Biennial radiotherapy error data analysis and learning report · Biennial radiotherapy error data...

Biennial radiotherapy error data analysis and learning report: January 2018 to December 2019

Report No. 6


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About Public Health England

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Contents

About Public Health England 2

Executive summary 4

References 7

1. Introduction 8

2. Background 9

3. Data 10

3.1 Obtaining the data 10 3.2 Number of reports 11 3.3 Lag time for reporting 13

3.4 Quality assurance of the data 13

4. Results 15

4.1 Main themes of RTE 15 4.2 Classification level of RTE 18

4.3 Breakdown of classification by process subcode 19 4.4 Safety barriers 28

4.5 Causative factors 32 4.6 Brachytherapy RTE 37

4.7 Inspectorate data 41

5. Discussion 47

5.1 Increase in RTE reporting 47

5.2 Main themes 49 5.3 Classification level of RTE 50

5.4 Safety barriers 53 5.5 Causative factors 53 5.6 Brachytherapy RTE 54 5.7 Inspectorate data 54

6. Conclusion 56

7. Recommendations 58

8. Acknowledgements and PSRT Steering Group membership 59

Acknowledgements 59

9. References 60


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Executive summary

The fundamental role of reporting and learning systems is to enhance patient safety by

learning from failures of the healthcare system(1). The value of near miss and error

reporting and learning processes is well appreciated in the UK radiotherapy (RT)

community with 100% of NHS RT providers subscribing to a national voluntary system

of reporting of RT error and near miss events.

This report is the sixth in a series of two-year reports(2), providing an overview of

Radiotherapy Error (RTE) data reported voluntarily to the National Reporting and

Learning System (NRLS) and directly to PHE between January 2018 and December

2019. The report also contains aggregate data from January 2010 to December 2019

and compares data with that from preceding 2-year periods. This report also contains

data received from the inspectorates for IR(ME)R for England, Wales, Northern Ireland

and Scotland. The analysis undertaken uses the taxonomies from ‘Towards Safer

Radiotherapy’(3) and the ‘Development of Learning from RTE’(4), thus facilitating

comparisons of national RTE trends with both local and network findings.

A total of 18,734 RTE reports were included in this analysis from 98.3% of UK RT

providers. An estimated reported RTE rate of 4 per 1,000 attendances or 45 per 1,000

prescriptions was calculated. An estimated report RTE rate for level-one events was

calculated as 0.4 per 1,000 prescriptions. It is worth noting that the clear majority of

these events did not impact on the patients’ planning, treatment or outcome.

Consistent with previous reports(2) RTE were spread across all 21 categories of

process codes; treatment unit process codes were the most frequently reported RTE

(42.3%, n = 7,923). The most frequently reported process subcode was ‘on-set

imaging: production process’, making up 12.3% (n = 2,310) of all RTE reported.

Of the RTE reports, 62.3% (n = 11,679) were ‘near miss’ or ‘other non-conformances’

with no impact on patient outcome. In total, 35.9% (n = 6,724) of the RTE reported

were not clinically significant and were classified as ‘minor radiation incidents’. Of the

remaining 1.8% (n = 331) RTE reports only 0.9% were reportable. When compared

with the results from the previous two-year report there has been a reduction in the

percentage of reportable radiation incidents from 1.0% to 0.9%.

Safety barriers (SB) are embedded across the RT pathway coding. The SB taxonomy

can be used to separately identify both failed and effective SB. Treatment process ‘use

of on-set imaging’ was the most frequently reported failed SB (10.5%, n = 1,392). For

this reporting period, the most frequently reported effective SB was ‘on-set imaging:

approval process’ (22.9%, n = 872). The use of a causative factor taxonomy enables

identification of system problems that could precipitate a range of different incidents.


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From the RTE which contained a root cause (RC), the most frequently reported was

individual ‘slips and lapses’, making up 43.8% (n = 8,058) of all RC. The most

frequently reported contributory factor was ‘adherence to procedures/protocols’ (41.5%,

n = 2,534).

Consistent with findings in the literature, there are a small number of significant

incidents and a greater number of lower level incidents. The proportion of significant

incidents has continued to decrease slightly since the previous two-year period.

On-set imaging associated RTE made up a significant proportion of all reported RTE.

This reflects the increase in automation of processes across the radiotherapy pathway.

On-set imaging processes now represent a focal point for decision making processes

on the pathway and are the last point on the pathway prior to initiating treatment

exposures. The most frequently reported root cause of RTE was individual ‘slips and

lapses’. This is reflected in the level of data and image interpretation required as part of

imaging processes. The risk of error in imaging processes may be amplified due to the

dynamic nature of online review and the rapid pace of development of new

technologies and techniques, together with an increase in imaging frequency. However,

the benefit image-guided RT brings to the patient is clear as it is frequently associated

with error detection methods and as such image guided RT (IGRT) remains a critical

safety barrier in RT.

Outputs from RTE analysis should be used to inform prospective risk assessments in

thematic areas identified in the analysis as part of a study of the risk of accidental and

unintended exposures to further mitigate against these types of RTE. This approach

supports compliance with regulation 8(2) and 8(3) of the Ionising Radiation (Medical

Exposure) Regulations (IR(ME)R) requires the recording analyses of events or

potentially involving accidental or unintended exposures (5,6).

RT is ever evolving with new techniques and technology. Therefore, these trends

should continue to be reported and learnt from. The move to increased hypo-

fractionation of external beam RT will reduce the opportunities to correct for RTE. The

role of reporting and learning systems will continue to play a part in helping identify and

address RTE.

This work supports a risk-based approach to improving safety both locally, regionally

and nationally and indicates a culture that is open, transparent and already present in

the UK RT community.


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Local provider recommendations are that:

• all UK RT providers should continue to use ‘Towards Safer Radiotherapy’(3) and

‘Development of Learning’(4) taxonomies to code all levels of RTE for local analysis to

inform local learning and practice

• UK NHS RT providers should continue to submit fully coded RTE reports, of all levels, to

the national voluntary reporting system using the mechanisms identified within this report,

monthly, to ensure timeliness of shared learning

• adherence to protocols / procedures and slips and lapses are the most frequently reported

causative factors. RT providers should consider working arrangements associated with

these reports

• consideration should be given to introducing a ‘pause and check’ policy for on-line image

capture, review and approval to reduce IGRT associated RTE

• a review of referral guidelines and procedures should be undertaken to ensure all required

diagnostic information is in place prior to justification and authorisation of treatment and

made available to inform planning processes to minimise the risk of a missed verification of

diagnosis / staging of disease

• consideration should be given to reviewing the effectiveness and timing of ‘end of process

checks’ to ensure they are optimal in the pathway to mitigate RTE

• local learning should be compared with the national picture and used to inform local and

network level practice

• independent providers should consider submitting RTE to the national voluntary reporting

system

• RTE analysis should be used to inform prospective risk assessments as part of a study of

the risk of accidental and unintended exposures to support compliance with IR(ME)R

(Regulation 8(2) and 8(3))

National recommendations are that:

• PSRT should continue to develop the national analysis and learning from RTE, with timely

dissemination of findings to the RT community for wider learning

• RTE should be used by the PSRT and individual RT providers as part of a risk-based

approach to allocating resources for improving patient safety in radiotherapy and to inform

audit and research

• PSRT should engage vendors in developments to reduce the rate of RTE related to

equipment failure and human factors.

• in areas demonstrating an initial increase in RTE that are then seen to fall, Learning from

Excellence may be useful. PSRT should develop RT based tools to support the

implementation of emerging patient safety theory


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References

1. World Health Organization. Reporting and learning for patient safety. Available at https://www.who.int/patientsafety/implementation/reporting_and_learning/en/

2. PSRT. Radiotherapy errors and near misses: biennial report. Nos 1-5. Available at www.gov.uk/government/publications/radiotherapy-errors-and-near-misses-data-report

3. RCR, SCoR, IPEM, NPSA, BIR. Towards Safer Radiotherapy. Royal College of Radiologists, London (2008). Available at www.rcr.ac.uk/towards-safer-radiotherapy

4. PSRT. Development of learning from radiotherapy errors. Available at www.gov.uk/government/publications/development-of-learning-from-radiotherapy-errors

5 The Ionising Radiation (Medical Exposure) Regulations 2017. The Stationery Office, London, SI 2017/1322.www.legislation.gov.uk/uksi/2017/1322/contents/made.

6 The Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018. The Stationery Office, London, SR 2018/17. www.legislation.gov.uk/nisr/2018/17/contents/made.

https://www.who.int/patientsafety/implementation/reporting_and_learning/en/

http://www.gov.uk/government/publications/radiotherapy-errors-and-near-misses-data-report

http://www.rcr.ac.uk/towards-safer-radiotherapy

http://www.gov.uk/government/publications/development-of-learning-from-radiotherapy-errors

http://www.legislation.gov.uk/uksi/2017/1322/contents/made


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1. Introduction

Patient safety in radiotherapy (RT) has been defined as the absence of an

unacceptable risk of harm when harm is excessive morbidity or sub-optimal tumour

control(1). A strong safety culture is a cornerstone of patient safety and is essential in

ensuring the risk of probability and magnitude of error are minimised. A reporting and

learning system contributes to an effective safety culture(2). It is imperative errors and

near misses are learned from and effective preventative measures are implemented(3).

The fundamental role of reporting and learning reporting systems is to enhance patient

safety by learning from failures of the healthcare system(4). It is known that most

problems are not just a series of random, unconnected one-off events; they are

provoked by weaknesses in systems and processes and often have common root

causes which can be generalised and corrected. Although each event is unique, there

are likely to be similarities and patterns in sources of risk that may go unnoticed if

incidents are not reported and analysed. To maintain or improve patient safety, errors

must be prevented or minimised by such reporting and analysis.

Experience has shown that as an organisation’s reporting culture matures, staff

become more likely to report radiotherapy error and near miss events (RTE). There is

an emerging evidence base that organisations with a higher rate of reporting have a

stronger safety culture(5). All RT providers should have clear guidelines in their quality

system on error management, and actions to be taken when errors occur.

The 2006(6) report of the Chief Medical Officer for England and Towards Safer

Radiotherapy (TSRT), published in 2008(7), were seminal documents in the field of RT

safety; both contained practical recommendations for the RT community aimed at

improving safety and reducing errors. These recommendations have been adopted by

UK RT providers. In 2016, the Development of Learning (DoL) from Radiotherapy

Errors(8), a guidance document supporting the enhancement of learning from RTE and

their analysis, was published. These key publications have facilitated the national

sharing of RTE.

