Integrated quality control: implementation and validation of instrument function checks and procedural controls for a cartridge-based point-of-care system for critical care analysis.

In this article, the process used to develop and validate an integrated quality-control system for a cartridge-based, point-of-care system for critical care analysis is outlined. Application of risk management principles has resulted in a quality control system using a combination of statistical quality control with onboard reference solutions and failure pattern recognition used to flag common failure modes during the analytical phase of the testing process. A combination of traditional external quality control, integrated quality control to monitor ongoing instrument functionality, operator training, and other laboratory-implemented monitors is most effective in controlling known failure modes during the testing process.