. An example is an interventional procedure where the practitioner continues to
expose the patient past the dose threshold (alarm) recognising that skin erythema will
occur but who makes the clinical decision that continuing with the procedure is in the best
interests of the patient. In making this decision, the practitioner must weigh up the dynamic
risk of potential skin erythema against the clinical risk of stopping the procedure.
An example of a radiology-related moderate harm incident from the NRLS is that of a broken
foot not detected on X-ray, resulting in the patient being sent for extensive physiotherapy
with a consequence of further pain and damage.103 This example would trigger a
requirement under duty of candour, but, as there is no increased dose and the exposure
was delivered as intended, this is not a CSAUE under IR(ME)R.
Stochastic effects
A CSAUE is defined as an accidental or unintended exposure to ionising radiation that
results in a 0.1% (1 in 1,000) or greater lifetime radiation-induced cancer risk. This is
consistent with the Chief Medical Officer’s report of 1995,104 which introduced risk
classification levels and defined ‘moderate risk’ as a lifetime probability of death or adverse
response of 1 in 1,000. The risk calculation should only assess the risk from the additional
accidental or unintended exposure.
For fetal exposures where the pregnancy was not known about, a 0.1% (1 in 1,000)
or greater risk of radiation-induced childhood cancer is considered a CSAUE. This is
consistent with the threshold for the highest childhood cancer risk group defined in
previous advice on radiation protection of pregnant patients.66
The MPE must contribute to incident analysis [Regulation 14(3)(f)]. Dose and risk estimates
for potential CSAUEs should be calculated by an MPE using age- and sex-appropriate
cancer risk factors.66,105 Consideration should be given to the lowering of lifetime radiation-
induced cancer risk associated with subjects with a reduced life expectancy, such as a
patient on a palliative care pathway. The MPE assessment of stochastic risks may result in
an incident being classified as a CSAUE despite the thresholds for SAUE under Regulation
8(4) of IR(ME)R not being met. At the time of producing this document, the SAUE guidance
requires all CSAUEs to be notified to the relevant authority.67
Deterministic tissue injuries

A CSAUE is defined as an unjustified exposure to ionising radiation greater than:
§ 0.5Gy to the lens of the eye106
§ 0.5Gy to the heart or brain106
§ 5Gy dose to skin including backscatter for skin reactions (for example, erythema for
more than two weeks, more severe skin reactions and permanent partial epilation);107
extravasation of some radiopharmaceuticals with long half-lives, such as 201Tl or 131I,
may result in skin doses greater than 5Gy; this is particularly relevant for therapeutic
administrations of radiopharmaceuticals
§ 50mGy to the thyroid following the administration of a radiopharmaceutical where there
has been a failure in the thyroid blocking procedure.
Psychological harm
The definition of ‘harm’ in the NRLS guide to good practice includes physical and
psychological harm.103 It is important to recognise that individuals may react differently to
being informed about an accidental or unintended exposure. This can be influenced by
many factors including:
§ The magnitude of the exposure
§ The age of the individual
§ The mental health of the individual
§ Whether the individual is pregnant or trying to conceive
§ The information provided following an analysis of the accidental or unintended
exposure (what they are told)
§ How the news of the accidental or unintended exposure is delivered (how they are told).
In rare circumstances, an accidental or unintended exposure may be a CSAUE if it affects

the individual’s quality of life to a level that requires intervention or treatment.
Regulation 8(1) requires that in the case of a CSAUE, the employer’s procedure [Schedule
2(l)] must set out the process for informing the referrer, practitioner and individual involved
or their representative when a CSAUE has occurred and provide information on the
outcome of the investigation of the incident.
Good practice will include the requirements of Schedule 2(l) within a comprehensive
radiation incident and near miss reporting procedure. Table 21.1 includes things to consider
for inclusion in a comprehensive employer’s procedure.
Table 21.1: Employer’s procedure for local incident reporting, investigation and
external notification
Area Things to consider
Preliminary § How and when duty holders identify, record and report
investigation events
process § Mechanism for local reporting
§ Specify information required to determine what
happened, where and when it happened, and the staff
involved
§ Immediate action to ensure the event is not repeated
(eg, equipment taken out of service)
§ Identify those responsible for managing the internal
escalation process (eg, the radiation protection
supervisor (RPS) or senior site lead)
§ Involvement of the MPE (eg, estimation of

overexposure)
§ External notification thresholds and timescales (eg,
SAUE Guidance,67 CSAUE definition)
§ Identify responsible person for notifying the relevant
enforcing authority (where required)
Detailed § Identify root causes and contributory factors

investigation § Remedial action to prevent or minimise similar
process recurrence
§ Provide exposure factors to estimate doses involved, to
allow the MPE to calculate the risk to the individual(s)
exposed
§ Establish if any other individuals may be similarly
affected
§ Trend analysis and comparison with other similar errors
§ Systems analysis and effectiveness of current safety
barriers
§ Report on what actually happened and compare with
what should have happened
Clinically significant § Estimation of dose delivered and risk to individual

accidental or exposed
unintended § Involvement of the MPE
exposures (CSAUE)
§ Informing the individual exposed or their representative,
the referrer and practitioner
Informing the § Identify the person responsible for informing the

individual exposed/ individual exposed or their representative
representative, § Record of information provided, and discussions held
referrer and
§ Record of a decision not to inform the individual
practitioner
exposed, including detailed justification
Analysis of events § Coding and classification of incidents or errors108

