Guidelines on risk assessment and analysis of adverse events and near misses

226 Pages·2013·6.69 MB·English

1
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3 http://www.accirad.eu
4 www.accirad-workshop.eu
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6
7 Contract ENER/D4/160-2011
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9
Patient safety in external beam radiotherapy –
10
Guidelines on risk assessment and
11
analysis of adverse events and near misses
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13
14 Draft 10, 26 April 2013
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ACCIRAD Guidelines, Draft 10, 26 April 2013 Page 1 of 226
1 FOREWORD
2
3 These guidelines are the main outcome of an EC project ENER/D4/160-2011, “Guidelines on a
4 risk analysis of accidental and unintended exposures in radiotherapy (ACCIRAD)”. The objective
5 of the project was
6 • to perform an EU-wide study on the implementation of the requirements of Article 11 of
7 the Council Directive 97/43/EURATOM (Medical Exposure Directive, MED) and
8 • to develop guidelines on a risk analysis of accidental and unintended exposures in
9 external beam radiotherapy.
10
11 Article 11 of MED requires that "Member States shall ensure that all reasonable steps to
12 reduce the probability and the magnitude of accidental or unintended doses of patients from
13 radiological practices are taken (...)" and stipulates that "the main emphasis in accident
14 prevention should be on the equipment and procedures in radiotherapy (...)". The overall aim of
15 this project has thus been to reduce of the probability and the magnitude of accidents in
16 radiotherapy.
17
18 The Guidelines are based on a thorough review of available international and national
19 documents, recommendations and guidelines, and the results of two steps of detailed
20 questionnaires to the EU Member States. The first step of the questionnaire addressed the
21 overall status and the legal and practical arrangements in EU Member States regarding the
22 implementation of Article 11 of MED. The second step collected more detailed information on
23 the systems and guidelines from those countries which had this information available. Moreover
24 relevant background information from on-going EC projects like MPE and MEDRAPET was also
25 taken into account. The draft European Guidelines was presented and subjected to critical
26 discussion at the European Workshop (Poznan, 4-6 June 2013) and, in addition, distributed for
27 comments to the several relevant international and European organisations.
ACCIRAD Guidelines, Draft 10, 26 April 2013 Page 2 of 226
1 LIST OF CONTENTS
2
3 FOREWORD...........................................................................................................................2
4 LIST OF CONTENTS.................................................................................................................3
5 EXECUTIVE SUMMARY...........................................................................................................6
6 1. Introduction.....................................................................................................................7
7 2. Purpose and Scope............................................................................................................9
8 3. Legislative and normative basis.......................................................................................10
9 3.1 “Safety requirements” in IAEA Basic Safety Standards ( BSS)...........................................10
10 3.2. Risk analysis in ISO 9001: 2000 standard for healthcare.................................................12
11 3.3. Safety issues in the European medical device directive..................................................12
12 3.4. Safety issue in Euratom BSS (proposal December 2012, to be updated)..........................13
13 3.5 Council recommendation on patient safety (2009/C151/01)...........................................13
14 3.6 Conclusions...................................................................................................................14
15 4. Risk Management...........................................................................................................14
16 4.1 General.........................................................................................................................14
17 4.1.1 Basic concepts and implementation.............................................................................................14
18 4.1.2. General concepts.........................................................................................................................16
19 4.2 Proactive risk assessment methods...............................................................................20
20 4.2.1 Generic features............................................................................................................................20
21 4.2.2 Methods Dedicated to External Radiotherapy..............................................................................26
22 4.2.3. Interests and Limits of the different proactive methods.............................................................26
23 4.2.4. National regulations or recommendations on proactive risk analysis.........................................28
24 4.2.5 Examples of local practice.............................................................................................................29
25 4.3. Reactive methods.........................................................................................................31
26 4.3.1 Generic features............................................................................................................................31
27 4.3.2 Method dedicated to external beam radiotherapy: Specific Human Factor (HFACS)..................36
28 4.3.3. Interests and limits of the different reactive methods................................................................37
29 4.3.4. National regulations or recommendations on reactive analysis of events..................................39
30 4.3.5. Examples of local practice............................................................................................................39
31 5. Classification and reporting of adverse events and near misses in radiotherapy................42
32 5.1. General Introduction....................................................................................................42
33 5.2. Terminology.................................................................................................................42
