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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.
- Staffing concerns
- Governance frameworks
- Key themes in diagnostic imaging
- Key themes in nuclear medicine
- Key themes in radiotherapy
- Revising guidance for professional bodies
- International Atomic Energy Agency Integrated Regulatory Review Service mission to the UK
- Heads of European Radiation Competent Authorities
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
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.
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.
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).
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.
Source: CQC SAUE Notifications and NHS England Diagnostic Imaging Dataset
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
- 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)
|Sub-modality||Number of notifications||Percentage of notifications|
|Plain film X-ray||57||17%|
|Dental (including CBCT)||6||2%|
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%).
Figure 4: Diagnostic imaging notifications received by detailed error type, 1 April 2020 to 31 March 2021
Tier 2: Employer's responsibility (9 notifications)
- Inadequate procedures (5 notifications)
- Equipment not fit for purpose (2 notifications)
- Inadequate staff training/supervision (1 notification)
- Lack of optimisation (1 notification)
Tier 2: Incorrect referral (91 notifications)
- Wrong patient (85 notifications)
- Wrong anatomy (4 notifications)
- Wrong modality (1 notification)
- Wrong timing (1 notification)
Tier 2: Incorrect information (26 notifications)
- Failure to cancel (16 notifications)
- Inaccurate clinical information (6 notifications)
- Duplicate/no check of previous imaging (4 notifications)
Tier 2: Incorrect justification (11 notifications)
- Incorrect justification (10 notifications)
- Protocol (1 notification)
Tier 2: Safety checks (5 notifications)
- Imaging history check failure (5 notifications)
Tier 2: Protocol (2 notifications)
- Illegible/unclear protocol (2 notifications)
Tier 2: Pre-exposure safety checks (38 notifications)
- Wrong patient position/set-up/protocol (25 notifications)
- Wrong use of equipment (13 notifications)
Tier 2: Safety checks (36 notifications)
- Patient ID error (33 notifications)
- Failure to check pregnancy/breastfeeding (3 notifications)
Tier 2: Clinical history (14 notifications)
- Failure to check history/details (14 notifications)
Tier 2: Post-examination (10 notifications)
- Failure to upload images (10 notifications)
Tier 2: Authorisation (4 notifications)
- Incorrect authorisation (4 notifications)
Tier 2: Pharmaceutical/contrast (1 notification)
- Administration (1 notification)
Tier 2: Equipment related (36 notifications)
- Hardware (23 notifications)
- Software (6 notifications)
- Ancillary failure (4 notifications)
- IT failure (3 notifications)
Tier 2: Administrative staff error (20 notifications)
- RIS input error (14 notifications)
- Other admin (6 notifications)
Tier 2: Interventional radiology/cardiology (10 notifications)
- Deterministic (7 notifications)
- 10xDRL (3 notifications)
Tier 2: Other (8 notifications)
- Other (8 notifications)
Tier 2: Patient related (5 notifications)
- Unknown pregnancy (4 notifications)
- Patient (1 notifications)
Tier 2: Made in error/withdrawn (1 notification)
- Below threshold (1 notification)
Tier 2: Clinically significant (1 notification)
- Not related to other (1 notification)
Tier 2: Test results (1 notification)
- Request based on incorrect results (1 notification)
Total: 329 notifications
Source: CQC SAUE notifications
- 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.
|Sub-modality||Number of notifications||Percentage of notifications|
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.
