Memorandum by the Quality, Reliability,
Safety and Teamwork Unit, Oxford University (QRSTU) (PS 34)
We attach our submission to the enquiry into
Patient Safety. We are a group of researchers at Oxford University
who formed a group (QRSTU) focussing on the safety and reliability
of surgical care. We note the terms of reference of the enquiry
and have responded to those terms which match our expertise and
experience. Specifically, we would like to comment on:-
The role of human error and systems failures
in patient harm
Adequate measurement and assessment of patient
Whether measures taken to secure patient safety
are supported by adequate evidence
How to ensure implementation of patient safety
How to identify and spread best practice
What data should be measured and assessed to
evaluate patient safety
In addition to our submission attached, we have
contributed to a submission by the Clinical Human Factors Group.
This therefore contains a small amount of our research data. Our
submission contains our reasoning based on our research, as well
as some research results. In the normal course of our work, some
of these data have been presented at scientific conferences whilst
others are contained in scientific papers being written or already
submitted to journals. We have not referenced our submission,
but a full list of references to the scientific evidence on which
it is based is available and we would be happy to provide this
1.1. There is conclusive evidence that modern
hospital care carries a high risk of harm to patients.
1.2. QRSTU write as a group of researchers
concerned to discover the truth about how harm due to healthcare
comes about, and how it can be prevented. Our particular focus
is on surgery, but we believe the relevant principles are common
to all hospital disciplines.
1.3. Analysis of the causes of patient harm
supports a model in which defects in (a) staff communication culture,
(b) systems of work and (c) technology can combine unpredictably
to cause harm.
1.4. We wish to submit some evidence from
our work about methods which appear effective in reducing error
and improving compliance with best practice in surgery.
1.5. We wish to report the experiences gathered
during these studies, and the insights they gave into the reasons
for resistance and failure in introducing safety interventions
in healthcare systems
1.6. We are concerned that the evidence
base on which recommendations are likely to be made is currently
very weak, and would submit that regulation, training and the
imposition of mandatory systems for harm reduction should be based
on sound scientific data.
1.7. We recommend an urgent increase in
the amount of research effort devoted to this problem, so that
innovation can proceed with confidence.
1.8. We recognise the need for urgent action
to improve the current situation, and do not wish to suggest that
action should be deferred until conclusive research findings are
available. We suggest instead that certain broad safety principles,
already capable of being enunciated and supported from current
evidence in healthcare and other industries, should be strongly
supported, and that mandatory systems and regulation should be
avoided except where sound evidence is available.
1.9. We recognise that current clinical
governance systems are largely ineffective, and recommend that
they are re-structured according to the principles referred to
2.1. The practice of surgery has seen dramatic
technological change over the last 50 years. The surgical community
has not always succeeded in keeping pace with the advances and
pressures placed on it. In the last decade, concern has been rising
about the risks of actual harm to patients involved in high-tech
medicine and particularly surgery. Surveys across a variety of
health systems internationally have shown a 3-16% incidence of
physical harm to patients by hospital treatment.
2.2. In most of these surveys, the presence
of a surgical intervention has been one of the strongest predictors
for the risk of harm. In a cross-section of studies contemporaneous
with this research, there is enormous variation in the key outcome
measures for surgery performed in different Units within the same
society, pointing to a system which is hugely variable in its
quality, safety and reliability.
