Guidance for the implementation of the IR(ME)R Regulations 2017

Question 1

1. Applying IR(ME)R general principles to breast screening

Accepted Answer

The purpose of IR(ME)R in relation to breast screening is to:

ensure that, in each case, the expected clinical benefit is assessed against the potential risk from exposure to ionising radiation
ensure individuals receive no greater radiation dose than is necessary to achieve a screening diagnosis within the limits of the current technology
ensure IR(ME)R practitioners and operators working in the NHS BSP are adequately and appropriately trained and entitled for the roles and tasks they perform
protect individuals (women and comforters and carers) from accidental or unintended exposures to ionising radiation
protect volunteers in research programmes

The Regulations apply across the whole breast screening pathway including the initial screening and assessment stages. IR(ME)R relates specifically to protect the patient or in breast screening the women. Anything pertaining to staff and public exposures comes under the Ionising Radiations Regulations (IRR2017).

The legal responsibility for compliance with IR(ME)R lies with the employer and each entitled duty holder has an individual responsibility to comply with employer’s procedures. For further details see IR(ME)R duty holder roles and responsibilities (see section 2 below). This document describes the policies, procedures and protocols which make up the safety framework for staff to follow and provides practical guidance to support compliance with the Regulations.

The practical measures needed to implement IR(ME)R in the NHS BSP must be considered in conjunction with each local breast screening service’s radiation protection arrangements.

For the purpose of this guidance the term ‘IR(ME)R practitioner’ is mentioned throughout to clearly differentiate between clinical practitioners and the IR(ME)R duty holder role of practitioner.

Wherever the term assistant practitioner (AP) is used, this also relates to the role of associate practitioners.

Where the term mammographer is used, it refers to both radiographers and APs.

When ‘client screening form’ is mentioned some services will refer to this document as the ‘client sheet’.

When written examination protocols are mentioned, services may refer to these documents as work instructions.

The breast screening programme automatically invites for screening all women from the age of 50 up to their 71st birthday who are registered with a GP as female. Some transgender and non-binary individuals are also eligible for breast screening. See further information in NHS population screening: information for trans and non-binary people. This guidance refers to ‘women’ throughout but it is important to note that the term ‘woman’ does not apply to all eligible individuals.

Question 2

2. 
IR(ME)R duty holder roles and responsibilities (employer, referrer, practitioner, operator)

Accepted Answer

IR(ME)R specifies 4 types of duty holders: the employer, referrer, practitioner and operator. Each duty holder has a personal and professional responsibility to ensure they comply with IR(ME)R. Individuals may be entitled to act as duty holders at different points in the care pathway, for example there may be different referrers for screening and assessment. An individual may be entitled to act in more than one duty holder role in the care pathway, for example a radiographer can act as an IR(ME)R practitioner to justify the exposure and as an operator to perform the exposure.

Figure 1 below provides an example flowchart showing how the entitlement for service delivery flows from:

the chief executive to the medical director
the medical director to the director of breast screening
the director of breast screening to the site lead radiographer, reporting radiologists and radiographers and medical physics experts
the site lead radiographer to consultant practitioner radiographers, radiographers, assistant practitioners and advanced practitioners and radiographers

Figure 1: example organisational flowchart for breast screening services
(to be adapted to fit with local service delivery)

2.1 Employer

The IR(ME)R employer must establish procedures and take steps to ensure they are complied with. The employer must provide a framework through written procedures, protocols and quality assurance programmes that support entitled duty holders to undertake their roles to safely deliver services using ionising radiation.

The employer must be clearly identified within an employer’s procedure (Schedule2(b)). In breast screening, this would be the organisation contracted by NHS England (NHSE) to provide the service.

The organisation should designate an accountable representative, for example the chief executive officer (CEO) of the Trust, to ensure the employer’s duties under IR(ME)R are fulfilled. A statement should be included in the employer’s procedures to clearly define this responsibility for example ‘The overall responsibility for ensuring that IR(ME)R is complied with lies with (named individual)’ as specified in professional body IR(ME)R guidance.

Where a ‘hub and spoke’ model of screening provision is in place, the commissioned organisation hosting the service (the hub) is responsible for ensuring that the employer’s procedures are in place for all the sub-contracted organisations (the spokes) and that the relevant duty holders are aware of which procedures they must follow. NHS BSP guidance on leading a breast screening service states that ‘the lead organisation must have internal sub-contract monitoring and oversight arrangements in place’.

It must be clear to all duty holders who the employer is for the breast screening service and which employer’s procedures they must follow.

The employer may delegate tasks for the implementation of the Regulations to appropriately trained and experienced individuals within the organisation. However, the employer will always retain the legal responsibility under IR(ME)R.

See the accompanying example templates for employer’s procedures.

IR(ME)R requirements for the employer

Under general procedures, protocols, and quality assurance (QA) for written IR(ME)R documentation (Regulation 6), the employer should:

establish written employer’s procedures, written protocols and QA programmes
ensure IR(ME)R practitioners and operators are adequately trained (see section 3)
establish dose constraints for research exposures (see section 22) and carers and comforters (see section 12)
ensure appropriate reviews are undertaken whenever diagnostic reference levels are consistently exceeded
take measures to raise awareness of the effects of ionising radiation amongst individuals capable of childbearing or breastfeeding

Under clinical audit (Regulation 7), the employer should ensure the procedure outlines how and when clinical audits are carried out (see section 6).

Under accidental or unintended exposures (Regulation 8), the employer should:

ensure the referrer, IR(ME)R practitioner and individual (or their representative) are informed of clinically significant accidental or unintended exposures (CSAUE) and the outcome of the analysis of the exposure
investigate, record and report significant or accidental or unintended exposures (see section 19)

Under clinical evaluation (Regulation 12), the employer should ensure clinical evaluation is performed and recorded (see section 13).

Under population dose (Regulation 13), the employer should ensure population dose estimates for breast screening examinations are collected (see section 15).

Under expert advice (Regulation 14(1)), the employer should appoint a suitable medical physics expert (MPE) (see section 17).

Under equipment (Regulation 15), the employer should:

establish and maintain a QA programme for equipment
keep an up to date equipment inventory at each breast screening service
test equipment before use, at regular intervals and following maintenance
implement measures to address poorly performing equipment
establish performance criteria (see section 18)

Under training records (Regulation 17(4), 17(5)), the employer should:

ensure all training records are up to date and available when requested by IR(ME)R inspectors
provide training records between employers as required (see section 3)

Under written employer’s procedures (Schedule 2), the employer should:

ensure the required minimum set of 14 employer’s procedures are available to all duty holders (see section 5)
establish a process for regular review and update of written procedures (see section 6)

2.2 Referrer

The referrer must be a registered healthcare professional who has been entitled by the employer in accordance with Part 2 of the NHS Service Reform and Health Care Professions Act 2002. They must read and comply with the written procedures set out by the employer relating to IR(ME)R.

The referral process in breast screening invites eligible women to attend for a mammography examination via an invitation letter rather than an individual referral from a healthcare professional. The invitation letter must be signed by a registered healthcare professional, who is entitled by the employer as a referrer, for example, the director of screening or the lead radiologist. See section 7 for further details.

Non-medical registered healthcare professionals for example, radiographers, may be entitled to refer as part of an extended role. Although not a requirement of IR(ME)R, it is expected that non-medical referrers will have had appropriate training and be deemed competent prior to entitlement for a defined scope of practice. The process for the entitlement of non-medical referrers should be locally agreed and documented.

IR(ME)R requirements for the referrer

Written procedures are complied with by the referrer (Regulation 6(2)), the referrer should ensure referrals comply with referral guidelines.

Referral guidelines should be made available (Regulation 6(5)(a)), the referrer should:

have access to established referral guidelines
understand how to seek advice on non-standard referrals, for example stereotactic biopsy

Clinically significant accidental or unintended exposures (CSAUEs) are communicated to referrer (Regulation 8(1)), the referrer should:

be involved in the process and be aware of the need to inform the woman (or their representative) of a CSAUE
provide advice when the decision is made not to inform the woman
have awareness of how the outcome of the analysis of the incident is shared

Sufficient medical data must be supplied (Regulation 10(5)), the referrer should:

provide enough information to identify the woman
supply sufficient data to justify the exposure

Individual entitlement (Schedule 2(b)), the referrer should:

understand their specified scope of practice
adhere to limited referral rights, where applicable

2.3 IR(ME)R practitioner

The IR(ME)R practitioner must be a registered healthcare professional who has been entitled by the employer. It is the IR(ME)R practitioner’s primary role to justify the exposure. They must weigh up the benefits of carrying out the exposure against the potential risks of the radiation dose. There must be evidence, for example via an electronic signature, that the justification process has taken place. This is known as authorisation. The IR(ME)R practitioner must be adequately trained, competent and entitled to carry out the intellectual task of justification.

2.4 Requirements for the IR(ME)R practitioner

Under Regulation 10(1) (Employer’s procedures), the practitioner should read and comply with the employer’s procedures

Under Regulations 10(2),11(2),11(3),11(4) (Justification of the exposure), the practitioner should:

justify and authorise exposures
request further information where necessary
evaluate information provided and establish that there is sufficient net benefit
consider guidelines issued by NHS BSP
authorise referrals that they have justified
consider the justification of the exposure to carers and comforters

Under Regulation 10(6) (Co-operate with other staff), the practitioner should:

co-operate with other staff such as MPEs, other specialists and duty holders
participate in multidisciplinary team meetings
request advice and support from medical physics where necessary

Under Regulation 11(5) (Authorisation), the practitioner should:

issue signed authorisation guidelines for operators (mammographers) to follow where it is not practicable for the IR(ME)R practitioner to authorise an exposure
retain responsibility for justification of exposures authorised under the authorisation guidelines

Under Regulation 12(1) (Optimisation), the practitioner should:

ensure exposures are optimised and kept as low as reasonably practicable
use non-ionising radiation modalities where appropriate
be aware of, and use, local and national diagnostic reference levels (DRLs)

Under (Regulation 12(8) (Optimisation), the practitioner should:

ensure the optimisation of health screening programme exposures for example, via QA programmes, establishment of specific screening protocols and so on
Check pregnancy and breastfeeding status (due to changes in breast tissue during pregnancy and when breastfeeding)

Note that mammography is not routinely performed when a woman is breastfeeding, due to the density changes in the breast tissue.

Under (Regulation 17(1) (Training), the practitioner should:

undertake adequate training required as defined in Schedule 3
receive training on local equipment and techniques
update training when new equipment/techniques are implemented

Under Schedule 2(b) (Individual entitlement), the practitioner should:

understand their specified scope of practice
ensure their entitlement is reviewed and updated when new skills are added
remove entitlement of specific tasks when no longer competent or required

In practice, an IR(ME)R practitioner will issue authorisation guidelines to enable operators (mammographers) to authorise exposures. The named IR(ME)R practitioner is responsible for the justification of each exposure authorised by operators following these guidelines. See section 8 for further details.

