Radiotherapy error and near-miss data report: December 2015 to November 2017 Report No. 5
Radiotherapy error and near-miss data report: December 2015 to November 2017
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About Public Health England
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Prepared by: Medical Exposures Group
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Published May 2019
PHE publications PHE supports the UN
gateway number: GW-446 Sustainable Development Goals
Radiotherapy error and near-miss data report: December 2015 to November 2017
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Contents
About Public Health England 2
Executive summary 4
1. Introduction 7
2. Background 8
3. Data 10
3.1 Obtaining the data 10 3.2 Number of reports 11 3.3 Lag time for reporting 13 3.4 Organisation of the database 13
3.5 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 code 19 4.5 Causative factors 28
4.6 Brachytherapy errors 30 4.7 Inspectorate data 31
5. Discussion 34
5.1 Increase in RTE reporting 34 5.2 Main themes 35
5.3 Classification level of RTE 36 5.4 Safety barriers 40
5.5 Causative factors 41 5.6 Inspectorate data 41
6. Conclusion 42
7. Recommendations 43
8. Acknowledgements and steering group 44
PSRT Steering Group membership 44
10. References 45
Appendix A: Radiotherapy error classification grid 47
Appendix B: Refined radiotherapy pathway coding (including safety barrier taxonomy) 48
Appendix C: Causative Factor Taxonomy 63
Radiotherapy error and near-miss data report: December 2015 to November 2017
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Executive summary
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 reporting of RT error and near-miss events system.
This report is the fifth in a series of 2-year reports1, providing an overview of
Radiotherapy Error (RTE) data reported voluntarily to the National Reporting and
Learning System (NRLS) and directly to Public Health England (PHE) between
December 2015 and November 2017. The report also contains aggregate data from
December 2009 to November 2015 and compares the new data with that from
previously published reports1. This fifth report includes analysis using the new
taxonomies2 including the refined pathway coding, safety barrier and causative factor
taxonomies. The analysis within this report facilitates comparisons of national RTE
reporting with both local and network trends.
A total of 15,830 RTE reports were included in this analysis. Consistent with previous
reports1 RTEs were spread across all 21 categories of process codes, treatment unit
process codes were the most frequently reported RTE (41.2%, n = 6,526). This is to be
expected as treatment processes are reliant on the accurate interpretation of the
planning information, and RT treatments usually span several visits, providing many
opportunities during the treatment unit process for RTE to occur.
Of the RTE reports, 65.8% (n = 10,414) were ‘near miss’ or ‘other non-conformances’
with no impact on patient outcome. In total, 31.8% (n = 5,035) of the RTEs reported
were not clinically significant and were classified as ‘minor radiation incidents’. Of the
remaining 2.4% (n = 381) RTE reports only 1.0% were reportable. When compared
with the results from the previous 2-year report there has been a reduction in the
percentage of reportable radiation incidents from 1.8% to 1.0%.
Safety barriers (SB) are embedded across the RT pathway coding. The SB taxonomy
can be used to separately identify both failed and effective SB. For this reporting
period, 5,191 subcodes were identified as failed SB, and ‘on-set imaging approval
process’ was the most frequently occurring failed SB (15.3%, n = 796). Future reports
will also contain effective SB or method of detection. There were 7,778 RTE reported
between January 2017 and November 2017 of which 35.9% (n = 2,793) contained
causative factors. The most frequently reported primary CF was ‘slips and lapses’
(32.1%, n = 897).
After 10 years of reporting, the proportion of significant incidents has started to reduce
slightly. RT is delivered in a complex and rapidly evolving landscape. Therefore, it is
imperative that RTE trends continue to be reported, analysed and monitored on a
Radiotherapy error and near-miss data report: December 2015 to November 2017
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cyclical basis, to inform ongoing safe and effective RT practice. This is especially
pertinent as new techniques and technologies are implemented and as new clinical RT
providers are established. 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. Providers are encouraged to
contact PHE if they have any queries about reporting or would like further advice.
Local provider recommendations are:
• all UK RT providers should continue to use Towards Safer RT3 and Development of
Learning2 to classify and code all levels of RTEs for local analysis to inform local
learning, policy and practice
• local learning should be compared with the national picture and used to inform local
and network level learning
• UK NHS RT providers should continue to submit coded and classified RTE reports
to the national voluntary reporting system using the mechanisms identified within
this report
• UK NHS RT providers should ensure all levels of RTE are reported locally and
nationally
• providers are encouraged to report monthly to ensure timeliness of learning
• UK RT providers should adopt all codes, including safety barriers and causative
factors when coding RTE and the use of secondary or additional subcodes
• independent providers should consider submitting all levels of RTE to the national
voluntary reporting system
• UK RT providers should review effectiveness of local end of process checks across
the entire pathway
National recommendations are:
• the patient safety in radiotherapy steering group (PSRT) should continue to develop
analysis of the reports, with regular dissemination of findings to the RT community
for group learning
• the data should be used both by the PSRT and by individual RT providers as part of
a risk-based approach to allocating resources for improving patient safety in RT and
to inform audit and research
• the mechanism to enable providers in Scotland and Northern Ireland to submit RTE
reports to PHE for collation and analysis as part of a UK dataset should be further
refined
• PSRT should review the effectiveness of corrective actions and preventative
measures (safety barriers)
Radiotherapy error and near-miss data report: December 2015 to November 2017
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• vendors should consider developments to reduce the rate of RTE related to
equipment failure1
1 PSRT. Radiotherapy errors and near misses: biennial report. Nos 1-4. Available at
www.gov.uk/government/publications/radiotherapy-errors-and-near-misses-data-report 2 PSRT. Development of learning from radiotherapy errors. Available at
www.gov.uk/government/publications/development-of-learning-from-radiotherapy-errors 3 RCR, SCoR, IPEM, NPSA, BIR. Towards Safer Radiotherapy. Royal College of Radiologists, London (2008).
Available at www.rcr.ac.uk/towards-safer-radiotherapy
Radiotherapy error and near-miss data report: December 2015 to November 2017
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1. Introduction
The fundamental role of reporting and learning reporting systems is to enhance patient
safety by learning from failures of the healthcare system1. 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, error
must be prevented, or minimised.
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 system of national voluntary reporting of RT error and near miss events.
The 20062 report of the Chief Medical Officer for England and Towards Safer
Radiotherapy (TSRT), published in 20083, 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
Errors4, a guidance document supporting the enhancement of learning from RTE and
their analysis, was published.
This report is the fifth in a series of 2-year reports5, providing an overview of
Radiotherapy Error (RTE) data reported voluntarily to the National Reporting and
Learning System (NRLS) and directly to PHE between December 2015 and November
2017. The report also contains aggregate data from December 2009 to November 2015
and compares the new data with that from previously published reports5.
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2. Background
TSRT3 provides definitions for the terminology to be used in discussing radiotherapy
(RT) errors that include near misses (RTE) and proposed 2 taxonomies for use in
describing RTEs. The ‘Classification of radiotherapy errors grid’ (Appendix A) describes
the severity of the error and the ‘Radiotherapy pathway coding’ described where in the
RT pathway the error occurred. In December 2016, a guidance document containing
the refinement of the RT pathway coding to include safety barriers (SB) (Appendix B)
and a proposed causative factor (CF) taxonomy (Appendix C) was published4. The
document also contains definitions and examples on the application of the taxonomies.
To aid the RT community in the adoption of the taxonomies, a workshop was held in
October 2017. The workshop also provided opportunities for sharing between the RT
community and the Patient Safety in Radiotherapy Steering Group (PSRT) on the
analysis of RTE. The new taxonomies have been adopted by NHS RT providers across
the UK.
In 2008, the PSRT was tasked with monitoring the implementation of the
recommendations from TSRT, through a collaborative programme of work with the RT
community. PSRT membership includes representatives from Public Health England
(PHE), Royal College of Radiologists, Society and College of Radiographers, Institute
of Physics and Engineering in Medicine and a lay representative. The Group is chaired
by PHE where detailed analysis of RTE reports is undertaken, reported to the PSRT
and disseminated to the RT community to provide learning opportunities.
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. PHE has a data sharing agreement with the NRLS and
under this agreement continues to facilitate extraction of RTE data from the NRLS, and
share learning from these events to make services safer for patients. This collaboration
led to the publication in July 20105 of the first 2-year data report on a back catalogue of
patient safety incidents reported to the NRLS between August 2007 and November
2009.
The first report aimed to provide learning from incidents already reported, to trial the
application of the taxonomies from TSRT and to test the mechanism for reporting.
Subsequently the PSRT asked RT provider staff to classify and code all errors
according to the taxonomies presented in TSRT within their local incident reporting
systems for subsequent submission for analysis by PHE staff as part of a voluntary
reporting scheme. This publication was closely followed in September 2010 by the
introduction of a series of newsletters entitled Safer Radiotherapy6 providing regular
updates on the analysis of RTE reports for professionals working in the RT community.
Radiotherapy error and near-miss data report: December 2015 to November 2017
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In 2012, a second report was published5. 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 inspectorates for IR(M)ER for England, Wales, Northern Ireland and
Scotland was published within the third and the fourth5 2 yearly reports.
This fifth report includes analysis using the new taxonomies4 including the refined
pathway coding, safety barrier and causative factor taxonomies.
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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 occurrence, as such, this data needs interpreting with care.
The data in this report is represented in three timeframes, the current analysis (for
reporting period December 2015 to November 2017), the previous 2016 analysis (for
reporting period December 2013 to November 2015), and the aggregate data (for
reporting period December 2007 to November 2015).
3.1 Obtaining the data
The voluntary data was obtained through 2 distinct routes: from the NRLS for providers
in England and Wales and directly from providers in Northern Ireland and Scotland.
These routes are described in detail below. An anonymised closed synopsis of
reportable radiation incidents was shared directly from the inspectorates for IR(ME)R
for England, Wales, Northern Ireland and Scotland with PHE for inclusion within the
database.
3.1.1 National voluntary reporting system
The clear majority of reports came through the NRLS7 at NHS England and
Improvement, 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’7.
PSIs are primarily reported by NHS organisations in England and Wales through bulk
upload via local trust risk management systems and web-based forms to the NRLS.
Independent providers are also starting to report using bulk upload. Patients, carers
and independent providers can also report directly through an open access form8. The
NRLS offers a unique dataset to help understand harm associated with healthcare. It
was established in 2003 and now has over 19.5 million PSI reports9, from many areas
of healthcare, in the database. The NRLS is now under redevelopment as part of the
patient safety incident management systems (DPSIMS) project10, the new system will
support learning, so the NHS can continue to improve safety.
Radiotherapy error and near-miss data report: December 2015 to November 2017
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The NRLS can be interrogated for relevant incidents by searching the free text field of
any incident report using key words 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 radiotherapy (RT) errors and near misses
effectively’11. This code is searched for in the free text field rather than using search
terms that were found to be less determinant. PSIs that are not RTEs, such as a report
of a patient falling in ‘radiotherapy’, are not included in the RTE dataset. An 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’3.
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 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 to further streamline the reporting mechanism for providers in Northern
Ireland and Scotland while continuing to receive and include this data in the tri-annual
analysis6.
3.2 Number of reports
A total of 15,979 RTE reports were submitted to the voluntary reporting scheme
between December 2015 and November 2017, with an average 666 reports per month.
There has been an increase in reporting since the last 2-year reporting period, where a
total of 12,800 RTE reports were submitted between December 2013 and November
2015, with an average 533 reports per month. Figure 1 indicates a peak in reporting in
October. This spike in October and peak in May could be related to the 6 monthly
NRLS reporting cut-off dates for their annual reports. RT providers may be more likely
to bulk upload in these 2 months of the year to hit this deadline9. The data also
indicated that 2 separate providers reported a backlog of data during October. This
variation highlights that not all providers report monthly as indicated in figure 1.
