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

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

Antonia Mourtzikou (University General Hospital “Attikon", Greece) and Marilena Stamouli (Naval and Veterans Hospital, Greece)
DOI: 10.4018/978-1-5225-2237-9.ch069
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Abstract

The aim of this study is to emphasize the need for accurate, relevant and reliable results provided by the clinical laboratories, in order to achieve the best patient outcomes. The improvement of clinical laboratory services through quality is a continuous process, which includes constant changes and new regulatory requirements. Further efforts must be made to raise the awareness of all health personnel involved in the total testing process and highlight the importance of quality indicator implementation for improving the quality of laboratory services and patient safety. Laboratories and physicians must audit, update and continuously e their critical result management practices in order to provide safe and reliable care to patients. Moreover, implementation of six-sigma, a state-of–the-art quality management strategy, can further improve laboratory quality, by identifying biased or imprecise assays, so that appropriate quality monitoring strategies can be used. Harmonization of the total testing process, as a process of recognizing, understanding, and explaining differences and taking steps to achieve uniformity of results is of utmost importance for the use of data obtained from different laboratories interchangeably.
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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).

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