This report is the sixth in a series of two-year reports(9), providing an overview of RTE

data reported voluntarily to the National Reporting and Learning System (NRLS)(10) and

directly to PHE between January 2018 and December 2019. The report also contains

aggregate data from January 2010 to December 2019.

https://www.gov.uk/government/publications/radiotherapy-errors-and-near-misses-data-report


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2. Background

This analysis has been undertaken by Public Health England (PHE) on RTE reported

voluntarily by NHS RT providers and the relevant enforcing authorities for the Ionising

Radiation (Medical Exposure) Regulations (IR(ME)R). The analysis has been reviewed

by the Patient Safety in Radiotherapy Steering Group (PSRT). This multidisciplinary

group's membership includes a patient representative alongside representatives from

the Institute of Physics and Engineering in Medicine (IPEM), Royal College of

Radiologists (RCR), Society and College of Radiographers (SCoR) and PHE. The

PSRT are tasked with leading a collaborative programme of work to improve patient

safety in RT.

TSRT(7) provides definitions for the terminology to be used in defining RT errors that

include near misses (RTE) and proposed 2 taxonomies for use in describing RTE. The

‘Classification of radiotherapy errors grid’ describes the severity of the error and the

‘Radiotherapy pathway coding’ describes where in the RT pathway the error occurred.

In December 2016, a guidance document containing the refinement of the

‘Radiotherapy pathway coding’ to include ‘Safety barriers’ (SB) and a proposed

‘Causative factor (CF) taxonomy’ was published(8). The document also contains

definitions and examples on the application of the taxonomies.

It has been stated that a critical safety feature of an organisation is how it learns from

its own and from others’ experience(3). The value of near miss and error reporting and

learning processes is well appreciated in the UK RT community with 100% of NHS RT

providers subscribing to a system of national voluntary reporting of RT error and near

miss events. The PSRT recommends learning from this analysis and the tri-annual

analyses(11). These publications facilitate the comparison of locally identified trends

against the national picture.

The National Reporting and Learning System (NRLS) is an anonymised voluntary

reporting system to collect and learn from patient safety incidents for England and

Wales. The NRLS is managed by the Patient Safety Team who currently sit within NHS

England and Improvement (NHSEI). PHE has a data sharing agreement with the NRLS

and under this agreement RTE data is extracted from the NRLS and shared with PHE

for analysis to support learning from these events with the principle aim of making

services safer for patients.

This collaboration led to the publication in July 2010(9) of the first two-year report on a

back catalogue of patient safety incidents reported to the NRLS between August 2007

and November 2009. In November 2013, a mechanism for providers in Northern

Ireland and Scotland to contribute to this voluntary reporting scheme was introduced.

Subsequently, data from across the UK, including data received from the relevant

https://www.gov.uk/government/publications/safer-radiotherapy-error-data-analysis-report




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enforcing authorities for IR(M)ER for England, Wales, Northern Ireland and Scotland

was published in subsequent two-year reports(9). The relevant enforcing authorities will

be referred to as inspectorates here after. The fifth report included analysis using the

new taxonomies(8) including the refined pathway coding, safety barrier and causative

factor taxonomies. This sixth report also contains analysis of the method of detection of

taxonomies.

3. Data

The data presented in this report is anonymised and received as part of a voluntary

reporting scheme. As with any voluntary reporting system, the data will only reflect

those incidents that are reported and may not necessarily be representative of the

actual levels of error occurrence, as such, this data requires interpreting with care.

Data for the reporting period January 2018 to December 2019 forms the focus for the

analysis. Where possible, comparisons are drawn against data for two-yearly reporting

periods going back over 10 years. This report includes data from January 2010 to

December 2019.

3.1 Obtaining the data

The voluntary data was obtained through 3 distinct routes: from the NRLS in England and

Wales and directly from providers in Northern Ireland and Scotland. These routes are

described in detail below. In addition, anonymised synopsis of closed reportable radiation

incidents was shared by the IR(ME)R inspectorates for England, Northern Ireland, Scotland

and Wales with PHE for inclusion in the analysis.

3.1.1 National voluntary reporting system

The vast majority of reports came through the NRLS(10) at NHSEI for providers, which

collates reports for England and Wales. The NRLS operates a voluntary reporting

system to collect and learn from patient safety incidents. A patient safety incident (PSI)

is defined as:

‘Any unintended or unexpected incident which could have, or did, lead to harm for one

or more patients receiving healthcare’(10).

PSIs are primarily reported by NHS organisations in England and Wales through bulk

upload via local trust risk management systems to the NRLS. Independent providers

are also able to report to the NRLS using web-based forms. Both healthcare staff and




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the general public are encouraged to report any incidents directly through an open

access form(12). The NRLS offers a unique dataset to help understand harm associated

with healthcare. It was established in 2003 and now has almost 22 million PSI

reports(13), from many areas of healthcare, in the database.

The NRLS can be interrogated for relevant incidents by searching the free text field of

any incident report using keywords or search terms. During the development of this

work, a system was created to extract targeted data from the NRLS using a trigger

code ‘TSRT9’. This was proposed and described in ‘Implementing Towards Safer

Radiotherapy: guidance on reporting RTE effectively’(14). This code is searched for in

the free text field rather than using search terms that were found to be less

determinant. A RTE is defined in TSRT as:

‘a non-conformance where there is an unintended divergence between a RT treatment

delivered or a RT process followed and that defined as correct by local protocol’(7).

PSIs that are not RTE, such as a report of a patient falling in a RT department, are not

included in the RTE dataset. These are reviewed, analysed and shared by NHSEI. The

NRLS is now under redevelopment as part of the patient safety incident management

systems (PSIMS) project(13), where the new system will support more learning

opportunities, so the NHS can continue to improve safety.

3.1 2 Northern Ireland and Scotland

A mechanism was developed to enable providers in Northern Ireland and Scotland to

participate in this scheme in 2013. Once agreements for data sharing were achieved

with health boards and hospital trusts, predefined criteria consistent with those

employed for the NRLS data were shared with RT providers in Northern Ireland and

Scotland for inclusion in reports.

Anonymised data has been accepted from providers on Microsoft® Office Excel

spreadsheets for direct upload into the PHE RTE incident database to minimise the

possibility of transcription error and to ensure the anonymity of the data. PHE is

working with the NRLS to further streamline the reporting mechanism for providers in

Northern Ireland and Scotland.

3.2 Number of reports

A total of 18,853 RTE reports were submitted to the voluntary reporting scheme

between January 2018 and December 2019, with an average 786 reports per month.

There has been an increase in reporting since the previous two-year reporting period,

where a total of 16,308 RTE reports were submitted between January 2016 and

December 2017, with an average 680 reports per month. Figure 1 indicates a peak in

https://report.nrls.nhs.uk/nrlsreporting/


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reporting in May and October. The peaks in October and May correlates with the 6

monthly NRLS reporting deadline for their annual reports(12). This variation highlights

that not all providers report monthly.

Figure 1. Average number of RTE reports submitted to the national voluntary reporting system by month (January 2010 to December 2019)

Due to the merging of 2 providers there are now 60 NHS providers across the UK. For

this two-year period, reports were received from the clear majority of NHS RT

providers, 59 (98.3%). This is the same as the previous two-year period where 59 out

of 61 NHS providers reported to the national analysis.

There is some variance in the number of reports submitted by provider. One provider

reported 1,450 RTE across all levels of RTE and 65.0% (n = 39) providers reported

less than the average of 312 RTE over the two-year period (Figure 2). It should be

noted that there is also variation in the numbers of treatments delivered between small,

medium and large providers.


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Figure 2. Number of RTE reported by provider (January 2018 to December 2019, n = 18,734, average =213)

It should be noted that those providers reporting higher numbers of RTE represent

providers with mature reporting cultures and should be encouraged to continue

reporting. A 2018 survey(15) of RT providers, showed providers were less likely to

submit level 5 RTE nationally where dual local reporting and learning systems were in

operation as to do so would require additional resource.

3.3 Lag time for reporting

A lag time between the date of the RTE and the date on which it was reported to the

NRLS or PHE was calculated for each report included in the dataset. This measures

the time from date of RTE discovery to date shared with PHE. A minimum reporting lag

of 0 days and a maximum 658 days was found for individual RTE. There was an

average lag time of 51 days and a mode of 21 days across providers. This is similar to

findings at the NRLS(16). This average lag time is also similar to that found in the

previous two-year analysis, where the average lag time was 48 days. The maximum lag

time has reduced from 871 days which indicates there are fewer outliers reporting with

extended lag times. A total of 27 reports were received with a lag time of over 500

days. Of these, 59.3% (n = 16) were reported from a single provider as part of a bulk

upload. There was no obvious explanation for the delay in reporting these 27 RTE.

3.4 Quality assurance of the data

All providers were asked to include a trigger code, classification(7), pathway coding,

including failed safety barriers, causative factor and, where applicable, effective safety

barriers (methods of detection)(8) in RTE reports to facilitate both local and national

analysis.


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On receipt of the reports, PHE staff with clinical RT expertise performed consistency

checking of the local application of the classification and coding. The coding was

reviewed for all RTE classified as reportable through to near miss (levels 1-4) and 10%

of non-conformances (level 5) RTE were audited. This formed part of the data quality

assurance process completed prior to analysis of the reports.

Reports were categorised into complete, incomplete or non-RTE. Complete reports

contain the classification and pathway coding, complete fixed reports are defined as

complete reports which have had the classification, and/or the pathway coding,

amended for consistency reasons. Further guidance is available on the application of

the classification, pathway and causative factor coding(8). Incomplete reports are

defined as reports without the classification and coding being applied locally prior to

submission, incomplete fixed reports are reports which had sufficient text descriptors to

assign the classification and/or pathway coding. In April 2018, the definition of a

complete report was changed to include reports with classification, pathway coding and

causative factor taxonomy to reflect the introduction of the new taxonomies. This is

displayed in figure 3, representing data for January to March 2018 (n = 1,954) and April

2018 to December 2019 (16,899) respectively.

