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Patient safety in external beam radiotherapy, results of the ACCIRAD project: Recommendations for radiotherapy institutions and national authorities on assessing risks and analysing adverse error-events and near misses
Abstract
The ACCIRAD project, commissioned by the European Commission (EC) to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy (EBRT), was completed in the year 2014. In 2015, the "General guidelines on risk management in external beam radiotherapy" were published as EC report Radiation Protection (RP)-181. The present document is the third and final report of the findings from the ACCIRAD project. The main aim of this paper is to describe the key features of the risk management process and to provide general guidelines for radiotherapy departments and national authorities on risk assessment and analysis of adverse error-events and near misses. The recommendations provided here and in EC report RP-181 are aimed at promoting the harmonisation of risk management systems across Europe, improving patient safety, and enabling more reliable inter-country comparisons.
... Regarding the non significant relationship between the presence of heart failure and mean raise in serum NGAL, this is justified by the point that only one of the heart failure patients in our group has NYHA class III which regard as risk factor for CI-AKI so it is statistically no significant. Helanova et al. had also described in their prospective cohort study that serum NGAL level elevation after primary PCI is an indicator of possible future renal damage, and that this elevation reflects higher risk for mortality in patients of acute coronary syndrome undergoing PCI [44]. Serum NGAL level 2 hours after PCI is reported to be adequate predictor for acute kidney injury [45], and increased level of serum NGAL even without having positive creatinine-based criteria of acute kidney injury may reflect a higher risk of renal complications, which may necessitate renal replacement therapy, and may also be associated with higher mortality [38]. ...
... However, radiotherapy is vulnerable to errors in its delivery process due to the complexity of the technology, techniques, processes and human resource quality [4,[11][12][13][14][15]17,18,21,22,26,[38][39][40][41][42][43][44][45][46]. ...
... Errors in radiation therapy delivery is presented as radiation inaccuracies and inequality between the real and the calculated theoretical value of radiation aspects and safety. Errors which often occur in radiation therapy delivery comprise of errors in radiation dose, equality of radiation site and irradiated patient, errors in the device or software, treatment planning system (TPS), and human errors [1,[11][12][13]17,18,21,22,26,40,[42][43][44][45][46][47][48][49][50]. ...
Objective:
The aim: This research aimed to show the achievement of Telecobalt60 radiation certainty using computed radiography, in comparation with non-verified computed radiography.
Patients and methods:
Materials and methods: This research is a quantitative study, randomized double-blind, and consecutive sampling design. The study was conducted by observing and com¬paring the data of verified computed radiography (VerC) computed radiograph for Telecobalt60 compared to the non-verified computed radiography (nVerC) Telecobalt60 data.
Results:
Results: The results showed that there are significant statistical differences in several measurement characteristics between the verified computed radiography arm and the non-verified computed radiography arm. All of the value divergences of the verified computed radiography arm are less than 7 mm while the non-verified computed radiography arm are 7 mm or more (P<0.050). Furthermore, all of the edge aspect of measurement in the verified computed radiography arms are less than the non-verified computed radiography, all without manual block utilization (P<0.050).
Conclusion:
Conclusions: We conclude that Telecobalt60 radiation certainty is significantly better achieved by using computed radiography, when compared to non-verified computed radiography Telecobalt60 use. This research contributes to provide evidence based for better Telecobalt60 radiation accuracy and quality of radiotherapy outcome by using computed radiography.
... Regarding the non significant relationship between the presence of heart failure and mean raise in serum NGAL, this is justified by the point that only one of the heart failure patients in our group has NYHA class III which regard as risk factor for CI-AKI so it is statistically no significant. Helanova et al. had also described in their prospective cohort study that serum NGAL level elevation after primary PCI is an indicator of possible future renal damage, and that this elevation reflects higher risk for mortality in patients of acute coronary syndrome undergoing PCI [44]. Serum NGAL level 2 hours after PCI is reported to be adequate predictor for acute kidney injury [45], and increased level of serum NGAL even without having positive creatinine-based criteria of acute kidney injury may reflect a higher risk of renal complications, which may necessitate renal replacement therapy, and may also be associated with higher mortality [38]. ...
... However, radiotherapy is vulnerable to errors in its delivery process due to the complexity of the technology, techniques, processes and human resource quality [4,[11][12][13][14][15]17,18,21,22,26,[38][39][40][41][42][43][44][45][46]. ...
... Errors in radiation therapy delivery is presented as radiation inaccuracies and inequality between the real and the calculated theoretical value of radiation aspects and safety. Errors which often occur in radiation therapy delivery comprise of errors in radiation dose, equality of radiation site and irradiated patient, errors in the device or software, treatment planning system (TPS), and human errors [1,[11][12][13]17,18,21,22,26,40,[42][43][44][45][46][47][48][49][50]. ...
Objective:
The aim: To define morphological and immunohistochemical signs of placental disorders of women after syphilitic infection.
Patients and methods:
Materials and methods: The prospective study of 60 pregnant women with history of syphilitic infection (main group) and 57 pregnant patients without syphilis (control group) was conducted. The morphological and immunohistochemical study of the afterbirth was performed.
Results:
Results: In the placentas of women of the main group the following phenomena were found out: circulatory disorders in the form of hemorrhages into the intervillous space and the stroma of villi; accumulation of fibrinoid around villi with dystrophically altered stroma, compensatory-adaptive reactions resulted in hyperplasia of terminal villi and vessels in them, which provoked narrowing of the intervillous space and disruption of blood supply in it. Pathogenic immune complexes containing Ig G, M and C3 of the complement fraction were located in the central part of the placenta - 45.00% of cases, 16.67% - in the regional, 8.33% - in both parts. Immune complexes with Ig M content occurred in 38.33% of cases. The content of pathogenic immune complexes was the most concentrated in the placentas of women with latent forms and secondary recurrent syphilis - 60.00% of cases.
Conclusion:
Conclusions: changes in morphohistological and immunohistochemical examination of the placenta of this group of women confirmed the detrimental effect of syphilitic infection in the anamnesis on the structure of placenta during the next pregnancies.
