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John Matthews, Paramedic NHS Ambulance Service
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Dear Editor, Your Research article entitled “Sensitivity of routine system for reporting patient safety incidents in an NHS hospital: a retrospective patient case note review” confirms what I and others have suspected all along. Existing attempts to introduce a culture of incident reporting are, and will continue to be, unworkable while we continue to run our organisations in the traditional ‘command and control’ way. No matter how much well intentioned clinicians try to foster a ‘no- blame’ culture in order to encourage transparency and learning, it will never work while the rest of the organisation continues to focus on people rather than processes in their attempts to remedy situations. Evidence these past few years has clearly shown that only by studying and improving processes that result in medical error can we ensure patient safety. Regrettably this simple truth has never really been widely understood or it would have been applied to everything else that we do in our various organisations. Nothing much has changed in the wider NHS or in my own field of operations – the ambulance service - nor is there much sign that it will. Unfortunately our managers remain locked into traditional management culture and ignorant about or resistant to new organisational thinking. Where effective approaches have or are being tried (lean thinking, for example) attempts are being made to use the methodology within existing, traditional systems. In other words, attempts are being made to graft successful methods onto dysfunctional systems. Moreover, these dysfunctional systems are governed by targets which are arbitrary measures that reflect desire rather than useful knowledge about our system’s capabilities – a prerequisite to improvement. Targets have had a number of drawbacks. One drawback is their effect of leading NHS organisations to concentrate on areas needing improvement at the expense of overall system harmony and, often, patient well-being. Another is to deflect focus away from appropriate method towards attaining results by fair means of fowl – often the latter in the absence of organisational knowledge about how to work differently and better. They are the reason we are in such a moral, structural and financial mess today. Management and government often complain about staff being resistant to change, but here we have an example of the reverse being the case. Managers are very keen to urge operational staff to use ‘best evidence’ for clinical practice, but have shown little or no inclination to question the very basis of their own actions. They are constrained by their limited training and experience, and are almost entirely focused on doing the government’s bidding in order to qualify for their funding. The government’s obsession with arbitrary targets and ‘carrot and stick’ approach ensures compliance with the worst kind of management thinking and behaviour. There is much evidence about the drawbacks of our traditional approach (recommended reading: “Hard Facts, Dangerous Half Truths & Total Nonsense”, J. Pfeffer & R. I. Sutton;). There are much better measures we could use and a wealth of knowledge and wisdom about organisational performance which, if we do not avail ourselves of them soon will lead to the dismantling of our NHS. The Government appears to have run out of ideas and instead seems to be relying more and more on using the private sector in order to attain some kind of illusory solution. Anyone tempted to believe as they do should read “Good To Great” by J. Collins in order to understand once and for all that most of the private sector have similar or worse problems than we do. The only difference is that they reward failure probably better than we do! We have all – government, managers, staff and patients - become victims of an ineffective and damaging organisational system. If we are sincere about improving patient safety, then we must have the courage to question the very basis of our organisational theory and practices. Anything less will guarantee failure and ever deteriorating quality of patient care and outcomes, with only occasional, short lasting and illusory advances. John Matthews Paramedic, Ambulance Service. Competing interests: None declared |
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Christian P Subbe, Consultant Acute Medicine and Intensive Care Wrexham Maelor Hospital, Wrexham, LL13 6TD
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I would like to congratulate Ali Baba-Akbari Sari and co-workers for the cumbersome task of reviewing a large number of medical files to provide estimates for the sensitivity of incident reporting. The results are as shocking as expected. The conclusion of the paper ("Structured case note review may have a useful role in surveillance of routine incident reporting and associated quality improvement programmes") is however not supported by data. It has been known for some time that large numbers of patients come to harm in hospitals in different health service settings [1,2]. The reason that this continues to be a problem is only partly to be blamed on poor reporting. A greater problem is the inability of organisations and their members to act on them. The efficiency of the response to incidents determines at the end of the day the impact of a quality assurance system not the completeness of its documentation of failure. Let's learn from the faults that we know about and then look for more. 1. Vincent C, Neale G, Woloshynowych M.Adverse events in British hospitals: preliminary retrospective record review. BMJ. 2001 Mar 3;322(7285):517-9. 2. Brown P, McArthur C, Newby L, Lay-Yee R, Davis P, Briant R. Cost of medical injury in New Zealand: a retrospective cohort study. J Health Serv Res Policy. 2002 Jul;7 Suppl 1:S29-34. Competing interests: None declared |
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Ram Kumar, Paediatric Neurology SpR Royal Manchester Children's Hospital, M27 4HA
