HPA-CRCE-035

© Health Protection Agency Centre for Radiation, Chemical and Environmental Hazards Chilton, Didcot Oxfordshire OX11 0RQ

Approval: June 2012 Publication: July 2012 £15.00 ISBN 978-0-85951-718-8

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

Data Report on Radiotherapy Errors and Near Misses

(December 2009 – November 2011)

Report No 2

Patient Safety in Radiotherapy Steering Group

The HPA currently chairs the Patient Safety in Radiotherapy Steering Group, having taken this function over from the National Patient Safety Agency in April 2010.

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EXECUTIVE SUMMARY

Within the UK, radiotherapy is considered to be a safe and effective treatment for cancer. However, radiotherapy is a highly complex, multi-step process that requires the input of many different staff groups in the planning and delivery of the treatment1. Though radiotherapy errors (RTE) are rare, when they do occur the consequences can be significant so it is imperative we do not become complacent about the associated risks.

Since the publication of Towards Safer Radiotherapy1 (TSRT) the Health Protection Agency (HPA), in conjunction with the National Patient Safety Agency (NPSA), has continued to work closely with partner organisations to develop a voluntary reporting system which is used to analyse patient safety incidents in relation to radiotherapy errors.

The National Reporting and Learning System (NRLS) at the NPSA, allows radiotherapy error reports to be completed using the same process as other patient safety incident reports. A trigger code ‘TSRT9’ is employed in addition to a dedicated coding system which describes where in the radiotherapy pathway the error occurred and a classification which defines the severity of the error as described in TSRT1. This system enables the radiotherapy specific data, to be easily extracted from the NRLS. The work of the NRLS has moved from the NPSA and continues within the NHS Commissioning Board and they continue to work together in partnership with NHS organisations to make services even safer for patients.

This report is the second in a series of 2 yearly reports of radiotherapy errors and near miss events. Since the previous report in 20103, the number of RTE reports submitted to the NRLS has increase significantly from 1,365 in 2010 to 3,411 in 2012. This increase in reporting is reflective of a maturing reporting culture and indicative of the acceptance and commitment of clinical departments and radiotherapy professionals to improving safety nationally.

When compared with the 2010 2 year report there has been a reduction in the number of higher level (Levels 1-3) RTE reported and an increase in the number of lower level RTE.

The Patient Safety in Radiotherapy Steering Group (PSRT) was set up to monitor the implementation of the recommendations from TSRT1. The Steering Group was chaired by the NPSA until 31st March 2010, with the HPA taking over this function as of the 1st

April 2010. Specialist radiotherapy staff at the HPA undertake the analyses of these RTE reports and share learning with the radiotherapy community to minimise the future occurrence of similar events.

During the period December 2009 until November 2011, an estimated 267,968 episodes of radiotherapy treatment were delivered in England and Wales. Of these RTE were detected and reported to the NRLS in only 1.2 % of episodes. The vast majority of these reports were categorised as lower level events thus not affecting the outcome of patient care. Further more, each episode is made up of multiple visits, ranging in

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number from 1 to 37. It should also be noted that each episode of radiotherapy may consist of several prescriptions treated consecutively and/or concurrently. The incidence of RTE events is therefore considered to be low when compared with the opportunity for error in radiotherapy.

This report provides a summary of data analysis, including a detailed breakdown by TSRT2 classification and coding of this data.

A total of 3,316 RTE reports from the time period 1st December 2009 until 30th November 2011 were included in this analysis and are presented below. The average number of RTE reported on a monthly basis was 142 during this period.

The reports identified errors in activities undertaken by various professional groups, throughout the patient pathway and across different service providers. A total of 47.8% (n=1,585) of RTE reported were associated with treatment unit processes and a further 35.8% (n=1,187) were associated with pre-treatment planning processes.

Of the RTE reports 71.6% (n=2.374) were near miss or other non-conformities with no impact on patient outcome and 25.8% (n=855) were deemed not clinically significant. Of the remaining 2.6% (n=87) of RTE reports, only 1.1% (n=38) were reportable under IR(ME)R9 to the appropriate authority. It should be noted that reportable radiation incidents occurred in approximately 0.01% of episodes of radiotherapy delivered in England and Wales. In addition the majority of these higher level incident reports affected only one fraction 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.

The following processes were identified as areas in the radiotherapy pathway where RTE commonly occur.

• Movements from reference marks

• Accuracy of data entry

• On-set Imaging: Approval Process

• End of process checks

• Management of process flow within planning

• Patient identification process

Guidance has already been published on how to minimise these frequently occurring RTE in the quarterly Newsletter ‘Safer Radiotherapy’ as ‘Error of the month’4.

Between the first 2 reports a change in error trend can be seen. This reinforces the need for a cyclic approach to reporting, analysis and timely sharing of learning from these events. Previously it was noted that although RTE occurred throughout the patient pathway and across professional groups, there was an emphasis on ‘referral’ and ‘communication of intent’ processes. Of note was the high number of ‘timing of chemo/irradiation’ reports. However ‘accuracy of data entry’ and ‘movements from reference marks’ were also highlighted.