2.5 Operator

There is no requirement for the operator to be a registered healthcare professional. Operators must be trained, assessed as competent and entitled to carry out their roles within a defined scope of practice. An individual’s scope of practice should outline the tasks the employer has entitled the operator to carry out. Each operator is responsible for the practical aspects they carry out in relation to the exposure.

Examples of some practical aspects of a mammography exposure

For patient identification, the operator should correctly identify the woman from the screening/assessment form.

For operating equipment, the operator should set up, choose correct exposure factors, and initiate the exposure. See the accompanying standard examination protocol.

For optimisation, the operator should:

accurately position the woman and breast
apply adequate compression
review doses and update DRLs (MPE)

For image processing and archive, the operator should:

perform checks to ensure adequate image quality
transfer image data to the IT system

For equipment quality control (QC) and quality assurance (QA), the operator should:

perform regular equipment performance testing and calibration, where appropriate
report equipment faults to NCCPM (via the faults database) and the local medical physics service

For clinical evaluation, the operator should:

assess the image
provide a written or electronic report

Medical physics staff may also carry out practical aspects when undertaking equipment performance testing, therefore they will need to be adequately trained and entitled as operators. Third-party manufacturer’s service engineers would not normally be entitled as operators.

To perform practical aspects of an exposure, an operator must show evidence of training and competency. Both the trainer and trainee should sign and date training records to demonstrate the correct level of competency has been achieved. Training records should be kept up to date and regularly reviewed.

Requirements for the operator

Under Regulation 10(1) (Employer’s procedures) the operator should read and comply with employer’s procedures.

Under Regulation 10(3)(4) (Practical aspects) the operator should:

be adequately trained and assessed as competent in all practical aspects of an exposure, local equipment and imaging techniques
authorise exposures following IR(ME)R practitioner’s guidelines (see the accompanying examples of authorisation guidelines)

Under Regulation 10(6) (Co-operate with other staff) the operator should:

work with MPEs, other specialists and duty holders
participate in multidisciplinary team meetings
request advice and support from medical physics, where necessary

Under Regulation 12(1) (Optimisation) the operator should:

ensure exposures are optimised and kept as low as reasonably practicable
be aware of, and use, local and national DRLs

Under Regulation 12(3) (Selection of equipment) the operator should:

choose the most appropriate equipment and technique
assess and evaluate dose

Under Regulation 12(8) (Pay particular attention) the operator should:

ensure health screening programme exposures are optimised
check pregnancy and breastfeeding status (due to changes in breast tissue during pregnancy and when breastfeeding

Note that mammography is not routinely performed when a woman is breastfeeding due to the density changes in the breast tissue.

Under Regulation 17(1) (Training) the operator should:

undertake adequate training as defined in Schedule 3
receive training on local equipment and techniques
update training when new equipment or techniques implemented

Under Schedule 2(b) (Individual entitlement) the operator should:

understand their specified scope of practice
ensure their entitlement is reviewed and updated when new skills are added
remove entitlement of specific tasks when no longer competent or required

An entitled operator may carry out the authorisation process by following authorisation guidelines issued by a named individual IR(ME)R practitioner. If the clinical information does not fit with the criteria in the authorisation guidelines (for example, if a woman is referred for stereotactic biopsy and this is not included in the authorisation guidelines), then the exposure cannot be authorised by the operator and must be justified by an IR(ME)R practitioner. See section 8.

Question 3

3. Training

Accepted Answer

3.1 Employer’s responsibility

The employer has the responsibility to ensure that all IR(ME)R practitioners and operators are adequately trained to perform the tasks within their defined scope of practice (Regulation 6 (3)(a)). This includes undertaking continuing education and training after qualification (Regulation 6(3)(b)).

Regulation 17(1) describes that an IR(ME)R practitioner or operator cannot undertake a medical exposure or a practical aspect without having been adequately trained.

Regulation 17(4) requires the employer to keep training records for IR(ME)R practitioners and operators and make them available, if requested, at an IR(ME)R inspection. How training records are kept and updated may differ from organisation to organisation, however, the process should be clearly described in the written procedures. The maintenance and accessibility of training records applies equally to all staff groups entitled as operators and practitioners for example, radiologists, radiographers, assistant practitioners and medical physics staff.

3.2 Adequate training

Schedule 3 of IR(ME)R outlines the areas of theoretical knowledge and practical experience required for training to be considered adequate. Areas of training must reflect the tasks that the duty holder will undertake, to perform their role.

All topics of knowledge under Schedule 3 must be covered in adequate breadth and depth so that an individual may be entitled for a defined scope of practice. Schedule 3 (Table 1) of IR(ME)R describes topics such as:

properties and hazards of radiation
radiation protection
justification
statutory requirements

Schedule 3 (Table 2) of IR(ME)R describes supplementary areas of knowledge, for example:

factors affecting radiation dose
image acquisition
optimisation

Schedule 3 (Table 2) also describes training relevant to specific areas of practice diagnostic radiology, radiotherapy and nuclear medicine.

Although initial radiology/radiography training provides adequate knowledge and practical training relevant to each professional group, there will be a need for further development in many of these areas. There is a need for supplementary training for example, when upgrading equipment or introducing new technology. All relevant staff will need to be trained on how to use the equipment and have their competency assessed and a record made.

Training is also required for operators for example, radiologists, radiographers and assistant practitioners, in the communication of the benefits and risks from exposures for women or others involved in an exposure, such as carers and comforters.

Adequate training example scenario

Tomosynthesis equipment is installed at a breast screening service which has not previously had this technology or used this particular manufacturer’s equipment. The applications specialist provides detailed training on this new equipment to core members of staff. They cascade this training to their colleagues who will also be using the equipment. Records of the training with the applications specialist and the subsequent cascade training are recorded for each individual. A record is also made for radiologists and the team of reporting radiographers who undertake a training programme for providing clinical evaluation on this technology.

3.3 IR(ME)R practitioner training records

Professional qualifications in clinical radiology, for example, Fellowship of the Royal College of Radiologists (FRCR) by examination and the subsequent award of a certificate of completion of training (CCT) by the General Medical Council (GMC), are suitable evidence of competence to act as an IR(ME)R practitioner (Regulation 17(2)).This is documented in IR(ME)R implications for clinical practice in diagnostic imaging interventional radiology and nuclear medicine.

Registered healthcare professionals, who are not medically qualified, for example radiographers, can be entitled by their employer to act as IR(ME)R practitioners. This may be for a defined scope of practice, for example, some radiographers are trained and entitled as IR(ME)R practitioners to justify additional images in assessment clinics. Professional body guidance is available to support IR(ME)R practitioner training.

Formal professional education, and subsequent training, assessment and proof of competency may be used as evidence of entitlement to act in an IR(ME)R practitioner role. This evidence requires regular review on an individual basis. See section 2 for further details.

3.4 Operator training records

Training records for operators to undertake the practical aspects of an exposure must be up to date and reflect training and competency achieved for the individual’s scope of practice. The training should be equipment specific for all staff groups (for example, radiologists, mammographers, medical physics staff) involved in exposures.

APs who have successfully completed the College of Radiographers (CoR) approved education course for mammography and have been accredited, have the necessary evidence of adequate training (both theoretical and practical to include mammography equipment specific training) for a defined scope of practice.

For APs whose training is not CoR accredited, a recognised programme of locally provided training may be deemed adequate. If successfully completed, to the required standard, this could provide evidence of competence to perform the tasks in an AP’s scope of practice and satisfy the requirements for entitlement. The CoR website contains information on the assistant practitioner role.

For radiographers, proof of adequate initial training will be provided by an appropriate qualification leading to registration with the Health and Care Professions Council (HCPC). For radiographers to work in the NHS BSP, a postgraduate course in mammography must be undertaken. However, this is not a specific requirement for radiographers working in symptomatic breast imaging.

For breast radiologists, adequate proof of training will be provided by their FRCR Part 1 training, supplemented by specialty training, conducted and assessed through the RCR training scheme and leading to the award of a CCT, specifically in mammography.

For operators, adequate training as defined by IR(ME)R Schedule 3 should only be considered the minimum standard.

The training should include equipment specific training for all staff groups including radiographers, radiologists, assistant practitioners, medical physics staff and anyone else involved in exposures.

Operating training records example scenario

A breast screening service employs an agency radiographer to support safe service provision. The employing agency has provided evidence of HCPC registration, a Certificate in Mammography and checked the radiographer’s mammography qualifications through its own recruitment processes. The agency radiographer is provided with a comprehensive training and induction programme encompassing all aspects of the local screening service provision. This includes clinical and equipment training. On completion of the training and induction programme an assessment of competencies is performed before the breast screening service entitles the radiographer as an operator. See section 4 for further details.

3.5 Supervision of mammographers (trainee qualified radiographers and trainee APs)

When an operator task is being performed by a trainee mammographer who is a qualified radiographer or an AP under supervision, the operator supervising the task retains responsibility for that task (Regulation 17(3)).

Individuals who have not completed training in mammography, for example a radiographer with a BSc in radiography (or equivalent) studying for the postgraduate module in mammography or an AP who is not fully trained in a specific practical aspect of mammography, cannot act without being directly supervised (Regulation 17(3)).

It is essential that the supervisor has agreed to oversee a particular task before the examination commences, and that the student or trainee is clear who is supervising them. The supervising mammographer takes full responsibility for the task being performed by the trainee and they should decide the level of supervision required. Very close supervision (constantly present and observing) will be required when the student or trainee is in the early stages of their training and a clear evidence trail is required. For more information see IR(ME)R Implications for clinical practice in diagnostic imaging, interventional radiology and diagnostic nuclear medicine.

When a trainee is considered to be fully trained and assessed as competent, they can be entitled to act as an operator in their own right.

For trainee breast radiologists (with an FRCR Part 1 qualification), their scope of practice and entitlement as an IR(ME)R practitioner and operator, should be commensurate with their knowledge and experience. It should be clear which aspects of their role requires supervision, the level of supervision and who is supervising.

3.6 Training records

Individuals joining a service, require induction into local practice. Training thereafter is a continuous process (Regulation 6(3)(b)) relevant to their role and development and in response to the introduction of new equipment, new techniques or as upgrades to operating software and systems of work occurs.

The employer is required to keep up to date training records for practitioner and operators and make these available for inspection by the relevant enforcing authority (Regulation 17(4).

The IR(ME)R inspector may ask to see records of:

registration and qualification
induction
equipment and technique specific training
dates and nature of training
competency sign off
scope of practice and entitlement

3.7 Continuing education and training

Training records need to reflect continuous development and local department-specific training, in addition to that achieved through supplementary external qualifications and courses.

Regulation 6(3)(b) requires employers to ensure that all IR(ME)R practitioners and operators engage in continuing education and training after qualification, relevant to their role and its development, with particular reference to the clinical use of new techniques and their radiation protection requirements.

