Interlaboratory comparisons in laboratory medicine - implementing the requirements of HRN EN ISO/IEC
Zlata Flegar Meštrić
Abstract
Zlata Flegar Meštrić
Abstract
The Croatian Society for Medical Biochemistry and Laboratory Medicine has a very long tradition in organizing external quality assessments (EQA) for medical biochemistry laboratories, therefore, in 2012, CROQALM - the Croatian centre for quality assessment in laboratory medicine was established. One of the main tasks of CROQALM is to apply the of the international and European standard for accreditation of proficiency testing providers adopted in the Republic of Croatia as the Croatian Standard HRN EN ISO/IEC 17043 Conformity assessment - General for proficiency testing. Standard represents internationally harmonised general requirements for the accreditation of proficiency testing (PT) providers and requires defining the scope and specifying the concerning the planning, design, testing, distribution, evaluation and reporting of PT/EQA results. In order to support implementation of ISO 17043, Croatian Accreditation Agency, as a national accreditation body, has established the Working Group for Interlaboratory Comparisons which works on PT/EQA regulations and guidelines. CROQALM subcontracts with commercial suppliers providing commutable, stable and homogenous material of high quality for various rounds and conducts schemes for the clinical chemistry, laboratory haematology and coagulation, and in the post-analytical phase, evaluation of laboratory reports. For the purpose of professional supervision, the Croatian Chamber of Medical Biochemists requests to be directly informed on laboratory participation in EQA schemes and achieved results. Therefore, according to the requirement of ISO 17043 regarding the confidentiality of all information supplied by a participant to the PT/EQA provider, CROQALM inform the participants of this action, in advance and in writing.
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The Croatian Society for Medical Biochemistry and Laboratory Medicine has a very long tradition in organizing external quality assessments (EQA) for medical biochemistry laboratories, therefore, in 2012, CROQALM - the Croatian centre for quality assessment in laboratory medicine was established. One of the main tasks of CROQALM is to apply the of the international and European standard for accreditation of proficiency testing providers adopted in the Republic of Croatia as the Croatian Standard HRN EN ISO/IEC 17043 Conformity assessment - General for proficiency testing. Standard represents internationally harmonised general requirements for the accreditation of proficiency testing (PT) providers and requires defining the scope and specifying the concerning the planning, design, testing, distribution, evaluation and reporting of PT/EQA results. In order to support implementation of ISO 17043, Croatian Accreditation Agency, as a national accreditation body, has established the Working Group for Interlaboratory Comparisons which works on PT/EQA regulations and guidelines. CROQALM subcontracts with commercial suppliers providing commutable, stable and homogenous material of high quality for various rounds and conducts schemes for the clinical chemistry, laboratory haematology and coagulation, and in the post-analytical phase, evaluation of laboratory reports. For the purpose of professional supervision, the Croatian Chamber of Medical Biochemists requests to be directly informed on laboratory participation in EQA schemes and achieved results. Therefore, according to the requirement of ISO 17043 regarding the confidentiality of all information supplied by a participant to the PT/EQA provider, CROQALM inform the participants of this action, in advance and in writing.
Key concepts: Accreditation, External quality assessment, Medical laboratory, Scope (computer science), Medical education, Medicine, Agency (philosophy), Quality management system