§ Systematic analysis of incidents or errors, as part of a
no-blame safety culture
§ Lessons learned, including identifying areas that
require review and improvement and informing of
changes to practice
§ Communicate and share learning themes to all
stakeholders within the organisation
When individuals are informed of errors and an explanation of the risks is given, it is
advisable to consider risks in broad categories.102,105 Employers may need to consider
appropriate training of duty holders and it may be helpful to develop supporting documents
to aid this process. Further details on communicating risk information can be found in
Chapter 14 (Communicating benefits and risks).
It is considered good practice for all near misses and errors to follow the same process, so
any lessons learned can be applied and may prevent an error from occurring. The process
of investigation should be standardised.
Regulation 8(4) sets out the process the employer must follow when it is believed an
accidental or unintended exposure has or may have occurred:
§ Carry out a preliminary investigation
§ Immediately notify the relevant enforcing authority in accordance with SAUE guidance67
§ Carry out a detailed investigation including assessing the potential dose received
§ Notify the relevant enforcing authority of the outcome and corrective actions.
Guidance is available from the enforcing authorities on situations where radiation incidents
should be notified to them, along with appropriate timescales for notification.67 Notifications
to the relevant enforcing authority should include contact details of an individual who can
provide further information as required. Such an individual should have a senior position in
the department involved, to ensure the correct information is made available. Notifications
should not include information that could identify the patient or staff involved.
IR(ME)R is enforced by different organisations across the UK:
§ In England, the enforcing authority is the Care Quality Commission (CQC)
§ In Northern Ireland, the Regulation and Quality Improvement Authority (RQIA) is the
regulator for inspection and enforcement of IR(ME)R (Northern Ireland) 2018
§ In Scotland, the Scottish Ministers delegate the powers to inspect compliance with
IR(ME)R to Healthcare Improvement Scotland (HIS)
§ In Wales, the Welsh Ministers ensure compliance with IR(ME)R through an operationally
independent part of the Welsh Government, Healthcare Inspectorate Wales (HIW).
Where the incident cause relates to equipment malfunction, other enforcing authorities
should be notified; for example, the Medicines and Healthcare Products Regulatory Agency
(MHRA) in England and Wales, Health Facilities Scotland in Scotland and the Northern
Ireland Adverse Incident Centre in Northern Ireland.
It is important that everyone involved in the analysis, reporting and notification of accidental
or unintended exposures understands the value of the process and actively contributes so
that learning can be shared and patient safety improved.109
System for recording analyses of events

Regulation 8(3) requires the employer to put in place systems for recording analyses of
events, proportional to the risks involved. Such systems must address both near misses and
errors.
Most errors or near misses are not just a series of random unconnected events. They may
be linked to poor systems, processes or culture. They often have common root causes,
which when recognised can be grouped together thematically and addressed. Although
each event is unique, there are likely to be similarities and patterns that may go unnoticed if
events are not reported and analysed. Guidance for coding and classification of errors and
near misses is available.108
Documentation relating to errors and near misses should be retained in line with relevant
guidance.110 Clinical departments should keep records of errors and near misses. These
should be made available to all staff to facilitate learning and support safer working.
Safety culture
Safety in healthcare is recognised as being about maximising the things that go right for
patients and minimising the things that go wrong. A systems approach to safety considers
multiple factors rather than apportioning individual blame.111
Staff are more likely to report errors or near misses where there is an open, blame-free
reporting culture and where the clear aim of reporting is to learn and to improve patient
safety. An increase in the reporting of events is not necessarily an indication of worsening
patient safety; it may indicate an increasing level of awareness of safety issues among
healthcare professionals and an evolving reporting culture within an organisation.
Employers should share the outcomes of analyses with all relevant staff and apply lessons
learned to mitigate these events in future.
Schedule 2(k) requires the employer to have an employer’s procedure to identify how the
probability and magnitude of accidental or unintended exposures are reduced. Table 21.2
provides examples for consideration of areas to include in this employer’s procedure.
Table 21.2: Employer’s procedure to reduce the probability and magnitude of

accidental or unintended exposures
Optimisation § Modality-specific training

§ Use of DRLs
§ Peer review of images to assess image quality,
positioning, collimation, and so on
§ Image optimisation teams (IOT)
§ MPE involvement
Communication § Effective communication with the patient to facilitate

compliance during the examination
§ Communication with all duty holders to share learning
themes and promote compliance with the employer’s
procedures
§ Communication with safety and governance committees
Audit § Audit of appropriateness of referrals and justification

§ Audit of adherence to ID process
§ Monitoring of compliance with employer’s procedures
QA programmes § Robust QA programme for documentation and equipment

§ Procedures and protocols are documented, regularly
reviewed and monitored through a robust programme of
internal and external audit
Training § Training for all duty holders, with supporting evidence of

programmes competence once training is complete, and ongoing CPD
Error and near § Analysis of trends to identify any need for change in
miss analysis practice or procedure or a need for further training
§ Shared learning internally or across a trust or health board
22. Regulation 5 requires employers and practitioners who administer radioactive substances
Nuclear medicine to hold a valid licence. Each employer licence is specific to the site where administrations
licensing will take place and lists the authorised procedures (examinations) that may be carried
out for diagnostic, therapeutic and research purposes. Each practitioner licence lists the
authorised procedures that may be justified by the named licence holder for diagnostic,
therapeutic and research purposes.
Applications for licences are assessed by the ARSAC and issued by the appropriate
licensing authority.94 Regulation 2 defines what the appropriate licensing authority is for
employers and practitioners in England, Scotland, Wales and Northern Ireland. These are
listed in Table 22.1.
Table 22.1: Licensing authorities in the UK
Employer licensing Practitioner licensing