3.8 Training for referrers

Training for referrers is not an explicit requirement under IR(ME)R, however, it is considered best practice for a referrer to receive local training. Examples of local training for referrers may include use of the electronic referral system (including how to request, cancel or change a referral) and having an awareness of their professional and legal responsibilities under IR(ME)R. They should also have an understanding of the biological effects of radiation and act in accordance with referral guidelines provided by the employer.

Professional guidance by the British Institute of Radiology advocates local training for non-medical referrers (for example radiographers). Non-medical referrers should undergo locally agreed and appropriate training before being entitled as referrers for a defined scope of practice. See section 7 for further details.

Question 4

4. Entitlement and scope of practice

Accepted Answer

Entitlement is the process of endorsement, by an appropriate person within an organisation, which ensures each duty holder has been adequately trained and is deemed competent to carry out their specific duty holder roles.

The task of entitling duty holders may be delegated by the IR(ME)R employer to an individual within the organisation, for example a director of breast screening or clinical lead. The individual who carries out the task of entitlement must have the required knowledge and experience in order to authorise the entitlement of a duty holder.

The employer’s procedure for entitlement must clearly outline the process of entitlement, showing lines of accountability and delegation of tasks within the organisation. It must identify individuals or groups, entitled to act as duty holders (Schedule 2(b)).

4.1 Points to consider for inclusion in the employer’s procedure for entitlement

Lines of IR(ME)R accountability should include:

clear governance structure, for example though an organisational flow chart
delegation of the task of entitlement (see Figure 1, section 2 above)
assessment of training, competencies and entitlement, for example, centrally held on an entitlement matrix

Qualification and additional training requirements for each duty holder/ group of duty holders should include evidence of:

a qualification that leads to registration with the HCPC as a radiographer, BSc (Hons) diagnostic radiography or equivalent, PgCert in mammography (radiographers)
a CoR approved education course (APs)
FRCR leading to a CCT in mammography (radiologists)

For professional registration requirements for referrer and practitioner, the employer must identify:

who checks individuals are registered healthcare professionals, for example GMC or HCPC
frequency of review (usually annual)

The duty holder/group of duty holders’ should:

read and comply with written procedures
work within a defined scope of practice

Evidence of entitlement should include:

how individuals know they are entitled
a letter or other means of demonstrating entitlement, for example entitlement matrix
defined scope of practice

Review/update of entitlement should occur:

annually, for example at appraisal
when additional training and competency is achieved and assessed

Group entitlement

Where group entitlement is used, each individual within the group must be identified and their names documented. They must have a scope of practice which defines the tasks they have been entitled to undertake once they have been deemed trained and competent.

Scope of practice

An individual’s scope of practice should outline the range of tasks for which they have been entitled to act as a duty holder. Information on skill mix and scope of practice is available on the Society of Radiographers website. An example template for individual scope of practice accompanies this guidance.

An individual’s scope of practice and entitlement should be reviewed and updated to accurately reflect individual’s roles. When a mammographer carries out additional training for example, to perform imaging for breast implants, their training records must be signed and dated by both trainer and trainee to demonstrate they are competent. Their scope of practice should be updated to reflect their competency in this task.

When an IR(ME)R duty holder role or scope of practice changes, this must be documented to ensure patient safety, Trust indemnity is in place, and appropriate governance is in place, for the new role/scope practice. A duty holder’s entitlement and scope of practice should be reviewed as part of the annual appraisal process or when they complete training and gain competency in an additional task.

A scope of practice may be limited for example, assistant practitioners may authorise a restricted range of exposures using authorisation guidelines.

Scope of practice example scenario

The director of screening is keen to offer development opportunities to staff within their breast screening service. The clinical lead radiologist provides a training programme and spends time training, mentoring and supervising one of the senior radiographers who has expressed an interest in performing stereotactic biopsies. Once the radiographer has completed their training and competencies, the clinical lead radiologist signs off and dates the training records. The training records and competency sign off documents are reviewed by the director of screening before they entitle the radiographer as an operator to carry out this advanced scope of practice.

Question 5

5. Employer’s procedures and written protocols (work instructions)

Accepted Answer

5.1 Employer’s procedures

Regulation 6 requires the employer to have in place written employer’s procedures, outlined in Schedule 2, as a minimum.

All duty holders must read and comply with the relevant employer’s procedures.

It may be appropriate for the breast screening service to adopt and be included in the host organisation’s employer’s procedures, or it may be more fitting to create specific employer’s procedures for the breast screening service. This will be a local decision. Employer’s procedures must:

outline the responsibilities of the duty holders involved in the delivery of the breast screening service
provide clear instructions on how and when a process is carried out
identify who is responsible for carrying out the tasks involved in that process.

The following employer’s procedures are relevant to the NHS BSP, however a full set of the Schedule 2 employer’s procedures is required.

The employer may wish to include additional procedures specific to their service.

5.2 Employer’s procedures relevant to NHS BSP

The Schedule 2 procedures relevant to the NHS BSP are:

Schedule 2 (a): the employer should check identification of the woman (see section 9) to be exposed to ionising radiation
Schedule 2 (b): the employer should check identification of individuals entitled to act as referrer, practitioner or operator (see section 4) within a defined scope of practice
Schedule 2 (c): the employer should make enquiries of women of childbearing potential to establish pregnancy or breastfeeding status (see section 10) (mammography is not routinely performed when a woman is breastfeeding due to the density changes in breast tissue)
Schedule 2 (d): the employer should have a procedure to ensure QA programmes for written procedures, protocols and equipment (see section 18) are followed
Schedule 2 (e): the employer should ensure dose is within safe limits (see section 15)
Schedule 2 (f): the employer should use and review diagnostic reference levels (see section 16)
Schedule 2 (g): the employer should carry out and record research programmes where appropriate including the use of dose constraints
Schedule 2 (i): the employer should provide adequate information in relation to the benefits and risks (see section 11) associated with the radiation dose
Schedule 2 (j): the employer should carry out and record clinical evaluation (see section 13) for each exposure
Schedule 2 (k): the employer should ensure the probability and magnitude (see section 21) of accidental or unintended exposures are reduced as far as practicable
Schedule 2 (n): the employer should establish appropriate dose constraints and guidance for the exposure of carers and comforters (see section 12)

A full set of employer’s procedures is a requirement. A brief statement, for example ‘non-medical imaging is not carried out in this department’ is sufficient.

The following employer’s procedures are also required by Schedule 2 of IR(ME)R but may not be relevant to the NHS BSP:

Schedule 2 (h): the employer should have written information and written instructions for patients receiving radioactive substances
Schedule 2 (l): the employer should ensure the referrer, practitioner and the individual exposed or their representative are informed of the occurrence of any relevant CSAUEs
Schedule 2 (m): the employer should have a written procedure for non-medical imaging

Information on what should be included in each employer’s procedure is described in the relevant sections.

5.3 Written examination protocols (work instructions)

Written examination protocols must be in place for every type of standard mammographic practice. In some services, examination protocols are known as work instructions.

Examination protocols include descriptions of how an examination is carried out. They should be locally established and written collaboratively by mammographers, radiologists and MPEs.

For consistency, a standard template should be considered. See the accompanying example standard examination protocol.

Robust management of written protocols is essential to ensure the correct radiographic techniques and exposure factors are used. Examination protocols are stored electronically and should be controlled and locked so that changes can only be made by a limited number of authorised staff.

A system should be in place to ensure that exposure factors and settings have not been inadvertently changed following routine service or repair of equipment. Controlled copies of written protocols should be available to cross check electronically embedded protocol settings. See section 18 for further details.

Examples for inclusion in written examination protocols are shown below. This list is not exhaustive and the MPE/operator may wish to include other aspects depending on the equipment/technique. Protocols should include:

acquisition mode
automatic exposure control (AEC) mode
dose setting (if applicable to a specific unit)
diagnostic reference levels (DRLs)
focal spot selection
grid
collimation
standard views
exceptions to standard exposure factors and/or views
transfer of images
post processing
fault reporting

Question 6

6. Document quality assurance and audit

Accepted Answer

IR(ME)R describes quality assurance as any planned and systematic actions necessary to provide adequate assurance that a structure, system, component or procedure will perform satisfactorily and safely, complying with agreed standards (Regulation 2(1)).

A robust document QA programme supports safer service delivery, promotes a consistent approach across the service, provides assurance of service quality to the employer and drives improvement through review.

IR(ME)R requires there is an employer’s procedure which describes the quality assurance programme in place for written employer’s procedures and examination protocols (Regulation 6(5)(b), Schedule 2(d)).

6.1 Documents QA

There are many aspects to document QA programmes including that documentation must be regularly reviewed, it is followed by staff, it reflects current clinical practice and that only the latest version is available.

The timeframe for review should be set out in the employer’s procedure and agreed locally to ensure documentation, for example employer’s procedures and examination protocols, are up to date and reflect current practice. This involves the establishment of a formal document issue and control system.

The NHS BSP requires all services to have a quality management system (QMS) in place which details all core processes and work instructions involved with service delivery.

In developing such a document control system, employer’s procedures and examination protocols should cover:

identification of who writes the work instructions
inclusion of a lead radiographer, QC radiographer and medical physics expert in the writing group producing the work instruction
how the procedures and protocols are ratified
the frequency of review
a process to demonstrate how work instructions are shared with staff to include how and when new updates are issued

Where paper copies are used, include a disclaimer stating ’uncontrolled when printed’.

The management of written procedures and protocols should ensure that only the latest version of any document is used by staff. This can be accomplished by using an electronic shared area on hospital servers that staff have ‘read only’ access to.

Printing of multiple copies should be discouraged as it may increase the possibility of outdated paper copies being used. With appropriate document control, however, paper copies may be acceptable. This decision should be made at a local level.

Employer’s procedures and examination protocols should include the following control measures:

document version number
revision history
date of approval
review date
author(s) and person(s) responsible for document

All documentation, including IR(ME)R employer’s procedures, should be reviewed regularly at an agreed timeframe or when practice changes. Document review is the responsibility of the breast screening unit management team and quality and audit manager (or equivalent). Monitoring of staff to demonstrate evidence of reading and understanding the written examination protocols is mandatory (see section 5).

6.2 Audit

The document QA programme for employer’s procedures and examination protocols should cover all aspects of the breast screening service. A system of regular audit is essential to ensure the document QA programme is being followed.

IR(ME)R audit

A schedule of IR(ME)R audits should be drawn up on a rolling programme to check employer’s procedures are in place and being followed.

IR(ME)R audits may cover (this list is not exhaustive):

ensuring IR(ME)R referrer, operator and practitioner entitlement is up to date and accurately reflects individual’s scope of practice
identifying the operator authorising an examination
ensuring IR(ME)R practitioner and operator training records are available and up to date
identifying the operator who performed the ID check and where or if this is recorded
calculating reject/repeat rates, and checking against NHS BSP standards and taking action where appropriate
checking evidence of a written clinical evaluation is completed for all examinations

Having a robust programme of appropriate IR(ME)R audits where review, improvement and change in practice can be demonstrated, may provide the employer with some assurance of a robust IR(ME)R framework.

