IR(ME)R annual report 2020/21

The Ionising Radiation (Medical Exposure) Regulations 2017 are known as IR(ME)R.

They provide a regulatory framework to protect people against the dangers from being exposed to ionising radiation in a healthcare setting. The regulations state that exposures need to be individually justified and optimised to ensure that the benefit for the patient outweighs the risk.

CQC enforces the regulations in England by carrying out inspections, acting on information from other areas of our work and by reviewing statutory notifications from healthcare services about significant accidental or unintended exposures to patients. In this report, we provide an update on what we found from notifications received between 1 April 2020 and 31 March 2021, and from our inspection and enforcement activity over this period.

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Contents

Key points

Notifications received in 2020/21

• Diagnostic imaging
• Nuclear medicine
• Radiotherapy
• Incident management

Inspections and enforcement in 2020/21

• Diagnostic imaging
• Nuclear medicine
• Radiotherapy

Key issues and themes in 2020/21

• Staffing concerns
• Training
• Governance frameworks
• Key themes in diagnostic imaging
• Key themes in nuclear medicine
• Key themes in radiotherapy

Our wider IR(ME)R activity in 2020/21

• Revising guidance for professional bodies
• International Atomic Energy Agency Integrated Regulatory Review Service mission to the UK
• Heads of European Radiation Competent Authorities

The year ahead

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Key points

This report covers the period 1 April 2020 to 31 March 2021. We provide data on the number of statutory notifications of errors we received from healthcare providers of significant accidental or unintended exposures (SAUE) based on the date of notification. We can’t make a direct comparison with the previous year’s data because of:

• the effects of the COVID-19 pandemic on levels of activity
• a change to reporting requirements for notifications from June 2019, which meant data for 2019/20 was a 10-month period only.

The numbers of SAUE notifications we received dropped during the first few months of the pandemic, reaching lowest levels in April 2020. This mirrors the significant drop in the number of examinations carried out in 2020/21. As activity resumed, the number of notifications increased, but we did again see a drop in notifications during the second wave of infections in January 2021, despite only a small decrease in examinations carried out.

In diagnostic imaging, the most common type of error continued to be where a patient received an examination meant for another patient. During this reporting period, we received notifications of errors where 85 patients had been wrongly referred for diagnostic imaging examinations and 33 cases where the operator failed to correctly identify a patient. Referrer errors overall accounted for the highest origin of incidents reported to us. The highest number of notifications was from computed tomography (CT).

In nuclear medicine, the highest number of notifications was from PET-CT and diagnostic imaging. In a change from previous years, referral errors were not the most common cause of nuclear medicine incidents. Instead, operator errors were the most prevalent, including incorrect preparation or administration of radiopharmaceuticals to people.

In radiotherapy, as in previous years, most incidents were attributed to operator errors during treatment. The number of errors relating to planning and verification imaging comprised 51% of all radiotherapy notifications received. A common theme in the root causes for radiotherapy incidents was insufficient staffing levels during the pandemic.

We stopped proactive inspection activity during the pandemic and targeted our resources to the level of concern and risk. Most inspections were in response to information of concern we received or concerns that we identified from statutory notifications. Our IR(ME)R team carried out 18 inspections during 2020/21, which included five inspections under the Health and Social Care Act with inspectors from our Hospitals Directorate.

Main issues and concerns

Capacity

COVID-19 has exacerbated pre-existing problems with staffing resources. Through our work we have seen the impact of staff shortages and recruitment difficulties on key clinical roles. This has had a knock-on effect on the ability of departments to maintain their regulatory compliance.

Training

There is a disparity in how departments record training for different staff groups, with poorly defined processes and records. It is important that departments recognise that the regulations relate to operators and practitioners regardless of their profession; the training standards need to be applied universally, and training records should be readily available to the enforcing authority.

Governance and audits

There must be clearly documented, consistent and effective lines of regular communication from the employer and senior leadership team down to the clinical departments, with well-defined roles and responsibilities. Without this communication we often see a poor understanding of regulatory duties at senior level, which is only gained when things go wrong.

We highlight some key issues around compliance with the regulations and provide examples of the actions that IR(ME)R employers have taken to improve the quality of care. We share these so that other employers, healthcare professionals and academic bodies can learn from them. This supports CQC’s strategic ambitions to support healthcare providers to improve the quality and safety of people’s care.

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Notifications received in 2020/21

• From 1 April 2020 to 31 March 2021, we received 499 notifications of significant accidental and unintended exposures (SAUE notifications) across all modalities (407 received from 1 June 2019 to 31 March 2020).
• The largest proportion of notifications came from diagnostic imaging (66% of all notifications).

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Figure 1: SAUE notifications received by modality, 1 April 2020 to 31 March 2021

499 notifications received

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Activity data in England

NHS England collects information about tests carried out on NHS patients in the Diagnostic Imaging Dataset. Provisional data for 2020/21 released in July 2021 shows that between April 2020 and March 2021, over 34 million imaging tests across all modalities were carried out in England. Of these examinations, 23 million used ionising radiation (including plain film X-rays, CT, fluoroscopy, nuclear medicine, PET-CT and SPECT, as opposed to other types of test such as ultrasound, MRI scans or medical photography). This is a significant reduction from about 45 million in the previous year (a reduction of 24%), which is most likely a result of the impact of the coronavirus (COVID-19) pandemic.

We can compare the trend in imaging activity with the number of SAUE notifications received each month in diagnostic imaging and nuclear medicine (figure 2). This shows that the number of notifications fell during the first peak of the pandemic, which mirrors the significant drop in the number of examinations carried out. The number of notifications increased as activity resumed, but we did again see a drop in notifications during the second wave of infections in January 2021, despite only a small decrease in examinations carried out.

