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Quality in the analytical phase

Oswald Sonntag ; Ortho Clinical Diagnostics GmbH, Scientific Affairs, Neckargemünd, Germany

Full text: english pdf 137 Kb

page 147-153

downloads: 941



In today's health care system the prevalence of medical errors seems to be high as stated by the report of the Institute of Medicine (IOM). An error rate of about 10% in clinical medical laboratories has been consistently reported in the literature. Most of these errors occur in the pre-analytical phase. Because only a small number of errors will be seen in the analytical phase, it is very likely that these might be very often ignored. This overview will deal with the requirements of quality that is not based on quality control sample measurement only. The knowledge of analytical interferences and critical sample quality will offer valuable solutions to improve the global quality of the total testing process. Some special areas of the analytical process such as calibration, quality control, reference interval, drug interference, statistical analysis, paraproteins and volume displacement effect will be discussed. With some examples from the literature and personal investigation, the impact of errors in the analytical process will be better understood and the examples will help reducing the number of analytical errors and interferences, so that a much better patient safety can be granted.


analytical errors; patient safety; clinical laboratory; quality control; drug interference; calibration; paraprotein; reference interval

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