Clinical audit

IR(ME)R Regulation 7 requires that the employer provides for the carrying out of clinical audit.

A clinical audit programme is a tool to identify and improve healthcare outcomes across the breast screening pathway.

Clinical audit involves a multidisciplinary team approach to identify when practice falls short of the specified best practice standards. Where clinical audit highlights areas requiring improvement, education and training should be offered, system processes reassessed and change actioned. After a specified period of time the changes should be re-audited to ensure the corrective action has had the required effect.

Examples of clinical audit in the breast screening programme include:

regular review of a set number of clinical images to ensure they meet NHS BSP technical requirements in the NHS BSP guidance for breast screening mammographers
regular review of clinical evaluation (written reports) compared against the required NHS BSP performance standards in the radiology guidance for the NHS BSP
review of technical recalls and repeats to monitor compliance with the NHS BSP programme standards (where necessary, appropriate action should be taken)

Question 7

7. Breast screening referral process

Accepted Answer

The referral process for breast screening is different to an individual imaging referral requested by a healthcare professional. Women are invited for screening if they meet the referral criteria in accordance with the national service specification. The screening invitation letter must be issued/signed by a registered healthcare professional, entitled by the employer as a referrer. This may be the director of screening or the lead radiologist.

Each breast screening service must have referral guidelines which outline the set criteria by which a woman is eligible for breast screening and should also include clear processes for dealing with exceptions.

A mammogram may be performed for routine invitations when:

the woman is registered with a GP practice
the woman is aged between 50 and up to her 71st birthday
a minimum of 6 months has elapsed since a previous mammogram
the woman has not had a bi-lateral mastectomy

The mammographer carrying out the examination will ask the woman when and where they had their last mammogram, and if known, the date and discussion must be documented. Verbal confirmation is sufficient and does not routinely require further checks. If the time since last mammogram is greater than 6 months, the mammographer will continue with the breast screening examination.

If any woman wishes to opt out from the breast screening programme they should be told to contact their local breast screening office and follow the process outlined in guidance on opting out (ceasing) from breast screening.

7.1 Non-routine invitations for screening

Each breast screening unit must have a written procedure which describes how to manage women with non-routine invitations for screening.

7.2 Women who attend for screening before the specified timeframe.

If the time lapse since the last mammogram is less than 6 months ago, no images should be taken at this appointment unless the woman is returning for screening following a technical recall appointment. The mammographer should advise the woman to contact the breast screening office to reschedule her appointment when the appropriate time has passed since her previous mammogram.

7.3 Women who attend for screening without an invitation

There are rare occasions when women who are eligible for breast screening attend but do not appear on that day’s clinic sheet/worklist and do not have a letter of invitation with them. This may include:

women who attend on the wrong day without their letter
women who have been previously invited but did not attend and now attend opportunistically

In these cases, mammograms must not be performed unless it is confirmed the woman is registered with the breast screening unit and the referral criteria are met.

When a woman attends without an invitation for screening on a mobile unit, mammographers may contact the breast screening office to check the woman’s previous screening history, or any other appropriate detail to establish eligibility. If they are registered with the breast screening unit, the mammogram may be carried out if the referral criteria are met.

A radiographer can act as a non-medical referrer if entitled to do so, to allow the examination to proceed. A non-medical referrer must be a registered healthcare professional, who is trained and is deemed competent to refer within a defined scope of practice relating to the specialty in which they work.

An AP may not be entitled as a referrer, as this staff group are not registered healthcare professionals.

If 2 APs are working together on the mobile unit with remote supervision and need a referral for a woman, they must speak with an entitled registered healthcare professional at the breast screening office who then acts as the referrer for this examination. If the referral criteria are met and the referral completed, the APs can then proceed to authorise and undertake the examination. The name of the individual acting as referrer must be recorded.

No images should be taken and women should be asked to contact their local breast screening service for advice if:

they are not registered with a GP
they are new to the area and have not yet been invited for screening
there is no entitled referrer available

7.4 Women over the current invitation age range

After their 71st birthday, women are no longer invited for routine screening. However, they may ask to be screened once every 3 years by contacting their local breast screening service. In this instance, the referrer remains the same as that for routine screening, and the trigger for an invitation comes from the woman herself.

7.5 Partial examinations

In exceptional circumstances, a mammogram may be taken which would be classed as a partial examination (where at least 50% of the breast is imaged). Appropriate information stating the limitations of the examination must be provided to the woman (for example, the national programme leaflet on partial or incomplete mammography). If the mammographer can image at least half of the breast, in any view, then the examination can be deemed to be clinically acceptable. Local written procedures should provide details on how to manage partial examinations based on national guidance on partial mammography .

7.6 Technical recall

In some circumstances, a woman may have to be recalled for technical reasons. The decision to recall will be made by the operator reporting the mammogram and they will act as the referrer for the technical recall views. They must be entitled as a referrer by the employer before they perform this task. This process should be reflected in the written procedures. Guidance on recording data on repeat mammograms is available.

7.7 Technical repeats

If a suboptimal image is produced, for example, inadequate image quality due to movement, a local protocol should indicate how and when repeats can be performed. The mammographer should use their clinical judgement when reviewing their images to decide when a repeat is necessary. Radiographers and APs must have adequate training and be deemed competent to recognise when technical repeats are necessary. It should be noted that technical repeats remain under the initial referral and existing justification.

7.8 Screening out of area

Women can choose to be screened at another service. There is a process and guidance to manage this. Where the woman is accepted for screening and sent an invitation by an alternative service (to her host service), the new service become the referrer under IR(ME)R.

7.9 Gender reassignment

Individuals undergoing female to male gender reassignment are invited for breast screening if they are registered with a GP as a woman.

Individuals undergoing male to female gender reassignment and who have been on hormone therapy should consider having breast screening as they have a higher risk of breast cancer compared to a man who has not had this hormone therapy. Their GP may refer for a screening appointment if they are eligible, based on their position within the reassignment pathway (which determines the amount of glandular tissue that is present).

If any individual wishes to be removed from the programme they should contact their local breast screening office. Further information is available in screening information for transgender people.

Question 8

8. Justifying and authorising breast screening exposures

Accepted Answer

8.1 Justification

Justification is the intellectual process of weighing up the expected benefit of an exposure to ionising radiation against the possible detriment of the radiation dose and the imaging process. For the breast screening programme, the benefit is the early detection and treatment of breast cancer or the knowledge that no disease is present. The detriment may be treatment of a very slow growing cancer which is unlikely to cause harm in the woman’s lifetime, false positive/negative results or radiation induced cancer.

Justification is the primary role of the IR(ME)R practitioner who must be a registered healthcare professional, such as a radiographer or radiologist. An assistant practitioner may not act as an IR(ME)R practitioner justifying exposures.

Justification must be carried out prior to an exposure and all exposures involving ionising radiation that apply under IR(ME)R must be justified. In the breast screening service, mammographers undertaking routine screening are entitled as operators working to authorisation guidelines provided by a named IR(ME)R practitioner.

The mammographer compares the completed client screening form against the authorisation guidelines and if these match the criteria, the exposure can be authorised, and the mammogram performed.

If the details on the client screening form fall outside the authorisation guidelines the mammographer cannot authorise the exposure.

Considerations for the justification of breast screening exposures (Regulation 11(2)

Specific objectives of the exposure and characteristics of the individual – consider:

Diagnostic benefits to the individual – consider if the exposure will answer the clinical question.

Detriment the exposure may cause – consider:

risk from radiation dose
potential exposure to carers and comforters
false recall
over treatment for a very slow growing cancer

Alternative techniques using less or no radiation (see higher risk guidance – consider:

how effective alternative techniques are (do they fit with the breast screening guidelines)
if the alternative is available locally

There are some additional considerations when justifying exposures for individuals who are part of a health screening programme.

Regulation 11(3)(c) says where a medical exposure is to be performed for early detection of disease, for example as part of a health screening programme, the IR(ME)R practitioner justifying the exposure must also take into account any guidelines issued by medical scientific societies, relevant bodies or the Secretary of State. The NHS BSP is an appropriate example of a relevant body for this requirement and screening assessment guidelines should be considered.

Justification of breast screening exposures – example scenario

A radiographer within a breast screening unit is entitled as a practitioner for a specific scope of practice. This includes justification and authorisation of all mammographic exposures performed on the mobile screening units and the majority of exposures carried out at the assessment unit. The radiographer is not entitled to justify stereotactic biopsy exposures. When referrals for these examinations are received, they must be justified and authorised by the advanced practitioner who is entitled as a practitioner for these examinations.

Justification of exposures to carers and comforters

Justification and authorisation for carers and comforters can be carried out by an IR(ME)R practitioner or an entitled operator using signed authorisation guidelines (further information on authorisation of exposures to carers and comforters can be found below).

In addition to the considerations for justification already described, there are some specific points that must be considered when justifying exposures to carers and comforters.

Additional considerations for justifying exposures to carers and comforters (Regulation 11(3)(b)(i-iii))

Likely health benefits to the individual being examined: consider having a diagnosis or knowing there is no underlying medical issue.

Possible benefits to the carer and comforter – consider:

reassurance of a relative or friend receiving medical attention
helping to support the examination going ahead

Detriment the exposure may cause – consider potential exposure to carer and comforter.

See section 12 for further details.

Justification for research exposures

All research exposures require individual justification and signed authorisation. Research exposures must be clearly identified and the research trial must have research ethics committee approval and approval by the breast research advisory committee (RAC). See section 22 for further details.

8.2 Authorisation

Authorisation is a separate process to justification. It is the documented evidence to show that the intellectual activity of justifying an individual exposure has taken place. Authorisation is the means by which it can be demonstrated that the justification process has been carried out.

The authorisation process may be completed by signing a referral form or a completed client screening form. This can be done either manually or electronically on a centralised system such as the client electronic record when an individual authorising the exposure can be identified by their login passcode or initials.

When it is not practicable for an IR(ME)R practitioner to individually justify an exposure then a suitably trained and entitled operator (mammographer) may authorise the exposure working to the signed authorisation guidelines provided by an individual IR(ME)R practitioner. The IR(ME)R practitioner who has issued the authorisation guidelines is responsible for the justification of all exposures authorised to their guidelines.

Authorisation of a referral can be carried out by an IR(ME)R practitioner at the time of justification or by an operator working to signed authorisation guidelines.

Authorisation of exposures to carers and comforters

As it is not always practicable for an IR(ME)R practitioner to justify exposures to carers and comforters, they may provide authorisation guidelines to allow an operator to authorise the exposures to these individuals. If the circumstances surrounding the exposure to a carer or comforter are not covered within the authorisation guidelines, the exposure must be justified by an entitled IR(ME)R practitioner. See section 12 for further details.