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Figure 2: Total imaging activity and notifications from diagnostic imaging and nuclear medicine, January 2020 to March 2021

Source: CQC SAUE Notifications and NHS England Diagnostic Imaging Dataset

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The National Cancer Registration and Analysis Service produces data for the Radiotherapy Dataset, which monitors all radiotherapy activity delivered in NHS hospitals in England. Between April 2020 and March 2021, there were just over 100,000 episodes of radiotherapy treatment in England, a decrease of around 12% on the previous year. Again, this is most likely a result of fewer people being treated during the pandemic.

Geographical distribution of notifications

We have analysed the number of notifications received in each region of England as a rate for every 100,000 people. This shows a variation from 0.6 notifications in the West Midlands to 1.2 in the North West. Although we cannot be sure of the exact reason for the variation, differing interpretations of the guidance for SAUE and variations in reporting culture within organisations or operational delivery networks may be a factor.

• West Midlands: 0.6 notifications per 100,000 people
• East of England: 0.7 notifications per 100,000 people
• East Midlands: 0.8 notifications per 100,000 people
• South East: 0.8 notifications per 100,000 people
• London: 0.8 notifications per 100,000 people
• North East: 0.9 notifications per 100,000 people
• Yorkshire and The Humber: 1.0 notification per 100,000 people
• South West: 1.2 notifications per 100,000 people
• North West: 1.2 notifications per 100,000 people

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Diagnostic imaging

• 329 diagnostic imaging notifications received from 1 April 2020 to 31 March 2021 (247 notifications received from 1 June 2019 to 31 March 2020)
• Represents 66% of all notifications received
• 88% of notifications were from NHS acute trusts
• The highest proportion of notifications in diagnostic imaging (72%) was from computed tomography (CT)

Figure 3: Diagnostic imaging notifications received by sub-modality, 1 April 2020 to 31 March 2021
 

Sub-modality	Number of notifications	Percentage of notifications
CT	236	72%
Plain film X-ray	57	17%
Interventional radiology/cardiology	14	4%
Mammography	9	3%
Dental (including CBCT)	6	2%
General fluoroscopy	3	1%
DXA	3	1%
Theatre/mobile fluoroscopy	1	<1%
Total	329	100%

Source: CQC SAUE notifications

Types of error

In August 2020, we made minor amendments to our guidance on statutory SAUE notifications. To increase use of the error coding in radiology and allow employers to directly compare incidents with our data we also updated our internal error categories to closer align with the Clinical Imaging Board’s guidance on Learning from ionising radiation dose errors, adverse events and near misses in UK clinical imaging departments. For diagnostic imaging this only resulted in amalgamating codes.

The most common type of error has continued to be where a patient received an examination meant for another patient (36%). During this reporting period we received notifications where 85 patients had been wrongly referred for diagnostic imaging examinations and 33 cases where the operator failed to correctly identify a patient. Figure 4 shows the number of detailed errors where tier 1 is the causative factor with tiers 2 and 3 the contributory factors.

Referrer errors overall accounted for the highest origin of incidents reported to us (36%).

Nuclear medicine

• 35 nuclear medicine notifications received from 1 April 2020 to 31 March 2021 (47 notifications from 1 June 2019 to 31 March 2020)
• Represents 7% of all notifications received
• 71% of notifications were from NHS acute trusts
• 49% of notifications were attributed to operator error, of which 82% related to mistakes in preparing or administering the radiopharmaceutical

Of the 35 notifications, 25 originated from 20 individual NHS trusts, with the remaining notifications from six independent healthcare employers. Over the reporting period, the greatest number of notifications received from a single employer was four.

The highest number of notifications was from PET-CT and diagnostic imaging (figure 5). More than half (56%) of the PET-CT notifications came from independent healthcare providers. This reflects NHS England’s selection of these providers to lead the delivery of the PET-CT national contract. There has been an increase in the use of radionuclide therapy – a systemic treatment that specifically targets diseased cells, and therefore reduces potential side effects. Greater use of this therapy is reflected in the number of notifications from this area as a proportion of all notifications in nuclear medicine. We combined the diagnostic imaging and SPECT sub-modalities when the SAUE guidance and webform were updated on 24 August 2020, so the SPECT category was not in use after this date.

These figures do not include any notifications relating to licensing breaches, where a SAUE did not occur. These voluntary notifications have been managed by a separate process and webform since July 2020.

Figure 5: Nuclear medicine notifications received by sub-modality, 1 April 2020 to 31 March 2021
 

Sub-modality	Number of notifications	Percentage of notifications
PET-CT	16	46%
Diagnostic imaging	10	29%
SPECT	1	3%
In vitro	1	3%
Therapy	7	20%
Total	35	100%

Percentages have been rounded so may not total 100%

Source: CQC SAUE notifications

Types of error

In a change from previous years, referral errors were not the most common cause of incidents. Instead, operator errors were the most prevalent. Of these, 14 related to incorrect preparation or administration of radiopharmaceuticals (figure 6). A contributing factor could be workforce capacity issues and the effects of the COVID-19 pandemic on services.

We continue to see a significant number of errors relating to equipment malfunction. These are commonly reported in nuclear medicine as, in many cases, a number of patients have already been administered with a radiopharmaceutical when an imaging system breaks down, which means the administration would have to be repeated at a later date.

