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Major clinical radiotherapy incidents have been reported, but many more have remained unrecognised or have not been reported. Our review of radiotherapy-related events in the last three decades (1976-2007) identified more than seven thousand (N = 7741) incidents and near misses.
Major clinical radiotherapy incidents have been reported, but many more have remained unrecognised or have not been reported. Our review of radiotherapy-related events in the last three decades (1976-2007) identified more than seven thousand (N = 7741) incidents and near misses.
Major clinical radiotherapy incidents have been reported, but many more have remained unrecognised or have not been reported. Our review of radiotherapy-related events in the last three decades (1976-2007) identified more than seven thousand (N = 7741) incidents and near misses.
An international review of patient safety measures in radiotherapy practice
Jesmin Shaq a, * , Michael Barton a , Douglas Noble b , Claire Lemer b , Liam J. Donaldson b a The Collaboration for Cancer Outcomes Research and Evaluation, University of New South Wales, Sydney, Australia b WHO World Alliance for Patient Safety, Avenue Appia 20, Geneva, Switzerland a r t i c l e i n f o Article history: Received 8 October 2008 Received in revised form 4 March 2009 Accepted 4 March 2009 Available online 22 April 2009 Keywords: Patient safety Radiation protection Radiotherapy accident/s Radiotherapy error/s Radiotherapy incident/s Quality assurance a b s t r a c t Errors from radiotherapy machine or software malfunction usually are well documented as they affect hundreds of patients, whereas random errors affecting individual patients are more difcult to be discov- ered and prevented. Although major clinical radiotherapy incidents have been reported, many more have remained unrecognised or have not been reported. The literature in this eld is limited as it is mostly published as a result of investigation of major errors. We present a review of radiotherapy incidents inter- nationally with the aim of identifying the domains where most errors occur through extensive review and synthesis of published reports, unpublished Grey literature and departmental incident data. Our review of radiotherapy-related events in the last three decades (19762007) identied more than seven thousand (N = 7741) incidents and near misses. Three thousand one hundred and twenty-ve incidents reported patient harm of variable intensity ranging from underdose increasing the risk of recurrence, to overdose causing toxicity, and even death for 1% (N = 38); 4616 events were near misses with no rec- ognisable patient harm. Based on our review, a radiotherapy risk prole has been published by the WHO World Alliance for Patient Safety that highlights the role of communication, training and strict adherence to guidelines/protocols in improving the safety of radiotherapy process. 2009 World Health Organization. Published by Elsevier Ireland Ltd. All rights reserved. Radiotherapy and Oncology 92 (2009) 1521 Introduction Radiotherapy treatment Radiotherapy is one of the major treatment options in cancer management. According to the best available evidence [2], 52% of patients should receive radiotherapy at least once during the treat- ment of their cancer. Together with other modalities such as sur- gery and chemotherapy radiotherapy plays an important role in the treatment of 40% of those patients who are cured of their can- cer [3]. Radiotherapy is also a highly effective treatment option for palliation and symptom control in cases of advanced or recurrent cancer. The process of radiotherapy is complex and involves under- standing of the principles of medical physics, radiobiology, radia- tion safety, dosimetry, radiotherapy planning, simulation and interaction of radiation therapy with other treatment modalities. The main health professionals involved in the delivery of radiation treatment are the radiation oncologists (RO), radiation therapists (RT) and medical physicists (MP). Each of these disciplines works through an integrated process to plan and deliver radiotherapy to patients. The sequential stages of the radiotherapy process of care (Fig. 1) were agreed by the Expert Committee of WHO World Alli- ance for Patient Safety [1]. Errors in radiotherapy treatment Accidental exposures to radiotherapy may result from an acci- dent with a radiation source or from an event or a sequence of events including equipment failures and operating errors [4]. Elab- orate quality assurance (QA) protocols have been issued by a num- ber of international and regional organisations in order to reduce the likelihood of accidents and errors occurring, and to increase the probability so that the errors will be recognized and rectied quickly if they do occur [513]. Still the potential for the errors in radiotherapy is high as it involves highly technical measure- ments and calculations of different radiation doses to many differ- ent parts of the body. Treatment is delivered in multiple daily doses and patient set-up must be accurate and reproducible. Mod- ern