Authorisation example – scenario 1

A woman arrives for her booked appointment at a mobile breast screening unit. She brings her appointment invitation letter and her completed client screening form. The mammographer takes the woman through her client screening form to confirm her name, date of birth, address and the last time she had a mammogram performed. Some clinical questions are asked about breast changes, pain or lumps. The answers provided by the woman match with the information on the client screening form and the authorisation guidelines provided by the director of screening who will be the IR(ME)R practitioner for this examination. The mammographer signs the client screening form to demonstrate the authorisation process has been completed and the mammogram is performed.

Authorisation example – scenario 2

A woman presents to the mobile mammography screening unit having seen it parked in her local area. The woman is asked to complete a client screening form to confirm and record her correct name, date of birth, address and when her last mammogram was performed. The mammographer telephones the breast screening unit to confirm if the woman is eligible for a screening mammogram. The woman is new to the area and is not yet registered with a local GP practice. The radiographer explains that the mammogram cannot be carried out today and advises the women to contact her local GP practice and that once registered she will in due course be invited into the programme.

Authorisation example – scenario 3

An organisation is involved in a pilot study to assess the practice of 2 assistant practitioners working with remote radiographic supervision on a mobile breast screening van. A woman arrives at the unit on the off chance of having a mammogram. She explains that she was sent an invitation letter but cannot find it and cannot remember when her appointment was. The woman is asked to complete a client screening form to confirm and record her correct name, date of birth, address and when her last mammogram was performed. One of the APs contacts the breast unit with this information. Having gained confirmation that the woman is eligible for a mammogram and her details match that on the National Breast Screening System (NBSS) she asks to speak with one of the radiographers who is entitled as an IR(ME)R practitioner and referrer. The radiographer completes the required referral documentation on the system and records that the exposure is justified. The AP acting as an operator, authorising to guidelines, completes the client screening form and adds their signature to record that the exposure has been authorised. The mammogram is performed.

Authorisation example – scenario 4

An AP and a radiographer are working together on a mobile mammography screening unit. The radiographer is busy in the X-ray room performing a mammogram. The AP is speaking with the next woman scheduled and is going through the completed client screening form. The woman has ticked the box stating they have breast implants but has not followed the instructions to inform the screening service about their implants. The AP is unable to authorise the exposure for women with breast implants as these are not included within the authorisation guidelines issued by the director of screening (the named IR(ME)R practitioner). The radiographer therefore performs the justification and authorisation for this woman as they are an entitled IR(ME)R practitioner for this group of exposures. The AP’s scope of practice as an operator does not include performing mammography on women with breast implants, so the radiographer performs the examination.

Authorisation example – scenario 5

Two trained, competent, and entitled APs are working together on a mobile van with remote HCPC registered radiographic supervision. One of the APs undertakes a routine set of mammographic images. On reviewing those images, they notice that one of the views is sub-optimal. The AP uses their clinical judgement and decides to perform a technical repeat. They do this autonomously as they have had the necessary training and competency to recognise when technical repeats are required. A local protocol is in place which clearly indicates how and when repeats can be performed. Where an AP requires additional support to make a decision whether a technical repeat is necessary, there is a robust and documented system in place to contact a supervising radiographer who provides advice and support.

Note that technical repeats remain under the initial referral and do not require further IR(ME)R justification. Technical repeats can be undertaken by an AP who is trained and deemed competent when the local protocol is adhered to.

Question 9

9. Identification of the individual to be screened (exposed)

Accepted Answer

Schedule 2(1) requires the employer to establish employer’s procedures to correctly identify the individual to be exposed to ionising radiation.

Operators must carry out identification checks at the first point of contact and before any examination is performed. Confidentiality should always be maintained, where possible.

For routine breast screening examinations, direct, positive questioning is required to establish identification as detailed in RCR guidance. Ask the woman for her:

full name
date of birth
first line of her address

All responses must be cross checked and match the information provided on the client screening form/day list if working on a mobile unit or the referral form for assessment clinics. The woman’s full name, date of birth (DOB) and NHS number must also be checked against the worklist on the acquisition workstation.

Correct identification of the woman is an operator task and must be carried out before any exposure is made. However, correct identification of the woman always starts with the referral. The identification process must be documented by the operator performing this task and this should be evidenced by a signature on the client screening form or electronic signature on NBSS and/or the radiology information system (RIS).

If positive identification cannot be confirmed, the woman should not be examined, and this must be documented on the client screening form and recorded as ‘attended not screened’ (ANS).

There are a number of circumstances when identification may be challenging. It is important that these situations are outlined in the employer’s procedure, identifying alternative means of robustly establishing the correct identity of the woman.

9.1 Example alternative methods for identification

Ask for identification to be checked by an accompanying person (for example, staff, carer, chaperone, family member) for women lacking capacity, vulnerable, confused or unable to respond (for example post stroke).

For women with sensory impairment (for example impaired sight or hearing) consider using:

written cards or sign language
other forms of identification (such as a photo ID driving license or passport)

For women who require an alternative language to communicate (assessment only): use an interpreter (for example, use of trust interpretation service via phone during assessment clinic), or an advocate can confirm details.

The mammographer should ensure the woman understands why she is attending for screening. In the assessment setting, the mammographer should carefully cross check the recall information they have available with the woman to ensure that the correct imaging is performed for the appropriate side(s). SoR guidance Have you paused and checked? A clinical imaging examination IR(ME)R operator checklist is available to support this process.

9.2 Training of operators to carry out the identification process

It is the responsibility of the employer to ensure entitled operators (for example mammographers and radiologists) read and follow the employer’s procedures and local work instructions to fulfil the requirements of the NHS BSP and comply with IR(ME)R.

The work instructions may include information on:

processes for identification of the women (IR(ME)R requirement)
change of details form
change of details letters
documentation checklist for breast imaging biopsies
client screening form

9.3 Multiple operators involved in mammography examinations

When multiple operators are involved in an examination, the woman may have identification checks performed at different points in the imaging pathway. The operator performing the exposure must confirm the correct identification of the woman. The identification check must be clearly documented to demonstrate which operator completed the final check before carrying out the exposure.

If a radiologist is also involved in the examination, for example, a biopsy, they should cross check the woman’s identification with the operator undertaking the exposure. Following biopsy, the clinician must verbally confirm with the woman that the name and date of birth on the ID label are correct before attaching the label on the sample container. The operator may make a final cross check of the ID and label.

9.4 Discrepancies in the identification process

If there are any identification discrepancies these must be clarified before the examination can commence. You must:

ask the woman to state her full address and/or telephone number for checking against the client screening form
check details of previous visits
check for photo ID if available
check all information against previous records on NBSS

The examination can only take place when the details have been verified and updated. Information must be written clearly on the woman’s screening form and a record made by the mammographer. A change of details form must be completed for any detail changes.

If the details still cannot be verified the examination cannot take place. The mammographer must explain to the woman the reason why the examination has been delayed, give the timescale for the next appointment and how the woman will be contacted to re-attend. The woman should be given a copy of the change of details letter as confirmation of the request to change.

There may be scenarios where identification may be a sensitive issue for some clients to enhance inclusivity. Mammographers should be familiar with information about screening for transgender (trans) individuals and trained to navigate the process appropriately.

Question 10

10. Pregnancy and breastfeeding enquiries

Accepted Answer

10.1 General population breast screening

There is no significant radiation risk to the foetus from mammography for breast screening in the general population. There is no requirement from a radiation dose perspective to routinely enquire about pregnancy prior to the exposure for routine breast screening imaging.

However, there may be significant radiological changes to breast tissue during pregnancy and when breastfeeding which can affect the diagnostic quality. Due to this, locally agreed protocols may specify enquiring about the status in women of child-bearing age, for example up to age 55 years, and how this is recorded. Further information on imaging surveillance in pregnancy and lactation is available in RCR guidance on screening and symptomatic breast imaging.

10.2 High risk and very high risk breast screening

Women with a high risk family history, particularly those who are BRCA gene carriers, continue to be at increased risk of breast cancer during pregnancy. Screening during pregnancy and lactation is therefore acceptable in these high-risk groups.

There is no significant radiation risk to the foetus from mammography, however the radiation dose to the breast will be raised, and the associated risk to this young, potentially radiosensitive population should be considered. The pregnancy/breast feeding status of high-risk women up to the age of 55 years should be asked and documented.

Question 11

11. Communicating benefits and risks of screening

Accepted Answer

IR(ME)R requires that, wherever practicable, and prior to an exposure taking place, the individual to be exposed (or their representative) should be provided with adequate information relating to the benefits and risks associated with the radiation dose arising from the exposure.

The employer must have in place an employer’s procedure which formalises the established practice of informing women of the benefits of having the exposure weighed against the potential detriment caused by the ionising radiation (Schedule 2(i)).

Women invited for screening are provided with the NHS breast screening invitation leaflet in advance of their first visit. The leaflet describes both the benefits and risks of screening mammography, and specifically includes information on the radiation risks. The current information states ‘X-rays can very rarely cause cancer. Having mammograms every 3 years for 20 years very slightly increases the chance of getting cancer over a woman’s lifetime’.

Subsequent screening invitations include links to the information online. The information is also available online in a range of languages.

It is not necessary for NHS BSP staff to provide additional information about the benefits and risks from the X-rays used in breast screening mammography unless specifically asked. However, the operator should ensure that the women have read and understood any information on radiation risks provided in either the leaflet or appointment letter. Posters can be provided in waiting areas and/or the X-ray room to supplement any information provided prior to the visit. An example of a suitable poster is provided by the Clinical Imaging Board.

The employer’s procedures should outline the information given to the woman. The operator must be trained and competent to provide this information. In the event of being asked for further information, the operator should explain that the radiation exposure from a routine two-view bilateral screening mammogram:

The IR(ME)R practitioner or the operator may need to proactively provide information on the radiation risks to women who undergo specialised imaging techniques such as digital breast tomosynthesis (DBT) or contrast enhanced mammography (CEM). Relevant posters and other materials provided by professional bodies should be displayed and made available in the department.

Further information on risk and communicating risk is available in Society and College of Radiographers (SCoR) guidance and professional body IR(ME)R guidance.

Where the operator is asked for further information, the representative radiation exposure from both CEM and DBT (including the 2D views) can be described as equivalent to around 6 months’ natural background radiation. The cancer induction risks from both techniques can be described as ‘very low’ compared the natural risks of cancer from all causes.

You can direct women to further online information about radiation risk. The Medical Physics Expert (MPE) and/or the IR(ME)R practitioner may also be consulted for advice where a woman needs more detailed information on the benefits and risks of having a screening mammogram.

Where women undergo procedures involving imaging for which additional written consent is required, (for example needle biopsies), information on the benefits and risks of the exposure may be provided on an individual basis where requested by the woman (usually after consulting the MPE). While there is no requirement under IR(ME)R to have explicit written consent to receive a radiation exposure during such procedures, this could provide the opportunity to include the benefit and risk information on the written consent check list.

