The British Journal of Radiology, 80 (2007), 297–301

COMMENTARY

Improving patient safety in radiotherapy by learning from near

misses, incidents and errors
M V WILLIAMS, MD, FRCP, FRCR

Faculty of Clinical Oncology, The Royal College of Radiologists, 38 Portland Place, London W1B 1JQ, UK

ABSTRACT. 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 Received 13 January 2007
classification and a searchable anonymized database with free access. There should be Revised 26 February 2007
a well designed system for analysis, response and feedback. This would ensure the Accepted 9 March 2007
dissemination of learning. The development of a more open culture for reports under
DOI: 10.1259/bjr/29018029
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 ’ 2007 The British Institute of
changes should help us to achieve greater safety for our patients. Radiology

Radiotherapy is seen as a mysterious procedure by
patients and the public alike. Treatments vary in their
intent, and in the number and size of fractions
administered. Because radiation is involved and because
it can neither be seen nor felt, there is an air of mystery
that adds to the perception of danger.
Staff recognize radiotherapy as a high risk procedure
because the process is complex and involves a large
number of different steps and staff groups: each hand-
over or data transfer offers the opportunity for mis-
communication and error. The risks are compounded
because radiotherapy is usually a repetitive procedure.
Treatment is administered as a series of fractions and
error can be perpetuated [1, 3–5]. Alternatively, a
dosimetry or calculation error can affect a series of
patients [2, 6–9]. Despite this, radiotherapy has a good
safety record and patient injury caused by error is rare.
Several international organizations have reviewed
major radiotherapy incidents [8, 9] and one might
conclude that it is now difficult to invent a new error.
Indeed, recently reported errors from Leeds [3–5] and
Glasgow [1] were repetitions of previous mistakes,
namely omission of a wedge compensator during
treatment [8] incorporated when a computer treatment
planning system was introduced [2]. However, it is
Address correspondence to: Dr Michael Williams, Faculty of Clinical
Oncology, The Royal College of Radiologists, 38 Portland Place,
London W1B 1JQ, UK. E-mail: michael-williams@rcr.ac.nhs.uk
important to understand the fine detail of the mechan-
isms by which a latent error was established [10, 11]: a
series of mistakes then resulted in the delivery of an
incorrect treatment. As technology develops, there will
be new possibilities for mistakes, but the root cause
usually lies not in the individual but in organizational
procedures, structure and governance [10–15]. These
details and their continual review in the light of incidents
and non-conformances are the key to safety [10, 14, 16].
Open reporting and the ‘‘no blame’’ culture
Open reporting of near misses, incidents and errors is
established as a key safety step in other high risk
industries [12, 14]. Aviation has seen a dramatic fall in
the incidence of accidents over the last 30 years, and this
has been attributed to the safety and reporting culture
[14, 16]. Anaesthesia has made safety a priority and has
replicated the achievements of aviation, significantly
reducing the risk of death from accidents [17]. Near
misses do not have legal implications and thus there are
fewer barriers to reporting. In addition, near misses are
3–300 times more common than adverse events and offer
learning opportunities without patient injury [16].
However, medicine has lagged behind other industries
in establishing a safety culture [12, 14, 16]. Reducing risk
requires a determination to achieve improvement, open
reporting and a ‘‘no blame’’ culture [14, 16–20]. It has

