Chapter 1
Setting the Stage: An Overview of Healthcare
Why Safety?
Avoidable harm caused by the process of healthcare itself, rather than by an underlying injury or disease, is called iatrogenic harm, and has been recognized since the time of Hippocrates, 2,400 years ago.1 However, it is only in the last decade that the extent of this harm has been widely appreciated. Recent data from studies in which investigators systematically searched medical records for instances of preventable harm to patients have established iatrogenic harm as one of the top four or five public health problems in the developed world; only cardiovascular disease, cancer, infection, smoking and mental health problems have a greater impact on society (Table 1.12â9). Many authorities were surprised to the point of disbelief when it was found that 10 per cent of admissions to acute-care hospitals are associated with an adverse event (an incident that results in harm to a patient),5 and that the number of deaths associated with these events exceeds the road toll.7
Table 1.1 A selection of important causes of death world-wide2
Cause of Death | No of Deaths per Day |
Lack of clean water and basic healthcare (children)3 | 30,000 |
Smoking4 | 14,000 |
Iatrogenic harm â acute care5 | 10,000 |
HIV/AIDS6 | 8,000 |
Road traffic accidents7 | 3,000 |
Natural disasters (earthquakes, tsunamis, floods, hurricanes)8 | 100 |
Terrorism9 | 20 |
Why was the scale of this problem not recognized sooner? One reason is that most of these adverse events had been given innocuous-sounding labels, such as âcomplicationâ, âmisadventureâ and âsequelaâ and had, over the years, become accepted as part of the usual pattern of clinical medicine. Also, many who work in healthcare recognize that they are applying an imperfect science to sick people, frequently under less than ideal conditions, and so have tended to accept as inevitable that things can and do go wrong. These problems were, for many years, viewed as part of the price to be paid for the great benefits of modern healthcare.10 Iatrogenic disasters involving death or major harm to a patient were regarded as isolated events âdeeply unfortunate and best forgottenâ.11 Because these events occurred one at a time and had been given a variety of labels, with no uniform system for collecting them, they had never been put together and counted. Occurring singly, they do not have the same public impact as disasters such as airline crashes in which several hundred people may die at one time. In fact, traveling in an airplane is far safer than being a patient in hospital (see Tables 2.1 and 2.2).
This book covers all aspects of quality in healthcare (Figure 1.1), but the emphasis is on safety. Safety has social value in that it reduces the uncertainty of interactions between healthcare professionals and patients and reduces the risk and cost of healthcare. Some authorities view safety as separate from quality in healthcare. This makes little sense; safety comes at a cost, and the benefit âpurchasedâ must be weighed against opportunities lost in other dimensions of quality in healthcare. However, the term âsafety and qualityâ has been used in recent years to place emphasis on the element of safety in the belief that this aspect of quality has often been neglected. It is hard to argue that a healthcare system could be of high quality unless it was also acceptably safe, and very safe healthcare facilities would be of little value unless they also provided effective treatments to those who need them.
It is important to keep the primary goal of healthcare in mind, namely the improvement of health. Health has been defined by the World Health Organization (WHO) as: âa state of complete physical, mental and social well-being and not merely the absence of disease or infirmityâ.12 One can identify three approaches to healthcare: the treatment of illness; the prevention of illness; and the promotion of health. The third of these goes well beyond the first two, and provides insight into what it means to fail patients. There is more to patient safety than simply the elimination of error or the avoidance of direct harm. We would argue that any avoidable failure to achieve the WHO definition of health, whether through error, violation, over treatment, under treatment or inappropriate treatment, constitutes harm to patients.