authority authority
England Secretary of State Secretary of State
Scotland Scottish Ministers Secretary of State
Wales Welsh Ministers Secretary of State
Northern Ireland Department of Health Department of Health
Employer licences
Employer licences are required at each site where radiopharmaceuticals are administered.
Employers are responsible for the safe administration of radioactive substances and hold
additional responsibilities such as establishing appropriate procedures, protocols and
QA systems [Regulation 6], entitlement of duty holders [Schedule 2(b)], management of
equipment and providing adequate facilities for administration [Regulation 15]. Licence
applications require the employer to demonstrate compliance with IR(ME)R.
Practitioner licences
Practitioner licences are required in addition to the employer licence. The practitioner
licence details the procedure codes that the practitioner may justify, and this may
be considered as part of the practitioner’s scope of practice. Individuals who hold a
practitioner licence must be entitled as practitioners in accordance with the employer’s
procedure. Where practitioners work at multiple sites or for multiple employers, their local
entitlement should be clear.
There is no reciprocal recognition of practitioner licences between Great Britain and
Northern Ireland. If a practitioner moves between Great Britain and Northern Ireland they
will need to apply for a new licence. Within Great Britain, practitioners may move between
England, Wales and Scotland and practise under the same licence.
In order to carry out a procedure (examination), the relevant procedure code must be
included on both the employer and practitioner licences for the same purpose.
A practitioner holds a licence for the full range of diagnostic nuclear medicine
procedure codes listed in the ARSAC Notes for Guidance. The licensed practitioner is
entitled by an employer at two hospital sites of a trust/health board, one of which has a
PET-CT scanner. At the site with the PET-CT scanner, the practitioner is entitled to justify
the full scope of procedure codes on their licence, but at the other site they are only
entitled to justify the non-PET procedure codes listed on their licence.
Detailed guidance on how to apply for a licence is provided by ARSAC.21
Licensing for research involving radioactive substances

Research involving the administration of sealed or unsealed radioactive substances
requires approval from ARSAC [Regulation 11(1)(d)]. Details of the approval process are
provided in Chapter 23 (Research).
ARSAC research approvals specify the approved procedure codes for each trial. To take
part in a research trial, the approved procedure codes for the study need to be held on both
the employer and practitioner licences for the purposes of research. If these procedure
codes are not held, the licences should be amended appropriately following ARSAC
guidance.21
Administration of other prescription-only medicines (POM) as part of a nuclear

medicine procedure
Regulation 240 of the Human Medicines Regulations 2012 allows IR(ME)R operators to
administer other medicines as part of a nuclear medicine procedure, such as diuretics as
part of a renogram or iodinated contrast as part of a PET-CT study.112 Certain conditions
need to be met prior to administration of the medicine:
§ The POM is administered by an operator in accordance with the protocol
§ The exposure is authorised by a practitioner or an operator following authorisation
guidelines
§ The practitioner holds a licence for the administration of the radioactive substance
§ The POM is not a product subject to special medical prescription
§ The administration of the POM is included in the protocol.
This regulation permits operators who are not registered healthcare professionals to
administer POMs, but each operator must also be trained and entitled to do this according
to the employer’s procedure.
23. IR(ME)R contains a number of research-specific requirements that must be met in addition
Research to those that apply to all medical and non-medical exposures. Table 23.1 lists examples of
the requirements and things to consider when carrying out research examinations.
Table 23.1: Additional requirements for research exposures
Regulations Requirements
Licensing § Appropriate employer and practitioner licences must be

Regulations 5 and in place prior to commencing research trials involving the
11(1)(a) administration of radioactive substances
Regulation 6(5)(d)(i) § Dose constraints must be in place for individuals taking

part in research trials where no direct medical benefit is
expected
Justification § All research trials must be approved by a recognised

Regulation 11(1)(d) research ethics committee (REC) before commencing
§ All research trials involving the administration of
radioactive substances must be approved by the ARSAC
Optimisation § Individuals concerned must participate voluntarily

Regulation 12(4) § Individuals must be told in advance about the risks of the
exposures
§ Dose constraints must be adhered to
§ Individual target levels of dose must be planned where the
participants are expected to receive a medical benefit
The employer is also required to have in place an employer’s procedure regarding

exposures involving ionising radiation for research purposes [Schedule 2(g)]. Table 23.2
lists the requirements under the regulations and gives some examples of how the written
procedure could describe how they may be addressed in practice.
Table 23.2: Considerations for inclusion in employer’s procedure on research
Requirement Things to consider
Approval by a recognised § Brief description of how the local research and

REC and ARSAC development approval process ensures that
(administration of REC and, where applicable, ARSAC approvals
radioactive substances) are in place
Practitioner and employer § Process to ensure that appropriate licences are

licences held to cover all administrations of radioactive
substances required by the research trial
Requirement Things to consider
Individuals participate § Clear description of the research consent

voluntarily process
§ The process for individuals who are unable to
consent (eg, paediatric patients)
Individuals informed in § Participant information sheet (PIS)

advance about the risks of § Radiation risk information within the PIS should
the exposure follow guidance from the Health Research
Authority (HRA)113
Dose constraints or dose Description of how a dose constraint or a dose

targets target is set for each research trial:
§ Dose constraints must be in place for research
trials where no direct medical benefit is
expected (eg, studies on healthy volunteers)
§ Dose constraints must be established
for all research trials involving standard
radiodiagnostic procedures
§ Dose targets must be established where direct
patient benefit is expected (eg, experimental
diagnostic or therapeutic practices)
Setting a dose constraint Description of how the local dose constraint is set:
§ When the research protocol and the total
research protocol dose (TRPD) has been
centrally reviewed and calculated (eg, through
the HRA radiations assurance process), there
may be situations where it is not appropriate to
use the TRPD as the local dose constraint
§ Local dose constraints should be optimised
and reasonable variations in local practice (eg,
available equipment) taken into consideration
Dose constraints are § Periodic dose audits, if applicable

