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New ISO standards for medical biology laboratories, prescriptions and deviations
Abstract
ISO published the draft for final approval of the revision of ISO 15189 standard. Following ISO directives, ISO 15189 must be aligned with ISO/IEC 17025:2017 and should be less prescriptive. Draft ISO/DIS 15189 deviates in some points from ISO 17025 and the ISO indications to limit prescriptiveness: equipment, uncertainty, quality control. This do not seem to be justified by medical specificities and could complicate the understanding of the new requirements in medical laboratories.
ISO 17025 chiede l'incertezza dei risultati ma non distingue tra quantitativi e qualitativi. La Guida EURACHEM/CITAC ha quindi una importanza straordinaria per risollevare il tema ad un livello paragonabile agli altri che compongono la complessa costruzione del sistema di gestione della qualità. È un vero peccato che la Guida EURACHEM/CITAC abbia scelto di non trattare tutti gli strumenti disponibili per la valutazione dell'incertezza dei risultati analitici qualitativi. Si sente pesantemente in particolare la mancanza di armonizzazione tra il vocabolario metrologico e quello informatico del riconoscimento di modelli. La mancanza più critica è tuttavia quella del concetto di precisione metrologica, in particolare di ripetibilità, il livello più elementare per stimare l'affidabilità di un esame di laboratorio. Emerge altresì il contrasto con ISO 15189 e ISO 20914 per i risultati qualitativi derivati da misure numeriche, ancora in attesa di una risoluzione. Le Raccomandazioni SIPMeL, prodotte prima che fosse disponibile la Guida EURACHEM/CITAC, raccogliendo elementi da fonti diverse sia ISO che CLSI, possono invece fornire soluzioni per tutti i principali casi che interessano i laboratori medici. --- ISO 17025 calls for uncertainty of results but does not distinguish between quantitative and qualitative. The EURACHEM/CITAC Guide is therefore of extraordinary importance in raising the issue to a level comparable to the others that make up the complex construction of the quality management system. It is unfortunate that the EURACHEM/CITAC Guide has chosen not to cover all available tools for the assessment of uncertainty in qualitative analytical results. In particular, the lack of harmonisation between the metrological vocabulary and the IT vocabulary of pattern recognition is severely felt. The most critical lack, however, is that of the concept of metrological accuracy, in particular repeatability, the most basic level for estimating the reliability of a laboratory test. There is also the contrast with ISO 15189 and ISO 20914 for qualitative results derived from numerical measurements, which is still awaiting resolution. The SIPMeL Recommendations, produced before the EURACHEM/CITAC Guide was available, collecting elements from different sources, both ISO and CLSI, can instead provide solutions for all major cases affecting medical laboratories.
Eurachem/CITAC published a very useful and important Guide on Uncertainty of Qualitative Results. However, the Guide does not include the evaluation of precision, and does not address the alternative of uncertainty of qualitative results obtained from quantitative measurements described by ISO documents.
Keywords: Uncertainty; Qualitative; Precision; ISO 17025; ISO 15189; ISO 20914; ISO 16393 - 50 days' free access to your article. Anyone clicking on this link before April 26, 2022 will be taken directly to the final version of your article on ScienceDirect, which they are welcome to read or download. No sign up, registration or fees are required.
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The order no. 2010-49 of January 13, 2010 has made the accreditation of medical biology laboratories in France mandatory. It is based on international standards: NF EN ISO 15189 for medical biology laboratories and NF EN ISO 22870 for point-of-care testing. The NF EN ISO 15189:2012 standard is an adaptation of the requirements relating to the quality management system according to the ISO 9001:2008 standard, to improve delivery performance. As a company's performance is closely linked to its quality culture, the establishment and development of a quality culture within a company appears fundamental. The purpose of this article is to explain how to create a common language on which to base the development of quality culture within a medical biology laboratory. It is a simple approach which consists in asking 3 questions concerning quality management to the members of the team of this laboratory (what do you value? what emotions give you these values? what do you not value?) then to organize the answers in a reference frame for quality management.
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