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Radiotherapy Errors and Near Misses Data Report (December 2013 to November 2015) Report No. 4

Radiotherapy Errors and Near Misses Data Report · a) Radiotherapy departments across the UK should continue to use Towards Safer Radiotherapy (TSRT) to classify and code all of their

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Page 1: Radiotherapy Errors and Near Misses Data Report · a) Radiotherapy departments across the UK should continue to use Towards Safer Radiotherapy (TSRT) to classify and code all of their

Radiotherapy Errors and Near Misses Data Report (December 2013 to November 2015)

Report No. 4

Page 2: Radiotherapy Errors and Near Misses Data Report · a) Radiotherapy departments across the UK should continue to use Towards Safer Radiotherapy (TSRT) to classify and code all of their

About Public Health England

Public Health England exists to protect and improve the nation's health and wellbeing, and

reduce health inequalities. It does this through world-class science, knowledge and intelligence,

advocacy, partnerships and the delivery of specialist public health services. PHE is an

operationally autonomous executive agency of the Department of Health.

Public Health England

133–155 Waterloo Road

Wellington House

London SE1 8UG

T: 020 7654 8000

www.gov.uk/phe

Twitter: @PHE_uk

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© Crown copyright 2016

You may re-use this information (excluding logos) free of charge in any format or medium, under

the terms of the Open Government Licence v3.0. To view this licence, visit OGL or email

[email protected]. Where we have identified any third party copyright information

you will need to obtain permission from the copyright holders concerned.

Any enquiries regarding this publication should be sent to

Chilton Information Office

Centre for Radiation, Chemical and Environmental Hazards

Public Health England

Chilton, Didcot, Oxfordshire OX11 0RQ

E: [email protected]

Published September 2016

PHE publications gateway number: 2016255

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PHE-CRCE-029

Centre for Radiation, Chemical and Environmental Hazards Public Health England Chilton, Didcot Oxfordshire OX11 0RQ

This report from the PHE Centre for Radiation, Chemical and Environmental Hazards reflects understanding and evaluation of the current scientific evidence as presented and referenced in this document.

Radiotherapy Errors and Near Misses Data Report (December 2013 to November 2015)

Report No. 4

Patient Safety in Radiotherapy Steering Group

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iii

Executive summary

The fundamental role of reporting and learning 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 poor systems and often

have common root causes that 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.

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

likely to report incidents. There is an emerging evidence base that organisations with a higher

rate of reporting have a stronger safety culture. 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.

This report is the fourth in a series of two-year reports, providing an overview of Radiotherapy

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

and directly to PHE from December 2013 until November 2015. This report also contains data

received from the inspectorates for IR(ME)R for England, Wales, Northern Ireland and Scotland.

Use of the terminology, classification and coding of TSRT, together with implementation of the

national voluntary reporting system described within this report, allows clinical departments to

compare their local analysis to the national picture.

This report identifies errors in activities undertaken by various professional groups, throughout

the patient pathway and across different service providers. A total of 41.4% (n = 5254) of the

RTEs reported were associated with ‘treatment unit process’ and 16.2% (n = 2053) occurred

during ‘pretreatment planning process’. RTEs were spread across all 21 categories of process

code. The vast majority of reports were categorised as lower level events, thus not affecting

the outcome of patient care.

In this analysis the following processes have been identified as areas in the radiotherapy

pathway where RTEs commonly occur, in order of descending frequency:

on-set imaging: production process (13z)

use of on-set imaging (13i)

on-set imaging: approval process (13aa)

accuracy of data entry (12f)

documentation of instructions/information (10j)

on-set imaging: recording process (13bb)

management of process flow within planning (11o)

recording of patient specific instructions (11n)

movements from reference marks (13l)

bookings made according to protocol (6a)

When compared with the 2014 two-year report2 a slight change in error trends can be seen.

Eight of the same process subcodes were found in the most frequently reported list in both the

current and 2014 analyses, seven of these were also within the 2012 analyses2. These ranked

differently between analyses.

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iv

In addition, when compared with results from the 20142 report there has been no overall

change in the percentage of reportable (1.7% in 2014 and 1.8% in 2016) and non-reportable

radiation incidents (1.3% in 2010 and 1.4% in 2016). However, there has been a slight

increase in the percentage of minor radiation incidents from 28.6% in 2014 to 31.5% in 2016.

There has been an overall decrease in the percentage of other non-conformances (41.6% in

2014 and 36.6% in 2016). It is known that clinical departments are more likely to submit

reports on higher level RTEs such as level 1 ‘reportable radiation incident’, level 2 ‘non-

reportable radiation incident’ and level 3 ‘minor radiation incident’3.

It is imperative that RTE trends continue to be reported, analysed and monitored on a cyclical

basis, in order to inform ongoing safe and effective radiotherapy practice. This is especially

pertinent as new techniques and technologies are implemented and as new clinical

radiotherapy departments are established. This work supports a risk-based approach to

improving safety both locally and nationally, and indicates a culture that is open, transparent

and already present in the UK radiotherapy community.

Key recommendations:

a) Radiotherapy departments across the UK should continue to use Towards Safer

Radiotherapy (TSRT) to classify and code all of their RTEs, including near misses for local

analysis to inform policy and practice

b) Radiotherapy departments across the UK should continue to submit coded and classified

RTE reports to the national voluntary reporting system using the mechanisms identified

within this report

c) To ensure timeliness of learning providers are encouraged to report on a monthly basis

d) Radiotherapy departments across the UK should consider all codes when coding RTE

and the use of secondary or additional subcodes

e) The Patient Safety in Radiotherapy Steering Group (PSRT) should continue to develop

analysis of the reports, with regular dissemination of findings to the radiotherapy

community for group learning

f) The data should be used both by the PSRT and by individual radiotherapy departments as

part of a risk-based approach to allocating resources for improving patient safety in

radiotherapy and to inform audit and research

g) The mechanism to enable departments 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

h) A mechanism should be developed to enable independent radiotherapy providers to

submit RTE reports to PHE for collation and analysis as part of a UK dataset

i) The radiotherapy pathway coding as described in TSRT should be refined to reduce any

ambiguity of codes and to reflect the use of emerging techniques and technologies, this

should include safety barriers and causative factor taxonomies.

j) Radiotherapy departments across the UK should consider reviewing their end of process

checks and consider pause and check work

References 1. World Health Organization. Reporting and learning for patient safety. Available at

http://www.who.int/patientsafety/implementation/reporting_and_learning/en/ 2. PSRT. Data report on radiotherapy errors and near misses. Available at

www.gov.uk/government/publications/radiotherapy-errors-and-near-misses-data-report 3. PSRT. Safer radiotherapy: supplementary survey analysis. Report 3 (2014). Available at

www.gov.uk/government/publications/safer-radiotherapy-supplementary-survey-analysis

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Contents

Executive Summary iii

1 Introduction 1

2 Background 1

3 Data 2

3.1 Number of reports 3

3.2 Obtaining the data 3

3.2.1 National voluntary reporting system 3

3.2.2 Northern Ireland and Scotland 4

3.3 Organisation of the database 4

3.4 Quality assurance of data 4

3.4.1 Consistency checking 4

3.4.2 Data quality 5

3.4.3 Lag time for reporting 6

4 Results 6

4.1 Classification level of RTE 6

4.2 Breakdown of classification by process code 7

4.2.1 Breakdown of level 1 (reportable radiation incident) RTE 7

4.2.2 Breakdown of level 2 (non-reportable radiation incident) RTE 9

4.2.3 Breakdown of level 3 (minor radiation incident) RTE 12

4.2.4 Breakdown of level 4 (near miss) RTE 14

4.2.5 Breakdown of level 5 (other non-conformance) RTE 16

4.3 Main themes of RTE 18

4.3.1 Breakdown of process codes 18

4.3.2 Breakdown of process subcodes 18

4.3.3 Additional process subcodes 19

4.3.4 End of process checks 20

4.4 Inspectorate data 21

5 Discussion 23

5.1 Increase in RTE reporting 23

5.2 Classification level of RTE 24

5.2.1 Level 1 (reportable radiation incident) RTE 26

5.2.2 Level 2 (non-reportable radiation incident) RTE 26

5.2.3 Level 3 (minor radiation incident) RTE 26

5.2.4 Level 4 (near miss) RTE 27

5.2.5 Level 5 (other non-conformance) RTE 27

5.3 Main themes 27

5.3.1 Breakdown of process codes 27

5.3.2 Breakdown of process subcodes 28

5.3.3 End of process checks 29

5.4 Inspectorate data 30

6 Conclusion 30

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7 Key recommendations 32

8 Acknowledgements 33

9 PSRT Steering Group Membership 33

10 References 34

Appendix A Radiotherapy error classification grid 35

Appendix B Radiotherapy pathway coding 36

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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 poor systems 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.