radiotherapy departments are multi-system-dependent envi- ronments that rely heavily on transfer of data between patient, machine and processing systems. Over the last decade, the rapid development of new technology has signicantly changed the way in which radiotherapy is planned and delivered. Three-dimensional computed tomography (CT)-based planning, multi-leaf collimation (MLC), improved 0167-8140/$ - see front matter 2009 World Health Organization. Published by Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.radonc.2009.03.007 * Corresponding author. Address: The Collaboration for Cancer Outcomes, Research and Evaluation (CCORE), South Western Clinical School, University of New South Wales, Liverpool Health Service, Locked Bag 7103, Liverpool BC, NSW 1871, Australia. E-mail address: Jesmin.Shaq@sswahs.nsw.gov.au (J. Shaq). Radiotherapy and Oncology 92 (2009) 1521 Contents lists available at ScienceDirect Radiotherapy and Oncology j our nal homepage: www. t hegr eenj our nal . com immobilization, and more sophisticated planning software now permit complex treatment plans to be developed for many patients [14]. The increased complexity of planning and treatment and ra- pid adoption of newtechnologies in the setting of increased patient volume may thus create an environment with more potential for treatment mishaps to occur. Especially, in the low and middle in- come countries there may be old systems with less interconnectiv- ity and fewer trained QA personnel. In addition, technologies intended to reduce the risk of treatment inaccuracy might para- doxically act as a new source of error [15]. Research on radiotherapy safety focuses on analyses of adverse events and near misses [16,17] as these might lead to the identi- cation of latent problems and weak links within a system that lie dormant for some time and then combine with a local trigger to create an incident [18]. The reporting of near misses has been iden- tied as a valuable tool in preventing serious incidents in the non- medical domain [19]. Although detailed reports of some major clinical radiation adverse events in the last 30 years [20,21] have been published, it is likely that many more have occurred but either went unrecognised or failed to be reported to the regulatory authorities or were not published in the literature [13]. Errors in software or treatment machine calibration do affect hundreds of patients and usually are well documented [13,22]. Random errors may affect individual patients and are more difcult to be discov- ered and prevented. Presented below are a collation and synthesis of evidence on radiation incidents and the recommended safety measures. Both published literature and unpublished data sources have been re- viewed. The areas of the highest risk in the process of care for radiotherapy have been identied. The risk issues require further attention, especially those not related to equipment and system failure and modiable through competency-based training of staff and changes in work practice culture in radiotherapy departments. Aim Our aim was to conduct an evidence-based review of current practice of patient safety measures in radiotherapy treatment facil- ities including an analysis of the previous incidents in radiotherapy delivery and identication of high risk areas through elaborate search of published literature and unpublished gray literature. Materials and methods Search strategy and selection criteria The terminology in patient safety can be confusing and in addi- tion clinical specialities have developed their own terminologies. According to the WHO World Alliance for Patient Safety taxonomy contained within the International Classication for Patient Safety [23] the medical safety incidents are dened as: A patient safety incident is an event or circumstance which could have resulted, or did result, in unnecessary harm to a patient. An adverse event is an incident which results in harm to a patient. A near miss is an incident that did not cause harm (also known as a close call). An error is a failure to carry out a planned action as intended or application of an incorrect plan, and may manifest by doing the wrong thing (an error of commission) or by failing to do the right thing (an error of omission), at either the planning or execution phase. According to the International Nuclear Event Scale (INES) de- scribed in the IAEA safety glossary an Incident (level 2) is dened as An event involving signicant failure in safety provisions, but with sufcient defence in depth remaining to cope with additional failures and Near miss is dened as A potential signicant event that could have occurred as the consequence of a sequence of ac- tual occurrences but did not occur owing to the plant conditions prevailing at the time [24]. We have used the INES denitions of Incident and Near Miss described in the IAEA safety glossary wherever possible within this report because this is the commonest taxonomy in the literature. However, this needs further discussion within the radiotherapy community to determine whether a uniform terminology as in other medical elds could be used in relation to