Bogomolets National Medical University
HONOR, MERCY, GLORY

STATE CERTIFICATION OF LABORATORIES OF ECM REASERCH INSTITUTE

In November 2015 took place the Commission for Attestation of the Laboratory of Immunology and Molecular Biology and the Laboratory of Clinical Laboratory Diagnostics, which can be used not only for research, but also for diagnostic purposes. Their participation in the clinical-diagnostic process is regulated by the presence in the ECM Research Institute of a license for medical practice in the specialty “clinical laboratory diagnostics”.

The commission was headed by the chief specialist of the department for the quality of medical care of the Department of Licensing and Quality of Medical Care of the Ministry of Health of Ukraine. The commission included representatives of various institutions, which carried out a comprehensive inspection of the laboratories condition. Thus, clinical and scientific areas were inspected by specialists of the Basic Department of Clinical Laboratory Diagnostics and Metrology of the Ministry of Health of Ukraine of the Ukrainian Reference Center for Clinical Laboratory Diagnostics and Metrology NDSL “OKHMATDIT” of the Ministry of Health of Ukraine; as well as Professor, Head of the Department of Pathophysiology, Immunology and Transplantology of the Ukrainian Scientific and Practical Center for Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine.

Significant importance was attached to the condition of the equipment and the accuracy of measurements. This fragment was carefully analyzed by the metrology auditor, the leading engineer of the scientific and technical department for certification of measuring laboratories of Ukrmetrteststandard.

Particular attention was paid to the verification of such items as:

  • Correspondence of education and specialization of specialists, who perform research, their qualification and measures to improve it,
  • Condition of premises and infrastructure of ECM Research Institute,
  • Permits, acts, all regulations,
  • Reagents, their quantity, quality, compliance with methods and equipment, serviceability,
  • Means for conducting a regular quality control system, both internally and at the state level,
  • Accounting and reporting documentation, maintaining an electronic database of results.

At all points there was a thorough check of documents and the actual compliance of each working place.

 

The heads of the laboratories received control material in the form of “blind” serum and the researchers performed the measurements directly during the work of the commission. Subsequently, the results were evaluated for compliance with the range of the passport provided control serum, and the data are reflected in the protocols.

The main remarks and wishes were mainly to support the future of the reagent base, and to update the laboratory furniture, but the work of the laboratory and their organization on all points was assessed by the commission as “excellent”.

According to the acts signed by the commission, the Laboratory of Immunology and Molecular Biology and the Laboratory of Clinical Laboratory Diagnostics of the ECM Research Institute received the right to conduct measurements (research) in the field of health care in accordance with the declared field of certification for five years.

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Participation in international research quality control activities

In order to objectively verify the results of research, the laboratories of the ECM Research Institute in November-December 2015 participated in four interlaboratory comparison programs, which are regularly conducted by the Ukrainian Reference Center and carried out by comparing the results obtained in the laboratory with a certified control sample in European reference laboratories.

For all measurements (which is 20-25 parameters in each program) very good results were obtained. The programs “Hematology” and “Hemostasis” showed a coincidence of 100%, the program “Clinical Biochemistry” – 89%, “Immunochemistry” – 79%. Such results give reason to be proud of the quality of research, but also highlight those problematic issues that still need improvement.