adhered to
Setting dose targets § Description of how local dose targets are set
and whether these are set at a trial or individual
level
The HRA defines exposures to ionising radiation as ‘research exposures’ where both the
following criteria are met:114
a. The exposure is required as an integral part of, and for the purpose of, the research. This
specifically includes:
i. Exposures undertaken prospectively to confirm the eligibility of potential
participants in the research trial and/or to provide (qualitative or quantitative) data
regarding disease status at baseline; and/or
ii. Radiotherapy as part of a treatment strategy to which patients are assigned
prospectively by the protocol, as part of either an experimental or control arm, and
which will be evaluated by the research trial; and/or
iii. Exposures undertaken at formal time points within the research protocol schedule
to assess disease status or response to treatment; and/or
iv. Exposures where there are clear requirements as to how they should be conducted
(for example, machinery to be used, imaging slice thickness); and/or
v. Image-guided procedures undertaken while the patient is enrolled in the research
trial.
b. Consent for the exposure is sought from potential participants as part of their consent to
take part in the research (including screening for eligibility).
Exposures that meet these criteria are research exposures, even where they are part of
normal clinical care and there are no ‘additional’ exposures. Exposures that are mandated
by the protocol and would be additional to the standard of care should be identified and a
dose constraint applied. Information relating to standard of care and additional exposures
should be available in the approved study documentation. A local review process should
ensure that the study documentation is satisfactory and that the local centre can comply
with the dose and risk estimations made in the approved study documentation.
Further guidance and typical examples are available from the HRA to help determine
whether a research trial includes research exposures.114
A study seeks to gain further data on the safety, performance and efficacy of a CE-
marked cardiac stent already established as standard treatment at participating
centres. Patients have fluoroscopy-guided insertion of the stent as standard clinical
practice. The research protocol specifies that the examinations are conducted
according to a standard of care at each centre and the data is collected for the purposes
of the research, but the research protocol does not specify any conditions on the data
(for example, the acquisition parameters).
The exposure in this scenario is not a research exposure. The examination is justified and
authorised as part of normal clinical care and not for the purpose of the research. Consent
to undergo the exposure is not part of the consent to participate in the research trial.
A randomised controlled trial will assess the efficacy of a novel chemotherapy agent in
comparison with the standard regime for patients with advanced ovarian cancer. The
research protocol requires patients to have CT scans after one month, three months, six
months and thereafter six-monthly until disease progression is in line with the standard
of care. A radionuclide bone scan will be performed to check for metastatic disease
prior to treatment and, if positive, this will be repeated at six-monthly intervals.
In this scenario, the CT scans and bone scans are research exposures (even though
they would be standard care outside the research trial). They are needed to assess the
endpoints of the research and are an integral part of the research protocol. The research
protocol gives clear information as to how the exposures should be conducted. It specifies
the frequency, administration, method, processing or clinical evaluation of the exposures,
including specifications of machinery to be used.
Approval and authorisation

Ethics committee approval
Before any research involving exposures to ionising radiation can go ahead, the research
study must be approved by a research ethics committee (REC). Further detailed guidance
is available from the HRA on how to apply for REC approval.114 This guidance includes a
number of typical examples where questions could arise about whether the trial involves
research exposures.
ARSAC approval
Research involving the administration of sealed or unsealed radioactive substances will
require approval from ARSAC. Research sponsors are responsible for obtaining ARSAC
approval. Detailed information on this process can be found on the ARSAC website.94
ARSAC research approvals will specify the approved procedures in the study.
Ethics committee and ARSAC approval does not automatically mean that all the research
exposures included in the study have been justified and authorised on an individual
level. These are separate activities. The practitioner may take into account the ethical
considerations regarding the study population, but the individual characteristics of each
patient, including contraindications, must also be considered.
Licensing
Appropriate employer and practitioner licences are required prior to commencing a
research study involving the administration of radioactive substances. The procedure
codes approved for the study need to be held on both the employer and practitioner
licences for the purposes of research. If these procedures are not held, the licences should
be amended appropriately following ARSAC guidance.94
Practical considerations
IR(ME)R requires employer’s procedures to provide safeguards for medical and biomedical
research trials. It is important that radiology and nuclear medicine staff can identify those
exposures that are for research purposes. This can be achieved in several ways, such as by
selecting a drop-down menu on the RIS or using a specific study code on the referral. These
processes should be described in the employer’s procedures. A list of current trials should
be made available to staff within radiology and nuclear medicine departments.
A specific protocol is required for each research trial and these should be readily available
to staff. This should include:
§ The dose constraint or dose target for all research exposures as appropriate
§ The number, type and timings of required exposures
§ The imaging protocol.
It may be helpful to consider having a radiology or nuclear medicine research file, network
drive or specified intranet location where all documentation can be easily accessed. Other
useful information should be stored including contact details of the local research team
members, the principal investigator, the expected end date of the research study, a copy of
all relevant approvals, including those from the ethics committee and ARSAC, and relevant
employer and practitioner licence information.
The employer’s procedure should also describe how referrers must identify research
exposures to enable staff to recognise the referral as research. This in turn enables the
practitioner and the operator to select the correct protocol for the research study.
Where the exposures in the whole study have been approved by the REC, HRA and ARSAC,
and contain information approved by a lead MPE and clinical radiation expert, a practitioner
under IR(ME)R should justify and authorise each exposure. Consideration should be given
to local processes for how this can be achieved.
Regular communication between the radiology department and/or the nuclear medicine
department and the research team is encouraged.
This document was approved by the RCR Clinical Radiology Professional

Support and Standards Board on 31 January 2020.
This document was approved by the Institute of Physics and Engineering in
Medicine on 29 January 2020.
This document was approved by the Society and College of Radiographers on
15 January 2020.
This document was approved by the British Institute of Radiology on 15 January
2020.
This document was approved by Public Health England on 17 January 2020.
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Appendix 1.
Glossary Term Definition
Adequate training Training that satisfies the requirements of IR(ME)R