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Figure 1. Average number of RTE reports submitted to the national voluntary reporting system by month
For this 2-year period, reports were received from the clear majority of NHS RT
providers, 59 (96.7%). This is a slight decrease on the previous analysis where 60 NHS
providers reported to the national analysis. It is clear there is some variance in the
number of reports provided, one provider reported 2,160 RTE across all levels of RTE
over the 2-year period and 62.3% (n = 38) providers reported less than the mean
average of 260 RTE over the 2-year period (Figure 2). There is a wide range in
provider size and capacity, and the number of reports per provider has not been
normalised to account for this variation. 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.
Figure 2. Number of RTE reported per provider, Dec 2015 to Nov 2017
0
200
400
600
800
1000
1200
Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov
Dec 15-Nov 17averageDec 13-Nov 15averageAggregateaverage
260
0
500
1000
1500
2000
2500
Num
ber
of R
TE
rep
orts
RT provider
Radiotherapy error and near-miss data report: December 2015 to November 2017
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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 the date of RTE or discovery of the RTE through local reporting on to
PHE.
A minimum reporting lag of 0 days and a maximum 871 days was found for the
individual RTE, with an average of 66 days and a median of 48 days across providers.
This lag time is like the previous 2-year analysis where the minimum reporting lag was
1 day and maximum 864 days for each individual RTE and an average of 58.8 days
across providers. There were 4 outliers of more than 2 years. Two reports did not
contain enough information to explain the extended time lag. One report was a level 1
RTE and may have been reported once the full investigation was completed. The other
outlier was identified when preparing a patient for a second course of treatment 861
days after the original error. This was a level 5 error and was found to be an error in the
recording of the patient summary.
3.4 Organisation of the database
An established SQL database acts as a repository for the data. Searches within the
database can include review of data by taxonomies, date and keyword searches. It also
supports the analysis of the data using scripted reports on frequency and trends
analysis. The database has access restricted to named individuals directly involved
with the quality assurance and analysis of the data. All data was submitted for upload
by PHE staff to the database by import of Microsoft Excel spreadsheets. For the
purposes of the analysis each RTE report submitted is included as a single report.
3.5 Quality assurance of the data
All providers were asked to include a trigger code, classification and coding in RTE
reports. In December 2016, the DoL4 taxonomies were published and providers were
asked to include a trigger code, classification, pathway coding, including failed safety
barriers, causative factor and, where applicable, effective safety barriers (detection
methods) to their RTE reports to facilitate both local and national analysis.
The data supplied was initially scrutinised by PHE staff and consistency checking of the
application of the coding and classification undertaken. Reports run in the database
were checked against manual calculations to verify the expected outcomes.
On receipt of the reports, PHE staff with clinical RT expertise performed consistency
checking of the local application of the classification and coding. During consistency
checking the coding is reviewed for all RTE classified as reportable through to near
Radiotherapy error and near-miss data report: December 2015 to November 2017
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miss (levels 1-4) and 10% of non-conformances (level 5) RTE are audited. This formed
part of the data quality assurance process completed prior to analysis of the reports.
Consistency checking of the appropriate application of the coding and classification
taxonomies remained high, with 82.4% agreed in this dataset. However, this is lower
than 87.1% agreement achieved in the 2016 report5. Data received between December
2015 and December 2016 indicated a 79.7% agreement rate, 85.4% consistency rate
was seen in the months January 2017 to November 2017. This increase in consistency
may be due to the DoL document which was published in December 2016, with an aim
to provide guidance on the application of the taxonomies4. The PSRT held a workshop
in October 2017 on the application of the refined pathway coding and new taxonomies
from the DoL4 one of the aims of the workshop was to allow consistency in the uptake
of the new and amended taxonomies.
Reports were categorised into complete, incomplete or non-RTE. Complete reports
contain the classification and coding, complete fixed reports are defined as complete
reports which have had the classification and/or the pathway coding amended for
consistency reasons. 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.
Of the 15,979 RTE reports received, a total of 15,830 reports were included in the
analysis 14,412 had been classified and coded by local RT providers (Figure 3). There
were 1,418 incomplete reports, all of which contained sufficient information to assign
classification and coding. The remaining 149 non-RTE or PSI reports, were excluded
from the analysis. A total of 99.1% (90.2% complete and 8.9% incomplete) of the data
submitted was included for analysis in this report, this is consistent with reported data in
20165.
Figure 3. Data quality Dec 2015 to Nov 2017 (n = 15,979)
11873
2539
01418 149
Complete Report
Complete - Fixed Report
Incomplete Report
Incomplete - Fixed Report
Non-RTE Report
Radiotherapy error and near-miss data report: December 2015 to November 2017
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4. Results
4.1 Main themes of RTE
The 15,830 RTE reports were categorised by classification, process code or process
subcode including failed and effective safety barriers and causative factors, so that the
main themes could be derived.
4.1.1 Breakdown of process codes
The entire dataset was broken down by process code and classification level. The RTE
reported associated with ‘treatment unit processes’ comprised 41.2% (n = 6,526) of the
data and 15.4% (n = 2,431) occurred during ‘pre-treatment planning process’ (Figure
4). RTEs were spread across all 21 categories of process code. In this subset of data, it
may be seen that the majority (64.6%, n = 9,698) of reports comprise of ‘near misses’
(Level 4) and ‘other non-conformances’ (Level 5). ‘Minor radiation incidents’ (Level 3)
made up 32.9% (n = 4,940) of these reports. The remaining 2.5% (n = 368) reports
were ‘non-reportable radiation incidents’ (level 2) and ‘reportable radiation incidents’
(Level 1).
Figure 4. Breakdown of RTE main activity Dec 2015 - Nov 2017 (15,006/15,830 subset of RTE)
The main activity was then reviewed for this 2-year period, the 2016 analysis and
aggregate data as shown in figure 5. The RTE reported associated with ‘treatment unit
6526
2431
1819
1130
997
745
509
333
264
252
0 1000 2000 3000 4000 5000 6000 7000
Treatment unit process
Pretreatment planning process
Pretreatment activities
Treatment data entry process
Booking process
Communication of intent
Referral for treatment
On-treatment review process
Process prior to first appointment
Timing
Number of RTE Reports
Level 1
Level 2
Level 3
Level 4
Level 5
Radiotherapy error and near-miss data report: December 2015 to November 2017
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processes’ and ‘pre-treatment activities’ has been consistent across this 2-year period
and the previous 2-year period. There has been a decrease in ‘pre-treatment planning
process’ activity from 17.3% across the aggregate data to 15.4% in this 2-year
reporting period. Both ‘booking process’ and ‘treatment data entry process’ has
increased since the last 2-year period and in the aggregate data.
Figure 5. Breakdown of RTE main activity as percentage of RTE reports
4.1.2 Breakdown of process subcodes
The most frequently reported process subcode was ‘on-set imaging: production
process’, making up 11.5% (n = 1,827) of all RTEs reported. This was followed by
‘accuracy of data entry’ 5.1% (n = 805) and ‘on-set imaging: approval process’ 5.0% (n
= 796). Of note, on-set imaging processes represented 4 of the most frequently
reported subcodes making up 24.1% (n = 3,813) of all RTE. The most frequently
reported subcodes and their classification levels are presented in figure 6. It can be
seen that most of the main themes are made up of ‘near misses’ (level 4) at 26.3% (n =
1,921) and ‘other non-conformance’ (level 5) at 29.1% (n = 2,127). In reality, the
incidence of level 4 and 5 reports is likely to be much higher as not all these events are
currently reported under the national voluntary reporting system12. ‘Minor radiation
incidents’ (Level 3) made up 43.2% (n = 3,155) of this subset of reports. The remaining
1.4% (n = 103) reports were ‘non-reportable radiation incidents’ (level 2) and
‘reportable radiation incidents’ (Level 1).
37.6%
17.3%
11.8%
6.9%
4.9%
41.3%
16.2%
11.4%
6.4%
5.2%
41.2%
15.4%
11.5%
7.1%
6.3%
0 5 10 15 20 25 30 35 40 45
Treatment unit process
Pretreatment planningprocess
Pretreatment activities
Treatment data entry process
Booking process
Percentage of RTE reports
2018, data for 2015-2017(n = 15,830)2016, data for 2013-2015(n = 12,691)Aggregate, 2009-2015(n = 23,662)
Radiotherapy error and near-miss data report: December 2015 to November 2017
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Figure 6. Breakdown of RTE main themes by classification Dec 2015 - Nov 2017 (7,306/15,830 subset of RTE)
The main themes were then reviewed for this 2-year period, the 2016 analysis and the
aggregate data as shown in figure 7. The RTE reported associated with ‘on-set
imaging: production process’ has increased from 6.5% of the aggregate data to 8.4% in
the last 2-year period and 11.5% in this 2-year period. ‘Accuracy of data entry’ and
‘documentation of instructions’ have also increased. Whilst ‘on-set imaging: approval
process’ and ‘use of on-set imaging’ has decreased.
Figure 7. Breakdown of RTE main themes 2018/2016 and aggregate for top 5
1827
805
796
758
646
544
443
398
391
363
335
0 200 400 600 800 1000 1200 1400 1600 1800 2000
(13z) On-set imaging: production process
(12f) Accuracy of data entry
(13aa) On-set imaging: approval process
(10j) Documentation of instructions/information
(13i) Use of on-set imaging
(13bb) On-set imaging: recording process
(11j) Generation of plan for approval
(11o) Management of process flow within planning
(11n) Recording of patient specific instructions
(6a) Bookings made according to protocol
(13l) Movements from reference marks
Total number of RTE
Level 1
Level 2
Level 3
Level 4
Level 5
6.5%
4.7%
5.4%
4.0%
5.0%
8.4%
4.3%
5.8%
4.2%
6.5%
11.5%
5.1%
5.0%
4.8%
4.1%
0 2 4 6 8 10 12
(13z) On-set imaging: production process
(12f) Accuracy of data entry
(13aa) On-set imaging: approval process
(10j) Documentation of instructions
(13i) Use of on-set imaging
Percentage of RTE reports
2018, data for2015-2017 (n = 15,830)
2016, data for2013-2015 (n = 12,691)
Aggregate, data for2009-2015 (n = 23,662)
Radiotherapy error and near-miss data report: December 2015 to November 2017
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4.2 Classification level of RTE
Each of the reports were classified as ‘other non-conformances’, ‘near miss’, ‘minor
radiation incident’, ‘non-reportable radiation incident’ and ‘reportable radiation incident’.
Figure 8 includes data for this 2-year period, the 2016 analysis and aggregate data.
Of the RTE reports, 65.8% (n = 10,414) were ‘near miss’ or ‘other non-conformances’
with no impact on patient outcome. In total, 31.8% (n = 5,035) of the RTEs reported
were not clinically significant and were classified as ‘minor radiation incidents’. Of the
remaining 2.4% (n = 381) of RTE reports only 1.0% were reportable under either of 2
statutory instruments, IR(ME)R13 or IRR14, to the appropriate authority. This is reflective
of the previous 2-year analysis. Of note, across both 2-year analyses and aggregate
data the ‘non-reportable radiation incidents’ have stayed the same at 1.4%, however
the ‘reportable radiation incidents’ have reduced from 1.8% during the last 2-year
analysis and 1.7% within the aggregate data to 1.0% within this 2-year analysis.
