CORE LABORATORY
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QUALITY ASSURANCE

Quality Overview

Medical laboratories are responsible for ensuring that test results are fit for clinical application by defining required analytical performance goals and selecting appropriate measurement procedures. The definition of quality and the ways to measure uncertainty.

Six Sigma Standards

With increasing demand for improved accuracy and reliability of results, Six Sigma is revolutionizing how clinical laboratories measure quality control. Assay and instrument developers understand the value of Six Sigma performance and apply it to quantify performance on diagnostic systems.

STATS-Link®

The Streck STATS® program is an effective way for laboratories to evaluate the performance of their instrument or method against a peer group and demonstrate compliance with quality practices. STATS® compiles data in personalized, easy-to-read reports to help labs detect changes in their systems before these significantly impact patient results.

Approaches to Quality Management and Accreditation

The three steps of quality assurance will be reviewed: Validation, Accreditation and Certification. Though quality assurance practices and regulations differ among countries, we will define common effective strategies for monitoring quality and correcting systemic deficiencies, as well as provide country-specific content.

Quality Assurance in the Total Testing Process

Quality in the clinical laboratory should be defined as the guarantee that each and every step in the total testing process (TTP) is correctly performed. The quality assurance practices for every step of TTP (pre-analytical, analytical and post-analytical will be covered.