EXECUTIVE SUMMARY

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Radiotherapy is a dynamic specialism where technological changes, emerging techniques and research rapidly feed into regular practice. This is especially true as new techniques and technologies are implemented and as new clinical radiotherapy departments are established. With a number of new radiotherapy departments under development, trends in RTE need to be continually monitored to gauge the safety of their establishment.

It is imperative that local radiotherapy departments continue to submit data using the trigger code for national analysis so trends in RTE can continually be monitored. A cyclic process of both local and national reporting, analysis and promulgation of learning is always required to facilitate trend analysis of errors so we can work together as a community to minimise the occurrence of these events in radiotherapy departments across the UK.

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CONTENTS

1 Introduction 1

2 Background 2

3 Data 3 3.1 Data Quality 3 3.2 Use of the Trigger Code 4 3.3 Consistency Checking 5 3.4 Local Reporting Culture 5

4 Results 7 4.1 Classification of RTE 7 4.2 Breakdown of Classification by Process Code 8

4.2.1 Breakdown of Level 1 (Reportable Radiation Incident) RTE 8 4.2.2 Breakdown of Level 2 (Non-Reportable Radiation Incident)

RTE 11 4.2.3 Breakdown of Level 3 (Minor Radiation Incident) RTE 13 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 16 4.3.1 Breakdown of Process Codes 16 4.3.2 Breakdown of Process Sub-codes 17 4.3.3 End of Process Checks 19

5 Discussion 20 5.1 Data Quality 20 5.2 Increase in RTE reporting 20 5.3 Classification 20 5.4 Main Themes 21 5.5 Learning from Errors 22

6 Conclusions 24

7 Future Work 26

8 Key Recommendations 27

9 PSRT Steering Group Membership 28

10 References 29

Appendix A Radiotherapy Error Classification Grid 30

Appendix B Radiotherapy Pathway Coding 31

INTRODUCTION

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1 INTRODUCTION

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 (CMO) for England and Towards Safer Radiotherapy1 (TSRT), published in 2008, were seminal documents in the field of radiotherapy safety; both contained practical recommendations to the radiotherapy community aimed at improving safety and reducing errors.

TSRT provides definitions for the terminology to be used in discussing radiotherapy errors that includes near misses (RTE) and proposed 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 2007, 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. The Group was chaired by the National Patient Safety Agency (NPSA) until 31st March 2010, with the Health Protection Agency (HPA), taking over this function as of the 1st April 2010. Detailed analysis of RTE reports is undertaken by the HPA and reported to the PSRT.

The promotion of the collation and analysis of radiotherapy errors and near miss events (RTE) is a fundamental part of this work programme. This led to the publication in June 20103 of the first 2 year data report on a back catalogue of patient safety incidents reported to the NRLS between August 2007 and November 2009.

This publication was closely followed in September 2010 by the introduction of a series of quarterly newsletters entitled ‘Safer Radiotherapy’4 providing regular updates on the analysis of radiotherapy error (RTE) reports for professionals working in the radiotherapy community.

This report provides an overview of RTE data reported to the NRLS from December 2009 until November 2011.

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2 BACKGROUND

The National Reporting and Learning Service (NRLS) operate 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.” 5.

Patient safety incidents are reported by NHS staff through local trust risk management systems and web based e-forms across England and Wales to the NRLS. Patients and carers can also report directly through the open access e-form on the National Patient Safety Agency (NPSA) website. The NRLS offers a unique dataset to help understand harm associated with healthcare. It was established in 2003 and now has over 8.8 million patient safety incident reports, from many areas of healthcare, in the database.

As with any voluntary reporting system, the NRLS 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. The NRLS can be interrogated for relevant incidents by searching the free text of any incident report using key words or search terms.

During the development of the radiotherapy initiative by the PSRT, 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 effectively6’. This code could be searched for in the free text rather than using search terms that were less determinant. Patient safety incidents that were not RTE such as a report of a patient falling in ‘radiotherapy’ would not be included in the RTE dataset. RTE is defined by TSRT1 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”

This initiative went further by asking radiotherapy department staff to classify and code the incident according to the taxonomies presented in TSRT within their current local incident reporting systems.

All reports to the NRLS containing the trigger code, classification and coding were shared with HPA staff for expert analysis and the results presented to the PSRT.

The work of the NRLS moved from the NPSA as of the 1st April 2012 and continues within the NHS Commissioning Board. The HPA have a data sharing agreement with the NRLS and under this agreement continue to extract RTE from the NRLS, and share learning from these events so as to make services safer for patients.

DATA

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3 DATA

A total of 3,411 RTE reports were identified by the NRLS as using the trigger code between December 2009 and November 2011 and were shared with the HPA for analysis.