Figure 8. Classification levels as a percentage of RTE reports
4.2.1 Providers reporting per classification
It is clear there is some variance in the classification levels reported as part of the
national voluntary scheme. Figure 9 indicates that not all providers report all levels of
errors. All providers submitting to this system reported ‘near miss’ data and the majority
98.3% (n = 58) reported ‘minor radiation incidents’, however only 91.5% (n = 54)
reported ‘other non-conformances’ this may be due to lack of resource and non-
electronic reporting systems15. Providers are required to report all ‘reportable radiation
incidents’ to the appropriate authority13,14. Only 74.6% (n = 44) of providers reported
reportable and non-reportable radiation incidents; this may be due to reporting burden
38.2%
29.0%
29.7%
1.4%
1.7%
36.6%
28.7%
31.5%
1.4%
1.8%
40.2%
25.6%
31.8%
1.4%
1.0%
0 5 10 15 20 25 30 35 40 45
5 Other non-conformance
4 Near miss
3 Minor radiation incident
2 Non-reportable radiation incident
1 Reportable radiation incident
Percentage of RTE reports
2018, data for 2015-2017(n = 15,830)2016, data for 2013-2015(n = 12,691)Aggregate, data for 2009-2015(n = 23,662)
Radiotherapy error and near-miss data report: December 2015 to November 2017
19
and not reporting incidents twice. A national survey of providers undertaken in
November 2018 by PHE staff confirmed this assessment12.
Figure 9. Classification level reported by providers Dec 2015 to Nov 2017
4.3 Breakdown of classification by process code
In this section, the RTE reports are broken down by classification into their attributed
process codes and subcodes.
4.3.1 Breakdown of Level 1 (reportable radiation incident) RTE
‘Reportable radiation incidents’ fall into the category of incidents reportable under either
of the statutory instruments, IR(ME)R13 or IRR14. Clearly, reporting to the national
voluntary reporting scheme does not negate regulatory requirements to report events to
the appropriate authority.
Most level 1 events reported affected only a single fraction of 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 159 Level
1 RTE (Figure 10). The most frequently reported occurred during ‘localisation of
intended volume’ comprising of 10.1% (n = 16) of all level 1 RTE. This was followed by
‘setting of couch position/angle’ (7.5%, n = 12), ‘on-set imaging: approval process’
(6.9%, n = 11) and ‘authorisation to irradiate’ (6.3%, n = 10). Examples of RTE
associated with ‘localisation of intended volume’ include when the incorrect anatomical
area of the patient is CT scanned for planning and requires multiple re-scans.
Examples of RTE associated with ‘setting of couch position/angle’ include when the
incorrect couch height is set for a post FSD patient. Examples of RTE associated with
‘on-set imaging: approval process’ includes when an image has been mismatched and
treated to the incorrect vertebrae leading to a clinically significant difference in
treatment.
54
59
58
44
44
0 10 20 30 40 50 60
5 Other non-conformance
4 Near miss
3 Minor radiation incident
2 Non-reportable radiation incident
1 Reportable radiation incident
Number of providers
Radiotherapy error and near-miss data report: December 2015 to November 2017
20
Figure 10. Breakdown of most frequently reported reportable radiation incidents (level 1) Dec 2015 to Nov 2017 (n = 88/159 subset of RTE)
The ‘reportable radiation incidents’ were then reviewed for this 2-year period, the 2016
analysis and aggregate data as seen in figure 11. There are similarities in percentage
with the previous 2-year reporting period and the aggregate data. However, there is an
increase across all the process subcodes shown in figure 10 for this reporting period.
There were only 52 out of 206 different subcodes associated with the level 1 RTE,
therefore the comparison graph should be interpreted with care.
Figure 11. Percentage of level 1 most frequently reported RTE for this 2-year reporting period compared with the 2016 analysis and aggregate
16
12
11
10
8
7
7
6
6
5
0 2 4 6 8 10 12 14 16
(10c) Localisation of intended volume
(13q) Setting of couch position/angle
(13aa) On-set imaging: approval process
(5k) Authorisation to irradiate (IR(ME)R)
(4i) Choice of other concurrent treatment
(13l) Movements from reference marks
(4b) Verification of diagnosis/extent/stage
(10f) Production of images demonstrating correct detail
(13g) Patient positioning
(13c) Patient data ID process
Number of RTE reports
7.8%
2.3%
4.3%
2.3%
2.5%
7.3%
2.2%
4.7%
3.9%
3.4%
10.1%
7.5%
6.9%
6.3%
5.0%
0 2 4 6 8 10 12
(10c) Localisation of intended volume
(13q) Setting of couch position/angle
(13aa) On-set imaging: approval process
(5k) Authorisation to irradiate
(4i) Choice of other current treatment or interventions
Percentage of RTE reports
2018, data for2015-2017(n = 159)2016, data for2013-2015(n = 232)Aggregate, datafor 2009-20015(n = 398)
Radiotherapy error and near-miss data report: December 2015 to November 2017
21
4.3.2 Breakdown of Level 2 (non-reportable radiation incident) RTE
A ‘non-reportable radiation incident’ is defined by TSRT as a radiation incident ‘not
reportable, but of potential or actual clinical significance’3.
There were 67 different subcodes used to report the Level 2 reports, and the most
frequently reported can be seen in figure 12. Of the level 2 reports, 14.9% (n = 33)
occurred during the ‘on-set imaging: approval process’. Examples of RTE reports
associated with ‘on-set imaging: approval process’ included the incorrect matching of
reference image and verification image and several reports indicated this was due to
matching the incorrect vertebrae level. This was followed by ‘localisation of intended
volume’ (7.7%, n = 17) which was also the most commonly reported subcode within the
level 1 reports. The 2017 Department of Health guidance16 contains guideline factors
for concomitant imaging; the reports classified as level 2 did not reach these guideline
factors. Examples of RTE associated with ‘localisation of intended volume’ include the
incorrect area of the patient CT scanned for planning and requires additional re-scan.
‘Production of images demonstrating correct detail’ made up 5.0% (n = 11) of all level 2
RTE. Examples of these types of RTE include when the image required for planning
does not contain previous permanent marks or patient scars.
Figure 12. Breakdown of most frequently occurring non-reportable radiation incidents (level 2) Dec 2015 to Nov 2017 (n = 125/ 222 subset of RTE)
The ‘non-reportable radiation incidents’ were then compared with the previous 2-year
analysis and the aggregate data as seen in figure 13. There has been a decrease in
the percentage of ‘on-set imaging: approval process’ and ‘movements from reference
marks’ associated RTE within this subcategory. An increase has been seen within the
level 2 RTE associated with ‘localisation of intended volume’, ‘production of imaging
33
17
11
10
10
7
6
6
5
5
5
5
5
0 5 10 15 20 25 30 35
(13aa) On-set imaging: approval process
(10c) Localisation of intended volume
(10f) Production of images demonstrating correct detail
(13l) Movements from reference marks
(13cc) Management of variations/unexpected events/errors
(13i) Use of on-set imaging
(13k) ID of reference marks
(13g) Patient positioning
(13c) Patient data ID process
(12f) Accuracy of data entry
(13r) Use of immobilisation devices
(13z) On-set imaging: production process
(13q) Setting of couch position/angle
Number of RTE reports
Radiotherapy error and near-miss data report: December 2015 to November 2017
22
demonstrating correct detail’ and ‘management of variations’ within the treatment unit
process area.
Figure 13. Percentage of level 2 most frequently reported RTE for this 2-year reporting period compared with 2016 analysis and aggregate
4.3.3 Breakdown of Level 3 (minor radiation incident) RTE
A ‘minor radiation incident’ is defined by TSRT as a radiation incident ‘in the technical
sense but one of no potential or actual clinical significance’3.
There were 133 different subcodes used to report the Level 3 reports, and the most
frequently reported can be seen in figure 14. The most frequently occurring subcode
was ‘on-set imaging: production process’ making up 32.2% (n = 1,620) of all Level 3
RTE. This was followed by ‘on-set imaging: approval process’ (8.0%, n = 404) and ‘use
of on-set imaging’ (6.5%, n = 330). Examples of RTE associated with ‘on-set imaging:
approval process’ includes the mismatch of verification images causing slight
inaccuracies in treatment. Examples of RTE associated with ‘use of on-set imaging’
includes the verification image being taken when not required leading to additional
radiation dose. Of note, all but one subcode from the top 10 most frequently reported
level 3 RTE and 48.4% (n = 2,435) was associated with the treatment unit process.
A review of the ‘on-set imaging: production process’ subcode of level 3 RTE revealed
that 49.3% (n = 799) related to procedural failures, 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’. The remaining 50.7% (n = 821) related to equipment 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’. This resulted in additional imaging exposure being undertaken. RT providers
13.7%
3.0%
2.7%
1.5%
8.8%
16.4%
2.3%
2.8%
1.7%
6.8%
14.9%
7.7%
5.0%
4.5%
4.5%
0 2 4 6 8 10 12 14 16 18
(13aa) On-set imaging: approval process
(10c) Localisation of intended volume
(10f) Production of images demonstrating correct detail
(13cc) Management of variations
(13l) Movements from reference marks
Percentage of RTE reports
2018, data for2015-2017(n = 222)2016, data for2013-2015(n = 177)Aggregate, data for2009-2015(n = 329)
Radiotherapy error and near-miss data report: December 2015 to November 2017
23
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)17 should be advised of all equipment
failures.
Figure 14. Breakdown of most frequently occurring minor radiation incidents (level 3) Dec 2015 to Nov 2017 (n = 3,602/ 5,035 subset of RTE)
The ‘minor radiation incidents’ were then reviewed for this 2-year period; the 2016
analysis and the aggregate data as seen in figure 15. There has been an increase in
percentage of ‘on-set imaging: production process and ‘patient positioning’ from the
previous 2-year report and the aggregate data. A decrease in percentage of RTE
associated with ‘use of on-set imaging’, ‘movements from reference marks’ and ‘on-set
imaging: approval process’ has been seen.
Figure 15. Percentage of level 3 most frequently reported RTE for this 2-year reporting period compared with 2016 analysis and aggregate
1620
404
330
246
232
200
173
150
131
116
0 200 400 600 800 1000 1200 1400 1600 1800
(13z) On-set imaging: production process
(13aa) On-set imaging: approval process
(13i) Use of on-set imaging
(13l) Movements from reference marks
(13g) Patient positioning
(13bb) On-set imaging: recording process
(13u) Use of compensators
(13cc) Management of variations/unexpected events/errors
(12f) Accuracy of data entry
(13r) Use of immobilisation devices
Number of RTE reports
18.0%
8.4%
9.3%
6.4%
2.4%
23.1%
9.0%
12.4%
5.3%
2.8%
32.2%
8.0%
6.6%
4.9%
4.6%
0 5 10 15 20 25 30 35
(13z) On-set imaging: production process
(13aa) On-set imaging: approval process
(13i) Use of on-set imaging
(13l) Movements from reference marks
(13g) Patient positioning
Percentage of RTE reports
2018, data for 2015-2017 (n = 5,035)
2016, data for 2013-2015 (n = 3,994)
Aggregate, data for 2009-2015 (n = 7,036)
Radiotherapy error and near-miss data report: December 2015 to November 2017
24
4.3.4 Breakdown of Level 4 (near miss) RTE
A ‘near miss’ is defined in TSRT as a potential radiation incident ‘that was detected and
prevented before treatment delivery’3.
There were 166 different subcodes used to report the level 4 RTE, the most frequently
reported can be seen in figure 16. The most frequently occurring subcode was
‘accuracy of data entry’ making up 9.9% (n = 400) of all level 4 RTE. Examples of RTE
associated with ‘accuracy of data entry’ includes the incorrect entry of information into
the oncology management system and other transcription inaccuracies. This was
followed by ‘documentation of instructions/information’ (8.0%, n = 323) and ‘on-set
imaging: approval process’ (5.0%, n = 204). Examples of RTE associated with
‘documentation of instructions/information’ include the incorrect documentation of
instructions including patient set-up or immobilisation, which was identified at treatment
set-up before commencement of treatment. Examples of RTE associated with ‘on-set
imaging: approval process’ includes the incorrect off-line image match leading to
incorrect reference moves which are picked up before treatment commences.