Licensing notifications

In July 2020, we introduced a separate webform for employers to notify us of licensing breaches, outside of the process for statutory notification of SAUEs. We have received only a small number of notifications in this area, but key themes included:

• certain procedures accidentally omitted from the application form when applying for a new or renewed licence
• practitioner’s licence had expired before renewal, and multiple patients administered with a radiopharmaceutical without a licence in place
• failure to obtain a particular patient licence (PPL)

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Radiotherapy

• 135 radiotherapy notifications received from 1 April 2020 to 31 March 2021 (113 notifications received from 1 June 2019 to 31 March 2020)
• Represents 27% of all notifications received
• 93% of notifications were from NHS acute trusts
• Planning and verification imaging errors accounted for 51% of all radiotherapy notifications received

Data from the National Cancer Registration and Analysis Service relating to the Radiotherapy Dataset showed there were over 100,000 episodes of radiotherapy treatment in England between April 2020 and March 2021, a decrease of around 12% on the previous year. This may be related to the drop in referrals to centres after March 2020 and the introduction of the five-fraction schedule of radiotherapy breast treatment that replaced the previous international standard 15-fraction regimen after primary surgery for early breast cancer.

Errors relating to planning and verification imaging (69) comprised 51% of all radiotherapy notifications received (figure 7). A common theme in the root causes for radiotherapy incidents was insufficient staffing levels during the pandemic.

We received two notifications relating to the incorrect selection of a verification pre-set (wrong image/patient data used), for example selecting a pelvis image type as opposed to chest. The amendment to the notification threshold level for verification imaging may have affected the number of notifications received.

Most notifications that fall into the category of ‘verification protocol error’ are as a result of a combination of incorrect verification image set up. For example, incorrect imaging protocol selected, imaging panel not fully extended, or image capture button not selected combined with a software or equipment failure that needs a third image. The centres that experienced these issues have reported fewer instances after they amended their verification imaging process – for example, linking up equipment to work in synergy and changing the process to manage equipment failure.

Figure 7: Radiotherapy notifications received by sub-modality, 1 April 2020 to 31 March 2021
 

Sub-modality	Number of notifications	Percentage of notifications
Planning and verification imaging	69	51%
External beam therapy	65	48%
Brachytherapy	1	1%
Total	135	100%

Source: CQC SAUE notifications

Types of error

As in previous years, most incidents were attributed to operator errors during the treatment phase (figure 8). The number of either partial or full geographical misses appeared to be because of the incorrect application of origin to isocentre moves or incorrect matching of anatomy during a verification image. Another common issue in notifications was pressure on staff because of available resources and communication difficulties.

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Incident management

Clinically significant accidental or unintended exposures

In 2020, the Clinical Imaging Board and the Radiotherapy Board published guidance and a recommendation on implementing the definitions for clinically significant accidental and unintended exposures (CSAUEs) in Implications for clinical practice for diagnostic imaging and for radiotherapy.

We have been monitoring this during inspections and by reviewing notifications that employers categorised as CSAUE. In diagnostic imaging, nuclear medicine and radiotherapy, we have reviewed copies of the corresponding employer’s procedures and in several cases have challenged the categorisation, usually where these incidents involve low dose imaging. Following discussions with the notifier, most cases were due to a misunderstanding of the term ‘CSAUE’ and how it differs to SAUE.

Along with guidance from the professional bodies, it is important for a multidisciplinary team to determine whether the exposure is clinically significant.

We have also looked at the type and appropriateness of information given to the patient, referrer and practitioner, required under Regulation 8(1). This is because a referrer may not always fully understand the context of risk. For example, we reviewed information relating to a notification following an unintended fetal exposure of less than 20mGy. We found information in the employer’s procedures relating to risks to the fetus. But, although this information was given to the referrer, they did not have the same understanding of radiation risk as someone from a radiation background and the terminology used in the information was unclear. It is therefore important to ensure that information provided as part of a CSAUE uses clear language and terms

Making a notification

Our webform for notifications includes an option to inform us of a second provider that may have been involved in an incident.

Despite this, we have received several notifications about the same incident from separate providers. We also received queries asking who should lead in notifying us and whether the notification should be made by the provider who made the error, the person who carried out the exposure, or the provider in charge of the patient pathway.

Identifying themes in notifications

We have received several queries asking whether a notification should be made as a ‘theme’. The number of possible scenarios is endless, so we rely on employers to use their professional judgements when deciding whether to make a notification.

The following are some examples of themes emerging where you need to make a notification:

• 3 patients received an injection of a radiopharmaceutical before a gamma camera failed, which meant they needed a re-scan (equipment error).
• The wrong preset information was used to image multiple patients (inappropriate procedure).
• 4 chest X-rays were carried out too early over five months (process failure).
• Suboptimal images meant that 28 patients needed to be recalled for a DXA scan (inadequate training).
• One radiographer failed to select the correct detector on multiple occasions (inadequate training).
• A persistent imaging fault on a linear accelerator affected multiple patients (equipment error).

However, it wouldn’t be a notifiable theme where:

• two incidents occurred over six months involving detector selections, with two different radiographers and two different pieces of equipment.

As well as investigating each individual incident, some employers have regularly reviewed their incidents as a whole and reported to their radiation protection committee twice a year.

These reports have used either local error categorisations or national coding systems such as those from the Towards Safer Radiotherapy report or reports from the Clinical Imaging Board. They provide an overview of incidents and look at trends including the type of equipment, time of day, skill mix, and pause and check. They have reviewed data over a year and compared this with a previous year.

This approach enables the employer to understand where risks and mitigations are in place and whether previous action had improved practice.

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Inspections and enforcement in 2020/21

We stopped proactive inspection activity during the pandemic and targeted our resources according to the level of concern and risk. This meant the majority of inspections were in response to information of concern received or from statutory notifications.