Of the 18,853 RTE reports received, a total of 18,734 reports were included in the

analysis, 15,358 had been classified and coded by local RT providers (1,817 between

January and March 2018 and 13,541 between April 2018 and December 2019, Figure

3).

Figure 3. Breakdown of report QA (January to March 2018, n = 1,954 and April 2018 to December 2019, n = 16,899)


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There were 127 incomplete reports between January and March 2018 and 3,250

between April 2018 and December 2019, only one of which did not contain sufficient

information to assign classification and coding. The remaining 118 non-RTE or PSI

reports, were excluded from the analysis. A total of 99.4% (81.5% complete and 17.9%

incomplete) of the data submitted was included for analysis in this report, this is

consistent with reported data in 2018(9). The number of complete reports fully coded,

submitted for analysis continues to increase as providers have adopted the new

taxonomies and adjusted to the new reporting requirements as feedback via the ‘Safer

Radiotherapy’ newsletter series(15).

4. Results

4.1 Main themes of RTE

The 18,734 RTE reports were categorised by classification(7), process code or process

subcode including failed and effective safety barriers and causative factors(8), so main

themes could be derived.

The data analysis has been presented using graphs, bar charts and pie charts to

facilitate local replication of the analysis using local data to enable data comparison.

Statistical tests were carried out using Stata® Software to look for differences and

emerging trends within the data. The test for proportions was based on Z-test statistics

and the test for trends was based on Chi2 test statistics.

4.1.1 Breakdown of process codes

The entire dataset was broken down by process code and classification level. RTE

reports were spread across all 21 categories of process code and level. The RTE

reported associated with ‘treatment unit process’ comprised 42.3% (n = 7,923) of the

data and ‘pretreatment planning process’ 14.7% (n = 2,763) (Figure 4).


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Figure 4. Breakdown of RTE process code by level (January 2018 to December 2019, 17,343/ 18,734 subset of RTE)

‘Treatment unit process’ process code reports were made up of ‘minor radiation

incidents’ (level 3) at 69.8% (n = 5,331), ‘near misses’ (level 4) at 16.6% (n = 1,318)

and ‘other non-conformance’ (level 5) at 14.1% (n =1,116). The remaining 2.0% (n =

158) of ‘treatment unit processes’ process code reports were ‘non-reportable radiation

incidents’ (level 2) and ‘reportable radiation incidents’ (level 1).

There have been few changes across the most frequently reported RTE process

codes. The main change to note is the decrease in ‘treatment data entry process’ which

has decreased from 7.1% in the previous two-year period to 6.0% for this two-year

period, which was statistically significant (p < 0.001). However, this reduction seems

less significant when compared with previous two-year datasets as shown in figure 5

(slope = −0.3%, p = 0.0002).

Figure 5 indicates a slight decrease in reported RTE associated with the ‘pretreatment

planning process’ (slope = −1.1%, p > 0.001) since January 2010. The largest increase

can be seen in RTE associated within the ‘treatment unit process’ (slope = 2.4%, p >

0.001).


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Figure 5. Trends for most frequently reported RTE by process code (January 2010 to December 2019)

4.1.2 Breakdown of process subcodes

The most frequently reported process subcode was ‘on-set imaging: production

process’, making up 12.3% (n = 2,310) of all RTE reported. This was followed by ‘on-

set imaging’ at 4.4% (n = 824) and ‘documentation of instructions/information’ at 4.3%

(n = 803). The most frequently reported subcodes and their classification level are

presented in figure 6. Most of the ‘on-set imaging: production process’ RTE were

classified as ‘minor radiation incidents’ (level 3) at 92.9% (n = 2,145).

Figure 6. Breakdown of RTE process subcodes by level (January 2018 to December 2019 (7,941/ 18,734 subset of RTE)


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The process subcodes were reviewed against the previous two-year period as shown

in figure 7. There has been a slight increase from 11.6% in the previous two-year

reporting period to 12.3% within this two-year reporting period (p = 0.045) for reports

associated with the subcode ‘on-set imaging: production process’. Other imaging

associated RTE which have also increased, include ‘use of on-set imaging’ and ‘on-set

imaging: recording. There has been a decrease in RTE associated with ‘accuracy of

data entry’, from 5.1% to 4.1% (p < 0.001). This was the most frequently reported RTE

in the reporting January 2010 to December 2012.

Figure 7 indicates the subcode ‘on-set imaging: production process’ has had the

biggest and most statistically significant increase (p < 0.001) since the 2 years of

January 2010 to December 2011; from 3.2% to 12.3% in this reporting period (slope =

2.4%, p < 0.001). The trend of RTE associated with ‘use of on-set imaging’ has

increased from 1.9% in the first two-year reporting period to 4.4% for this reporting

period (p < 0.001). This peaked in the two-year reporting period January 2014 to

December 2015 (slope = −0.45%, p < 0.001).

Figure 7. Trends for most frequently reported RTE process subcodes (January 2010 to December 2019)

4.2 Classification level of RTE

Each of the reports were classified as ‘other non-conformances’ (level 5), ‘near miss’

(level 4), ‘minor radiation incident’(level 3), ‘non-reportable radiation incident’ (level 2)

and ‘reportable radiation incident’ (level 1)(7). Figure 8 includes data for this two-year

period, the previous two-year period and aggregate data (Jan 2010 – Dec 2019).


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Of the RTE reports, 62.3% (n = 11,679) were ‘near miss’ or ‘other non-conformances’

with no impact on patient outcome. In total, 35.9% (n = 6,724) of the RTE reported

were classified as ‘minor radiation incidents’. Of the remaining 1.8% (n = 331) of RTE

reports only 0.9% were reportable under IR(ME)R (7, 17, 18), to the relevant inspectorate.

This is similar to the previous two-year period, when the ‘reportable radiation incidents’

were 1.0% (n = 161, p = 0.336). The ‘non-reportable radiation incidents’ have reduced

from 1.4% (n = 221) during the previous two-year period to 0.9% (n = 64, p < 0.001).

There has also been a decrease in percentage of ‘other non-conformances’ from

40.4% (n = 4,095) within the previous two-year period to 37.9% (n = 7,102, p < 0.001).

The only increase was seen in the ‘minor radiation incidents’ which has increased from

31.9% to 35.9% (p < 0.001).

Figure 8. Classification levels as a percentage of RTE reports (January 2010 to December 2019)

4.3 Breakdown of classification by process subcode

In this section, the RTE reports are broken down by classification into their attributed

process subcodes.

4.3.1 Breakdown of level 1 (reportable radiation incident) RTE

‘Reportable radiation incidents’ (level 1) as defined in TSRT(7) fall into the category of

reportable under IR(ME)R(7, 17, 18). Clearly, reporting to the national voluntary reporting

scheme does not negate regulatory requirements to report events to the relevant

inspectorate. The majority of level 1 events reported affected only a single fraction of


20

treatment and thus were correctable over the remaining fractions with no significant

impact on the patient or outcome of treatment.

There were 52 different subcodes associated with the 167 level 1 RTE (Figure 9).

These were reported by 49 of the 59 providers that submitted data for analysis. The

most frequently reported subcode was ‘on-set imaging: approval process’ comprising

12.5% (n = 21) of all level 1 reports. An example of this type of reportable RTE includes

the mismatch of vertebral level during verification image review and approval leading to

a geographical miss.

Figure 9. Breakdown of most frequently reported level 1 RTE (Jan 18 - Dec 19, n = 98/ 167 subset of RTE)

The most statistically significant change in this level of RTE is the increase in ‘on-set

imaging: production process’ which has increased from 0.6% in the previous 2 years to

6.6% (p < 0.001). The trends for level 1 RTE are indicated in figure 10.


21

Figure 10. Trends for most frequently level 1 RTE by process subcode (January 2010 to December 2019)

There has been an increase in level 1 RTE reported associated with ‘on-set imaging:

approval process’ which has increased from 2.7% in the first two-year reporting period

to 12.6% within this reporting period (slope = 2.8%, p = 0.0006). The frequency of ‘on-

set imaging: production process’ associated level 1 RTE has fluctuated over the years

with no clear trend (p = 0.169). ‘Verification of diagnosis/ extent/ stage’ has increased

from 5.4% in the first two-year period to 9.6% (p = 0.0046).

Of note ‘movements from reference marks’, ‘ID of reference marks’ and ‘patient

positioning’ comprised of 33% (n = 25) of level 1 RTE reported in the 2-year period

ending in 2012. These made up 9% (n = 15) of level 1 RTE reports in the most recent

reporting period. It is likely the extended availability and use of image guided RT

(IGRT) has been central to the reduction in these types of errors in recent years.

4.3.2 Breakdown of level 2 (non-reportable radiation incident) RTE

A ‘non-reportable radiation incident’ is defined as a radiation incident which is not

reportable, but of potential or actual clinical significance(7). There were 61 different

subcodes associated with level 2 reports. The most frequently reported level 2 RTE can

be seen in figure 11. These were reported by 43 of the 59 providers that submitted data

for analysis.


22

Figure 11. Breakdown of most frequently reported level 2 RTE by process subcode (January 2018 to December 2019, n = 93/ 164 subset of RTE)

The most frequently reported level 2 reports were associated with ‘on-set imaging:

approval process’ (18.9%, n = 31). An example of RTE associated with ‘on-set imaging:

approval process’ includes the mismatch of reference and verification imaging which

does not lead to a total or partial geographical miss as defined as a significant or

unintended accidental exposure.

All the most frequently reported level 2 subcodes have increased since the previous two-year

reporting period, except ‘localisation of intended volume’, which has decreased from 7.7% to

6.1% (p = 0.543). The trends for level 2 RTE are indicated in figure 12.


23

Figure 12. Trends for most frequently reported level 2 RTE by process subcode (January 2010 to December 2019)

There has been an increase from 10% within the first two-year reporting period to

18.9% within this reporting period with ‘on-set imaging: approval process’ (slope =

2.3%, p = 0.036) level 2 RTE. There has been an increase in all of the most frequently

reported level 2 subcodes, apart from ‘patient positioning’ which has seen a fluctuation

and slight decrease (slope = −0.1%, p = 0.811).

Of note ‘movements from reference marks’ was the most frequently reported level 2

RTE in the 2-year period ending in December 2012 (12.5%, n = 12). This has been

reduced to 1.9% (n = 3) in the most recent reporting period. It is likely the extended

availability and use of IGRT has been central to the reduction in these types of errors in

recent years.