On receipt of the reports, HPA staff with clinical radiotherapy expertise performed consistency checking of the local application of the classification and coding from TSRT. This was part of the quality assurance process of the data completed prior to analysis of the reports.

3.1 Data Quality

These reports were categorised into Patient Safety Incidents (PSI), Radiotherapy Error (RTE) and Incomplete Radiotherapy Error (IRTE). PSI and RTE have been previously defined. IRTE reports did not have the classification and coding added and there was insufficient detail in the report to allow classification and coding of the RTE. There were 83 PSI and 12 IRTE reports. This left a total of 3316 RTE reports which were included for analysis (Figure 1).

Figure 1: Type of RTE identified from the NRLS reports. December 2009 until November 2011 (n=3,411)

This demonstrated a significant improvement in the quality of the data submitted that formed the previous 2010 report as demonstrated in table 1 below. 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.

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TABLE 1 Comparison of Data Quality between Current Dataset and previous 2010 Report 2010 Report

Aug 07 – Dec 09 Current Report Dec 09 - Nov 11

n % n %

No of RTE 1365 46 3316 97.2

No of NRTE / PSI ~1209 41 83 2.4

Incomplete RTE ~375 13 12 < 0.4

Total no of Reports received 2949 100 3411 100

3.2 Use of the Trigger Code

The introduction of the trigger code in August 2009 resulted in a significant reduction in the number of unrelated NRTE and incomplete reports for analysis (see Table 1). Since its implementation 70% of radiotherapy centres across England and Wales have adopted it for use when submitting RTE reports to the NRLS.

This adoption rate was consistent with the findings of a survey of radiotherapy centres across England and Wales carried out in September 2011 by the PSRT Steering Group7. Findings also suggested that the planned implementation or commissioning of electronic local reporting systems in some of the remaining centres would facilitate the use of the trigger code for future reporting in these centres.

The average number of RTE reported on a monthly basis using the trigger code has also increased since its introduction as demonstrated in figure 2. A linear trend line for this data is included in black in the figure and demonstrates an average increase of better than 6 reports per month. This increase in reporting is reflective of a maturing reporting culture and indicative of the acceptance and commitment of clinical departments and radiotherapy professionals to improving safety nationally. It is expected that this increase will continue as the remaining departments adopt the trigger code.

A recent review of the NRLS using search terms instead of the trigger code for a dataset between December 2009 and November 2011 demonstrated that every NHS radiotherapy provider in England and Wales had submitted RTE reports to the NRLS. However the frequency of submission varied widely. The HPA will continue to monitor the adoption of the trigger code and frequency of data submission going forward.

DATA

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Figure 2: Number of RTE reports extracted from the NRLS using the trigger code by month. December 2009 until November 2011. (n=3,316)

3.3 Consistency Checking

HPA staff undertook consistency checking of the application of the classification and coding by local departments and an agreement of 88% was achieved. This positive result is in part due to the publication of guidance on the use of the trigger code and application of the coding and classification6,8. In addition individual clinical departments have reported that familiarity with the taxonomies expedites the coding and classification process.

3.4 Local Reporting Culture

The 2011 survey7 of clinical departments revealed that although all RTE are shared irrespective of process code, a proportion of those departments that submit RTE reports to the NRLS do not share all levels of RTE. It was shown that clinical departments were more likely to submit reports on higher level RTE such as Level 1 ‘reportable radiation incident’, Level 2 ‘non-reportable radiation incident’ and Level 3 ‘minor radiation incidents’. The largest discrepancy was seen with TSRT Level 5 ‘other non-conformance’ incidents.

All departments reported all levels of RTE for local analysis. Reasons cited for not reporting all levels of RTE to the NRLS included local Trust policy, a perceived lack of risk to patients and insufficient staffing levels to facilitate the reporting process. This is discussed further in section 5.2. Those departments with electronic reporting systems were most likely to report all levels of RTE.

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Figure 3: RTE reports submitted to the NRLS by clinical departments by TSRT classification level. (Taken from the 2011 Reporting Survey7)

RESULTS

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4 RESULTS

A total of 3,316 RTE reports from the time period 1st December 2009 until 30th November 2011 were included in this analysis and are presented below. Use of the taxonomies from TSRT provided the focus for the analysis of this data. ‘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 sub-codes which are reproduced from TSRT in Appendix B.

4.1 Classification of RTE

Each of the 3,316 reports was classified as ‘other non-conformance’, ‘near miss’, ‘minor radiation incident’, ‘non-reportable radiation incident’ and ‘reportable radiation incident’ (Figure 4). Of the RTE reports 71.6% (n=2.374) were near miss or other non-conformities with no impact on patient outcome. In total 25.8% (n=855) of the RTE reported were not clinically significant. Of the remaining 2.6% (n=87) of RTE reports, only 1.1% (n=38) were reportable under IR(ME)R9 to the appropriate authority.