34 5.2.1 Terms and definitions in generic use............................................................................................42
35 5.2.2 Definition of terms for patient safety in radiotherapy.................................................................45
36 5.2.3. Conclusions..................................................................................................................................46
37 5.3. Classification................................................................................................................46
38 5.3.1. Purpose of classification..............................................................................................................46
39 5.3.2. Classification criteria....................................................................................................................47
40 5.3.3. General classification system vs Radiotherapy-specific classification system.............................64
41 5.3.4. Taxonomy of causes.....................................................................................................................64
42 5.3.5. Harmonization of taxonomies......................................................................................................65
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1 5.3.6. Conclusion....................................................................................................................................66
2 5.4. Event Reporting and Learning Systems..........................................................................66
3 5.4.1. Characteristics of reporting and learning systems.......................................................................68
4 5.4.2. Investigation of events.................................................................................................................75
5 5.4.3. How to encourage reporting: 10 golden rules.............................................................................77
6 5.4.4. Training........................................................................................................................................78
7 5.4.5. Communication strategies...........................................................................................................79
8 5.4.6. Conclusions..................................................................................................................................80
9 6. Preventive measures/ risk reduction interventions...........................................................82
10 6.1 Hierarchy of effectiveness of preventive measures.........................................................82
11 6.2 Quality assurance and quality control programs.............................................................86
12 6.3 Clinical audit..................................................................................................................87
13 7. Recommendations...........................................................................................................90
14 7.1. Risk management for external beam radiotherapy........................................................90
15 7.1.1 How to prepare/get prepared for making proactive and reactive risk assessment.....................90
16 7.1.2 How to implement risk management...........................................................................................91
17 7.1.3 How to follow up/monitor the results, how to learn, benefit, improve the system....................92
18 7.1.4 Recommendations or “Roadmap” for risk management at radiotherapy institutions.................92
19 7.2 Classification and reporting of adverse events and near misses in external beam
20 radiotherapy.......................................................................................................................94
21 7.2.1 Terminology and classification......................................................................................................94
22 7.2.2. Reporting and learning systems – General principles.................................................................95
23 7.2.3. Reporting and learning systems – Investigation of events..........................................................96
24 7.2.4. Reporting and learning systems – Dissemination of information................................................96
25 7.2.5. Reporting and learning systems – Follow-up and supplementary actions..................................97
26 References..........................................................................................................................98
27 ANNEX 1. EXAMPLES OF TERMS AND DEFINITIONS FOR EVENT CLASSIFICATION AND
28 REPORTING........................................................................................................................106
29 ANNEX 2: Status of MED implemention...............................................................................112
30 A2.1 General......................................................................................................................112
31 A2.2 Questionnaire structure..............................................................................................112
32 A2.3 Satistics of replies.......................................................................................................113
33 A2.4 Regulatory framework and guidelines.........................................................................113
34 A2.4.1 Risk management.....................................................................................................................113
35 A2.4.2 Classification of adverse events and near misses.....................................................................115
36 A2.4.3 Reporting of adverse events and near misses..........................................................................116
37 A2.5 Some national features of external beam radiotherapy...............................................118
38 A2.5.1 QA and QC programs................................................................................................................118
39 A2.5.2 Regulatory control....................................................................................................................119
40 A2.5.3 Clinical audit.............................................................................................................................121
41 ANNEX 3: Status of risk management.................................................................................123
42 A3.1 Proactive risk assessment...........................................................................................124