Figure 6: Nuclear medicine notifications received by detailed error type, 1 April 2020 to 31 March 2021
Tier 2: Employer's responsibility (1 notification)
- Equipment not fit for purpose (1 notification)
Tier 2: Incorrect referral (4 notifications)
- Wrong patient (3 notifications)
- Wrong requested modality (1 notification)
Tier 2: Pharmaceutical (14 notifications)
- Preparation (8 notifications)
- Administration (6 notifications)
Tier 2: Authorisation (1 notification)
- Incorrect authorisation (1 notification)
Tier 2: Clinical history (1 notification)
- Imaging history check failure (1 notification)
Tier 2: Safety checks (1 notification)
- Inappropriate use of equipment (1 notifications)
Tier 2: Equipment related (9 notifications)
- Hardware (7 notifications)
- Software (2 notifications)
Tier 2: Equipment (3 notifications)
- Local changes to protocol (3 notifications)
Tier 2: Patient related (1 notification)
- Patient (1 notifications)
Total: 35 notifications
Source: CQC SAUE 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)
- 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.
|Sub-modality||Number of notifications||Percentage of notifications|
|Planning and verification imaging||69||51%|
|External beam therapy||65||48%|
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.
Figure 8: Radiotherapy notifications received by detailed error type, 1 April 2020 to 31 March 2021
Tier 2: Incorrect referral (9 notifications)
- Not in accordance with guidelines (5 notifications)
- Wrong treatment protocol/dose/fractionation (4 notifications)
Tier 2: Referral information (4 notifications)
- Failure to check relevant history (4 notifications)
Tier 2: Incorrect justification (1 notification)
- Target volume/outlining error (1 notification)
Tier 2: Other (1 notification)
- Administrative error (1 notification)
Tier 2: Treatment (54 notifications)
- Verification protocol error (19 notifications)
- Geographical miss - shift error (16 notifications)
- Geographical miss - verification image (6 notifications)
- Geographical miss - online matching error (6 notifications)
- Incorrect immobilisation (4 notifications)
- Patient ID / queuing error (3 notifications)
Tier 2: Planning (17 notifications)
- Calculation/checking/data entry error (10 notifications)
- Inappropriate plan generated (4 notifications)
- Wrong image/patient data used (2 notifications)
- Authorisation of plan (1 notifications)
Tier 2: Pre-treatment (6 notifications)
- Patient positioning error (3 notifications)
- Wrong scan protocol selected (3 notifications)
Tier 2: Other (1 notification)
- Administrative error (1 notification)
Tier 2: Equipment-related (34 notifications)
- Hardware (13 notifications)
- Software (12 notifications)
- IT failure (8 notifications)
- QC/Calibration issue (1 notification)
Tier 2: Made in error or withdrawn (4 notifications)
- Below threshold (2 notifications)
- Duplicate notification/other error (2 notifications)
Tier 2: Patient related (3 notifications)
- Unknown pregnancy (2 notifications)
- Patient (1 notification)
Tier 2: Other (1 notification)
- Other (1 notification)
Total: 135 notifications
Source: CQC SAUE notifications
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
Actions for employers
Make sure you clearly distinguish a SAUE from a CSAUE, and that the person submitting a notification completes the webform accurately.
The employer’s procedure should take into account (as per professional guidance):
- what would trigger a multidisciplinary team review
- who will inform the referrer and practitioner
- how this feeds into the employer’s duty of candour processes
- what information should be provided to the patient
- how the information is recorded, including where a decision is made not to inform the patient.
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.
Actions for employers
- Where multiple care providers are involved in an IR(ME)R pathway, for example a GP, dentist or hospital provider, there should be an agreement about who notifies CQC of incidents. Providers need to cooperate and have assurances from each other’s investigations whenever there is an error in an IR(ME)R pathway.
- We recommend that the radiation employer who carried out the exposure should make the notification – even when the error happens at another provider, for example where a patient was incorrectly referred. The radiation employer should have assurances that the referring provider has addressed the error and put actions in place to reduce the risk of a repeat.
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.
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.
- 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.
- 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.
- 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.
Key issues and themes in 2020/21
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.
Actions for employers
- Consider the need for additional staffing resource when planning new services and equipment.
- Actively monitor the risks of staffing issues, for example where a single individual fulfils a key role, such as the licence-holding practitioner, or where staff have to handle management and governance responsibilities on top of their clinical workload.
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.
Actions for employers
- Make sure your procedures specifically or quantitatively define the process of achieving and maintaining competency.