2.3. It is generally recognised that health
professionals have a strong altruistic vocational motivation,
and one would therefore expect that evidence of this kind would
lead to strenuous efforts on their part to take part in change
processes to improve overall quality. Repeated experience, however,
reports strong negative staff reactions and resistance to practice
change. To accurately delineate the reasons for this requires
extensive qualitative research, but the problem appears to be
rooted in the professional ethos of healthcare workers. The professional
model for patient care assumes that individuals have a moral duty
to ensure that no harm befalls each individual patient. It follows
from this that the direct carers for a patient are individually
and completely responsible for all aspects of their care, and
that they are expected to be alert, vigilant and in full possession
of all the relevant information at all times. How to achieve this
is taught through an apprenticeship learning system, following
the practices of respected and experienced practitioners. Since
the theoretical demands of the professional model on the individual
model are in practice impossible, individual workers experience
considerable stress and guilt when adverse events occur. This
leads to both sub-conscious denial and conscious avoidance of
responsibilities, which is never publicly acknowledged. The increasingly
complex inter-relationships between specialists required in modern
healthcare compound this problem. Effectively, healthcare workers
are left with a belief system based on an older and simpler model
of healthcare, which loads anxiety and guilt on them and prevents
them from accepting a systems-based approach to safety in their
3.1. Our analysis of previous research has
led us to develop a three dimensional theoretical model of the
influences on patient safety in hospitals. The influences on error
and harm can be categorised as acting through failures of (a)
the systems of work, (b) the interpersonal relations making up
the workplace culture or (c) the technology used.
3.2. Many of the individual faults are small,
but combination of a large enough number of small errors is liable
to result in a combination which produces significant patient
harm. These faults combine in unpredictable ways to bring about
adverse events and patient harm. This model predicts that successful
interventions to prevent harm will be most effective if they address
all three dimensions of potential harm.
3.3. However we also need models to help
us design effective interventions, since our work has shown that
successful implementation is difficult. One of the most successful
models for explaining the success or failure of new ideas and
innovations within organisations and cultures is the theoretical
framework provided by Everett Rogers in his book "Diffusion
of innovations". This comprehensive digest of published research
draws together important conclusions about the nature of innovations
which promote or prevent their successful uptake. It is very interesting
to reflect on the nature of innovations in surgery which are directed
at preventing harm to patients. Using Rogers' model, we can see
that there are a number of aspects of typical interventions which
are inimical to their successful adoption.
3.3.1. As illustrated above, the healthcare
culture and belief system is antithetical to the adoption of a
"no blame" learning culture with a flat hierarchy. This
type of culture has been shown to be optimal in reducing the risk
of error, but is very difficult to accept for workers whose professional
development has been entirely formed in a culture which holds
opposite views about individual responsibility, hierarchy and
blame. Rogers' key examples show that logical and beneficial innovations
which run counter to the prevailing culture are often very difficult
3.3.2. The goal is preventative. Rogers
shows that innovations which achieve a positive and tangible benefit
are more easily adopted than those which prevent an adverse outcome
which may not occur anyway. This is particularly valid in a system
such as healthcare where the social and cultural barriers to recognising
harm from care are already strong.
3.3.3. The results are not immediate. Rogers
shows, not unexpectedly, that innovations with an immediate gain
for the innovator tend to be taken up quickly. It's clear that
this does not apply to most safety innovations.
3.3.4. The innovation is not simple. Most
safety and quality improvement initiatives are multifactorial
and relatively difficult to implement. Again, the research indicates
unsurprisingly that innovations which make life easier for the
innovator tends to be adopted more easily than those which require
3.3.5. Management is weak. In the UK healthcare
system, the ability of hospital management to impose innovations
on staff is extremely limited. For an innovation to be taken up
widely within an institution is therefore necessary for the individual
clinicians to adopt it voluntarily.
3.3.6. Hierarchy is strong. The importance
of opinion leaders in the professional culture of doctors in hospital
is extremely significant. Rogers described a sigmoid curve of
adoption of new procedures. The early phase of adoption is slow
because it relies on innovators defined as members of society
who do not conform to social norms and are interested in novelty
and experimentation for their own sake. These individuals are
not generally trusted by the majority, and the rapid increase
in adoption of innovations tends to occur only once opinion leaders
known as early adopters take it up. These individuals are identified
as being wealthier, better educated and more cosmopolitan than
the average member of society, but crucially as adhering closely
to all social norms. In societies with a strong hierarchy, early
adopters tend to be more cautious, as they have more to lose if
they incorrectly adopt an innovation which turns out to be unsuccessful.