In 2020/21, our IR(ME)R team carried out 18 inspections, including five inspections under the Health and Social Care Act with inspectors from our Hospitals Directorate

We responded to the pandemic by changing our inspection methods, which helped to streamline processes and reduce the need to visit. One change was to test virtual inspections. Some of these worked well, but there were difficulties in reviewing paper documentation and assessing the working environments. We will continue to explore options of inspecting virtually, but the vast majority of inspections will continue to be on site wherever possible.

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Diagnostic imaging

• 6 inspections of diagnostic imaging departments
• 5 recommendations made

Because of the pandemic, we were only able to carry out two inspections of radiology services during the late summer 2020 using our usual methods. Neither inspection resulted in any enforcement action, but we made some recommendations for employers:

• Regulation 6(1)(a)/(b) (two recommendations): Review the IR(ME)R policy, employer’s procedures and standard operating procedures to ensure they are consistent with the regulatory requirements and accurately reflect clinical practice.
• Regulation 6(5)(a) (one recommendation): Establish referral guidelines, including for cardiac procedures, and make them available to the referrer.
• Regulation 15(2) (one recommendation): Ensure that the equipment inventory contains all the required fields including year of manufacture.
• Regulation 17(4) (one recommendation): Maintain adequate training records for all operators and practitioners, including radiologists.

In January, February and March 2021, we tested a new method when inspecting a large independent mobile service. This was the first of a number of small inspections looking at how we can regulate this type of provider in the best way. This inspection process is still ongoing.

We supported three further inspections under the Health and Social Care Act in response to concerns. One inspection followed concerns raised where an employer had rapidly rolled out a new authorisation protocol in CT without providing sufficient information or training to radiographers. The second inspection related to a scheduled re-visit to an employer following enforcement action served under the Health and Social Care Act, which resulted in CQC cancelling the provider’s registration for the regulated activity of Diagnostic and screening procedures.

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Nuclear medicine

• 6 inspections of nuclear medicine departments
• 6 recommendations made
• 2 Improvement Notices served

The pandemic meant that all inspection activity was based on where there were risks to patient safety rather than our planned programme. This included:

• 3 reactive inspections, two of which were held remotely
• 1 joint inspection with the Health and Safety Executive
• 1 inspection under the Health and Social Care Act
• 1 re-inspection to assess compliance with an enforcement notice

Of the reactive inspections, the two virtual inspections were in response to SAUE notifications of concern, both of which led to enforcement action. We made the following recommendations:

• Regulation 4(2)(b) (one recommendation): Clearly define the role of the practitioner when administering nuclear medicine so it aligns with the conditions on the employer’s licence.
• Regulation 6(4) (one recommendation): Review procedures to ensure they set out clear work instructions for staff with reference to current guidance.
• Regulation 8(2) (one recommendation): Carry out a study of risk for all radiotherapeutic practices, considering factors affecting the likelihood of accidental or unintended exposures, for example the number of patients treated in each session and staffing requirements.
• Regulation 8(4)(iii) (one recommendation): Make sure the medical physics expert assesses the dose to the patient from an accidental or unintended exposure, and makes this available to the enforcing authority.
• Regulation 12(2) (one recommendation): Review the administration tolerances of radiotherapeutic agents to ensure they are consistent with professional guidance.
• Regulation 14(3)(f) (one recommendation): Involve the medical physics expert in the analysis of events where there is an accidental or unintended exposure.

In 2020/21, we served two Improvement Notices in nuclear medicine departments following reactive inspections triggered by SAUE notifications of concern. The notices referenced seven breaches under IR(ME)R.

One Notice cited five breaches under IR(ME)R (6(1)(a), 6(1)(b), 14(1), 17(1) and 17(4)). The employer was required to make the following improvements within eight weeks:

• review the governance arrangements and structure to outline clear pathways to senior management, creating and ratifying procedures and policies, and sharing these with all relevant groups of staff
• review the process to manage training records for all practitioners and operators to include achieving and maintaining competence in line with IR(ME)R Schedule 3
• formally appoint a medical physics expert.

The second Notice cited two breaches (17(1) and 17(3)). The employer was required to make the following improvements within six weeks:

• review training arrangements for clinical staff to ensure they meet the requirements of IR(ME)R, including Schedule 3
• provide evidence of post-registration education and training for radiographers at postgraduate level appropriate to the role of a lead or advanced practitioner, such as the one set out by the Society of Radiographers Education and Career Framework for the Radiographic Workforce, or equivalent for clinical technologist roles
• set out specific competence arrangements to deliver radionuclide therapies
• review arrangements for training and supervision, to ensure that clinical staff are always acting within an appropriate scope of practice
• review how training records are managed, so there is clear documentation of individual competence for practitioners and operators.

You can see further information about these breaches in our enforcement registry. We also provide further information in the key themes section relating to radiation protection governance and training for duty holders.

We judged that both these employers were compliant when we re-inspected at the end of their compliance date.

