Harmonization in clinical laboratories. Concepts and problems. Metrological continuity, standardization, harmonization
Abstract
Objective: Review on the contemporary state of harmonization of measurement results in laboratory medicine. Methods: The state of reference, harmonization protocols, and initiative of AACC and EFLM on this field are described.
Results: With using many recent literature sources we describe contemporary state of metrological traceability, standardization and harmonization of medical laboratories. The influence of harmonization factors on the comparability, quality control and modern precision and digitalized medicine with emphasizing on its patient orientation is described.
Redefinition of relationship between laboratories and producers of IVD MD and possible changes after acceptation of newly issued ISO 17511 are introduced. Conclusion: Harmonization and namely standardization is key condition to creating the modern, on patients-oriented laboratory medicine, prepared to its more effective and digitalized form.