... Regarding the non significant relationship between the presence of heart failure and mean raise in serum NGAL, this is justified by the point that only one of the heart failure patients in our group has NYHA class III which regard as risk factor for CI-AKI so it is statistically no significant. Helanova et al. had also described in their prospective cohort study that serum NGAL level elevation after primary PCI is an indicator of possible future renal damage, and that this elevation reflects higher risk for mortality in patients of acute coronary syndrome undergoing PCI [44]. Serum NGAL level 2 hours after PCI is reported to be adequate predictor for acute kidney injury [45], and increased level of serum NGAL even without having positive creatinine-based criteria of acute kidney injury may reflect a higher risk of renal complications, which may necessitate renal replacement therapy, and may also be associated with higher mortality [38]. ...
... However, radiotherapy is vulnerable to errors in its delivery process due to the complexity of the technology, techniques, processes and human resource quality [4,[11][12][13][14][15]17,18,21,22,26,[38][39][40][41][42][43][44][45][46]. ...
... Errors in radiation therapy delivery is presented as radiation inaccuracies and inequality between the real and the calculated theoretical value of radiation aspects and safety. Errors which often occur in radiation therapy delivery comprise of errors in radiation dose, equality of radiation site and irradiated patient, errors in the device or software, treatment planning system (TPS), and human errors [1,[11][12][13]17,18,21,22,26,40,[42][43][44][45][46][47][48][49][50]. ...
Objective:
The aim: This study was undertaken to investigatethe possible lung protective potential effect of zileuton during polymicrobial sepsis, through modulation of inflammatory and oxidative stress pathway.
Patients and methods:
Materials and methods: 24 adult male Swiss-albino mice aged 8-12 weeks, with a weight of 25-35g, were randomized into 4 equal groups n=6, sham (laparotomy without CLP), CLP (laparotomy with CLP), vehicle (equivalent volume of DMSO 1 hour prior to CLP), and Zileuton (5 mg/kg 1 hour prior to CLP) group. After 24 hrs. of sepsis, the lung tissue harvested and used to assess IL-6, IL-1B, IL-17, LTB-4,12(S) HETE and F2-isoprostane as well as histological examination.
Results:
Results: Lung tissue inflammatory mediators IL-6, IL-1B, IL-17, LTB, 12 (S) HETE) and oxidative stress were carried out via ELISA. Lung tissue levels of IL-6, IL-1B, IL-17, LTB4, 12(S) HETE and oxidative stress (F2 isoprostan)level were significantly higher in sepsis group (p<0.05) as compared with sham group, while zileuton combination showed significant (p<0.05) lower level in these inflammatory mediators and oxidative stress as comparedto sepsis group. Histologically, All mice in sepsis group showed a significant (p<0.05) lung tissue injury, while in zileuton pretreated group showed significantly (p<0.05) reduced lung tissue injury.
Conclusion:
Conclusions: The results of the present study revealed that zileuton has the ability to attenuate lung dysfunction during CLP induced polymicrobial sepsis in male mice through their modulating effects on LTB4,12(S) HETE and oxidative stress downstream signaling pathways and subsequently decreased lungtissue levelsof proinflammatory cytokines (IL-1β, and IL-6,IL-17).
... Research, Society andDevelopment, v. 11, n. 3, e56211326935, 2022 (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v11i3.26935 3 O tratamento radioterápico considerado bem-sucedido, necessita de acesso a equipamentos de alta tecnologia e equipe profissional bem treinada. Entretanto, esforços contínuos e combinados relacionados ao gerenciamento de riscos durante o procedimento são indispensáveis, pois, aumentam o benefício da assistência prestada, permitindo que a equipe apresente uma solução na tentativa de reduzir os riscos e melhorar a SP (Malicki, 2018;. ...
... O gerenciamento de incidentes, auditorias de qualidade de dose (dosimetria), discussão e revisão dos Research, Society andDevelopment, v. 11, n. 3, e56211326935, 2022 (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v11i3.26935 planos técnicos e erros registrados por meio de reuniões regulares entre toda a equipe também são imprescindíveis (Jung et al., 2020;Malicki et al., 2018;Mazur et al., 2017;Weintraub et al., 2021). ...
... Dessa forma, há a possibilidade de ocorrência de incidentes, mesmo com suporte de equipe profissional capacitada. A prevenção e redução de incidentes requer uma prática firme e resolutiva, amparada por políticas institucionais e evidências sólidas, baseadas em recomendações nacionais e internacionais (Malicki et al., 2018;ASTRO, 2019). ...
Objetivo: Identificar e sintetizar as evidências científicas da segurança do paciente oncológico no tratamento por teleterapia. Metodologia: Trata-se de uma scoping review, segundo Joanna Briggs Institute e PRISMA-ScR. Pesquisa realizada de outubro de 2021 a janeiro de 2022, nas bases de dados National Library of Medicine and National Institutes of Health, Cummulative Index to Nursing and Allied Health Literature, Web of Science, SCOPUS, Literatura Latino-Americana e do Caribe em Ciências da Saúde, Embase, Cochrane Library e em oito catálogos de teses e dissertações, sem aplicação de limite temporal. Resultados: Sessenta e sete estudos foram selecionados para esta revisão, 85,08% são do tipo descritivo e a maioria (53,73%) foi conduzido nos Estados Unidos da América, em geral os estudos foram produzidos por grupos multiprofissionais em saúde. As evidências encontradas recomendam o uso das seguintes medidas para prevenir e reduzir a ocorrência de incidentes tratamento por teleterapia: implementar programas de gerenciamento de riscos e processos; promover o fluxo de trabalho seguro; usar sistemas de notificação voluntária de incidentes e aprendizagem com incidentes e promover a cultura de segurança do paciente. Considerações finais: A segurança do paciente em tratamento por teleterapia ocorre quando há o gerenciamento de riscos e processos e a promoção da cultura de segurança, baseados em evidências e praticados por meio de esforços institucionais e multiprofissionais.
... The introduction of advanced techniques has improved clinical outcomes by allowing for precise dose delivery to the target while reducing radiation doses to critical organs. However, given the importance of ensuring the precision of radiation delivery [1][2][3], it is essential to optimize the radiotherapy process and to implement procedures designed to detect and prevent errors [4]. In this context, clinical audits are an important tool to objectively assess clinical protocols, procedures, and processes. ...