Figure 16. Breakdown of most frequently occurring near misses (level 4) Dec 2015 to Nov 2017 (n = 2,009/ 4,058 subset of RTE)
The ‘near miss’ RTE were then reviewed for this 2-year period, the 2016 analysis and
the aggregate data as seen in figure 17. There has been an increase in the percentage
of RTE associated with ‘accuracy of data entry’ and ‘documentation of instruction’
within the level 4 RTE. There has been a decrease in the percentage of ‘on-set
imaging: approval process’ within this 2-year reporting period when compared to the
aggregate and previous 2-year period. The prevalence of level 4 RTE associated with
400
323
204
196
191
181
174
121
111
108
0 50 100 150 200 250 300 350 400
(12f) Accuracy of data entry
(10j) Documentation of instructions/information
(13aa) On-set imaging: approval process
(13bb) On-set imaging: recording process
(11j) Generation of plan for approval
(11n) Recording of patient specific instructions
(13i) Use of on-set imaging
(11i) Target and organ at risk delineation
(13z) On-set imaging: production process
(5a) Completion of request for treatment (paper/electronic)
Number of RTE reports
Radiotherapy error and near-miss data report: December 2015 to November 2017
25
‘generation of plan for approval’ and ‘on-set imaging: recording process’ is shown to be
consistent with the 2016 analysis and the aggregate data.
Figure 17. Percentage of level 4 most frequently reported RTE for this 2-year reporting period compared with 2016 analysis and aggregate
4.3.5 Breakdown of Level 5 (other non-conformances) RTE
‘Other non-conformances’ is defined by TSRT as ‘non-compliance with some other
aspect of a documented procedure but not directly affecting RT delivery’3.
There were 182 different subcodes used to report the level 5 RTE, and the most
frequently reported can be seen in figure 18. The most frequently occurring subcode
was ‘management of process flow within planning’ making up 5.9% (n = 372) of all level
5 RTE. Examples of level 5 RTE associated with ‘management of process flow within
planning’ include plan being delayed and not ready for treatment time. This was
followed by ‘documentation of instructions/information’ (5.1%, n = 323) and bookings
made according to protocol’ (4.7%, n = 298). Of note, only 2 of the most frequently
occurring level 5 RTE subcodes were associated with the treatment unit process.
Examples of RTE associated with ‘documentation of instruction/ information’ includes
the incorrect documentation of patient set-up or immobilisation which was identified at
the data entry checking stage before treatment. Examples of RTE associated with
‘bookings made according to protocol’ includes booking patient treatment course onto
the incorrect machine, require movements of appointments at data entry checking
stage.
8.1%
6.5%
6.6%
4.3%
4.3%
7.2%
7.2%
6.6%
4.6%
4.1%
9.9%
8.0%
5.0%
4.8%
4.7%
0 1 2 3 4 5 6 7 8 9 10
(12f) Accuracy of data entry
(10j) Documentation of instructions
(13aa) On-set imaging: approval process
(13bb) On-set imaging: recording process
(11j) Generation of plan for approval
Percentage of RTE reports
2018, data for2015-2017 (n = 4,058)
2016, data for2013-2015 (n = 3,646)
Aggregate, data for2009-2015 (n = 6,858)
Radiotherapy error and near-miss data report: December 2015 to November 2017
26
The ‘other non-conformances’ RTE were then reviewed for this 2-year period, 2016
analysis and the aggregate data as seen in figure 19. Non-conformances associated
with ‘management of process flow within planning’ and ‘documentation of instructions’
had a similar percentage within the aggregate data and the 2016 data, however they
have decreased and increased respectively within this 2-year reporting period.
Figure 18. Breakdown of most frequently occurring non-conformances (level 5) Dec 2015 to Nov 2017 (n = 2,465/ 6,356 subset of RTE)
Figure 19. Percentage of level 5 most frequently reported RTE for this 2-year reporting period compared with 2016 analysis and aggregate
372
323
298
266
219
206
194
154
145
144
144
0 50 100 150 200 250 300 350 400
(11o) Management of process flow within planning
(10j) Documentation of instructions/information
(6a) Bookings made according to protocol
(12f) Accuracy of data entry
(6d) Communication of appointments to patient
(11j) Generation of plan for approval
(6b) Bookings made according to request details
(5a) Completion of request for treatment (paper/electronic)
(11n) Recording of patient specific instructions
(13bb) On-set imaging: recording process
(13aa) On-set imaging: approval process
Number of RTE reports
7.3%
3.5%
4.2%
3.3%
3.5%
7.4%
3.6%
5.0%
3.7%
4.1%
5.9%
5.1%
4.7%
4.2%
3.4%
0 1 2 3 4 5 6 7 8
(11o) Management of process flow within planning
(10j) Documentation of instructions
(6a) Bookings made according to protocol
(12f) Accuracy of data entry
(6d) Communication of appointments to patient
Percentage of RTE reports
2018 data for2015-2017(n = 6,356)2016, data for2013-2015(n = 4,642)Aggregate, datafor 2009-2015(n = 9,041)
Radiotherapy error and near-miss data report: December 2015 to November 2017
27
4.4 Safety Barriers
Critical control points, detection methods or defence in depth, are any process steps
whose primary function is to prevent errors occurring or propagating through the RT
workflow18.
The new safety barrier (SB) taxonomy was published in the DoL in December 2016 and
the application of these codes was actively encouraged from then onwards. As SBs
form part of the pathway coding, analysis of data before the publication of the was
possible. There are 86 safety barriers (SB) embedded across the 206 pathway codes4.
Each RTE report can contain multiple SB codes to identify all the points in the pathway
where the error was not detected. All subcodes were analysed across the 15,830 RTE
reports for the reporting period December 2015 to November 2017, and a total of 5,191
subcodes were identified as failed SB. ‘On-set imaging: approval process’ was the
most frequently reported failed SB (15.3%, n = 796) followed by ‘use of on-set imaging’
(12.4%, n = 646). Only 2.9% (n =150) of reported failed SB led to a level 1 or 2 RTE as
represented in figure 20.
The SB taxonomy can also be utilised to identify effective SB or methods of detection,
these will be included in analysis in future publications.
Owing to the complex and multi-faceted nature of RT it is usual to have checking
processes in place at points in the pathway where patient data is handed over to a new
part of the pathway. Therefore the ‘end of process check’ SB subcode is repeated
across the RT pathway. Failed SB associated with ‘end of process checks’ made up
8.7% (n = 451) of all reported failed SB for this reporting period. This is a vast decrease
from 20.4% (n = 2,584) since the previous 2-year reporting period5. The most
frequently reported ‘end of process check’ was at pre-treatment planning (33.5%, n =
151) whereas in the last 2-year reporting period5 the most frequently occurring ‘end of
process check’ subcode occurred at the treatment unit process (34.1%, n = 883).
Radiotherapy error and near-miss data report: December 2015 to November 2017
28
Figure 20. Breakdown of failed primary safety barriers by classification level reported, Dec 2015 to Nov 2017 (n = 2,916/ 5,191 subset of RTE)
4.5 Causative factors
Use of causative factor taxonomy enables identification of system problems or root
causes that could precipitate a range of different incidents19.
The new causative factor (CF) taxonomy was published in the DoL in December 2016
and the first CF code was allocated to RTE reported in January 2017. Therefore, only
11 months of data is presented within this 2-year report. There were 7,778 RTE
reported between January 2017 and November 2017 of which 35.9% (n = 2,793)
included a CF. Figure 21 illustrates the most frequently reported primary CF which can
be seen as the root cause of an incident. A root cause can be defined as an identified
event that leads to anticipated operational occurrences or accident conditions20. The
most frequency occurring primary CF was ‘slips and lapses’ (32.1%, n = 897), followed
by ‘adherence to procedures/ protocols’ (18.7%, n = 521). ‘Slips and lapses’ was most
frequently attributed to ‘on-set imaging: production process’ (8.7%, n = 78) and
‘adherence to procedures/protocols’ was most frequently attributed to ‘accuracy of data
entry’ (8.8%, n = 46).
796
646
391
266
185
181
157
151
143
0 100 200 300 400 500 600 700 800
(13aa) On-set imaging: approval process
(13i) Use of on-set imaging
(11n) Recording of patient specific instructions
(13cc) Management of variations/unexpected events/errors
(11m) Recording of definitive treatment prescription
(4j) Consent process and documentation
(14c) On-treatment review of notes
(11t) End of process checks
(12g) End of process checks
Number of RTE
Level 1
Level 2
Level 3
Level 4
Level 5
Radiotherapy error and near-miss data report: December 2015 to November 2017
29
Figure 21. Breakdown of most frequent primary causative factors by classification level, Jan to Nov 2017 (n = 2,686/ 2,793 subset of RTE)
Several CF codes can be attributed to each individual RTE. A review of the second to
fifth CF codes indicates the contributory factors associated with each RTE. 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 weakness20. Contributory
factors were indicated across 607 reports; of these 92 contained multiple contributory
factors leading to 699 contributory factors in total. Figure 22 shows the most frequently
reported contributory factors. The most frequently occurring was ‘adherence to
procedures/protocols’ (34.8%, n = 243); these were most frequently attributed to ‘on-set
imaging: approval status’ (8.2%, n = 20) and ‘use of on-set imaging’ (7.8%, n = 19).
Figure 22. Breakdown of most frequently occurring contributory factors, Jan to Nov 2017 (n = 618/ 699 subset of RTE)
897
521
468
351
127
103
96
55
34
34
0 100 200 300 400 500 600 700 800 900
(CF 1c) Slips and lapses
(CF 2c) Adherence to procedures / protocols
(CF 1d) Communication
(CF 3a) Equipment or IT network failure
(CF 5d) Inadequate staffing
(CF 1a) Failure to recognise hazard
(CF 1b) Decision making process
(CF 7a) Other
(CF 2b) Inadequate procedures / protocols
(CF 2d) Process design
Number of RTE reports
Level 1
Level 2
Level 3
Level 4
Level 5
243
115
78
70
35
25
18
17
17
0 50 100 150 200 250
(CF 2c) Adherence to procedures / protocols
(CF 1d) Communication
(CF 1c) Slips and lapses
(CF 2d) Process design
(CF 5d) Inadequate staffing
(CF 2b) Inadequate procedures / protocols
(CF 5e) Inadequate training
(CF 1a) Failure to recognise hazard
(CF 1b) Decision making process
Number of times contributory factor reported
Radiotherapy error and near-miss data report: December 2015 to November 2017
30
4.6 Brachytherapy errors
Errors coded with brachytherapy process codes as the primary code account for 0.5%
(n = 80) of RT errors for the reporting period December 2015 to November 2017, which
is a slight increase since the previous reporting period (0.4%, n = 46)5. Brachytherapy
is a small specialised practice within RT, therefore the number of brachytherapy-
associated RTE would be expected to be low. Most of the brachytherapy RTE reported
were ‘near misses’ or ‘non-conformances’ (77.5%, n =62), none were reported as
reportable incidents and only 2.5% (n =2) were classified as a non-reportable incident
(Figure 23). ‘Initial positioning of applicators/ sources’ was the most frequently reported
brachytherapy associated RTE (22.5%, n = 18). An example of this type of RTE
includes the incorrect grid positioning of needles for prostate brachytherapy, or the
incorrect positioning of the intrauterine tube for gynaecological patients.