Women who undergo mammography imaging as part of a research trial approved by an ethics committee should have specific information about the radiation exposure and corresponding risks provided by the patient information leaflet/consent form. See section 22 for further details.

Where a woman requests further information about the risks, the operator could include an explanation of how each exposure has been justified and the benefit of having the examination outweighs the small risk of the radiation dose.

11.1 Information on communicating benefits and risks to carers and comforters

Carers and comforters who support women during breast screening examinations should be informed of the benefit and risk information as specified in the local employer’s procedure. They could be informed that the risk from such an exposure is considered minimal. See section 12 for further details.

11.2 Women who lack capacity to understand information provided on benefits and risks

An explanation of the mammographic procedure, before it is performed, must include the use and implications of the exposure to radiation by ensuring that the information provided prior to screening has been understood. For consent to be valid, it must be given voluntarily (without pressure from others), as part of an informed choice, and the woman must have the capacity to consent.

SoR guidance on mental capacity decisions in diagnostic imaging and radiotherapy is available. Capacity means the individual can understand information about the procedure, including benefits and risks. Mammographers should use professional judgement to decide if consent has been given prior to, and maintained throughout, the examination. If consent is withdrawn at any stage, the examination must be stopped, and a record of the events documented.

Question 12

12. Screening exposures involving carers and comforters

Accepted Answer

Regulation 2(1) describes carers and comforters as individuals who are knowingly and willingly exposed to ionising radiation by supporting individuals undergoing an exposure, other than as part of their occupation. IR(ME)R requires that breast screening services establish written procedures for the exposure of carers and comforters, including appropriate dose constraints and guidance (Schedule 2(n)).

The support required may be physical, emotional and/or cognitive. Support from a carer or comforter should only be sought where it is considered necessary in order to achieve a good mammogram, or where lack of support may mean that the exposure is inadequate or has to be repeated.

Physical support should only be given where the objectives cannot be achieved by mechanical or other means, for example, by imaging the woman in a chair. Wherever practicable, carers and comforters required to provide physical support should stand behind the woman where they will partly be shielded by her. Carers and comforters providing emotional support should stand behind a protective screen such as the lead glass panel at the console.

12.1 Justification of exposures to carers and comforters

Regulation 11(3)(b) requires that exposures of carers and comforters are justified and authorised. The individual acting as the IR(ME)R practitioner for the woman’s exposure can also act as the IR(ME)R practitioner for the carer or comforter. Some employers will entitle their radiographers as IR(ME)R practitioners for a limited scope of practice for example, to enable them to justify exposures to carers and comforters.

Where it is not practicable for the IR(ME)R practitioner to authorise an exposure, entitled operators can do so in accordance with authorisation guidelines issued by the practitioner. Authorisation guidelines must describe the situations and circumstances in which the exposure to carers and comforters are justified. An entitled operator who may be an AP, or a radiographer working to the guidelines, can authorise the exposure if the criteria are met. Any exposures not described in the authorisation guidelines would need to be justified by an IR(ME)R practitioner. See section 8 for further details.

The suitability of a person to act as a carer or comforter will be assessed by the operator, taking into account their ability to understand and follow instructions and to provide consent. Children under the age of 18 years and pregnant individuals would not normally be designated as carers and comforters.

Support of a carer or comforter may be required for women:

who physically cannot support themselves and where positioning may be difficult due to physical challenges
with learning disabilities
with visual or hearing impairments, for example to help provide instructions
who lack capacity for other reasons for example, if they cannot be left alone for their own or others safety or if they have been sectioned

The operator must use their professional judgement to determine whether the circumstances meet the above criteria. If in doubt, they should seek guidance from a more experienced operator or an IR(ME)R practitioner.

Use the client support form to make enquires and record:

the name of the carer or comforter
the carer’ s or comforter’s relationship to the woman
whether they are over 18 and whether they are pregnant (where relevant)
whether they have ever provided support before and if so, how many times, and for what procedures
details of the number of exposures and the reasons why support was necessary

The operator should gain verbal consent from the carer or comforter to be in attendance during the mammogram, and inform them of:

the risks of the exposure – these should be explained simply and clearly, for example ‘we believe the risks to you from providing this support are very small, and your assistance will help us to diagnose your relative/friend’
what (and what not) to do and where to stand

The operator should sign and date the carer and comforter support form (see the accompanying example form. This form:

confirms all the information that has been entered
acts as confirmation that the carer or comforter has consented to providing their support
confirms that the exposure has been authorised.

A record of the carer and comforter support form should be kept, for example by scanning into the IT system.

Every effort should be made to ensure the dose received by the carers and comforters are as low as reasonably practicable. Dose constraints must be set for the exposure of carers and comforters, taking into account the doses that these individuals are likely to receive and the number of times they might be required to support a woman (Regulation 6(5)(d)(ii),Schedule 2 (n)).

A whole-body dose constraint of 0.3 mSv per year may be considered appropriate for mammography, but this should be supported by a risk assessment.

The exposure of workers, for example care home staff, who help in the support and comfort of women is regulated by the Ionising Radiation Regulation 2017 not IR(ME)R. These are considered occupational exposures. More published information is available on working with ionising radiation. The same measures would be taken to restrict exposures to these individuals. Wherever practicable a carer or comforter should provide support in preference to a mammographer.

Question 13

13. Clinical evaluation when reporting breast imaging

Accepted Answer

Clinical evaluation is the clinical interpretation of an image and the recorded outcome (documentary evidence) of that reading. IR(ME)R Regulation 12(9) states that a clinical evaluation for each exposure must be recorded. There must be systems in place to ensure all images are clinically evaluated and formally reported.

Clinical evaluation is an operator duty holder task and is a practical aspect of the exposure. An operator is any person who is entitled to carry out practical aspects of an exposure (for example clinical evaluation). Clinical evaluation can only be performed by operators who have undertaken specialist training and achieved a recognised qualification in breast image interpretation and are entitled to do this task by the employer.

Clinical evaluation is reported electronically on the NBSS, which is available to all staff who have the appropriate permissions. In some scenarios, for example where a biopsy is performed, clinical evaluation may be written by the operator in the woman’s clinical notes. The dose factors may also be recorded in the clinical evaluation, if required. Each process for documenting clinical evaluation should be clearly described in the employer’s procedure (Schedule 2(j)). Each employer must have a process for the management of repeat and rejected images of non-diagnostic quality and partial mammography.

The NHS BSP has a robust system of double reporting in place. This involves 2 image readers independently providing clinical evaluation on a set of images. If 2 or more image readers do not reach consensus from the initial clinical evaluation, then a process called arbitration is instigated. Screening services undertake arbitration in different ways using either individual or a panel of readers to arbitrate cases.

The processes for clinical evaluation, arbitration and the recording of the outcome of the assessment should be clearly described in the employer’s procedure.

If artificial Intelligence (AI) is used to support decision making, the process for its use should be described in the employer’s procedure. Under IR(ME)R a person must be involved in the clinical evaluation process for each exposure and AI cannot be used alone to perform image interpretation. If an AI image reader is used, the human reader remains responsible for the clinical evaluation. Currently, the use of AI has not been approved by the UK National Screening Committee (UK NSC) for use within the NHS BSP.

Question 14

14. Optimisation for breast imaging

Accepted Answer

One of the key principles of optimisation is to ensure that doses are kept as low as reasonably practicable (ALARP), consistent with the desired clinical results. This is important in the context of health screening programmes (Regulation 12(8)(b)) to meet population screening programme standards.

Optimisation is the joint responsibility of the IR(ME)R practitioner, operator (Regulation 12) and the MPE (Regulation 14(2)(c), Regulation 14(3)(a)). A multidisciplinary approach, which includes mammographers, radiologists and the MPE, is required as optimisation is not limited to dose reduction but linked with an understanding of image quality, how the equipment is used and efficient working practices. Optimisation of the equipment begins with procurement (when appropriate equipment is selected for the breast screening programme), critical examination, acceptance testing and commissioning.

Over the lifetime of the equipment, optimisation will include specific periodic reviews of the following:

DRLs
image quality
automatic exposure control (AEC) performance
service maintenance and robust quality assurance programmes (see section 18 for further details)

Optimisation is based on advice from the local MPE, the NCCPM, information provided by the manufacturer, and via consultation with clinical staff including mammographers and radiologists.

For every exposure, the operator must select the optimal method to ensure adequate image quality is achieved every time. For example, for standard screening mammograms, the AEC mode specified in the written examination protocol for the X-ray equipment should be used. For some examinations, such as screening women with breast implants, the work instructions will define the use of manual exposure factors or an adjustment to the automatic mode. Guidance on screening women with breast implants is available.

14.1 Considerations when optimising exposures

The following regulations are applicable, covering:

training (Regulation 17(1)): operators should be adequately trained how to use the equipment and position the woman
written protocols (Regulation 6(4)): note that examination protocols are required for standard views
quality assurance (QA) programmes (Regulation 6(5), Regulation 12(3), Regulation 15(1), (Schedule 2(d)): the employer should ensure QA programmes are in place for equipment and written procedures
clinical audit (Regulation 7): the employer is responsible for audit of practice - for example, image quality reject analysis

Optimisation should be reviewed on a regular basis over the lifetime of the equipment as performance may become sub-optimal when equipment ages. Escalating such issues through local risk registers and equipment replacement programs is essential.

14.2 Protocols for mammographic exposures

Image quality and dose assessment should be taken into account when creating written protocols for standard mammographic examinations. All images, technical repeats and additional views, must be described in the relevant written examination protocols and documented to include the relevant circumstances to comply with NHS BSP guidance on recording repeat examinations. For example, operators may repeat images from the standard breast screening views, if deemed technically inadequate.

Standard exposure factor charts must be available to the operator for examinations where the written protocol indicates that the AEC is not used, for example mammography of women with breast implants and implantable devices.

The written protocol for each mammographic examination should take into account the need for optimisation and should specify the appropriate equipment settings. The written protocol should cover:

acquisition mode
AEC mode
dose setting (if applicable to a specific unit)
focal spot
grid
collimation
standard views
exceptions to standard exposure factors and/or views
transfer of images
post processing
DRLs

A record should be made of the image processing settings along with the software version and following software upgrades the impact of the upgrade on the exposure and image processing settings must be checked by the MPE. This information is available in the DICOM header but may need to be provided by the supplier to the MPE due its complexity.

Mammographic exposure example – scenario 1

A woman arrives for her mammogram and informs the mammographer that she has a cardiac implantable device. As the device will affect the performance of the AEC and may increase the milliampere-seconds (mAs) significantly, the standard exposure protocol is not used. Instead the mammographer refers to the specific written examination protocol for implantable devices to optimise the exposures. As the device is sited on the left side of the chest, the right breast is imaged first using the AEC as per the standard mammogram exposure factors. The image is reviewed and as the exposure and image quality is acceptable the exposure factors are recorded. The mammographer sets a manual exposure to reflect the dose received to the right breast and performs the imaging of the left breast using these factors.

