<abstract xmlns="http://www.w3.org/1999/xhtml"><p> Analytical laboratory results greatly influence medical diagnosis, about 70% of medical decisions are based on laboratory results. Quality assurance and quality control are designed to detect and correct errors in a laboratory’s analytical process to ensure both the reliability and accuracy of test results. Unreliable performance can result in misdiagnosis and delayed treatment. Furthermore, improved quality guarantees increased productivity at a lower cost. Quality assurance programmes include internal quality control, external quality assessment, proficiency surveillance and standardization. It is necessary to try to ensure compliance with the requirements of the standards at all levels of the process. The sources of these standards are the International Standards Organization (ISO), national standards bodies, guidelines from professional organisations, accreditation bodies and governmental regulations. Laboratory networks increase the performance of laboratories in support of diagnostic screening programme. It is essential that genetic laboratories of a network have procedures underpinned by a robust quality assurance system to minimize errors and to reassure the clinicians and the patients that international standards are being met. This article provides an overview of the bases of quality assurance and its importance in genetic tests and it reports the EBTNA quality assurance system which is a clear and simple system available for access to adequate standardization of a genetic laboratory’s network.</p></abstract>

Analytical laboratory results greatly influence medical diagnosis, about 70% of medical decisions are based on laboratory results. Quality assurance and quality control are designed to detect and correct errors in a laboratory’s analytical process to ensure both the reliability and accuracy of test results. Unreliable performance can result in misdiagnosis and delayed treatment. Furthermore, improved quality guarantees increased productivity at a lower cost. Quality assurance programmes include internal quality control, external quality assessment, proficiency surveillance and standardization. It is necessary to try to ensure compliance with the requirements of the standards at all levels of the process. The sources of these standards are the International Standards Organization (ISO), national standards bodies, guidelines from professional organisations, accreditation bodies and governmental regulations. Laboratory networks increase the performance of laboratories in support of diagnostic screening programme. It is essential that genetic laboratories of a network have procedures underpinned by a robust quality assurance system to minimize errors and to reassure the clinicians and the patients that international standards are being met. This article provides an overview of the bases of quality assurance and its importance in genetic tests and it reports the EBTNA quality assurance system which is a clear and simple system available for access to adequate standardization of a genetic laboratory’s network.

Quality assurance of genetic laboratories and the EBTNA practice certification, a simple standardization assurance system for a laboratory network

The EuroBiotech Journal

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Analytical laboratory results greatly influence medical diagnosis, about 70% of medical decisions are based on laboratory results. Quality assurance and...

Quality assurance of genetic laboratories and the EBTNA practice certification, a simple standardization assurance system for a laboratory network

Article Category: Guidelines and Clinical Algorithms

Published Online: Oct 27, 2018

Page range: 215 - 222

DOI: https://doi.org/10.2478/ebtj-2018-0052

Keywords
Quality assurance, ISO, EBTNA Quality System, laboratory network, genetic tests

© 2018 Vincenza Precone, Munis Dundar, Tommaso Beccari, Eda Tahir Turanli, Stefano Cecchin, Giuseppe Marceddu, Elena Manara, Matteo Bertelli, published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

Supplementary Material Details

Supplementary Material Details

Supplementary Material Details

Quality assurance of genetic laboratories and the EBTNA practice certification, a simple standardization assurance system for a laboratory network

Article Category: Guidelines and Clinical Algorithms

Published Online: Oct 27, 2018

Page range: 215 - 222

DOI: https://doi.org/10.2478/ebtj-2018-0052

KeywordsQuality assurance, ISO, EBTNA Quality System, laboratory network, genetic tests

© 2018 Vincenza Precone, Munis Dundar, Tommaso Beccari, Eda Tahir Turanli, Stefano Cecchin, Giuseppe Marceddu, Elena Manara, Matteo Bertelli, published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

Supplementary Material Details

Supplementary Material Details

Supplementary Material Details

Keywords
Quality assurance, ISO, EBTNA Quality System, laboratory network, genetic tests