A total of 85 subcodes were identified across the 80 brachytherapy associated RTE
reports; only 10 different subcodes were identified as failed SB (12.9%, n = 11).
‘Correct applicators/sources’ was the most commonly reported failed SB within this
subset of data.
Figure 23. Breakdown of brachytherapy RTE coded 15 by classification level, Dec 2015 to Nov 2017 (n = 80)
Brachytherapy RTE were then reviewed for this 2-year period. The new data, the 2016
analysis and the aggregate data can be seen in figure 24. Both ‘initial position of
applicators/sources’ and ‘planning of treatment’ have a similar frequency within the
aggregate data and this 2-year reporting period; there has also been a slight decrease
in both since the previous 2-year reporting period.
1817
1110
44
3
3
22
2
2
11
0 2 4 6 8 10 12 14 16 18
(15g) Initial positioning of applicators / sources
(15h) Planning of treatment
(15e) Correct applicators /sources
(15n) Management of variations
(15i) Maintenance of position of applicators /sources
(15c) Source calibration
(15f) Correct theatre equipment
(15p) On-set imaging: production process
(15j) Removing of applicators / sources
(15m) Authorisation of plan
(15o) Use of on-set imaging
(15l) Validation of applicator/ source position
(15d) Sterility of sources
(15b )Delivery of sources
Number of RTE reports
Level 1
Level 2
Level 3
Level 4
Level 5
Radiotherapy error and near-miss data report: December 2015 to November 2017
31
Figure 24. Percentage of brachytherapy most frequently reported RTE for this 2-year reporting period compared with 2016 analysis and aggregate
4.7 Inspectorate data
There is a requirement that the appropriate authority is notified of all level 1
incidents13,14. The inspectorates for IR(ME)R for England, Wales, Northern Ireland and
Scotland were approached and asked to share their anonymised synopsis of closed
reportable radiation incidents from December 2015 to November 2017.
A total of 288 reports were shared; this is a decrease in the numbers since the last
report where 437 reports were shared for the same time period5. This decrease may be
due to the Department of Health guidance on what constitutes a reportable event,
published in January 201716. There were 159 level 1 reports received through the
voluntary scheme; this highlights a difference in the number of incidents reported to the
appropriate authorities and the voluntary reporting and learning scheme. The
classification and coding from the DoL document4 was applied to the inspectorate
incidents.
On review of the inspectorate data it became clear that there was wide variation in the
locally applied classification of events. It was found that 44.4% (n = 128) of the reported
events could have also been reported as level 2 (non-reportable radiation incidents) or
level 3 (minor radiation incidents). Examples of these include single repeat on-set
verification images which were reported to the inspectorate but could be classified as
level 3 (minor radiation incidents). The 2017 DH guidance16 sought to address this
disparity and contains guideline factors for concomitant imaging.
Of the 288 Level 1 inspectorate RTE reports shared, 45.1% (n = 130) occurred during
‘treatment unit process’. A comparison of inspectorate and voluntary data (Figure 25)
revealed a similar pattern of spread in the higher frequency reports. The inspectorate
23.6%
19.8%
7.5%
0.9%
10.4%
1.9%
26.5%
24.5%
10.2%
2.0%
10.2%
2.0%
22.5%
21.3%
13.8%
12.5%
5.0%
5.0%
0 5 10 15 20 25 30
(15g) Initial positioning of applicators / sources
(15h) Planning of treatment
(15e) Correct applicators /sources
(15n) Management of variations/unexpected events/errors
(15i) Maintenance of position of applicators /sources
(15c) Source calibration
Percentage of RTE reports
2018, data for2015-2017 (n = 80)2016, data for2013-2015 (n = 49)Aggregate, data for2009-2015 (n = 106)
Radiotherapy error and near-miss data report: December 2015 to November 2017
32
data indicated that 7.3% (n = 21) of incidents shared were associated with ‘referral for
treatment’, however this was higher in the voluntary data (11.3%, n = 18). This trend is
similar with reportable RTE associated with ‘communication of intent’ where the
inspectorate data indicates 6.9% (n =20) and the voluntary data is 13.8% (n =22). The
inspectorate data contains 2.1% (n = 6) brachytherapy associated RTE, however the
voluntary data did not contain any reportable radiation incidents associated with
brachytherapy. The text descriptors for the inspectorate data were more detailed than
those of the voluntary data, which may explain differences in coding.
Figure 25. Percentage frequency of process codes found in reportable radiation incidents from the inspectorate and voluntary datasets, Dec 2015 to Nov 2017
The inspectorate data was also broken down by most frequently occurring process
subcode. This revealed pre-treatment ‘localisation of intended volume’ (8.3%, n = 24)
and treatment ‘on-set imaging: production process’ (8.0%, n = 23) were the most
frequently occurring process subcodes within the inspectorate data (Figure 26). There
are similarities in subcode frequency of the inspectorate and voluntary data, however
there is a significant difference in the treatment ‘on-set imaging: production process’
associated reportable radiation incidents. This difference may be due to the guidance
issued in 201716 and a large proportion of these types of events being classified as
level 3, see figure 7. The most frequently reported subcodes for this reporting period
are similar to the previous reporting period (December 2013 to November 2015) where
all the subcodes featured in the previous most frequently reported inspectorate data
apart from ‘verification of diagnosis/extent/stage’ and ‘patient data ID process’5.
Due to the detail contained within the inspectorate data CF could be applied to all
reports. CF for the inspectorate data was analysed and indicated that slips and lapses
were most frequently reported as the primary CF (46.2%, n = 133). This is consistent
with the voluntary data where the most frequent level 1 CF was slips and lapses
(36.8%, n = 7).
45.1%
21.9%
9.4%
7.3%
6.9%
2.4%
2.1%
2.1%
2.7%
40.3%
20.1%
7.5%
11.3%
13.8%
1.9%
0.0%
0.6%
4.6%
0 5 10 15 20 25 30 35 40 45 50
Treatment unit process
Pretreatment activities
Pretreatment planning process
Referral for treatment
Communication of intent
Treatment data entry process
Brachytherapy
Booking process
Miscellaneous
Percentage of RTE reports
Voluntary data (n = 159)
Inspectorate data (n = 288)
Radiotherapy error and near-miss data report: December 2015 to November 2017
33
Figure 26. Breakdown of inspectorate and voluntary data as a percentage of most frequently occurring process subcodes, from Dec 2015 to Nov 2017
8.3%
8.0%
6.3%
5.6%
5.2%
4.9%
3.8%
3.8
3.1%
10.1%
0.6%
6.9%
7.5%
3.8%
4.4%
3.1%
4.4%
2.5%
0 2 4 6 8 10 12
(10c) Localisation of intended volume
(13z) On-set imaging: production process
(13aa) On-set imaging: approval process
(13q) Setting of couch position/angle
(10f) Production of images demonstrating correct detail
(4b) Verification of diagnosis/extent/stage
(13c) Patient data ID process
(13l) Movements from reference marks
(5a) Completion of request for treatment
Percentage of Level 1 RTE reports
Voluntary data (n = 159)
Inspectorate data (n = 288)
Radiotherapy error and near-miss data report: December 2015 to November 2017
34
5. Discussion
The analysis within this report facilitates comparisons of national RTE reporting with
both local and network trends. Aggregate data and previous reports have been used for
comparison to this 2-year period, this representation of the data allows local providers
to compare their RTE over time. As local analysis and learning from RTE is developed
consideration should be given to the appropriateness of corrective actions and
preventative measures.
5.1 Increase in RTE reporting
During this 2-year reporting period, there has been an increase in the numbers of RTE
reported to the national voluntary reporting system. As seen in section 3.2 a total of
15,979 RTE reports were submitted to the voluntary reporting scheme between
December 2015 and November 2017, compared with the last 2-year reporting period,
where a total of 12,800 RTE reports were submitted, 7,655 for the 2014 report and
3,316 for the 2012 report5. This is an increase in reporting levels of 24.8% since the
2016 report and 381.8% increase since the 2012 report5.
The increase in reported RTE reflects a maturing reporting culture. Further increases in
the number of RTE reports submitted to the national voluntary reporting system are
expected as service provision increases and as providers develop full electronic
reporting solutions and reporting mechanisms are further streamlined.
The number of providers contributing to this initiative was 59 (96.7%), this is a decrease
from the previous reporting period where 100% (n = 60) NHS providers reported to the
national analysis5. This decrease in number of providers contributing to the national
scheme may be due to resources and changes in local procedures. Providers are
encouraged to contact PHE if they have any queries about reporting or would like
further advice.
The Euratom/European Union Basic Safety Standards Directive 2013 (BSSD) sets out
standards for radiation protection21; additional requirements included recording of
analyses of incidents involving or potentially involving accidental and unintended
exposures. This was transposed into UK legislation in February 201813. Additionally,
recommendations of the Francis report22 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 ethos of these requirements has mainly been adopted across UK RT
providers reflecting a mature reporting culture.
Radiotherapy error and near-miss data report: December 2015 to November 2017
35
There is still some disparity in the number of reports received per provider, reporting
ranged from a minimum of 1 incident to 2,160 incidents reported per provider over the
2-year period. This variation is also reflected in the lag time for reporting, as seen in
section 3.3, which ranged from 0 days to a maximum of 871 days. All providers are
encouraged to report monthly to ensure timeliness of learning.
Data received from the National Cancer Registration and Analysis Service (NCRAS)23
revealed an estimated 335,354 RT prescriptions were delivered across 3,668,047
attendances in England during the period from December 2015 until November 2017.
This data was extrapolated for the UK population to an estimated 396,876 prescriptions
across 4,340,962 attendances in the UK for the same period. This is a slight decrease
from the estimated 402,998 prescriptions (delivered across 4,518,571 attendances)
within the previous 2-year period. This reflects the adoption of hypofractionation of
breast, prostate and bony metastases treatments and the introduction of stereotactic
regimes.
To establish a reported error rate, it was accepted the clear majority of RTEs reported
affected a single attendance as part of a prescription. With this caveat an estimated
reported error rate per prescription of 4.0% was calculated for the current reporting
period. This compares with an estimated reported error rate of 3.2% for the previous 2-
year reporting period, marking a slight increase in the reported error rate. However,
using the same premise an estimated reported error rate of level 1 events to the
inspectorates for 0.07% can be calculated, for the current reporting period marking a
decrease from 0.11% for the previous 2-year reporting period 5. This suggests that
whilst the reporting culture continues to grow a slight decrease in level 1 events is
being seen.
This decrease in percentage of reported level 1 RTEs in relation to prescriptions should
be interpreted carefully. Also, it should be noted that the majority of reported events
(65.8%) did not impact on the patient’s treatment and opportunities to correct for
detected RTE was possible in an additional 33.2%.
5.2 Main themes
Analysis of the RTE reports demonstrates that generation of error is not confined to
one professional group or to any particular point in the pathway. It also indicates that
the pattern of errors is replicated across service providers in the UK.
5.2.1 Breakdown of process codes
Consistent with previous reports5 RTEs were spread across all 21 categories of
process codes (as seen in section 4.1.1), treatment unit process codes were the most
frequently reported RTE (41.2%, n = 6,526). RTEs attributed to treatment unit
Radiotherapy error and near-miss data report: December 2015 to November 2017
36
processes are consistent with the previous 2-year report (41.3%, n = 5,254). This is to
be expected as treatment processes are reliant on the accurate interpretation of the
planning information and RT treatments usually span a number of visits, providing
many opportunities during the treatment unit process for RTE to occur.
5.2.2 Breakdown of process subcodes
The areas in the RT pathway where RTEs frequently occur can be seen in table 1.
Guidance has already been published on how to minimise all these frequently occurring
RTEs in the periodic newsletter Safer Radiotherapy through the ‘error of the month’
column as some of these trends were noted in the regular analysis6.