43 A3.1.1 Regulation.................................................................................................................................124
44 A3.1.2 Proactive risk assessment method...........................................................................................126
45 A3.2. Reactive risk analysis and reporting...........................................................................127
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1 A3.2.1 Regulation and guidance..........................................................................................................127
2 A3.2.2. Reactive analysis methods.......................................................................................................131
3 A3.3. Periodical review of the results of risk assessment conducted by radiotherapy centres
4 ..........................................................................................................................................132
5 A3.4. Organization for feedback on risk assessment............................................................132
6 ANNEX 4: Examples of local risk management.....................................................................134
7 ANNEX 5: Status of classification and reporting of adverse events and near misses..............148
8 A5.1 INTRODUCTION..........................................................................................................148
9 A5.2 RESULTS.....................................................................................................................149
10 A5.3 CONCLUSIONS............................................................................................................160
11 ANNEX 6. Summaries of the risk assessment systems (proactive and reactive).....................161
12 A6.1. Proactive risk assessment method............................................................................162
13 A6.1.1. Failure Mode and Effect Analysis.............................................................................................162
14 A6.1.2. Preliminary Risk Analysis (PRA)................................................................................................165
15 A6.1.3 Fault Tree Analysis (FTA)...........................................................................................................168
16 A6.1.4. Event Tree Analysis (ETA)........................................................................................................170
17 A6.1.5. Process Analysis including critical points.................................................................................172
18 A6.1.6. Dedicated to External Radiotherapy: Specific FMEA (ASN, France)........................................173
19 A6.1.7. Dedicated to External Radiotherapy: Risk Matrix Methodology (Spain – FORO)...................178
20 A6.2. Reactive risk assessment methods............................................................................186
21 A6.2.1 Root cause analysis RCA..........................................................................................................186
22 A6.2.2. ALARM.....................................................................................................................................188
23 A6.2.3. Causal tree analysis (CTA)........................................................................................................189
24 A6.2.4 ORION.....................................................................................................................................191
25 A6.2.5 Dedicated methodology to External Radiotherapy: Specific Human Factor (HFACS)..............193
26 ANNEX 7. Existing reporting and learning systems for patient safety in radiotherapy...........197
27 A7.1. Introduction.............................................................................................................197
28 A7.2. Results......................................................................................................................198
29 ANNEX 8. Relation between ISO 9001: 2000 standard for healthcare and ASN quality
30 management guidelines for safety and quality....................................................................220
31 ANNEX 9. Safety issues in European medical device directive...............................................223
32 ANNEX 10. List of national contact persons.........................................................................225
33
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1 EXECUTIVE SUMMARY
2
3 [To be written at the end; summary of the main conclusions and recommendations, and advice
4 on how to use this guideline ]
ACCIRAD Guidelines, Draft 10, 26 April 2013 Page 6 of 226
1 1. Introduction
2
3 Radiotherapy is one of the major treatment options in cancer management. According to
4 best available practice1, 52% of patients should receive radiotherapy at least once during the
5 treatment of their cancer. Together with other modalities such as surgery and chemotherapy it
6 plays an important role in the treatment of 40% of those patients who are cured of their
7 cancer2. Radiotherapy is also a highly effective treatment option for palliation and symptom
8 control in cases of advanced or recurrent cancer. Thus, radiotherapy effectively saves lives,
9 prolongs lives and improves the quality of life.
10
11 While radiotherapy is widely known to be one of the safest areas of modern medicine, yet,
12 for some, this essential treatment can bring harm, personal tragedy and even death. Though
13 errors in radiotherapy are rare, when they do occur the consequences can be significant for the
14 patient, as proved by severe radiotherapy accidents occurred during the last years. Review of
15 available literature3 has shown that in the years 1976 to 2007, 3125 patients were reported to
16 be affected by radiotherapy incidents that led to adverse events. About 1% (N=38) of the
17 affected patients died due to radiation overdose toxicity. Only two reports estimated the
18 number of deaths from under-dosage. In the years 1992 to 2007, more than 4500 near misses
19 (N=4616) were reported in the literature and publically available databases. Looking at these
20 event rates, it is also important to recognize that the radiotherapy-related error rate compares
21 favourably with the rate of other medical errors3. For example, the risk of mild to moderate
22 injurious outcome to patients from these errors was about 1500 per million treatment courses,
23 which was much lower than the hospital admission rates for adverse drug reactions (about 65
24 000 per million)4.