- Ideally, records should be held electronically, and be easily accessible to all staff groups, and the enforcing authority when requested.
- Review competencies regularly, for example at annual review or after long periods of absence, to determine whether staff still deem themselves competent or need further training.
- Make sure training includes the relevant subjects detailed in Schedule 3.
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.
Actions for employers
A radiation safety policy and supporting radiation protection frameworks should provide fundamental information including:
- how tasks are delegated from the employer and to whom (either person or committee)
- how risks and assurances will be fed back to the employer or senior leadership team (reference to an organisation chart)
- the terms of reference for any radiation protection committees (representatives and required number to include clinical staff)
- how departments outside of radiology, nuclear medicine or radiotherapy will specifically engage with committees, such as cardiology, dental and orthopaedic theatres
- how individual departments feed into a radiation protection committee (this may be through departmental regulatory audits)
- how subcommittees are monitored and their terms of reference
- how actions and risks will be monitored.
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.
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.
Examples of issues in a clinical audit
- Clinicians identified renal impairment as a result of administering contrast during CT scans. This prompted a clinical audit to identify whether reducing the bolus dose from 100mls to 50mls would reduce the burden on the kidneys without any adverse effect on image quality.
- Requests for plain abdominal radiographs from the emergency department were audited to make sure they were being performed appropriately, as advised in the iRefer guidelines from the Royal College of Radiologists.
Examples of issues in a regulatory audit
- Are pregnancy enquiries carried out and documented as in the procedure?
- Is each medical exposure justified by a practitioner or authorised under guidelines?
Actions for employers
- Make clinical audit an established practice in every department. It should always have a multidisciplinary approach, which you can use to educate and train staff to maintain quality in radiology, nuclear medicine and radiotherapy.
- Make sure you’re familiar with the requirements for clinical audit and check the Royal College of Radiologists AuditLive for examples of templates to carry out audits that directly correlate with the requirements of IR(ME)R. There is also guidance on how to comply with regulations in the 2020 publications Implications for clinical practice for both diagnostic imaging and radiotherapy.
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.
Actions for employers
- Have a named person responsible for managing the quality assurance programmes for written procedures and protocols, with the ability to escalate issues to senior management teams or meetings.
- Have a multidisciplinary approach to developing policies and procedures, and ensure all duty holders have the opportunity to attend relevant meetings.
- Make sure procedures and protocols are fit for purpose and reviewed regularly by the duty holders who use them.
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.
Actions for employers
When considering the IR(ME)R pathway, particularly where there are multiple employers involved in a community diagnostic centre, there are several important things to consider:
- Entitlements of duty holders must be clear, particularly where patients are coming from different referral points. Where there are shared responsibilities in relation to entitlements, the radiation employer must have clear, transparent audits and should request assurances from other employers where appropriate.
- For non-medical referrers, it’s important to cooperate with other employers about training to ensure there is no duplication, with clear and consistent scope of practice.
- When establishing procedures, it’s useful to walk through a patient pathway specifically from an IR(ME)R point of view. This will allow you to identify potential gaps or issues at an early stage. Also identify all duty holders where they work, the role they will be undertaking, the procedures or protocols they will be following, and what training and auditing there will be.
- Where a single member of staff is expected to work with different protocols or procedures from multiple organisations there could be the potential for errors. Therefore, consider standardising processes, documentation and procedures wherever appropriate.
- Implement a procedure to enable operators to escalate concerns or request advice from a practitioner or referrer at another employer.
- Adopt a multidisciplinary team approach that involves all duty holders in the establishment.
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.
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.
Actions for employers
- Follow guidance from bodies such as EANM, the British Nuclear Medicine Society (BNMS) and the Internal Dosimetry User Group (IDUG) to inform the dosimetry programme. We expect to see justification for why patient-specific dosimetry has not been deemed necessary and specific criteria where it would be used for individual patients.