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Interesting article. I would like to know how many of these adverse incidents occurred in acutely unwell patients, and how many occurred in elective patients. "Adverse incidents" in acutely unwell patients might just be part of the natural history of their illness, or might be unavoidable to some extent e.g. someone with multiorgan failure on multiple drugs and infusions is more likely to subject to a drug error (but need to be exposed to that risk) than someone who just attends for a routine out-patients. I think investigating and doing something about adverse incidents in elective patients might be a more efficient use of precious time. Competing interests: None declared |
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John H Williamson, Consultant Specialist Australian patient Safety Foundation, GPO Box 400, Adeliade, South Australia 5001
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Thank you to Drs Ali Baba-Akbari Sari, Trevor A Sheldon, Alison Cracknell and Alastair Turnbull, for their useful study. Their findings show, once again, that no single source of data for safety improvements in healthcare will suffice for learning what may go wrong and how to prevent it. Many different data sources (e.g. medical records, audits, complaints, coroners' reports, medical publications, closed claims studies, incident reports and even some media material) are required to obtain a balanced and correct prespective of all healthcare risks. That said, incident reporting, although only capable of providing "numerator data", remains a powerful contributor to safety improvements. In this context its adoption by and within healthcare teams also helps to diminish any "balme culture" and to improve workplace morale, team trust and 'esprit de corps'. Competing interests: Part-time employee of the Australian Patient Safety Foundation, a not-for-profit, recognised Australian qualtiy assurance activity organisation. |
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Jeffrey C McILwain, Consultant, Clinical Risk Management St Helens & Knowsley NHS Trust
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The authors may wish to be aware that such case note review systems have been used in the NHS. In our Trust we started a Clinical Outcomes Committee four years ago that reports into the Governance system and is an established case review system on a regular basis. We published our work [Analysing clinical incidents by clinical mini Root Cause Analysis. Ince C. McILwain J.C. Health Care Risk Report. 2004.vol 10 no 9 September issue. Pages 12 - 15] and are still maintaining detailed senior professional analysis of reported concerns and random sampling of case records Trustwide. We have uncovered many issues aside from traditionally reported incidents and brought about effective changes in clinical practice in patient safety issues. We use case record reviews to a structured causal analysis based upon care-service timeline review. To undertake record review requires both a system and people who understand how to assess and analyse discovered information. We usually get through three case records a month in great detail. Each case is reviewed by three senior clinicians (doctors and nurses), two as assessors and one a case lead in conference. Results and findings are fed back to both the clinicians and Trust Governance Board to ensure all lessons to be learned are communicated. A singular persistent issue is communication between health professionals – something that any incident reporting system will never uncover. There is much to learn from adversity and as described by the authors there is no single methodology. In this Trusts we have both an integrated incident reporting system linked to complaints and litigation as well as to the National reporting database and our case review system running independently. I would have to say that perhaps we have learned more from case analysis (random and referred) than incident statistics. In the coming year it is our hope to extend the case review / incident reporting analysis tools down deeper into the organisation into clinical departments akin to the methodologies used for CNST maternity assessments – the risk forum. Competing interests: None declared |
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Grace Barden, SHO Leeds General Infirmary, LS1
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I was impressed to read the article entitled “Sensitivity of routine system for reporting patient safety incidents in an NHS hospital: a retrospective patient case note review”, and felt that the authors have touched on a point of risk management which perhaps fill junior medical staff with worry about blame and reprisals from their more senior colleagues. I work in an area of medicine where structured case notes review on a day to day basis is already in operation (no doubt stimulated because of requirements by CNST maternity standards). Whilst I don’t claim that all the admissions to our department have a case notes review, all the previous days deliveries are reviewed and in a multidisciplinary meeting which encourages members of the whole team to learn from previous mistakes and to see where improvements to the service can be made. This method of case notes review means that all patients, both those who have perhaps just come to the hospital for elective surgery, and acute admissions are seen. If a patient has been an inpatient for a while and then delivers, their notes are also included in the review. Although a relatively informal meeting, it does do some important jobs. Firstly it enables questions to be asked and answered with regards to care, it institutes a “hopefully” non blame and non judgemental enquiry into patient management if necessary. It enables juniors to find out how risk could have been reduced or management changed in the non acute environment and allows discussion with both senior medical and non medical staff. It also and I think very importantly with regards to the article, stimulates the filling in of hospital incident forms. I don’t think that incident reporting should be replaced by case note review – that would seem to be a very laborious task, which would potentially need a team specially employed to do just this action, and in a NHS which seems to be struggling to keep health care employees in post, I think that that would be perhaps unnecessary expenditure. However, if in my department where we can manage to spend an hour each day to review the previous day’s notes and find learning points and potentially fill out the dreaded incident forms. Then across the NHS as a whole this could be a manageable option, and help to reduce the fear and blame that some seem to associate with incident form filling! Competing interests: None declared |