Figure 4: Classification of RTE reports extracted from the NRLS. December 2009 until November 2011. (n=3,316)

When compared with results from the 2010 report a reduction in the percentage of reportable (1.1% from 3.8%), non-reportable radiation incidents (1.5 % from 2.7%) and minor radiation incidents (29.8% to 25.8%) can be seen, with an increase in the percentage of lower level incident, near misses (30% to 35%) and other non-conformances (33.7% to 36.6%). In short there has been a reduction in the number of higher level RTE reported and an increase in the number of lower level RTE including

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near miss and other no-conformances between reports. This is demonstrated in figure 5 below.

Figure 5: Comparison of classification of RTE reports extracted from the NRLS. 2012 (n=3,316) and 2010 Report Data (n=680).

4.2 Breakdown of Classification by Process Code

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

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)R9 or IRR9910. Clearly reporting to the NRLS 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 1.1% (n=38) of the RTEs reported to the NRLS (Figure 4). Of theses 38 reports, 63.1% (n=24) occurred during ‘treatment unit processes’ (Figure 6).

RESULTS

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Figure 6: Breakdown of Level 1 (reportable radiation incident) RTE reports by process code extracted from the NRLS. December 2009 until November 2011. (n=38)

Further analysis of the ‘treatment unit process’ reports indicates the points in the pathway at which the reportable radiation incidents occurred (Figure 7). ‘Movements from reference marks’ and ‘ID of reference marks’ comprised 36.8% (n=14) of all reportable radiation incidents reported to the NRLS for this time period. Examples of these types of reports included moves from reference tattoos to isocentre made in the wrong direction or by the wrong dimension, where a freckle or mole was mistaken for a tattoo or the wrong reference marks were used for set-up on an immobilisation device.

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Figure 7: Breakdown of Level 1 (reportable radiation incident) RTE reports associated with process code 13 (treatment unit process) extracted from the NRLS. December 2009 until November 2011. (n=24/38 subset of RTE)

Not all departments currently submit data to the NRLS using the trigger code, - hence the inspectorates for IR(ME)R for England and Wales were approached and asked to share their synopsis of reportable radiation incidents from the same time period. Only anonymised and closed events were shared. The coding from TSRT was applied to these reports and they are presented below in Figure 8.

Figure 8: Breakdown of Level 1 (reportable radiation incident) RTE reports from the Inspectorates for IR(ME)R by process code. December 2009 until November 2011. (n=69)

RESULTS

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Of the 69 level 1 RTE reported to the Inspectorates for England and Wales 63.8% (n=44), occurred during ‘treatment unit processes’. This is consistent with findings in the NRLS dataset. Further analysis of the ‘treatment unit processes’ indicates the points in the pathway at which the reportable radiation incidents occurred (Figure 9). ‘Movements from reference marks’ and ‘ID of reference marks’ formed 33.3% (n=23) of all reportable radiation incidents. Once again this is consistent with findings from the NRLS dataset.

Figure 9: Breakdown of Level 1 (reportable radiation incident) RTE reported to the Inspectorates associated with process code 13 (treatment unit process). December 2009 until November 2011. (n=44/72 subset of RTE)

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’. Non-reportable radiation incidents comprised 1.5% (n=49) of the RTE reports in the NRLS data. Of these Level 2 reports 46.9% (n=23) occurred during ‘treatment unit processes’ (Figure 10).

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Figure 10: Breakdown of Level 2 (Non-reportable radiation incident) RTE by process code extracted from the NRLS. December 2009 until November 2011. (n=49)

Further analysis of the ‘treatment unit processes’ indicates the points in the pathway at which the reportable radiation incidents occurred (Figure 11). ‘Movements from reference marks’ were the highest (30.4%, n=7)) occurring event within this subset of non-reportable radiation incidents.

Figure 11: Breakdown of Level 2 (Non-reportable radiation incident) RTE reports associated with process code 13 (treatment unit process) extracted from the NRLS. December 2009 until November 2011. (n=23/49)

RESULTS

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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’. Minor radiation incidents comprised 25.7%, (n=855) of the coded RTE reports in the NRLS data as seen in Figure 12. ‘Treatment unit processes’ was the most common code for these reports, at 57.8% (n=494).

Figure 12: Breakdown of Level 3 (Minor Radiation Incident) RTE reports by Process Code extracted from the NRLS . December 2009 until November 2011. (n=855)

Further analysis of the ‘treatment unit processes’ indicates the points in the pathway at which the minor radiation incidents occurred (Figure 13). ‘Movements from reference marks’ were once again the highest occurring event within this subset of minor radiation incidents. However this was closely followed by ‘use of beam shaping devices’ and ‘on-set imaging approval processes’. Examples of the former code (13s) include inappropriate use of lead or cerrobend shielding or electron end-frame resulting in an error. Examples of RTE included in ‘on-set imaging approval processes’

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included inaccurate analysis of field placement or image approval not being undertaken in a timely manner.