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Radiotherapy

• 8 inspections of radiotherapy departments
• 12 recommendations made
• 5 Improvement Notices served

Again, all inspection activity was based on where there were risks to patient safety rather than our planned programme. This included:

• 2 comprehensive inspections
• 3 reactive inspections
• 1 inspection to support colleagues under the Health and Social Care Act
• 2 re-inspections to assess compliance with an enforcement notice

Of the reactive inspections, two were site visits in response to notifications of concern and one was carried out remotely. Two inspections related to the quality of information in the department’s key documents and led to enforcement action. We also issued enforcement notices relating to quality assurance of documents following the comprehensive inspections:

• Regulation 6 (one recommendation): Review the entitlement of referrers and practitioners to ensure that their scope of practice is clearly documented.
• Regulation 6(4) (one recommendation): Review departmental protocols used to create treatment plans to ensure they include sufficient detail to inform clinical practice.
• Regulation 7 (one recommendation): Ensure there is an employer’s procedure for carrying out clinical audit.
• Regulation 8(2) (two recommendations): Include a study of risk for all radiotherapeutic practices that considers factors affecting the likelihood of accidental or unintended exposures  in the employer’s quality assurance programme.
• Regulation 8(3) (four recommendations): Establish a system for recording analyses, with regular and consistent reviews of incidents to identify themes.
• Regulation 17 (three recommendations): Maintain training records of all entitled practitioners and operators and ensure they are comprehensive, detailing the nature of training and how they achieve and maintain competency.

In 2020/21, we served five Improvement Notices in radiotherapy departments that referenced eight breaches under IR(ME)R.

Notices served to one employer cited four breaches under IR(ME)R (6(1)(a), 6(4), 6(5)(b) and 17(1)). The employer was given eight weeks to make the following improvements:

• Ensure there are written procedures in place where required by the regulations, and that written protocols for planning and checking treatments are sufficiently detailed.
• Establish a quality assurance programme for reviewing and revising protocols and procedures to ensure the quality and accuracy of content.
• Train all duty holders before implementing new processes and document this training.
• Develop and review competency frameworks for all staff training and processes, in line with Schedule 3 of IR(ME)R, to include evidence of how competency is achieved.

A second notice cited two breaches (6(5)(b), 15(1)(a) and 15(3)(b)) and the employer was given eight weeks to make the following improvements:

• Establish a quality assurance programme for reviewing and revising all protocols and procedures, to ensure the quality and accuracy of content.
• Implement and maintain a quality assurance programme for equipment and ensure staff follow this for routine equipment testing.

A further third Notice cited two breaches (6(1)(a)(b) and 6(5)(b)), with the employer given six weeks to make the following improvements:

• Establish a quality assurance programme for reviewing and revising all protocols and procedures, to ensure quality and accuracy of content. Circulate all documentation to relevant duty holders.

We judged all employers to be compliant after we re-inspected at the end of their compliance date. The enforcement page on our IR(ME)R webpages provides summary information on all enforcement and compliance activity.

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Key issues and themes in 2020/21

Staffing concerns

Before the pandemic, the 2020 report of the Independent Review of Diagnostic Services for NHS England described diagnostic services in the NHS as reaching a tipping point. COVID-19 has exacerbated these pre-existing problems and, with the proposed reform of diagnostic imaging services as recommended in the report, it is important that new services and equipment are introduced carefully and that safe staffing levels are built into any proposals.

Through our work we have seen the impact of staff shortages and recruitment difficulties on key clinical roles. This has had a knock-on effect on the ability of departments to maintain their regulatory compliance in a number of ways:

• staff holding key governance roles as well as clinical responsibilities, meaning they need to juggle delivering care to patients with maintaining regulatory compliance
• nuclear medicine departments relying on a single practitioner to support the service
• reliance on agency or locum staff to backfill long-standing clinical vacancies
• new and agency staff deemed capable to work clinically but with insufficient assessment of their training and competence
• staff routinely working overtime to complete governance tasks without affecting patients, or to keep up with clinical demands
• clinical protocols and procedures significantly overdue for review
• clinical audits not happening because of insufficient support from clinical oncologists
• backlogs of equipment testing because of unavailability of staff and the high demand for use.

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Training

We have seen several different approaches to training processes and record keeping. Some departments have adopted a competency-based approach to training. This approach has clear processes that demonstrate how to achieve and maintain a competency, with matrices held centrally and accessible to all. This system allows departments to carry out training needs analysis, identifies when a competency is due for review and gives clear advice on how to maintain it.

However, there is still a disparity in how departments record training within staff groups. Training of radiographic operators tends to be managed better compared with other duty holders such as clinicians when they are acting as operators, for example radiologists administering radiopharmaceuticals to patients or oncologists outlining volumes on the treatment planning system. We have previously taken enforcement action against breaches of the regulations relating to training, although this has primarily focused on training records of radiographic operators.

Training of duty holders who are not radiographers or technologists has sometimes been managed separately, with poorly defined processes and records. Nevertheless, it is important that departments recognise that the regulations relate to operators and practitioners regardless of their profession and that the training standards need to be applied universally and records made available to the enforcing authority.

Guidance from the Royal College of Radiologists for the implications for clinical practice for diagnostic imaging and for radiotherapy is clear on the importance of maintaining training records for specified duty holders. It specifies that they should demonstrate appropriate skills, knowledge, experience and assessed competence within a clearly defined scope of practice. A practitioner or operator must have been trained in the subjects set out in Schedule 3, as appropriate to their role and area of practice, to be deemed adequately trained.

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Governance frameworks

An effective radiation protection governance framework needs a multidisciplinary approach. We regularly find that departments rely on medical physics experts who have no experience in the workflows or areas of work to supervise arrangements. The result is that documentation, such as the employer’s procedures, do not reflect what happens in established departmental practices. We then routinely find that these procedures are not embedded into practice and are of no use to the staff working in the departments.

There is also a need to involve much wider clinical leadership when developing these frameworks, to ensure that radiation protection is embedded in an everyday working culture across all professional groups rather than relying only on a medical physics department. Many employers have a lead IR(ME)R radiographer or clinical governance role, which raises the profile of radiation protection and provides a much greater oversight of local arrangements. However, we sometimes see these roles at Band 6 or 7 without a clear job description, dedicated administrative time or the ability to influence senior management to effect change.