The need to further improve the safety of patients undergoing radiotherapy treatments has

gathered worldwide momentum in recent years. The 2006 report2 of the Chief Medical Officer

for England and Towards Safer Radiotherapy3 (TSRT), published in 2008, were seminal

documents in the field of radiotherapy safety; both contained practical recommendations for

the radiotherapy community aimed at improving safety and reducing errors.

More recently, recommendations of the Francis Report4 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.

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

likely to report incidents. There is an emerging evidence base that organisations with a higher

rate of reporting have a stronger safety culture. 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.

This report is the fourth in a series of two-year reports, providing an overview of Radiotherapy

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

and directly to PHE from December 2013 until November 2015.

2 Background

Towards Safer Radiotherapy3 (TSRT) provides definitions for the terminology to be used in

discussing radiotherapy errors that include near misses (RTE) and proposes two 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’ (Appendix B)

describes where in the radiotherapy pathway the error occurred. The proposed terminology

and taxonomies have now been adopted and are in use in radiotherapy departments across

the UK.

In 2008, the Patient Safety in Radiotherapy Steering Group (PSRT) was tasked with

monitoring the implementation of the recommendations from TSRT, through a collaborative

programme of work with the radiotherapy 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 patient

representative. The group is currently chaired by PHE where detailed analysis of RTE reports

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is undertaken, reported to the PSRT and disseminated to the radiotherapy community to

provide learning opportunities.

The NRLS operates an anonymised voluntary reporting system to collect and learn from

patient safety incidents for England and Wales. As of April 2016 the NRLS moved from NHS

England to NHS Improvement. PHE has a data sharing agreement with the NRLS and under

this agreement continues to extract RTE data from the NRLS, and share learning from these

events so as to make services safer for patients. This collaboration led to the publication in

July 20105 of the first two-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 radiotherapy

department 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

radiotherapy error (RTE) reports for professionals working in the radiotherapy community. In

2012 a second report was published7. 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 then published within the

third two yearly report in November 20148.

This fourth report will compare data from previously published reports.

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 level of occurrence. As

such, this data needs interpreting with care.

A total of 12,800 RTE reports were submitted to the voluntary reporting scheme between

December 2013 and November 2015 (Figure 1). On average 533 RTE reports were received

each month, this is a marked increase from average of 323 within the last report8. The number

of reports received ranged from 323 in March 2014 to 839 in November 2015.

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Radiotherapy Errors and Near Misses Data Report (December 2013 to November 2015)

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3.1 Number of reports

Figure 1: Number of RTE reports submitted to the national voluntary reporting system by month, from December 2013 to November 2015 (n = 12800)

Between December 2013 and November 2015 a total of 60 NHS providers submitted RTE.

The number of providers reporting per month fluctuated between 34 and 52 with a mean

average of 42 NHS providers reporting per month, this is a vast increase from the report in

2014 where an average of 28 providers submitted data each month8. The variation highlights

that not all providers report on a monthly basis.

3.2 Obtaining the data

The voluntary data was obtained through two distinct routes: from the NRLS for providers in

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

described in detail below.

3.2.1 National voluntary reporting system

The vast majority of reports came through the NRLS, 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 NHS care’9.

PSIs are reported by NHS staff through local trust risk management systems and web based

forms to the NRLS. Patients and carers can also report directly through an open access form.

The NRLS offers a unique dataset to help understand harm associated with healthcare. It was

established in 2003 and now has over 11.8 million PSI reports10

, from many areas of

healthcare, in the database.

0

100

200

300

400

500

600

700

800

900

Dec

-13

Jan-

14

Feb

-14

Mar

-14

Apr

-14

May

-14

Jun-

14

Jul-1

4

Aug

-14

Sep

-14

Oct

-14

Nov

-14

Dec

-14

Jan-

15

Feb

-15

Mar

-15

Apr

-15

May

-15

Jun-

15

Jul-1

5

Aug

-15

Sep

-15

Oct

-15

Nov

-15

Num

ber

of R

epor

ts

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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 errors and near misses effectively’11

. This code could be searched for

in the free text field rather than using search terms that were less determinant. PSIs that were

not RTEs, such as a report of a patient falling in ‘radiotherapy’, would not be included in the

RTE dataset. An RTE is defined by TSRT as:

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

treatment delivered or a radiotherapy process followed and that defined as correct by local

protocol’3.

3.2.2 Northern Ireland and Scotland

A mechanism was developed to enable departments 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 radiotherapy 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 radiotherapy 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 analyses6.

3.3 Organisation of the database

An established database continues to act as a repository for the data. It also supports the

analysis of the data through the use of 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.

3.4 Quality assurance of data

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.

3.4.1 Consistency checking

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

checking of the local application of the classification and coding from TSRT. Up to four

individual pathway codes can be allocated locally by radiotherapy departments to each RTE

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report. 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 87.1% agreed in this dataset, and is slightly higher than

83.7% agreement achieved in the 2014 report8.

It is thought the positive result in consistency checking is in part due to the publication of a

guidance document11

on the use of the trigger code and application of the coding and

classification, development of a supplementary series on good practice in RTE reporting12

and

familiarisation with the taxonomies.

All providers are asked to include a trigger code, classification and coding in RTE reports to

facilitate both local and national analysis.

3.4.2 Data quality

Reports were categorised into patient safety incidents (PSI), radiotherapy errors (RTE) and

incomplete radiotherapy errors (IRTE). PSI and RTE have been previously defined. IRTE

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

to submission.

Radiotherapy department staff were asked to classify and code incidents according to the

taxonomies presented in TSRT within their current local incident reporting systems. The

introduction of the trigger code in August 2009 resulted in a significant reduction in the number

of unrelated non-radiotherapy errors for analysis (see Table 1).

Since the publication of the first two-year report in 20105 the quality of the data received has

improved significantly, as demonstrated in the table. Previously a significant number of non-

radiotherapy error (NRTE) reports had been included in the data. These included incident

reports from radiological disciplines other than radiotherapy. However in the 2016 report 1528

reports did not include the classification and coding outlined within TSRT, this may be due to

departments submitting RTE reports before the classification and coding has been included

locally.

Table 1: Comparison of data quality between the current dataset and the previous reports showing the overall percentage of reports submitted

Type of data report

2016 report (Dec 13 – Nov 15) (n = 12,800)

2014 report (Dec 11 – Nov 13) (n = 7742)

2012 report (Dec 09 – Nov 11) (n = 3411)

2010 report (Aug 07 – Nov 09) (n = 1365)

% RTE 87.2 90 97.2 46

% NRTE/PSI 0.8 1 2.4 41

% IRTE 12 9 <0.4 13

PSI patient safety incident; RTE radiotherapy error; IRTE incomplete radiotherapy error; NRTE non-radiotherapy error

Of the 12,800 RTE reports received, a total of 12,691 reports were included in the analysis

11,163 had been classified and coded by local RT providers. There were 1,540 IRTE reports

of which 1,528 had sufficient detail to allow PHE staff to classify and code. The remaining 12

IRTE, in addition to 97 PSI reports, were excluded from the analysis (Figure 2).

A total of 99.1% (87.2% RTE and 11.9% IRTE) of the data submitted was included for analysis

in this report; this is consistent with reported data in 20148.

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Figure 2: Type of RTE identified in reports submitted from December 2013 to November 2015 (n = 12800)

3.4.3 Lag time for reporting

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

calculated for the dataset. This measures the time from the date of incident or discovery of the

incident through local reporting and on to PHE.

A minimum reporting lag of 1 day and a maximum of 864 days, with a mean reporting lag of

58.8 days and a mode of 21 days was found. There were two outliers of over 800 days; these

two outliers were reported on discovery of the error, which was not until a significant time after

the event. However the majority of departments are reporting in a timely fashion. To ensure

timeliness of learning providers are encouraged to report on a monthly basis.

4 Results

The use of the taxonomies from TSRT provided the focus for the analysis of this data. The

‘classification of radiotherapy errors grid’ describes the severity of the incident and is made up

of five levels, one being the most severe and five being a non-conformance. The classification

grid from TSRT is reproduced in Appendix A. The ‘radiotherapy pathway coding’ describes

where on the patient pathway the error has occurred. This has 21 constituent codes and 193

subcodes, which are reproduced from TSRT in Appendix B.

4.1 Classification level of RTE

Each of the 12691 reports was classified as ‘other non-conformance’, ‘near miss’, ‘minor radiation

incident’, ‘non-reportable radiation incident’ and ‘reportable radiation incident’ (Figure 3).

Of the RTE reports, 65.3% (n = 8288) were near miss or other non-conformities with no

impact on patient outcome. In total, 31.5% (n = 3994) of the RTEs reported were not clinically

significant and were classified as ‘minor radiation incidents’. Of the remaining 3.2% (n = 409)

RTE (n=11163) 87.2%

PSI (n=97) 0.8%

IRTE included (n=1528)

11.9%

IRTE excluded (n=12) 0.1%

Other (n=1540) 12.0%

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RTE reports, 1.8% (n = 232) were reportable under either of two statutory instruments, the

Ionising Radiation (Medical Exposure) Regulations (IR(ME)R)13

or the Ionising Radiations

Regulations (IRR99)14

, to the appropriate authority.