Figure 13: Breakdown of Level 3 (Minor radiation incident) most frequently occurring RTE reports associated with process code 13 (treatment unit process) extracted from the NRLS. December 2009 until November 2011. (n=378/855 subset of RTE)

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’. Near misses comprised 35.0% (n=1,162) of the coded RTE reported to the NRLS during this period. RTE reports covered 18 different codes within this classification. Once again ‘treatment unit processes’ was the most common code for these reports, making up 30.4% (n=353) of these reports. Only the top ten most frequently occurring codes are presented here Figure 14 which includes 97.2% (n=1130) of the total number of RTE reports within this Level 4 reports submitted to the NRLS.

RESULTS

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Figure 14: Breakdown of Level 4 (Near miss) most frequently occurring RTE reports by process code extracted from the NRLS. December 2009 until November 2011. (n=1,129/ 1,162 subset of RTE)

A total of 28 different treatment unit process sub-codes from process code 13 are included in this classification. The top-ten most frequently occurring processes are presented here, which make up 86.4% (305 of the 353) of the RTE reported under process code 13 within this level. Pathway points of interest are: ‘on-set imaging approval processes’, ‘on-set imaging production processes’ and ‘movements from reference marks’ (Figure 15).

Figure 15: Breakdown of Level 4 (Near miss) most frequently occurring RTE reports associated with process code 13 (treatment unit process) extracted from the NRLS. December 2009 until November 2011. (n=305/353 subset of RTE)

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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’ and made up 36.6% (n=1,212) of those RTE reports coded.

In the classification other non-conformance, ‘management of process flow within planning’ can be seen to contribute significantly to the number of RTE reported. Examples of this type of RTE report included delays the delineation of the clinical target volume and organ at risk and mismanagement of changes made to plans.

Figure 16: Breakdown of Level 5 (Other non-conformance) most frequently occurring RTE reports by Process Code extracted from the NRLS. December 2009 until November 2011. (n=575/1,212, subset of RTE)

4.3 Main themes of RTE

The 3,316 RTE reports were categorised by process code and then by process sub-code according to TRST irrespective of classification, so that main themes could be derived.

4.3.1 Breakdown of Process Codes The 10 most frequently reported processes in the radiotherapy pathway are presented in Figure 17 by process code. Almost 32% (n=1,061) of the RTE reported were

RESULTS

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associated with ‘treatment unit processes’ and 21.5% (n=713) occurred during ‘pre-treatment planning processes’.

Figure 17: Breakdown of RTE reports most frequently occurring process codes extracted from the NRLS. December 2009 until November 2011. (n=3175/3316 subset of RTE)

4.3.2 Breakdown of Process Sub-codes The most frequently occurring process sub-code was ‘management of process flow within planning’ making 6.9% (n=230) of all RTE reported to the NRLS. This was followed by ‘on-set approval process’, at 5.9% (n=194) and ‘accuracy of data entry’, at 5.7% (n=188). The 10 most frequently reported sub-codes are presented in Figure 18 below. This demonstrates a change in the reporting profile since the previous 2 year report in 20103. At that time ‘timing of chemo/irradiation’ was the most frequently reported RTE at 15.4% (n=64), followed by ‘accuracy of data entry’, at 14.4% (n=60) and ‘movements from reference marks’/ completion of request for treatment’/ ‘transport issues’ each at 10.8% (n=46).

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Figure 18: Breakdown of RTE most frequently occurring reports by process sub-code extracted from the NRLS. December 2009 until November 2011. (n=1353/3316 subset of RTE)

In a further breakdown of the most frequently occurring reports by process sub-code (Figure 18) classification of these reports was included and is presented in Figure 19. It may be seen that the majority (76.2%, n=1.031) of reports are made up of ‘near misses’ (Level 4) and ‘non-conformities’ (Level 5).

Figure 19: Breakdown of RTE most frequently occurring reports by process sub-code with classification extracted from the NRLS. December 2009 until November 2011. (n=1353/3316 subset of RTE)

RESULTS

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4.3.3 End of Process Checks Throughout the data analysis, the secondary activity sub-code ‘end of process checks’ was a consistent theme. It includes process sub-code’s 9k, 10l, 11t, 12g and 13hh (Figure 20). Due 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’ sub-code is repeated across the radiotherapy pathway. A total of 17.2% (n=570) of the RTE reported were not captured during end of process checks. This would seem to suggest that the ‘end of process checks’ are failing to detect RTEs in some cases.

Figure 20: Breakdown of ‘End of process checks’ by point in the radiotherapy pathway from RTE reports extracted from NRLS. December 2009 until November 2011. (n=643/3316 subset of RTE)

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5 DISCUSSION

5.1 Data Quality

Since the introduction of the trigger code and local application of the classification and coding the quality of the data received has improved significantly. This is evidenced in the reduction in the number of non-radiotherapy errors and incomplete reports submitted for analysis since the previous 2 year report in 2010. In addition consistency checking of the application of the coding and classification taxonomies showed 88% agreement.