Background: Clinical audits are an important tool to objectively assess clinical protocols, procedures, and processes and to
detect deviations from good clinical practice. The main aim of this project is to determine adherence to a core set of consensus-
based quality indicators and then to compare the institutions in order to identify best practices.
Materials and methods: We conduct a multicentre, international clinical audit of six comprehensive cancer centres in Poland,
Spain, Italy, Portugal, France, and Romania as a part of the project, known as IROCATES (Improving Quality in Radiation
Oncology through Clinical Audits — Training and Education for Standardization).
Results: Radiotherapy practice varies from country to country, in part due to historical, economic, linguistic, and cultural
differences. The institutions developed their own processes to suit their existing clinical practice.
Conclusions: We believe that this study will contribute to establishing the value of routinely performing multi-institutional
clinical audits and will lead to improvement of radiotherapy practice at the participating centres.
... This project aims to promote harmonisation between different European centres and essentially improve patient safety. 1 The recommendations put forward by the ACCIRAD project are as follows. ...
Introduction
Radiotherapy is an ever-changing field with constant technological advances. It is for this reason that risk management strategies are regularly updated in order to remain optimal.
Methodology
A retrospective audit of all reported incidents and near misses in the audited department between 1 November 2020 and 30 April 2021 was performed. The root cause of each radiotherapy error (RTE), safety barrier (SB) and the causative factor (CF) would be defined by the Public Health England (PHE) coding system. The data will then be analysed to determine if there are any frequently occurring errors and if there are any existing relationships between multiple error.
Results
670 patients were treated during the study period along with 35 reports generated. 77·1% (n = 27) were incidents, and 22·9% (n = 8) were near misses. 2·8% (n = 1) were reportable incidents. The ratio of RTEs to prescriptions was 0·052:1 (5·2%). 37% of RTEs were associated with image production. Slips and lapses were involved in 54·2%. Adherence to procedures/protocols was a factor in 48·5% (n = 17). Communication was a factor in 11·4% (n = 4).
Discussion
The proportion of Level 1 incidents was higher in this department (2·8%) than in the PHE report (0·9%). Almost one-third, 31·4% (n = 11) of errors stemmed from one technical fault in image production. SB breaches were prevalent at the pre-treatment planning stage of the pathway. A relationship between slips/lapses and non-conformance to protocols was identified.
Conclusion
The rate of reported radiotherapy incidents in the UK is lower when compared with this department; this could be improved with the implementation of the quality improvement plan outlined above.
... All the above actions have been recommended in the literature but it has been stressed that strong safety culture has to be developed in the clinical environment to ensure safety improvements. 60,21,57 This statement was also strongly supported by Malicki et al. 65 at the final report of the ACCIRAD project (published as the European Commission report, Radiation Protection 181 16 ) as a key feature to successful risk management. ...
Objectives
Stereotactic radiosurgery (SRS) refers to an advanced radiotherapy technique that requires a high level of precision and accuracy and a flawless workflow. Failures within the SRS process can lead to serious consequences due to high doses delivered per treatment. This narrative review aimed to identify the riskiest failure modes (FMs) and the stages at which they occur in the SRS process, as well as the strategies applied to mitigate the risks. It was based on the analysis of published failure mode and effects analysis (FMEA) data.
Key findings
From the literature search in PubMed and Scopus, 7 articles met the eligibility criteria for inclusion in the qualitative synthesis. In total, 9 radiotherapy departments conducted FMEA in the SRS process. 4 of them were community hospitals and 5 were academic centers. Overall, 54 high-risk FMs were identified with treatment planning (FMs: 18), treatment delivery (FMs: 12), consultation and patient registration (FMs: 10) being the riskiest stages. 10 FMs were stereotactic specific, while the remaining 44 could be met in any radiotherapy technique. Failures associated with contouring, medical records review, target reirradiation, and patient positioning were mostly outlined. Risk mitigation strategies included timeouts, double-checks, checklists, training and changes in the working practice.
Conclusion
Our review demonstrated that crucial FMs can occur in all SRS stages. Although generalisations were challenging, the FMs analysis provided a significant source of information about potential high risks and continuous improvement strategies that can be applied both in the SRS and other radiotherapy processes.
Implications for practice
The results of this research will assist radiotherapy facilities in proactive risk management studies and will allow radiotherapy professionals to reflect on their practice and learn from others’ experiences.
... Patient safety in external beam radiotherapy, results of the ACCIRAD project [22,23]. This two publications of 2017 and 2018, describe the current status of the implementation of European directives for risk management in radiotherapy in European countries, and assesses the variability in risk management in the following areas: Regulatory framework in the country; proactive risk assessment; reactive analysis of events; and information and learning systems. ...
Purpose
The Working Group on Patient Safety and Quality of the Spanish Society of Radiation Oncology, revised the most relevant national and international recommendations, selecting a series of important aspects for patient safety, evaluating whether they are included in Spanish legislation
Materials and methods
We have considered a concept as relevant to the patient safety in radiotherapy if so defined in at least 8 of the 16 documents reviewed.
Results
12 subjects were selected: training and qualification, human resources, protocols, safety culture, communication, peer review, accreditation: audits, checklists, areas without interruptions, maps of processes and risks, prospective risk analysis, notification, registration and incident learning, and quality control of the equipment.
Conclusions
At the legislative level, as well as the professional organizations and the health center directorates, the implementation of safety culture must continue to be fostered. Only in this environment will the tools and measures to increase patient safety be effective. The current Spanish legislation must be revised and updated, in accordance with directive 2013/59/EURATOM and the Patient Safety Strategy 2015–2020 of the Spanish National Health System, introducing the obligation to perform risk analysis and incidents management. Audits and accreditations must be carried out, thus raising the general level of practice of the specialty. In this process, the Spanish Society of Radiation Oncology must continue playing its fundamental role, collaborating with the institutions and the rest of the scientific societies involved in the radiotherapy process, issuing recommendations on patient safety and disseminating the safety culture in our specialty.
... Quality has become one of the major interests of radiotherapy teams [53], especially for patient safety [54]. While medical physics work is increasingly being divided between physicists, dosimetrists, nurses, technicians and medical physicists, clinical involvement should remain a strong reality, especially in QA and risk assessment [55]. ...