Mammographic exposure example – scenario 2

Following a routine maintenance service visit the appropriate QC tests are performed by the mammographer before the equipment is returned to clinical use. It is noted that there is a change in the mode selected for standard mammography imaging and the mammographer immediately informs the superintendent radiographer and MPE. Whilst the new mode will provide adequate image quality it is not the optimised set up. The equipment is not returned into clinical use and the service engineer returns to site and re-programmes the optimised exposure settings. On completion, further QC tests are performed and once the MPE is satisfied the correct protocol is now in place the unit is put back into clinical use.

Mammographic exposure example – scenario 3

A model of mammographic X-ray equipment is found to have low dose but also low image quality. Discussions are held at clinical professional groups (medical physics, radiographers and radiologists) to look at the evidence from local dose audits and national collation of dose audits through NCCPM along with image quality scores. A decision is made that for this particular model of X-ray equipment that the dose setting should be optimised in order to ensure the required image quality is achieved. This is implemented at a local level through the MPE.

Question 15

15. Dose assessment and recording

Accepted Answer

An employer’s procedure (Schedule 2(e)) is required for the assessment of dose. The procedure should describe how each exposure is recorded and must include dose information for repeat or additional exposures.

In the NHS BSP, the exposure parameters necessary for dose estimates are automatically stored in a digital record (DICOM header). However, there may still be local differences in how this information is collated, recorded or accessed for the purposes described below.

IR(ME)R requires dose to be recorded to:

establish local diagnostic reference levels (DRLs) (Regulation 6(5)(c))
establish whether a significant accidental or unintended exposure has occurred (Regulation 8(4)(a)(iii))
optimise and standardise protocols (Regulation 12)
collect dose estimates as required (Regulation 13)
establish dose constraints for research exposures (Regulation 6(5)(d)(i))
establish dose constraints for carers and comforters (Regulation 6(5)(d)(ii))

Factors relevant to dose may also be recorded as part of the clinical evaluation where appropriate (Regulation 12(9)).

Operators must be aware of which dose quantities and corresponding units should be recorded in accordance with their employer’s procedures. For example, mean glandular doses (MGD) in milliGray (mGy). They should be familiar with any patient dose indicators available on the system and should ensure that any available detector dose indicators are within the expected range.

Doses displayed on the system are useful indicators for the operator. However, unless they have been validated by the medical physics service, they should not be used for formal dose estimates (for example audits or incidents). Instead an independent dose calculation is required. Where a bespoke dose calculation is necessary it should be performed following the national protocol. This specifies the factors that are required and describes the method for calculating the mean glandular dose. The NCCPM have provided software to aid with such calculations.

Doses in the NHS BSP must be regularly monitored (at least every 3 years, or when there are changes to the mammographic equipment or technique used). This is achieved by evaluating the doses for a random sample of at least 200 women attending for routine breast screening or assessment. To allow comparison with DRLs there should be at least 40 women, included in the random sample, who are within the 50 to 60mm compressed breast thickness range. These sample sizes are the minimum acceptable values and are intended for sites without the ability to use automated methods for downloading data. Where automated methods are available larger sample sizes should be used.

The employer is required to collect dose estimates, accounting for age and size, and provide these to the NCCPM. These audits may be made available to the Secretary of State if requested. This is normally undertaken by the medical physics department in conjunction with the breast screening unit.

The delivery of a consistent radiation dose must be confirmed as part of the regular daily and monthly user QC checks and 6 monthly physics QC tests typically using polymethylmethacrylate (PMMA) blocks. See section 18 for further details.

Question 16

16. Diagnostic reference levels (DRLs) in breast screening

Accepted Answer

DRLs are typical dose levels for groups of standard sized individuals, or standard phantoms, for broadly defined types of equipment. The employer must provide operators with DRLs for exposures for typical examinations carried out as part of medical diagnosis or treatment (Regulation 6(5)(c)(i)(bb)(ii)).

Individual women’s doses should not be compared to mammography DRLs which are used as audit tools.

16.1 National DRLs

The current national DRLs for mammography are defined for breasts in the 50mm to 60mm compressed breast thickness range and are based on national dose audits organised in the NHSBSP. National DRLs are subject to periodic review. In addition, there are remedial levels applied to measurements of mean glandular dose (MGD) made using different thicknesses of PMMA blocks simulating breasts of different thickness. These may be different from national and local DRLs. National DRLs are subject to periodic review. The latest values for mammography DRLs are available online.

16.2 Local DRLs

An MPE should be involved in the process of setting the local DRLs and determining what, if any, action is required should they be consistently exceeded. Local DRLs should be regularly reviewed by the MPE in conjunction with clinical staff. Specific guidance on the establishment and use of local DRLs for diagnostic examinations is available published by the International Commission on Radiological Protection. Dose audit data should be compared to existing local DRLs which should have regard for European and national DRLs.

DRLs should not be consistently exceeded where good and normal practice is applied. Where they are consistently exceeded an appropriate review must be undertaken (Regulation 6(7)). Where necessary, this should lead to corrective action. This process should be clearly outlined in the employer’s procedures Schedule 2(f).

In accordance with NHS BSP guidance for medical physics services, reviews of DRLs should be undertaken every 3 years or when a change to equipment may affect dose. Reviews of doses against DRLs can be considered as part of the optimisation of image quality and dose.

DRL example – scenario 1

Mammographers help to collect mammography exposure data from one of their systems for a local dose audit (system A). The medical physics service calculates the MGD for each woman and an MPE reviews the data looking for unusual or undesirable features in the dose data and dose distributions. The MPE informs the mammographers that the doses for women in the 50-60mm compressed breast thickness range are significantly higher for this system than an identical unit next door (system B) but are still comfortably below the national DRL. The clinical lead carries out a review of the image quality and concludes that, in this instance, the higher dose is justified. The higher doses provide better image quality than on system B and are likely to result in a lower false positive rate. The local DRL is increased and the AEC on system B is adjusted appropriately.

DRL example – scenario 2

A breast screening centre has mammography X-ray equipment with a range of technologies and imaging modes. One of their X-ray units has a fundamentally different system of acquisition which achieves satisfactory images at a very different dose. After discussions with the MPE, it is decided to establish and use a separate set of local DRLs for this piece of equipment.

Question 17

17. Role of the medical physics expert (MPE)

Accepted Answer

IR(ME)R formalises the requirements for MPE recognition, clarifies the MPE role and requires breast screening services to appoint one or more suitably trained and appropriately experienced MPEs (Regulation 14(1). RPA 2000 holds the list of all individuals with the required competence to be entitled as an MPE. Further information for MPEs is available on the IPEM website.

The appointment of the MPE should be formalised in writing and the scope of practice clearly documented. Appointed MPEs and other medical physics staff who carry out practical aspects of an exposure, for example, equipment performance testing, must be trained and entitled as an operator by the IR(ME)R employer of the service they are contracted to support.

Appointed MPEs must have the necessary level of expertise to cover specialised techniques such as digital breast tomosynthesis and contrast-enhanced mammography (and so on) where appropriate. Training records held by the MPE should reflect how they maintain their expertise and knowledge by appropriate continuing professional development (CPD).

Regulation 14(2) and 14(3) clearly defines the role of the MPE and their required level of involvement in service provision. Roles of the MPE include:

contributing to equipment quality assurance programmes required by NHS BSP standards and guidance
involvement and advice on optimisation
involvement in dose audits
setting local DRLs and comparing against national DRLs
advising on selection, procurement and installation design of mammography equipment
advising on compliance with the requirements of IR(ME)R and associated guidance
contributing to the analysis of events involving or potentially involving accidental or unintended exposures
contributing to the training of practitioners and other staff in relation to radiation protection
liaising with Radiation Protection Advisor (RPA), where appropriate
providing advice and training on local quality control testing and protocols
advising on the introduction of new imaging technologies and techniques
assisting with developing employer’s procedures for breast screening exposures, ensuring they remain relevant and fit for purpose

Full details of the role of medical physics services in the NHS BSP are available in breast screening guidelines for medical physics services. This document can be used as a reference guide when devising a service level agreement for MPE services for a breast screening service. It also provides further details of the standards expected of MPE services, the necessary qualifications and experience for MPEs working for the NHS BSP and requirements for continuing professional development.

Question 18

18. Equipment and quality assurance (QA) within breast screening

Accepted Answer

IR(ME)R outline the duties of the employer in relation to equipment that delivers ionising radiation to an individual undergoing an exposure.

Regulation 15(1)(b) states that the employer must compile, and keep up to date, an inventory of all radiological equipment at each installation under their control. The inventory should be made available to the relevant ‘enforcing authority’ upon request. The inventory should include the equipment manufacturer, model, serial number, year of manufacture, and year of installation (Regulation 15(2)).

It should also include any ancillary equipment which could affect the exposure. It is unlikely that there will be any ancillary items in a routine breast screening setting. In the breast assessment setting however, there will be equipment such as biopsy attachments and sample imaging attachments which should be recorded on the inventory.

The employer must implement and maintain a QA programme for all radiological equipment that they control (Regulation 15(1)). In the NHS BSP this will include performance testing by both the users (mammographers) and the medical physics service(s). An MPE should be involved in defining such a programme and the associated measures of performance (Regulation 14(3)(b)).

Issues to consider in the QA programme include:

frequency of testing
equipment required
which staff groups will carry out the tests
how to set up and carry out the tests
recording of results
establishing tolerance levels of acceptable performance
actions required when results are out of tolerance

A written employer’s procedure is required which will include processes to ensure the equipment QA programme is implemented and maintained (Schedule 2(d)).

The employer must undertake suitable testing of radiological equipment before it is first used, at regular intervals thereafter, and following any maintenance which has the potential to impact performance (Regulation 15(3)). The processes of an equipment life cycle include:

specifying the requirements of the service (a multi-disciplinary task, which must consider future proofing)
selection of equipment (scoring against original specifications)
installation of equipment
critical examination (checking the system is safe to use)
acceptance testing (checking the system meets specifications)
commissioning (characterise the system and establish baseline measurements)
beginning clinical use
routine daily, weekly, and monthly user QC tests (thereafter until decommissioning)
bi-annual physics QC tests (thereafter until decommissioning)
reporting any faults found in clinical use or during QC testing
routine servicing and maintenance including rectification of any faults found

In practice, the critical examination, acceptance testing and commissioning of equipment are usually performed at the same time, as there is overlap between the tests performed.

Appropriate handover arrangements must be in place to ensure that equipment is safe for clinical use following visits by service engineers and applications specialists, including arrangements for performance testing. In the NHS BSP, acceptable performance criteria (as required by Regulation 15(6)(b)) are given for QC tests (see equipment report 0604, PDF, 1833KB) and for user tests (see equipment report 1303, PDF, 585KB).

