Background. Quality assurance issues are the core activities in modern laboratory of clinical chemistry making all other laboratory processes facing directly to it. The aim of the article was to analyze traditional quality assurance practices in laboratories of clinical chemistry, its effectiveness and capabilities of Total Quality Management principals to be implemented in Lithuanian laboratories.
The article describes quality assurance design and some metrics to be applied for quality measurements. Design and goals of right analytical quality control system together with applicable criterions for evaluation of its results are described. Analysis of measurement errors type and ways for error detection are described. Concept of biological variation for setting up analytical quality requirements is described. Aims of external quality assessment, advances and disadvantages of those schemes are detailed. Total Quality Management Process Framework and recommendations on its implementation as scientific method in quality management with regard to clinical chemistry environment are described. View of total testing process including patient preparation and clinical validation of test result which goes beyond what is traditionally considered to be part of the laboratory testing process is presented.
Conclusions. Due to changes of normative documents and legal regulations critical improvements of total testing processes were introduced in Lithuanian clinical laboratories. Elements of Total Quality Management were introduced and concept of biological variation for analytical quality requirements was applied.
