CONTROL MATERIALS-MEDICAL DEVICES FOR INCREASING THE QUALITY OF CLINICAL LABORATORY ANALYSES

Clinical Laboratory is a major of great importance in modern medicine. Laboratory tests results are objective indicators of the status of the body. A large percentage of diagnoses of various diseases are placed on the basis of laboratory analyses. At the current stage of development of the healthcare systems, great consideration is given to the assessment of the quality in providing medical cares. Quality in Clinical Laboratories is a system of actions, at all levels of the clinician and laboratory process, aimed at achieving a maximum correct result, which will help doctors-clinicians in specifying the diagnosis, monitoring the treatment and predicting the course of the disease concerned, the provision of quality laboratory medical services being the responsibility of every professional. Clinical Laboratory major, when used optimally, generates knowledge that guides clinicians and serves to properly treat and monitor patients, which in turn is the key to more cost-effective and quality health cares. There are many definitions of a ‘Quality Laboratory Medical Care’ but they are all united around the thesis that the good quality of laboratory testing assists clinicians in practicing modern medicine at a high level. To achieve a high level of quality in Clinical Laboratory and a maximum accuracy of laboratory analyses, control materials–medical devices are used in the clinical and laboratory process to control the analytical reliability of the laboratory methods. Control materials used in the Clinical Laboratory should: closely resemble patient specimen; remain stable over time; have a concentration of ingredients within the clinically relevant areas and reference ranges. Values stated in control materials should be obtained with primary reference methods and should be traceable to international standards, as well as to use controls in several concentration areas. The use of control materials certified at different levels is at the heart of the concept of ‘quality’ in Laboratory Medicine. This concept is focused not only on analytical accuracy but on a more comprehensive basis, including all the steps of the Clinical Laboratory process, providing valuable information in the course of making important clinical diagnostic decisions on patient-centered health cares.