Root Cause Analysis (RCA) is a structured process used to perform a comprehensive, system-based investigation of any unexpected or undesirable event, uncover the underlying management, organizational and environmental contributing factors, identify the systemic flaws that lead to errors and failures, and subsequently develop effective solutions to prevent recurrence. In short, the RCA helps determine what happened, why it happened, and what systemic changes need to be made to prevent it from happening again. Rather than constantly dealing with the apparent symptoms of the problem, the RCA applies a wide variety of tools and techniques to identify and permanently address the key causal factors that underlie variations in performance. The RCA takes into consideration fundamental sensory, cognitive and motor characteristics of humans that predispose them to error and accepts the basic premise that humans will inevitably make errors. Instead of blaming healthcare professionals, the RCA is focused on identifying the true causes of errors, designing resilient systems and developing effective risk management strategies to eliminate or significantly reduce the likelihood of these errors.
The RCA process may be triggered by a wide variety of events such as occupational health and safety incidents, near misses, equipment failures, internal and external quality audits, patient complaints, patient satisfaction surveys, property damage, significant variation in performance, loss of health records, breach of confidentiality, etc. However, the RCA in healthcare organizations is typically associated with adverse events defined as unintended injuries or complications resulting in death, disability or prolonged hospital stay that arise from healthcare management. Examples of preventable adverse events include medication errors, blood transfusion errors, patient falls, outbreaks of nosocomial infection, avoidable delays in treatment, unintended retention of a foreign object in a patient after surgery, wrong surgical procedure performed on a patient, surgery performed on the wrong patient, intravascular air embolism, and many others. Adverse events result in unanticipated outcomes that are clearly unrelated to the patient’s underlying condition or natural progression of the illness. Concurrent analysis of a group of similar adverse events may uncover trends, system influences and interrelationships among contributing factors that are not easily observable. While there are certain differences in definitions, the terms adverse events, critical occurrences, sentinel events, patient safety incidents, clinical errors, and medical errors are often used interchangeably.
Growing attention to severe consequences resulting from medical errors was generated in 2000 by the Institute of Medicine (IOM) report To Err is Human: Building a Safer Health System. Based on the two large studies and extrapolation to over 33.6 million admissions to the hospitals in the United States the IOM report concluded that between 44,000 and 98,000 Americans die each year as a result of medical errors and many more are seriously harmed. It was truly a startling revelation that more people die every year as a result of medical errors than from motor vehicle accidents, breast cancer or AIDS. In 2004 the Canadian Medical Association Journal published results from a landmark study on the incidence of adverse events among hospital patients in Canada. Dr. Baker and the study team randomly selected one teaching, one large community and two small community hospitals in five Canadian provinces and reviewed the total of 3,745 medical charts for non-psychiatric, non-obstetric adult patients. Physicians reviewed all the positively screened charts to identify adverse events and determine if they were preventable. After adjustment for the sampling strategy, the overall rate of adverse events was 7.5 per 100 hospital admissions. Among the patients who experienced adverse events 36.9% of those events were judged to be preventable while death occurred in 20.8%. It was also estimated that 1,521 additional hospital days were associated with adverse events. By extrapolation, results of this study suggest that every year about 185,000 hospital admissions are associated with an adverse event and close to 70,000 of these adverse events are potentially preventable. Allowing for the differences in definitions and methods used, several retrospective studies carried out in Australia, the United States, Denmark, United Kingdom, New Zealand, and other countries around the world produced similar results. The results of these studies are summarized in the table below.