Figure 3: Classification of reports from December 2013 to November 2015 (n = 12691)

4.2 Breakdown of classification by process code

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

codes and subcodes.

4.2.1 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 IRR9914

. Clearly, reporting to the national voluntary

reporting scheme does not negate regulatory requirements to report level 1 events to the

appropriate authority.

The majority of the 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. Reportable radiation incidents comprised 1.8% (n = 232) of the RTEs

reported (Figure 3). Of the level 1 events, 50.0% (n = 116) occurred during ‘treatment unit

process’, 22.0% (n = 51) during ‘pretreatment activities/imaging’ and 11.2% (n = 26) during

‘communication of intent’ (Figure 4).

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

5 Other non-conformance

4 Near miss

3 Minor radiation incident

2 Non-reportable radiation incident

1 Reportable radiation incident

Number of Reports

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Figure 4: Breakdown of level 1 (reportable radiation incident) reports by process code, from December 2013 to November 2015 (n = 232)

Further analysis of the ‘treatment unit process’ reports indicates the points in the pathway on

the treatment unit at which the reportable radiation incidents occurred (Figure 5).

‘Movements from reference marks’ comprised 10.8% (n = 25) of all reportable radiation

incidents reported for this time period. Examples of these types of reports included moves

from reference marks to isocentre made in the wrong direction, the wrong dimension or not at

all. Some reports added the error was not picked up until images were reviewed offline.

Figure 5: Breakdown of the most frequently occurring level 1 (reportable radiation incident) reports associated with process code 13 (treatment unit process), from December 2013 to November 2015 (n = 94/116 subset of reports)

0 20 40 60 80 100 120

13 Treatment unit process

10 Pretreatment activities / imaging

5 Communication of intent

4 Referral for treatment

11 Pretreatment planning process

12 Treatment data entry process

9 Mould room/workshop activities

7 Process prior to first appointment

8 Pretreatment: preparation of patient

Number of reports

0 5 10 15 20 25

13l Movements from reference marks

13z On-set imaging: production process

13k ID of reference marks

13aa On-set imaging: approval process

13g Patient positioning

13i Use of on-set imaging

13q Setting of couch position/angle

13r Use of immobilisation devices

13m Setting of treatment machine parameters

Number of reports

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9

Level 1 reports were also broken down by most frequently occurring process subcode

(Figure 6). This revealed ‘movements from reference marks’ followed equally by ‘on-set

imaging: production process’ and ‘localisation of intended volume’ as the most frequently

occurring process subcodes in this group. An example of the latter type of RTE was the

requirement to rescan a patient due to not capturing the intended volume on the initial scan.

A common example of ‘on-set imaging: production process’ RTE was repeat scans due to

selection of incorrect presets when performing cone beam CTs. On-set imaging: production

process was not part of the most frequently occurring level 1 process subcodes in the 2014

report8, the rise in incidence of this error may be due to an increased uptake in the use of on-

set imaging.

Figure 6: Breakdown of the most frequently occurring level 1 (reportable radiation incident) process subcodes, from December 2013 to November 2015 (n = 134/232 subset of reports)

4.2.2 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.

Non-reportable radiation incidents comprised 1.4% (n = 177) of the RTE reports. Of these

level 2 reports, 59.3% (n = 105) occurred during ‘treatment unit process’ (Figure 7). RTEs

were spread across 12 categories of process code for level 2 classifications. A subset of these

reports were grouped into ‘miscellaneous’ as the numbers reported within the process codes

were deemed statistically less significant.

0 5 10 15 20 25

13l Movements from reference marks

13z On-set imaging: production process

10c Localisation of intended volume

13k ID of reference marks

10b Positioning of patient

13aa On-set imaging: approval process

10f Production of images demonstrating correct detail

5a Completion of request for treatment

13g Patient positioning

5k Authorisation to irradiate

Number of reports

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Figure 7: Breakdown of level 2 (non-reportable radiation incident) reports by process code, from December 2013 to November 2015 (n = 177)

Further analysis of the ‘treatment unit process’ indicates the points in the pathway on the

treatment unit at which the reportable radiation incidents occurred (Figure 8).

‘On-set imaging: approval process’ was notably the most frequently occurring event at 27.6%

(n = 29) within the subset of non-reportable radiation incidents (Figure 8). Examples of RTE

reports associated with ‘on-set imaging: approval process’ included the incorrect matching of

reference and verification image and several reports indicated this was due to matching to the

wrong vertebrae level.

Level 2 reports were also broken down by most frequently occurring process subcode

(Figure 9). Findings were consistent with those above, with ‘on-set imaging: approval process’

being the most frequently occurring event within this subset of non-reportable RTE.

0 20 40 60 80 100 120

13 Treatment unit process

10 Pretreatment activities / imaging

11 Pretreatment planning process

12 Treatment data entry process

5 Communication of intent

4 Referral for treatment

15 Brachytherapy

9 Mould room/workshop activities

2 New equipment

Miscellaneous

Number of reports

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Figure 8: Breakdown of most frequently occurring level 2 (non-reportable radiation incident) reports associated with process code 13 (treatment unit process), from December 2013 to November 2015 (n = 84/105 subset of reports)

Figure 9: Breakdown of the most frequently occurring level 2 (non-reportable radiation incident) process subcodes, from December 2013 to November 2015 (n = 86/177 subset of reports)

0 5 10 15 20 25 30

13aa On-set imaging: approval process

13l Movements from reference marks

13z On-set imaging: production process

13i Use of on-set imaging

13m Setting of treatment machine parameters

13g Patient positioning

13q Setting of couch position/angle

13r Use of immobilisation devices

13c Patient data ID process

Number of reports

0 5 10 15 20 25 30

13aa On-set imaging: approval process

13l Movements from reference marks

13z On-set imaging: production process

13i Use of on-set imaging

13m Setting of treatment machine parameters

13g Patient positioning

13q Setting of couch position/angle

10f Production of images demonstrating correct detail

10b Positioning of patient

Number of reports

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4.2.3 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.

Minor radiation incidents comprised 31.5% (n = 3994) of the coded RTE reports as seen in

Figure 10. ‘Treatment unit process’ was the most common code for these reports, at 75.1%

(n = 2998). RTEs were spread across 18 categories of process code for level 3 classifications.

A subset of these reports was grouped into ‘miscellaneous’ as the numbers reported within

process codes were deemed statistically less significant.

Figure 10: Breakdown of level 3 (minor radiation incident) reports by process code, from December 2013 to November 2015 (n = 3994)

Further analysis of the ‘treatment unit process’ indicates the points in the pathway at which

the minor radiation incidents occurred (Figure 11). ‘On-set imaging: production process’ was

the most frequent occurring event, at 30.8% (n = 922) within the subset of minor radiation

incidents. Examples of this type of RTE included incorrect or inappropriate imaging settings

selected during verification imaging.

A review of the ‘on-set imaging production process’ subset of RTE reports revealed that

48.9% (n = 451) 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

51.1% (n = 471) of this subgroup related to equipment failure. Examples of these types of

reports included ‘failure of the imaging device during image acquisition’, ‘image not captured

after exposure’, ’flooded image’ or ‘image unavailable offline’. This resulted in additional

imaging being undertaken. Radiotherapy providers are encouraged to audit and report these

events locally so appropriate and timely preventative measures might be implemented. In

addition, the Medicines and Healthcare products Regulatory Agency (MHRA) should be

advised of all equipment failures.

0 500 1000 1500 2000 2500 3000

13 Treatment unit process

10 Pretreatment activities / imaging

11 Pretreatment planning process

12 Treatment data entry process

5 Communication of intent

18 Timing

9 Mould room/workshop activities

4 Referral for treatment

3 Routine machine QA

6 Booking process

Miscellaneous

Number of reports

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Figure 11: Breakdown of the most frequently occurring level 3 (minor radiation incident) reports associated with process code 13 (treatment unit process), from December 2013 to November 2015 (n = 2690/2998 subset of reports)

Level 3 reports were also broken down by most frequently occurring process subcode (Figure 12).

The findings were consistent with those in Figure 11, with ‘on-set imaging: production process’

being the most frequently reported RTE within the minor radiation incident grouping. Of note

when compared to the 2014 report8 all of the most frequently occurring subcodes within this

classification were the same except for ‘patient positioning’ which replaces ‘setting of couch

position’.

