The work of Scientific & Practical Conference with International Participation “DSTU EN ISO 15189:2015 – Roadmap to Laboratory Tests Quality” held on 19-20 October 2016 by the Association of Clinical Chemistry and Laboratory Medicine Ukraine, by P.L. Shupyk’s National Medical Academy of Postgraduate Education, by the Technical Committee for Standardization 166 “Clinical laboratory testing and in vitro diagnostic test systems», and by the Ukrainian Society of Clinical Laboratory Diagnostics, with the assistance of the Ministry of Health of Ukraine, was finished. The Conference was attended by more than 800 experts in the field of laboratory diagnostics.
At the Conference, the experience of implementation of the requirements of DSTU EN ISO 15189:2015 “Medical laboratories. Requirements for quality and competence”, both in Ukraine and abroad, particularly in Germany, was presented. In particular, the Head of the CCDL of KRC PI “Kyiv Regional Clinical Hospital” Lidiia Produsevich shared experience of the gradual introduction of ISO 15189 requirements into the work of her lab in order to continually improve its performance.
Advisor to the laboratory diagnosis of Disease Control and Prevention Centers (CDC) in Ukraine Marianna Azarskova shared experience of CDC in preparing for accreditation of medical laboratories in countries with limited resources, as well as existing international instruments of implementation of quality management systems for medical laboratories of low- and middle-income countries.
Executive secretary of TC 166 “Clinical laboratory testing and in vitro diagnostic test systems» Dmitrii Shakhnin criticized the outdated and flawed approach to the implementation of quality assurance systems into the practice of medical laboratories in Ukraine, as reflected in the Order of Ministry of Health of Ukraine from 10.01.2015 No. 644 “On approval of the concept of quality management system in the medical laboratories of Ukraine in accordance with international standards and of the Action Plan for its implementation.” He also presented a project of stepwise introduction of DSTU EN ISO 15189 into the practice of medical laboratories of Ukraine based on the approach of LQMS-SIP Program being implemented in the Caribbean region countries.
Special attention was paid to the metrological aspects, in particular, to the accuracy. Assoc. Prof. of Chair of forensic toxicology and clinical biochemistry of KhMAPE Vladimir Protsenko told about the metrological part of DSTU EN ISO 15189:2015 described in more detail in other national standards, particularly in the DSTU EN ISO 17511:2015 “In vitro diagnostics medical devices. Measurement of quantities in samples of biological origin. Metrological traceability of values assigned to calibrators and control materials”, as well as about the need to establish national reference intervals and accuracy requirements to the results of clinical laboratory tests.
Also, attention was paid to the use of audits in the activities of medical laboratories and contradictions between the requirements of existing national legislation and international standards. Assist. Prof. of Chair of clinical laboratory diagnostics of NMAPE Irina Tanasiichuk reported on the peculiarities of the national regulatory base for the documents flow process in medical laboratories and on the benefits of the internal audits to continually improve the quality of the results of clinical laboratory tests.
In general, the conference highlighted the main points, in particular the need to address the requirements of other documents, including national standards, which need to be taken into accounts during the introduction of laboratory quality assurance system, as well as provide an opportunity to discuss the optimal sequence of implementation of DSTU EN ISO 15189:2015 requirements as a way to improve the quality of tests results in medical laboratories in Ukraine.
Within the framework of the Conference, General Assembly of Association of Clinical Chemistry and Laboratory Medicine of Ukraine was held together with the Congress of the Ukrainian Society of Clinical Laboratory Diagnostics, where it was decided that the Society will join the Association. This decision is due to the need to create better conditions for cooperation and to raise the qualification level of laboratory experts, as well as to facilitate the systematic work on projects for the development in the field of laboratory medicine, both at the national and at the international levels.