- Patient-specific dosimetry should form part of the patient pathway for any non-standardised therapy radiopharmaceuticals, such as 177Lu-PSMA (prostate specific membrane antigen), to mitigate the risk to patients. For standardised treatments, such as Iodine-131 for differentiated thyroid cancer or Radium-223 for palliation of bone pain, use other methods of treatment verification, for example post-therapy confirmation imaging or monitoring of blood counts. Where therapies are carried out on children, we expect to see particular attention to optimisation (Regulation 12(8)(a)), and therefore the role of dosimetry in achieving this.
- When signing up to deliver new treatments, consider whether there is enough resource to deliver dosimetry. Focus on involving the medical physics expert as required under Regulation 14(2)(b). The Administration of Radioactive Substances Advisory Committee (ARSAC) also enquires about adequate staffing when issuing an employer’s licence to include therapy procedures, as set out in its Notes for Guidance.
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.
Example: Changing prescribed activity
A patient received a 15% underdose of lutetium-177 DOTATATE during a single fraction, due to a delay at customs. There was also a setup error, which further reduced the activity delivered to the patient. The employer reported this to us as a SAUE under notification code 9.2, as the delivered activity fell outside +/-10% of the prescribed activity.
In the investigation report, the practitioner confirmed that the lower administered activity was not clinically significant – it was considered justified based on the patient’s clinical history, and the fact that subsequent cycles would ensure the patient received sufficient activity overall to meet the clinical purpose.
Actions for employers
- Do not amend the prescribed activity after the administration has taken place.
- Notify us of any SAUEs that meet the thresholds set out in the guidance, even if the change to patient administered activity is not deemed clinically significant.
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.
Example: Failing to review practitioners’ licences
Once sufficiently trained, oncologists at a centre worked under letters of delegation from the licensed IR(ME)R practitioners. This was common practice under MARS1978, rather than authorisation guidelines as required under Regulation 11(5). These letters were valid until the practitioners’ licence expired.
One practitioner was unsuccessful when they applied to renew their licence, so they moved to work under a delegation of another practitioner, whose licence was renewed successfully. At this stage, the practitioner failed to notify the organisation that they were no longer licensed, and the department failed to review the delegations in place.
Subsequently, seven therapies were carried out without a suitably licensed practitioner in place before this breach was discovered. Fortunately, a review of these cases found that the treatments were clinically appropriate and delivered according to local protocol.
The department notified the ARSAC support unit and made a voluntary notification to CQC. The department made changes including:
- incorporating licences into a quality management system, which alerts the head of radiotherapy three months before they expire
- including checking the licence status in the agenda of existing brachytherapy meetings, which includes stock and resource levels
- reviewing practitioners’ licences as part of the appraisal process
- suspending the service until the practitioner’s licence was successfully renewed.
Example: Clear delegated authorisation
We inspected a department that had a clear process for delegated authorisation. The licence-holding practitioners had developed two sets of guidelines for authorisation of diagnostic nuclear medicine procedures. These were underpinned by lists of entitled operators.
One document allowed any appropriately entitled operators, such as technologists and radiographers, to authorise a set of routine diagnostic examinations for specific clinical queries.
The second set included additional clinical information which specified that only consultants and registrars could authorise an examination – for example, a ventilation-perfusion scan following an unreported chest x-ray that the operator deemed normal, or white cell imaging for infection/inflammation.
Both sets of guidelines also clearly stated that all other examinations must be authorised by the licence-holding practitioner.
As well as meeting regulatory requirements, this process also helped to mitigate the effects of having a limited number of radiologists available to authorise examinations, and provided a framework to support radiology trainees.
Actions for employers
- When using authorisation guidelines, make sure they are written and ratified by one named IR(ME)R practitioner. When medical staff are acting under the supervision of a licensed practitioner, this should be as part of their training and the practitioner should be involved in oversight and mentorship, with appropriate authorisation guidelines in place.
- Once appropriately qualified and trained, medical staff should obtain their own licence and be entitled as a practitioner. This is particularly important in therapies, where there are higher risks, and the practitioner should be closely involved in justifying the procedure. The practitioner should have oversight of the procedure for which they are responsible.