This is in part due to the publication of a guidance document6 on this topic, the development of a supplementary series on good practice in RTE reporting8 and through familiarisation with the taxonomies.

5.2 Increase in RTE reporting

The increase in the number of RTE reported to the NRLS is of note during this 2 year period. A total of 3,411 RTE reports were submitted to the NRLS between December 2009 and November 2011 compared with 1,399 between August 2007 and November 2009.

An increase may also be seen in the number of centres reporting using the trigger code ‘TSRT9’. A total of 38 English and Welsh centres have adopted the trigger code since its introduction in August 2009.

The overall increase in voluntary reporting is indicative of 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. It is likely that this also demonstrates an increasing awareness of the importance of sharing data nationally to improve learning from these events. Much work was undertaken across the UK to highlight this initiative in the RT community during this time and the community demonstrated it’s commitment to this work through it’s involvement and support.

A further increase in the number of RTE submitted to the NRLS is expected as more Trusts adopt the trigger code ‘TSRT9’ when reporting to the NRLS and as commissioning of electronic systems streamline the submission RTE.

5.3 Classification

The vast majority of the 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 treatment. This meant that corrective

DISCUSSION

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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.

When compared with results from the 2010 report a reduction in the percentage of reportable (1.1% from 3.8%), non-reportable (1.5 % from 2.7%) and minor radiation incidents (25.8% from 29.8%) can be seen, with an increase in the percentage of lower level incidents, near misses (30% to 35%) and other non-conformances (33.7% to 36.6%). In short there has been a reduction in the number of higher level RTE reported and an increase in the number of lower level RTE including near miss and other non-conformances between reports.

This overall trend found in both 2 year reports of a small number of higher level incidents and 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. Heinrich11 illustrated this point in 1931 (Figure 21). It may be seen that as the severity of the incident decreases, the probability of it occurring increases. The distribution of data in Figure 4, which shows a break down of the entire dataset by classification supports this theory.

Figure 21: Heinrich’s Triangle reproduced from Towards Safer Radiotherapy1

TSRT reported that root cause analysis of minor and near miss RTE events have been shown to provide valuable lessons which can prevent serious incidents. Therefore to investigate this theory in more detail the PSRT are 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.

5.4 Main Themes

Analysis of the RTE reports demonstrated that generation of error is not confined to one professional group or to any particular point in the pathway. They also indicate that the pattern of errors is replicated across service providers.

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The following processes have been identified as areas in the radiotherapy pathway where RTE commonly occur both in this report and through the quarterly analysis undertaken and published by the HPA4&12

• Movements from reference marks (13l)

• Accuracy of data entry (12f)

• On-set Imaging: Approval Process (13aa)

• End of process checks (9k, 10l, 11t, 12g & 13hh)

• Management of process flow within planning (11o)

• Patient identification process (4a, 5b, 9a, 10a, 11a, 11b, 12e, 12d, 13b & 13c)

Guidance has already been published on how to minimise these frequently occurring RTE in the quarterly Newsletter ‘Safer Radiotherapy’ as ‘Error of the month’4.

In some areas sample numbers are small and care must be taken in interpreting the results. However on reviewing the current 2012 dataset alongside the 2010 data set we can start to look for trends in the RTE reported and provide guidance on how the risk of these events occurring might be reduced.

When compared with the 2010 2 year report a change in error trend can be seen. This reinforces the need for a cyclic approach to reporting, analysis and timely sharing of learning from these events. Previously it was noted that although RTE occurred through out the patient pathway and across professional groups, there was an emphasis on ‘referral’ and ‘communication of intent’ processes. Of note was the high number of ‘timing of chemo/irradiation’ reports. However ‘accuracy of data entry’ and ‘movements from reference marks’ were also highlighted.

5.5 Learning from Errors

The adoption of the terminology, classification and coding from TSRT by clinical radiotherapy departments nationally together with the implementation of the voluntary reporting system described within this report has facilitated both local and national learning.

Trend analysis at a national level has led to the publication of guidance by the PSRT on how common RTE might be minimised, through a series of quarterly publications4. Trend analysis at a local level can be used by individual departments as part of a risk based approach to inform practice so as to improve patient safety in radiotherapy. Use of agreed terminology and taxonomies also allows comparison of local trends with the national picture.

Radiotherapy is a dynamic specialism where technological changes, emerging techniques and research rapidly feed into regular practice. With a number of new radiotherapy departments under development, trends in RTE events need to be continually monitored to gauge the safety of these new innovations.

DISCUSSION

23

It is recognised that once errors and the learning from them are dealt with, future errors tend to occur at a different point on the radiotherapy pathway. This is especially true as new techniques and technologies are introduced. A cyclic process of both local and national reporting, analysis and promulgation of learning is always required to facilitate any trend analysis of errors so that we can work together as a community to minimise the occurrence of future errors in radiotherapy departments across the UK.

