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

Paul D'Orazio; Sohrab Mansouri

doi:10.1016/j.cll.2012.11.001

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

Clin Lab Med. 2013 Mar;33(1):89-109. doi: 10.1016/j.cll.2012.11.001. Epub 2012 Dec 20.

Authors

Paul D'Orazio¹, Sohrab Mansouri

Affiliation

¹ Research and Development, Instrumentation Laboratory, 180 Hartwell Road, Bedford, MA 01730, USA. [email protected]

PMID: 23331731
DOI: 10.1016/j.cll.2012.11.001

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.

MeSH terms

Critical Care / standards*
Humans
Medical Laboratory Science / instrumentation*
Medical Laboratory Science / standards*
Point-of-Care Systems / standards*
Quality Assurance, Health Care / standards*
Quality Control
Risk Management