Purpose:
Fixed-field intensity modulated radiation therapy (FF-IMRT) or volumetric modulated arc therapy (VMAT) beams complexity is due to fluence fluctuation. Pre-treatment Quality Assurance (PTQA) failure could be linked to it. Several plan complexity metrics (PCM) have been published to quantify this complexity but in a heterogeneous formalism. This review proposes to gather different PCM and to discuss their eventual PTQA failure identifier abilities.
Methods and materials:
A systematic literature search and outcome extraction from MEDLINE/PubMed (National Center for Biotechnology Information, NCBI) was performed. First, a list and a synthesis of available PCM is made in a homogeneous formalism. Second, main results relying on the link between PCM and PTQA results but also on other uses are listed.
Results:
A total of 163 studies were identified and n = 19 were selected after inclusion and exclusion criteria application. Difference is made between fluence and degree of freedom (DOF)-based PCM. Results about the PCM potential as PTQA failure identifier are described and synthesized. Others uses are also found in quality, big data, machine learning and audit procedure.
Conclusions:
A state of the art is made thanks to this homogeneous PCM classification. For now, PCM should be seen as a planning procedure quality indicator although PTQA failure identifier results are mitigated. However limited clinical use seems possible for some cases. Yet, addressing the general PTQA failure prediction case could be possible with the big data or machine learning help.
... The legal frameworks are diverse, and a wide range of tools to conduct proactive risk assessment and reactive event analysis are used [5,6]. The third and final report of the ACCIRAD project, presented in this issue, sets forward general recommendations for radiotherapy departments to establish systems for reporting, analysing and learning and provides guidelines on prospective and retrospective risk analysis methods [7]. It also provides national authorities with a set of strategies to promote and improve patient safety culture. ...
Background and Objectives
Medical risks are considered to endanger patients and impact the health care system. Such iatrogenic risks necessitate hospitals taking a more proactive method to quantitatively analyze medical risk, and then to implement more targeted precautions. To address this problem, a novel quantitative risk assessment framework is proposed and further applied in radiotherapy risk assessment.
Methods
A framework combining DMAIC (Define, Measure, Analyze, Improve, Control) and bow-tie model is used to assess health care risk. The uncertainty of medical risks is quantified with fuzzy set theory. The impact and the priority of medical risks were classified based on the risk matrix, and then the precautions were implemented to mitigate their impact. A case study of radiation treatment is provided.
Results
The probabilities and impacts of risk events for radiation treatment were quantified based on the proposed framework, and risk protection measures were proposed to mitigate the undesired consequence.
Conclusion
The proposed framework showing an effective method of quantitative risk assessment of health care. The study also enriches the risk assessment methods in health care by providing a conductive and normalized framework.
Introduction of new methods of nuclear medicine, X-ray diagnostics and therapy using medical sources of ionizing radiation inevitably leads to an increase in the number and types of accidents (abnormal situations). In international practice in recent years, special attention has been paid to the prevention of radiation accidents and incidents from medical exposure. The main focus is put on accidental exposure (overexposure) of patients in X-ray and radionuclide diagnostics and therapy. These approaches are implemented in Russian regulatory and methodological documents in a limited and formal way. The main attention is paid to large-scale technogenic radiation accidents, and accidents (abnormal situations) from medical irradiation are undeservedly ignored. The aim of the work was to analyze the terminology and classification of radiation accidents and incidents from medical exposure in the Russian Federation and foreign countries to develop proposals to improve approaches to their classification within the framework of revision of existing regulatory and methodological documents. The results of the work indicate that it is necessary to actualize Russian approaches to the definition and classification of radiation accidents in medicine considering the specifics of medical exposure. For this purpose, it is advisable to introduce different levels of accidents (abnormal situations), differing from each other by the scale of impact and consequences for patients, workers and public. Considering the absence of elaborated scenarios of accidents (abnormal situations) in Russian regulatory and methodological documents, such gradation can be borrowed from international regulatory documents provided that it is adapted to the specifics and realities of the Russian health care system
Background:
QuADRANT was a research project funded by the European Commission to evaluate clinical audit uptake and implementation across Europe, with an emphasis on clinical audit as mandated within the BSSD (Basic Safety Standards Directive).
Aim:
Focusing on the QuADRANT objectives - to obtain an overview of European clinical audit activity; identify good practices, resources, barriers and challenges; provide guidance and recommendations going forwards; identify the potential for European Union action on quality and safety focusing on the field of radiotherapy.
Results:
A pan-European survey, expert interviews and a literature review conducted within the framework of the QuADRANT project indicated that developments in national clinical audit infrastructure are required. While in radiotherapy, there is a strong tradition and high level of experience of dosimetry audits and well-established practice through the IAEA's QUATRO audits, few countries have a well-established comprehensive clinical audit programme or international/national initiatives on tumour specific clinical audits. Even if sparse, the experience from countries with established system of quality audits can be used as role-models for national professional societies to promote clinical audit implementation. However, resource allocation and national prioritisation of clinical audit are needed in many countries. National and international societies should take the initiative to promote and facilitate training and resources (guidelines, experts, courses) for clinical audits. Enablers used to enhance clinical audit participation are not widely employed. Development of hospital accreditation programmes can facilitate clinical audit uptake. An active and formalised role for patients in clinical audit practice and policy development is recommended. Because there is a persisting variation in European awareness of BSSD clinical audit requirements, work is needed to improve dissemination of information on the legislative requirements relating to clinical audit in the BSSD and in relation to inspection processes. The aim is to ensure these include clinical audit and that they encompass all clinics and specialties involved in medical applications using ionising radiation.
Conclusion:
QuADRANT provided an overarching view of clinical audit practice in Europe, with all its related aspects. Unfortunately, it showed that the awareness of the BSSD requirements for clinical audit are highly variable. Therefore, there is an urgent need to dedicate efforts towards ensuring that regulatory inspections also incorporate an assessment of clinical audit program(s), affecting all aspects of clinical work and specialties involved in patient exposure to ionising radiation.