25
26 The potential for adverse effects and near misses in radiotherapy is dictated by the fact that
27 radiotherapy is a highly complex, multi-step process, which requires the input of many different
28 staff groups in the planning and delivery of the treatment. Complexity arises from the wide
29 range of conditions treated, professional involved, technologies used and professional expertise
30 needed. This complexity is compounded by the multiple steps involved and the fact that
31 processes are continually changing in the light of research and the introduction of new
32 technologies. Over the last decade, the rapid development of new technology has significantly
33 changed the way in which radiotherapy is planned and delivered: three-dimensional computed
34 tomography (CT) based planning, multi-leaf collimation (MLC), improved immobilization, and
35 more sophisticated planning and data management software now permit complex treatment
36 plans to be prepared individually for many patients5. Modern radiotherapy departments are
37 multisystem-dependent environments that rely heavily on transfer of patient data between
38 different units, systems and staff of different disciplines.
39
40 The understanding of the complex process of radiotherapy requires many kinds of expertise:
41 it involves understanding of the principles of medical physics, radiobiology, radiation safety,
42 dosimetry, radiotherapy planning and simulation and interaction of radiation therapy with other
43 treatment modalities, among others. Several professional groups are needed for the team work
44 of radiotherapy; the main professionals involved are the Radiation Oncologists (RO), Radiation
45 Therapists (RT) and Medical Physicists (MP). Each of these disciplines work through an
46 integrated process to plan and deliver radiotherapy to patients. Skills and competences in
47 radiation protection requirements are essential for all radiation treatment health professionals.
48
49 A high level of accuracy is needed at every step of the radiotherapy process so that the
50 maximum tumour control probability is produced with minimal risk to normal tissue. Risks
51 should be managed prospectively and dose errors should be maintained within acceptable
ACCIRAD Guidelines, Draft 10, 26 April 2013 Page 7 of 226
1 tolerances; for external beam radiotherapy, the radiation dose should be delivered within 5% of
2 the prescribed dose6. Several studies have concluded that, for certain types of tumours, the
3 accuracy should be even better (up to 3.5%)7-9.
4
5 It is imperative that proper QA measures are in place in order to achieve and maintain the
6 required high accuracy, and to reduce the likelihood of adverse events and errors occurring, and
7 increase the probability that the errors will be recognized and rectified if they do occur. Studies
8 in radiotherapy practice have shown that development of a comprehensive QA system,
9 including an explicit and uniform protocol for implementation and timely assessment of errors,
10 may reduce the level of incidents10-12. Radiation treatment-specific quality assurance guidelines
11 have been issued by a number of worldwide organizations such as the World Health
12 Organization (WHO), the International Atomic Energy Agency (IAEA), and the International
13 Commission on Radiological Protection (ICRP)13-16.
14
15 There is a long history of documenting incidents and examining adverse events in
16 radiotherapy. However, there is a consensus neither in the basic terminology of adverse events
17 and near misses nor in the way how to classify and report these events. Several international
18 and national systems of classification, recording and reporting of the events have been
19 developed. It is of interest, therefore, to study the available systems and the possibility to find
20 out a more harmonized way to manage the events.
21
22 It is unrealistic to expect to reduce the error rate to zero, in any field, including radiotherapy,
23 but every effort should be taken to keep the rates low. International safety guidelines have been
24 developed and are regularly updated to deal with radiotherapy errors related to equipment and
25 dosimetry. However, there is no consensus as yet as to how best to deal with errors not covered
26 by regular system quality assurance checks. Recently, several organizations have addressed the
27 need for proactive risk analysis in radiotherapy, to supplement the most common reactive
28 analysis of adverse events and near misses. From the study of the events and the factors
29 underlying them it has been possible to map the risks3. Risk model researchers17 generally claim
30 that errors can always be reduced to the minimum possible consistent with the accumulated
31 experience by effective error management systems and tracking progress in error reduction
32 down the learning curve. This can also lead to identification of incidents earlier in the process
33 with less serious consequences.