4.3.3 Breakdown of level 3 (minor radiation incident) RTE

A minor radiation incident is defined as a radiation incident in the technical sense, but

of no potential or actual clinical significance(7). There were 143 different subcodes

associated with level 3 reports. The most frequently reported RTE in this sub-group can

be seen in figure 13. These were reported by all 59 of the providers that submitted data

for analysis.

‘On-set imaging: production process’ made up 31.9% (n = 2,145) of all level 3 RTE.

Further examples of these types of level 3 RTE can be seen in section 4.5.3.


24

Figure 13. Breakdown of most frequently reported level 3 RTE by process subcode (January 2018 to December 2019, n = 4,766/ 6,724 subset of RTE)

There hasn’t been a statistically significant change in the most frequently reported level

3 RTE for this reporting period. A decrease in ‘on-set imaging: production process’ from

32.3% to 31.9% (p = 0.643) was seen. The only statistically significant decrease can be

seen with ‘on-set imaging: approval process’ which has decreased from the previous

two-year period, from 7.8% to 5.8% for this two-year period (p < 0.001) (Figure 14).



25

The main increase seen in the level 3 most frequently reported RTE can be seen with

the increase in ‘on-set imaging: production process’, which has increased from 4.7% in

January 2010 to December 2011 to 31.9% for this reporting period (p < 0.001). This

increase will be linked to the significant update of IGRT since 2010. There has been a

slight decrease in RTE reported associated with ‘use of on-set imaging’ (slope =

−0.5%, p = 0.0009), ‘on-set imaging: approval process’ (slope = −0.7%, p < 0.001) and

‘movements from reference marks’ (slope = −0.7%, p < 0.001).

Of note ‘movements from reference marks’ was the most frequently reported level 3

RTE (7.2%, n = 119) reported in the 2-year period ending in 2012. There has been little

or no change in the frequency of level 3 ‘on-set imaging: recording process’ (slope

=0.07%, p = 0.5754).

4.3.4 Breakdown of level 4 (near miss) RTE

A ‘near miss’ is defined as a potential radiation incident that was detected and

prevented before treatment delivery(7). There were 172 different subcodes associated

with the level 4 RTE. The most frequently reported RTE can be seen in figure 15.

These were reported by 58 of the 59 providers that submitted data for analysis.

The most frequently reported subcode was ‘documentation of instruction/ information’,

making up 7.4% (n = 339) of all level 4 RTE. An example of RTE associated within

‘documentation of instructions’ includes the incorrect entry of information regarding the

set-up, positioning and immobilisation of a patient at pretreatment. These types of RTE

were recognised and rectified at time of patient set up at treatment.



26

Figure 16 shows a decrease in percentage of RTE reported associated with ‘accuracy

of data entry’ from 10.0% to 6.4% (p < 0.001) from the previous two-year period to this

reporting period. This is likely due to a general decrease in manual data entry.

However, in the same time there has been an increase in the reporting of level 4 RTE

associated with on-set imaging. The ‘use of on-set imaging’ has increased from 4.1%

during the last two-year period to 6.3% (p < 0.001) and ‘on-set imaging: recording

process’ has increased from 4.8% to 6.2% (p = 0.004).


The frequency of level 4 RTE associated with ‘accuracy of data entry’ has decreased

since reporting period January 2010 to December 2011 from 9.3% to 6.4%, (slope =

−0.6%, p = 0.0016). All other level 4 RTE in figure 16 show an increase in frequency of

reporting.

4.3.5 Breakdown of level 5 (other non-conformances) RTE

Other non-conformance is defined as a non-compliance with some other aspect of a

documented procedure, but not directly affecting RT delivery(7).

There were 192 different subcodes associated with the level 5 RTE reported. The most

frequently reported RTE are represented in figure 17. These were reported by 56 of the

59 providers that submitted data for analysis.


27

The most frequently occurring subcode was ‘bookings made according to protocol’

making up 5.1% (n = 363) of all level 5 RTE. An example of other non-conformances

associated with ‘bookings made according to protocol’ includes; the incorrect booking

of appointments or not including electronic check lists and on treatment review

appointments. All non-conformances are detected before affecting the patient’s

planning and treatment processes.


The level 5 RTE were then reviewed for this two-year period and compared with

previous two-year reporting periods as shown in figure 18.



28

Four of the 5 most frequently reported level 5 RTE have increased in percentage since

the last two-year reporting period. The most statistically significant increase was seen

in RTE associated with ‘consent process and documentation’, from 2.4% to 3.4% (p =

0.001). There has been an increase in percentage for all the top 5 reported RTE in this

sub-group over the past 10-year period. The positive slope of each of the trends is

statistically significant (p < 0.001) apart from ‘consent process and documentation’ level

5 RTE which has increased from 1.0% to 3.4% (p = 0.0435), the variability of the data

and the peak in 2012/2013 may be why there is no statically significance for this level 5

pathway code.

Of note ‘management of process flow within planning’ (11.3%, n= 249) was the most

frequently reported of all level 5 RTE in the 2-year period ending in December 2012.

This has been reduced to 2.9% in the most recent reporting period. It is likely the

extended use of electronic booking and task tracking components of oncology

management systems is linked to the reduction in these types of errors in recent years.

4.4 Safety barriers

A safety barrier (SB) is a critical control point, detection method or defence in depth, or

any process step whose primary function is to prevent errors occurring or propagating

through the RT workflow(19). The ‘radiotherapy pathway coding’ has 206 different

process subcodes, including 86 SB(8).

4.4.1 Failed safety barriers

Multiple SB can be allocated to each RTE report to identify all points in the pathway

where the error was not detected (failed SB). Each of the 18,734 RTE reports were

analysed and a total of 13,287 failed SB (FSB) were identified.


29

Figure 19. Breakdown of most frequently reported failed safety barrier across all pathway codes by level (January 2018 to December 2019, n = 9,011/ 13,287 subset of RTE)

Figure 19 indicates the most frequently reported FSB, across all pathway codes, was

‘use of on-set imaging’ (10.5%, n = 1,392). ‘End of process checks’ comprised of 34.4%

(n = 4,566) of failed SB reports. ‘End of process checks’ occur at the end of each

discrete part of the pathway and comprise of 6 different pathway codes. These include;

‘mould room/ workshop activities (9k)’, ‘pretreatment activities (10l)’, ‘pretreatment

planning process (11t)’, ‘treatment data entry process (12g)’, ‘treatment unit process

(13hh)’ and ‘brachytherapy (15s)’.

‘End of process checks’ are the last opportunity to identify an error and stop it

propagating across the pathway. Ideally RTE should be identified earlier to mitigate risk

of harm. A further review of the data was undertaken to identify which was the most

frequently reported primary FSB. A total of 6,189 subcodes were identified as a primary

FSB. FSB associated with ‘treatment unit processes’ were attributed to 40.7% (n =

2,516) of all primary FSB. The most frequently reported primary FSB are represented in

figure 20.

Treatment process ‘use of on-set imaging’ was the most frequently reported primary FSB

(13.3%, n = 824) and 8.0% (n = 498) were coded as ‘end of process checks’. Only 2.6% (n =

163) of primary FSB led to a level 1 or 2 RTE, these included ‘on-set imaging: approval

process’ (n = 21/163), which has been discussed in the level 1 RTE (see section 4.3.1) and

‘verification of diagnosis/extent/stage’ (n = 16).


30

Figure 20. Breakdown of most frequently reported primary failed safety barrier by level (January 2018 to December 2019, n = 3,742/ 6,189 subset of RTE)

Figure 21 shows the most frequently reported primary FSB from January 2010 to

December 2019. The most statistically significant changes were associated with ‘on-set

imaging: approval process’, which has decreased from 17.5% to 10.3% (p < 0.001),

and ‘management of variations/ unexpected events/ errors’, which has increased from

5.0% to 6.9% (p < 0.001). FSB associated with ‘management of variations/ unexpected

events/ errors’ for example, include the transfer of patients between unmatched linacs

without an appropriate replan. The FSB ‘consent process and documentation’ has also

increased from 3.7% within the previous two-year reporting period to 4.9% within this

reporting period (p = 0.002).


31

Figure 21. Trends for most frequently reported primary failed safety barrier (January 2010 to December 2019)

The difference between the most frequently reported primary FSB and FSB across all

reported pathway codes indicates that multiple pathway codes should be shared as an

opportunity for valuable RTE learning.

4.4.2 Effective safety barriers or method of detection

Barriers or control measures are in place across the RT pathway to prevent incidents;

when these barriers fail, incidents can occur. An effective SB (ESB) or method of

detection (MD) can be utilised to identify when the RTE is detected or prevented from

escalating. The first MD code was received in April 2018, between this date and

December 2019, 3,809 reports contained MD. The most frequently reported MD can be

seen in figure 22.

For this reporting period, the most frequently reported MD was ‘on-set imaging:

approval process’ (22.9%, n = 872). This was followed by ‘end of process checks’ as

part of treatment processes (18.9%, n = 711).


32

Figure 22. Breakdown of most frequently reported effective safety barrier (method of detection) by level (April 2018 to December 2019, n = 2,732/ 3,809 subset of RTE)

4.5 Causative factors

The use of a causative factor taxonomy enables identification of system problems that

could precipitate a range of different incidents(20). The root cause is an event which

leads to anticipated operational occurrences or accidental conditions(21). A contributory

factor is defined as the latent weakness that allows or causes the observed cause of an

initiating event to happen, including the reasons for the latent weakness. Within the

DoL(8) taxonomy the primary causative factor is the root cause (RC); any subsequent

reported causative factors are considered to be contributory factors (CF). The first

causative factor code was reported in January 2017; therefore, only 3 years of data are

included in this analysis.

4.5.1 Root cause

Figure 23 shows the most frequently reported root cause (RC). A total of 18,405 of the

18,734 (98.2%) RTE reported contained a RC or enough information for PHE staff to

code it. From the RTE which contained a RC the most frequently reported was

individual ‘slips and lapses’, making up 43.8% (n = 8,058) of all RC.


33

Figure 23. Breakdown of most frequently reported primary causative factor (root cause (RC)) by level (January 2018 to December 2019, n = 17,848/ 18,405 subset of RTE)

A comparison of 3 years of data can be seen in figure 24.

