Implementation of the quality system according to ISO 15189:2015 in the Laboratory of Clinical Diagnostics of the Clinical Diagnostic Center at the National University of Pharmacy: applied aspects




validation, methods of determination, gamma-glutamyltransferase, alkaline phosphatase, convergence and reproducibility, accuracy and uncertainty of measurements


One of the stages in development and implementation of the quality system in medical laboratories is to conduct the validation works. The main objects of these works are the methods by which measurements of various parameters in
the laboratory are carried out.
Aim. To study the quality assurance aspects in the Laboratory of the Clinical Diagnostics of the Clinical and Diagnostic Center at the National University of Pharmacy (NPhU) by carrying out validation procedures to assess the intra-laboratory reproducibility of biochemical methods.
Materials and methods. The objects of the study were standardized biochemical methods for determining the levels of gamma-glutamyltransferase (GGT) and alkaline phosphatase in the samples of biological fluids. The “Chemical control.
A reagent kit” produced by High Technology, Inc. (USA) with the known concentration of analytes was selected as a control serum. The measurements were carried out using the Express Plus automatic biochemical analyzer manufactured by Bayer (Germany). When processing the results of the research the indicators of descriptive statistics were used, and statistical estimates were made.
Results. The assessment of intralaboratory convergence and reproducibility of the methods for determining the concentration of GGT and alkaline phosphatase by the photometric method when working on the Express Plus biochemical
analyzer carried out by two operators-laboratory technicians of the same qualification indicates the absence of gross errors in the analyzer operation and statistically significant differences in the measurements. The assessment of the
method correctness using the standard sample has proven that the systematic error is insignificant (according to the  criterion of acceptability specified). Thus, these methods provide the correctness of measurements within the laboratory. The increased uncertainty calculated as a metrological assessment of acceptability has shown that the values of the GGT and alkaline phosphatase levels obtained can be considered accurate and reliable.                            Conclusions. The validation of the methods for determination of GGT and alkaline phosphatase in the human blood by the photometric method has proven that these methods have performance characteristics corresponding to the regulated ones, satisfy the criteria specified, and the parameters measured with them correspond to the proper ones.


Doroshenko, I. V. (2008). Therapia. Ukrainskyi medychnyi vіsnyk, 4 (25), 75.

Nakaz vіd 1 zhovtnia 2015 roku № 644. Pro zatverdzhennia Kontseptsii systemy menedzhmentu yakostі v medychnykh laboratorіiakh Ukrainy u vіdpovіdnostі do vymoh mіzhnarodnykh standartіv ta Planu zahodіv shchodo ii realіzatsіi.

Chudutova, D. (2010). Apteka Online.UA., 746 (25).

DSTU EN ISO 15189:2015. Medychnі laboratorіi. Vymohy do yakostі ta kompetentnostі.

Grizodub, A. I., Leontev, D. A., Denisenko, N. V., Podpruzhnikov, Yu. V. (2004). Farmakologiia, 3, 1–15.

Dobrova, V. Ye., Zupanets, K. O., Mіsiurova, S. V., Mazur, N. S. (2015). Systema obrobky іnformatsіi, 2 (127), 104–107.

DSTU ISO/ІES 17025:2006. Zahalnі vymogy do kompetentnostі vyprobuvalnykh ta kalіbruvalnykh laboratorіi.

Ukrainski akredytovanі orhany z otsіnky vidpovіdnostі (UkrAO) (2007). Standart Asotsіatsіi, 5.

DSTU ISO 3534 – 3:2005. Statystyka. Slovnyk termіnіv і poznachennia. Chastyna 3. Planuvannia eksperymentu.

Dobrova, V. Ye. (2010). Upravlіnnia, ekonomіka ta zabezpechennia yakostі v farmatsіi, 3 (11), 6 – 11.

Ratushna, K. L., Mazur, N. S., Zupanets, K. O., Dobrova, V. Ye. (2013). Ukrainskyi bіofarmatsevtychnyi zhurnal – Ukrainian biopharmaceutical journal, 4 (27), 17.

Derzhavna farmakopeia Ukrainy, 1–e vyd. (2001). Kharkіv: RIREH, 556.

ISO 15189–2009 – 40. Laboratorіi medychnі. Okremі vymohi do yakostі ta kompetentnostі.

Dobrova, V. Ye., Zupanets, І. A. (2011). Klіnіchna farmatsіia – Clinical Pharmacy, 15 (4), 18 – 20.





Clinical Pharmacology and Pharmacotherapy