Pro-Active Detection of Potentially Wrong Diagnoses Due to Substantial Changes of Laboratory Measurements

For guiding decisions on medical diagnoses and diagnoses, it is crucial to receive valid laboratory test results. However, such results can be implausible for the physician, even if the measurements are within the range of known reference values. There are technical sources of implausible results that are related to the laboratory environment, which are frequently not detected through usual measures for ensuring technical validity. Here, we describe the development of a quality assurance tool that tackles this problem and replaces the current manual statistical analyses at the Center for Laboratory Medicine in St Gallen (ZLM). Further analysis of the factors responsible for shifts in laboratory test results requires to collect and analyze data related to reagents as well as calibration or reference probes. Due to a lack of standard operating procedures in many laboratories with respect to these processes, this remains one of the big challenges.