Schedule 3 with theoretical knowledge and practical
experience.
Authorisation Confirmation that the process of justification has

occurred. Evidenced either by hand or electronic
signatures.
Carer and comforter Individual knowingly and willingly incurring an

exposure to ionising radiation, other than as part of their
occupation, by helping in the support and comfort of an
individual undergoing or having undergone an exposure.
Clinical audit A systematic examination or review of medical

radiological procedures that seeks to improve the quality
and outcome of patient care.
Clinical evaluation An assessment of an exposure by an appropriately

trained and competent operator to evaluate the
outcome.
Clinically significant An accidental or unintended exposure that has had

accidental or or is expected to have caused moderate harm to the
unintended exposure individual. Effects may be physical or psychological and
may require intervention or treatment to the individual
exposed.
Continuous The planned acquisition of knowledge, experience

professional and skills and the development of personal qualities
development throughout the working life of an individual.
Dose constraint Part of the optimisation process; a dose constraint is a

restriction set on a prospective dose.
Dose target Target levels of doses planned for research exposures

where direct patient benefit is expected (eg,
experimental diagnostic practices).
Diagnostic reference Radiation dose levels, or administered activity, for typical

level (DRL) diagnostic examinations on standard size adults and
children for broadly defined types of equipment.
Employer The employer, as a duty holder, is responsible for

providing a framework within which professionals
undertake their functions. The definition of employer
relates to health and safety functions rather than
employment matters.
Entitlement This is the process of verifying that the duty holder has
the necessary training and competencies to undertake
the task as defined in their scope of practice.
Error A failure to carry out a planned action as intended or

an application of an incorrect plan. Not all errors lead
to radiation incidents (for example, when the error is
detected before the individual is exposed).
Event Something that happens to or involves a patient.
Image optimisation A multidisciplinary team of experts working to ensure a

team consistent approach to optimisation across modalities.
Justification An intellectual process of weighing up the potential

benefit of an exposure against the detriment from the
radiation dose received by that individual.
Licensing authority For practitioner licences, in Great Britain, the Secretary

of State; in Northern Ireland, the Department of Health.
For employer licences, in England, the Secretary of
State; in Scotland, the Scottish Ministers; in Wales, the
Welsh Ministers; in Northern Ireland, the Department of
Health.
Medical physics expert 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
medical exposure whose competence in this respect is
recognised by the Secretary of State.
Near miss A potential radiation incident that was detected and an

error prevented at any point before an exposure takes
place.
NHS trust/health board A division within the NHS generally serving a

geographical area. In Scotland and Wales these are
referred to as health boards. Where the term trust has
been used in this document, any comments apply
equally to health boards and independent healthcare
providers.
Non-medical imaging Exposures that do not have a direct health benefit to the
individual undergoing the exposure.
Operator Any person who is trained and entitled to carry out the
practical aspects of an exposure.
Optimisation The process by which individual doses are kept as low

as reasonably practicable.
Policy A high-level statement governing the conduct of

activities in an organisation. Policies outline what will be
done with minimal detail as to how this will be achieved.
Practitioner A registered healthcare professional who is entitled

to take responsibility for an individual exposure. The
primary role of the practitioner is to justify and authorise
exposures.
Procedure A detailed and documented description of the steps that

should be taken or the method that should be followed.
Protocol Written protocols include step-by-step descriptions

of how an examination is carried out. They should be
evidence-based, reflect current practice and be ratified
through the QA process.
Quality assurance 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; quality
control is a part of quality assurance.
Quality control The set of operations (programming, co-ordinating,

implementing) intended to maintain or to improve
quality, including monitoring, evaluation and
maintenance at required levels, of all characteristics
of performance of equipment that can be defined,
measured and controlled.
Radiation incident An error where the delivery of radiation is different to that

intended and which resulted in unnecessary harm to the
patient.
Referrer A registered healthcare professional who is entitled

to refer individuals for exposures involving ionising
radiation. In Northern Ireland this also includes medical
practitioners registered with the Medical Council of
Ireland.
Registered healthcare A person who is a member of a profession regulated by

professional a body mentioned in Section 25(3) of the National Health
Service Reform and Health Care Professions Act 2002.
Relevant enforcing Enforcing authorities for IR(ME)R:

authority England, Care Quality Commission
Northern Ireland, Regulation and Quality Improvement
Authority
Scotland, Healthcare Improvement Scotland
Wales, Healthcare Inspectorate Wales.
Significant accidental An exposure that was significantly greater than that

or unintended intended. The regulations require that significant
exposure accidental or unintended exposures are notified to the
relevant enforcing authorities.
Scope of practice A range of skills and tasks based on professional

registration, education, training, knowledge and
experience.
Supervision The action or process of watching and directing what

someone does or how something is done and being in a
position to change this when required.
Appendix 2.
Abbreviations used Abbreviations
in this document
AHCS Academy for Healthcare Science
ALARP As low as reasonably practicable
ARSAC Administration of Radioactive Substances Advisory Committee
AXREM Association of Healthcare Technology Providers for Imaging,

Radiotherapy and Care
CCT Certificate of Completion of Specialist Training
COMARE Committee on Medical Aspects of Radiation in the Environment
CoR College of Radiographers
CSAUE Clinically significant accidental or unintended exposure
CT Computed tomography
CTDI Computed tomography dose index
DAP Dose area product
DHSC Department of Health and Social Care
DLP Dose length product
EANM European Association of Nuclear Medicine
FRCR Fellowship of the Royal College of Radiologists
GMC General Medical Council
HCPC Health and Care Professions Council
HRA Health Research Authority
IHA Independent health assessment
IPEM Institute of Physics and Engineering in Medicine
IRAS Integrated Research Applications System
LDRL Local diagnostic reference level

LMP Last menstrual period
MGD Mean glandular dose
MRI Magnetic resonance imaging
NDRL National diagnostic reference level
NICE National Institute for Health and Care Excellence
NRLS The National Reporting and Learning System
PACS Picture Archiving and Communications System
PET-CT Positron emission tomography/computed tomography
PIS Participant information sheet
POM Prescription-only medicines
QA Quality assurance
QC Quality control
RCR Royal College of Radiologists
REC Research ethics committee
RIS Radiology information system
RPA/RPS/RWA Radiation protection adviser/radiation protection supervisor/

radioactive waste adviser
SAUE Significant accidental or unintended exposure
SCoR Society and College of Radiographers
SPECT Single photon emission computed tomography
WHO World Health Organization

Appendix 3. Regulation 6(1) requires the employer to have in place written procedures as specified
Key things to consider in Schedule 2. Table A3 lists the employer’s procedures required and provides examples
when writing of what the employer may wish to consider for inclusion, but this list is not exhaustive.
The employer may provide additional Schedule 2 procedures to the minimum required
employer’s procedures
by IR(ME)R. Further information can be found in the main body of this guidance, and this
should be read in conjunction with this appendix.
Table A3: Things to consider including in employer’s procedures
(a) Identification of individual to be exposed
§ Who is responsible for carrying out ID checks?