34
35 The present guidelines aim at giving basic information and recommendations for an overall
36 risk management in radiotherapy, as highlighted above: proactive risk analysis and reactive
37 assessment of events (Section 5), classification, reporting and learning from adverse events and
38 near misses in radiotherapy (Section 6) and preventive measures to reduce the risks (Section 7).
39 The main emphasis will be on the two first items, as the third one has been traditionally
40 discussed in a more comprehensive and compact way in several international
41 recommendations.
42
43 References to Section 1:
44
45 1. Delaney G et al. The role of radiotherapy in cancer treatment: Estimating optimal
46 utilization from a review of evidence-based clinical guidelines. Cancer,2005,
47 104:1129–1137.
48 2. The Swedish Council on Technology Assessment in Health Care (SBU). Systematic
49 Overview of Radiotherapy for Cancer including a Prospective Survey of Radiotherapy
50 Practice in Sweden 2001 –Summary and Conclusions. Acta Oncologica, 2003,42:357–
51 365.
52 3. World Health Organization (WHO). Radiotherapy Risk Profile. WHO 2008.
ACCIRAD Guidelines, Draft 10, 26 April 2013 Page 8 of 226
1 4. Munro AJ. Hidden danger, obvious opportunity: error and risk in the management of
2 cancer. British Journal of Radiology, 2007, 80:955-966.
3 5. Huang G et al. Error in the delivery of radiation therapy: results of a quality assurance
4 review. International Journal of Radiation Oncology Biology Physics, 2005,
5 61(5):1590–1595.
6 6. International Commission on Radiation Units and Measurements (ICRU).
7 Determination of Absorbed Dose in a Patient Irradiated by Beams of X or Gamma
8 Rays in Radiotherapy Procedures. ICRU Report 24. Bethesda, MD: ICRU, 1976.
9 7. Brahme A et al. Accuracy requirements and quality assurance of external beam
10 therapy with photons and electrons. Acta Oncologica, (Suppl. 1) 1988.
11 8. Mijnheer BJ, Battermann JJ, Wambersie A. What degree of accuracy is required and
12 can be achieved in photon and neutron therapy? Radiotherapy and Oncology, 1987,
13 8:237–252.
14 9. Mijnheer BJ, Battermann JJ, Wambersie A. Reply to: Precision and accuracy in
15 radiotherapy. Radiotherapy and Oncology, 1989, 14:163–167.
16 10. Huang G et al. Error in the delivery of radiation therapy: results of a quality assurance
17 review. International Journal of Radiation Oncology Biology Physics, 2005,
18 61(5):1590–1595.
19 11. Yeung TK et al. Quality assurance in radiotherapy: evaluation of errors and incidents
20 recorded over a 10 year period. Radiotherapy and Oncology, 2005, Mar;74(3):283–
21 291.
22 12. Lawrence G et al. The Impact of changing technology and working practices on errors
23 at the NCCT. 1998–2006. Clinical oncology (Royal College of Radiologists),
24 2007;19(3):S37.
25 13. World Health Organization (WHO). Quality Assurance in Radiotherapy. Geneva:
26 WHO, 1988.
27 14. Comprehensive audits of radiotherapy practices: a tool for quality improvement:
28 Quality Assurance Team for Radiation Oncology (QUATRO) — Vienna: International
29 Atomic Energy Agency, 2007.
30 15. Setting up a radiotherapy programme: clinical, medical physics, radiation protection
31 and safety aspects. — Vienna: International Atomic Energy Agency (IAEA), 2008.
32 16. International Commission on Radiological Protection (ICRP). Radiological Protection
33 and Safety in Medicine. ICRP 73. Annals of the ICRP, 1996, Vol. 26, Num. 2.