Figure 12: Breakdown of the most frequently occurring process subcodes in level 3 (minor radiation incident) reports, from December 2013 to November 2015 (n = 2723/3994 subset of reports)

0 200 400 600 800 1000

13z On-set imaging: production process

13i Use of on-set imaging

13aa On-set imaging: approval process

13l Movements from reference marks

13bb On-set imaging: recording process

13u Use of compensators

13g Patient positioning

13cc Management of variations

13q Setting of couch position/angle

13r Use of immobilisation devices

Number of reports

0 200 400 600 800 1000

13z On-set imaging: production process

13i Use of on-set imaging

13aa On-set imaging: approval process

13l Movements from reference marks

13bb On-set imaging: recording process

13u Use of compensators

13g Patient positioning

12f Accuracy of data entry

13cc Management of variations

10j Generation of plan for approval

Number of reports

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4.2.4 Breakdown of level 4 (near miss) RTE

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

prevented before treatment delivery’3.

Near misses comprised 28.7% (n = 3646) of the coded RTEs reported during this period.

Once again, ‘treatment unit process’ was the most common code for these reports, making up

32.2% (n = 1174) of them (Figure 13). RTEs were spread across 20 categories of process

code for level 4 classifications. A subset of these reports was grouped into ‘miscellaneous’ as

the numbers reported within the process codes were deemed statistically less significant.

Figure 13: Breakdown of level 4 (near miss) reports by process code, from December 2013 to November 2015 (n = 3646)

Further analysis of the ‘treatment unit process’ indicates the points in the pathway at which the

near misses occurred (Figure 14). A total of 34 different treatment unit process subcodes from

process code 13 are included in this classification. The top 10 most frequently occurring

processes are presented below, which made up 78.4% (921 out of 1174) of the RTEs reported

under process code 13 within this level. Pathway points of interest are focused on imaging

tasks and include ‘on-set imaging: approval process’, ‘use of on-set imaging’, ‘on-set imaging:

recording process’ and ‘on-set imaging: production process’ (Figure 14).

Level 4 reports were also broken down by most frequently occurring process subcode

(Figure 15). This revealed ‘documentation of instructions’ (15%, n = 262) and ‘accuracy of

data entry’ (15%, n = 261) as the most frequently reported RTEs within the near miss incident

grouping. Examples of RTE associated with documentation of instructions include incorrect or

missing patient set up information.

0 200 400 600 800 1000 1200

13 Treatment unit process

11 Pretreatment planning process

10 Pretreatment activities / imaging

12 Treatment data entry process

5 Communication of intent

4 Referral for treatment

6 Booking process

9 Mould room/workshop activities

7 Processes prior to first appointment

14 On-treatment review process

Miscellaneous

Number of reports

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Figure 14: Breakdown of the most frequently occurring level 4 (near miss) reports associated with process code 13 (treatment unit process), from December 2013 to November 2015 (n = 921/1174 subset of reports)

Figure 15: Breakdown of the most frequently occurring process subcode in level 4 (near miss) reports, from December 2013 to November 2015 (n = 1741/3646 subset of reports)

0 50 100 150 200 250

13aa On-set imaging: approval process

13i Use of on-set imaging

13bb On-set imaging: recording process

13z On-set imaging: production process

13l Movements from reference marks

13h Use of IVD according to local protocol

13a Availability/timeliness of all required documentation

13cc Management of variations/unexpected events/errors

13g Patient positioning

13r Use of immobilisation devices

Number of reports

0 50 100 150 200 250 300

10j Documentation of instructions

12f Accuracy of data entry

13aa On-set imaging: approval process

13i Use of on-set imaging

13bb On-set imaging: recording process

11n Recording of patient specific instructions

11j Generation of plan for approval

11i Target and organ at risk delineation

13z On-set imaging: production process

11m Recording of definitive treatment prescription

5a Completion of request for treatment

Number of reports

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4.2.5 Breakdown of level 5 (other non-conformance) RTE

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

documented procedure but not directly affecting radiotherapy delivery’3 and made up 36.6%

(n = 4642) of those RTE reports coded.

A breakdown of level 5 reports revealed ‘pretreatment planning process’ as the most common

code for these reports, making up 22.2% (n = 1,032) of them. RTEs were spread across

20 categories of process code for level 5 classifications (Figure 16). A subset of these reports

was grouped into ‘miscellaneous’ as the numbers reported within the process codes were

deemed statistically less significant.

Figure 16: Breakdown of level 5 (other non-conformance) reports by process code, from December 2013 to November 2015 (n = 4642)

A total of 22 different pretreatment planning process subcodes have reports associated with

them in this classification. The top 10 most frequently occurring processes are presented here,

which made up 90.8% (937 of the 1,032) of the RTEs reported under process code 11 within

this level (Figure 17).

‘Management of process flow within planning’ can be seen to contribute significantly to the

number of RTEs reported. Examples of this type of RTE report included mismanagement of

changes made to plans leading to delays in planning and/or treatment.

Level 5 reports were also broken down by most frequently occurring process subcode

(Figure 18). This agreed with the above findings that ‘management of process flow within

planning’ was the most frequently reported RTE at 7.4% (n = 344) within the other non-

conformance grouping. 97 (28.2%) of these errors had secondary codes reported of which 72

(21%) elicited the error affected the ‘availability/timeliness of all required documentation’ at the

treatment unit.

0 200 400 600 800 1000 1200

11 Pretreatment planning process

13 Treatment unit process

6 Booking process

10 Pretreatment activities / imaging

5 Communication of intent

12 Treatment data entry process

4 Referral for treatment

7 Processes prior to first appointment

14 On-treatment review process

18 Timing

Miscellaneous

Number of reports

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Figure 17: Breakdown of the most frequently occurring level 5 (other non-conformance) reports associated with process code 11 (pretreatment planning process), from December 2013 to November 2015 (n = 937/1032 subset of reports)

Figure 18: Breakdown of the most frequently occurring level 5 (other non-conformance) reports by process subcodes, from December 2013 to November 2015 (n = 1594 /4642 subset of reports)

0 50 100 150 200 250 300 350

11o Management of process flow within planning

11n Recording of patient specific instructions

11j Generation of plan for approval

11t End of process checks

11v Other

11q Timeliness of plan production

11i Target and organ at risk delineation

11m Recording of definitive treatment prescription

11k Authorisation of plan

11h Choice of technique

Number of reports

0 50 100 150 200 250 300 350

11o Management of process flow within planning

6a Bookings made according to protocol

6d Communication of appointments to patient

12f Accuracy of data entry

10j Documentation of instructions

5a Completion of request for treatment

4j Consent process

11n Recording of patient specific instructions

13bb On-set imaging: recording process

Number of reports

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4.3 Main themes of RTE

The 12,691 RTE reports were categorised by process code or process subcode according to

TSRT and then by classification, so that the main themes could be derived.

4.3.1 Breakdown of process codes

The entire dataset was broken down by process code and classification level. 41.4%

(n = 5,254) of the RTEs reported were associated with ‘treatment unit process’ and 16.2%

(n = 2,053) occurred during ‘pretreatment planning process’. RTEs were spread across all

21 categories of process code. A subset of these reports was grouped into ‘miscellaneous’ as

the numbers reported within the process codes were deemed statistically less significant and

for this reason they are not included in Figure 19.

In this subset of data it may be seen that the majority (64.6% n = 7,821) of reports are made

up of ‘near misses’ (level 4) and ‘non-conformities’ (level 5). Minor radiation incidents (level 3)

comprised 32.2% (n = 3,895) of these reports. The remaining 3.3% (n = 394) reports were

‘reportable radiation incidents’ and ‘non-reportable radiation incidents’.

Figure 19: Breakdown of most frequently occurring process codes by classification, from December 2013 to November 2015 (n = 12110/12691 subset of reports)

4.3.2 Breakdown of process subcodes

The most frequently occurring process subcode was ‘on-set imaging: production process’,

making up 19.6% (n = 1,067) of all RTEs reported. This was followed by ‘use of on-set

imaging’, at 15.1% (n = 825), and ‘on-set imaging: approval process’, at 13.4% (n = 733). Of

note, on-set imaging processes represented 4 out of the 10 most frequently occurring process

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 5500

13 Treatment unit process

11 Pretreatment planning process

10 Pretreatment activities / imaging

12 Treatment data entry process

5 Communication of intent

6 Booking process

4 Referral for treatment

7 Processes prior to first appointment

18 Timing

14 On-treatment review process

Number of reports

Level 1

Level 2

Level 3

Level 4

Level 5

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subcodes reported. The 10 most frequently reported subcodes and their classification levels

are presented in Figure 20.

It may be seen that the majority (52.8% n = 2,882) of reports are made up of ‘near misses’

(level 4) and ‘other non-conformities’ (level 5). 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 system. Minor radiation incidents (level 3) comprised 44.6% (n = 2,434) of

this subset of reports.

