Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO)

Abstract

Abstract: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 Unauthenticated Download Date | 5/11/18 12:26 PM 1174 Thelen et al.: EFLM guidance on ISO15189 flexible scope risk-based, discipline and competence-based, and focuses on defining a uniform terminology transferable across the borders of scientific disciplines, laboratories and countries.

Quality Assurance in Clinical Chemistry: A Touch of Statistics and A Lot of Common Sense

“…Accreditation according to ISO standards, as commonly practiced today, therefore risks becoming not only an obstacle but also a real enemy of the necessary paradigm shift in laboratory medicine made possible by advances in automation and information technologies. Flexible scope of accreditation (17, 20) may represent a partial solution to this challenge, but a more radical scheme of more intensive monitoring by the accreditation authorities during periods of major transitions for accredited laboratories may be needed in order to avoid the need to abandon forma accreditation when performing major restructuring.…”

The quality indicator paradox

“…In addition, many clinical laboratories adopt only a few, conventional QIs, thus failing to cover all the steps and processes in the extra-analytical phase. Finally, the awareness of the importance of harmonized QIs and related performance criteria by some national accreditation bodies is still limited [24,25]. It may be simple to identify current issues limiting the participation of clinical laboratories in the MQI programme, and thus compromising the provision of data needed for defining reliable performance specifications in the extra-analytical phases, but it is far more difficult to identify corrective measures.…”

Elements of Effective Practice in Patient-Centred Laboratory Medicine

“…There are two associated systems for medical laboratory accreditation: International standard system for medical laboratory, ISO15189:2012 offered by International Organization for Standardization [4,5] which provides international standards in medical laboratory and, a US system, accreditation of laboratory through College of American Pathologists (CAP accreditation) which is an accreditation programme based on ISO15189 [6].…”