The concept of quality and its control in clinical laboratories was introduced in the nineteen forties by S. Levy and E.R. Jennings who based their work on a publication written in 1931 by A.R. Shewhart. Shewhart demonstrated the economic importance of laying down exact specifications for mass-produced articles and then monitoring production line output to ensure that variations keep within them. Clinical biochemistry laboratories rely heavily on automated analytical systems and they are often likened to industrial production lines. An analyst in a clinical laboratory must carefully select and test a new method and establish some means of monitoring its reliability when it is in routine use. This book in the ACOL series covers the processes of method selection, testing, quality control and quality assessment. Statistical notions and techniques as seen from the practice of the biochemical laboratory are introduced, but are kept relatively simple. The major topics featured are: Selection and evaluation of biochemical assay methods; calibration and control materials; internal quality control; external quality assessment. Like other titles in the Analytical Chemistry by Open Learning series Assessment and Control of Biochemical Methods provides a comprehensive and integrated coverage of analytical chemistry, covering basic concepts, classical methods and instrumental techniques. The learning objectives are clearly identified and the student's understanding of the material is constantly challenged by self-assessment questions with reinforcing or remedial responses. The overall objective of Analytical Chemistry by Open Learning is to enable the student to select and apply appropriate methods and techniques to solve analytical problems, and to interpret the results obtained.
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