Laboratory management: Quality assurance and inspection

Abstract

It is essential for molecular pathology laboratories to be in a state of inspection readiness at all times. Thorough and complete documentation of each step conducted by the laboratory allows for inspectors to follow a specimen through all phases of testing. Assays must be validated by the performing laboratory before testing can begin on patient samples, and a comprehensive procedure must be available to testing personnel. A well-developed quality management plan ensures laboratory quality is monitored and corrective actions taken if thresholds set by laboratories are exceeded.