Reporting and learning are key components of quality and safety in radiotherapy. Each event must be reported to national authorities if considered significant according to national criteria. Lessons learnt from analysis of causal factors are primordial to decrease the risk of reoccurrence or the severity of further events. Thanks to national or international, mandatory or voluntary incidents reporting systems, and experience feedbacks, various sources of learning are available to improve risk management. This article aims to compare the regulations about mandatory declarations of significant events and describe national or international incident reporting and learning systems available.
Background and purpose:
Quality indicators (QIs) for radiotherapy have been proposed by several groups, but no study has been conducted to correlate the implementation of indicators specific to patient safety over the course of the clinical process with an institution's background. An initial large-scale survey was conducted to understand the implementation status of QIs established for quality assurance and patient safety in radiotherapy and the relationship between implementation status and an institutions' background.
Materials and method:
Overall, 68 QIs that were established by this research team after a pilot survey were used to assess structures and processes for quality assurance and patient safety. Data on the implementation of QIs and the institutions' backgrounds were obtained from designated cancer care hospitals in Japan.
Results:
Overall, 284 institutions (72%) responded and had a median QI achievement rate of 60.8%. QIs with low implementation rates, such as the implementation of an error reporting system and establishment of a quality assurance department, were identified. The QI achievement rate and scale of the institution were positively correlated, and the achievement rate of all QIs was significantly higher (p < 0.001) in institutions capable of advanced treatments, such as intensity-modulated radiotherapy, and those with a quality assurance department.
Conclusion:
A large-scale survey on QIs revealed their implementation and relationship with a facility's background. QIs that require improvement were identified, and that these QIs might be effective in providing advanced medical care to many patients.
Background: A radiotherapy incident reporting system should (1) record and classify incidents, (2) assess the impact of incidents on patients in terms of dose errors and (3) identify areas of improvement in the incident reporting system. Such a system at the Independent Clinical Oncology Network (ICON) Oncology is investigated.
Aim: An ‘incident’ is defined by ICON as ‘any occurrence that may prevent the patient from receiving the prescribed dose in the prescribed time period or may cause unplanned harm to the patient or may infringe upon the patient’s rights’.
Setting: Incidents reported between December 2011 and December 2020.
Methods: Incidents were analysed looking at various factors such as institutional timelines compared with major projects, incident error and areas, reporting frequencies amongst tumour-sites and professional groups.
Results: Over the course of 9-years, 78 521 patients were treated at ICON’s centres and a total of 924 reports were filed involving 1355 patients. This shows an incident rate of 1.7% of all patients in radiotherapy. The difference in incident number versus patients is because one incident may involve many patients. Reporting amongst professional groups has more distinctive differences, with 86.0%, 11.6% and 2.4% reported cases per annum for radiotherapists, physicist and oncologist, respectively. For the errors in dose-delivery, 43.0% of the incidents were discovered with no dosimetric or clinical consequence, 53.6% with dosimetric consequence but no clinical consequence and 3.4% with dosimetric and clinical consequence.
Conclusion: Incident reporting is not a new quality assurance (QA) indicator for radiotherapy treatment. However, it requires continuous effort and innovation to uphold and maintain a high standard of patient and staff safety within an organisation. Errors are present during every stage of the radiotherapy process, whether it be human, technical, organisational or patient related. From the statistics of all the patients treated at ICON, 0.04% have been reported to have had an associated incident that involved some form of clinical consequence. Yet, if undetected, the incident could lead to increase in dose errors to patients.
Resumen
Introducción
La radioterapia (RT) es un proceso complejo que utiliza altas dosis de radiación con finalidad terapéutica. La notificación y el análisis de incidentes, además de ser un requisito legal en RT, aporta información que ayuda a mejorar la seguridad de los pacientes. En este trabajo se describe nuestra experiencia tras 9 años utilizando un sistema local de notificación y aprendizaje de incidentes (SNAI) específico en RT.
Materiales y métodos
El centro dispone de 4 aceleradores lineales que tratan a un total 1.900 pacientes anualmente. La primera acción que se llevó a cabo para abordar la seguridad de los pacientes fue la constitución de un grupo multidisciplinar de seguridad en RT (GSRT). Se decidió utilizar una metodología basada en la notificación de incidentes. Para ello se implementó un SNAI local adaptando el sistema de registro de incidentes ROSEIS, utilizado y consolidado por la Sociedad Europea Radioterapia Oncológica (ESTRO). Todos los incidentes donde algún paciente recibió alguna sesión de RT incorrecta se consideraron eventos adversos (EA) y fueron analizados. Finalmente, a través de una encuesta, se valoró la opinión de los profesionales con relación al SNAI y al funcionamiento del grupo de seguridad.
Resultados
Desde junio del 2009 hasta octubre del 2018 se registraron 1.708 incidentes. Se observó un aumento de notificaciones a lo largo de los años. Un 2,5% de los incidentes reportados fueron EA, el resto fueron sucesos que no tuvieron impacto en el paciente. En la fase de administración del tratamiento, se detectaron el 55% de los incidentes, siendo los técnicos de RT los profesionales que más registraron. La mayoría de los casos provenían de fallos organizativos relacionados son la comunicación o protocolos de trabajo. Se implementaron acciones de mejora dirigidas a reducir la frecuencia de EA y facilitar su detección temprana. Las acciones realizadas fueron básicamente; redacción y revisión de protocolos y circuitos, implantación de listas de verificación y acciones formativas.
Un 85% de los trabajadores encuestados valoraron positivamente la incorporación del SNAI y el funcionamiento del grupo de seguridad. Sin embargo, un 15% de los profesionales consideraron que la metodología empleada en el análisis de incidentes no fue totalmente objetiva y tenía carácter punitivo.
Conclusiones
Se ha abordado la seguridad del paciente que recibe RT a partir de una metodología basada en la implementación de un SNAI local. El análisis de los incidentes notificados ha promovido diversas acciones dirigidas a mejorar la seguridad de los pacientes que reciben RT. La metodología empleada ha sido bien valorada por los trabajadores y ha ayudado a introducir la cultura de la seguridad en la mayoría de profesionales implicados. Además, el SNAI local facilita dar cumplimiento a la normativa europea en cuanto a la obligación de registrar incidentes en RT.
