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[Significance of participation in programs of external quality assessment in molecular diagnostic--our experience].

Mirjana Mariana Kardum Paro, Zoran Šiftar, Dubravka Juretić, Zlata Flegar-Meštrić

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Abstract

Harmonization of molecular diagnostic tests in laboratories in the Republic of Croatia has only just started. According to laboratory accreditation standard ISO 15189 participation in external quality assessment (EQA) schemes or programs is a prerequisite and support tool for clinical laboratory accreditation process. As there are no national quality assurance schemes yet, an European external quality assessment (EQA) scheme or program should be found. Because of variation in the molecular diagnostic test performance of clinical laboratories across Europe, EQA is recognized as a system whereby a set of reagents and techniques are assessed by an external provider making inter-laboratory performance comparability possible through already integrated recommendations and practice guidelines of molecular diagnostic test performance. Today, wide range of various EQA schemes and programs already in action have been available and most of them began within the last ten years. This paper is therefore intended to present and summarize the four-year EQA activities in the Institute of Clinical Chemistry, Merkur University Hospital, in three different international EQA schemes: United Kingdom National External Quality Assessment Scheme (UK NEQAS), the European Molecular Genetic Quality Network (EMQN) and Multi-National External Quality Assay program (EQUAL- qual)) and to point out their educational role in standardization of laboratory performance of any test intended for patient testing. from a laboratory point of view.

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Harmonization of molecular diagnostic tests in laboratories in the Republic of Croatia has only just started. According to laboratory accreditation standard ISO 15189 participation in external quality assessment (EQA) schemes or programs is a prerequisite and support tool for clinical laboratory accreditation process. As there are no national quality assurance schemes yet, an European external quality assessment (EQA) scheme or program should be found. Because of variation in the molecular diagnostic test performance of clinical laboratories across Europe, EQA is recognized as a system whereby a set of reagents and techniques are assessed by an external provider making inter-laboratory performance comparability possible through already integrated recommendations and practice guidelines of molecular diagnostic test performance. Today, wide range of various EQA schemes and programs already in action have been available and most of them began within the last ten years. This paper is therefore intended to present and summarize the four-year EQA activities in the Institute of Clinical Chemistry, Merkur University Hospital, in three different international EQA schemes: United Kingdom National External Quality Assessment Scheme (UK NEQAS), the European Molecular Genetic Quality Network (EMQN) and Multi-National External Quality Assay program (EQUAL- qual)) and to point out their educational role in standardization of laboratory performance of any test intended for patient testing. from a laboratory point of view.

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Available abstract

Harmonization of molecular diagnostic tests in laboratories in the Republic of Croatia has only just started. According to laboratory accreditation standard ISO 15189 participation in external quality assessment (EQA) schemes or programs is a prerequisite and support tool for clinical laboratory accreditation process. As there are no national quality assurance schemes yet, an European external quality assessment (EQA) scheme or program should be found. Because of variation in the molecular diagnostic test performance of clinical laboratories across Europe, EQA is recognized as a system whereby a set of reagents and techniques are assessed by an external provider making inter-laboratory performance comparability possible through already integrated recommendations and practice guidelines of molecular diagnostic test performance. Today, wide range of various EQA schemes and programs already in action have been available and most of them began within the last ten years. This paper is therefore intended to present and summarize the four-year EQA activities in the Institute of Clinical Chemistry, Merkur University Hospital, in three different international EQA schemes: United Kingdom National External Quality Assessment Scheme (UK NEQAS), the European Molecular Genetic Quality Network (EMQN) and Multi-National External Quality Assay program (EQUAL- qual)) and to point out their educational role in standardization of laboratory performance of any test intended for patient testing. from a laboratory point of view.

Key concepts: External quality assessment, Accreditation, Quality assurance, Standardization, Medical physics, Harmonization, Comparability, Medicine

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