XXI međunarodna konvencija o kvalitetu JUSK ICQ – 29 – 31. maj 2025, Beograd, (166-172 str.)
АУТОР(И) / AUTHOR(S): Gordana Dmitrašinović 
Download Full Pdf 
DOI: 10.46793/XXIJUSK-ICQ.166D
САЖЕТАК / ABSTRACT:
In their daily work, clinical biochemical laboratories are required to implement internal quality control to ensure that the system they use is functioning properly and that they can reliably issue laboratory results. In addition to deciding on the type of control rules to apply, the number of control measurements, and their frequency, laboratories often face problems due to the lack or inadequacy of predefined ranges for certain parameters in the selected control material. This issue arises from the expectation that laboratories will establish their own target values (mean and standard deviation) for a given control sample. The approach to solving this problem depends on whether the control material they use is from the same manufacturer as the equipment and reagents, or independent controls (so-called third-party controls) are used. A practical example demonstrates that one of the critical factors in overcoming these challenges is professional support and collaboration between the laboratory and the manufacturer/distributor of control materials, reagents, and equipment.
КЉУЧНЕ РЕЧИ / KEYWORDS:
internal quality control, control material, predefined range
ПРОЈЕКАТ / ACKNOWLEDGEMENT:
ЛИТЕРАТУРА / REFERENCES:
- Plebani, M., Laposata M., Lippi G., A manifesto for the future of laboratory medicine professionals. Clinica Chimica Acta, Vol. 489, pp. 49-52, 2019.
- Price, C.P., John, A.S., Christenson, R., et al., Leveraging the real value of laboratory medicine with the value proposition. Clinica Chimica Acta, Vol. 462, pp. 183-186, 2016.
- Gruber, L., Hausch, A., Mueller, T., Internal Quality Controls in the Medical Laboratory: A Narrative Review of the Basic Principles of an Appropriate Quality Control Plan. Diagnostics, Vol. 14, No. 19, p. 2223, 2024.
- CLSI C24-Ed4; Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions. 4th ed. Clinical and Laboratory Standards Institute, Wayne, PA, USA, 2016.
- Wheeler, S.E., Blasutig, I.M., Dabla, P.K., et al., Quality standards and internal quality control practices in medical laboratories: an IFCC global survey of member societies. Clinical Chemistry and Laboratory Medicine, Vol. 61, No. 12, pp. 2094-2101, 2023.
- ISO 15189: Medical Laboratories—Requirements for Quality and Competence. International Organization for Standardization, Geneva, Switzerland, 2022.
- SRPS EN ISO 15189:2023 Medical laboratories – Requirements for quality and competence (ISO 15189:2022) (in Serbian), Institute for standardization of Serbia, Belgrad, Serbia, 2023.
- Braga, F., Pasqualetti, S., Aloisio, E., Panteghini, M., The internal quality control in the traceability era. Clinical Chemistry and Laboratory Medicine, Vol. 59, No. 2, pp. 291-300, 2020.
- Ricos, C., Fernandez-Calle, P., Perich, C., et al., Internal quality control – past, present and future trends. Advances in Laboratory Medicine,Vol. 3, No. 3,pp. 243-262, 2022.
- van Schrojenstein Lantman, M., et al., An approach for determining allowable between reagent lot variation. Clinical Chemistry and Laboratory Medicine,Vol. 60, No. 5, pp. 681-688, 2022.