A system should be in place to ensure that exposure factors and settings have not been inadvertently changed following routine service or repair of equipment. Controlled copies of protocols should be available to cross check electronically embedded protocol settings on the unit.

Regulation 14 requires the employer to appoint and involve a suitable medical physics expert. In the NHS BSP, the employer must have a service level agreement in place with one or more medical physics providers. Guidelines for medical physics services are available. The guidelines give requirements for appropriate MPE involvement, equipment testing, dose audits, and support for QC.

A suitable service and maintenance contract together with a planned equipment replacement programme should be in place for all radiological equipment to help to ensure that any inadequate performance is addressed.

Procedures must be in place for escalating equipment faults and addressing inadequate or defective equipment (Regulation 15(6)(a) and (c)). Guidance on reporting equipment faults, incidents and issues is available.

Radiological equipment installed on or after 6 February 2018 must be capable of displaying parameters for assessing dose and to transfer this information to the record of the exposure, where appropriate (Regulation 16 (6)(a)(b)). All radiological equipment currently in use in the breast screening service has this capability. With the completed transition to digital systems it is also possible to transfer this information digitally to the client record and/or a separate dose monitoring system.

Question 19

19. Accidental or unintended exposures

Accepted Answer

Accidental or unintended exposures may arise as a result of a number of scenarios including equipment malfunction, referrer, practitioner or operator error, or a failure to follow employer’s procedures. Unnecessary exposures should be avoided. All incidents and near misses must be documented and appropriate action taken to avoid repetition. NHS BSP guidance on reporting equipment faults, incidents and issues is available.

Every employer must have a system, documented in a procedure, for the analysis, recording and reporting of accidental or unintended exposures of all types, including those in breast screening (Regulation 8(3)). This procedure must include how incidents and near misses are escalated, investigated and followed up both locally and within the organisation hosting the breast screening service. It should also describe how and when safety incidents need to be escalated externally to other organisations, for example the Screening Quality Assurance Service (SQAS). Guidance on managing safety incidents in NHS screening programmes is available.

Accidental or unintended exposures can be categorised as:

an accidental exposure is when the individual received an exposure in error, when no exposure of any kind was intended
an unintended exposure is when an individual receives an exposure significantly greater or different to that intended

Accidental or unintended exposure example – scenario 1

A woman attends the breast assessment clinic following recall to further investigate a lesion in her right breast found on a routine screening mammogram. The breast to be assessed was not clearly recorded on the client screening form and the pictogram was annotated incorrectly, therefore at the assessment planning meeting further imaging of the wrong breast (left) was requested.

This examination was performed, and no lesion was identified. The woman was reassured and discharged from the clinic back to the routine screening programme. When the assessment clinic data entry on NBSS was attempted for the incorrectly imaged (left) breast, the error was identified as the IT system had the correct (right) breast entered on NBSS. The woman was informed of the error and asked to return to the assessment clinic to have the correct breast (right ) assessed. The incident did not meet the significant accidental or unintended exposure (SAUE) notification criteria, however, it was locally reported, investigated and the learning from the incident shared across the breast screening service.

Accidental or unintended exposure example – scenario 2

Two women with similar surnames from different clinic sites required technical recall (TR) views following their initial screening mammograms. TR client screening forms were created but were attached to the wrong original client screening forms which resulted in both women undergoing TR imaging of the wrong breast. The initial administrative error was not picked up at the TR imaging stage as the primary source data (initial client screening form) was not used to identify each of the women. The error was highlighted at clinical evaluation and both women re-imaged. The incident did not meet the SAUE notification criteria, however, it was locally reported, investigated and the learning from the incident shared across the breast screening service.

19.1 Significant accidental or unintended exposure (SAUE)

When an incident is deemed to be a SAUE it must be notified to the relevant enforcing authorities under Regulation 8(4). Incidents reportable to the enforcing authorities are also reportable to NCCPM and SQAS. Always seek advice from the MPE before reporting to an external regulatory body.

Start a preliminary investigation immediately when it has been identified that an incident has (or may have) taken place. These preliminary investigation processes should be detailed in the employer’s procedure and must include:

identifying who is responsible for managing the escalation process
specifying the information required to establish what happened, where and when it happened, and the staff involved
any immediate action required to prevent recurrence which may include suspending the use of equipment
establishing the exposure parameters relating to the incident to enable assessment of dose and risk
identifying the number of women involved in the incident
informing the MPE

The MPE estimates the breast dose and the associated risk. If the MPE advises that a significant accidental or unintended exposure (SAUE) has occurred, then the relevant enforcing authority needs to be informed within the specified timelines according to Care Quality Commission (CQC) guidance on significant accidental and unintended exposures.

The enforcing authorities for IR(ME)R are:

It may also be useful to report equipment faults to the Medicines and Healthcare products Regulatory Agency (MHRA).

The subsequent detailed investigation should include:

identification of root causes and contributory factors
any remedial action required to prevent or minimise recurrence
establishing if anyone else was affected
trend analysis and comparison with similar events
analysis of systems in place and effectiveness of current safety barriers
reporting of what happened and comparison with what should have happened
implementation and monitoring of any learning outcomes or action plans
sharing learning with colleagues or other departments where appropriate

Although not a requirement of IR(ME)R, it is considered best practice to inform a woman who has received a SAUE, unless it is considered to be in the woman’s best interests not to do so. Guidance on duty of candour and best practice should be followed. The referrer and the IR(ME)R practitioner should be involved in this decision. The decision on who should inform the patient may be made on a case by case basis and a record made.

Question 20

20. Clinically significant accidental or unintended exposure (CSAUE)

Accepted Answer

If an incident is deemed to be a CSAUE it must be notified to the relevant enforcing authorities under Regulation 8(1). The referrer, practitioner and individual exposed (or their representative) should be informed.

A CSAUE is defined as an exposure resulting in an additional lifetime cancer risk of 1 in 1000 or greater; or which results in deterministic effects or psychological harm that affects the individual’s quality of life to a level that requires intervention or treatment. The definition and guidance for CSAUE is available in https://www.cqc.org.uk/guidance-providers/ionising-radiation/ionising-radiation-medical-exposure-regulations-irmer/criteria-making-notification

CSAUEs are unlikely to occur in mammography or the breast screening programme. Schedule (I) of the employer’s procedures on clinically significant exposures could include the following statement: ‘It is not expected that any exposures performed as part of the breast screening service will meet the notifiable criteria for a clinically significant accidental or unintended exposure’.

Question 21

21. Ensuring the probability and magnitude of accidental or unintended exposures are reduced

Accepted Answer

Schedule 2(k) requires the employer to have in place an employer’s procedure to identify how the probability and magnitude of accidental or unintended exposures are reduced. In the breast screening programme this may be achieved by consideration of many aspects of the employer’s procedures described elsewhere in this guidance, and includes, but is not limited to:

Question 22

22. Research exposures relating to IR(ME)R in breast screening

Accepted Answer

IR(ME)R requires that all research studies must be approved by a research ethics committee (REC) before commencing. In addition, NHS BSP studies must also be approved by the NHS Breast Screening Programme Research Innovation and Development Advisory Committee (RIDAC).

Information on submitting proposals to the BSP RIDAC is available. Although trials within the NHS BSP are more likely to involve the exposure of healthy individuals, this does not affect the processes required for approval or for compliance with IR(ME)R. The IR(ME)R requirements for justification and authorisation are separate from the ethics committee approval process and must still be undertaken for research exposures.

The employer must establish dose constraints for individuals who undergo an exposure as part of a clinical trial (if no direct medical benefit to the individual is expected) (Regulation 6(5)(d)(i)). The dose constraints must be expressed as individual effective or equivalent doses over an appropriate period. The mean glandular dose should be used in mammography. An MPE must be involved in establishing dose constraints and in the optimisation of doses for research exposures.

Occasionally a study may involve an experimental diagnostic procedure from which the individual is expected to receive a diagnostic benefit. This may be an entirely novel imaging technology or a trial of an existing imaging technique from another modality applied to breast screening. For these research studies the practitioner must plan individual target dose levels. The target dose levels must be high enough to enable the technology or technique to form diagnostic images but not so high that the detriment from the exposure outweighs the benefits of the procedure. In practice the levels chosen are likely to be based on recommendations and advice from the manufacturer and MPE.

Participants in research trials must enrol voluntarily having been informed, in advance, of the risks from the exposures. The participant information sheet should inform potential participants of the benefits and risks to help them to make an informed decision about taking part. Guidance about consent and participant information is available. The information about the radiation dose and the potential risks must be in a form that is easily understandable.

Regulation 12(4) requires the employer to have written procedures in place for:

ensuring enrolment is voluntary
informing participants of the risks of the exposure
ensuring that dose constraints are adhered to (for example performing periodic dose audits) when no direct medical benefit is expected
provisions for practitioners to plan individual target levels where there is an expected diagnostic benefit

The breast unit must have a written employer’s procedure detailing the local research process for initiating research trials or participating in existing multi-centre trials (Schedule 2 (g)).

Research referrals must be clearly identifiable to the IR(ME)R practitioner and operator. A list of all currently active trials should be made available to the operators. This should include details of how the individuals in each study are to be identified and the correct protocol to use. The protocols should detail the number of views, the timings, and any prescribed exposure settings. Operators must be aware that participants have the right to withdraw their consent at any point without giving any reason and that their medical care or legal rights will not be affected.

The Health Research Authority (HRA) provides guidance on the definition of research exposures. Where a research trial involves what the HRA class as research exposures involving ionising radiation, information relating to the exposure must be included on the research application for REC approval. Details on the research process are available online by accessing the Integrated Research Application System.

Research exposures example – scenario 1

A study is proposed to compare the performance of a novel artificial intelligence algorithm with the combined results of a group of reporting radiologists. The study requires the use of mammographic images such as those acquired during breast screening. The images used for this study have already been acquired as part of the standard breast screening programme.

The study does not involve research exposures as defined in guidance by the HRA because:

consent for the exposures was not required as part of consent for a research study
no protocol describing how the exposures are to be conducted was required
the women did not receive any additional exposures

However, it will still be necessary to receive REC and BSP RIDAC approval for this study.

Research exposures example – scenario 2

A study is proposed to investigate a new mammographic acquisition mode intended to reduce motion artefacts for larger breasts. The resulting dose is exactly equivalent to the standard 2D acquisition mode.

Although no additional dose is required, a specific acquisition protocol is prescribed as part of the study. Since this is an experimental method, the participants are only imaged with this method after consent to the study.

The imaging technique and equipment are novel and may reasonably be expected to provide clinical benefit to the individual. The practitioner will need to work with the MPE and the manufacturer to set appropriate target dose levels.

The study does involve research exposures as defined in guidance by the HRA because there is an imaging protocol prescribing how the exposures should be conducted and the consent for the exposures is sought as part of the consent to the study.

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