The Procedure for Accreditation of Medical Laboratories for Compliance with the Requirements of GOST R ISO 15189-2015 «Medical Laboratories. Particular Requirements for Quality and Competence» in the National Accreditation System

Abstract

Introduction. The laboratory should have a quality management system for laboratory research. The objective was to analyze the requirements of regulatory documentation related to the accreditation of medical laboratories in the National Accreditation System for compliance with GOST R ISO 15189-2015. Methods and materials. A retrospective analysis of the requirements of national and industry standards related to medical laboratories was carried out. Results. The policy management of the activities of the National Accreditation System is based on strict compliance with the requirements of international rules. The provisions of the regulations of the Ministry of Economic Development are a priority for the Federal Accreditation Service. Applicants must comply not only with GOST R ISO 15189-2015, but also with the accreditation criteria of the National Accreditation System. Failure to comply with the requirements related to the traceability of measurement results, measurement uncertainty during calibrations and rules for registration of protocols, entails refusal of accreditation or suspension of its validity. It is mandatory to provide information on the results of activities, including information on issued reports (protocols) with the attachment of an electronic document «in the form of an electronic image (scanned copy) of the document» using the Federal State Information System, about changes in the composition of its employees and their competence, changes in technical equipment in the field of accreditation, about the temporary absence of an employee. Work experience in the field of employee accreditation needs to be documented. Participation in qualification verification programs in the field of accreditation is a criterion of laboratory competence and confirmation of the reliability of measurement results issued by laboratories. It is important to observe strictly defined deadlines for submitting documents to confirm competence. Submitting an application outside of school hours leads to refusal. Conclusion. It is necessary to recommend participation in voluntary accreditation for laboratories conducting research at the interstate level. It is necessary to form a state policy in the field of quality of laboratory diagnostics based on GOST R ISO 15189-2015 and formulate it in the format of a federal law. The formed chain of metrological traceability should include reference, calibration and routine laboratories. It is necessary to introduce changes and clarifications into the regulatory framework of the National Accreditation System, taking into account the peculiarities of medical laboratories.