It is important that there are also clearly documented, consistent and robust lines of regular communication from the employer and senior leadership team down to the clinical departments, where roles and responsibilities are well-defined. Without this communication we often see a poor understanding of regulatory duties at senior level, which is only gained when things go wrong.

Difference between clinical audit and regulatory audit

Through our work with Heads of European Radiation Competent Authorities (HERCA), we have been leading on a working party to strengthen the understanding of the requirements of regulation of clinical audit across Europe. This work has also been in parallel with the QuADRANT project from the European Society of Radiology.

There is still some confusion among the medical professions and regulators across Europe regarding differing types of ‘audit’ and how these apply to the Council Directive 2013/59/Euratom and subsequently IR(ME)R. To clarify:

• Clinical audit, as defined in IR(ME)R, is an important tool within clinical governance that ensures continuous quality improvement of a healthcare service. There is a specific requirement to undertake clinical audit of medical radiological practices under the Basic Safety Standards Directive article 58(e). See examples on the Royal College of Radiologist’s AuditLive webpages.
• In contrast, the aim of a regulatory audit is to verify that practice is compliant with regulations and to ensure that clinical practice correctly reflects employers’ procedures and policies. These are not a requirement under IR(ME)Rand should be considered separately due to the differences in their outcomes and criteria. Regulatory audit often involves cross referencing procedures against actual practice.

Following a position paper on clinical audit published in 2019, HERCA has released a further addendum to clarify the differences.

During inspections we often see that employers have put too much emphasis on using checklists when checking compliance with regulations. Although we encourage this practice to ensure good regulatory oversight, compliance with regulations is not part of clinical audit as required by IR(ME)R Regulation 7.

Many departments now participate in accreditation programmes. However, accreditation and the processes adopted to be part of an accredited department does not necessarily ensure compliance with IR(ME)R to undertake clinical audit. Accreditation does not replace clinical audit.

There are various approaches to radiological clinical audit that all aim to improve patient care and clinical outcomes within practices that use ionising radiation. A clinical audit aims to establish a quality improvement process in healthcare and tells providers and patients where their services are doing well and where they can improve clinical care and outcomes for people.

Procedural quality assurance

Of the five Improvement Notices issued this year, three have related to a breach of Regulation 6(5)(b), with common quality assurance (QA) themes including:

• references to out-of-date regulations (for example, IR(ME)R 2000, MGTI, MARS)
• documents with IR(ME)R and clinical references spelled incorrectly, showing a lack of thorough review before ratification
• documents not reviewed in line with the employer’s specified QA cycle
• documents that do not reflect practice
• incorrect version history and review dates
• no process for quality reviews of documents.

Although we allowed for a period of grace to enable organisations to embed the 2017 legislation changes, it is not acceptable for organisations to still hold documents that refer to out-of-date legislation or guidance.

We identified several common factors that contributed to enforcement action, including:

• no identified person responsible for managing the quality of documents
• no escalation process or effective quality assurance of poor-quality documents
• an unmanageable number of documents held in a quality management system

These factors suggest that an organisation has an ineffective review process and that operators are being given incorrect information – for example, if a department is paperless but all procedures refer to the paper pathway, or if protocols refer to out-of-date SAUE guidance.

When duty holders are working outside of standard working hours, the protocol information will often be the first place they check to review practice, which needs accurate and current information. Several high-profile incidents have directly cited poor information available to staff as a root cause, so it is vital that duty holders are able to access the correct information to ensure that patient care is not compromised.

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Key themes in diagnostic imaging

Our work in diagnostic imaging over 2020/21 has enabled us to identify some key themes and issues, along with some recommendations and examples of errors and actions to mitigate them.

Community diagnostic centres

The 2020 report Diagnostics: Recovery and Renewal – Report of the Independent Review of Diagnostic Services for NHS England was an independent review of capacity in NHS diagnostic services in response to the NHS Long Term Plan. One of the major recommendations in this report was the rapid establishment of community diagnostic centres. The Department of Health and Social Care has since announced that 40 new community diagnostic centres are set to open across England in community settings, designed to reduce hospital visits and improve diagnosis. Some are already up and running, and others will be fully operational by March 2022.

Over the past 12 months, our IR(ME)R team has identified and consulted with a number of employers about becoming early adopters of the new community diagnostic centre model and how IR(ME)R should be described in the service level agreements. Our early conversations show the benefits of this model of care, but some will involve complex patient pathways requiring careful and considered regulatory oversight.

From our experience of other complex pathways involving multiple employers, clear lines of accountability and well considered service level agreements are crucial for a safe and effective service that meets with IR(ME)R.

We will continue to work closely with the professional bodies, NHS England and colleagues in our Hospitals Directorate to ensure there is a clear national picture and consistency of approach.

Patient identification errors

In a radiology notification, the wrong patient was brought to imaging and underwent a contrast enhanced CT scan. Believing this was another patient, the blood results and subsequent records failed to identify that the patient had renal impairment. Unfortunately following the contrast administration, the patient suffered significant harm.

Although this outcome is rare, we received 33 notifications during this reporting period where failure to follow the employer’s procedures resulted in the wrong patient being exposed. The final responsibility to correctly identify the patient in these cases lay with the operator.

We discussed how to prevent these uncommon but high-risk incidents with the Society of Radiographers and a short life working party was set up to assess incidents in the UK, analyse the common causes and any contributory factors, and promote existing guidance. The results will be published as a resource to support employers to develop improved organisational safety cultures.

