The problem of adverse events in healthcare is not new. The past decade has witnessed a stream of publications in leading medical journals documenting serious shortcomings in relation to the safety of patients. A major study in Harvard University found that 4% of patients suffer some kind of harm in hospital in the United States; 70% of the adverse events resulted in short-lived disability, but 14% of the incidents lead to death. A report by the Institute of Medicine estimated that "medical errors" cause between 44,000 and 98,000 deaths annually in hospitals in the USA - more than car accidents, breast cancer or AIDS. The UK Department of Health, in its 2000 report, "An Organisation with a Memory", estimated that adverse events occur in around 10% of hospital admissions or about 850,000 adverse events a year. The Quality in Australian Health Care Study (QAHCS), released in 1995, found an adverse-event rate of 16.6% among hospital patients. The Hospitals for Europe's Working Party on Quality Care in Hospitals estimated, in 2000, that every tenth patient in hospitals in Europe suffers from preventable harm and adverse effects related to his or her care. Studies in New Zealand and Canada have also suggested relatively high rates of adverse events at around 10%. Moreover, while errors may be more easily detected in hospitals, they afflict every health care setting: day-surgery and outpatient clinics, retail pharmacies, nursing homes, as well as home care.
There are no comparable studies in relation to Irish public healthcare, but should we expect things to be any better or worse than in those other countries? Is it possible that there may well be a serious problem in the Irish healthcare system which is not directly evident? In a paper presented in 2002 at a conference of the Irish Hospital Consultants Association, a speaker extrapolated the American experience into the Irish acute hospital setting. Her extrapolation indicated that some 937 deaths could occur annually as a result of preventable clinical error, and that death due to preventable clinical errors could exceed the number attributable to breast cancer, then the sixth leading cause of death in Ireland. This implied that, in 2002, more people would die as a result of preventable clinical error (937) than from Breast Cancer (602). If this extrapolation could be proven then this would truly be an appalling vista.
Traditionally, medical errors have been considered performance problems that can be addressed by counseling, retraining, re-educating, and restricting practice. Blame is placed on the individual without consideration of the factors contributing to the error e.g. medications may have similar names or packaging, which can lead to the misreading of a label, they may come in multiple strengths and concentrations and are often dispensed in combination with other medications. These factors can present a higher risk if a caregiver is rushed, tired, distracted, or under pressure during an urgent or emergency situation. Environmental and situation factors, such as poor lighting, noise, or interruptions, can contribute to errors at the "sharp end" where healthcare staff provide care and interact with patients.
Should unsafe practice be blame-free and punishment free? The answer is no. However, a just culture should not be confused with one in which there is no accountability. Medical professionals must be accountable for any deliberate actions that may result in patient injury, and those who are reckless or choose to violate rules must be held accountable for these actions.
The Ombudsman is impressed by the following Statement of Principle enunciated by the National Patient Safety Foundation, an organisation established by the American Medical Association, and she has used it as the framework for the statement of rights enunciated in the Code of Good Administrative Practice, which will guide her in the examination of complaints in this area.
"When a health care injury occurs, the patient and the family or representative are entitled to a prompt explanation as to how the injury occurred, together with its anticipated short and long-term effects. When an error contributes to the injury, the patient and the family or representative should receive a truthful and compassionate explanation about the error and the remedies available to the patient. They should be informed that the factors involved in the injury will be investigated so that steps can be taken to reduce the likelihood of similar injury to other patients."
Of particular importance is the right that each individual has to expect that health care staff who report existing risks to their superiors and/or peers will be protected from possible adverse consequences. A blame-free, nonpunitive culture encourages individuals to report errors and truly learn from their mistakes. It also supports organisations in their efforts to better understand those errors and make improvements. A just environment assumes that staff at the sharp end of care are concerned about patient safety, but are working within complex systems and in situations that potentially contribute to errors.