Copies available from: https://www.crcpress.com/On-Treatment-Verification-Imaging-A-Study-Guide-for-IGRT/Kirby-Calder/p/book/9781138499911
Summary
On-treatment verification imaging has developed rapidly in recent years and is now at the heart of image-guided radiation therapy (IGRT) and all aspects of radiotherapy planning and treatment delivery.
This is the first book dedicated to just this important topic, which is written in an accessible manner for undergraduate and graduate therapeutic radiography (radiation therapist) students and trainee medical physicists and clinicians. The later sections of the book will also help established medical physicists, therapeutic radiographers, and radiation therapists familiarise themselves with developing and cutting-edge techniques in IGRT.
Features:
Clinically focused and internationally applicable; covering a wide range of topics related to on-treatment verification imaging for the study of IGRT
Accompanied by a library of electronic teaching and assessment resources for further learning and understanding
Authored by experts in the field with over 18 years’ experience of pioneering the original forms of on-treatment verification imaging in radiotherapy (electronic portal imaging) in clinical practice, as well as substantial experience of teaching the techniques to trainees
New evidence based regimens and novel high precision technology have reinforced the important role of radiotherapy in the management of cancer. Current data estimate that more than 50% of all cancer patients would benefit from radiotherapy during the course of their disease. Within recent years, the radiotherapy community has become more than conscious of the ever-increasing necessity to come up with objective data to endorse the crucial role and position of radiation therapy within the rapidly changing global oncology landscape. In an era of ever expanding health care costs, proven safety and effectiveness is not sufficient anymore to obtain funding, objective data about cost and cost-effectiveness are nowadays additionally requested. It is in this context that ESTRO is launching the HERO-project (Health Economics in Radiation Oncology), with the overall aim to develop a knowledge base and a model for health economic evaluation of radiation treatments at the European level. To accomplish these objectives, the HERO project will address needs, accessibility, cost and cost-effectiveness of radiotherapy. The results will raise the profile of radiotherapy in the European cancer management context and help countries prioritizing radiotherapy as a highly cost-effective treatment strategy. This article describes the different steps and aims within the HERO-project, starting from evidence on the role of radiotherapy within the global oncology landscape and highlighting weaknesses that may undermine this position.
Global advances in patient safety have been hampered by the lack of a uniform classification of patient safety concepts. This is a significant barrier to developing strategies to reduce risk, performing evidence-based research and evaluating existing healthcare policies relevant to patient safety. Since 2005, the World Health Organization's World Alliance for Patient Safety has undertaken the Project to Develop an International Classification for Patient Safety (ICPS) to devise a classification which transforms patient safety information collected from disparate systems into a common format to facilitate aggregation, analysis and learning across disciplines, borders and time. A drafting group, comprised of experts from the fields of patient safety, classification theory, health informatics, consumer/patient advocacy, law and medicine, identified and defined key patient safety concepts and developed an internationally agreed conceptual framework for the ICPS based upon existing patient safety classifications. The conceptual framework was iteratively improved through technical expert meetings and a two-stage web-based modified Delphi survey of over 250 international experts. This work culminated in a conceptual framework consisting of ten high level classes: incident type, patient outcomes, patient characteristics, incident characteristics, contributing factors/hazards, organizational outcomes, detection, mitigating factors, ameliorating actions and actions taken to reduce risk. While the framework for the ICPS is in place, several challenges remain. Concepts need to be defined, guidance for using the classification needs to be provided, and further real-world testing needs to occur to progressively refine the ICPS to ensure it is fit for purpose.
Ensuring safe operation for a medical accelerator is a difficult task. Users must assume more responsibility in using contemporary equipment. Additionally, users must work closely with manufacturers in promoting the safe and effective use of such complex equipment. Complex treatment techniques and treatment modality changeover procedures merit detailed, unambiguous written procedural instruction at the control console. A thorough "hands on" training period after receiving instructions, and before assuming treatment responsibilities, is essential for all technologists. Unambiguous written instructions must also be provided to guide technologists in safe response when equipment malfunctions or exhibits unexpected behavior or after any component has been changed or readjusted. Technologists should be given a written list of the appropriate individuals to consult when unexpected machine behavior occurs. They should be assisted in identifying aberrant behavior of equipment. Many centers already provide this instruction, but others may not. Practiced response and discussion with technologists should be a part of an ongoing quality assurance program. An important aspect of a safety program is the need for continuous vigilance. Table III gives a summary of a comprehensive safety program for medical accelerators. Table IV gives a list of summary recommendations as an example of how one might mitigate the consequences of an equipment failure and improve procedures and operator response in the context of the environment described. Most of these recommendations can be implemented almost immediately at any individual treatment center.
To describe and classify process errors and preventable adverse events that occur from medical care in outpatient primary care settings.
Systematic review and synthesis of the medical literature.
We searched MEDLINE and the Cochrane Library from 1965 through March 2001 with the MESH term medical errors, modified by adding family practice, primary health care, physicians/family, or ambulatory care and limited the search to English-language publications. Published bibliographies and Web sites from patient safety and primary care organizations were also reviewed for unpublished reports, presentations, and leads to other sites, journals, or investigators with relevant work. Additional papers were identified from the references of the papers reviewed and from seminal papers in the field.
Process errors and preventable adverse events.
Four original research studies directly studied and described medical errors and adverse events in primary care, and 3 other studies peripherally addressed primary care medical errors. A variety of quantitative and qualitative methods were used in the studies. Extraction of results from the studies led to a classification of 3 main categories of preventable adverse events: diagnosis, treatment, and preventive services. Process errors were classified into 4 categories: clinician, communication, administration, and blunt end.
Original research on medical errors in the primary care setting consists of a limited number of small studies that offer a rich description of medical errors and preventable adverse events primarily from the physician's viewpoint. We describe a classification derived from these studies that is based on the actual practice of primary care and provides a starting point for future epidemiologic and interventional research. Missing are studies that have patient, consumer, or other health care provider input.
To examine error rates in the delivery of radiation therapy (RT), technical factors associated with RT errors, and the influence of a quality improvement intervention on the RT error rate.