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.
Example: Licensing breach
When applying to renew an employer’s licence, it became clear that the service did not have a licensed practitioner for breast sentinel lymph node (SLNB) studies, as the previous practitioner had retired. Fifty-five patients had undergone SLNB procedures without a practitioner licence in place, over six months. This breach was a result of a failure of the governance process to identify that the retiring individual was the only SLNB licensed practitioner.
There was no additional risk to these patients because of a clearly defined and well managed pathway, with experienced staff who worked as a multidisciplinary team to discuss each patient and their needs. The pathways of every patient in the cohort were examined retrospectively, and the exams were deemed to be clinically appropriate and considered justifiable.
To improve the process for managing licences, the employer:
- introduced new triggers for long-term sickness or retirement of practitioners
- rationalised the employer’s licence to ensure it only included active procedures
- reviewed and rationalised all practitioner licences
- devised a licensing matrix that sets out which practitioners hold licences for each procedure
- amended governance procedures to include detail on the licence management procedure and responsible parties
- reviewed employer’s procedures to reflect these changes
- investigated an automated document system to support this process
- launched a recruitment drive for additional radiologist posts to mitigate the risk of having a single licensed practitioner
- ensured that the Medical Exposures Committee oversees the entire licence management process, including matrices, and that all practitioners agree this.
Actions for employers
- Licence management is a key part of IR(ME)R compliance. Make sure you manage licences appropriately, as a key part of regulatory compliance. Clearly set out the responsibilities for oversight of this process and check regularly. We expect to see a robust and active process for managing licences, with clear responsibilities.
- Although practitioners are responsible for making sure they have a valid and appropriate licence, we expect employers to keep records of their practitioners’ licences. This enables you to manage practitioners’ entitlements and provides assurance of regulatory compliance.
Key themes in radiotherapy
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.
Example: Overriding automaticity
A patient attended for radical treatment to the proximal humerus and received 50Gy in 25 fractions planned with a parallel opposed pair at 6MV.
On fraction 12 of 25, the patient attended for treatment and was imaged using an anterior MV image, with the couch adjusted so the field position was in tolerance. A further anterior MV image was acquired after the move to confirm that shifts were correct.
Treatment operators noticed that the couch vertical and longitudinal were out of tolerance and were overridden with the annotation ‘non-indexed set up’ added to the R&V system. The anterior beam was then delivered, and the operators entered the room to move the gantry round to the posterior position, it was at this point they realised the couch was too low to reach correct position. The FSD reading was 123.0cm instead of 97.1cm, therefore the anterior beam was treated with a 25.9cm discrepancy on the vertical position.
Causative factors for this error included that staff expected the longitudinal to be out of tolerance as the immobilisation was not indexed and the ‘standard’ tolerance table was used, therefore the staff expected to have to override the set up. Discussion during the investigation also identified that there had been a failure to record couch parameters on fraction 1, so there had been persistent overrides for this patient.
The employer responded by:
- auditing overrides over a set period
- reviewing tolerance tables in the department with a view to creating site specific tolerance tables
- working towards indexing all immobilisation, even for non-standard techniques
- giving advice to staff about annotation regarding overrides in the R&V system.
Actions for employers
- Regularly audit overrides in the department and carry out thematic reviews to identify when tolerances need to be adjusted.
- Use site-specific tolerance tables.
- Have a clear protocol for capturing couch parameters for fraction 1 of treatment.
- Use indexing of immobilisation for all patients.
- Input couch heights for all treatments into the recording and verification systems.
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.
Example: Cross-checking patient ID on different systems
Patient A attended for treatment of 60Gy in 20 fractions to the prostate using a Volumetric Modulated Arc Therapy (VMAT) technique. Patient B also attended the same unit for treatment of 20Gy in 5 fractions to the right lung using static beams. Patient A was called into the room and the operators loaded up his information into the R&V system and opened his treatment chart. At this point the patient, who required a full bladder for treatment, advised that he had not finished his drinking and so was not ready.