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6 CONCLUSIONS

When the opportunity for error is weighed against the incidence of error, radiotherapy may be seen as a safe form of treatment for cancer. Though RTE are rare, when they do occur the consequences can be significant so it is essential we do not become complacent about the associated risks.

Utilisation of the terminology, classification & coding of TSRT together with the implementation of the voluntary reporting system described within this report allows clinical departments to compare their local analysis to the national picture.

The number of clinical radiotherapy departments adopting the trigger code ‘TSRT9‘ when submitting data to the NRLS for HPA analysis continues to increase month on month. Also it may be seen that as clinical departments adopt electronic reporting systems, all levels of RTE are submitted for analysis. This is reflective of a mature safety culture and of the commitment of the radiotherapy community to minimise the risk and occurrence of these events.

This report identified errors in activities undertaken by various professional groups, throughout the patient pathway and across different service providers. A total of 47.8% (n=1,585) of RTE reported were associated with treatment unit processes and a further 35,8% (n=1,187) were associated with pre-treatment planning processes. The vast majority of reports were categorised as lower level events thus not affecting the outcome of patient care.

From this 2 year analysis and through the quarterly analysis undertaken and published by the HPA4&12 the following processes were identified as areas in the radiotherapy pathway where RTE commonly occur.

• Movements from reference marks

• Accuracy of data entry

• On-set Imaging: Approval Process

• End of process checks

• Management of process flow within planning

• Patient identification process

Guidance has already been published on how to minimise these frequently occurring RTE in the quarterly Newsletter ‘Safer Radiotherapy’ as ‘Error of the month’4.

When compared with the 2010 2 year report a change in error trend can be seen. This reinforces the need for a cyclic approach to reporting, analysis and timely sharing of learning form these events. Previously it was noted that although RTE occurred through out the patient pathway and across professional groups, there was an emphasis on ‘referral’ and ‘communication of intent’ processes. Of note was the high

CONCLUSIONS

25

number of ‘timing of chemo/irradiation’ reports. However ‘accuracy of data entry’ and ‘movements from reference marks’ were also highlighted.

In addition a reduction in the percentage of reportable (1.1% from 3.8%), non-reportable (1.5 % from 2.7%) and minor radiation incidents (25.8% from 29.8%) can be seen, with an increase in the percentage of lower level incidents, near misses (30% to 35%) and other non-conformances (33.7% to 36.6%). In short there was a reduction in the number of higher level RTE reported and an increase in the number of lower level RTE between reports.

It is imperative that all radiotherapy departments in England and Wales adopt the trigger code ‘TSRT9’ when submitting reports to the NRLS, otherwise their reports will not be extracted for HPA analysis and will not contribute to the national dataset. Clinical departments are encouraged to submit all levels of RTE to the NRLS.

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.

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7 FUTURE WORK

a Collation of RTE data from Northern Ireland and Scotland The HPA is currently working with a pilot clinical department to streamline the reporting mechanism for Scotland. Once this is complete the mechanism will be opened up to all other Scottish departments as well as Northern Ireland.

b Development of Causative Factor and Detection Method Taxonomy to develop analysis and improve learning from RTE events The PSRT have completed a pilot with 10 clinical departments of draft taxonomies and guidance document for their application. These are currently being refined prior to a second pilot with a larger group of 20 clinical departments before being presented for national use.

c Keep Reporting Clinical radiotherapy departments are asked to continue reporting RTE of all levels to the NRLS from NHS radiotherapy providers in England and Wales for analysis by the HPA and presentation in the quarterly newsletter ‘Safer Radiotherapy’. In addition departments are encouraged to use the trigger code ‘TSRT9’ when reporting or their reports will not contribute to the national dataset. The PSRT will continue to work with individual clinical departments to support the adoption of the trigger code and increased reporting levels.

d Transfer of NRLS to the NHS Commissioning Board Following the publication of the report of the arms-length body review, the National Patient Safety Agency (NPSA) was abolished in March 2012. However the system for the voluntary reporting of patient safety incidents will continue to be managed by the NRLS. The work of the NRLS will continue within the new proposed structure of the NHS Commissioning Board and it will continue to work together in partnership with NHS organisations to make services even safer for patients. The HPA has a data sharing agreement with the NRLS and under this agreement will continue to extract RTE from the NRLS, and share learning from these events.

KEY RECOMMENDATIONS

27

8 KEY RECOMMENDATIONS

a RT departments should use TSRT2 to classify and code all their RTEs, including near misses.

b All departments in England and Wales should continue to submit reports of RTE events, via their Risk Management Departments, to the NRLS. These reports should contain written descriptions of events, the trigger code TSRT9, and the TSRT1 classification and coding.

c A mechanism should be developed to enable departments in Scotland as well as Northern Ireland to submit reports of RTE events to the HPA for collation and analysis as part of a UK dataset.

d PSRT should continue to develop analysis of the reports, with regular dissemination of findings to the RT community for group learning.

e The data should be used both by the PSRT and individual RT departments as part of a risk based approach to allocating resources for improving patient safety in radiotherapy and to inform audit and research.

