Patient safety and clinical effectiveness as imperatives for achieving harmonization inside and outside the clinical laboratory.

摘要

For clinical laboratorians, the case for standardization and harmonization has been evident for more than 4 decades, since Radin first proposed using traceable reference standards for calibration as a means to harmonize laboratory results produced with different in vitro diagnostic methods (1). Over the intervening period, the subject has been reviewed (2) and debated extensively-both inside and outside the laboratory community-yet a striking majority of our physician and surgeon colleagues still fail to grasp or understand the limitations of current laboratory measurements, the lack of interchangeability of results obtained by different analytical methods, and the resulting effects on interpretation, clinical decision-making, and patient management.