Operators then brought patient B into the room, along with his treatment sheet, and loaded his information into the SGRT system. The patient was correctly identified against the treatment sheet and SGRT system. However, patient A was still open on the R&V system. Patient B was set up and the SGRT system advised they were in the correct position. Outside the room, the treatment chart for patient A was exited to allow the verification image to be taken, but the patient was not closed. The verification image was within tolerance and operators continued to treatment, re-opening the treatment chart. They noted that a 6.2cm lateral and 4.7cm longitudinal couch override was needed. Although they discussed this, the imaging was correct, and they decided to proceed.
Treatment of the first beam started and after a short delay the operator noticed that the gantry was moving (i.e. VMAT treatment) when this should be a static beam delivery. Treatment was terminated and patient B was taken off the couch. The operators noticed that the 10MV prostate VMAT beam intended for patient A had been initiated, not the 6MV static anterior beam for patient B.
There were several causative factors for this error:
- Non-synergistic link between SGRT and R&V.
- Non-synergistic link between verification imaging system & R&V system.
- Although the ID process was followed correctly in the treatment room, it was not cross-checked across all systems and mediums.
- The department was implementing paper-lite, which meant that operators needed to repeat some tasks, for example identification across multiple systems, resulting in increased probability of error.
- Failure to follow departmental protocol for checking treatment.
The department synergistically linked the SGRT and R&V systems immediately. They were unable to link to the verification system due to software upgrade requirements, although they are planning this in the future. Review of processes during the investigation showed that protocols had not been correctly updated to reflect the interim paper-lite solution.
Actions for employers
- When implementing paperless or paper-lite processes, make sure there is effective project management to mitigate risks during the change period.
- Update documents in a timely way, so that they always reflect clinical practice.
- Collaborate with other centres to help implementation, as they will all face similar challenges. Some departments are developing innovative solutions that would benefit others that are not as advanced in the process.
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.
Example: Checking and challenging referral information
A patient was referred for radiotherapy by a consultant, supported by a registrar, for treatment to metastases in the lower pelvis and proximal femurs. The patient attended their planning scan appointment and the scan was exported to the treatment planning system. Two weeks previously the patient had been referred by the same clinical team, at the same centre and had received treatment to the right Sacro-Iliac joint (SIJ) for pain control.
During the planning of the treatment to the proximal femurs and lower pelvis, it was noted that the previous treatment field had in fact treated the right hemi-pelvis – not just right SIJ as previously thought. Therefore, the patient could not receive radiotherapy due to significant overlap, and the scan was not necessary.
The initial referral had stated right SIJ as the target area but the plan, which was available in the R&V system, clearly stated that the right hemi-pelvis had been treated. When questioned, it became clear that the pre-treatment staff, who had scanned on both occasions, did not query the overlap as they did not consider it their responsibility.
Causative factors included:
- time pressures on the consultant as a result of the impact of the pandemic
- a perceived difficulty in accessing the R&V system at external clinics, which meant the clinician only used the referral form, a copy of which was in patient notes, to make decisions
- no specific section for re-treats on the referral form
- operators not being empowered to challenge referrals
- no specific annotation about checking referral information and when to challenge
- no protocol for re-treatments.
The employer responded by providing refresher training on the process for all referrers and reviewing the time it takes to access relevant information at external clinics. They also reviewed the re-treatment process and made changes to the referral form to include a question on previous treatment. The incident, and learning, was highlighted at several meetings to reiterate the importance of checking and challenging referral information.
Actions for employers
- Have clear guidance on the information that’s needed for a referral to be accepted, for example histological or diagnostic confirmation, and multidisciplinary team referral.
- In protocols and procedures for pre-treatment activities, make sure there’s a process for checking source data relating to referrals, and factor in time into the patient journey to allow for this.
- Encourage a culture of challenge so operators feel able to query referral information.
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.
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).
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.
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.
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.
- Last updated:
- 04 November 2021