Safety in anaesthesia.
Iatrogenic harm is a major problem in healthcare, and incident
reporting is one of various methods of identifying areas for improvement
in patient safety. The World Health Organisation has introduced a
three-phase checklist to reduce error and improve teamwork and
communication during surgery. Use of this checklist has been shown to
reduce harm. Incident reporting will be invaluable in monitoring its
effectiveness and identifying areas for refinement.
KEYWORDS Incident reporting / Checklist / Patient safety
Anesthesia (Health aspects)
Perioperative care (Safety and security measures)
|Author:||Merry, Alan F.|
|Publication:||Name: Journal of Perioperative Practice Publisher: Association for Perioperative Practice Audience: Academic Format: Magazine/Journal Subject: Health; Health care industry Copyright: COPYRIGHT 2009 Association for Perioperative Practice ISSN: 1750-4589|
|Issue:||Date: Oct, 2009 Source Volume: 19 Source Issue: 10|
|Topic:||Event Code: 350 Product standards, safety, & recalls; 260 General services|
|Organization:||Organization: World Health Organization|
The Safe Surgery Saves Lives initiative of the World Alliance for
Patient Safety of the World Health Organization (WHO) (World Alliance
for Patient Safety 2008) is one of the most important steps towards
improving the safety of patients undergoing surgery since the Institute
of Medicine's report 'To Err is Human' (Kohn et al 1999)
called for urgent action on iatrogenic harm.
The pursuit of health, defined as: 'a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity' (World Health Organization 1946) depends on a social structure which includes an absence of war, adequate supplies of food, and respect for human rights (including those of women and children) (United Nations 1997). It also depends on the traditional pre-requisites for public health--control of infectious disease and safe childbirth for example. Surgery has perhaps been seen as less critical, expensive, and something of a luxury in the context of the priorities in many countries. However, work undertaken as part of this initiative has identified access to surgery as more important than previously realized. It has been estimated that about 11% of the global burden of disease arises from conditions amenable to surgical treatment (Debas et al 2006). It turns out that about 234 million operations are undertaken around the world every year, which is actually more than the number of babies born (Haynes et al 2009). Unfortunately, these operations are not evenly distributed: only 3.5% serve the needs of the 34.8% of the global population who live in countries spending $100 or less per person on healthcare, while 58.9% are performed on the 15.6 % who live in countries spending over $1000.
Sadly, even those patients who do receive surgery do not necessarily reap its benefits, even in those countries with the highest incomes. The risk of something going wrong is surprisingly high. Inpatient surgery in countries such as the UK and the USA is typically associated with a rate of major complications between 3 and 17%, and of mortality between 0.4 and 0.8%. About half of these complications are probably preventable (Haynes et al 2009).
To make matters worse, not all of these operations are actually appropriate. It is over twenty years since Wennberg showed that variation in the frequency with which particular surgical procedures are undertaken is substantial even within single regions and that this variation is out of proportion to any identifiable differences in case mix or resource (Wennberg & Gittelsohn 1982). If twice as many patients served by hospital A have hysterectomies by age 70 as those served by hospital B, (given similar denominators and case mix), it is obvious that both rates cannot be appropriate: one must be too high and/or one too low. Similarly, more recent evidence from McGlynn et al indicates that even in the USA (where one might expect the influence of litigation to be all-pervasive) compliance with accepted guidelines for best practice is often very poor (McGlynn et al 2003). It follows that some patients are receiving operations of debatable value while others are failing to receive operations they really need--and neither of these approaches is likely to promote 'a state of complete physical, mental and social wellbeing'.
Understanding the elements of quality in healthcare (Table 1) is central to improving the health of any population, and striking a balance between adequate access and overuse, and between effectiveness and safety, is a challenge everywhere (Seddon & Merry 2002, Seddon 2006).