Frequently occurring process subcodes Safer Radiotherapy guidance6
On-set imaging: production process (13z) Issue 7, 16, 25
Accuracy of data entry (12f) Issue 2
On-set imaging: approval process (13aa) Issue 3, 7
Documentation of instructions/information (10j) Issue 8
Use of on-set imaging (13i) Issue 7
On-set imaging: recording process (13bb) Issue 7
Generation of plan for approval (11j) Issue 15
Management of process flow within planning (11o) Issue 5
Recording of patient specific instructions (11n) Issue 10
Bookings made according to protocol (6a) Issue 17
Movements from reference marks (13l) Issue 1, 22
Table 1. Frequently occurring process subcodes and associated newsletter guidance
All the main themes within this reporting period were also the most frequently occurring
process subcodes within the previous 2-year report5, as seen in section 4.1.2. The
percentage of RTE associated with ‘on-set imaging: production process has increased
from 6.5% within the aggregate data to 8.4% in the last 2-year period and 11.5 % in this
reporting period. This notable increase may be associated with the increase in the use
of on-set verification images due to its further availability and the recognition of its
preventative role in minimising geographical displacement during treatment24.
5.3 Classification level of RTE
The clear majority of reports were of lower level events, thus not affecting the outcome
of patient care. Of the level 1 and 2 incidents reported, it is known most them affected
only one fraction of a course of treatment. This meant that corrective action could be
taken over the remaining treatment fractions, so the incident did not have a significant
Radiotherapy error and near-miss data report: December 2015 to November 2017
37
impact on the patient or the outcome of their treatment. This was like the trends seen in
each of the previous 2-year reports.
A small number of higher level incidents and a much greater number of lower level
incidents are consistent with findings in the literature. It is known that for every level 1
‘reportable radiation incident’ that occurs, many lower level incidents are also seen.
Heinrich illustrated this point in 19313 (Figure 27), it may be seen that as the severity of
an incident decreases, the probability of its occurrence increases.
Figure 27: Heinrich’s triangle (reproduced from Towards Safer Radiotherapy3)
As seen in section 4.2.1 the ‘non-reportable radiation incident ‘(level 2) and ‘minor
radiation incident’ (level 3) have stayed consistent across the 2018, 2016 and
aggregate analyses, as seen in section 4.2.1, however the level 1 ‘reportable radiation
incidents’ have reduced over time. A comparison of the 2018/2016 and aggregate data
with Heinrich’s illustration can be seen in figure 28. This indicates that there are a
smaller number of higher level incidents and a larger number of lower level incidents.
However, the ratios of the RTE data are different to the ratio of Heinrich’s triangle.
Radiotherapy error and near-miss data report: December 2015 to November 2017
38
Figure 28: Comparison of Heinrich’s triangle and 2018, 2016 and aggregate data.
When compared with the results from the previous 2-year report there has been a
change in the percentage of ‘reportable radiation incidents’ from 1.8% to 1.0%. This
reduction may be due to further guidance on reporting much greater than intended
exposures published in January 201716. As seen in section 4.2.1 all providers do not
report all classification of incidents, this may be due to resources or local protocol. With
this in mind the analysis should be interpreted carefully.
Experience has shown that as an organisation’s reporting culture matures, staff
become more likely to report incidents. High reporters aim to learn from incident
reporting to make patient care safer. With this in mind an increase in incident reporting
should not necessarily be taken as an indication of worsening patient safety. It may
indicate an increasing level of awareness of safety issues among healthcare
professionals and a more open and transparent culture across the organisation.
5.3.1 Level 1 (reportable radiation incident) RTE
There were 52 different subcodes associated with the 159 level 1 RTE. With the move
towards hypofractionated treatments there is less opportunity to correct, therefore there
may be opportunity for an increase in level 1 RTE in future analysis. As seen in section
4.3.1 the most frequently reported Level 1 RTE occurred during ‘localisation of intended
0
10
20
30
40
50
60
70
80
90
100
Heinrich (n = 330) 2018 (n = 15,830) 2016 (n = 12,691) Aggregate (n =23,662)
90.9%
65.8% 65.3% 67.2%
8.8%
33.2% 32.9% 31.1%
0.3% 1.0% 1.8% 1.7%
Inci
dent
per
cent
age
Level 1
Level 2+3
Level 4+5
Radiotherapy error and near-miss data report: December 2015 to November 2017
39
volume’ (10.1%, n = 16). The comparison with previous data could be difficult to
interpret due to only 52 out of 206 different subcodes associated with the level 1 RTE.
From these 52 different subcodes only 36 were present in the previous 2-year analysis5
which included 55 different subcodes.
5.3.2 Level 2 (non-reportable radiation incident) RTE
There were 62 different subcodes associated with the 222 level 2 RTE, as seen in
section 4.3.2. ‘On-set imaging: approval process’ was the most frequently occurring
level 2 RTE (14.9%, n = 33). The frequency of this subcode within the level 2 RTE has
decreased since the 2016 analysis5 (16.4%, n = 29) but is an increase from the
aggregate data (13.7%, n = 45). There were similarities in the percentage of Level 2
RTE within the aggregate data and the 2016 analysis5 associated with ‘localisation of
intended volume’, ‘production of images demonstrating correct detail’ and
‘management of variations’. However, there has been an increase in percentage seen
within this reporting period.
5.3.3 Level 3 (minor radiation incident) RTE
There were 133 different subcodes associated with the 5,035 level 3 RTE, as seen in
section 4.3.3. The most frequently occurring subcode was ‘on-set imaging: production
process’ (32.2%, n = 1,620), this is a vast increase from the aggregate data (18.0%, n
= 1,265) and an increase since the 2016 analysis5 (23.1%, n = 922). A review of the
‘on-set imaging: production process’ subcode of level 3 RTE revealed that 49.3% (n =
799) related to procedural failures and the remaining 50.7% (n = 821) were due to
equipment malfunction, this is very similar to the 2016 analysis4.
Of note, when compared to the 2016 report4, all the most frequently occurring
subcodes within this classification were the same, apart from ‘use of immobilisation
devices’ which replaces ‘generation of plan for approval’.
It should be noted that equipment failure reports should be reported to local engineers,
the manufacturers and the MHRA, as appropriate. Equipment failure adverse incidents
above the threshold levels set out in PM7725 (until further guidance is available) should
be reported to the appropriate enforcing authorities as specified within IR(ME)R13. It
would seem the errors reported in this subset are spread across manufacturers and
varied in type. Consideration should be given to undertaking a risk assessment in the
case of a 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.
Radiotherapy error and near-miss data report: December 2015 to November 2017
40
5.3.4 Level 4 (near miss) RTE
There were 166 different subcodes associated with the 4,058 level 4 RTE, as seen in
section 4.3.4. The spread of reported level 4 RTEs across the process codes was
consistent with the 2016 analysis5. The most frequently occurring level 4 subcode was
‘accuracy of data entry’ (9.9%, n = 400). This has increased since the 2016 analysis5.
Electronic systems are in use across the majority of RT providers; however, it is seen
from the frequency of level 4 RTE that information is still being incorrectly input into the
oncology management system. Further guidance on reducing this type of error can be
seen in Safer RT6.
5.3.5 Level 5 (other non-conformances) RTE
There were 182 different subcodes associated with the 6,356 level 5 RTE, as seen in
section 4.3.5. The most frequently reported level 5 subcode was ‘management of
process flow within planning’ (5.9%, n = 372), this was also the most frequently
occurring level 5 subcode in the previous analysis5, however the percentage has
decreased from 7.4% (n = 344).
5.4 Safety barriers
Safety barriers (SB) are embedded across the RT pathway coding. The DoL document4
contains an update to the pathway taxonomy and indicated SB. Several original
pathway codes were identified as SB. There are 206 different subcodes, 86 of which
are identified as SB. The SB taxonomy can be used to identify both failed and effective
SB. As seen in section 4.4 for this reporting period 5,191 subcodes were identified as
failed SB, and ‘on-set imaging approval process’ was the most frequently occurring
failed SB (15.3%, n = 796). Future reports will contain details of effective SB or
methods of detection.
‘End of process checks’ are one form of safety barrier in error detection and, as such
should include safety-critical elements of the pathway. The frequency and effectiveness
of checking and verifying procedures should be audited to ensure they are of value.
Failed SB associated with ‘end of process’ checks comprised 8.7% (n = 451) of all
reported failed SB for this reporting period. This is a vast decrease from the 2016
analysis4 (20.4%, n = 2,584). This reduction may be due to the ‘pause and check’
posters26. Interestingly, the most frequently occurring end of process check was at pre-
treatment planning (33.5%, n = 151) whereas in the last 2-year reporting period the
most frequently occurring end of process check subcode occurred at the treatment unit
process (34.1%, n = 833). Providers should consider reviewing their minimum criteria
for checking across the entire pathway.
Radiotherapy error and near-miss data report: December 2015 to November 2017
41
5.5 Causative factors
The causative factor (CF) taxonomy was published in December 2016; the first CF was
allocated to a RTE reported in January 2017. There were 7,778 RTE reported between
January 2017 and November 2017 of which 35.9% (n = 2,793) contained CF, as seen
in section 4.5. The primary CF is the root cause of an incident and for this reporting
period the most frequently reported CF was ‘slips and lapses’ (32.1%, n = 897). The
contributory factors are the secondary CF indicated in a report. There were 699
contributory factors within this analysis and the most frequent was ‘adherence to
procedures/protocols’ (34.8%, n = 243).
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 incident19. 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’, 821 level 3 RTE, would be significantly reduced.
5.6 Inspectorate data
A total of 288 reports were shared by the inspectorates compared to 159 received
through the voluntary reporting system. The incongruity between the numbers of level 1
reports received by the inspectorates and the voluntary reporting system may be
explained by several factors. Firstly, only anonymised and closed events were shared
by the inspectorates, which may create different time lags. Secondly, the voluntary data
does not contain RTE from the independent sector. Finally, as seen in section 4.7 there
is some variation on the locally applied classification of events, and 44.4% (n = 128) of
the reportable radiation incidents reviewed within the inspectorate data could have
been reported as other classification of incidents within the voluntary data. Like the
level 1 ‘reportable radiation incident’ reports received through the voluntary reporting
scheme, ‘localisation of intended volume’ emerged as the most common process
subcode.
Radiotherapy error and near-miss data report: December 2015 to November 2017
42
6. Conclusion
Although RTEs are rare, when they do occur the consequences can be significant, so it
is essential the RT community does not become complacent about the associated
risks, which may be even greater as new approaches and technologies are utilised.
The overall increase in voluntary reporting indicates a maturing reporting culture. It also
demonstrates the RT community’s commitment to maximise learning from these events
and to minimise the frequency of their occurrence in the future. A further increase in the
number of RTE reports submitted to the national voluntary reporting scheme is
expected, as more clinical providers are encouraged to submit all levels of RTEs
monthly.
The use of all taxonomies as described within the DoL document4 allows wide-ranging
learning from RTE at both a local and national level. This includes the classification,
pathway coding and causative factor taxonomy. The pathway coding can be used to
indicate where in the RT pathway the error first occurred, failed safety barriers and
effective safety barriers shown as method of detection. The implementation of the
national voluntary reporting system described within this report allows clinical providers
to compare their local analysis within networks and with the national picture. Further
improvements can be attained when using the learning from RTE to incorporate
corrective and preventative measures into the RT process.
After 10 years of reporting, the proportion of significant incidents has started to reduce
slightly. RT is delivered in a complex and rapidly evolving landscape. Therefore, it is
imperative that RTE trends continue to be reported, analysed and monitored on a
cyclical basis, to inform ongoing safe and effective RT practice. This is especially
pertinent as new techniques and technologies are implemented and as new clinical RT
providers are established. 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.
