Bmri2014 392596
Bmri2014 392596
Bmri2014 392596
Research Article
Implementation of Incident Learning in the Safety and Quality
Management of Radiotherapy: The Primary Experience in a New
Established Program with Advanced Technology
Ruijie Yang, Junjie Wang, Xile Zhang, Haitao Sun, Yang Gao, Lu Liu, and Lei Lin
Department of Radiation Oncology, Peking University Third Hospital, Beijing 100191, China
Correspondence should be addressed to Junjie Wang; junjiewang47@yahoo.com
Received 28 May 2014; Accepted 14 July 2014; Published 22 July 2014
Academic Editor: An Liu
Copyright 2014 Ruijie Yang et al. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Objective. To explore the implementation of incident learning for quality management of radiotherapy in a new established
radiotherapy program. Materials and Methods. With reference to the consensus recommendations by American Association of
Physicist in Medicine, an incident learning system was specifically established for reporting, investigating, and learning of individual
incidents. The incidents that occurred in external beam radiotherapy from February, 2012, to February, 2014, were reported. Results.
A total of 28 near misses and 5 incidents were reported. Among them, 5 originated in imaging for planning, 25 in planning, and 1
in plan transfer, commissioning, and delivery, respectively. One near miss/incident was classified as wrong patient, 7 wrong sites,
6 wrong laterality, and 5 wrong dose. Five reported incidents were all classified as grade 1/2 of dosimetric severity, 1 as grade 0,
and the other 4 as grade 1 of medical severity. For the causes/contributory factors, negligence, policy not followed, and inadequate
training contributed to 19, 15, and 12 near misses/incidents, respectively. The average incident rate per 100 patients treated was 0.4.
Conclusion. Effective implementation of incident learning can reduce the occurrence of near misses/incidents and enhance the
culture of safety.
1. Introduction
With the rapid development of equipment and technology,
the technique of radiotherapy becomes more and more complicated. The treatment planning and delivery of radiotherapy
are a highly complex, multiple-step process, with multiple
professional groups involved. Every step of the care process
in radiation oncology requires knowledge in the management
of cancer and certain benign disease, radiobiology, medical
physics, and radiation safety that can only be achieved by
systematic and structured training. There are many steps
where incidents might occur, although major radiotherapy
incidents are rare. And it is challenging to determine the
actual error rate in radiotherapy. The quality management
of radiotherapy is paramountly important to guarantee the
appropriateness, quality, and safety of radiotherapy.
As a systematic tool and approach of quality management,
incident learning has proved its value in many industries
[1]. It has also already been successfully used for a number
2
about incidents allows better process optimization with
information about likely severity and frequency of specific
errors and helps prioritize quality management initiatives [5
8]. A number of references suggest reporting and learning
radiotherapy incidents or near misses.
While it is generally accepted that incident learning is
important in the radiation therapy setting, implementing
incident reporting and learning represents a considerable
challenge. It requires additional clinical resources and a welldesigned system for report, analysis, and response. What is
more important is the development of a more open mindset
and just culture for reporting near misses and incidents,
with an increased emphasis on incident learning to uncover
latent error pathways. Studies analyzing the effects of incident
learning on patient safety and quality in individual clinics
remain scarce, while several departments reported their
experience [913].
The purpose of this work is to explore the implementation and effectiveness of incident learning using a system
developed based on AAPM recommended database structure
in a new established program of radiation oncology with
advanced technology.
3
Table 1: Summary of reported incidents and near misses.
First year
Second year
Total
Incident
3
2
5
Near miss
19
9
28
Patients treated
537
725
1262
Incident (%)
0.56
0.28
0.40
Total (%)
4.10
1.52
2.61
3. Results
A total of thirty-three reports were analyzed, including 28
near misses and 5 actual incidents. During this period, a total
of 1262 patients were treated. The summary of reported near
misses and incidents are given in Table 1. The average incident
rate per 100 patients treated was 0.4; this rate fell to 0.28% in
the second year from 0.56% in the first year. The rate of near
miss fell to 1.24% from 2.22%.
Table 2 gives the incident category of reported error
type. The rates of all types of incidents/near miss decreased
except the suboptimal plan quality type. Among them, the
wrong patient incident occurred due to the wrong patient
plan calling out with the same last name of two patients,
which was found when the other patient was treated in the
same afternoon. Of the 7 wrong site near misses/incidents,
2 occurred due to the field shape unchanged to conform
to the target projection after adding wedge and adjusting
the collimator angle, not noticed by the planner, found and
corrected during the plan physics review. Three incorrect
shifts from computed tomography (CT) reference marks
were reported, due to the wrong/missing setting the fiducial
reference point when planning, which were caught during
physics check and CT repositioning before treatment. One
geographic miss resulted from forgetting shifting the treatment isocenter after modifying plan with the prescription
dose delivered to the wrong volume. One electronic transfer
Table 3: Summary of the origin of reported incidents (in parentheses) and near misses.
