Effectiveness and efficiency of root cause analysis in medicine.

PREVENTABLE MISTAKES ARE COMMON IN MEDICINE. FOR example, at 1 hospital, a patient received patientcontrolled analgesia (PCA), a combination of local anesthetic and narcotic. The medication was intended to be infused into the epidural space. Instead, a nurse inadvertently connected the tubing to an intravenous catheter, delivering potentially lethal anesthetic into the patient’s bloodstream. What followed were the nurse’s anguish and guilt and, almost as inevitably, the hospital’s root cause analysis (RCA). In the last decade, this process has become the main way medicine investigates mistakes and tries to prevent future mistakes. But like many innovations in medicine, RCA has never been evaluated for effectiveness. In the case mentioned above, the team identified flaws in the design of the epidural catheter, but thought that fixing those flaws was beyond their scope. Therefore, they made a recommendation they could implement: reeducating staff about the equipment’s use. In the end, despite a significant investment of resources, this solution did not remove the underlying hazard and had little effect outside the institution. No one had confidence that things were safer. Indeed, since 1999, the US Pharmacopeia has received 1600 reports of epidural-to-intravenous misconnection (MEDMARX data in file, USP 2007). Many of these incidents undoubtedly received their own RCAs, but the mistake continues to occur. Root cause analysis was originally developed in psychology and systems engineering to identify “the basic and causal factor(s) that underlie variation in performance.” It provides structure to the retrospective analysis of errors and has been used successfully for decades to uncover latent errors in high reliability organizations, such as aviation and nuclear power. Root cause analysis is now a familiar tool for hospitals and health care organizations and has helped to identify many problems and solutions. The RCA process is designed to answer 3 basic questions: what happened, why did it happen, and what can be done to prevent it from happening again? What is missing in medicine is a fourth question: has the risk of recurrence actually been reduced? The fact that it generally is not known whether risk has been reduced is causing concern that some of the considerable resources and efforts expended on RCA are being wasted.