4.1. Since the focus of our research group
is safety and reliability, we were extremely interested in research
and hypotheses which drew parallels between the work of civil
aviation air-crew and operating theatre staff. A series of articles
drew attention to the extreme reliability of civil aviation, and
made the case that this appeared to be correlated with the introduction
of crew resource management, a teamwork training system which
has been refined over the last 20-30 years. Contrasts have been
drawn between this and the absence of any such training for operating
theatre personnel, who arguably do an equally safety-critical
and complex task.
4.2. There has been a small body of research
looking at teamwork and error in operating theatres, and it has
been shown by ourselves amongst others that there is a definite
correlation between the teamwork (non-technical skills) performance
and the technical error rate in operating theatre work.
4.3. The hypothesis that improving operating
theatre teamwork could improve technical error rates and therefore
clinical outcomes is an extremely attractive one but had not previously
been formally tested. We therefore conducted a small before/after
study using two types of relatively complex surgery in one hospital.
4.3.1. We observed the teamwork skills and
technical performance of theatre teams using objective prospective
scales for six months, then submitted them to a three-month training
programme based on civil aviation principles, and finally observed
them for a further six month period. This study showed an improvement
in teamwork and in technical errors (the latter by between 30
and 50%), the first time this had been demonstrated.
4.3.2. In addition, we noted strong correlations
between technical error rates and sub-scales of the teamwork performance
rating system, eg the most important factor in surgical technical
error appeared to be surgical situation awareness.
4.3.3. One striking finding during this
work, however, was the significant subjective impression of cultural
resistance to the program amongst some members of staff. Despite
the positive short-term outcome, we further observed that once
the team coaching and support system were dismantled, the theatre
teams quickly abandoned the routines they had been taught. The
training regime therefore lacks sustainability and ownership.
This was in line with our expectations, having become familiar
with Roger's work. In our subsequent research project we therefore
addressed safety in hospital wards with the issue of sustainability
and cultural acceptability very much in mind.
5.1. Our intention was to develop a program
to improve safety and reduce patient harm through errors on acute
surgical wards. Previous survey work has identified this as the
next riskiest area for patients after the operating theatre in
terms of harm due to error.
5.2. Since care on the wards is continuous
and not episodic unlike theatre work, we felt that an approach
based on systems analysis and re-design was essential, and we
were also now determined to develop an approach which resulted
in staff engagement and ownership. We therefore proposed to use
the industrial continuous quality improvement approach known as
the Toyota production system ("lean" thinking). This
group of techniques was originally developed to eliminate waste
and improve quality and value in the Japanese car industry. The
system has been credited with remarkable success in the optimisation
of efficiency in business generally.
5.3. The reasons that we selected "lean"
were the interesting harmonies between its elements and the critical
determinants of adoption of innovations identified by Rogers.
The most important of these were:
5.3.1. "lean" eliminates waste
and minimises effort. It therefore has the obvious and immediate
advantage for the worker that it makes life easier not more difficult
5.3.2. "lean" makes systems problems
instantly visible. This circumvents the problem with preventative
measures identified earlier. If the systems problems are instantly
identifiable, a preventative measure becomes extremely visible
and therefore more desirable.
5.3.3. "Lean" involves grass-roots
staff in process mapping and solution design. This circumvents
the problem of cultural adaptation which has proved a powerful
disincentive in healthcare safety innovations as described earlier.
Solutions designed by the staff are not likely to have problems
due to culture clash since they are developed within the existing
5.3.4. The "lean" plan-do-check-act
(PDCA) cycle endows interventions with testability. Rogers identifies
the ability to experiment with, and if necessary abandon innovations
as one of the key factors which makes them acceptable. The PDCA
cycle allows brief experimentation which gives the worker confidence
that he or she is not completely committed to the innovation at
5.4. The environment for our study of "lean"
was a 36-bedded Surgical Emergency Unit in a large teaching hospital.
The Unit is used by over 20 Consultant teams and has a high patient
turnover. We carried out direct observational studies of patient
harm using existing academic definitions of an adverse event and
potential adverse event.