§ When does the ID check happen?
§ What questions will the operator ask the individual?
§ What if there is more than one operator involved in the examination?
§ What is the process if there is a discrepancy with the individual’s demographics?
§ What is the process if verbal communication is not possible, because of, for example, language barriers, age, mental
capacity, or being unconscious or sedated?
§ How is the ID checking process recorded?
§ How is the correct radiopharmaceutical identified for nuclear medicine?
(b) Identification of individuals entitled as duty holders
§ How are duty holders made aware of their responsibilities under IR(ME)R?
§ How is the task of entitlement delegated by the employer?
§ How is entitlement authorised and who can entitle duty holders?
§ How are training and competencies assessed and signed off?
§ Should a training matrix be used?
§ How often are training, competencies and entitlement reviewed and by whom?
§ How do staff demonstrate their entitlement and scope of practice?
§ Who holds the training records?
(c) Enquiries to individuals who may be pregnant or breastfeeding
§ Who is responsible for checking pregnancy and breastfeeding status? (include staff outside radiology)
§ What is the age range for pregnancy and breastfeeding enquiries?
§ When is pregnancy and breastfeeding checking required? (describe any exceptions)
§ When and where do the pregnancy and breastfeeding checks happen? (include areas outside radiology)
§ How will responses be recorded?
§ What are the measures to raise awareness? (eg, posters, appointment letters)
§ Is there an explanation of when the 10/28-day rule applies?
§ What is the process when more than one operator is involved in an exposure?
§ Where is information documented?
§ What is the process if an individual is unsure of or says that they are pregnant?
§ How are protocols optimised for pregnant or breastfeeding individuals?
§ Include contact details and safeguarding procedures.
§ Include breastfeeding interruption times for common examinations.
(d) Quality assurance programme for written procedures and equipment
Written procedures § What should be included for a standard template? (eg, version number, author,
authorised by, issue date, review date)
§ What is the document control authorisation process?
§ How often and when are procedures/protocols reviewed?
§ Who is responsible for the review process and accuracy of content?
§ How do different staff groups access procedures and protocols?
§ How are changes communicated to all relevant staff?
Equipment § What equipment is there and how often will it be tested? (eg, daily, monthly, annually)
§ Who will carry out the tests?
§ How and where are results recorded?
§ What happens when results are out of tolerance?
§ Who acts on results? (eg, who contacts MPE, manufacturers)
§ How is equipment handed over and how is this documented?
§ How are equipment issues reported and to whom?
§ How is training provided to those carrying out equipment QC?
§ How is equipment returned to service?
§ What is the process for corrective actions when defective or inadequate equipment is
identified?
(e) Assessment of patient dose and administered activity
§ What dose information needs to be recorded and where?

§ Who is responsible for recording dose (include areas outside of radiology/NM)
§ What dose indicators for each modality will be recorded?
§ What is the process for setting threshold trigger levels (eg, audible alarms)?
(f) Use and review of diagnostic reference levels
§ What DRLs are in place? (eg, local, national, paediatric)

§ Where they can be found?
§ How often are they reviewed and by whom?
§ How will staff know if DRLs are being consistently exceeded?
§ What actions are to be taken by staff and the employer if DRLs are consistently exceeded?
§ What DRLs are needed for hybrid imaging?
(g) Research
§ What is the process for local research and development approval?

§ What is the process to ensure appropriate employer and practitioner licences are in place?
§ Is there a link to the participant information sheet?
§ Is there a description of how dose constraints are set?
§ Is there a description of how dose targets are set?
§ Is there a description of how adherence to dose constraints is ensured?
§ How do duty holders identify research exposures?
§ What is contained in the research file and how can duty holders access this?
(h) Written information for nuclear medicine
§ How is the advice on precautions to observe after the exposure provided?

§ How is the individual informed of the risks from the exposure?
§ When is the information provided to the patient/individual?
§ Where can additional information be found?
(i) Communication of benefits and risks
§ What information will be given to the individual exposed or their representative?

§ Who will provide this information?
§ How will the information be provided? (eg, verbal, posters, information leaflets)
§ Where will the information be provided?
§ How will staff access support for additional information if required? (eg, MPE)
§ What training is provided for staff on the delivery of this information?
§ How will the method and level of communication reflect the risk? (eg, general radiography posters, interventional
procedures, verbal and written information given as part of the consent process)
§ What is the process where verbal communication is not possible?
(j) Recording of clinical evaluation
§ How is clinical evaluation recorded?

§ Where is it recorded? (eg, RIS, PACS or in the patient’s notes)
§ Who records the clinical evaluation? (include areas remote from radiology)
§ When should exposure factors be included in the clinical evaluation?
§ What happens if clinical evaluation takes place outside the radiology department?
§ How is training provided to staff carrying out and recording clinical evaluation? (include those working remotely from
radiology)
§ How is the operator carrying out this task identified and entitled?
§ What is the process in place for unexpected findings?
§ How and when are audits carried out to assess compliance with the employer’s procedure and discrepancies with
clinical findings?
(k) Reduction of the probability and magnitude of accidental or unintended exposures
Include a list of local measures that are taken to reduce the probability and magnitude of accidental or unintended
exposures, such as:
§ Adherence to the individual/patient identification process
§ Review of employer’s procedures to ensure they reflect local practice
§ Optimisation process
§ MPE involvement
§ Establishment and use of DRLs
§ Image optimisation team (IOT)
§ Equipment QA programme in line with recommended guidance
§ Training and competency assessments
§ Induction programmes for new staff
§ Peer review of images
§ Clinical audit
§ Investigation and analysis of errors and near misses
§ How feedback is shared with staff following incidents
(l) Clinically significant unintended or accidental exposures
§ How do duty holders identify and report radiation incidents including near misses?
§ What information is required and who communicates the information to the MPE?
§ How and where is this information recorded?
§ Who investigates?
§ Who will inform the referrer, practitioner and individual?
§ How will the information be communicated (eg, verbally, written) and where is this communication recorded?
§ If the decision is made not to inform the individual or their representative, where is this recorded?
§ How are CSAUEs notified to the relevant enforcing authority and who is responsible for the notification?
§ How will the outcome of the investigation be shared?
§ How will feedback and learning be delivered to staff?
(m) Non-medical imaging (NMI) exposures
§ How are NMI referrals identified?

