Accreditation and Quality Assurance for Clinical Liquid Chromatography-Mass Spectrometry Laboratories

Abstract

For mass spectrometry (MS) testing in the clinical laboratory, postimplementation monitoring for quality is just as important as method development and validation but often receives less attention. Quality-assurance monitoring for liquid chromatography-tandem MS (LC-MS/MS) testing should be proactive rather than reactive and should monitor the entire testing process. An LC-MS/MS quality-assurance plan should cover overall batch review parameters, individual peak review parameters, system and reagent changes, and assessment of long-term accuracy. This article discusses Clinical Laboratory Improvement Amendments' regulations as they apply to LC-MS/MS-based testing and reviews available guidelines for LC-MS/MS quality assurance and postimplementation monitoring.

Keywords: CLSI C62A; Clinical laboratory accreditation; Liquid chromatography mass spectrometry; Quality assurance; Quality control; Quality management system.