Statistical evaluation in laboratory information systems
Project duration: 1 year, 9 months
Brief description
Implementing statistical evaluation of quality control and instrument behavior in the context of measurements on patients for a laboratory information system. The module is integrated in the central laboratory. The aim of the module is to allow the laboratory to identify fluctuations in QC measurements and routine measurements, and determine their causes. The results, which are delivered in the form of statistics for quality control as well as patient measurements, serve to optimize instrument configuration in the system, which thereby optimizes sample throughput. The project includes requirements analysis and documentation, as well as validation and verification.
Subject description
Patient measurements as well as quality controls are carried out using instruments in the central laboratory. Both are subject to constant monitoring, which informs users as soon as a pre-defined measurement range or target value is departed from. The quality controls allow users to set up a QC lock following a QC error. This can then result in blocking validation of patient results. The user must then manually decide whether the affected QC result can be approved, along with the patient results to which it applies. Independent of quality control, users can track measurement fluctuations in patient routines. Fluctuations may result from special indications, such as dialysis patients. The system supports the "floating median," which as a parameter allows for continuous monitoring of patient measurements. If a pre-defined measurement range is departed from, a validation block can be set up for patient results.