Select Committee on Health Written Evidence


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 harm

    Whether measures taken to secure patient safety are supported by adequate evidence

    How to ensure implementation of patient safety interventions

    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 on request.

1.  EXECUTIVE SUMMARY

  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 above.

2.  INTRODUCTION

  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 workplace.

3.  DEVELOPMENT OF THEORY: MODEL OF ERROR AND PROPERTIES OF SUCCESSFUL SAFETY INTERVENTIONS IN HEALTHCARE

  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 to promote.

  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 additional work.

  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.  INNOVATION AND RESISTANCE: TEAMWORK TRAINING AND OPERATING THEATRES

  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.  DESIGNING SAFETY INNOVATIONS FOR OPTIMAL ADOPTION: THE USE OF "LEAN" THINKING

  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 staff culture.

  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 inception

  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.  ASSESSMENT

  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.

7.  CONCLUSION

  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.

Peter McCulloch

Clinical Reader in Surgery

Nuffield Department of Surgery

September 2008






 
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