radiotherapy safety. We reviewed the worldwide occurrence of radiotherapy treat- ment incidents and near misses in the last 30 years (from 1976 to 2007) through appraisal of published materials (technical re- ports, journal articles, guidelines) and unpublished sources of information such as radiotherapy-related incident data maintained by the health services. An initial computer-based search of Google and Google Scholar search engines and PubMed search of the e- journal collections on radiotherapy, medical physics and nuclear medicine was performed supplemented by the searches of rele- vant links for appropriate citations and article bibliographies for further relevant sources. The key words used were: patient safety, radiation protection, radiotherapy accident/s, radiotherapy er- ror/s, radiotherapy incident/s, radiotherapy overexposure, qual- ity assurance, safety measures and variations of these terms in combination. In addition, we performed a broader search to iden- tify relevant literature from developing countries using the above key words combined with the terms Asia, Africa, developing countries, Latin America and low and middle income countries. The bibliography of the individual literature retrieved was iter- atively searched for additional citations. For articles published in other languages (e.g. French, Japanese), we reviewed the translated Decision to Treat Simulation, Imaging & Volume Determination Planning Treatment Information Transfer Assessment of Patient Patient Set-up Treatment Delivery Treatment Review Prescribing Treatment Protocol Immobilization & Positioning Equipment and Software Commissioning Fig. 1. Radiotherapy process of care [1]. 16 Patient safety in radiotherapy abstracts and veried them with the study ndings from other sources in English (if available). Our search strategy further in- cluded selection of the Grey literature (materials that are not for- mally published) such as working papers, organisational reports (e.g. IAEA and ICRP reports) and conference proceedings available from web-based sources. We also searched for radiotherapy safety-related incidents and near misses that were available from local, national and interna- tional databases including the Radiation Oncology Safety Informa- tion System (ROSIS) database, a voluntary web-based safety information database for radiotherapy set by a group of medical physicists and radiation therapists in Europe, 1 data from the UK peer review report that is in the process of publication 2 and Austra- lian State-based Department of Radiation Oncology annual incident reports collection. 3 The incidents were recorded according to the following categories: Description Direct cause/s Contributing factors Stage/s (described as in Fig. 1) of the treatment process during which the incident occurred Reported impact or outcome Corrective actions and prevention of future incidents. We explored and synthesised the data available from all sources to nd out at what stage most accidents or incidents occurred, what were the existing deciencies and contributing factors that led to the errors and how these errors could have been prevented. A conceptualisation of radiotherapy risk according to the stages of planning and delivery of treatment was presented in the UK Chief Medical Ofcers Annual Report in 2006 [25]. This led to clinical policy recommendations for radiotherapy services in that country. We developed this further and mapped incidents onto a grid of the stage of care at which they occurred. Results Radiotherapy incidents A summary of all widely reported major radiotherapy incidents that led to signicant harm to patients (such as radiation injury and death) that occurred in the last three decades (19762007) is presented in Table 1 [13,22,24,26,27,3034,3639]. The coun- tries of occurrence were middle and high income countries in the US, Latin America, Europe and Asia. About 3000 (N = 3125) patients were affected and of them 38 (1.4%) patients were reported to have died due to radiation overdose toxicity or failures due to under- dose. Fifty-ve percent of incidents (N = 1702) were in the plan- ning stage and of the remaining 45%, incidents were due to errors that occurred during the introduction of new systems and/ or equipment such as megavoltage machines (25%), errors in treatment delivery (10%), information transfer (9%) or in multiple stages (1%). In the years from 1992 to 2007, 4616 near misses that re- sulted in no recognisable patient harm were identied from the published literature from European countries, Canada and the US [14,15,18,28,29,35,40] and unpublished incident reporting databases from Europe, 1 UK 2 and Australia 3 (Table 1). A major source (N = 854) of the recent non-injurious events was the Radiation Oncology Safety Information System (ROSIS) data- base, 1 a voluntary web-based safety information database for radiotherapy set-up by a group of radiation therapists and med- ical physicists) in Europe. Of all such near misses without any known harm to patients, 9% (N = 420) were related to the plan- ning stage; 38% (N = 1732) were related to transfer of informa- tion and 18% (N = 844) to