Quality improvement in healthcare in New Zealand Part 2: are our patients safe - and what are we doing about it? By Alan Merry and Mary Seddon Summarised for Brilliant New Zealand Ltd by Malcolm Macpherson The evidence is incontrovertible: we are harming patients by the very healthcare intended to help them. Most developed countries have responded to this evidence with substantial funding for dedicated patient-safety campaigns. New Zealand has not, at either the national or the organisational level. The reasons include a lack of understanding of the causes of medical error and of the difference between error and violation. Insistence on randomised controlled trial evidence and a business model misunderstands the constructs at stake and may prevent urgently needed safety strategies. In the first of this series of articles, the question was asked, What would a high quality healthcare system look like? In answering it, patient safety was identified as one of the most important dimensions of quality. Why? Because approximately 10% of admissions to acute-care hospitals in the developed world are associated with an adverse event, and around 1.5% are associated with permanent disability or death. This startling fact comes from studies conducted in different countries over the last 15 years. The most recent, in New Zealand, showed that the extent of the problem here is much the same as it is everywhere else. The number of deaths attributable to this harm in the USA exceeds the road toll and equates to three jumbo jets full of passengers crashing every 2 days. Despite the fact that the vast majority of these deaths are in elderly and/or very sick patients, and it could be argued that even in the absence of an adverse event few would have been alive and well 3 months later, there is general agreement that preventable harm to patients caused by the very healthcare that was intended to help them is a substantial public health problem. What has been the response to evidence of harm? The international community was galvanised by the US Institute of Medicine's 2000 publication To Err is Human: Building a Safer Healthcare System which made the extent of harm obvious, even if met with initial scepticism from doctors. However, Governments in Australia, the US and the UK have taken these data seriously, and have responded by funding patient safety. In New Zealand, there is now a reasonable level of awareness about the issue of harm at a National or Governmental level. The Health and Disability Services (Safety) Act 200114 makes explicit the responsibility to promote the safe provision of health and disability services to the public. The establishment of the office of the Health and Disability Commissioner (HDC) was a response to harm done to New Zealand women by healthcare, identified in the Cartwright Report. The Commissioner has unusually wide ranging powers that allows him to enquire as to the contribution to an adverse event by anyone responsible for the provision of healthcare, including administrators. This has facilitated a world-leading focus on addressing aspects of the system, which contribute to patient harm rather than only seeking to identify individual scapegoats when things go wrong. Recent changes to Accident Compensation Corporation (ACC) legislation, have also moved in this direction by removing the requirement for patients to demonstrate medical error (in effect, negligence) in order to obtain compensation for harm from avoidable adverse events. This was accompanied by the establishment of a dedicated patient safety function within ACC, but we still have a long way to go in translating these initiatives into practical gains at the organisational or facility level. What are the challenges to improving patient safety? (1) The first challenge is to promote understanding of the causes of error, and to be clear about the distinction between violations and error, because it is only with this knowledge that one can start finding effective solutions. Making errors is part of the human condition. The propensity to err is integral to such attributes as creativity, distractibility and the facility to undertake multiple tasks simultaneously which have contributed to the evolutionary success of our species. These attributes also underlie our ability to undertake tasks whose complexity and difficulty is at times astonishing. This is often the case in healthcare, and as the complexity of an activity increases so does the propensity for error. Errors involve people trying to do the right thing but actually doing the wrong thing. Errors cannot be decreased by exhorting staff to try harder (most are trying hard already) or by punishing those at the sharp end of the error chain. Violations on the other hand have an element of choice, they are deliberate (choosing not to wear a seatbelt or not to wash one’s hands between patients) and they can be decreased by appropriate deterrence. To improve patient safety there needs to be an increased awareness of the difference between these two. On one hand, responding to error as though it were deliberate violation does not lead to lasting change, and indeed it is likely to lead to a culture of fear where errors and near-misses go unreported. Blaming and removing the person who made the error does not make the situation any safer for the next patient. On the other hand, all involved with healthcare, from the minister, through senior consultants and chief executive officers, to the newest trainee nurse, need to understand fully their responsibility for deliberate choices that have the potential to impact on safety. To reduce harm to patients from error we will need to accept human fallibility, and concentrate on improving the design of the healthcare system. At present, the system is highly complex, poorly coordinated and very prone to error. What is needed are changes that reduce the chance of error, and the propensity for any errors which do occur to cause harm. Prompt and open disclosure is key to the second objective. If an error is identified immediately, its consequences