5.5. In parallel, we collected information
on compliance with best practice for safety-related medical and
nursing processes, including the administration of deep vein thrombosis
prophylaxis measures, completion of fluid balance monitoring charts,
compliance with the early warning "alert" system for
patient deterioration, direct doctor/nurse communication levels
on ward rounds, use of alcohol gel to prevent cross-infection
and drug prescribing.
5.6. The results indicate a wide degree
of non-compliance with best practice (between 20 and 70%), associated
with an adverse event rate of 11.4% and a potential adverse event
rate of an additional 14.8%. These figures might appear alarming,
but are completely in line with the available data from acute
hospital settings in the UK.
5.7. This data was collected over a six-month
period following which a "lean" intervention was introduced.
Ward staff were involved in a description of the processes that
they undertake and the problems inherent in these. They developed
a series of priority areas and devised safety projects to improve
performance in each of these.
5.8. Preliminary data are available on several
projects. The rate of deep vein thrombosis prophylaxis measures
was improved from 33% to 93% over a three-month period and has
been sustained at the latter level for a further eight months
to date. This improvement was brought about through a series of
four or five PDCA cycles developing and testing different innovations.
5.9. In line with "lean" principles,
none of the innovations was difficult and each was intended to
reduce rather than increase staff workload. The key innovation
proved to be the production of a drug prescription chart with
the prescription for anti-thrombosis stockings already printed
in the chart. This not only gave a default position of compliance
which had to be actively cancelled by medical staff, but also
reminded them to prescribe the anti-coagulant drugs which formed
the other limb of the anti-thrombosis strategy.
5.10. Another innovation was a method to
improve ward round communication. Prior to this it was commonplace
for multiple surgical teams to arrive simultaneously in the morning
and attempt to go around their patients. The doctors wished to
speak to the nurses looking after their patients, but this was
often impossible because of the multiplicity of ward rounds at
a time of day when nurses were also serving meals, handing out
medications, and bathing patients. An initial survey showed that
the doctor in charge of a patient got to speak to the nurse looking
after them less than 50% of the time.
5.11. Using "lean" principles,
a series of experimental innovations were developed with the full
involvement of all the staff. Using a three-pronged approach comprising
very simple changes, nurse/doctor communication improved from
under 50% to over 90% and was again sustained at this level.
6.1. This study is incomplete and we are
not yet aware of the effects on whether adverse events and potential
adverse events, but the subjective lessons from this research
have been very striking and are worthy of reflection.
6.2. The initial stages of each "lean"
project are extremely time-consuming and expensive in terms of
coaching and discussion support for the ward staff. Once a suitable
plan has been devised, however, the early success rate is dramatic
and the effect on staff morale excellent. Perhaps most important,
initiatives developed by the staff themselves with the support
of the research team, appear to have excellent sustainability.
6.3. Whilst these features are extremely
encouraging for the potential of "lean" to transform
the safety a reliability of surgical care, there are also some
concerns. The process is time-consuming, and cannot be rushed.
There is a clear need for Institutional support, to avoid heavy-handed
management from crushing the initiative of ward staff who have
developed an attitude of "learned helplessness" through
years of negative experience. The compatibility of this system
with traditional management cultures is therefore open to question.
It also risks a "Balkanisation" effect in that no two
ward settings are likely to develop exactly the same set of priorities
and solutions, and therefore over time an Institution may well
develop very significant heterogeneity of practice.
6.4. The value of "lean" is therefore
not amenable to final analysis at present. Its effectiveness in
transforming safety related processes and its dramatic affects
on staff attitudes and engagement are however extremely encouraging
and indicative it deserves further study as a potentially important
knowledge transfer implementation method in healthcare.
These studies are small and preliminary, and
cannot be regarded as definitive evidence, but very few other
intervention studies have yet been performed. We believe the need
for a greatly increased research effort in this area is self-evident.
Clinical Reader in Surgery
Nuffield Department of Surgery