It is generally recognized that attempts to improve any system require measurement: certainly, in the absence of measurement, progress cannot be assessed. Measurement is essential for guiding the iterative process of Plan-Do-Check-Act (PDCA, or PDSA with S standing for Study) originally conceived as a technique for quality improvement by Walter Shewhart and later adopted by W. Edwards Deming (Runciman et al. 2007). Donabedian provided the well known framework of structure, process and outcome for measuring the quality of healthcare (Donabedian 2003). It was logical, therefore, for one of the working groups established under the Safe Surgery Saves Lives initiative to be tasked with defining statistics for monitoring the state of health in any region. What was needed was a small number of metrics that were cost-effective to obtain, reliable, and meaningful. After much research and debate this working group proposed the following: the number of operating rooms, credentialed surgeons, and credentialed anaesthesia professionals in a country (as measures of structure); the number of operations carried out (as a measure of process); and the rates of death on the day of surgery and while in-hospital (as measures of outcome). I undertook the exercise of obtaining this information for Auckland City Hospital for 2008, and confirmed that the data were indeed obtainable, although with more difficulty than I would have expected: it is surprising that global indicators of this type have not been embedded in healthcare and therefore immediately available in any hospital in the world long before now.
However, data of this type are not the only way, nor even necessarily the most effective way, of identifying problems for focused investment in quality improvement. Anaesthetists have a strong reputation for promoting patient safety (Cooper & Gaba 2002) and have pioneered the use of incident reporting to this end. The term 'critical incident' is attributable to Flanagan who, in 1954, used interviews to collect data to improve safety in the context of military aviation (Flanagan 1954). In 1978 Cooper and his colleagues adopted this technique, and interviewed staff and resident anaesthesiologists to obtain descriptions of preventable incidents in anaesthesia (Cooper et al 1978). Cooper was the first to recognise the importance of near misses, which tend to be much more common than adverse events, and are particularly valuable in identifying problems early, so that something can be done before patients are harmed. Numerous studies on incident reporting followed, from this group and others, with the emphasis on learning from mistakes and preventing recurrences rather than allocating blame (Cooper et al. 1982, Runciman et al 1993a, Webster et al 2001, Abeysekera et al 2005, Merry 2007, 2008).
The nursing profession has adopted incident reporting with particular enthusiasm. Britain is unusual in having a unified health system across the whole country--the NHS. The chief medical officer of health, Sir Liam Donaldson, has made patient safety a priority in recent times, and amongst other things established the National Patient Safety Agency (NPSA) to promote this objective. As one of its many achievements, the NPSA has developed the first comprehensive national reporting system for patient safety incidents in the world--the National Reporting and Learning System (NRLS). In this system the aim is for any 'unintended or unexpected incident that could have or did lead to harm for one or more patients receiving NHS funded care' to be reported. Recently, Catchpole, Bell and Johnson published an analysis of 12,606 incidents related to anaesthesia during for the period January 2004 to February 2006, in which an impressive 550,000 reports were made to the NRLS overall (Catchpole et al 2008).
This report was an impressive achievement, and it was disappointing, therefore, that the authors themselves admitted that 'the lack of detail inherent in generic data fields prohibits translation of these results into robust arguments for immediate change in clinical practice.' Obviously if incident reporting is to achieve its full potential, appropriate detail is required, and this will not be obtained simply through large numbers. It might be thought that the authors could have gone back to the staff who submitted the reports for further information, but of course the reports are de-identified. There are strong arguments to support de-identification in this context (Runciman. 2001), in light of the strong emphasis on blame that seems to pervade society today and in particular the alarming spate of prosecutions of doctors for manslaughter in England recently, (Merry & McCall Smith 2001, Merry 2007) reminiscent of that seen in New Zealand towards the end of the last millennium (Mellars et al 1995, Merry & Peck 1995, McCall Smith & Merry 1996). What is needed, perhaps, is a smaller number of more detailed reports. As Cooper realised, the key to learning from incidents lies in capturing key points about events and near misses that might assist in learning from experience before patients are harmed. This point is well made by the authors of this very helpful paper (Catchpole et al 2008).
Catchpole et al were unable to identify the sources of their reports, but thought that the majority would have been submitted by nursing staff. Anecdotally, this seems to be typical of incident reporting everywhere. For example, in Australia and New Zealand, hospitals with similarly generic incident reporting systems seem to receive relatively few reports from medical staff. Engagement by the practitioners actually involved in the incidents is essential for the success of incident reporting. This engagement was evident in the early days of the very successful Australian Incident Monitoring Study (AIMS) (Runciman et al 1993b). Unfortunately, even in the case of AIMS, the subsequent move to a more universal approach to incident reporting has been associated with a loss of perceived ownership of the process by anaesthetists.