Figure 24. Percentage of most frequently reported primary causative factor (root cause (RC)) (January 2017 to December 2019, n = 18,983/ 21,699 subset of RTE)

There has been a gradual increase in the RC ‘slips and lapses and ‘equipment and IT

failure’ and ‘communication’ and a gradual decrease in the RC ‘adherence to

procedures/ protocols’ and failure to recognise a hazard. This decrease might be linked


34

to the adoption of ‘pause and check’ procedures as recommended by the Society and

College of Radiographers(22).

4.5.2 Level 1 RTE by process subcode and RC

The most frequently reported level 1 process subcodes were broken down by RC

(figure 25), where this information was available.

Figure 25. Correlation between most frequently reported level 1 RTE by process subcodes and primary causative factor (root cause) (January 2018 to December 2019,

subset of RTE)

Level 1 ‘on-set imaging: approval process’ RTE were most frequently reported as RC

‘slips and lapses’ (42.9%, n = 9). Only 9 of the 21 level 1 RTE associated with ‘on-set

imaging: approval process’ included an MD, 5 of which were detected during the offline

review process. ‘Verification of diagnosis/ extent/ stage’ was most frequently reported

as RC ‘decision making process’ (31.3%, n = 5). ‘On-set imaging: production process’

and ‘patient positioning’ were both associated with several different RC and ‘choice of

other concurrent treatment’ was most frequently reported as having a RC of

‘communication’ (66.7%, n = 6).


35

4.5.3 Level 3 process subcode ‘on-set imaging: production process’ by RC

A review of the ‘on-set imaging: production process’ subcode of level 3 RTE can be

seen in figure 26. This revealed that 46.2% (n = 987/2,136) related to RC technical,

equipment or IT network failure. Examples of these types of reports included ‘failure of

the image device during image acquisition’, ‘image not captured after exposure’,

flooded image’, or ‘image unavailable offline’. Individual slips and lapses, was related to

39.6% (n = 846/2,136). Examples of which included ‘incorrect imaging parameters

selected’, ‘wrong image acquisition image mode selected’, ‘incorrect blade moved for

image capture’, and ‘imager not extended or appropriately positioned’. This resulted in

additional imaging exposures being undertaken.

RT providers are encouraged to audit and report these events locally so appropriate

and timely preventative measures might be implemented. In addition, the Medicines

and Healthcare products Regulatory Agency (MHRA)(23) should be advised of all

equipment failures.

Figure 26. Breakdown of level 3, ‘on-set imaging: production process’ process subcode RTE by primary causative factor (root cause) (January 2018 to December 2019, n = 2,136)

4.5.4 Contributory factors

Several contributory factor (CF) codes can be attributed to each individual RTE. A

review of the second to fifth causative factor codes indicate the CF associated with an

incident. CF were indicated across 5,028 reports; 810 of these contained multiple CF

totalling 6,106 codes. Figure 27 shows the most frequently reported CF codes. The

most frequently reported CF code was ‘adherence to procedures/protocols’ (41.5%, n =

2,534).


36

Figure 27. Breakdown of most frequently reported contributory factors (January 2018 to December 2019, n = 5,670/ 6,106 subset of RTE)

A comparison of 3 years’ data, since the introduction of the CF taxonomy, can be seen

in figure 28. There has been an increase of CF ‘adherence to procedures/ protocols’

from 35.1% to 45.8%. This is of note when considering the importance of adherence to

local procedures and protocols in demonstrating due diligence in clinical care. This

code most frequently followed a RC of ‘slips and lapses’.

Figure 28. Percentage of contributory factors most frequently reported (January 2017 to December 2019, n = 5,405/ 6,865 subset of RTE)


37

4.6 Brachytherapy RTE

Brachytherapy (BRT) is a RT sub-speciality which involves the placement of a sealed

source inside or close to the treatment area(24). Reports coded with BRT process codes

as the primary code account for 0.8% (n = 159) of RTE for this two-year reporting

period. BRT makes up less than 3% of all RT episodes(25). The number of BRT

associated RTE would be expected to be low.

The overall number of BRT reports has increased from 85 in the previous reporting period,

reflecting a maturing reporting culture in this area. This represents an 87.1% increase

in RTE reported. Reporting of BRT RTE is to be encouraged to facility learning as the

nature of these events are likely to be different to external beam due to the differences

in their planning and delivery approaches and techniques and technologies employed.

4.6.1 Classification level of BRT RTE

The classification level for BRT RTE was compared to all RTE (including BRT). This

indicated differences in the distribution between datasets (Figure 29). The percentage

of BRT ‘reportable radiation incidents’ (level 1) for this reporting period was 3.1%

compared with 0.9% for all RTE reports (p = 0.004). This might be explained in part by

the hypo-fractionated nature of BRT delivery. There is also a statistically significant

difference between ‘minor radiation incidents’ (level 3) with BRT RTE reported at 15.1%

compared to 35.9% for all RTE reports (p < 0.001). The percentage of other ‘non-

conformances’ (level 5) is also statistically significantly higher within the BRT RTE

reports at 50.3% compared to 37.9% (p < 0.001) for all RTE reports. Figure 29. Breakdown of brachytherapy RTE compared with all RTE by level (January 2018 to December 2019)


38

4.6.2 Breakdown of BRT process subcodes

Figure 30 shows the most frequently reported process subcode associated with BRT

RTE was ‘initial positioning of applicators/ sources’ (14.5%, n = 23). An example of this

type of RTE included the application of seeds in the incorrect position. ‘Delivery of

sources’ comprised 11.3% (n = 18) of all BRT RTE. Some 94.4% (n = 17) of these

reports were submitted by a single provider who reported issues with ordering and

delivery of radiopharmaceuticals.

Figure 30. Breakdown of most frequently reported BRT RTE by process subcode

(process code 15) and level (January 2018 to December 2019, n = 109/159)

The percentages of BRT RTE most frequently reported were compared with the

previous two-year period and aggregate data, as shown in figure 31. The most

statistically significant difference in percentage of RTE was ‘delivery of sources’, which

was 1.2% within the last two-year reporting period and 11.3% within this two-year

period (p = 0.005).

The decrease in BRT RTE associated with ‘planning of treatment’ (decrease of 11.8%)

and ‘initial positioning of applicators /sources’ (decrease of 7.9%) are of note. These

are most likely due to the wider adoption of CT based dosimetry and verification

imaging of brachytherapy patients.


39

Figure 31. Most frequently reported BRT RTE by process subcode (January 2010 to December 2019, n = 348/593 subset of RTE)

4.6.3 Breakdown of BRT RTE by safety barrier

SB are defined in section 4.4. All SB were broken down by classification as seen in

figure 32.

Figure 32. Breakdown of reported BRT failed safety barrier by level (January 2018 to December 2019, n = 110/113 subset of data)


40

The most frequently reported BRT FSB was ‘management of variations’ (23.9%, n =

27) compared with 5.0% (n = 669) for the entire dataset. Only 15.1% (n = 24) of the

BRT RTE reports included an effective SB or method of detection (MD). Of these, the

most frequently reported MD, at 37.5% (n = 9), was ‘end of process checks’.

4.6.4 Breakdown of BRT RTE by causative factor

Causative factors are defined in section 4.5. The most frequently reported root cause

(RC) associated with BRT RTE was ‘equipment or IT network failure’, making up 27.0%

(n = 41) (figure 33). This is different to findings from external beam associated RTE.

This might be due to linear accelerator-based deliveries having better integrated

systems compared with BRT planning and delivery systems.

These 41 ‘equipment or IT network failure’ RC were associated with 12 different BRT

process subcodes. In total 19.5% (n = 8) of these were associated with ‘initial

positioning of applicators/ sources’. ‘Slips and lapses’ made up 23.7% (n = 36) of all

BRT RTE. This is different to the total RTE dataset for this reporting period, where the

most frequently reported RC was ‘slips and lapses’ (43.8%, n = 8,058). ‘Equipment or

IT network failure’ RC made up 10.5% (n = 1,929) of all RTE reported.

Figure 33. Breakdown of most frequently reported brachytherapy RTE by primary causative factors (root cause) and level (January 2018 to December 2019, n = 134/ 152 subset of RTE)

There were 32 contributory factors (CF) across the 159 brachytherapy RTE; the most

frequently reported was ‘adherence to protocols /procedures’, making up 21.9% (n = 7)

of all CF for reported BRT RTE.


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4.7 Inspectorate data

There is a requirement on RT providers to notify the relevant enforcing authority of all

‘reportable radiation incidents’ (level 1) (7, 17, 18). For the purposes of this report the

relevant enforcing authorities will be referred to as the inspectorates hereafter. The

inspectorates for IR(ME)R for England, Northern Ireland, Scotland and Wales were

approached and asked to share anonymised synopses of closed reportable radiation

incidents from January 2018 to December 2019 for analysis.

A total of 300 reports were shared. This is similar to the number of reports shared

between December 2015 to November 2017 (n = 288). On review of the inspectorate

data it became clear that there was some variation in the locally applied classification of

incidents. Some 15.7% (n = 47) of the reported incidents might be coded as level 2 or

3. Examples of these include single repeat CT planning images. As the local provider

deemed the incidents reportable they have either been classified as level 1 or 2 within

figure 34. These level 2 or 3 notifications were excluded from further analysis (n = 253).

The inspectorates published guidance in June 2019(26) which sought to address this

disparity and includes guideline factors for concomitant imaging. The most frequently

occurring subcode within the inspectorate data was ‘on-set imaging: approval process’

(13.7%, n = 41).

Figure 34. Breakdown of most frequent inspectorate notifications by process subcode (January 2018 to December 2019, n = 179/ 300 subset of RTE)


42

4.7.1 Breakdown of inspectorate data by process subcodes

The level 1 inspectorate data (n = 253) was then compared to the level 1 voluntary data

(n = 167, figure 35).

‘On-set imaging: approval process’ was the most frequently reported level 1 process

subcode in both datasets. ‘Use of on-set imaging’ made up 1.8% of level 1 voluntary

data, and 5.1% of level 1 inspectorate data. Examples of RTE associated with ‘use of

on-set imaging’ included completion of a daily CBCT in place of kV imaging as part of

verification. ‘Verification of diagnosis/ extent/ stage’ was the second most frequently

reported RTE at 9.6% to the inspectorates.