The British Journal of Radiology, May 2007 297


been observed that all reporting is in some sense
voluntary and that, to be effective, it needs to be linked
to a system for analysis, response and feedback [18].
For the NHS, these principles were enunciated in the
two publications ‘‘Organisation with a memory’’ [12]
and its successor ‘‘Building a safer NHS for patients’’
[13], which led to the establishment of the National
Patient Safety Agency (NPSA). The difficulty for radio-
therapy is that we are far removed from the ideal
solution that these reports describe. We are still locked
into a ‘‘past’’ where attention focuses on individual
error, leading to scapegoating and fear of reprisals;
adverse events are regarded as ‘‘one-offs’’, subject to a
short-term fix; and other staff do not hear the outcome of
investigations that are considered to be only relevant to
the team involved [12]. We are still a long way from the
‘‘future’’ where individuals are held accountable for
their actions within a system approach to hazards,
blame-free reporting is encouraged with regular feed-
back, the potential for replication is recognized and
lessons are disseminated to others [12].
There is still a strong blame culture: indeed, the report
on the Glasgow incident devoted considerable effort to
apportioning blame to different individuals [1]; although
managerial failures were documented, there was little
emphasis on overall responsibility at a high level [1]. It
has been argued that leaders should take personal
responsibility for the safety of the processes and systems
in which individuals work if sustained improvement is
to be achieved [20].
Internal reporting of radiotherapy incidents
and the NPSA
Radiotherapy departments in the UK are required to
have a quality management system [21] and, within this,
quality assurance programmes specific to the various
processes are required, implicitly or explicitly, by UK
legislation. It is usual to seek accreditation by an outside
body. Quality assurance systems require internal report-
ing and audit of incidents and non-conformances: such
events are reviewed at weekly or monthly meetings.
Trends can be identified and remedial action put in
place. In England, these reports are fed into NHS Trust
risk reporting systems and then forwarded to the NPSA,
where they are anonymized and fed into a database held
on a separate server [22]. The difficulty with this
laudable system is that it contains some 50 000 oncology
incidents, half of which are trips, slips and falls. These
are not usually informative about the radiotherapy
process and, although important to the patient and the
hospital, are essentially a byproduct of collecting data
through risk management systems. The database is not
searchable and there is no use of keywords. It may be
difficult to deduce whether a dose error refers to a
chemotherapy or a radiotherapy event. This may explain
why the NPSA stated that it possessed no data on any
adverse incidents that could have been of assistance to
the panel reviewing the Leeds incident [4]. Only a single
clinical oncologist has access to the NPSA database, and
feedback mechanisms have yet to be established. If it is to
be useful in the future, these limitations need to be
addressed: as it is anonymized, there is no reason why it
298
M V Williams
should not be open to professional or even public
scrutiny.
Reports under the Ionising Radiation (Medical
Exposure) Regulations
In the UK, radiotherapy errors that result in a dose
greater than intended are reportable to the inspectorate
under the Ionising Radiation (Medical Exposure)
Regulations (IR(ME)R) [23]. The regulations were laid
before parliament to fulfil our obligations under a
European Council directive [24]. This gave member
states the responsibility for implementing a system of
inspection to enforce the provisions of the directive. In
particular, there is a requirement that:
Member states shall ensure that all reasonable steps to
reduce the probability and the magnitude of accidental
or unintended dose of patients from radiological
practices are taken, economic and social factors being
taken into account.
The main emphasis in accident prevention should be
on the equipment and procedures in radiotherapy, but
some attention should be paid to accidents with
diagnostic equipment. ((Article 11) [24])
One can draw two conclusions about the implementa-
tion of this directive through the IR(ME)R in the UK.
First, there seems to be an inappropriate focus on very
small misexposures in diagnostic practice, which clearly
was not the intention of those drafting the directive.
Raising the reporting and external investigation thres-
hold for incidents to encompass only those carrying a
risk of carcinogenesis of greater than 1 in 10 000 has been
proposed [25]. Second, the wording ‘‘accidental or
unintended doses’’ includes both over- and underdoses,
but only the former are reportable in the UK, despite the
major detriment that can follow an underdose [2, 7].
Interestingly, despite the legal position, the new
Healthcare Commission form permits the reporting of
underdoses.
Enquiries under the Freedom of Information Act have
elicited the fact that over the last 6 years there have been
211 radiotherapy incidents reported under the IR(ME)R
[26, 27]. The data do not include underdoses (which are
not reportable under these regulations) or overdoses that
were recoverable by revising the radiotherapy plan or
did not breach the reporting threshold. There is no public
or professional access to any of these data other than
under the Freedom of Information Act.
Investigations under the IR(ME)R are conducted
under criminal law and usually under caution [1, 23].
The results of the IR(ME)R investigations are therefore
confidential and are not disseminated unless unusual
steps are taken. This is not a specified feature of the core
European legislation [24] as the details of the legislation,
regulation and administrative provisions are a matter for
each country (Article 14(1) of [24]). In Denmark, things
are very different: the Danish Act on Patient Safety came
into force on 1 January 2004 [28]. It obliges frontline
personnel to report adverse events to a national system.
The purpose is to learn, not punish, and the act contains a
paragraph protecting staff from sanctions: an individual
The British Journal of Radiology, May 2007