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9 PSRT STEERING GROUP MEMBERSHIP

Charlotte Beardmore (SCoR - Professional Officer for Radiotherapy)

Martin Duxbury (SCoR Clinical Representative – Deputy Head of Radiotherapy, St. James Institute of Oncology, Leeds)

Leslie Frew (IPEM – Head of Radiotherapy Physics Service, Belfast City Hospital)

Tony Murphy (Lay Representative)

Tom Roques (RCR – Consultant Clinical Oncologist and Clinical Director for Oncology & Haematology, Norfolk and Norwich University Hospital NHS Foundation Trust)

Úna Findlay (HPA & Group Chair)

Acknowledgements

Many thanks to Maria Murray, SCoR Professional Officer, UK Radiation Protection Lead for her comments during the writing of this report.

REFERENCES

29

10 REFERENCES

1. Towards Safer Radiotherapy. 2008. 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. http://www.rcr.ac.uk/index.asp?PageID=149&PublicationID=281

2. Radiotherapy: Hidden Dangers. Chapter 5. Chief Medical Officers Annual Report 2006 (2007). http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/AnnualReports/DH_076817

3. Patient Safety in Radiotherapy Steering Group Activity (November 2007 – March 2010). Data report on patient safety incidents from August 2007 until November 2009. 2010. Patient Safety in Radiotherapy Steering Group. http://www.hpa.org.uk/Publications/Radiation/CRCEScientificAndTechnicalReportSeries/HPACRCE002/

4. Safer Radiotherapy: Radiotherapy Newsletter of the HPA. http://www.hpa.org.uk/ProductsServices/Radiation/Radiotherapy/RadiotherapyNewsletters/

5. NPSA Definition of a Patient Safety Incident (PSI). Available at http://www.npsa.nhs.uk/nrls/reporting/what-is-a-patient-safety-incident/

6. Implementing Towards Safer Radiotherapy: guidance on reporting radiotherapy errors and near misses effectively. http://www.nrls.npsa.nhs.uk/resources/clinical-specialty/radiology-and-radiotherapy/

7. National reporting of radiotherapy errors (&near misses). Survey Report No 2 – December 2011. http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1317131849571

8. Supplementary Guidance Series: Good Practice in Radiotherapy Error Reporting. No 1-4. http://www.hpa.org.uk/ProductsServices/Radiation/Radiotherapy/RadiotherapyGuidanceDocuments/

9. The Ionising Radiation (Medical Exposure) Regulations (2000). The Stationery Office, London. SI 2000/1059. Available from http://www.opsi.gov.uk/si/si2000/20001059.htm The Ionising Radiation (Medical Exposure) (Amendment) Regulations (2006). The Stationery Office, London. SI 2006/2523. Available from http://www.opsi.gov.uk/si/si2006/20062523.htm and the Ionising Radiation (Medical Exposure) (Amendment) Regulations (2011). The Stationery Office, London. SI 2011/1567. Available from http://www.legislation.gov.uk/uksi/2011/1567/introduction/made

10. The Ionising Radiations Regulations (1999). The Stationery Office, London. SI 1999/3232. Available from http://www.opsi.gov.uk/si/si1999/19993232.htm

11. Heinrich HW. Industrial accident prevention: a scientific approach. 1st edn. New York: McGraw-Hill Book Company Inc., 1931.

12. Supplementary Data Analysis: Full Quarterly Radiotherapy Error Data Analysis. No 1-6. http://www.hpa.org.uk/ProductsServices/Radiation/Radiotherapy/RadiotherapyNewsletters/

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APPENDIX A

Radiotherapy Error Classification Grid

Reproduced from Towards Safer Radiotherapy1

No

No

Potentially or actually clinically

significant?

Radiotherapy error

Yes No

Yes

No Yes

Yes

Correctable radiation incident?

Level 1Reportable radiation

incident

Level 2Non-reportable

radiation incident

Level 3Minor radiation

incident

Level 4Near miss

Level 5Other non-

conformance

Potential for radiation incident?

Radiation incident?

Reportable?

Yes

No

APPENDIX B

31

APPENDIX B

Radiotherapy Pathway Coding

Reproduced from Towards Safer Radiotherapy1

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)

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3i Regular preventative maintenance and repair programme

3j Handover of radiotherapy equipment after planned QA and maintenance

3k Routine radiation safety checks

3l Other

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

APPENDIX B

33

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

7g Availability of consent documentation

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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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

13n Setting of collimator angle

13o Setting of jaw position

13p Setting of asymmetry

APPENDIX B

35

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

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

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36

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

20 Availability of staff with competency appropriate to procedure