Figure 35. Comparison of most frequently reported process subcode in inspectorate and level 1 voluntary datasets (January 2018 to December 2019, n = 228/420 subset of data)

The variance in reporting numbers was noted between reporting systems. A total of 59

of 60 UK NHS RT providers submitted data to the voluntary scheme for analysis. This

meant 1 RT provider did not submit data to the voluntary scheme. In addition,

independent RT providers report to the inspectorates but not to the voluntary scheme.

This in part accounts for the disparity in numbers. A further review of the inspectorate

data indicated a notable lag between the incident occurring and the date the report

received at PHE for analysis. This varied between 89 and 1,239 days with an average


43

of 515 days. This time lag reflects, only anonymised closed events are shared for

inclusion in this analysis.

To better understand the likely impact of time lag on the variance in number of reports,

a review of the incidents by date of occurrence (between January 2018 and December

2019) was carried out (Figure 36). The trends in the RTE type were similar to those

seen in figure 35.

Figure 36. Comparison of most frequently reported process subcode in inspectorate and level 1 voluntary datasets (Incident date January 2018 to December 2019, n =

195/369 subset of data)

4.7.2 Breakdown of inspectorate data by safety barrier

Safety barriers (SB) are defined in section 4.4. The most frequently reported FSB within

the inspectorate data was reviewed and compared with the level 1 voluntary data

(figure 37). A total of 431 and 190 FSB codes were revealed for the inspectorate and

voluntary data respectively. Treatment ‘end of process checks’ (23.9%, n = 105) was

the most frequently reported FSB followed by ‘on-set imaging: approval process’

(12.1%, n = 52). The order of these was reversed in the voluntary dataset. However,

the number of reports included in the voluntary reported dataset was much smaller.


44

Figure 37 Comparison of most frequently reported failed safety barrier in inspectorate and level 1 voluntary datasets (January 2018 to December 2019, n = 353/621 subset of data)

Treatment ‘end of process checks’ is the last opportunity to identify an error before it

affects the patient. RTE need to be identified earlier to mitigate risk of harm. A further

review of the data was undertaken to identify the most frequently reported primary FSB

(figure 38). A total of 130 subcodes were identified. The most frequently reported failed

SB across both datasets was ‘on-set imaging: approval process’ (31.5%, n = 41),

followed by ‘verification of diagnosis/ extent/ stage’ (14.6%, n= 19).

Figure 38. Comparison of most frequently reported primary failed safety barrier in inspectorate & level 1 voluntary datasets (January 2018 to December 2019, n = 146/216 subset of data)


45

There was sufficient detail in the inspectorate data to assign effective safety barriers

(method of detection (MD)) to the inspectorate data (Figure 39). The first MD code in

the voluntary dataset was received part way through the reporting period (April 2018).

A total of 48 level 1 reports included MD. The most frequently reported MD was ‘on-set

imaging: approval process’ (30.4%, n = 77 and 33.3%, n = 16 respectively). This was

followed by ‘end of process checks’ as part of treatment processes (28.1%, n=71 and

18.8%, n = 9)

Figure 39. Comparison of most frequently reported effective safety barrier in inspectorate & level 1 voluntary datasets (January 2018 to December 2019,

n = 231/301subset of data)

4.7.3 Breakdown of inspectorate data by causative factor

Causative factors, root cause (RC) and contributory factors (CF) are defined in section

4.5. The RC were reviewed for the level 1 inspectorate and voluntary data as seen in

figure 40.

The majority of the level 1 inspectorate data (n = 253) and voluntary reports (n = 162)

included RC codes or sufficient free text to allocate a code to them. The most

frequently reported RC within the inspectorate data was ‘slips and lapses’ (39.5%, n =

100). This was followed by ‘communication’ (18.2%, n = 46). Examples of this type of

report included a failure in communication between outside departments or wards and

the RT department, or failings associated with sharing of referral data.


46

Figure 40. Comparison of most frequently reported root cause in inspectorate & level 1 voluntary datasets (January 2018 to December 2019, n = 351/415 subset of data)

The CF were reviewed for the inspectorate data and compared with the level 1

voluntary data (figure 41).

Figure 41. Comparison of most frequently reported contributory factor in inspectorate and level 1 voluntary datasets (January 2018 to December 2019, n = 200/294 subset of data)


47

Not all of the inspectorate data or voluntary RTE reports included RC codes or

sufficient free text to allocate a code to them. In total 97.7% (n = 208) of the level 1

inspectorate data and 55.1% (n = 86) of the voluntary level 1 RTE contained a RC. The

most frequently reported CF in the inspectorate data was ‘adherence to procedures/

protocols’ (23.1%, n = 48). The CF ‘slips and lapses’ made up 18.8% of both datasets

(inspectorate data n = 39, voluntary data n = 16).

5. Discussion

Participation in the national voluntary reporting and learning scheme(9, 10, 27) is indicative

of an open and transparent safety culture. This provides opportunities to learn from a

greater pool of data and facilitates local benchmarking of events with the national

picture to support a reduction in the magnitude and probability of RTE. Learning from

RTE should be local, national and international.



unintended exposures.

The European Commission(3) advocates proactive risk assessment as an effective tool

of risk management in RT to identify preventative measures. The EC provides a useful

definition for risk management as referring to “all the various organizational structures

and processes that are designed to improve safety and prevent or reduce risks, or that

limit the consequences of risks (that is, all risk preventive measures). Risk

management is, therefore, part of the overall quality management program.”

A study of risk, or a proactive risk assessment is a process that helps organisations to

understand the range of risks (both internal and external) that they face, their capacity

to control those risks, the likelihood (probability) of the risk occurring and the potential

impact thereof. This involves quantifying risks, using judgment, assessing and

balancing risks and benefits and weighing these against cost(3).

5.1 Increase in RTE reporting

Between January 2010 and December 2019, 100% of NHS providers across the UK

voluntarily reported 58,913 RTE to the national reporting and learning system. Of

these, 32.0% (n = 18,853) were reported between January 2018 and December 2019.

As seen in figure 1 the average number of reports submitted monthly to the national

voluntary scheme increased by 15.6% from 680 in the previous two-year reporting


48

period to 786 within this two-year period. A significant increase in reporting over time

has been seen in other incident learning systems(28).

Although 100% of NHS RT providers have reported to the national analysis only 98.3%

(n = 59) reported between January 2018 and December 2019. This decrease in

reporting may be due to local resourcing challenges and change to local reporting

procedures. There is also some disparity in the number of reports received per provider

per month. Reporting levels ranged from 1 to 1,450 reports per provider over the two-

year period. There may be a number of reasons for this disparity. These includes the

differences in local reporting systems used such as whether they are electronic or

paper based, or if there is a requirement to use more than one reporting system. Also,

reporting culture may vary within providers. Moreover, providers differ in terms of the

RT services they provide and capacity, and the number of reports per provider has not

been normalised to account for this variation. This variation is also reflected in the lag

time for reporting, which ranged from 0 days to 658 days. The PSRT encourage all RT

providers to report monthly. Providers can contact PHE ([email protected])

with reporting queries or if they would like further advice on participation in this scheme.

The increase in RTE reported monthly should be interpreted with care and

demonstrates the commitment RT providers have to improving patient safety in RT and

reflects a mature reporting culture. It is expected that a further increase in reporting

continues as providers further develop full electronic reporting solutions allowing all

levels of RTE to be reported nationally.

NHS England included the requirement to engage in national reporting and learning

from RTE and the use of the TSRT(7) and DoL(8) taxonomies as part of the external

beam service specification(29). Regulation 8(3) of the IR(ME)R regulations requires the

recording of analyses of events involving or potentially involving accidental or

unintended exposures (7, 17, 18). Additionally, recommendations of the Francis report(30)

into failings at the Mid-Staffordshire NHS Foundation Trust included a requirement for

openness, transparency and candour throughout the NHS to support a culture of

protecting patients and removing poor practice. The patient safety ethos and

recommendations within these documents have mainly been adopted across the UK

with 98.3% of all NHS providers reporting over this two-year period, indicating a mature

reporting culture.

According to the Radiotherapy Dataset(25), the estimated number of prescriptions

across NHS providers within England for this reporting period was 346,488 across

3,701,280 attendances. This data was extrapolated for the UK population to an

estimated 415,786 prescriptions across 4,441,536 attendances. To establish a reported

error rate, it was accepted the clear majority of RTE reported affected a single

attendance as part of a prescription. With this caveat an estimated reported RTE rates

of 4 per 1,000 attendances or 45 per 1,000 prescriptions were calculated. It is worth


49

noting that the clear majority of these events did not impact on the patients’ planning or

treatment. However, using the same premise an estimated report RTE rate for level 1

events was calculated as 0.4 per 1,000 prescriptions.

5.2 Main themes

5.2.1 Breakdown of process codes

The reported RTE were spread across all 21 categories of process code (as seen in

section 4.1.1); treatment unit process codes were the most frequently reported RTE

(42.3%, n = 7,923). The treatment process represents the last opportunity to identify

errors. Accurate treatment relies on the correct interpretation of the treatment plan and

set-up details which need to be replicated at each fraction of treatment. This might

explain prevalence of RTE reported associated with ‘treatment unit processes’.

When reviewing the data for this two-year period (January 2018 to December 2019)

against the previous two-year period (January 2016 to December 2017) there has been

a significant decrease in RTE reported in the treatment data entry process. This

decrease may be due to a gradual change in data entry processes from manual

transcription to electronic transfer of data, reducing the requirement for manual data

transfer process. This had already been largely achieved for radical treatments and

more recently for palliative treatments.

5.2.2 Breakdown of process subcodes

‘On-set imaging: production process’ made up 12.3% (n = 2,310) of all the RTE

reported for this two-year reporting period. Most of these RTE were classified as level 3

(92.9%, n = 2,145). These RTE were seen to be largely on-treatment verification

images.

Imaging associated RTE have increased within this two-year reporting period. These

RTE included: ‘on-set imaging: production process’, ‘use of on-set imaging’ and ‘on-set

imaging: recording’. The incidence of on-set imaging associated RTE reflects the

increase in automation in set-up and the focusing of decision making processes during

on-set imaging resulting in more imaging related errors. This is reflected in the level of

data and image interpretation required as part of imaging processes. This risk may be

amplified due to the dynamic nature of online review and the rapid pace of

development of new technologies. This equates to more imaging-based errors.

