Quality control materials should have the following characteristics.They should have the same matrix as patient specimens, including viscosity, turbidity, composition, and color.For example, a method that assays serum samples should be controlled with human serum based controls. The manufacturer should recommend in their product labeling the period of time within which the accuracy and precision of the instruments and reagents are expected to be stable.Each laboratory should use this information to determine their analytical run length, taking into consideration sample stability, reporting intervals of patient results, cost of reanalysis, work flow patterns, and operator characteristics.The user's defined run length should not exceed 24 hours or the manufacturer's recommended run length.Quality control samples must be analyzed at least once during each analytical run.Manufacturers should recommend the nature of quality control specimens and their placement within the run.Random placement of quality control samples yields a more valid estimate of analytical imprecision of patient data than fixed placement and is preferable. Quality control material is usually run at the beginning of each shift, after an instrument is serviced, when reagent lots are changed, after calibration, and when patient results seem inappropriate.A quality control scheme must be developed that minimizes reporting of erroneous results, but does not result in excessive repitition of analytical runs. The purpose of including quality control samples in analytical runs is to evaluate the reliability of a method by assaying a stable material that resembles patient samples.Quality control is a measure of precision or how well the measurement system reproduces the same result over time and under varying operating conditions.Pathologists need to be involved in development of quality control protocols, the selection of quality control materials, long term review of quality control data, and decisions about repeating patient samples after large runs are rejected.These quality control activities play an important part in assuring the quality of laboratory tests. Quality control is designed to detect, reduce, and correct deficiencies in a laboratory’s internal analytical process prior to the release of patient results.Quality control samples are special specimens inserted into the testing process and treated as if they were patient samples by being exposed to the same operating conditions.
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