The Australian and New Zealand Tripartite Anaesthetic Data Committee has recently been established by the Australian and New Zealand College of Anaesthetists and the Australian and the New Zealand Societies of Anaesthesia, with the express aim of reengaging anaesthetists in incident reporting. The idea is to provide a web based incident reporting system that will be owned by the speciality and be designed to facilitate the entry of data by anaesthetists. This will not replace the generic reporting currently carried out in many hospitals in the region (largely by nurses), but instead will supplement it. Much useful information does come from generic incident reporting, if only because nurses themselves are often involved with incidents in healthcare. If possible, the new system will be aligned to existing ones to allow data entered by anaesthetists to be transferred painlessly to the databases already established in these hospitals.
Timely feedback is a pre-requisite for success in incident reporting, and this will be given great emphasis. It is worth acknowledging the importance of the report from Catchpole et al in providing this sort of feedback, and thereby maintaining the momentum of incident reporting in the UK while more specific systems are developed for anaesthetists, and in due course other speciality groups as well.
Collecting data is of course of no value unless something is done in response to the information gathered. In the case of the Safe Surgery Saves Lives Initiative, three more working groups were established to identify key areas for attention in relation to anaesthesia, surgery and teamwork. What was needed was an intervention that would be practical, affordable, and universally applicable. It became apparent that the things which go wrong in surgery are often incredibly simple (like operating on the wrong patient or failing to give prophylactic antibiotics at the right time), and that the primary cause is often a breakdown in communication and teamwork. The outcome was a process tool long established as integral to safety in aviation: a checklist.
Of course checking has been integral to practice in operating rooms for many years, and more recently many institutions have adopted the concept of a 'surgical pause' or 'timeout' just before an incision is made, to ensure a final check of the essentials. The WHO Checklist builds on these established processes, but is divided into three phases: 'Sign In' (before anaesthesia is induced); 'Time Out' (before an incision is made); and 'Sign Out' (at the end of each procedure). It is novel in its emphasis on communication (staff are required to introduce themselves during the Time Out), and on the promotion of teamwork (surgeons, anaesthetists and nurses are all expected to contribute to identifying issues of potential concern during Time Out and Sign Out).
It is extremely hard to prove that any safety intervention in healthcare actually works. In line with standard WHO process, pilot data were collected from eight sites around the world before and after introducing the checklist. A significant and substantial reduction in harm associated with surgery was demonstrated.(Haynes et al 2009) This is encouraging, to say the least: the checklist was developed through a thorough process of research and consultation, and has been underpinned by guidelines based an extensive review the available evidence , so perhaps it is not really surprising. Use of the checklist makes sense and is very inexpensive: it is gratifying to see its uptake spreading rapidly through many countries around the world.
The checklist is just a tool. It will not eliminate problems, but it will reduce their occurrence. It is expected that local modifications will be made to ensure its relevance wherever it is used. Its success will depend on the degree to which practitioners engage their minds in making the process meaningful rather than just a formality of ticking boxes. All concerned are responsible for this--anaesthetists, surgeons and nurses. Anecdotally, there seems to be little doubt that we can rely on the enthusiasm of nursing staff everywhere, so perhaps the challenge will be for the other groups to match this strong commitment to patient safety.
It will be interesting to see whether improvements in the quality of healthcare around the world can be demonstrated over the next few years using the WHO metrics. In the meantime, incident reporting will be invaluable in alerting us to ongoing problems, and providing guidance for refining the checklist to ensure that it is relevant in every locality that uses it.
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Alan F Merry
FANZCA, FFPMANZCA, FRCA, Hon FFFLM
Professor and HOD, Department of Anaesthesiology, University of Auckland and Auckland City Hospital, New Zealand
The author has declared an interest in a company that markets a patient safety system.
Correspondence address: Department of Anaesthesiology, University of Auckland, Private Bag 92019, Auckland, New Zealand. Email: email@example.com
Table 1. The elements of quality in healthcare (Runciman et al 2007) Safety Access Efficiency Effectiveness Timeliness Acceptability Appropriateness The degree to which it is patient-centred
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