Patient Safety and Clinical Effectiveness as Imperatives for Achieving Harmonization inside and outside the Clinical Laboratory

Abstract

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. Some incremental progress has been made in addressing these issues through professional organizations, multidisciplinary practice guidelines developed by national and international committees, peer-review publications, and the global in vitro diagnostic manufacturing industry. Notable successes include the National Glycohemoglobin Standardization Program (including the recommendations of the Diabetes Control and Complications Trial), the National Cholesterol Education Program, and the National Kidney Disease Education Program, which have helped drive improvements in laboratory methods for hemoglobin A1c, total cholesterol, and creatinine, respectively, and helped establish clinical practice guidelines based on laboratory measurements that meet defined performance criteria. As recently as October 2010, the AACC hosted an international conference for a diverse group of stakeholders to improve harmonization of laboratory results and to make recommendations for the future. Regrettably, personnel in the clinical laboratory must continue to cope on a day-to-day basis with the blissful ignorance or blatant denial of these multifactorial methodologic differences by many practicing clinicians and, sadly, a few fellow laboratory colleagues. Harmonization of results remains the “holy grail.” How often have we been asked, “Isn't one test result the same as another from a different laboratory?” Even after careful explanation and intensive efforts to educate, …