the treatment delivery stage. The remaining 35% of the incidents occurred in the categories of pre- scription, simulation, patient positioning or in a combination of multiple stages. Fig. 2 describes a summary of injurious incidents including pa- tient deaths due to radiotherapy toxicity or failure for the last 30 years (N = 3125), the highest number of injurious incidents (N = 1702, 22% of all) was reported in the planning stage; the number of deaths (N = 17) was also highest in this stage. A summary of the potentially highest risk areas in the radio- therapy process of care and the recommended interventions to im- prove patient safety, generated through the review of both published and unpublished radiotherapy incident reports and through input from the international expert committee of radio- therapy professionals involved in the development of Radiother- apy Risk Prole, a WHO Alliance for Patient Safety initiated radiotherapy safety project [1] is shown in Table 2. Radiotherapy incidents in developing countries No detailed reports on radiotherapy-related adverse events were available from low resource countries in Asia or Africa. The only published studies are the evaluation of the dosimetry prac- tices in hospitals in developing countries through the IAEA and World Health Organisation (WHO) sponsored Thermoluminescent Dosimetry (TLD) postal dose quality audits carried out on a regular basis [42,43]. These studies reported that facilities that operate radiotherapy services without qualied staff or without dosimetry equipment have poorer results than those facilities that are prop- erly staffed and equipped. Strengthening of radiotherapy infra- structure has been recommended for the under-resourced centres such as those in Latin America and Caribbean to improve their audit outcomes as comparable to those of developed coun- tries [42]. An external audit of an Asian oncology practice was able to identify areas of need in terms of gaps in knowledge and skills of the staff involved. The study found that about half (52%) of the patients audited received suboptimal radiation treatment, poten- tially resulting in compromised cure/palliation or serious morbid- ity. Inadequate knowledge and skills and high workload of the radiation oncology staff were described as the reasons for poor quality of service [44]. Discussion Although radiotherapy is perceived as risky and complex [25], the risk of mild to moderate injurious outcome to patients from radiotherapy errors was about 1500 per million treatment courses that were much lower than the hospital admission rates for ad- verse drug reaction in Canada and US (about 65,000 per million admissions) [45]. Also the reported rate of death from adverse events in radiotherapy (1%) was lower than the reported rates of death from the population-based adverse event studies (about 5 14%) [46]. It is apparent that in the earlier 1990s major radiother- apy incidents occurred mainly due to inexperience in using new equipment and technology during radiotherapy. These errors are now much less frequent. In more recent times errors in data 1 ROSIS database: a voluntary safety reporting system for Radiation Oncolgy. Available from: www.rosis.info [accessed 10 September 2007]. 2 Optimising patient safety: reducing errors and incidents in radiotherapy. UK peer review report (in progress), September 2007. 3 Sydney South West Cancer Services, Radiation oncology treatment related incident report database 2005. J. Shaq et al. / Radiotherapy and Oncology 92 (2009) 1521 17 transfer constitute the greatest bulk of radiotherapy-related inci- dents. These incidents included transcription errors, rounding off errors, forgotten data or interchange of data and were attributed to human mistakes or inattention [47]. The United States Nuclear Regulatory Commission (NRC) that maintains a large database of radiotherapy misadministration incidents estimated that about 60% or more of misadministrations were due to human errors [48]. It is now a well recognised challenge in radiotherapy and a large number of preventative guidelines and safety protocols have been established by the radiation safety-related authorities at the local and international level [49,50,10,51,52]. The incidents in radiotherapy which are mainly related to pa- tient assessment prior to treatment involve history, physical exam- ination, imaging, biochemical tests, pathology reviews and errors during radiotherapeutic decision making which involve treatment intent, tumour type, individual physician practice and type of equipment used [53]. Comprehensive QA protocols have been developed that include medical aspects of the radiotherapy treat- ment such as clinician decisions and patient assessment [7] and are implemented in several centres in Europe. However, these pro- tocols have not been widely adopted in the radiotherapy centres worldwide. This has, amongst other issues, led to a systematic reporting bias which favours certain types of incidents, particularly those related to technology rather than clinical judgements. It is therefore important to view the data analysed in this paper taking this into