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Laboratory medicine has made tremendous strides in establishing safety and quality practices as part of our culture. In the past, most of the efforts of the profession have focused on error detection, classification, peer comparison and compliance. However, laboratory errors that significantly affect patient care can still evade detection. With increasing automation in the laboratory, there has been a gradual decline in the technical knowledge of the laboratory staff. This is in part contributed by the general lack of access to instrument raw data and low transfer for technical knowledge and troubleshooting expertise from the instrument manufacturer to the laboratory end user. Failure mode and effects analysis (FMEA) is a quality tool that aims to: (I) identify potential failures, including their cause and effect; (II) evaluate and prioritize the failure modes; and, (III) propose actions to eliminate or reduce the chance of failure. Drawing from recent lessons learned from the Boeing 737 Max tragedies, we suggested that laboratory medicine as a community should adopt FMEA to better understand the root cause of laboratory errors to improve preventive and troubleshooting efforts. Manufacturers have important roles to play, both to share instrument data and technical expertise, as well as actively engage in meaningful conversation to improve product design.

Asking why: moving beyond error detection to failure mode and effects analysis