Radiotherapy error and near-miss data report: December 2015 to November 2017
43
7. Recommendations
Local provider recommendations are:
• all UK Radiotherapy (RT) providers should continue to use Towards Safer RT3 and
Development of Learning2 to classify and code all levels of RTEs for local analysis
to inform local learning, policy and practice.
• local learning should be compared with the national picture and used to inform local
and network level learning
• UK NHS RT providers should continue to submit coded and classified RTE reports
to the national voluntary reporting system using the mechanisms identified within
this report
• UK NHS RT providers should ensure all levels of RTE are reported locally and
nationally
• providers are encouraged to report monthly to ensure timeliness of learning
• UK RT providers should adopt all codes including safety barriers and causative
factors when coding RTE and the use of secondary or additional subcodes
• independent providers should consider submitting all levels of RTE to the national
voluntary reporting system
• UK RT providers should review effectiveness of local end of process checks across
the entire pathway
National recommendations are:
• PSRT should continue to develop analysis of the reports, with regular dissemination
of findings to the RT community for group learning
• the data should be used both by the PSRT and by individual RT providers as part of
a risk-based approach to allocating resources for improving patient safety in RT and
to inform audit and research
• the mechanism to enable providers in Scotland and Northern Ireland to submit RTE
reports to PHE for collation and analysis as part of a UK dataset should be further
refined
• PSRT should review the appropriateness of corrective actions and preventative
measures
• vendors should consider developments to reduce the rate of RTE related to
equipment failure
Radiotherapy error and near-miss data report: December 2015 to November 2017
44
8. Acknowledgements and steering group
We would like to acknowledge:
• NHS Radiotherapy Providers across the UK
• National Reporting and Learning System (NRLS) at NHS England and Improvement
• Inspectorates for IR(ME)R
• National Cancer Registration and Analysis Service (NCRAS)
PSRT Steering Group membership
The membership of this group is reviewed on an annual basis. The members contributing to this report were:
• Julia Abernethy (Patient Safety Team, NHS England and Improvement) (Member
March 2019 onwards)
• 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)
• Marianne Illsley (Royal College of Radiologists – Consultant Clinical Oncologist and
Medical Director, St Luke’s Cancer Centre, Royal Surrey County Hospital
Foundation Trust) (Member April 2018 onwards)
• Maria Murray (Society and College of Radiographers – Professional Officer for
Scotland and UK Radiation Protection Lead)
• Tony Murphy (Lay Representative)
• Tom Roques (Royal College of Radiologists – Consultant Clinical Oncologist and
Clinical Director for Oncology and Haematology, Norfolk and Norwich University
Hospital NHS Foundation Trust) (Member 2010-April 2018)
• Carl Rowbottom (Institute of Physics and Engineering in Medicine – Head of
Physics, The Clatterbridge Cancer Centre NHS Foundation Trust)
Radiotherapy error and near-miss data report: December 2015 to November 2017
45
10. References
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2. Radiotherapy: Hidden Dangers. Chapter 5. Chief Medical Officer’s Annual Report 2006 (2007). Available at webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/AnnualReports/DH_076817
3. RCR, SCoR, IPEM, NPSA, BIR. Towards Safer Radiotherapy. Royal College of Radiologists, Society and College of Radiographers, Institute of Physics and Engineering in Medicine, National Patient Safety Agency, British Institute of Radiology. Royal College of Radiologists, London (2008). Available at www.rcr.ac.uk/towards-safer-radiotherapy
4. PSRT. Patient Safety in Radiotherapy Steering Group Activity, Development of learning from radiotherapy errors. Available at www.gov.uk/government/publications/development-of-learning-from-radiotherapy-errors
5. PSRT. Patient Safety in Radiotherapy Steering Group Activity, Radiotherapy errors and near misses: biennial report. Nos 1-4. Available at www.gov.uk/government/publications/radiotherapy-errors-and-near-misses-data-report
6. PHE. Safer Radiotherapy: Radiotherapy Newsletter of PHE and Supplementary Data Analysis: Full Quarterly Radiotherapy Error Data Analysis. Nos 1–27. Available at www.gov.uk/government/publications/safer-radiotherapy-error-data-analysis-report
7. NHS Improvement, Report a patient safety incident. Available at https://improvement.nhs.uk/resources/report-patient-safety-incident/
8. NRLS reporting tool, Available at https://report.nrls.nhs.uk/nrlsreporting/ 9. NHS Improvement, National patient safety incident reports. Available at
https://improvement.nhs.uk/resources/national-patient-safety-incident-reports-27-march-2019/ 10. NHS Improvement, The future of the patient safety incident reporting: upgrading the NRLS.
Available at https://improvement.nhs.uk/news-alerts/development-patient-safety-incident-management-system-dpsims/
11. NPSA. Implementing Towards Safer Radiotherapy: guidance on reporting radiotherapy errors and near misses effectively. Available at www.nrls.npsa.nhs.uk/resources/clinical-specialty/radiology-and-radiotherapy/ https://webarchive.nationalarchives.gov.uk/20110318152355/http://www.nrls.npsa.nhs.uk/resources/clinical-specialty/radiology-and-radiotherapy/?entryid45=75033&p=1
12. PHE. Safer Radiotherapy: Radiotherapy Newsletter of PHE Issue no 27. Available at www.gov.uk/government/publications/safer-radiotherapy-error-data-analysis-report
13. The Ionising Radiation (Medical Exposure) Regulations (2000). The Stationery Office, London. SI 2000/1059. Available at www.opsi.gov.uk/si/si2000/20001059.htm. The Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) (2000) The Stationery office, London NISR 2000/194. Available at www.legislation.gov.uk/nisr/2000/194/contents/made Updated - The Ionising Radiation (Medical Exposure) Regulations (2017). The Stationery Office, London, SI 2017/1322. Available at www.legislation.gov.uk/uksi/2017/1322/pdfs/uksi_20171322_en.pdf The Ionising Radiation (Medical Exposure) (Amendment) Regulations (2018). The Stationery Office, London, SI 2018/121. Available at www.legislation.gov.uk/uksi/2018/121/contents/made The Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) (2018). The Stationery Office, London, SI 2018/17. Available at www.legislation.gov.uk/nisr/2018/17/contents/made
14. The Ionising Radiations Regulations (1999). The Stationery Office, London. SI 1999/3232. Available at www.opsi.gov.uk/si/si1999/19993232.htm Updated - The Ionising Radiations Regulations (2017). The Stationery Office, London SI 2017/1075. Available at www.legislation.gov.uk/uksi/2017/1075/contents/made
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15. PSRT. Safer radiotherapy: supplementary survey analysis. Report 3 (2014). Available at www.gov.uk/government/publications/safer-radiotherapy-supplementary-survey-analysis
16. DH, IRMER guidance on much greater than intended- updated January 2017. Available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/583637/MGTI_guidance_Jan_17.pdf
17. Medicines and healthcare products regulatory agency. Available at https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
18. Ford E. et al. Consensus recommendations for incident learning database structures in radiation oncology. Medical Physics. 2012; December 39 (12); 7272-7290.
19. Clark B et al. The management of radiation treatment error through incident learning. Radiotherapy and Oncology. 2010; Vol.95, pp344-349.
20. Boadu M & Mohan Rehani M. Unintended exposure in radiotherapy: Identification of prominent causes. Radiotherapy and Oncology. 2009; Vol. 93, pp609-617
21. Basic Safety Standards Directive, (2013/59/Euratom) available at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32013L0059
22. Francis R. Report of the Mid Staffordshire NHS Foundation Trust public enquiry. HMSO, London (2013). Available at www.gov.uk/government/publications/report-of-the-mid-staffordshire-nhs-foundation-trust-public-inquiry
23. National Cancer Registration and Analysis Service (NCRAS), available at https://www.gov.uk/guidance/national-cancer-registration-and-analysis-service-ncras
24. National Radiotherapy Implementation Group. Image Guided Radiotherapy. Guidance for implementation and use. National Cancer Action Team (2012). Available at www.sor.org/sites/default/files/document-versions/National%20Radiotherapy%20Implementation%20Group%20Report%20IGRT%20Final.pdf
25. HSE. Equipment used in connection with medical exposure. Guidance Note PM77 (3rd ed) (2006). Available at www.hse.gov.uk/pubns/guidance/pm77.pdf
26. SCoR, Have you paused and checked? Radiotherapy, Available at www.sor.org/learning/document-library/have-you-paused-and-checked-radiotherapy
Radiotherapy error and near-miss data report: December 2015 to November 2017
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Appendix A: Radiotherapy error
classification grid
Reproduced from Towards Safer Radiotherapy3
No
No
Potentially or
actually clinically
significant?
Radiotherapy error
Yes No
Yes
No Yes
Yes
Correctable
radiation
incident?
Level 1
Reportable radiation
incident
Level 2
Non-reportable
radiation incident
Level 3
Minor radiation
incident
Level 4
Near miss
Level 5
Other non-
conformance
Potential for
radiation
incident?
Radiation
incident?
Reportable?
Yes
No
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Appendix B: Refined radiotherapy pathway coding (including
safety barrier taxonomy)
Reproduced from Development of Learning guidance4.
Text in red denotes additions to pathway coding in terms of descriptors and new codes.
SB denotes pathway codes that are also safety barriers.
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Safety
barrier
Process
code Activity code
0 Infrastructure
SB 0a Implementation of national and international codes of practice for radiation dosimetry
0b Development of dosimetry algorithms for local application (includes locally developed software/ programs/ tools for clinical use)
0c Development of treatment planning algorithms for local application
0d Other
0e IT infrastructure (includes change in hardware/ software/ upgrades/ network changes/ archive process/ system compatibility/ data transfer)
Equipment-specific activities
1 Room design
SB 1a Patient safety (includes alteration of room design or use)
SB 1b Staff and public safety (includes alteration of room design or use)
SB 1c Environmental controls
SB 1d Access control
1e Other
2 New equipment
2a Installation
SB 2b Manufacturer’s tests
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SB 2c Acceptance tests
SB 2d Critical examination under IRR99
2e Customisation and configuration of equipment
SB 2f Commissioning
2g Data recording
2h Preparation of data files for planning systems (to include treatment planning systems, virtual simulation, independent dosimetry checking
software etc.)
2i Other
3 Routine machine QA
SB 3a Daily consistency checks – geometric parameters (including CT, Linac, gated equipment, in vivo dosimetry devices etc. and discrepancies
between reporting and action level)
SB 3b Daily consistency checks – dosimetric calibration (including CT, Linac, gated equipment, in vivo dosimetry devices etc. and discrepancies
between reporting and action level)
SB 3c Daily consistency checks – safety (IRR compliance)
SB 3d Daily verification of accuracy of data transfer between TPS, R&V system and treatment equipment
SB 3e Planned QA programme checks – geometric parameters (including CT, Linac, gated equipment, in vivo dosimetry devices etc. and
discrepancies between reporting and action level)
SB 3f Planned QA programme checks – dosimetric calibration (including CT, Linac, gated equipment, in vivo dosimetry devices etc. and
discrepancies between reporting and action level)
SB 3g Planned QA programme checks – safety (IRR compliance)
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SB 3h Planned QA programme checks – image quality parameters (including CT, MR, portal, cone-beam, film processor)
SB 3i Regular preventative maintenance and repair programme
3j Handover of radiotherapy equipment after planned QA and maintenance (including handover to other department such as diagnostic
colleagues)
SB 3k Routine radiation safety checks
3l Other
Patient-specific activities
4 Referral for treatment
SB 4a Identification of patient (verification against primary source data)
SB 4b Verification of diagnosis/extent/stage (including laterality)
4c Choice of dose
4d Choice of modality
4e Choice of energy
4f Choice of fractionation
4g Choice of start date
SB 4h Consideration of patient condition/co-morbidities (including ICED or pacemaker status, prosthesis, patient unsuitable for IV contrast and
changing performance status)
SB 4i Choice of other concurrent treatment or interventions and their sequencing or timing (including patient selection criteria not met)
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SB 4j Consent process and documentation
4k Other (previously 4i)
5 Communication of intent
5a Completion of request for treatment (paper/electronic) (including incomplete requests or insufficient data and failure to handover referral)
5b Recording of patient ID
5c Completion of required demographics
5d Completion of tumour-specific information (including laterality)
5e Completion of radiation-specific information
5f Completion of details of other professionals
5g Completion of administrative data (including documentation of MDT outcomes)
SB 5h Recording of previous radiotherapy treatment details
SB 5i Recording of patient’s specific requirements (includes communication/ handover/ documentation of patient specific information etc.)
