Quality management and standardization programs in hemostaseology.

Total quality management (TQM) of laboratory services is connected with a comprehensive system of quality assurance, which integrates quality development, quality maintenance, and quality improvement. TQM concentrates not only on analytic performance and organizational issues, including specimen collection, reporting, and interpretation of results, but focuses also on the benefits to society related to the use of specific laboratory tests in prevention, early detection, and therapy monitoring, as well as on outcome measures. A prerequisite to TQM are international and national standardization programs for the establishment of optimized and standardized methods, as well as for the development and evaluation of suitable reference materials. Reference materials that have been or are being prepared, calibrated, and certified by international and national reference institutions will certainly contribute to the harmonization of results, with different test systems in hemostaseology, improving their quality and value.