An Update on Best Practices and Regulatory Requirements for the Improvement of Clinical Laboratory Services Through Quality

Quality Improvement Programs

A laboratory quality improvement program is designed to detect, reduce, and correct deficiencies in a laboratory’s work process. It is defined as the set of operations, processes, and procedures which ensure that the right test is carried out on the right specimen and that the right result and right interpretation are delivered to the right person at the right time (Berte, 2007). These programs include organization principles and personnel requirements, quality assurance, laboratory environment safety and facilities, equipment and measuring systems, reagents and materials, analytical procedures, result reporting, and archiving of patient medical data (Berte, 2007). The development of a quality improvement program takes into account the pre-analytical, analytical and post-analytical activities. Pre-analytical is the term that describes activities that occur before the time the sample arrives in the laboratory. Analytical is the term that describes activities that happen during the handling and analysis of the sample in the laboratory. Post-analytical is the term that describes activities that happen after a result is measured. All three phases are equally important, and each one includes factors that may directly influence the acceptability of a measurement result (Berte, 2007).