Quality in the analytical phase

Abstract

In today's healthcare system the prevalence of medical errors seems to be high as stated by the report of the In sti tu te of Me di ci ne (IOM). An er ror ra- te of about 10% in clinical medical laboratories has been consistently reported in the literatu re. Most of these errors occur in the pre-a nalytical pha- se. Because only a small number of errors will be seen in the analytical phase, it is very likely that the se might be very often ignored. This over view wi ll deal with the requiremen ts of quality that is not based on quality control sample measurement only. The knowledge of analytical interferences and critical sample quality wi ll offer valuable solutions to improve the global quality of the totaltesting 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 bet ter under stood and the examples will help reducing the number of analytical errors and interferences, so that a much better patient safety can be granted.