§ Who will authorise and justify these referrals?
§ How are these exposures optimised? (eg, specific protocols, reduced number of views)
§ If NMI is not performed, is this clearly stated in the employer’s procedure?
(n) Carers and comforters
§ Who will justify and authorise the exposure?

§ When may an individual be a designated carer and comforter?
§ What information is recorded and where? (eg, relationship to individual, on RIS)
§ What information will be provided in relation to benefits and risks?
§ How will this information be presented?
§ How are pregnancy enquiries carried out and recorded?
§ How will the dose be ALARP? (eg, PPE, where to stand, restrict close contact time)
§ What are the dose constraints?
§ Are there special considerations for those who will not normally be a carer or comforter? (eg, pregnant women,
children acting in a caring role)
§ Are there non-standard situations where additional information is required?
Appendix 4. This is an example of how a training record could be presented. The detail provided is
Example template for not intended for direct adoption in the clinical environment. Employers should adapt the
a local training record template to reflect local service provision and practice.
Name of duty holder
Job title
Qualification(s) and year

obtained
Training records held by
Department
Equipment
Tasks Trained by Trainer signature Trainee signature Date

(name and role) and date
Switch equipment
on, and off location of
emergency stop
Warm-up procedure
Daily/weekly QC test
Selecting patient from

work list
Selecting correct
protocol
This record indicates that the above individual has received training, demonstrated satisfactory understanding to the
expected standards and can apply the knowledge into practice consistently and competently. Their signature indicates
their agreement with the above and confirmation that they have read and understood the associated documentation.
Name and signature of assessor: Name and signature of trainee: Date completed:
Appendix 5. This is an example of how an individual scope of practice could be presented. The detail
Example template provided is not intended for direct adoption in the clinical environment. Employers should
for individual scope adapt the template to reflect local service provision and practice.
of practice
Name of duty holder
Job title
Qualification(s) and year

obtained
Registration number Date checked
Training records held by
IR(ME)R employer’s Signature Date

procedures read by duty holder
Referrer functions Competency Signature Duty holder Date

assessed by and date signature
(name & role)
Competent to refer for all general

radiography examinations
Competent to refer for nuclear

medicine imaging studies
Competent to refer for non-

medical imaging examinations
Practitioner functions Competency Signature Duty holder Date

(name and role)
Competent to justify referrals

for all X-ray general radiography
examinations
Competent to justify referrals

for nuclear medicine imaging
procedures as outlined in their
practitioner licence
Competent to justify referrals for

mammography
Operator functions Competency Signature Duty holder Date

(name and role)
Competent to carry out patient

identification
Competent to authorise against

nuclear medicine guidelines
issued by the practitioner
Competent to clinically evaluate

appendicular general radiography
examinations for adults
Additional functions Competency Signature Duty holder Date

(name and role)
It is the professional responsibility of the above individual to request a competency review if they feel their knowledge
and skills do not meet the expected standard. The appropriate manager will update the competency matrix until
reassessment.
Removed functions Entitlement Signature Duty holder Date

removed by and date signature
(name and role)
This record indicates that the above individual has received training, demonstrated satisfactory understanding to the
expected standards and can apply the knowledge into practice consistently and competently. Their signature indicates
their agreement with the above and confirmation that they have read and understood the associated documentation.
Entitled by (name and role): Signature: Date:

Appendix 6. Group entitlement may be adopted in situations where a group of duty holders have the
Group entitlement same defined scope of practice (for example, GP referrers). Below is an example of how this
may be summarised for referrers in the employer’s procedures or the radiation safety policy,
but this format can be extended to other duty holder roles. Additional detail is required to
define the group scope of practice and identify the trained individuals within the group.
The detail of examples given is not intended for direct adoption in the clinical environment.
Employers should consider how this template could be adapted to their local practice.
Referrers
Staff group Registration Example scope of referral Entitled by
General GMC § General radiography Clinical director

practitioners examinations only
Radiographers HCPC § Orbits X-ray; IOFB for Radiology

MRI services
§ CT chest following manager
positive CTC
Emergency nurse NMC § Extremity radiography Clinical director

practitioners of patients >5 years
Radiologists GMC § All examinations Clinical director
Cardiologists GMC § All cardiac imaging Clinical director
Specialist NMC § NM bone scan Clinical director

oncology nurse
practitioners
Appendix 7.
Referral received
Example pregnancy
flow chart Discuss with referrer
for clarification or
Justified OR authorised under
No additional information
guidelines issued by the practitioner?
or suggest an
alternative examination
Yes
Does the individual fall between the

local age range for pregnancy checks No
(eg, 12 to 55 years) AND the primary
beam would cover the pelvic area?
Yes
Ask the individual: ‘Are you, or

Yes No
might you be, pregnant?’
Not sure
Is menstrual Is the examination

Yes No Yes
period overdue? low dose?
No
High-dose procedure – is today within the

first ten days of the patient’s menstrual cycle?
Yes
No
Review justification with practitioner (who
may consult the referrer). Is the referral still
justified? No Can pregnancy be excluded? Yes
No Yes
Postpone or reschedule for modality Proceed to examination. Minimise fetal Proceed to

involving no ionising radiation or cancel. dose. Seek advice from MPE. examination
Appendix 8. Working party membership