Effects of coronavirus

We summarise some key causes of incidents from the notifications received during the pandemic.

• Outsourcing: Several notifications related to duplicated CT scans that were carried out at multiple locations using the same request. In these instances, an employer outsourced a scan to another employer, who carried out the scan on their behalf; but the original employer also carried out the scan. Notifications also involved patients who went on to have a scan that was no longer needed because cancellation messages were not passed on.
• Changes to processes: Some notifications resulted from introducing new working arrangements suddenly, such as avoiding cross-contamination risks of handling paper, and introducing new electronic systems in a hurried way.
• Referral systems: In one error, the introduction of a new referral system led to many non-medical referrers using a single colleague’s login. Although this happened at the height of the pandemic it was not necessarily a direct result. At the time, there were online consultations and referrers were working from home so a member of the administrative staff placed orders on the system on their behalf as referrers had no access to it.
• Communication: We heard that face masks made it difficult for staff to hear properly, specifically when radiographers asked standard pause and check questions. There were similar misunderstandings between radiographers and operators, when confirming whether patient checks had been completed.

Along with partner IR(ME)R enforcing authorities across the devolved administrations, we published practical guidance on several IR(ME)R issues, which acknowledged the overriding priorities and requirements to cope with the pandemic. This included training for staff, maintaining equipment, reviewing equipment QA testing cycles, support from medical physics services, and the need to continue to make notifications to us.

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Key themes in nuclear medicine

Dosimetry for nuclear medicine therapies

Personalised dosimetric planning is a key part of the patient pathway in external beam radiotherapy, but it is not commonly used in nuclear medicine therapies. Article 56 of EC Directive 2013/59/Euratom, and its transposition in IR(ME)R 2017 as Regulation 12(2), states a requirement that radiotherapeutic exposures need to be appropriately verified. The regulations are also clear that the term radiotherapeutic includes “nuclear medicine for therapeutic purposes”.

The regulations set out a clear need to verify delivering nuclear medicine therapies. However, we recognise that the practice of routine patient-specific dosimetry for all therapies is not yet common, especially where there is limited resource. The position paper published by the European Association of Nuclear Medicine (EANM) in 2020 aims to set out a method to comply with the optimisation principle of the Euratom directive, and therefore IR(ME)R. The paper details three levels of dosimetric practice, based on the complexity and standardisation of the type of therapy. This provides a good framework for departments to work to so that they comply with this aspect of the regulations at a minimum.  

Changes to prescribed activity

We are aware that in some cases, where patients are administered activities that are significantly different from those originally prescribed, IR(ME)R practitioners are adjusting and justifying the prescription after the administration based on what is available. This effectively means that we are not always informed when patients are receiving an under or over-dose compared with the intended activity.

Although this change in activity might not have a significant clinical impact on the patient, the prescribed activity should not be adjusted after administration.

Employers need to notify us of these instances, so we have a better understanding of issues affecting doses to patients in nuclear medicine. Even when there has been no procedural failure, it is useful for us to identify themes, for example with delays to international radiopharmaceutical shipments, and share these with other relevant agencies. We also need to be notified where it falls outside the thresholds set out in the SAUE guidance.

Delegated authorisation

The authorisation of an exposure by someone other than the licensed practitioner is commonly referred to as delegated authorisation. This practice is common in nuclear medicine, both through authorisation guidelines for operators to authorise routine imaging exposures as well as clinicians under supervision authorising more complex procedures. Regulation 11(5) states that “where it is not practicable for the practitioner to authorise an exposure… the operator must do so in accordance with guidelines issued by the practitioner”.

However, there is a risk around the long-term use of delegated authorisation, particularly when the process is not actively managed alongside the validity of practitioners’ licences and certificates. Notifications show that this practice has caused incidents. These include operators incorrectly authorising scans because they don’t have enough dedicated time for the task, and unjustified therapy procedures where delegated authorisation was not well managed, as set out in the following example.

Managing licences

We continue to deal with incidents involving licensing breaches, as well as voluntary notifications of licence breaches through our dedicated webform. In many cases, the gap in licensing arrangements has been caused by the lack of a robust process to manage these critical documents. This is often made worse where organisations have a mixture of licences under IR(ME)R17 and certificates under MARS1978 or have a number of sites undertaking different types of procedure.

However, we have seen departments use different methods to effectively manage their licences, including:

• Incorporating the process for managing licences in the departmental quality management system
• a bespoke database where licences for employers and practitioners can be checked
• reviewing licence arrangements at therapy multidisciplinary teams or medical exposures committees
• monthly checks as part of the duty physicist role
• regular audit as part of rolling audit schedule.

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Key themes in radiotherapy

Tolerance tables

The use of tolerance tables has been key in addressing gross shift or positional errors. However, applying tight tolerances – which therefore need regular overriding – can lead to automaticity, which results in accepting incorrect table parameters. In several notifications, we identified that when a couch parameter was overridden without investigation, it was either assumed that:

• the couch parameters had not been captured on day 1 of treatment
• key parameters such as table height had not been input into the recording and verification system (R&V), or
• the treating radiographers had become so used to overriding that they didn’t query the value.

Reviewing overrides has been cited as a useful exercise, and has identified several issues including the need for site-specific tables and adjustment of tolerances.

Paperless or ‘paper-lite’

Although there is a movement towards paperless working in departments, there are several challenges to the process. Many departments have yet to go fully paperless and are operating a ‘paper-lite’ approach. This means nearly all key documents are held electronically (for example, consent forms or plan approval signatures), or certain stages of treatment are now paperless.