We undertook a review of all RT errors that occurred at the Princess Margaret Hospital (Toronto) from January 1, 1997, to December 31, 2002. Errors were identified according to incident report forms that were completed at the time the error occurred. Error rates were calculated per patient, per treated volume (>/=1 volume per patient), and per fraction delivered. The association between tumor site and error was analyzed. Logistic regression was used to examine the association between technical factors and the risk of error.
Over the study interval, there were 555 errors among 28,136 patient treatments delivered (error rate per patient = 1.97%, 95% confidence interval [CI], 1.81-2.14%) and among 43,302 treated volumes (error rate per volume = 1.28%, 95% CI, 1.18-1.39%). The proportion of fractions with errors from July 1, 2000, to December 31, 2002, was 0.29% (95% CI, 0.27-0.32%). Patients with sarcoma or head-and-neck tumors experienced error rates significantly higher than average (5.54% and 4.58%, respectively); however, when the number of treated volumes was taken into account, the head-and-neck error rate was no longer higher than average (1.43%). The use of accessories was associated with an increased risk of error, and internal wedges were more likely to be associated with an error than external wedges (relative risk = 2.04; 95% CI, 1.11-3.77%). Eighty-seven errors (15.6%) were directly attributed to incorrect programming of the "record and verify" system. Changes to planning and treatment processes aimed at reducing errors within the head-and-neck site group produced a substantial reduction in the error rate.
Errors in the delivery of RT are uncommon and usually of little clinical significance. Patient subgroups and technical factors associated with errors can be identified. The introduction of new technology can produce new ways for errors to occur, necessitating ongoing evaluation of RT errors for quality assurance. Modifications to processes of care can produce important reductions in error rates.
Purpose:
To describe the current status of implementation of European directives for risk management in radiotherapy and to assess variability in risk management in the following areas: 1) in-country regulatory framework; 2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems.
Material and methods:
The original data were collected as part of the ACCIRAD project through two online surveys.
Results:
Risk assessment criteria are closely associated with quality assurance programs. Only 9/32 responding countries (28%) with national regulations reported clear "requirements" for proactive risk assessment and/or reactive risk analysis, with wide variability in assessment methods. Reporting of adverse error events is mandatory in most (70%) but not all surveyed countries.
Conclusions:
Most European countries have taken steps to implement European directives designed to reduce the probability and magnitude of accidents in radiotherapy. Variability between countries is substantial in terms of legal frameworks, tools used to conduct proactive risk assessment and reactive analysis of events, and in the reporting and learning systems utilized. These findings underscore the need for greater harmonisation in common terminology, classification and reporting practices across Europe to improve patient safety and to enable more reliable inter-country comparisons.
In 2011 the European Commission launched a tender to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy. This tender was awarded to a consortium of 6 institutions, including the ESTRO, in late 2011. The project, denominated “ACCIRAD”, recently finished the data collection phase. Data were collected by surveys administered in 38 European countries. Results indicate non-uniform implementation of event registration and classification, as well as incomplete or zero implementation of risk assessment and events analysis. Based on the survey results and analysis thereof, project leaders are currently drafting proposed guidelines entitled “Guidelines for patient safety in external beam radiotherapy – Guidelines on risk assessment and analysis of adverse-error events and near misses”. The present article describes the aims and current status of the project, including results of the surveys.
Knowledge and lessons from past accidental exposures in radiotherapy are very helpful in finding safety provisions to prevent recurrence. Disseminating lessons is necessary but not sufficient. There may be additional latent risks for other accidental exposures, which have not been reported or have not occurred, but are possible and may occur in the future if not identified, analyzed, and prevented by safety provisions. Proactive methods are available for anticipating and quantifying risk from potential event sequences. In this work, proactive methods, successfully used in industry, have been adapted and used in radiotherapy. Risk matrix is a tool that can be used in individual hospitals to classify event sequences in levels of risk. As with any anticipative method, the risk matrix involves a systematic search for potential risks; that is, any situation that can cause an accidental exposure. The method contributes new insights: The application of the risk matrix approach has identified that another group of less catastrophic but still severe single-patient events may have a higher probability, resulting in higher risk. The use of the risk matrix approach for safety assessment in individual hospitals would provide an opportunity for self-evaluation and managing the safety measures that are most suitable to the hospital's own conditions.
Purpose:
Incident learning plays a key role in improving quality and safety in a wide range of industries and medical disciplines. However, implementing an effective incident learning system is complex, especially in radiation oncology. One current barrier is the lack of technical standards to guide users or developers. This report, the product of an initiative by the Work Group on Prevention of Errors in Radiation Oncology of the American Association of Physicists in Medicine, provides technical recommendations for the content and structure of incident learning databases in radiation oncology.
Methods:
A panel of experts was assembled and tasked with developing consensus recommendations in five key areas: definitions, process maps, severity scales, causality taxonomy, and data elements. Experts included representatives from all major North American radiation oncology organizations as well as users and developers of public and in-house reporting systems with over two decades of collective experience. Recommendations were developed that take into account existing incident learning systems as well as the requirements of outside agencies.
Results:
Consensus recommendations are provided for the five major topic areas. In the process mapping task, 91 common steps were identified for external beam radiation therapy and 88 in brachytherapy. A novel feature of the process maps is the identification of "safety barriers," also known as critical control points, which are any process steps whose primary function is to prevent errors or mistakes from occurring or propagating through the radiotherapy workflow. Other recommendations include a ten-level medical severity scale designed to reflect the observed or estimated harm to a patient, a radiation oncology-specific root causes table to facilitate and regularize root-cause analyses, and recommendations for data elements and structures to aid in development of electronic databases. Also presented is a list of key functional requirements of any reporting system.
Conclusions:
Incident learning is recognized as an invaluable tool for improving the quality and safety of treatments. The consensus recommendations in this report are intended to facilitate the implementation of such systems within individual clinics as well as on broader national and international scales.
The purpose of this investigation was to analyse incidents discovered in our radiation therapy department by means of human factor analysis and classification system (HFAC S). We adapted the original framework of the HFAC S and apply it to the analysis of incidents discovered in our radiotherapy department during a five-year period. Results showed that recurrent causal factors of incidents were attention failures and distracted/overconfidence behaviour as well as loss of situational awareness and mental fatigue. In our radiation therapy department the HFAC S allowed to highlight recurrent errors causal factors. Consequently we defined corrections factors for operators behaviour and implemented an operational protocol which improve operators attitude.