Safety has been defined as âfreedom from hazardâ where hazard is âa circumstance or agent that can lead to harm, damage or lossâ (see definitions in Appendix I). Safety is inversely related to risk: safety increases as risk is reduced to an acceptable level. Acceptability of risk in healthcare relates to a balance between the potential for harm, the likelihood of doing good, and the choices available at the time. In healthcare there is often risk in doing nothing. Social context is very important in determining priorities in healthcare. For some services the balance between risks and benefits leaves no room for any compromize on safety. Heart lung transplantation is a good example of a procedure in which the net benefit of a whole programme may be small even when things go well, and the balance can be shifted from positive to negative by a few preventable adverse events. If heart lung transplantation is to be undertaken at all, the imperative to do so safely is very high (see Box 1.1). On the other hand, there are situations in which patientsâ immediate needs offset the requirement for a high level of safety. For example, after the 2004 Boxing Day tsunami, the demand for basic, life-saving healthcare was overwhelming.13 Although safety remained important, certain compromises were justified simply so that services could be provided at all. Under such circumstances an anaesthetic without sophisticated monitoring may be better than no anaesthetic at all.14
Why Ethics?
There is a minefield of often conflicting considerations that has to be navigated in the everyday work of a healthcare professional (see Table 7.1). Politicians put pressure on administrators, administrators put pressure on managers, and managers and patients (and their families) make demands of frontline clinicians. These pressures and demands are sometimes difficult to reconcile. The basic premise of this book is that healthcare professionals have a duty to do the right thing, as defined from the perspective of their patients. Unfortunately, it is not always easy to determine what the right thing is. The clinical aspects of a situation may be far from clear, and the issue may be further complicated by the values and beliefs of patients, healthcare workers and the society in which they interact. Some healthcare professionals believe it is their duty to do everything possible to advance the cause of their particular patients, and some place their own beliefs ahead of the desires and needs of patients (see page 164). Sometimes what is right for one patient can only be provided at the expense of a large number of other patients (see page 12). For example, always giving broad spectrum antibiotics to your patients is likely to facilitate the breeding of âsuper bugsâ for which there is no effective treatment, and may actually harm others.
Good communication is all-important in managing this type of conflict, at the level of individuals and at the level of the community in which the individuals live, work and depend on each other. Open and frank discussion between health professionals and their patients (and their patientsâ friends, relatives and carers), their colleagues, and the community at large helps resolve difficult questions about appropriateness in healthcare. The healthcare system exists for the benefit of patients. We need continually to ask âWould I be happy if this were happening to me or one of my loved ones?â Given that resources are finite and often fall short of expectations, the answer may at times be âNoâ, at least for some patients. In effect this represents a conflict between a âcommon goodâ view of health economics, and the principle of duty to individuals. Because a resource spent on one patient cannot be used on another, a sound ethical framework will be helpful in identifying the right thing to do (see Chapter 7 for further discussion of these issues).
The Dimensions of Quality in Healthcare
The tragic case of Jessica Santillan (Box 1.1) sets the scene for a book on safety and ethics in healthcare. Was this operation (and more particularly the second operation) appropriate in the first place, given the shortage of organs in the United States and (more fundamentally) the difficulties in accessing basic healthcare experienced by many of this countryâs citizens?
Box 1.1 A death at Duke15
In February 2003, at Duke University Medical Centre, Jessica Santillan (who was 17) died after undergoing heart-lung transplantation because of a simple mistake. The circumstances of this case were particularly poignant. Her family and the wider community had gone to extraordinary lengths to make her operation possible. Jessica had been brought to the United States by her father, a truck driver from Guadalajara, Mexico, to seek treatment for her condition. She suffered from a severe congenital heart problem, and was disabled to the extent that she fainted on any exertion. The only treatment for her condition was a heart-lung transplant. Her family begged in the streets to raise funds for Jessicaâs procedure, until a North Carolina businessman adopted her cause. Money was then raised by a grass-roots foundation by building houses with donated materials and selling them.
On the evening preceding the operation, there were considerable logistical difficulties in obtaining the organs. They were eventually implanted, but, after a short time it became apparent that they were not functioning well. The transplant coordinator then called to inform the team that the transplanted organs were incompatible: Jessicaâs blood type was O and the donorâs was A. Jessica spent two weeks in intensive care, critically ill. She underwent ...