Figure 20: Breakdown of reports by most frequently occurring process subcode and classification level, from December 2013 to November 2015 (n = 5454/12691 subset of reports)

4.3.3 Additional process subcodes

The primary process subcode is the point in the pathway at which the RTE first occurred; each

of the 12,691 RTEs reported contained primary process codes. Each RTE can contain a

primary subcode and up to three further subcodes. Only 34.4% (n = 4,372) RTE contained a

secondary process code, indicating a second point in the pathway where the original had gone

undetected. A third process code was indicated in just 6.8% (n = 865) and a fourth in just

1.6% (n = 199) of all the RTEs. The most frequently occurring additional process subcodes

are presented in Figure 21. Departments are encouraged to consider additional process

subcodes, this allows the identification of all points in the pathway where errors occurred.

0 200 400 600 800 1000 1200

13z On-set imaging: production process

13i Use of on-set imaging

13aa On-set imaging: approval process

12f Accuracy of data entry

10j Documentation of instructions/information

13bb On-set imaging: recording process

11o Management of process flow within planning

11n Recording of patient specific instructions

13l Movements from reference marks

6a Bookings made according to protocol

Number of reports

Level 1

Level 2

Level 3

Level 4

Level 5

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Figure 21: Breakdown of reports by most frequently occurring process subcodes across all four subcodes, from December 2013 to November 2015 (n = 3316/12691 subset of reports)

4.3.4 End of process checks

Owing to the complex and multifaceted nature of radiotherapy 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’ subcode is repeated across the

radiotherapy pathway, for example following completion of ‘pretreatment activities’ or

‘pretreatment planning process’. A breakdown of all process subcodes within the dataset by

‘end of process check’ was undertaken. It includes process subcodes 9k, 10l, 11t, 12g and

13hh (Figure 22). 20.4% (n = 883) of the ‘end of process check’ RTEs reported were

associated with ‘treatment unit process’, of these 56.6% (n = 500) were associated with on-set

imaging.

A total of 20.4% (n = 2,584) of the RTEs reported were not captured during the ‘end of

process checks’. This would seem to suggest that the ‘end of process checks’ are failing to

detect RTEs in some cases. At time of writing it is understood ‘pause and check’ work is

underway to replicate the work of the operator checklist within clinical imaging15

for

radiotherapy departments.

0 200 400 600 800 1000

(13hh) End of process checks (treatment unit)

(11t) End of process checks (pretreatment planning)

(12g) End of process checks (treatment data entry)

(10l) End of process checks (pretreatment activities)

(13z) On-set imaging: production process

(13i) Use of on-set imaging

(13a) Availability/timeliness of all required documentation

(13l) Movements from reference marks

(13cc) Management of variations/unexpected events/errors

(13aa) On-set imaging: approval process

(12f) Accuracy of data entry

Number of reports

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Figure 22: Breakdown of end of process checks by point in the radiotherapy pathway, from December 2013 to November 2015 (n = 2584)

4.4 Inspectorate data

There is a requirement that the appropriate authority is notified of all level 1 incidents13

. 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 the same time period as for the voluntary system for this report.

A total of 437 reports were shared, this is a vast increase in numbers since the last report

where 103 reports were shared for the same period of time8. This increase may be due to

guidance notes published in 201216

. There were 232 level 1 reports received through the

voluntary scheme, this highlights a difference in the number of reports reported to the

appropriate authorities and the voluntary reporting and learning scheme.

The coding from TSRT3 was applied to these reports. On review of the inspectorate data it

became clear that there was wide variation on the locally applied classification of events, it

was found that 17.8% (n = 78) of the reported events could have also been reported as level 2

(non-reportable radiation incidents) or level 3 (minor radiation incidents).

Of the 437 level 1 RTE reports shared, 47.1% (n = 206) occurred during ‘treatment unit

process’ and 25.4% (n = 111) during ‘pretreatment activities’. A comparison of inspectorate

and voluntary data (Figure 23) revealed a similar pattern of spread in the higher frequency

reports. Interestingly reports associated with process codes ‘new equipment’, ‘routine machine

QA’, ‘booking process’, ‘follow up process’ and ‘document management’ were reported in the

inspectorate data, but not within the voluntary data. These outliers were deemed as

9k Mouldroom activities, 1%

10l Pretreatment activities , 15%

11t Pretreatment planning process,

27% 12g Treatment

data entry process, 23%

13hhTreatment unit process, 34%

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statistically less significant and grouped as miscellaneous. The text descriptors for the

inspectorate data was more detailed than the voluntary data, which may explain this difference

in coding.

Figure 23: Percentage frequency of process codes found in reportable radiation incidents from the inspectorate and voluntary datasets, from December 2013 to November 2015 (n = 437 and 232, respectively)

Further analysis of the treatment unit process indicates the points in the pathway at which the

reportable radiation incidents most commonly occurred (Figure 24). ‘Movements from

reference marks’ formed 21.4% (n = 44) of the treatment unit inspectorate data, which is

similar to the 21.6% (n = 25) from the voluntary data.

Figure 24: Breakdown of inspectorate and voluntary data as a percentage of most frequently occurring reportable radiation incident reports within process code 13 (treatment unit process), from December 2013 to November 2015 (n = 174/206 and 91/116, respectively)

0 5 10 15 20 25 30 35 40 45 50

13 Treatment unit process

10 Pretreatment activities

5 Communication of intent

11 Pretreatment planning process

4 Referral for treatment

12 Treatment data entry process

15 Brachytherapy

9 Mould room/workshop activities

Miscellaneous

Percentage of reports

Voluntary data

Inspectorate data

0 5 10 15 20 25

(13l) Movements from reference marks

(13z) On-set imaging: production process

(13k) ID of reference marks

(13aa) On-set imaging: approval process

(13q) Setting of couch position/angle

(13c) Patient data ID process

(13g) Patient positioning

(13ff) Recording of delivered treatment data

(13i) Use of on-set imaging

(13w) Availability of treatment accessories

Percentage of reports

Voluntary data

Inspectorate data

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The inspectorate data was also broken down by most frequently occurring process subcode.

This revealed treatment ‘movements from reference marks’ (10.1% n = 44) and pretreatment

‘localisation of intended volume’ (10.8% n = 41) were the most frequently occurring process

subcodes within the inspectorate data (Figure 25). ‘Movements from reference marks’ also

accounted for the most frequently occurring process subcodes within the level 1 voluntary

data, this was followed by localisation of intended volume’ and ‘on set imaging production

process’.

Figure 25: Breakdown of inspectorate and voluntary data as a percentage of most frequently occurring process subcodes, from December 2013 to November 2015 (n = 248/437 and 121/232, respectively)

A total of 67.0% (n = 293) of the inspectorate reports contained further process subcodes,

highlighting further points in the pathway where the error went undetected. Of these 54.9%

(n = 161) RTEs were not captured during the ‘end of process checks’.

5 Discussion

5.1 Increase in RTE reporting

During this two year reporting period there has been a large increase in the number of RTEs

reported to the national voluntary reporting system. A total of 12,691 reports were included in

this analysis for the period December 2013 until November 2015, compared with 7,655 for the

2014 report8 and 3,316 for the 2012 report

7. This is an increase in reporting levels of 66%

since 2014 report8and 282% since the 2012 report

7.

The number of providers contributing to this initiative has increased from the previous two year

report published in 20148 with an average of 28 providers reporting per month to an average

of 42 per month for this reporting period.

0 2 4 6 8 10 12

(13l) Movements from reference marks

(10c) Localisation of intended volume

(10f) Production of images demonstrating correct detail

(13z) On-set imaging: production process

(13k) ID of reference marks

(10b) Positioning of patient

(5a) Completion of request for treatment

(13aa) On-set imaging: approval process

(13q) Setting of couch position/angle

Percentage of reports

Voluntary data

Inspectorate data

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The overall increase in voluntary reporting indicates a mature reporting culture. The increase

in providers contributing also demonstrates the radiotherapy community’s commitment to

maximise learning from these events to minimise the frequency of their occurrence in the

future.

Since November 2013 data has been collated, analysed and reported for the UK as a whole.

This and the increase in the average number of providers participating in this initiative may

explain the increase in RTE reporting. However, there is still some variation in the frequency

of reporting, this is shown in the increase in the average lag time from 49 days in the 2014

report8 and 58.8 days in this reporting period. To ensure timeliness of learning providers are

encouraged to report on a monthly basis.

Data received from NATCANSAT17

shows that activity for radiotherapy providers has also

increased slightly during this reporting period. Using the NATCANTSAT data for England UK-

wide data was extrapolated. An estimated 313,876 episodes of radiotherapy were delivered

during the period from December 2013 until November 2015 compared with 308,730 from the

2014 report8. Each episode is made up of multiple visits ranging 1 to 37. It should also be

noted that each episode of radiotherapy may consist of several prescriptions treated

consecutively and/ or concurrently. RTEs were detected and reported to the national voluntary

reporting scheme in 4.0% of episodes, which is an increase from 2.5% in the 2014 report8.

