EFLM Consensus Provides Minimum and Best-in-Class Solutions for ISO 15189 Pre-Analytical Requirements
The EFLM Working Group for Pre-analytical Phase produced a consensus document translating every pre-analytical requirement in ISO 15189:2012 into two tiers: a minimal recommendation that all laboratories should implement, and a best-in-class solution representing current state-of-the-art practice. The guidance addresses significant inter-auditor variability in interpreting pre-analytical standards and provides an actionable roadmap for laboratories seeking to systematically improve specimen quality and pre-analytical process control.
The original study
How to meet ISO15189:2012 pre-analytical requirements in clinical laboratories? A consensus document by the EFLM WG-PRE.
- Authors
- Vermeersch P, Frans G, von Meyer A, Costelloe S, Lippi G, Simundic AM
- Journal
- Clinical chemistry and laboratory medicine
- Type
- Journal Article, Consensus Statement
- PMID
- 33554545
Original abstract
The International Organization for Standardization (ISO) 15189:2012 standard aims to improve quality in medical laboratories through standardization of all key elements in the total testing process, including the pre-analytical phase. It is hence essential that accreditation bodies, assessing laboratories against ISO15189:2012, pay sufficient attention to auditing pre-analytical activities. However, there are significant differences in how technical auditors interpret the pre-analytical requirements described in ISO15189:2012. In this consensus document, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Pre-analytical Phase (WG-PRE) sets out to review pre-analytical requirements contained in ISO15189:2012 and provide guidance for laboratories on how to meet these requirements. The target audience for this consensus document is laboratory professionals who wish to improve the quality of the pre-analytical phase in their laboratory. For each of the ISO requirements described in ISO15189:2012, members of EFLM WG-PRE agreed by consensus on minimal recommendations and best-in-class solutions. The minimal consensus recommendation was defined as the minimal specification which laboratories should implement in their quality management system to adequately address the pre-analytical requirement described in ISO15189:2012. The best-in-class solution describes the current state-of-the-art in fulfilling a particular pre-analytical requirement in ISO15189:2012. We fully acknowledge that not every laboratory has the means to implement these best-in-class solutions, but we hope to challenge laboratories in critically evaluating and improving their current procedures by providing this expanded guidance.