Clinical Trials

While many areas of health care are still struggling with the issue of patient safety, laboratory diagnostics has always been a forerunner in pursuing this issue. Significant progress has been made since the release of “To Err is Human.”1 This article briefly reviews laboratory quality assessment and looks at recent statistics concerning laboratory errors. Keywords: laboratory error, patient safety, medical error. It has been 12 years since the Institute of Medicine (IOM) reported the alarming data on the cause and impact of medical errors in the United States.1 Besides causing serious harm to patients, medical errors translate into huge costs for the national economy. In 1999, Berwick and Leape published that the estimated cost of medical errors in the United States was between $17 billion-$29 billion a year.2 In 2006, Null and colleagues published an article indicating the overall estimated annual economic cost of improper medical intervention was much higher, approaching $282 billion.3 While many areas of health care are still struggling with the issue of patient safety, laboratory diagnostics has always been a forerunner in pursuing this issue. The concepts and practices of quality assessment programs have long been routine in laboratory medicine, and error rates in laboratory activities are far lower than those seen in overall clinical health care.4 This article briefly reviews laboratory quality assessment and looks at recent statistics concerning laboratory errors.