Working party § British Institute of Radiology (BIR)
membership – Elizabeth Benson
– Cristiona Logan
§ British Society of Paediatric Radiology (BSPR)
– Dr Jeannette Kraft
§ Institute of Physics and Engineering in Medicine (IPEM)
– Debbie Saunders and members of the DR SIG
– Debbie Peet and members of the RP SIG
– Peter O’Sullivan and members of the NM SIG
§ Public Health England Medical Exposures Group
– Louise Fraser
– Yvonne Sullivan
– Gail Woodhouse (interim chair)
§ The Royal College of Radiologists (RCR)
– Dr Peter Riley (chair)
– Dr Richard Graham
– Dr Stewart Redman
– Fionnuala Morrissey (secretariat)
§ Society and College of Radiographers (SCoR)
– Lynda Johnson
– Maria Murray
Clinically significant working party membership

§ The Royal College of Radiologists (RCR)
– Dr Peter Riley (chair)
– Dr Richard Graham
§ Public Health England Medical Exposures Group
– Louise Fraser (interim chair)
– Gail Woodhouse (observer)
§ British Institute of Radiology (BIR)
– Dr John Kotre
§ Institute of Physics and Engineering in Medicine (IPEM)
– Matthew Dunn
§ Society and College of Radiographers (SCoR)
– Lynda Johnson
The Royal College of Radiologists
63 Lincoln’s Inn Fields
London WC2A 3JW
+44 (0)20 7405 1282
enquiries@rcr.ac.uk
www.rcr.ac.uk
@RCRadiologists
The Royal College of Radiologists. IR(ME)R: Implications

for clinical practice in diagnostic imaging, interventional
radiology and diagnostic nuclear medicine. London:
The Royal College of Radiologists, 2020.
Ref No. BFCR(20)3
© The Royal College of Radiologists, June 2020.
The Royal College of Radiologists is a Charity registered
with the Charity Commission No. 211540.
For permission to reproduce any of the content contained
herein, please email: permissions@rcr.ac.uk
This material has been produced by The Royal College of
Radiologists (RCR) for use internally within the specialties
of clinical oncology and clinical radiology in the United
Kingdom. It is provided for use by appropriately qualified
professionals, and the making of any decision regarding the
applicability and suitability of the material in any particular
circumstance is subject to the user’s professional judgement.
While every reasonable care has been taken to ensure
the accuracy of the material, the RCR cannot accept any
responsibility for any action taken, or not taken, on the
basis of it. As publisher, the RCR shall not be liable to any
person for any loss or damage, which may arise from the
use of any of the material. The RCR does not exclude or
limit liability for death or personal injury to the extent only
that the same arises as a result of the negligence of RCR,
its employees, Officers, members and Fellows, or any other
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Institute of Physics and

1. This guidance document is intended to provide a practical approach to implementing

§ Reporting of accidental and unintended exposures (Chapter 21)

Table 1.1: Types of exposure

Medical exposures § Patients, as part of their medical § X-ray imaging, computed

§ Individuals as part of health § Imaging a group or population for a

§ Individuals participating in research § Patients taking part in clinical trials

§ Carers and comforters § Individuals who provide support

§ Asymptomatic individuals § Investigations to exclude disease on

Non-medical exposures § Individuals undergoing non-medical § Health assessment for employment,

§ Have and express a professional view, where appropriate, as to whether those

Professionally it is the responsibility of healthcare staff to challenge the decisions of others if

Table 2.1: Requirements for the employer

Regulation Requirement Things to consider

Regulation 5(1)(a) Licensing for the § Ensure appropriate, valid employer

Regulation 6 General procedures, § Establish written employer’s

Regulation 7 Clinical audit § Ensure the employer’s procedure

Regulation Requirement Things to consider

Regulation 8 Accidental or § Ensure referrer, practitioner

Regulation 12(9) Clinical evaluation § Ensure that a clinical evaluation is

Regulation 13 Population doses § Ensure dose estimates from

Regulation 14(1) Expert advice § Appoint a suitable medical physics

Regulations 15(1), Equipment § Implement and maintain an

Regulations 17(4), Training records § Keep appropriate training records

Schedule 2 Written employer’s § A minimum requirement of 14

Table 2.2: Requirements for the referrer

Regulation Requirement Things to consider

Regulation 6(2) Written procedures § Ensure referrals comply with

Regulation 6(5)(a) Referral guidelines § Access to established guidelines

Regulation 8(1) Clinically § Ensure involvement in the process

Regulation 10(5) Sufficient medical § Provide enough information to

Schedule 2(b) Individual § Understand specified scope of

Table 2.3: Requirements for the practitioner

Regulation Requirement Things to conside

Regulation 10(1) Employer’s § Read and comply with employer’s

Regulation 10(2) Justification of § Weigh up benefit and risk

Regulation 10(6) Co-operate § Share relevant information

Regulations 11(2), Justification of § Evaluate the information provided

Regulation Requirement Things to conside

§ Consider justification of exposures to

Regulation 11(5) Task of § Issue authorisation guidelines to be used by

Regulation 12(1) Optimisation § Ensure exposures are kept as low as

Regulation 12(8) Pay particular § Optimisation of:

Regulation 17(1) Training § Adequate training as defined in Schedule 3

Schedule 2(b) Individual § Understand specified scope of practice

Table 2.4: Requirements for the operator

Regulation Requirement Things to consider

Regulation 10(1) Employer’s § Read and comply with employer’s

Regulations Practical aspects § Training required to carry out any

Regulation 10(6) Co-operate with § Share relevant information

Regulation 12(1) Optimisation § Ensure exposures are kept as low as

Regulation 12(3) Selection of § Choose the most appropriate

Regulation 12(8) Pay particular § Paediatric exposures (Chapter 15)

Regulation Requirement Things to consider

Regulation 17(1) Training § Adequate training to carry out any

Schedule 2(b) Individual entitlement § Understand specified scope of

3. Procedures and protocols

Quality assurance programmes for documentation

Table 3.1: Considerations when establishing a QA programme for documentation