Thelen Marc H M, Vanstapel Florent J L A, Kroupis Christos, Vukasovic Ines, Boursier Guilaime, Barrett Edward, Bernabeu Andreu Francisco, Brguljan Pika Meško, Brugnoni Duilio, Lohmander Maria, Sprongl Ludek, Vodnik Tatjana, Ghita Irina, Vaubourdolle Michel, Huisman Willem
Clin Chem Lab Med. 2015 Jul;53(8):1173-80. doi: 10.1515/cclm-2015-0257.
The recent revision of ISO15189 has further strengthened its position as the standard for accreditation for medical laboratories. Both for laboratories and their customers it is important that the scope of such accreditation is clear. Therefore the European co-operation for accreditation (EA) demands that the national bodies responsible for accreditation describe the scope of every laboratory accreditation in a way that leaves no room for doubt about the range of competence of the particular laboratories. According to EA recommendations scopes may be fixed, mentioning every single test that is part of the accreditation, or flexible, mentioning all combinations of medical field, examination type and materials for which the laboratory is competent. Up to now national accreditation bodies perpetuate use of fixed scopes, partly by inertia, partly out of fear that a too flexible scope may lead to over-valuation of the competence of laboratories, most countries only use fixed scopes. The EA however promotes use of flexible scopes, since this allows for more readily innovation, which contributes to quality in laboratory medicine. In this position paper, the Working Group Accreditation and ISO/CEN Standards belonging to the Quality and Regulation Committee of the EFLM recommends using an approach that has led to successful introduction of the flexible scope for ISO15189 accreditation as intended in EA-4/17 in The Netherlands. The approach is risk-based, discipline and competence-based, and focuses on defining a uniform terminology transferable across the borders of scientific disciplines, laboratories and countries.
ISO15189的最新修订进一步巩固了其作为医学实验室认可标准的地位。对于实验室及其客户而言，明确此类认可的范围至关重要。因此，欧洲认可合作组织（EA）要求负责认可的国家机构以一种方式描述每个实验室认可的范围，使特定实验室的能力范围毫无疑义。根据EA的建议，范围可以是固定的，列出认可范围内的每一项单独检测项目；也可以是灵活的，提及实验室具备能力的医学领域、检测类型和材料的所有组合。到目前为止，国家认可机构一直沿用固定范围，部分原因是惯性，部分原因是担心过于灵活的范围可能导致对实验室能力的高估，大多数国家仅使用固定范围。然而，EA提倡使用灵活范围，因为这更有利于创新，有助于提高检验医学质量。在本立场文件中，欧洲临床实验室医学联合会（EFLM）质量与法规委员会的认可工作组及ISO/CEN标准工作组建议采用一种方法，该方法已成功地按照EA-4/17的预期在荷兰引入了ISO15189认可的灵活范围。该方法基于风险、学科和能力，重点在于定义一种可跨越科学学科、实验室和国家边界的统一术语。