Improving patient safety in radiotherapy
who reports an adverse event cannot as a result of that
report be subjected to investigation or disciplinary action
by the employer, the Board of Health, or the Court of
Justice [28]. Similar protection is offered in Australia and
New Zealand, and in other industries. In Denmark,
hospital owners are obliged to act on the reports, and the
national Board of Health is obliged to communicate the
learning nationally. The punitive system adopted by
the UK was a matter of choice, made doubly strange by
the earlier publication of ‘‘Organisation with a memory’’
[12].
Reports of inquiries into major incidents
Major incidents in which a patient comes to harm or
where there is a system failure, such that a series of
patients are exposed to risk, are investigated to deter-
mine what went wrong. But it is also essential that the
results be made public and the lessons disseminated. The
Scottish Executive is to be congratulated for publishing
the report on the investigation into the unintended
overdose in Glasgow [1]. This action had a huge impact
on the radiotherapy community in the UK and has
certainly banished complacency. In contrast, in 2004 a
radiotherapy incident occurred in Leeds whereby a
patient received treatment to the breast without a wedge
compensator in place for a series of 14 fractions [3, 4]. An
alert was published by the Department of Health [5] and
disseminated through the risk management system,
rather than directly to radiotherapy departments. The
document is striking for its brevity and it had little
impact. This has been identified as a common failing of
such alerts [29]. The only report that has been published
deals with ‘‘involuntary automaticity’’, the psychological
mechanism proposed by the authors to explain the
repetitive error made by a series of staff members [3].
The issue of how the incorrect data were entered into the
treating linear accelerator in the first place was not
addressed at all. A full enquiry was commissioned by the
Trust, but the report has been kept confidential. Access
under the Freedom of Information Act reveals that it
contains significant recommendations for national prac-
tice [27]; for example, on workload, training, working
practices, manual data transfer, checking procedures and
the replacement of outdated computer programs [4]. It is
very disheartening that the Trust that commissioned it
has not seen fit to publish the report. However, this
behaviour is inkeeping with the findings of the Leeds
report itself, which states that:
Very little information seems to be collected or
publicly shared on radiotherapy adverse events either
nationally or internationally. Indeed keeping such
information confidential seems to take a higher
priority than finding a way to use it to prevent similar
accidents from taking place. [4]
There are a large number of other serious incidents
that have been identified under the Freedom of
Information Act and published both in the press [26]
and on websites [30]. For the most part, these have not
been fed back to other departments in an effective way.
The British Journal of Radiology, May 2007
Hospitals fear the public disclosure of reports that may
damage their reputation [31]. However, the media
usually learn about embarrassing accidents from other
sources [31], and this occurred in the Leeds case when
the error was reported the in local press [4]; the article is
available on the internet [30]. Others have wrestled more
effectively with the dilemma posed for a hospital by the
public management of medical error [19]: at Sturdy
Memorial Hospital mistakes in prostate biopsy reporting
were discovered, patients were notified and a review of
6000 specimens was commissioned. There was little
support from professional bodies and a flurry of media
attention, but overall the experience was judged to have
been positive and there was no impact on the hospital’s
workload or finances. Openness reaffirmed the hospital’s
reputation for putting patients first. Patients accepted the
inevitability of human error and were impressed that
something was being done about it [19].
International reporting systems
Lessons learned from the investigation of therapy
misadministration events have been reported by the
United States Nuclear Regulatory Commission (NRC)
[32]. They reviewed seven events, involving radioiso-
topes, investigated in 1991–92, and emphasised the
importance of a comprehensive safety culture. The
International Atomic Energy Agency (IAEA) has pub-
lished a report on ‘‘Lessons learned from accidental
exposures in radiotherapy’’, reviewing 92 anonymized
radiotherapy incidents together with a classification of
causes and recommendations on prevention [8]. The
International Commission on Radiological Protection
(ICRP) has published ‘‘Prevention of accidental expo-
sures to patients undergoing radiation therapy’’, review-
ing seven case histories of major large scale accidental
exposures [9]. Their main recommendations were for
quality assurance systems and a programme of in vivo
dosimetry within departments [9]. A taxonomy of
radiation incidents has been proposed to support risk
analysis and organizational learning: 437 incidents from
databases held by the NRC, the IAEA and the Radiation
Oncology Safety Information System (ROSIS) were
reviewed and classified into systemic and sporadic,
and by the process domain in which they occurred [33].
The reporting of adverse events in healthcare has been
reviewed by Leape [31]. He argues that to be effective it
is necessary to mimic the aviation safety system so that
reporting is simple, safe (for the reporter) and worth-
while. Successful reporting systems are non-punitive,
confidential, independent, timely, responsive and subject
to expert analysis [31]. Recommendations should focus
on changes in systems, processes or products rather than
on individual performance [31]. Both the IAEA and ICRP
reports draw attention to the virtues of the open
reporting systems in aviation [8, 9] and the desirability
of anonymous reporting and dissemination to the wider
community [8]. Nevertheless, there is no such compre-
hensive system in the UK or elsewhere. The nearest
approximation is ROSIS, which was established in 2001
with pump-priming funds from the European Society for
Therapeutic Radiology and Oncology (ESTRO). It is a
voluntary reporting system that now holds on its website
299