consideration. An evaluation of radiotherapy incident reporting using three well-known incident data sources, namely, IAEA, ROSIS and NRC datasets revealed relatively fewer incidents in the Prescription domain than in the Preparation and Treatment domains [54]. According to the report of a QA meeting in the UK in 2000, much effort has been directed at QA of system and equipment-related components of radiotherapy such as planning computers, dosime- try audit and machine performance. Few initiatives have been ta- ken to standardize medical processes including target drawing, the application of appropriate margins and the verication of set- up involved in radiotherapy [55]. These errors may cause varia- tions in target delineation leading to changes in the biological doses that have the potential for a signicant impact in patient safety. Studies of radiotherapy practice have shown that the develop- ment of an explicit and uniform protocol for implementation and timely assessment of error rates can ensure that incidents are re- duced to the lowest possible level [14,29]. Systematic minor errors often suggest problems with infrastructure or information man- agement that may carry an inherent risk of more serious errors. Holmberg and McClean [18] claimed that detection and correction of near misses through practice of a systematic multilayered pre- treatment check-up system in their centre was preventing occur- rence of about 14 adverse events per 1000 treatment plans. An- other recent evaluation at a cancer centre in the United Kingdom reported a signicant decrease in the number of recorded incidents Table 1 Chronological summary of radiotherapy incidents and near misses by region and country. Country Year(s) Causes/contributing factors Incidents with harm (n) Near misses (n) References Toxicity Death USA 19741976 Co-60 unit wrong decay chart 426 [26] 19851987 Therac-25 software programming error 6 3 [27] 1992 Patient sent home with brachytherapy source left inside 1 [26] 19992000 Incorrect data entry, errors in treatment site identication 9 [15] a Canada 19891996 Errors in indications for radiotherapy, choice of dose and target volume critical structures at risk, inhomogeneous dose distribution 234 [28] 19922002 Incorrect treatment plan parameters, data transfer/data generation errors, errors due to inadequate communication, incorrect placement of accessories 596 [29] 19972002 Incomplete/incorrect prescription, record and verify (R and V) system programming errors, calculation errors 555 [14] 20042007 Incorrect output determinations for eld sizes 326 b [30,31] Costa Rica 1996 Co-60 unit calibration error 114 6 [32] Panama 20002001 Wrong data entry into the Computerized Treatment Planning System (TPS) 28 11 [33] UK 19821991 Inappropriate commissioning of TPS 1045 b [24] 1988 Co-60 unit calibration error 250 [13] 19881989 Cs-137 brachytherapy source identication error 22 [13] 20002006 Incorrect treatment plan parameters, data transfer errors, errors in patient positioning, eld size 28 UK peer review 1 20052006 Linac data management system updating error 5 1 [22,34] Germany 19861987 Co-60 unit wrong dose table 86 [13] Spain 1990 Linear accelerator (Linac) maintenance error 27 9 [26] Belgium 19951997 Incomplete/incorrect prescription and calculation errors 1769 [35] Ireland 19982000 Errors related to TPS utilisation, calculation, and documentation 177 [18] Poland 2001 Failure of safety recheck on a Linac after power failure 5 [36] France 20042005 Linac updating error and misinformation errors 25 6 [37,38] Europe (not specied) 20012007 Incorrect treatment plan parameters, data transfer/data generation errors, miscommunication errors, errors related to patient identication, bolus application and block/wedge placement 854 ROSIS database 2 Japan 19902004 Errors related to TPS updating, errors due to inadequate communication 734 1 [39] Australia 19931995 Errors in prescriptions and planning 235 [40] 2005 Incorrect treatment plan parameters, data transfer/data generation errors, and errors related to bolus application, shielding 159 (SAC 13) c SSW Cancer Services 3 All incidents 3087 38 4616 a The incidents described were the ones only related to the computerised record and verify system. b Radiation underdose of 335% may have lead to high rate of local recurrence. c Severity Assessment Code (SAC) is a numerical score applied to an incident based on the type of event, its likelihood of recurrence and its consequence. The scale ranges from 1 (extreme) to 4 (low) [41]. 18 Patient safety in radiotherapy 6 17 13 2 790 1685 276 304 32 3087 38 1 10 100 1000 10000 I m m o b i l i z a t i o n
