PROBLEMS OF STANDARDIZATION IMPLEMENTATION IN CLINICODIAGNOSTIC LABORATORIES OF UKRAINE
Journal Title: Праці Наукового товариства ім. Шевченка - Year 2015, Vol 43, Issue 2
Abstract
Introduction. Clinical informational content and analytical reliability determine the quality of laboratory tests, which is achieved by creating a system to guarantee quality through standardization. The lack o f standardization, which is closely linked to certification and accreditation, at this stage hampers the development ofLaboratory Medicine in Ukraine. The standards are developed by international organizations in the field o f medicine and standardization, such as WHO and the International Organization for Standardization. National standards are based on international practices and are adapted to the specifics and general conditions o f the country. Ukraine has the legislative framework, the bodies that carry out technical regulation, standardization and conformity assessment, but because of the lack o f legal framework in the field of laboratory medicine national laboratory results are not being recognized abroad. Prerequisite o f standardization is the national regulations system. The adoption of standards containing scientific and reasonable criteria for the proper implementation of certain technological operation will enhance the quality o f laboratory research. Such ISO are important in connection with the organisation of the clinicodiagnostic laboratories activity in the field o f laboratory medicine: 15189, 22869, 22,870.15190; to create the necessary reference system in Ukraine for cooperation with international institutions - ISO: 15193, 15194, 15195, 17511, 18153, 20776-1. ISO 15189 is the basic law for clinicodiagnostic laboratories. This standard is intended for use only by medical laboratories, it is based on ISO 17025 and ISO 9001 it embraces all areas o f activity, laying down the principles and rules of action. In our country to regulate the market for Laboratory Medicine TC 166 in cooperation with the Association o f Clinical Chemistry and Laboratory Medicine in Ukraine developed 55 standards, 24 approved, the rest are in the prosses o f expertise. Aim. The goal is to find out the problem o f implementing in Ukraine standardization and quality assurance system for research in the field of laboratory medicine in accordance with international standards to create a system o f medical laboratories accreditation. Conclusions. Sovling the problem o f standardization will improve the quality o f medical care, i.e.: it will set the rules for the organization o f medical laboratories, requirements to the reference system; will provide the reliable and comparable information, confirm the accuracy o f metrological measurements; regulate the means of testing manufacturers the greatest accuracy o f matching products characteristics with the requirements of sensitivity, specificity, accuracy and precision of research methods conducted by means o f these.
Authors and Affiliations
Oksana YASTREMSKA
Keywords
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