STANDARDIZATION AS AN APPROACH TO IMPROVING THE QUALITY OF CLINICAL AND LABORATORY WORK

Standardization is defined as an activity that regulates the general and repetitive application of a system of prescriptions on different (including specific) issues in order to achieve optimal order in certain circumstances. It involves the creation, dissemination and implementation of standards aimed at improving the common properties (quality, suitability, etc.) of products, processes and services. Standards are documents that contain rules, norms, and requirements for a product or service, in order to achieve better efficiency and meet the expectations of consumers and customers. Standards are means of information, serving to improve quality, to support the economic development and contributing to the benefit of the whole Society. The term ‘Standard’ is at the core of the standardization process. Applied to the health system, the standard is a regulatory document developed on the basis of different consensus and validated by a relevant body. This regulatory document establishes a set of rules and requirements concerning different types of medical activities and the results of their implementation. An important objective of each healthcare system is to provide the population with accessible, quality and safe medical care. The introduction of a system of standards in healthcare and in medicine, in particular, is a powerful tool for its achievement. This ensures high quality of the medical assistance offered, a rational use of financial, material and personnel resources as well as an optimization of the diagnostic and healing process. Standards set a minimum/optimal level of Quality Assurance through mandatory requirements that are the basis of State guarantees for affordable medical care, range and types of health services, lists of specific technologies with proven effectiveness, as well as guidelines to further improve the level of quality by formulating further scientifically substantiated recommendations. Standards allow for aggregation of information, which leads to optimization of solutions at all levels in the healthcare system. Standardization is one of the main means of achieving and maintaining the necessary level and one of the main tools in Quality Management. In laboratory medicine, standardization is an approach for the optimization of clinical and laboratory activities. The provision of high quality services is the responsibility of every professional working in the respective diagnostic structure. The quality and standardization in the Specialization of “Clinical Laboratory” are focused not only on the accuracy of laboratory results, but also they step on a broader basis, including each stage of the clinical and laboratory analysis, in order to make important medical decisions subject to patient care.