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David I Ben-Tovim, Director, Redesigning Care and Clinical Edipemiology Units Flinders Medical Centre, Bedford Park, South Australia 5042
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Taken together, the articles and reports in the current edition of the British Medical Journal paint a clear picture of the key issues in contemporary health care. But the viewer needs to stand back from the picture before the individual brush-strokes resolve into a clear image. First, there is the important article by Sari and colleagues. The authors concern is to demonstrate that routine reporting systems have a very low sensitivity for identifying hospital adverse events in comparison to case- note review. They draw less attention to the observation that some kind of patient safety incident occurred in 22% of hospital admissions, and that at least one safety event resulting in patient harm occurred in 11% of admissions. Then there is the truly breathtaking news report by Caroline White (doi: 10.1136/bmj.39091.494213.DB) about the decision not to publish a report about the standards of care provided for heart surgery patients in the St Mary’s Hospital NHS trust. The report quotes a spokesperson from the Healthcare Commission thus ‘information about clinical risk is quite complex and can be subject to misinterpretation. This is not hiding things from patients; but it’s also about not causing undue anxiety to existing and prospective patients.’ There are two further snippets of note. One a shortcut about a meta- analysis demonstrating that the impact of audit and feedback on improving practice is small (doi: 10.1136/bmj.334.7584.68-c), and the other a news report by Michael Day (doi: 10.1136/bmj.39090.709803.4E) about mismatch in NHS staffing levels, that states that many NHS staff will lose their jobs as trusts seek to contain spiralling deficits. Finally there is the excellent editorial by Charles Vincent (Vincent C. BMJ 2007; 334; 51-2) that argues that of itself, reporting does not change behaviour. What is needed is action. In my view, Vincent does not go far enough in simply calling for ‘improvement programs’. Let us take the Healthcare Commission first. I don’t think there is anything complex about the statistics for risk in healthcare. Any industry that harms one in ten of its customers is unsafe. Full stop. The fact that some places are relatively worse than others pales into insignificance against the underlying rate of harm. Prospective patients have every right to be anxious, and no change is likely without that anxiety being voiced often, and persistently. Furthermore, it is inherently unlikely that detectable safety incidents stand alone. It is much more likely that they are the manifest outcomes of care processes that are error-prone at every step, with many potential errors fortunately being detected prior to a safety incident actually occurring, but requiring considerable re-work in the process. We have to take hospital safety out of the safety and quality ghetto and beyond strategies such as clinical audit and feedback that embed existing levels of error into baseline best-practice outcomes. And are then relatively ineffective in getting practice even to function at existing error prone best- practice levels. For the last three years we have been experimenting with the application of Lean thinking1 to care processes across our teaching general hospital. Lean thinking is an approach to improving the sequential processes involved in production of manufactured goods and services of all kinds. Whilst the approach was first described in relation to manufacturing, it has since been applied to many industry sectors, and interest in Lean thinking is beginning to emerge in healthcare also. To the Lean thinker, error in execution of a process is an absolute waste. No one benefits from it. Once it is acknowledged that errors resulting in an overt patient safety incident occur in one in five hospital admissions, further retrospective error analysis is of limited value. No existing care system can be satisfactory if it generates the level of error found in studies such as those by Sari and colleagues. Simply adding another incident report to the existing pile will not change anything. Instead, we prospectively examine and redesign care processes of all kinds to make doing the right thing easier than making errors. A prospective examination of existing processes, to identify potential weaknesses and opportunities to improve, encourages the improvement team to work at the system level rather than the level of individual blame. It also avoids sterile debate about relative risk. Over a three year period, we have halved the number of serious safety events that have had to be reported to our insurers, despite a substantial increase in the numbers of patients seeking care in our hospital. There are many other benefits from a systematic process of redesign using Lean thinking principles, some of which have been described elsewhere2. It is notworthy that at the beginning of our Lean thinking journey, our hospital was struggling to contain a deficit. In the last financial year, we were several millions dollars in the black in relation to our activity. Without extreme measures such as shedding staff. Poorly designed clinical processes are dangerous for patients, and frustrating for staff, They are also enormously wasteful. Improving the processes of care by the systematic application of comprehensive methodologies such as Lean thinking is not easy. But it improves outcomes for patients and directs precious resources to the provision of care, rather than making good the effect of error. It can be done. All that is needed is the will to do it. 1. Womack JP, Jones DT. Lean thinking. Banish waste and create wealth in your corporation. London. Simon & Schuster 1996. 2. King DL. Ben-Tovim DI. Bassham J. Redesigning emergency department patient flows: application of Lean Thinking to health care. Emerg Med Australas. 2006;18(4):391-7. Competing interests: None declared |