During this reporting period an estimated 397,402 prescriptions were delivered, compared to

413,730 prescriptions in the previous reporting period. RTEs were detected in 3.2% of

prescriptions, which is an increase from 1.9% during the last reporting period8. This decrease

in prescriptions and increase in activity may be due to an increase in complex radiotherapy

and hypofractionation regimes.

This increase in percentage of RTEs in relation to activity should be interpreted carefully and

reflects a maturing reporting culture.

Treatment unit process associated RTEs made up 41.4% (n = 5254) of all RTEs, an estimated

15,001,416 treatment exposures were delivered. A treatment exposure is the delivery of one

radiotherapy treatment field, this does not include imaging exposures. Treatment process

RTEs were detected in 0.03% of treatment exposures.

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.

5.2 Classification level of RTE

The vast majority of the RTE 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 the majority of

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

impact on the patient or the outcome of their treatment.

This was similar to the trend seen in each of the previous biennial reports. A small number of

higher level incidents and a much greater number of lower level incidents is 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 26), it may be seen that as the severity of an incident decreases, the probability of its

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occurrence increases. The distribution of data in Figure 27, which shows a breakdown of the

entire dataset by classification, supports this theory.

Figure 26: Heinrich’s triangle (reproduced from Towards Safer Radiotherapy3)

Figure 27: Classification levels as a percentage of RTE reports across the four two-year reports, from December 2007 to November 2015

When compared with results from the 20148 report there has been no overall change in the

percentage of reportable (1.7% in 2014 and 1.8% in 2016) and non-reportable radiation

incidents (1.3% in 2014 and 1.4% in 2016). Although the percentage of level 1 RTEs has

remained similar since the last analysis in 2014 the number of reportable radiation incidents

has increased significantly (n = 128 in 2014 and n = 232 in 2016) with a slight increase in

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 reports

2010 (n=680)

2012 (n=3316)

2014 (n=7655)

2016 (n=12691)

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activity. Further analysis of the raw data indicates that this increase can be attributed to the

increase in reporting of pre-treatment and verification imaging exposure related RTEs to the

inspectorates.

There has been a slight increase in the percentage of minor radiation incidents from 28.6% in

2014 to 31.5% in 2016. There has been an overall decrease in the percentage of other non-

conformances (41.6% in 2014 and 36.6% in 2016). This might be explained in it is known that

clinical departments with limited resource are more likely to submit reports on higher level

RTEs such as level 1 ‘reportable radiation incident’, level 2 ‘non-reportable radiation incident’

and level 3 ‘minor radiation incident’18

only.

TSRT3 stated that root cause analysis of minor and near miss RTE events has been shown to

provide valuable lessons which can prevent serious incidents. Therefore to investigate this

theory in more detail the PSRT is committed to the collation of all levels of RTE events and

their inclusion in the analysis for promulgation to the radiotherapy community. Clinical

departments are encouraged to continue reporting all levels of RTE to facilitate this process.

5.2.1 Level 1 (reportable radiation incident) RTE

The spread of the level 1 RTE reports across process coding was similar to findings in the

2014 report8 with seven of the same process codes. An increase from 43.0% to 50.0% in

reports from ‘treatment unit processes’ has been seen. Whilst the contribution of the subcode

‘movements from reference marks’ remained comparable (10.9%, 2014 and 10.8%, 2016) the

subcode ‘on-set imaging: production process’ which accounted for 7.3% (n = 17) of level 1

errors in the 2016 report was not reported as a frequently occurring subcode in the 2014

report8. The increase in the process subcode ‘on-set imaging: production process’ may

explain the increase in treatment unit related reports.

5.2.2 Level 2 (non-reportable radiation incident) RTE

The spread of these RTE reports across process coding was similar to findings in the 2014

report8 with the seven most frequent process codes being the same for this subgroup.

‘On-set imaging: approval process’ was notably the most frequently occurring event at 16.3%

(n = 29), followed by ‘movements from reference marks’ (6.7%, n = 12) within the subset of

non-reportable radiation incidents. The 2014 report8 presented these two subcodes as equally

the most frequent subcodes each at 9.7% (n = 10).

5.2.3 Level 3 (minor radiation incident) RTE

The spread of RTE reports across process coding was consistent with findings in the 2014

report8 for this subgroup. ‘Treatment unit process’ was the most common code for these

reports, at 75.1% (n = 2,998).

The 2014 report8 presented the most frequently reported event within this subset of minor

radiation incidents as ‘On-set imaging: production process’ (13.8%, n = 302), this percentage

has increased to 23.1% (n = 922) within this reporting period. A review of the ‘on-set imaging

production process’ subset of RTE reports revealed that 48.9% (n = 451) related to procedural

failures and the remaining 51.1% (n = 471) of this subgroup related to equipment failure, this

is a decrease in percentage from the 2014 report8 where 61.2% (n = 185) were due to

equipment failure.

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Of note when compared to the 2014 report8, all of the most frequently occurring subcodes

within this classification were the same, apart from ‘patient positioning’ which replaces ‘setting

of couch position’.

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 PM7719

should continue to be reported to the Health and Safety

Executive (HSE). 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.

5.2.4 Level 4 (near miss) RTE

Once again the spread of reported RTEs across process codes is consistent with the 2014

report8, ‘treatment unit process’ was the most common code for these reports, making up

32.2% (n = 1174).

Although treatment unit process was the most common code for these reports, the most

frequently occurring process subcodes were ‘documentation of instructions’ (7.2%, n = 262)

and ‘accuracy of data entry’ (7.2%, n = 261), the latter was also the most frequently reported

subcode presented within the near miss incident grouping in the 2014 report8

(9.3%, n = 191).

5.2.5 Level 5 (other non-conformance) RTE

‘Pretreatment planning process’ was the most common code for these reports making up

22.2% (n = 1,032) of them, this percentage is similar to the 2014 report8 where 20.0% (n =

638) were associated with pretreatment planning process.

The most frequently reported RTE within this classification was associated with ‘management

of process flow within planning’ at 7.4% (n = 344), this was followed by ‘bookings made

according to protocol’ at 5.0% (n = 233). This is a slight change from the 2014 report8 where

‘consent process’ was the most frequently reported RTE within this classification with 5.6% (n

= 177) followed by management of process flow within planning at 3.9% (n = 125).

5.3 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.

5.3.1 Breakdown of process codes

Consistent with previous reports RTEs were spread across all 21 categories of process codes,

treatment unit process codes were the most frequently reported RTE (41.4%, n = 5,254). This

is to be expected as some radiotherapy treatments may span a number of visits, providing

many opportunities during the treatment unit process for RTE to occur. RTEs attributed to

treatment unit processes have increased from 33.5% (n = 2,568) in the 2014 report8 to 41.4%

(n = 5,254) within this reporting period. This may be due to a continued increase in the use of

imaging and imaging associated RTEs. Radiotherapy is evolving and the increase in RTE

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associated with treatment unit process may continue due to the uptake in complex techniques

and adaptive radiotherapy20

.

5.3.2 Breakdown of process subcodes

The following processes have been identified as areas in the radiotherapy pathway where

RTEs frequently occur:

on-set imaging: production process (13z)

use of on-set imaging (13i)

on-set imaging: approval process (13aa)

accuracy of data entry (12f)

documentation of instructions/information (10j)

on-set imaging: recording process (13bb)

management of process flow within planning (11o)

recording of patient specific instructions (11n)

movements from reference marks (13l)

bookings made according to protocol (6a)

Guidance has already been published on how to minimise all of 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 quarterly analyses6.

When compared with the 2014 two-year report8 a change in error trends can be seen. This

reinforces the need for a cyclical approach to reporting, analysis and timely sharing of learning

from these events. Eight of the same process subcodes were found in the most frequently

reported list in both the current and 2014 analyses, seven of these were also within the 2012

analyses. These ranked differently between analyses, as shown in Table 2.

‘Consent process’ and ‘generation of plan for approval’ did not appear in the most frequently

reported process subcode list in the current analysis. These were replaced by ‘bookings made

according to protocol’ and ‘management of process flow within planning’. This change may be

due to the increasing complexity of booking appointments and the management of workflow

throughout a department.

The most frequently occurring process subcode was ‘accuracy of data entry’ in the 2014

report8. Within this reporting period this is now the fourth most frequently occurring subcode,

this may be due to a change towards paper-light or electronic working and a reduction in

transcription. On-set imaging processes represented 4 out of the 10 most frequently occurring

process subcodes reported. This rise in ‘on-set imaging processes’ related reports may reflect

the increased uptake in on-set imaging due to its further availability and the recognition of its

preventive role in minimising geographical displacement during treatment21

. In addition, it is

likely that error rates might be higher as new techniques and technologies are adopted locally

in this field.

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Table2. Comparison of most frequently reported process subcodes in 2012, 2014 and 2016 report trends.