However, the benefit IGRT brings to the patient is clear. Further guidance on imaging

associated RTE has been published(31).


50

Although there has been a general increase in RTE associated with ‘use of on-set

imaging’ there was a peak within the reporting period January 2014 to December 2015

and a gradual decrease thereafter. The decrease from this peak may be due to the

uptake of more competency-based imaging review protocols and adoption of national

guidance on the implementation and use of IGRT(32). Consideration should be given to

introducing a ‘pause and check’ policy for on-line image capture, review and approval

to reduce these types of RTE.

In areas demonstrating an initial increase in RTE that are then seen to fall, such as on-

set imaging, Learning from Excellence (LfE) may be useful. By reporting and studying

successes from RT providers, learning can be augmented, patient outcomes improved,

with LfE also impacting positively on resilience and culture in the workplace(33).

5.3 Classification level of RTE

The majority of reports were classified as lower level events, thus not affecting the

treatment outcome for the patient. Of the level 1 and 2 RTE reported, it is known most

of them affected only one fraction of a course of treatment. This meant that corrective

action could be taken over the remaining treatment fractions. There has been an

increase in the reported level 3 incidents; this may be due to the increase in imaging-

associated RTE as discussed in section 5.2.2.

Figure 42. Comparison of Heinrich’s triangle with RTE data (January 2018 to December 2019, January 2016 to December 2017, January 2010 to December 2019)

A small number of higher level incidents and a much greater number of lower level

incidents are consistent with findings in the literature(34). It is known that for every level

1 incident that occurs, many lower level incidents are also seen. Heinrich illustrated this


51

point in 1931(34). It may be seen that as the severity of an incident decreases, the

probability of its occurrence increases.

It can be seen in figure 42 that there are more lower level incidents from this voluntary

reporting system, however the ratios are different to Heinrichs’s illustration. This might

be explained by the fact that all providers do not report all levels of RTE. Where all

levels of RTE are not shared for analysis there are missed opportunities for learning

form these events. A 2018 survey(15) of RT providers, showed providers were less likely

to submit level 5 RTE nationally where dual local reporting and learning systems were

in operation as to do so would require additional resource.

The most frequently reported level 1 RTE process subcode was ‘on-set imaging:

approval process’ (12.5%, n = 21), as seen in section 4.3. Most of these ‘on-set

imaging: approval process’ level 1 RTE, were associated with individual causative

factors (85.7%, n = 18). The incidence of on-set imaging associated RTE reflects the

level of manual input and interpretation involved in imaging processes. These types of

RTE were detected after the treatment occurred and were most frequently detected

during the review process as part of the offline review process. Of note is the increase

in ‘verification of diagnosis/ extent/ stage’ reported RTE from 2.2% in the two-year

period January 2012 to December 2013 to 9.6% in January 2018 to December 2019.

Consideration should be given to ensure robust referral guidelines and procedures are

in place to make sure all required diagnostic information is accessible prior to

justification and authorisation of treatment and made available to inform planning

processes.

There were 52 different subcodes associated with the 167 level 1 RTE. Of the 52

different process subcodes reported only 32 were present in the previous two-year

reporting period. This demonstrates the importance of ongoing cyclic monitoring of

RTE.

There were 61 different process subcodes included in reported level 2 RTE. The most

frequently reported level 2 RTE subcode was ‘on-set imaging: approval process’ (18.9%, n =

31). This subcode was the most frequently reported RTE across both level 1 and 2 reports.

This may be due to the increasing frequency in the use of verification imaging and the post

treatment checks which are in place to detect these types of errors. The main difference

between a level 1 and level 2 RTE associated with ‘on-set imaging: approval process’ is that a

level 1 RTE would equate to a complete or significant geographical miss, whereas a level 2

would not.

There were 143 different process subcodes included in level 3 reports. The most

frequently reported subcode was ‘on-set imaging: production process’, making up

31.9% (n = 2,145). Of these, 46.2% (n = 987) were related to individual ‘slips and

lapses’ and 39.6% (n = 846) related to equipment failure. The errors associated with


52

equipment malfunction were spread across manufacturers and were mainly related to

on-set imaging devices. Consideration should be given to undertaking a risk

assessment in the case of frequently recurring fault, especially where no resultant

image acquisition is achievable to inform the treatment process, as to whether imaging

on that device should continue.

The main increase seen in the level 3 most frequently reported RTE can be seen with

the increase in ‘on-set imaging: production process’, which has increased from 4.7% to

31.9% over the past 10 years.

Equipment failure reports should be reported to local engineers, the manufacturer and

the MHRA(23) as appropriate. Accidental or unintended reportable radiation incidents

associated with equipment failure should also be reported to the relevant enforcing

authority(26).

There were 172 process subcodes included in reported level 4 RTE. The most

frequently reported subcode was ‘documentation of instruction/ information’ (7.4%, n =

339). Only 71 of this subset of RTE contained an effective safety barrier (MD). Of

these, 33.8% (n = 24/71) indicated the RTE was detected during patient set up and

28.2% (n = 20/71) were detected during end of process checks at the treatment stage.

This indicates these type of RTE were not picked up at the ‘end of process check’

stage during pretreatment. It has been stated that end of process checks are some of

the most important processes to identify safety issues(35). Consideration should be

given to reviewing the effectiveness and timing of these interventions to ensure they

are optimal in the pathway for the mitigation of RTE.

Since the previous two-year period, there has been a decrease in the RTE associated

with both ‘documentation of instructions/ information’, from 8.0% to 7.4%, and

‘accuracy of data entry’, from 10.0% to 6.4%. The reduction in these 2 level 4 process

subcodes could be due to an uptake in the use of electronic systems leading to a

reduction of manual transcription, particularly for palliative treatments. Consideration

should be given to reviewing and extending the use of electronic systems wherever it

can contribute to the reduction of RTE. The palliative, superficial and brachytherapy

pathways might benefit from this in particular.

Within level 5 RTE reports the process subcode ‘consent process and documentation’

has increased from 2.4% (n = 155) in the previous two-year reporting period to 3.4% (n

= 239) within this reporting period. There was also a peak seen in the two-year

reporting period January 2012 to December 2013 at 5.7% (n = 183). There may be

some correlation between this peak, and subsequent reduction in percentage of this

type of RTE with the uptake of electronic consent processes.


53

5.4 Safety barriers

It is known there are risks inherent in the planning and delivery of RT. Therefore, a

number of safety barriers (SB) are built into the patient pathway to identify and stop

RTE propagating across the pathway and affecting the patient. Analysis of SB can

identify failed and effective safety barriers, so resources might be focused where they

would be most beneficial in mitigating RTE.

All failed SB subcodes were analysed across the 18,734 RTE reports for this two-year

period, and a total of 6,189 subcodes were identified as FSB. Primary FSBs associated

with ‘treatment unit processes’ were attributed to 40.7% (n = 2,516) of all failed SB.

This might be explained as ‘treatment unit process’ codes were the most frequently

reported across all RTE (42.3%, n = 7,923). ‘Use of on-set imaging’ process subcode

was the most frequently reported failed SB (13.3%, n = 824).

The most frequently reported MD was ‘on-set imaging: approval process’ (22.9%, n =

872) and 10.0% of all FSB. This MD is designed specifically to pick up errors in patient

position before treatment occurs, and as seen in section 4.4.2, detected several patient

position RTE, including ‘movements from reference marks’, ‘patient positioning’ and

imaging associated RTE. Although the subcode ‘on-set imaging: approval process’ was

the most frequently reported level 1 and 2 subcode (see sections 4.3.1 and 4.3.2) this

was also the most frequently reported MD, making this an effective safety barrier. The

increase in the use of online image verification has already been discussed in this

report.

5.5 Causative factors

Not all RTE contained a causative factor, nor contained enough detail to code. The

PSRT recommends all RTE contain all taxonomies and includes enough text to

appropriately define the event. The benefit of the use of causative factor taxonomy is

that it enables identification of system problems or root causes that could precipitate a

range of different incidents. If the root causes are addressed, it can be expected that

overall system safety is enhanced and not just a weakness associated with a particular

incident(20). For example, if the most frequently occurring equipment malfunction issues

associated with CBCT failures are addressed, the number of level 3 RTE associated

with ‘on-set imaging: production process’, 987 level 3 RTE, could be significantly

reduced.

The most frequently reported RC was individual ‘slips and lapses’ (n = 8,058). This is

consistent with findings in the literature. It has been suggested that human error is a

determining factor in 70 to 80% of incidents occurring in medicine(36). As seen in

section 4.5.1 there has been a gradual decrease in the RC ‘adherence to

procedures/protocols’ and an increase in ‘slips and lapses’ this is due to the uptake in


54

using multiple codes and the assigning of both ‘slips and lapses’ as the RC and

‘adherence to procedures/protocols’ as a CF. The increase in the reporting of

‘adherence to procedures/protocols’ as a CF is of note. This is particularly of note when

considering the importance of adherence to local procedures and protocols in

demonstrating due diligence in clinical care. Consideration should be given locally to

this and a review undertaken of the accessibility of quality management systems

(QMS). This might extend to the location of the QMS and access rights to electronic

QMS. Also activate engagement of staff in review of procedures is key to ensuring they

are fit for purpose. The RC ‘communication’ was the second most frequently reported

(15.2%, n = 2,799) code. This is consistent with findings from other reporting and

learning systems(35).

5.6 Brachytherapy RTE

BRT is a sub-specialty of RT, so it is expected the number of BRT RTE would be low

(n=159). It was noted there was a higher percentage of level 1 BRT RTE at 3.1%

compared to the 0.9% for all RTE. This might be explained in part by the hypo-

fractionated nature of BRT delivery. The clear majority of RT is by external beam

delivery which tends to have a longer fractionation scheme that allows for correction. A

difference was also noted in the level 3 RTE; only 15.1% of the BRT RTE were

classified as level 3 compared with 35.9% of all RTE. This difference in level 3 RTE

may be due to the differences in the uptake of IGRT between BRT and external beam

RT.

The most frequently occurring process subcode associated with BRT RTE was ‘initial

positioning of applicators/ sources’ (14.5%, n = 23). The most frequently reported RC

associated with brachytherapy RTE was ‘equipment or IT network failure’ (27.0%, n =

41). This is different to the most frequently reported RC for all RTE, ‘slips and lapses’.