can often be limited. These are the changes that high-reliability organisations (for example nuclear power stations) have built into their culture. In response to the repeated error of injecting vincristine into the intrathecal space (where it is neurotoxic and usually fatal), James Reason said: When a similar set of conditions repeatedly provokes the same kind of error in different people, it is clear that we are dealing with an error prone situation rather than with error prone, careless, or incompetent individuals. Once we accept this point, the focus of the patient safety improvement programme switches from the individual to the process of care and it is only then that it is likely to be effective. (2) The second challenge lies in justifying the cost of safety initiatives in a sector which struggles with funding deficits. It is often impossible to quantify precisely the reduction in risk likely to be achieved by any given intervention. Furthermore, in New Zealand, unlike many other countries, the fear of litigation is not a major financial incentive for an organisation to invest in safety. (3) A third barrier to investing in patient safety has been the misuse of the concept of grading the strength of evidence. As Sackett has made clear, evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. Which evidence is best depends substantially on the question to be answered. For some questions, the randomised controlled trial (RCT) is the best source of evidence, but there are many questions for which other research tools are more appropriate. In 2001, in response to the To Err is Human report, the Evidence-based Practice Centre was commissioned to evaluate the evidence for safety improvement practices. The practices were ranked on the basis of the strength of evidence with the RCT at the top. The resulting list was criticised for having only 11 practices, of which only 3 could be characterised as true safety issues (anticoagulation for the prevention of deep venous thrombosis, antibiotic prophylaxis to prevent surgical infections, and use of pressure-relieving materials to prevent pressure sores); many well-accepted safety measures were omitted altogether. There are several reasons that the report failed to identify more patient safety initiatives. Error prevention is a young field which has received little funding. This of course means that formalised evidence is not as abundant as it is in relation to the efficacy of drugs, for example. More importantly, there is a lack of appreciation of the limitations of traditional methods of research in this area. Randomised controlled trials are not always feasible or warranted in patient safety. They may not be feasible because randomisation is impossible or because the outcomes of interest (adverse events), although sometimes catastrophic, are rare. Randomised controlled trials are best suited to evaluating the efficacy of individual interventions or therapies, whereas patient safety is primarily a function of how well the system of care is performing, evaluating safety is more like evaluating the effectiveness of a treatment in actual practice. These are systems issues that will be improved with reference to human factors theory, process engineering, and systems theory by the institution of a number of small changes guided by repeated evaluations through a cycle of continuous quality improvement. These changes, like those that resulted in the dramatic improvements in aviation safety and in anaesthesia, are not amenable to RCTs. Human factors principles such as standardisation, simplification, and the use of checklists are commonly applied to improve patient safety. These are supported by common sense and evidence from industry. There is no need for an RCT to justify their application, anymore than there is need for an RCT to justify the use of a parachute when jumping from an aeroplane at altitude. For example, the standardisation of prescribing to require the use of leading zeros (0.5 mg not .5 mg, which can easily be misread as 5 mg), and to eliminate trailing zeros (1 mg not 1.0 mg, which can easily be misread as 10mg), eliminates a potentially dangerous prescription, but to find RCT evidence that this reduced adverse drug events would be difficult, expensive, and actually quite pointless. As Leape, Berwick, and Bates say: For policymakers to wait for incontrovertible proof of effectiveness before recommending a practice would be a prescription for inaction and an abdication of responsibility. The prudent alternative is to make reasonable judgments based on the best available evidence combined with successful experiences in health care. While some errors in these judgments are inevitable, we believe they will be far outweighed by the improvement in patient safety that will result. If we are to deal with the current epidemic of harm and promote a safer healthcare system in New Zealand, we need to persuade those who are responsible for healthcare expenditure that safety really does deserve the highest priority. This is not for trite reasons; we acknowledge that some risk is necessary if we are to balance achieving acceptable levels of safety with the other elements of quality (to be discussed in the remaining articles in this series). It is because the data are overwhelming, our hospitals are not acceptably safe at present, and until they are, the gains on expenditure from addressing this problem will arguably be greater than expenditure on most other initiatives in healthcare today. Huge investment into biomedical research has improved the effectiveness of drugs and technology and transformed healthcare: we now possess and have already largely deployed the means to cure many important illnesses. The challenge today is to use these therapies to help patients, rather than harm them in the attempt. The public are well aware of this risk, not least because of several highly visible enquiries into failures of exactly this type: addressing concerns about patient safety will go some considerable distance towards re-establishing trust in our healthcare system.