34 17. Duffey RB, Saull JW. Know the risk: Learning from errors and accidents: Safety and
35 risk in today’s technology. US: Butterworth-Heinemann Publications, 2003.
36 2. Purpose and Scope
37
38 Article 11 of MED requires that "Member States shall ensure that all reasonable steps to
39 reduce the probability and the magnitude of accidental or unintended doses of patients from
40 radiological practices are taken (...)" and stipulates that "the main emphasis in accident
41 prevention should be on the equipment and procedures in radiotherapy (...)". As shown in
42 Section 2.4, these requirements will be re-enforced in the proposed update of the European
43 BSS.
44
45 The objective of these guidelines, dealing with a risk analysis and assessment of accidental
46 and unintended exposures in external beam radiotherapy, is to support Member States in the
47 implementation of the legislative requirement derived from the provision of Article 11 of MED
48 (and the future update of the European BSS). These requirements are aimed at the reduction of
49 the probability and the magnitude of adverse events in radiotherapy.
ACCIRAD Guidelines, Draft 10, 26 April 2013 Page 9 of 226
1
2 The document provides a comprehensive review of the risk assessments methods, both
3 proactive and reactive, and discusses their benefits and shortcomings as for the application in
4 external beam radiotherapy (Section 4). Because the effective management and comparison of
5 events requires clear and sufficiently consistent terminology and classification systems, the
6 terminology used and the available systems of classification are discussed in detail (Section 5).
7 As the main purpose of recording and reporting adverse events and near misses is to achieve an
8 efficient learning system for their prevention, a sample of the available national and
9 international reporting and learning systems are also reviewed and discussed in Section 5.
10 Finally, because quality management should incorporate and promote a safety culture that aims
11 at preventing adverse events and near misses, such preventive measures (quality assurance,
12 quality control, clinical audit, education and training etc) are also briefly summarized (Section 6).
13 For the main topics of risk assessment and the classification and reporting of events, a set of
14 conclusions and recommendations are given, based on the reviews and discussion (Section 7).
15 As such, the document will clarify the links between the risk analysis, the principle of defence in
16 depth and user experience feedback, and stress the benefits of an effective exchange of risk
17 analysis results between equipment manufacturers and users.
18
19 While the scope of the guidelines by definition is limited to external beam radiotherapy,
20 many of the general principles of risk analysis, event classification and reporting, and preventive
21 measures, are also applicable to other modalities of radiotherapy (brachytherapy etc).
22 3. Legislative and normative basis
23
24 Risk assessment and risk analysis in relation with accidental and unintended medical
25 exposures has been addressed in international and European safety standards. In the following,
26 a critical review of these standards is presented.
27
28 3.1 “Safety requirements” in IAEA Basic Safety Standards ( BSS)
29
30 As stated in the Fundamental Safety Principles [X, date] issued by IAEA, “The fundamental
31 safety objective is to protect people and the environment from harmful effects of ionizing
32 radiation”. In relation with this very fundamental objective, ten Safety Fundamental principles
33 have been defined. Among them, at the same level than the justification and optimisation
34 principles, well known by medical practitioners, appears the principle of prevention of accidents
35 which could occur in the use of ionising radiations for medical or industrial or research purposes.
36
37 A definition of this safety fundamental principle which also applies to accidental and
38 unintended medical exposure, is given : “Principle 8 - Prevention of accidents - All practical
39 efforts must be made to prevent and mitigate nuclear or radiation accidents”.
40
41 (i) Prime responsibility in protection and safety [IAEA, General Safety Requirements,
42 part 3]
43
44 The prime responsibility for safety must rest with the person or organization responsible for
45 facilities and activities that give rise to radiation risks. Other parties also bear certain
46 responsibilities (manufactures and suppliers of radiation generators for instance). In the case of
47 medical exposures, primary responsibility for protection and safety for patients lies with the
48 health professional responsible for administration of the radiation dose, so called “the
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