This difference may be due to the variance in BRT and external beam techniques.

For the entire dataset, there is a disparity in the number of reports received per

provider per month. Within the small BRT dataset, a single provider may skew the data.

This can be seen within the BRT process subcode ‘delivery of sources’ (11.3%, n = 18),

the majority (94.4%, n = 17) of which were reported by a single provider.

5.7 Inspectorate data

A total of 300 reports were received from the IR(ME)R inspectorates compared to 167

from the voluntary reporting scheme. This difference may be due to several different

factors. Firstly, only anonymised closed events were shared by inspectorates which

may create a difference in time lag. In reviewing this PHE will look at reducing this lag

by incorporating inspectorate analysis into the triannual analysis(11). Secondly, the

voluntary data does not include data from independent providers. There is also some


55

disparity in the locally applied classification of events as seen in section 4.7. Finally, it

is known that barriers to reporting include reporting to multiple reporting systems(37).

For this two-year reporting period, the process subcode ‘on-set imaging: approval

process’ has been the most frequently reported pathway subcode. This extended to

most frequently reported failed SB and MD across both the inspectorate and level 1

voluntary data. The use of IGRT to aid patient set up and verify treatment position has

now become embedded within standard RT practice. Due to the frequency in using

IGRT there has been a sustained increase in on-set imaging associated RTE. Although

there are differences in the number of level 1 RTE reported to the relevant inspectorate

and the voluntary reporting system, the most frequently reported primary subcode,

failed SB, MD and the causative factor were the same across both datasets.

UK RT providers have well-established local reporting and learning systems in place for

the recording, investigation, escalation, analysis and learning from RTE. IR(ME)R (Reg

8(3)) mandates this practice (17-18).

Documentation relating to RTE should be retained in line with relevant guidance(38). RT

providers should have a forum which includes a record of RTE that is available for all

staff to review to ensure best practice is maintained, by sharing lessons learnt with all

staff locally and applying lessons learnt to mitigate RTE.


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6. Conclusion

Staff are more likely to report RTE where there is an open reporting culture and where

the clear aim of reporting is to learn and to improve patient safety. High reporting

numbers of RTE is indicative of an awareness of safety issues among healthcare

professionals and a well-established reporting culture.

Reporting of RTE will only be effective if there is a willingness to learn from errors and

to alter practice accordingly. Employers should share the outcomes of analyses with all

relevant staff and apply lessons learnt to mitigate these events in future.

Although 100% of RT NHS providers across the UK have reported to the RT reporting

and learning system since the introduction of this scheme, analysis indicates one

provider has not submitted data for this 2-year period. Also, it is noted that not all

providers report all levels of RTE, particularly ‘near miss’ and ‘other non-conformances’.

It is expected that numbers of RTE reports will continue to increase with the

consolidation of local reporting services and through the redevelopment of the NRLS as

PSIMS.

An estimated reported RTE rate of 4 per 1,000 attendances or 45 per 1,000

prescriptions was calculated. An estimated reported RTE rate for level 1 events was

calculated as 0.4 per 1,000 prescriptions. It is worth noting that the clear majority of

these events did not impact on the patients’ planning, treatment or outcome.

For the first time this two-year report includes learning from across all taxonomies,

including the classification, pathway coding, safety barriers, methods of detection and

causative factor taxonomy. The use of all taxonomies allows wide-ranging learning from

RTE at local, network and national level.

Consistent with findings in the literature, there are a small number of significant

incidents and a greater number of lower level incidents. The proportion of significant

incidents has continued to decrease slightly since the previous two-year period.

On-set imaging associated RTE made up a significant proportion of all reported RTE.

This reflects the increase in automation of processes across the RT pathway. On-set

imaging processes now represent a focal point for decision making processes on the

pathway and is the last point on the pathway prior to initiating treatment exposures. The

most frequently reported root cause of RTE was individual ‘slips and lapses’. This is

reflected in the level of manual input and data and image interpretation required as part

of imaging processes. The risk of error in imaging processes may be amplified due to

the dynamic nature of online review and the rapid pace of development of new

technologies and techniques, together with an increase in imaging frequency. This


57

equates to more imaging-based errors. However, the benefit image guided RT (IGRT)

brings to the patient is clear. Further guidance on imaging-associated RTE has been

published(31).



unintended exposures to further mitigate against these types of RTE.

In areas demonstrating an initial increase in RTE that then are seen to fall, such as on-

set imaging, Learning from Excellence (LfE) may be useful. By reporting and studying

successes from RT providers, learning can be augmented and patient outcomes

improved; this also impacts positively on resilience and culture in the workplace(33).

RT is ever evolving with new techniques and technology; therefore, these trends should

continue to be reported and learnt from. The move to increased hypo-fractionation of

external beam RT will reduce the opportunities to correct for RTE. The role of reporting

and learning systems will continue to play a part in helping identify and address RTE.


58

7. Recommendations

Recommendations for local providers are that:

• all UK RT providers should continue to use Towards Safer Radiotherapy(3) and

Development of Learning(4) taxonomies to code all levels of RTE for local analysis

to inform local learning and practice

• UK NHS RT providers should continue to submit fully coded RTE reports, of all

levels, to the national voluntary reporting system using the mechanisms identified

within this report, monthly, to ensure timeliness of shared learning

• adherence to protocols / procedures and slips and lapses are the most frequently

reported causative factors – RT providers should consider working arrangements

associated with these reports

• consideration should be given to introducing a ‘pause and check’ policy for on-line

image capture, review and approval to reduce IGRT associated RTE

• a review of referral guidelines and procedures should be undertaken to ensure all

required diagnostic information is in place prior to justification and authorisation of

treatment and made available to inform planning processes to minimise the risk of a

missed verification of diagnosis / staging of disease

• consideration should be given to reviewing the effectiveness and timing of ‘end of

process checks’ to ensure they are optimal in the pathway to mitigate RTE

• local learning should be compared with the national picture and used to inform local

and network level practice

• independent providers should consider submitting RTE to the national voluntary

reporting system

• RTE analysis should be used to inform prospective risk assessments as part of a

study of the risk of accidental and unintended exposures to support compliance with

IR(ME)R (Regulation 8(2) and 8(3))

National recommendations are that:

• PSRT should continue to develop the national analysis and learning from RTE, with

timely dissemination of findings to the RT community for wider learning

• RTE should be used by the PSRT and individual RT providers as part of a risk-

based approach to allocating resources for improving patient safety in radiotherapy

and to inform audit and research

• PSRT should engage vendors in developments to reduce the rate of RTE related to

equipment failure and human factors.

• in areas demonstrating an initial increase in RTE that are then seen to fall, Learning

from Excellence may be useful. PSRT should develop RT based tools to support the

implementation of emerging patient safety theory


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8. Acknowledgements and PSRT Steering

Group membership

Acknowledgements

The Patient Safety in Radiotherapy Steering Group would like to thank all stakeholders

for their ongoing commitment to advancing safer RT. We hope this report will support

the RT community by informing their practice. In particular, we would like to thank:

• NHS RT Providers and RTE reporters across the UK

• National Reporting and Learning System (NRLS) at NHS England and Improvement

• enforcing authorities for IR(ME)R across the UK

• the Care Quality Commission (CQC) in England

• the Regulation and Quality Improvement Authority (RQIA) in Northern Ireland

• Healthcare Improvement Scotland (HIS) in Scotland

• Healthcare Inspectorate Wales (HIW) in Wales

• the National Cancer Registration and Analysis Service (NCRAS) – this work uses

attendance and prescription data that has been provided by patients and collected

by the NHS as part of their care and support; the data is collated, maintained and

quality assured by NCRAS, which is part of Public Health England

• Wei Zhang (Medical Statistician, Public Health England)

PSRT Steering Group membership

• Julia Abernethy (Patient Safety Team, NHS England and Improvement)

• Helen Best (Public Health England)

• Martin Duxbury (Society and College of Radiographer’s Clinical Representative –

Deputy Head of Radiotherapy, St James Institute of Oncology, Leeds)

• Úna Findlay (Public Health England and Group Chair)

• Petra Jankowska (Royal College of Radiologists – Consultant Clinical Oncologist,

Taunton and Somerset Foundation Trust and Quality and Safety Lead at RCR)

• Maria Murray (Society and College of Radiographers – Professional Officer for

Scotland and UK Radiation Protection Lead)

• Tony Murphy (Lay Representative)

• Carl Rowbottom (Institute of Physics and Engineering in Medicine – Head of

Physics, The Clatterbridge Cancer Centre NHS Foundation Trust)

https://www.cqc.org.uk/guidance-providers/ionising-radiation/irmer-inspections

https://www.rqia.org.uk/guidance/guidance-for-service-providers/ionising-radiation-(medical-exposure)-regulations/

http://www.healthcareimprovementscotland.org/our_work/inspecting_and_regulating_care/ionising_radiation_regulation.aspx

https://hiw.org.uk/healthcare-organisations-use-ionising-radiation-medical-purposes


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Improvement in Patient Safety Culture Over 5 Years With Use of High-volume Incident Learning System. Practical radiation oncology. 2019;9(4):e407-e16.

3. European Commission. Radiation Protection No. 181, General guidelines on risk management in external beam radiotherapy. https://ec.europa.eu/energy/sites/ener/files/documents/RP181web.pdf, 2015.

4. World Health Organization. Reporting and learning for patient safety. https://www.who.int/patientsafety/implementation/reporting_and_learning/en/

5. NHS Improvement. NRLS organisation patient safety incidents reports: commentary. 2019. https://improvement.nhs.uk/documents/5066/OPSIR_commentary_March_2019_Final.pdf.

6. Department of Health. Radiotherapy: Hidden Dangers. Chapter 5. Chief Medical Officer’s Annual Report 2006 (2007). https://webarchive.nationalarchives.gov.uk/20130105021748/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/AnnualReports/DH_076817.

7. Royal College of Radiologists, Society and College of Radiographers, Institute of Physics and Engineering in Medicine, National Patient Safety Agency, British Institute of Radiology. Towards Safer Radiotherapy. London: Royal College of Radiologists, 2008. https://www.rcr.ac.uk/system/files/publication/field_publication_files/Towards_saferRT_final.pdf.

8. Public Health England. Radiotherapy: learning from errors. https://www.gov.uk/government/publications/development-of-learning-from-radiotherapy-errors.

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