Category
Wrong patient
Wrong site
Wrong laterality
Wrong dose
Wrong prescription
Suboptimal plan quality
Total
Category
Imaging for planning
(simulation)
First year
(1)
4 (2)
4
4
5
2
19 (3)
Second year
0
0 (1)
2
1
2
4 (1)
9 (2)
Total
1
7
6
5
7
7
33
First year
Second year
Total
treatment planning
Plan transfer
Commissioning
Treatment delivery
13 (1)
(1)
1
(1)
9 (2)
0
0
0
25
(1)
1
(1)
Total
19 (3)
9 (2)
28 (5)
First year
5 (3)
2
3
3
6
19 (3)
Second year
5 (2)
1
3
0
0
9 (2)
Total
10 (5)
3
6
3
6
28 (5)
First year
(1)
7 (2)
1
9
2
19 (3)
Second year
0
6 (2)
0
3
0
9 (2)
Total
(1)
13 (4)
1
12
2
28 (5)
Table 6: Summary of causes/contributory factors for reported incidents (in parentheses) and near misses.
Category
1biv
1cii
1ciii
1civ
1div
2bii
2biv
3f,
6aiii
6div
6eii
7
Total
First year
7 (5)
2 (1)
3
3
2
1
(1)
12 (3)
1
1
(1)
0
32 (11)
Second year
3
1
1
1
1
0
0
4
0
4
0
2
17
Total
10 (5)
3 (1)
4
4
3
1
(1)
16 (3)
1
5
(1)
2
49 (11)
Comments: The data indicate the number of causes/contributory factors, not the number of near misses/incidents.
4. Discussion
Our results demonstrated that incident learning can be
used for the safety and quality management of radiotherapy,
even for a department with new established program with
advanced technology, new equipment from different vendors,
no much safety, and quality management experience. Implementation of an effective incident learning system may serve
to reduce the occurrence of actual incidents and enhance the
culture of safety at the individual health care professional
level and at the multidisciplinary team level by addressing
quality improvement initiatives collaboratively with transparent accountability. Incident learning also improved event
communication and identification of clinical areas which
needed process and safety improvements and encouraged
the reporting of potential incidents as a proactive means of
enhancing safety and quality in a radiation treatment program. The reported data were also useful for the evaluation of
corrective measures and recognition of ineffective measures
and efforts.
Implementing Incident learning in radiotherapy is a
systematic and complicated project. A rigorous system of
learning, feedback, and action are required for this approach
to have a meaningful impact on patient care. The corresponding departmental infrastructure and facilities, organization,
and culture are needed. The related academic society, organization, and state health administrative department should
encourage and protect the reporting and learning of near
misses/incidents by advocacy, regulation, and legislature.
6
In addition, the severity assignment of an actual incident
or near miss is difficult, especially for the near-misses since
one has to estimate the harm that would have reached
the patient several steps down the chain of events. The
dosimetric severity scale could not fully be expressed by
dose; it will be better if evaluated with biological effective
dose. For a near miss reported in our study, in which the
physicians prescription of 60.00 Gy/2.0 Gy/30 f was planned
with 60.00 Gy/0.3 Gy/200 f, the dose was the same, but it
would result in severe effect if not found.
33 near misses/incidents were reported in two years in
this study. The volume of reports varies with the report
criteria, quality and safety culture, equipment, and techniques
used for different institutions. Mutic et al. have observed
an incident report rate of 1 per 1.6 patients treated (this
includes both incidents that reach the patient and near-miss
incidents that are intercepted before reaching the patient)
[16]. We collected a large number of incidents including near
misses with very limited or zero clinical impact on patients,
such as the plans of suboptimal plan quality, efficiency, beam
energy, beam orientation, susceptibility to setup error, and
organ motion, which were found and corrected prior to
treatment. Such an approach facilitates continuous proactive
improvement which can lead to the correction of small and/or
latent system weaknesses before they result in much more
severe events, to improve the safety and quality of care by
supporting the systematic learning from errors [17, 18].
The rate of reported near misses/incidents decreased
significantly in the second year, although more near misses of
suboptimal plan quality were reported due to the enhanced
quality and safety culture in the second year. The high
rate of reported near misses/incidents in the first year may
be attributed to the introduction of new equipment, new
techniques, and new staff. Through the analysis of the
occurrence of near misses/incidents, the cause/contribution
factors, we found the weaknesses in the clinical process and
implemented series of proactive measures to enhance the
safety and quality. At the start of 2013, we introduced a more
comprehensive check list in an attempt to reduce these errors
and the error rate fell dramatically. Morganti et al. report a
reduction in error through the use of independent checks
[19]. Clear communication program et al. also contributed
to the decrease, which included the efforts focusing on communication ambiguities (e.g., technicians not informed of
cancelled treatment, changed plan or special appointment,
or change in number of treatments, doctor unavailable for
assigned appointment, etc.) and unclear physician directive,
and additional policy and procedure changes addressing
verbalization of treatment parameters prior to treatment
delivery, laterality and documentation of change in prescription, and planning. Other examples of such interventions
include changes in staffing levels to concentrate effort in more
vulnerable parts of the process and modification of the quality
assurance processes to focus on weaknesses in the treatment
preparation process, enhance staff training, competency evaluation and supervision, strictly follow clinical protocol, and
standardization of processes.
An important feature of the incident learning system is
that it requires an investigation of sufficient depth to discover
5. Conclusions
Our results show that implementation of an effective incident
learning system may serve to reduce the occurrence of
actual incidents, enhance the culture of safety, and encourage
the reporting of potential incidents as a proactive means
of enhancing safety and quality in a radiation treatment
program. Incident learning can be used for the safety and
quality management of radiotherapy according to our primary experience.
Conflict of Interests
None of the authors have any actual or potential conflict of
interests related to this work.
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