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i n c i d e n t s Death Overdose/underdose N = 3125 Fig. 2. Radiotherapy incidents with adverse patient outcomes (19762007) by stage of treatment. Table 2 Potential risk areas ( ) a in radiotherapy treatment. Stages Patient factors Equipment or system factors Staff factors Suggested preventive measures History Clinical examination Pathology Communication Guidelines/ protocol Training No. of staff Patient assessment and decision to treat Peer review process Evidence-based practice Prescribing treatment protocol Peer review process Standard protocol Competency certication Consultation with seniors Immobilisation and positioning Competency certication QA check and feedback Incident monitoring Simulation and Imaging Competency certication QA check and feedback Incident monitoring Planning QA check and feedback New staff and equip- ment orientation Competency certication Incident monitoring Treatment information transfer Clear documentation Treatment sheet check Record and verify system In vivo dosimetry Patient set-up Competency certication Incident monitoring Supervisor audit Treatment delivery Incident monitoring Imaging/portal lm In-vivo dosimetry Treatment review Competency certication Incident monitoring Independent audit a Priority measures suggested for the factors with mark in all stages. J. Shaq et al. / Radiotherapy and Oncology 92 (2009) 1521 19 over the past eight years. Changes in working practices during that time such as relocation of different procedures, increased use of specialist staff and regular discussion amongst staff regarding changes in relation to the requirements of new technology were identied as factors promoting incident reduction [56]. An important initiative in preventing radiotherapy errors in decision making and poor or incorrect work practice could be behavioural modication achieved through frequent audit and reg- ular peer review of the specialists protocols, processes, procedures and personnel involved [6,57]. Shakespeare et al. [44] observed that their audit acted as an informal learning needs assessment for the radiation oncology staff of the audited centre. They became more aware of their knowledge and skills gaps and implemented peer review of all patients simulated, weekly departmental contin- uing medical education activities, a portal lm review process and have been performing literature search and peer discussion of dif- cult cases. They recommended that the establishment of an ade- quate radiation oncology training system, preferably one based on available evidence, is an essential element of improved safety prac- tice, especially in the low income countries [44]. Any investment in resource development (e.g. time, personnel, and training) would vary from country to country because of the variability of the radiotherapy workforce-related costs between high, middle and low income countries [58]. European experts suggested that taking initiatives to improve the culture of clinical governance and setting the standards of practice through medical peer review of target drawing and dose prescription would be a signicant positive step in improving the quality of radiotherapy services [55]. In our review, we have added a descriptive summary of inci- dents categorized according to the stage, examined the causes, contributing factors, suggestions and recommendations that were made. The sources that were found described a wide variety of incidents that occurred all through the radiotherapy process. Though a large proportion of reported incidents were related to the system failures due to incorrect use of equipment and set-up procedures, for a number of them the contributing factors were incorrect treatment decisions, incorrect treatment delivery and inadequate verication of treatment due to inexperience and inad- equate knowledge of the staff involved. These errors were not as well reported as the system-related errors documented predomi- nantly by the medical physicists, as observed in our review. The severity of incidents was not described with a standardised system and incidents were not collected prospectively. It was not possible to compare severity between incidents except when the incident resulted in death. Hence, development of a set of stan- dards highlighting the patient-centred risk areas in radiotherapy treatment with suggested improvements tailored to the need of individual countries and specic departments would be relevant for all stakeholders. Each radiotherapy service should individually and repeatedly examine its risk prole and incidents as well as near misses should be prospectively collected, measured and categorised. Conclusion Radiotherapy-related errors are not uncommon even in the countries with the highest level of health care resources but the error rates compare favourably with the rate of other med- ical errors [46]. It is unrealistic to expect to reduce the error rate to zero but every effort should be taken to keep the rates low. Risk model researchers Duffy and Saull say Errors can always be reduced to the minimum possible consistent with the accu- mulated experience by effective error management systems and tracking progress in error reduction down the learning curve [48]. This can also lead to the identication of incidents earlier in the process with less serious consequences. The WHO World Alliance for Patient Safety has taken an ini- tiative to address the risk areas in the radiotherapy process of care that is complimentary to the IAEA developed safety mea- sures and other previously developed standards [1]. 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