Process subcode

Number of reports

Percentage of reports

Increase 13z On-set imaging: production process 2012 109 3.3%

2014 366 4.8%

2016 1067 8.4%

13i Use of on-set imaging 2012 65 2.0%

2014 302 3.9%

2016 825 6.5%

10j Documentation of instructions/information 2012 120 3.6%

2014 295 3.9%

2016 528 4.2%

13bb On-set imaging: recording process 2012 74 2.2%

2014 222 2.9%

2016 463 3.6%

Decrease 13l Movements from reference marks 2012 130 3.9%

2014 226 3.0%

2016 313 2.5%

12f Accuracy of data entry 2012 188 5.7%

2014 387 5.1%

2016 543 4.3%

Neither 11n Recording of patient specific instructions 2012 80 2.4%

2014 223 2.9%

2016 336 2.6%

13aa On-set imaging: approval process 2012 194 5.9%

2014 343 4.5%

2016 733 5.8%

5.3.3 End of process checks

‘End of process checks’ are one form of safety barrier in error detection and, as such should

include safety-critical elements of the pathway. By their very nature they should be clearly

defined within local protocols with appropriately trained staff clearly assigned to undertake

these duties and their results should be clearly recorded3. The frequency and effectiveness of

checking and verifying procedures should be audited to ensure they are of value.

Not all RTE report submissions include secondary or subsequent process coding, so the

reported 20.4% (n = 2,584) of RTE including ‘end of process checks’ where points in the

pathway at which the RTE has gone undetected may be higher than those reported. This is a

slight percentage increase in the findings of the 2014 report8 where 17.9% (n = 1,369) RTE

included end of process checks.

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5.4 Inspectorate data

A total of 437 reports were shared by the inspectorates compared to 232 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, some of which

could also have been reported to the voluntary scheme as lower level incidents. Secondly

data from the inspectorate for IRR9914

is not included nor are independent sectors. Finally

there is a greater time lag in submitting RTEs to the voluntary reporting scheme than to the

inspectorates.

Similar to the level 1 ‘reportable radiation incident’ reports received through the voluntary

reporting scheme, ‘movements from reference marks‘ emerged as the most common process

subcode. This was the jointly the most common process subcode within the inspectorate data

shared in the 2014 report8.

6 Conclusion

When the opportunity for error is weighed against the incidence of error, radiotherapy may be

seen as a safe form of treatment for cancer. Although RTEs are rare, when they do occur the

consequences can be significant so it is essential the radiotherapy community does not

become complacent about the associated risks.

The overall increase in voluntary reporting indicates a maturing reporting culture. It also

demonstrates the radiotherapy 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 electronic systems are locally commissioned to enable streamlining of submission of

RTE at all levels. Clinical departments are encouraged to submit all levels of RTEs.

Use of the terminology, classification and coding of TSRT, together with implementation of the

national voluntary reporting system described within this report, allows clinical departments to

compare their local analysis to the national picture. In this, the first two-year report that

includes RTE reports from across the UK, it can be seen that with the addition of data from

Northern Ireland and Scotland the error trends in the types of RTE reported remain consistent.

This would suggest that the types of RTE that occur across the UK are consistent.

This report has identified errors in activities undertaken by various professional groups,

throughout the patient pathway and across different service providers. A total of 41.4%

(n = 5,254) of the RTEs reported were associated with ‘treatment unit process’ and 16.2%

(n = 2,053) occurred during ‘pretreatment planning process’. RTEs were spread across all

21 categories of process code. The vast majority of reports were categorised as lower level

events, thus not affecting the outcome of patient care.

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In this analysis the following processes have been identified as areas in the radiotherapy

pathway where RTEs commonly occur:

on-set imaging: production process (13z)

use of on-set imaging (13i)

on-set imaging: approval process (13aa)

accuracy of data entry (12f)

documentation of instructions/information (10j)

on-set imaging: recording process (13bb)

management of process flow within planning (11o)

recording of patient specific instructions (11n)

movements from reference marks (13l)

bookings made according to protocol (6a)

Guidance has already been published on how to minimise all of these frequently occurring

RTEs in the quarterly newsletter Safer Radiotherapy through the ‘error of the month’ column,

as some of these trends were noted in the routine analyses6.

When compared with the 2014 two-year report8 a slight change in error trends can be seen.

Eight of the same process subcodes were found in the most frequently reported list in both the

current and 2014 analyses, seven of these were also within the 2012 analyses. These ranked

differently between analyses.

In addition, when compared with results from the 20148 report there has been no overall

change in the percentage of reportable (1.7% in 2014 and 1.8% in 2016) and non-reportable

radiation incidents (1.3% in 2010 and 1.4% in 2016). However there has been a slight

increase in the percentage of minor radiation incidents from 28.6% in 2014 to 31.5% in 2016.

There has been an overall decrease in the percentage of other non-conformances (41.6% in

2014 and 36.6% in 2016). It is known that clinical departments are more likely to submit

reports on higher level RTEs such as level 1 ‘reportable radiation incident’, level 2 ‘non-

reportable radiation incident’ and level 3 ‘minor radiation incident’18

.

It is imperative that RTE trends continue to be reported, analysed and monitored on a cyclical

basis, in order to inform ongoing safe and effective radiotherapy practice. This is especially

pertinent as new techniques and technologies are implemented and as new clinical

radiotherapy departments are established. This work supports a risk based approach to

improving safety both locally and nationally and indicates a culture that is open, transparent

and already present in the UK radiotherapy community.

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7 Key recommendations

a) Radiotherapy departments across the UK should continue to use TSRT to classify and

code all of their RTEs, including near misses for local analysis to inform policy and

practice

b) Radiotherapy departments across the UK should continue to submit coded and classified

RTE reports to the national voluntary reporting system using the mechanisms identified

within this report

c) To ensure timeliness of learning providers are encouraged to report on a monthly basis

d) Radiotherapy departments across the UK should consider all codes when coding RTE

and the use of secondary or additional subcodes

e) PSRT should continue to develop analysis of the reports, with regular dissemination of

findings to the radiotherapy community for group learning

f) The data should be used both by the PSRT and by individual radiotherapy departments as

part of a risk-based approach to allocating resources for improving patient safety in

radiotherapy and to inform audit and research

g) The mechanism to enable departments 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

h) A mechanism should be developed to enable independent radiotherapy providers to

submit RTE reports to PHE for collation and analysis as part of a UK dataset

i) The radiotherapy pathway coding as described in TSRT should be refined to reduce any

ambiguity of codes and to reflect the use of emerging techniques and technologies, this

should include safety barriers and causative factor taxonomies.

j) Radiotherapy departments across the UK should consider reviewing their end of process

checks and consider safety critical elements of the pathway

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8 Acknowledgements

National Clinical Analysis and Specialised Applications Team (NATCANSAT)

National Reporting and Learning System (NRLS)

NHS Radiotherapy Providers across the UK

Inspectorates for IR(ME)R

9 PSRT Steering Group Membership

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)

Leslie Frew (Institute of Physics and Engineering in Medicine – Head of Radiotherapy Physics

Service, Belfast City Hospital)

Maria Murray (Society and College of Radiographers – Professional Officer for Scotland and

UK Radiation Protection Lead)

Tony Murphy (Lay Representative)

Madeleine Ottrey (Public Health England)

Tom Roques (Royal College of Radiologists – Consultant Clinical Oncologist and Clinical

Director for Oncology and Haematology, Norfolk and Norwich University Hospital NHS

Foundation Trust)

Carl Rowbottom (Institute of Physics and Engineering in Medicine – Head of Physics, The

Clatterbridge Cancer Centre NHS Foundation Trust)

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10 References

1. World Health Organization. Reporting and learning for patient safety. Available at

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

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/An

nualReports/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. 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

5. PSRT. Patient Safety in Radiotherapy Steering Group Activity (November 2007 – March 2010). Data report on patient

safety incidents from August 2007 until November 2009. 2010. HPA-CRCE-002 (2010). Available at

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

6. PHE. Safer Radiotherapy: Radiotherapy Newsletter of PHE (previously of the HPA) and Supplementary Data Analysis:

Full Quarterly Radiotherapy Error Data Analysis. Nos 1–19. Available at www.gov.uk/government/publications/safer-

radiotherapy-error-data-analysis-report

7. PSRT. Data report on radiotherapy errors and near misses (December 2009 – November 2011). HPA-CRCE-035

(2012). Available at www.gov.uk/government/publications/radiotherapy-errors-and-near-misses-data-report

8. PSRT. Data report on radiotherapy errors and near misses (December 2011 – November 2013). PHE-CRCE-016 (2014). Available at www.gov.uk/government/publications/radiotherapy-errors-and-near-misses-data-report

9. NPSA. Definition of a patient safety incident (PSI). Available at www.npsa.nhs.uk/nrls/reporting/what-is-a-patient-safety-incident/

10. NRLS. Quarterly Data Workbook up to March 2015. Available www.nrls.npsa.nhs.uk/resources/collections/quarterly-data-summaries/?entryid45=135507

