Features of the Functioning of the National Metrological System in the Health Sector

Abstract

The legislative requirements for metrological support in the healthcare sector, the issues of ensuring metrological traceability and the hierarchical scheme of calibrations and measurements in laboratory medicine according to the recommendations of JCTLM and their adaptation at the national level are considered. The features of the provided metrological control of measuring instruments for medical purposes, including when conducting their compliance assessment with the requirements of technical regulations. The current state of affairs in the confirmation of the technical competence of medical laboratories, including the need for their participation in proficiency testing schemes through inter-laboratory comparisons, in the transition from certification to accreditation is considered.
 The analysis of the used methods and means of calibration and reference measurements proposed by JCTLM and other leading orga­nizations in the field of laboratory medicine is observed. Information is provided on the work carried out by the SE «Ukrmetrteststandart» for metrological support of medical measuring instruments. The necessity of legal improvement, the regulatory and methodological base of the metrological system in the field of healthcare is substantiated. As a result of the work performed, the authors consider:
 
 the legislative base of metrological support in the field of healthcare is not perfect and in need of refinement of the profile of the central executive authorities in order to build technically sound organizational and regulatory frameworks for metrological support in this area;
 proficiency testing through interlaboratory comparisons in the field of laboratory medicine is an effective tool for confirming the technical competence of the laboratory. Laboratories should parti­cipate in proficiency testing schemes on a regular basis. Proficiency testing providers should pay particular attention to the method of determining reference values of indicators in proficiency testing samples, using predominantly metrologically sound procedures based on the use of standards, certified reference materials and/or reference measurement methods;
 the heads of medical laboratories should be careful about the choice of suppliers of legal acts in the metrology.