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Katharine J Tylko, Patient Bath BA2 3AB, Mitzi Blennerhassett
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Courageous Lisa Norris - the Glasgow teenage brain-tumour patient who blew the whistle on radiotherapy safety - was not monitored by in vivo dosimetry. These cheap and simple diodes are the seat-belts of radiotherapy ... recommended by the International Atomic Energy Agency for use even in the 'less developed countries' where resources are scarce. The diodes are quick to use and protect patients and staff from the majority of accidental overexposures. Although standard in several European countries, routine in vivo dosimetry is not yet compulsory in NHS radiotherapy departments, despite years of conscientious campaigning by eminent UK physicists, clinical oncologists and radiographers. In May 2006 the Royal College of Radiologists convened its 'Near Misses, Incidents and Errors in Radiotherapy' working party which will "seek to identify procedures which will minimise the risk or error. The problem of disseminating learning from incidents and near misses that do occur is not in the remit of that working party, but the College will be undertaking further work in that area." The report is due for publication in autumn 2007. We are two former radiotherapy patients agitating for the DH to ring- fence funding for in vivo dosimetry in all NHS radiotherapy centres NOW! Thank you Ben-Tovim and Matthews for your useful advice about Lean thinking. Competing interests: None declared |
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Mark F Lambert, Director of Public Health Gateshead NHS PCT, Team View, 5th Ave Business Park, Team Valley Trading Estate, Gateshead NE16 5LQ, Malathi Natajaran
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The work undertaken by Sari et al provide a useful empirical contribution to this field. They are right to point out that routine hospital reporting systems can miss incidents reporting in harm. Reporting from primary care should also be an important method of identifying system failure. But despite the estimate that 19% of inpatients may experience a critical indicident at discharge [Forster AJ et al Ann Intern Med 2003;138:161-7], reporting is low. We reviewed 20 months (April 2004 to December 2005) of safety indicidents from primary care practitioners in our Primary Care Trust. We identified 35 reports in the study period. At this time there were 32,000 inpatient spells each year at our local hospital provider. This is equivalent to 0.07% of discharges. More needs to be done to improve reporting, and use of this information to improve patient safety. Competing interests: None declared |
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Guy Haller, Consultant Quality of Care Unit-Department of Anaesthesia & Intensive Care-Geneva University Hospital CH
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Dear Editor, I read with much interest the article by Sari et al 1 on the sensitivity of routine reporting systems for patient safety incidents measurement. The authors compare a routine incident reporting system to screened case note review to demonstrate that many incidents occurring during patient care are voluntarily not reported. This comparison is often used for assessing the sensitivity of incident reporting systems.2,3 By doing so, however, the authors compare two fundamentally different measures. As nicely illustrated in C. Vincent’s editorial,incidents largely reflect individual perceptions of events by hospital staff members.4 Unless incidents are rigorously defined, this will lead to a lot of variability in the type of events reported and of what may be defined as an incident. On the other hand, events identified through casenote reviews largely reflect the choice of the screening and analysis methodology.5 Only cases identified through pre-defined criteria will be selected. As a consequence, it is not surprising that Sari et al find only 17% of their pre-defined incident types reported in a routine incident reporting system. Had they used other pre-defined screens, they may have reached different conclusions. Another limitation relates to the failure of the authors to report how they took into account the technical characteristics of the incident reporting system they assessed. All systems are not similar. Some are paper-based, others are electronic. Some include pre-defined categories of events while others have an exclusively narrative content. Technical characteristics and design of reporting systems can significantly impact on the level of reporting. Computer-based incident reporting systems tend to be more often used than their paper-based counterparts. When the electronic reporting systems is standardised and incorporated into an electronic patient record the use of the incident reporting system can increase to 85%.6 Although it is rarely done, the technical characteristics of an incident reporting and their impact on the level of reporting should be systematically considered when assessing reporting systemsperformance. If such limitations were more often considered and carefully addressed, incident reporting systems would probably have a better chance. References 1. Sari AB, Sheldon TA, Cracknell A, Turnbull A. Sensitivity of routine system for reporting patient safety incidents in an NHS hospital: retrospective patient case note review.BMJ 2007;334:79-81. 2. Cullen DJ, Bates DW, Small SD, Cooper JB, Nemeskal AR, Leape LL: The incident reporting system does not detect adverse drug events: a problem for quality improvement. Jt Comm J Qual Improv 1995; 21: 541-8. 3. Stanhope N, Crowley-Murphy M, Vincent C, O'Connor AM, Taylor-Adams SE: An evaluation of adverse incident reporting. J Eval Clin Pract 1999; 5: 5-12. 4. Vincent C. Incident reporting and patient safety.BMJ. 2007;334:51. 5. Bates DW, O'Neil AC, Petersen LA, Lee TH, Brennan TA: Evaluation of screening criteria for adverse events in medical patients. Med Care 1995; 33: 452-62. 6.Haller G, Myles PS, Stoelwinder J, Langley M, Anderson H, McNeil J. Integrating incident reporting into an electronic patient record system. J Am Med Inform Assoc. 2007 Jan 9 (in press). Competing interests: None declared |
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