over 700 incidents from 37 departments across 19
countries [34]. The data are anonymized, made fully
searchable and are in the public domain. Details of
incidents and their causes are given in an abbreviated
form, and it is not possible to analyse them in detail.
In response to reports of harm to patients caused by
radiotherapy, a new initiative has been launched by the
World Health Organization World Alliance for Patient
Safety [35, 36]. There are two primary issues of concern.
First, can a set of standardized safety interventions be
developed to reduce harm to patients? Second, can
lessons from errors be translated into international
learning? A timely and worldwide response to safety
incidents has been achieved in aviation but not in
medicine [37]. One of the aims of the World Alliance
for Patient Safety is that the learning from the inad-
vertent death of a patient in a hospital in one country
could save the lives of many others around the world
[37].
Recommendations
First, learning from the past should be consolidated by
setting up a publicly available website to hold copies of
the reports of previous radiotherapy incident enquiries.
This should help to ensure that the learning from them is
not forgotten. In the UK alone, there have been a number
of public enquiries about radiotherapy incidents that
affected a series of patients. These include those at Exeter
[6] and North Staffordshire [2]. These are in the public
domain, but the incident at Glasgow showed us that very
similar errors can still occur [1].
Second, dissemination of learning from near misses
and non-reportable incidents should be improved. This
could be achieved by changing the way in which the
NPSA database works and by providing effective
analysis and feedback [18]. At present, radiotherapy
incidents are submitted internally and then sent to a
central server where they are anonymized [22]; no
analysis has been published. Lack of feedback was one
of several criticisms made by the National Audit Office
[29], and the Department of Health has responded with a
plan to remedy the deficiencies [38]. The NPSA system as
it applies to radiotherapy could be improved if a
classification of radiotherapy incidents could be agreed
and if reports included:
N Agreed key words
N A description of how the error occurred
N Identification of how the error was detected
N Patient outcome and corrective action taken
N Lessons to be learnt
N Free text for further comments.
The Royal College of Radiologists has established a
multidisciplinary working party whose remit includes these
issues; it will also make recommendations on error
prevention and detection. The report will be completed by
the end of 2007 and should provide the basis for developing
an open reporting system for radiotherapy incidents. We
hope to work with the NPSA to achieve this objective. In
addition, it is hoped that full analysis of these complex
incidents could be assisted by support services provided by
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M V Williams
the Health Protection Agency, working with the professions
involved in radiotherapy delivery to provide specialist
expertise. Detailed investigation of selected near misses and
other incidents that are not statutorily reportable would
maximize learning. The results must then be linked to an
effective system of dissemination that would reassure staff
that reporting is worthwhile.
Third, the development of a more open culture for
reports under the IR(ME)R is essential. Since 1 November
2006, the Healthcare Commission has been the responsible
authority; this change may provide the opportunity for
greater openness. The Scottish Executive has already
shown that reports initiated under these regulations can
be published. The Healthcare Commission’s vision is ‘‘to
make a difference to the delivery and quality of healthcare
by inspecting, informing and improving’’. To fulfil their
informing role, they should routinely publish the results of
enquires under the IR(ME)R. This would be consistent
with their policy on the reports of other investigations and
would help to ensure that errors are not repeated
elsewhere. This could be facilitated by establishing a
website to host anonymized reports of enquiries, or at the
very least their main findings and recommendations.
In conclusion, if these objectives could be achieved,
then the UK could become a world leader in reporting
and learning from radiotherapy incidents. This should
improve the safety of our patients and would take us a
step nearer to passing the ‘‘orange wire test’’, whereby a
safety incident results in a rapid worldwide response as
in aviation [37].
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