SB 5j Recording of non-standard information/protocol variations
SB 5k Authorisation to irradiate (IR(ME)R) (including requests not signed by appropriately entitled practitioner and authorisation of additional
imaging)
5l Other
6 Booking process (pre-treatment, planning, treatment and follow up)
6a Bookings made according to protocol
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6b Bookings made according to request details (including requested changes following initial booking)
6c Recording of booked appointments (including requested changes following initial booking)
6d Communication of appointments to patient (including requested changes following initial booking)
6e Other
6f Communication of appointment between staff groups (including requested changes following initial booking)
7 Processes prior to first appointment
7a New patient: registration with healthcare organisation’s PAS
7b New patient: registration with department PAS
7c New patient: generation of notes (including their availability as required across the patient pathway)
7d Old patient: location of healthcare organisation’s notes
SB 7e Old patient: location of department notes/previous treatment details (including availability of archived materials)
SB 7f Availability of reports/imaging required by protocol for treatment (including requirements for these at all points on the pathway)
SB 7g Availability of consent documentation
7h Other
8 Pre-treatment: preparation of patient
SB 8a Confirmation of ID
SB 8b Confirmation of consent
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SB 8c Confirmation of fertility/pregnancy status
SB 8d Advice on procedure (including training on breath hold, bladder or bowel preparation, ICED or pacemaker status, information on pre-
medication, fiducial insertion etc.)
8e Other
9 Mould room/workshop activities
SB 9a Confirmation of ID
9b Pre mould room diagnostics/interventions
9c Production of immobilisation devices
SB 9d Checking/fitting of immobilisation devices
9e Production of other accessories/personalised beam shaping device
SB 9f Checking of other accessories/personalised beam shaping device
9g Labelling of mould room/workshop outputs
9h Recording of information in patient record (includes communication/ handover/ documentation of patient specific information etc.)
9i Instructions to patient
SB 9k End of process checks
9l Other
10 Pre-treatment activities / imaging (to include CT, simulation, clinical mark-up, reference image production)
SB 10a Confirmation of ID
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10b Positioning of patient
10c Localisation of intended volume (including insufficient scan length, incorrect scanning protocol, incorrect laterality)
10d Production of images using correct imaging factors (including production of reference images)
10e Production of images using appropriate field sizes (including production of reference images)
10f Production of images demonstrating correct detail (including incorrect scanning protocol and production of reference images)
10g Labelling of images (including pre-scan data entry e.g. ID format, orientation etc. and production of reference images)
10h Saving of planning geometry data
SB 10i Recording of radiation data
10j Documentation of instructions/information
10k Marking of patient or immobilisation device
SB 10l End of process checks (including timeliness of sending scans to treatment planning)
10m Identification of staff
10n Other
SB 10o Assessment of patient prior to exposure
10p Use of contrast (including unplanned event such as leaking out, extravasation, timing of contrast etc.)
10q Use of gating (including discrepancy between intended treatment technique and pre-treatment scan, scan acquisition, construction of image
sequence or application of gating equipment etc.)
11 Pre-treatment planning process (including virtual simulation and replans)
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SB 11a Verification of patient ID, orientation and data entry format to include all patient data, imaging etc.
11b Recording of patient ID on plan
11c Importing of data from external and internal administrative sources
11d Importing of data from external and internal imaging sources
11e Choice of data for planning purposes and to inform planning e.g. MRI, PET, angio, contrast, pre-op/post op data etc.
11f Choice of dose and fractionation inputs
SB 11g Availability of source data
11h Choice of technique/modality (including IMRT/ volumetric/ ART/ superficial or protons etc.)
11i Target and organ at risk delineation (including incorrect growing of volume)
11j Generation of plan for approval (to include DVH, incorrect labelling, inappropriate beam arrangement, replans or missing plan information
etc.)
SB 11k Authorisation of plan
SB 11l Verification of plan/identification of responsible staff
SB 11m Recording of definitive treatment prescription
SB 11n Recording of patient specific instructions
11o Management of process flow within planning (including plan export)
11p Management of authorisation process
11q Timeliness of plan production or approval
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11r Calculation process for non-planned treatments
SB 11s Calculation checking process for non-planned treatments
SB 11t End of process checks
SB 11u Identification of responsible staff
11v Other
12 Treatment data entry process
SB 12a Pre-data entry verification (including OMS data import)
12b Choice of data entry method (input vs. transcription)
SB 12c Use of correct data
SB 12d Correct ID of patient/all patient input data
SB 12e Correct ID of patient output data
12f Accuracy of data entry (including field sequencing and image scheduling and any required amendments)
SB 12g End of process checks (including OMS data import)
SB 12h Identification of responsible staff
12i Other
13 Treatment unit process (including EXBRT, Protons and Superficial)
13a Availability/timeliness of all required documentation
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SB 13b Patient ID process
SB 13c Patient data ID process
13d Explanation/instructions to patient
SB 13e Confirmation of pregnancy/fertility status
SB 13f Assessment of patient prior to treatment (including pre-medication prior to treatment e.g. analgesia, antiemetics etc., pace-maker or ICED
status)
13g Patient positioning
SB 13h Use of IVD according to local protocol
SB 13i Use of on-set imaging (including imaging according to local protocol)
13j Transfer of marks
13k ID of reference marks
13l Movements from reference marks
13m Setting of treatment machine parameters
13n Setting of collimator angle
13o Setting of jaw position
13p Setting of asymmetry
13q Setting of couch position/angle (incorrect setting of couch following movement to allow gantry clearance)
13r Use of immobilisation devices (including gating equipment)
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13s Use of beam shaping devices
13t Use of beam direction aids/applicators
13u Use of compensators (including bolus)
13v Use of wedges
13w Availability of treatment accessories
13x Setting of energy
13y Setting of monitor units
13z On-set imaging: production process (including inappropriate exposure used, image not captured, incorrect CBCT filter used or left in for kV
image, incorrect field localisation of exposure, unsuitable positioning of imaging panel)
SB 13aa On-set imaging: approval process (including image review not completed, image review inaccurate, image matched to wrong reference
image, incorrect prioritisation of structures for matching)
13bb On-set imaging: recording process (recording of result of image review not undertaken, resultant actions from image review not undertaken,
documentation and application of systematic correction)
SB 13cc Management of variations/unexpected events/errors (including management of replans, migration of fiducials, transfer between treatment
machines)
SB 13dd Communication between treatment unit and V&R
13ee Recording of patient attendance
13ff Recording of delivered treatment data
13gg Recording of additional information
SB 13hh End of process checks (including checking of clearance for automated set-ups)
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SB 13ii Identification of responsible staff
13jj Other
14 On-treatment review process
SB 14a On-treatment review of patient according to protocol by RT staff
SB 14b On-treatment review of patient according to protocol by other professional
SB 14c On-treatment review of notes/data to according protocol (including omission of weekly chart checks)
14d Actions following on-treatment review
14e Other
15 Brachytherapy (including Molecular RT and sealed source IORT)
15a Ordering of sources
15b Delivery of sources
SB 15c Source calibration
SB 15d Sterility of sources
SB 15e Correct applicators /sources
SB 15f Correct theatre equipment
15g Initial positioning of applicators / sources
15h Planning of treatment (including replans)
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15i Maintenance of position of applicators /sources
15j Removing of applicators / sources
15k Other
SB 15l Validation of applicator/ source position
SB 15m Authorisation of plan
SB 15n Management of variations/unexpected events/errors (including management of replans, seed migration or fiducial migration etc.)
SB 15o Use of on-set imaging (including imaging according to local protocol)
15p On-set imaging: production process (including inappropriate exposure used, image not captured, incorrect field localisation of exposure,
unsuitable positioning of imaging panel)
SB 15q On-set imaging: approval process (including image review not completed, image review inaccurate, image matched to wrong reference
image, incorrect prioritisation of structures for matching)
15r On-set imaging: recording process (recording of result of image review not undertaken, resultant actions form image review not undertaken,
documentation and application of systematic correction)
SB 15s End of process checks
16 End of treatment process
16a Communication of appropriate end of treatment information to patient
SB 16b Recording of treatment summary information in notes
16d Communication of information to referring clinician/GP/CNS etc.
16e Organisation of follow-up appointment to protocol
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16f Communication of follow-up to patient
16g Other
17 Follow-up process
17a Follow-up consultation and documentation
17b Management of non-attendance
17c Archiving of details of treatment
Other activities contributing to protocol violations
18 Timing
SB 18a Timing of chemo/irradiation
18b Transport issues
18c Portering issues
19 Document management
SB 19a Availability of current protocol, procedures, work instructions forms, training and competency documentation
20 Staff management
SB 20a Availability of staff with competency appropriate to procedure (including engineers, IT, medical, nursing, physics, radiographer etc.)
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Appendix C: Causative Factor Taxonomy
Reproduced from Reproduced from Development of Learning guidance4
Category Code Description
Category CF 1 Individual
Sub-category CF 1a Failure to recognise hazard (knowledge-based etc.)
CF 1b Decision making process (rule-based or old or invalid rule used etc.)
CF 1c Slips and lapses (skill-based, involuntary automaticity etc.)
CF 1d Communication (inaccuracy or omission of verbal, written etc.)
CF 1e Violation (deliberate action, acting outside scope etc.)
Category CF 2 Procedural
Sub-category CF 2a No procedures / protocols (not in place or unavailable etc.)
CF 2b Inadequate procedures / protocols
CF 2c Adherence to procedures / protocols
CF 2d Process design (impractical and inefficient processes etc.)
Category CF 3 Technical
Sub-category CF 3a Equipment or IT network failure (including immobilisation & accessories)
CF 3b Commissioning/ calibration/ maintenance (including immobilisation & accessories)
CF 3c Device / Product design
Category CF 4 Patient Related
Sub-category CF 4a Medical condition (inability to remain still etc.)
CF 4b Communication with the patient (language issues, comprehension etc.)
CF 4c Non-compliance
Category CF 5 Teamwork / Management / Organisational
Sub-category CF 5a Inadequate leadership (inadequate supervision, congruence or consistency etc.)
CF 5b Unclear responsibilities and lines of accountability (across the radiotherapy pathway)
CF 5c Inadequate capital resources (equipment in use no longer fit for purpose etc.)
CF 5d Inadequate staffing (insufficient staffing levels or skill mix necessary to meet the demands of a service etc.)
CF 5e Inadequate training (inadequate or lack of training etc.)
CF 5f Inadequate risk assessment (poor change management etc.)
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Category Code Description
Category CF 6 Environmental
Sub-category CF 6a Physical (power cut, control area excessively noisy, distractions etc.)
CF 6b Natural factors (fire, flood etc.)
Category CF 7 Other
CF 7a Other