To establish an incident reporting system to (1) record and classify incidents, (2) assess the impact of incidents on patients in terms of dose errors, and (3) evaluate the effectiveness of the quality assurance checking program implemented at the Radiation Treatment Program at the Northeastern Ontario Regional Cancer Centre (NEORCC).
An 'incident' is defined as an event or a series of events that has led to, or would have led to if undiscovered, dose errors to a patient undergoing radiation therapy treatment. The incidents reported between November 1992 and December 2002 were analyzed according to their source of error, stage of discovery and dose errors.
Between November 1992 and December 2002, 13385 patients have undergone radiation treatment at the NEORCC. Over this period of time, 624 'incidents' were reported. Source of error: the majority of the incidents (42.1%) were related to errors in 'documentation' and most of these could be attributed to 'error in data transfer' or 'inadequate communication'. 'Patient set-up error' accounted for 40.4% of the incidents and about half of these errors were related to shielding. Errors in 'treatment planning' accounted for 13.0% of the incidents. Stage of discovery: independent checks by another dosimetrist/physicist and checking during patient first set-up and port film were effective in detecting documentation errors and errors in treatment planning. The use of portal imaging (Siemens Beamview) has enabled us to detect and correct for more than 85% of reported shielding errors in patient set-up. Dose errors: 40% of the incidents were discovered before the first treatment with no dose error to patients. Overall 97.9% of the incidents had dose error of <5%.
Human errors occur during the various stages of the complex process of radiation therapy. If uncorrected, these could lead to substantial dose errors to patients. The implementation of a quality assurance checking program can substantially reduce these human errors but never totally eliminate them.
Radiotherapy utilization rates for cancer vary widely internationally. It has previously been suggested that approximately 50% of all cancer patients should receive radiation. However, this estimate was not evidence-based. The aim of this study was to estimate the ideal proportion of new cases of cancer that should receive radiotherapy at least once during the course of their illness based on the best available evidence. An optimal radiotherapy utilization tree was constructed for each cancer based upon indications for radiotherapy taken from evidence-based treatment guidelines. The proportion of patients with clinical attributes that indicated a possible benefit from radiotherapy was obtained by adding epidemiologic data to the radiotherapy utilization tree. The optimal proportion of patients with cancer that should receive radiotherapy was then calculated using TreeAge (TreeAge Software, Williamstown, MA) software. Sensitivity analyses using univariate analysis and Monte Carlo simulations were performed. The proportion of patients with cancer in whom external beam radiotherapy is indicated according to the best available evidence was calculated to be 52%. Monte Carlo analysis indicated that the 95% confidence limits were from 51.7% to 53.1%. The tightness of the confidence interval suggests that the overall estimate is robust. Comparison with actual radiotherapy utilization data suggests a shortfall in actual radiotherapy delivery. This methodology allows comparison of optimal rates with actual rates to identify areas where improvements in the evidence-based use of radiotherapy can be made. It provides valuable data for radiotherapy service planning. Actual rates need to be addressed to ensure better radiotherapy utilization.
Radiation treatment (RT) for cancer is susceptible to clinical incidents resulting from human errors and equipment failures. A systematic approach to collecting and processing incidents is required to manage patient risks. We describe the application of a new taxonomic structure for RT that supports risk analysis and organizational learning.
A systematic analysis of the RT process identified five process domains. Within each domain we defined incident type groups. We then constructed a database reflecting this taxonomic structure and populated it with incidents from publicly available sources. Querying this database provides insights into the nature and relative frequency of incidents in RT.
There are relatively few reports of incidents in the Prescription domain compared with the Preparation and Treatment domains. There are also fewer reports of systematic and infrastructure incidents in comparison to sporadic and process incidents. Infrastructure incidents are mainly systematic in nature, while process incidents are more likely to be sporadic.
The lack of a standard, systems-oriented framework for incident reporting makes it difficult to learn from existing incident report sources. A clear understanding of the potential consequences and relationships between different incident types will guide incident reporting, resource allocation, and risk management efforts.
Radiotherapy incidents involving a major overdose such as that which affected a patient in Glasgow in 2006 are rare. The publicity surrounding this patient's treatment and the subsequent publication of the enquiry by the Scottish Executive have led to a re-evaluation of procedures in many departments. However, other incidents and near misses that might also generate learning are often surrounded by obsessive secrecy. With the passage of time, even those incidents that have been subject to a public enquiry are lost from view. Indeed, the report on the incident in Glasgow draws attention to strong parallels with that in North Staffordshire, the report of which is not freely available despite being in the public domain. A web-based system to archive and make available previously published reports should be relatively simple to establish. A greater challenge is to achieve open reporting of near misses, incidents and errors. The key elements would be the effective use of keywords, a system of classification and a searchable anonymized database with free access. There should be a well designed system for analysis, response and feedback. This would ensure the dissemination of learning. The development of a more open culture for reports under the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) is essential: at the very least, their main findings and recommendations should be routinely published. These changes should help us to achieve greater safety for our patients.
Recent publications in both the scientific and the popular press have highlighted the risks to which patients expose themselves when entering a healthcare system. Patient safety issues are forcing us to, not only acknowledge that incidents do occur, but also actively develop the means for assessing and managing the risks of such incidents. To do this, we ideally need to know the probability of an incident's occurrence, the consequences or severity for the patient should it occur, and the basic causes of the incident. A structured approach to the description of failure modes is helpful in terms of communication, avoidance of ambiguity, and, ultimately, decision making for resource allocation. In this report, several classification schemes or taxonomies for use in risk assessment and management are discussed. In particular, a recently developed approach that reflects the activity domains through which the patient passes and that can be used as a basis for quantifying incident severity is described. The estimation of incident severity, which is based on the concept of the equivalent uniform dose, is presented in some detail. We conclude with a brief discussion on the use of a defined basic-causes table and how adding such a table to the reports of incidents can facilitate the allocation of resources.
Therapy technologies.
- Preventing Accidental Exposures from New External Beam Radiation