title: 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.
abstract: 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.
authors: Research and Development, Instrumentation Laboratory, 180 Hartwell Road, Bedford, MA 01730, USA. pdorazio@ilww.com
authors: Paul
authors: P
authors: D'Orazio
authors: Sohrab
authors: S
authors: Mansouri
mesh_terms: D003422:Critical Care / Q000592:standards*; D006801:Humans; D013677:Medical Laboratory Science / Q000295:instrumentation* / Q000592:standards*; D019095:Point-of-Care Systems / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000592:standards*; D011786:Quality Control; D012308:Risk Management