To err is human: improving patient safety through failure mode and effect analysis

Patient care errors occur in the laboratory. Traditionally, most errors have been thought to occur because of individual human failure. The assumption is that with adequate training, education; and orientation, technologists will perform flawlessly. Laboratory processes are designed on the premise that nothing will go wrong. Health-care professionals are looking at new methods of error prevention including Failure Mode and Effect Analysis (FMEA). Based on long experience in the engineering field, FMEA assumes everything will fail, humans err frequently, and the cause of an error often is beyond the individual's control. FMEA is a proactive, systematic, multidisciplinary team-based approach to error prevention. Patient safety is now a high priority with the Joint Commission on Accreditation of Healthcare Organizations, and this article introduces FMEA, a new method for improving our processes to enhance patient safety.