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/

12. PHE. Supplementary Guidance Series: Good Practice in Radiotherapy Error Reporting. Nos 1–4. Available at

www.gov.uk/government/publications/radiotherapy-good-practice-in-error-reporting

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

The Ionising Radiation (Medical Exposure) (Amendment) Regulations (2006). The Stationery Office, London. SI

2006/2523. Available at www.opsi.gov.uk/si/si2006/20062523.htm The Ionising Radiation (Medical Exposure)

(Amendment) Regulations (Northern Ireland) 2010. The Stationery office, London NISR 2010/29. Available at

http://www.legislation.gov.uk/nisr/2010/29/contents/made and the Ionising Radiation (Medical Exposure) (Amendment)

Regulations (2011). The Stationery Office, London. SI 2011/1567. Available at

www.legislation.gov.uk/uksi/2011/1567/introduction/made

14. The Ionising Radiations Regulations (1999). The Stationery Office, London. SI 1999/3232. Available at

www.opsi.gov.uk/si/si1999/19993232.htm

15. Pause and check, SCoR Available at www.sor.org/sites/default/files/sor_pause_check_a2.pdf

16. DOH. Information on IRMER (2000) available

at www.gov.uk/government/uploads/system/uploads/attachment_data/file/329842/Medical_exposures.pdf

17. Natcansat www.natcansat.nhs.uk/ 18. PSRT. Safer radiotherapy: supplementary survey analysis. Report 3 (2014). Available at

www.gov.uk/government/publications/safer-radiotherapy-supplementary-survey-analysis

19. HSE. Equipment used in connection with medical exposure. Guidance Note PM77 (3rd ed) (2006). Available at

www.hse.gov.uk/pubns/guidance/pm77.pdf

20. Cancer research UK and NHS England. Vision for radiotherapy 2014-2024. (2014) available at

www.cancerresearchuk.org/sites/default/files/policy_feb2014_radiotherapy_vision2014-2024_final.pdf

21. 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

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Appendix A

35

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 Radiotherapy pathway coding

Reproduced from Towards Safer Radiotherapy3

Process code Activity code

0 Scientific infrastructure

0a Implementation of national and international codes of practice for radiation dosimetry

0b Development of dosimetry algorithms for local application

0c Development of treatment planning algorithms for local application

0d Other

Equipment-specific activities

1 Room design

1a Patient safety

1b Staff and public safety

1c Environmental controls

1d Access control

1e Other

2 New equipment

2a Installation

2b Manufacturer’s tests

2c Acceptance tests

2d Critical examination under IRR99

2e Customisation and configuration of equipment

2f Commissioning

2g Data recording

2h Preparation of data files for planning computers

2i Other

3 Routine machine QA

3a Daily consistency checks – geometric parameters

3b Daily consistency checks – dosimetric calibration

3c Daily consistency checks – safety (IRR compliance)

3d Daily verification of accuracy of data transfer between TPS, R&V system and treatment

equipment

3e Planned QA programme checks – geometric parameters

3f Planned QA programme checks – dosimetric calibration

3g Planned QA programme checks – safety (IRR compliance)

3h Planned QA programme checks – image quality parameters (including CT, MR, portal,

cone-beam, film processor)

3i Regular preventative maintenance and repair programme

3j Handover of radiotherapy equipment after planned QA and maintenance

3k Routine radiation safety checks

3l Other

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Appendix B

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Process code Activity code

Patient-specific activities

4 Referral for treatment

4a Identification of patient

4b Verification of diagnosis/extent/stage

4c Choice of dose

4d Choice of modality

4e Choice of energy

4f Choice of fractionation

4g Choice of start date

4h Consideration of patient condition/co-morbidities

4i Choice of other interventions and their sequencing

4j Consent process

4i Other

5 Communication of intent

5a Completion of request for treatment (paper/electronic)

5b Recording of patient ID

5c Completion of required demographics

5d Completion of tumour-specific information

5e Completion of radiation-specific information

5f Completion of details of other professionals

5g Completion of administrative data

5h Recording of previous treatment details

5i Recording of patient’s specific requirements

5j Recording of non-standard information/protocol variations

5k Authorisation to irradiate (IR(ME)R)

5l Other

6 Booking process (pretreatment and treatment)

6a Bookings made according to protocol

6b Bookings made according to request details

6c Recording of booked appointments

6d Communication of appointments to patient

6e Other

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

7d Old patient: location of healthcare organisation’s notes

7e Old patient: location of department notes/previous treatment details

7f Availability of reports/imaging required by protocol for treatment

7g Availability of consent documentation

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Radiotherapy Errors and Near Misses Data Report (December 2013 to November 2015)

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Process code Activity code

7h Other

8 Pretreatment: preparation of patient

8a Confirmation of ID

8b Confirmation of consent

8c Confirmation of fertility/pregnancy status

8d Advice on procedure

8e Other

9 Mould room/workshop activities

9a Confirmation of ID

9b Pre mould room diagnostics/interventions

9c Production of immobilisation devices

9d Checking/fitting of immobilisation devices

9e Production of other accessories/personalised beam shaping device

9f Checking of other accessories/personalised beam shaping device

9g Labelling of mould room/workshop outputs

9h Recording of information in patient record

9i Instructions to patient

9k End of process checks

9l Other

10 Pretreatment activities/imaging (to include CT, simulation, clinical mark-up)

10a Confirmation of ID

10b Positioning of patient

10c Localisation of intended volume

10d Production of images using correct imaging factors

10e Production of images using appropriate field sizes

10f Production of images demonstrating correct detail

10g Labelling of images

10h Saving of planning geometry data

10i Recording of radiation data

10j Documentation of instructions/information

10k Marking of patient or immobilisation device

10l End of process checks

10m Identification of staff

10n Other

11 Pretreatment planning process

11a Verification of patient ID to include all patient data, imaging etc

11b Recording of patient ID on plan

11c Importing of data from external administrative sources

11d Importing of data from external imaging sources

11e Choice of data

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Appendix B

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Process code Activity code

11f Choice of dose and fractionation inputs

11g Availability of source data

11h Choice of technique

11i Target and organ at risk delineation

11j Generation of plan for approval (to include DVH etc as app.)

11k Authorisation of plan

11l Verification of plan/identification of responsible staff

11m Recording of definitive treatment prescription

11n Recording of patient specific instructions

11o Management of process flow within planning

11p Management of authorisation process

11q Timeliness of plan production

11r Calculation process for non-planned treatments

11s Calculation checking process for non-planned treatments

11t End of process checks

11u Identification of responsible staff

11v Other

12 Treatment data entry process

12a Pre-data entry verification

12b Choice of data entry method (input vs transcription)

12c Use of correct data

12d Correct ID of patient/all patient input data

12e Correct ID of patient output data

12f Accuracy of data entry

12g End of process checks

12h Identification of responsible staff

12i Other

13 Treatment unit process

13a Availability/timeliness of all required documentation

13b Patient ID process

13c Patient data ID process

13d Explanation/instructions to patient

13e Confirmation of pregnancy/fertility status

13f Assessment of patient prior to treatment

13g Patient positioning

13h Use of IVD according to local protocol

13i Use of on-set imaging

13j Transfer of marks

13k ID of reference marks

13l Movements from reference marks

13m Setting of treatment machine parameters

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Radiotherapy Errors and Near Misses Data Report (December 2013 to November 2015)

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Process code Activity code

13n Setting of collimator angle

13o Setting of jaw position

13p Setting of asymmetry

13q Setting of couch position/angle

13r Use of immobilisation devices

13s Use of beam shaping devices

13t Use of beam direction aids/applicators

13u Use of compensators

13v Use of wedges

13w Availability of treatment accessories

13x Setting of energy

13y Setting of monitor units

13z On-set imaging: production process

13aa On-set imaging: approval process

13bb On-set imaging: recording process

13cc Management of variations/unexpected events/errors

13dd Communication between treatment unit and V&R

13ee Recording of patient attendance

13ff Recording of delivered treatment data

13gg Recording of additional information

13hh End of process checks

13ii Identification of responsible staff

13jj Other

14 On-treatment review process

14a On-treatment review of patient according to protocol by RT staff

14b On-treatment review of patient according to protocol by other professional

14c On-treatment review of notes/data to according protocol

14d Actions following on-treatment review

14e Other

15 Brachytherapy

15a Ordering of sources

15b Delivery of sources

15c Source calibration

15d Sterility of sources

15e Correct applicators/sources

15f Correct theatre equipment

15g Initial positioning of applicators/sources

15h Planning of treatment

15i Maintenance of position of applicators/sources

15j Removing of applicators/sources

15k Other

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Appendix B

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Process code Activity code

16 End of treatment process

16a Communication of appropriate end of treatment information to patient

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

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

18a Timing of chemo/irradiation

18b Transport issues

18c Portering issues

19 Document management

19a Availability of current protocol documentation

20 Staff management

20a Availability of staff with competency appropriate to procedure