The process of moving to paperless working is complicated and raises specific challenges to the operators, particularly when they use multiple systems to treat the patient, for example electronic imaging sheet, paper treatment sheet and separate surface guided radiotherapy (SGRT) imaging and verification imaging systems. In these cases, the operators are required to check the patient’s identity on multiple systems and mediums, which greatly increases the chance of an identification error.

We have also found that when a department is implementing paperless or paper-lite working, protocols are often not updated to reflect the changes in a timely way. Departments tell us that they want to reduce the number of times they update a protocol and therefore they wait until the process is finished before updating documents. However, it is vital that these documents contain relevant and correct information for operators to comply.

Referral information and operator responsibility

In 2019/20, we received a significant number of errors in relation to referrals, which continues to be a theme in 2020/21. The lack of diagnostic referral information available at the time of referral is still a persistent causative factor. We have also heard that referrers can have difficulty – or perceive there is difficulty – in accessing patient information at external clinics, which results in patients being referred incorrectly for treatment. Anecdotal comments relate to the length of time it takes to log on remotely, and the use of multiple imaging systems holding relevant information is often cited as a root cause.

Not all employers have definitive criteria about the information that must be present to constitute a referral. Some centres clearly set out requirements, for example histology, diagnostic reports or multidisciplinary team review. But others are less definitive and often refer to referrals being accepted in ‘extenuating circumstances’ with no audit of these incidents or even a clear idea what this would apply to. This results in some confusion for the operators about when they should challenge referrals.

We heard of several incidents where operators felt it was not their responsibility to challenge the referral, and this was not documented as part of a pre-treatment check. They felt that if the clinician had referred then it must be correct, so they would not check source data. Operators have a professional responsibility to ensure that they are delivering a justified exposure, and departments must foster and encourage a culture of challenge to ensure patient safety.

Study of risk

Regulation 8(2) requires a study of risk of accidental or unintended exposures as part of an organisation’s quality assurance programme. We’ve found during our inspection programme that, although most radiotherapy departments do conduct risk assessments on all aspects of treatment delivery, few have a specific document relating to accidental or unintended exposures.

There has been significant discussion regarding this, with some good examples in the guidance from the Radiotherapy Board, IR(ME)R: Implications for clinical practice in radiotherapy, and The Safer Radiotherapy e-Bulletin number 4 – May 2021.

We plan to investigate this further as part of our ongoing inspection programme.

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Our wider IR(ME)R activity in 2020/21

Revising guidance for professional bodies

We continue to review and advise professional bodies on publishing guidance relating to radiation governance and working practices in radiology and radiotherapy. This year, we have been involved in working parties looking at:

• inclusive pregnancy enquiries
• patient identification errors
• IR(ME)R guidance for the NHS breast screening programme
• consultation into the Quality Standards for Imaging (QSI) accreditation programme
• exposures carried out as part of research
• clinical audit as required under Council Directive 2013/59/Euratom, as part of the QuADRANT working party.

We also provide expert advice to support CQC’s review of reports from the Healthcare Safety Investigation Branch (HSIB).

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International Atomic Energy Agency Integrated Regulatory Review Service mission to the UK

In last year’s report we gave an overview of the 2019 Integrated Regulatory Review Service (IRRS) mission. Following the publication of the Integrated Regulatory Review Service (IRRS): 2019 mission report we provide some updates to actions:

• Radiation Safety Group: The first couple of recommendations related to strengthening a UK-wide approach to enhance the effectiveness of the regulatory infrastructure for nuclear, radiation, radioactive waste and transport safety. In response to the mission, a radiation safety group (RSG) was set up to include representatives from all government and regulatory bodies involved in the regulation of radiation safety. The RSG aims to coordinate where possible a collaborative approach to radiation regulation across all sectors and is a multi-stakeholder group. Within this new framework a working party has been established with operational colleagues from each sector. The RSG has recently published a multi-regulator UK-wide policy on how we regulate radiological practices.
• Graded approach: Although we have ensured we target our resources to higher risk activities, this has previously taken a more informal approach. We are defining a graded approach, allowing us to ensure our methods are consistent and based on evidence.
• Increasing the number of inspections: Until the start of the pandemic in 2020, we had been steadily increasing inspection activity over the last five years. Since April 2021, we have been carrying out our next phase of inspections at some pace, with 18 IR(ME)R inspections already carried out during April, May and June, and 19 in July, August and September. We are currently reviewing this to align with our capacity and resources.
• Producing guidance: In response to the IAEA mission, an action was placed on CQC to produce guidance. We are reviewing the way we produce guidance and our IR(ME)R team will also collaborate more with professional bodies about the guidance they produce and the extent of the input required from CQC as the enforcing authority.

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Heads of European Radiation Competent Authorities

We continue to represent the UK as part of the medical applications work package. Meetings have once again been held remotely, but we hope to resume face-to-face meetings in the spring.

In 2020/21, there was an addendum to the HERCA position paper on clinical audit, a radiotherapy inspection workshop programme started, and multiple work packages are being considered to begin in 2022.

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The year ahead

Our programme of planned inspections includes departments across diagnostic imaging, radiotherapy and nuclear medicine. We will focus on several key topics, including:

• exposures carried out as part of research
• study of risk in radiotherapeutic exposures
• clinically significant accidental or unintended exposures
• dosimetry in nuclear medicine therapies
• the information that healthcare providers give to people about the risks and benefits associated with radiation exposure
• making more use of data to inform our work
• developing guidance with professional bodies to reduce errors involving patient identification and pregnancy-related errors
• using regulatory position statements in collaboration with the devolved administrations for health
• developing an approved code of practice for IR(ME)R
• a review of the duties of enforcing authorities under Regulation 9.