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Le parole per i laboratori nel vocabolario internazionale - Words for laboratories in the international vocabulary
Abstract
We are now witnessing a renewed interest in words, symbols and graphics in science subjects, including in the technical field of laboratories, with interesting spin-offs for medical laboratories. We do not yet have a certain, unassailable reference for words in the life and health sciences. Although a certain hierarchy can be identified, at the top of which VIM undoubtedly stands. The considerable amount of curious phenomena, ambiguities, repetitions, useless synonyms that are detected of the standard documents urges to work for their resolution. With a few main objectives. First, consistency between a term and its roots, as well as with the concreteness of laboratory activities. Then, timely word-for-word translation into national languages to promote understanding of meanings and combat the phenomenon of "false friends." A single international vocabulary, at the ISO level, would perhaps be desirable, but would require considerable harmonization efforts. Instead, at least at the national level, official language versions of important words, compiled in a single authoritative document, may be a useful and reasonable goal.
... 1, 2 SIPMeL tuttavia aveva dal canto suo elaborato e proposto alla comunità scientifica un complesso di raccomandazioni sulle parole in lingua italiana da usare nelle attività dei laboratori medici, basate su diversi standard ISO, 3 che più recentemente sono state elaborate alla luce delle indicazioni del Vocabolario Internazionale di Metrologia (VIM3), 4 nonché delle più recenti innovazioni nel campo delle misure di laboratorio. 5 A queste raccomandazioni si affiancano a quelle sull'incertezza di misura 6, 7 e per il controllo di qualità. 8,9 Le attività dei laboratori tossicologico-forensi e medicolegali sono regolate per l'accreditamento dai requisiti della norma ISO 17025, 10 talvolta inserite in laboratori medici sottoposti ad accreditamento ISO 15189. ...
The GTFI document (DOI: 10.23736/S1825-859X.23.00204-9) has the merit of inducing laboratories to reflect on methods and activities related to forensic toxicology examinations, avoiding the uncritical passive application of procedures, and of promoting harmonisation between laboratories. However, one cannot fail to notice a certain mismatch between this version of the guidelines, the current ISO standards and the requirements for accreditation, putting laboratories and inspectors at risk of litigation or even the very outcome of inspections. GTFI and SIPMeL can continue to work together to improve their respective recommendations. --- Il documento GTFI (DOI: 10.23736/S1825-859X.23.00204-9) ha il merito di indurre i laboratori a riflettere sui metodi e le attività connesse agli esami tossicologico forensi, evitando l’applicazione passiva acritica delle procedure, e di promuovere armonizzazione tra i laboratori stessi. Tuttavia, non si può non notare un certo disallineamento tra questa versione delle linee guida, le vigenti norme ISO e i requisiti per l’accreditamento, mettendo a rischio laboratori e ispettori di contenziosi se non addirittura dello stesso esito positivo delle verifiche ispettive. GTFI e SIPMeL possono continuare a lavorare insieme per migliorare le rispettive raccomandazioni.
I laboratori medicisono forse la maggiore industria di misurazioni al mondo, con numeri e fatturati da capogiro e un impatto profondo sulla salute e la nostra vita quotidiana. Presentiamo ora un’analisi un po’ più sistematica della terminologia della metrologia nelle norme tecniche e nelle linee guida per i laboratori medici. Questa nota sarà seguita da un secondo contributo in cui verranno descritti altri casi in cui la terminologia metrologica ha svolto un ruolo significativo nella redazione di documenti ISO e CLSI.
Medical laboratories are perhaps the largest measurement industry in the world, with staggering numbers and revenues and a profound impact on health and our daily lives. We now present a somewhat more systematic analysis of metrology terminology in technical standards and guidelines for medical laboratories. This note will be followed by a second contribution describing other cases where metrology terminology has played a significant role in the drafting of ISO and CLSI documents. In Tutto Misure: Vol. Anno XXVI n. 3 - Settembre 2024
https://tuttomisure.org/
SIPMeL actively participates in the standardisation work carried out in the Technical Committee UNI 044 'Biomedical and Diagnostic Technologies' and through this in at least two international technical committees, one in Europe (CEN/TC 140) and one worldwide (ISO/TC 212). The work of the European committee is intensive and of great relevance to medical laboratories. The standards developed by CEN/TC 140 have supported the uniform application of the requirements of the European Directive 98/79/EC on 'In vitro diagnostic medical devices' and are about to do the same for the IVD Regulation 2017/746 on 'In vitro diagnostic medical devices'. In this note, the points of the CEN standards on NGS methods that are of particular relevance for ISO accreditation visits and the preparation of related evidence of conformity to requirements are highlighted. The study of the standards allows the distillation of some general considerations and the identification of some critical points that deserve attention and resolution. NGS methods demolish the traditional classification of laboratory tests based simplistically on results: numerical (quantitative), nominal (qualitative), ordinal. The complexity of the multi-stage process is reflected in the complexity of the presentation of results. The glossary of standards on NGS methods contains many terms that would also be useful in other standards documents, including those at ISO level. However, in the CEN standards, confusions between clinical, metrological, numerical and nominal results are noted, even with internal contradictions. In addition to the revision of these specific documents, specific standardisation tools aimed at resolving conflicts between industry glossaries and basic and general standards, such as the International Metrology Vocabulary and standards on statistical concepts applied to laboratory methods, could be useful. --- SIPMeL partecipa attivamente al lavoro normativo svolto nella Commissione tecnica UNI 044 “Tecnologie biomediche e diagnostiche” e attraverso questa ad almeno due comitati tecnici internazionali, uno in ambito europeo (CEN/TC 140) ed uno mondiale (ISO/TC 212). Il lavoro del comitato europeo è intenso e di grande rilevanza per i laboratori medici. Le norme sviluppate dal CEN/TC 140 hanno sostenuto l’applicazione uniforme dei requisiti della Direttiva europea 98/79/CE sui "Dispositivi medico-diagnostici in vitro" e si apprestano a fare altrettanto per il Regolamento IVD 2017/746 sui "Dispositivi medico-diagnostici in vitro". In questa nota sono stati evidenziati i punti delle norme CEN sui metodi NGS particolarmente significativi per le visite di accreditamento ISO e la predisposizione delle relative evidenze di conformità ai requisiti. Lo studio degli standard consente la distillazione di alcune considerazioni di carattere generale e l’individuazione di alcune criticità, meritevoli di attenzione e risoluzione. I metodi NGS demoliscono la tradizionale classificazione degli esami di laboratorio basata semplicisticamente sui risultati: numerici (quantitativi), nominali (qualitativi), ordinali. La complessità del processo, articolato in diverse fasi, si riflette nella complessità della presentazione dei risultati. Il glossario degli standard sui metodi NGS contiene molti termini che sarebbero utili anche in altri documenti normativi, compreso quelli di livello ISO. Tuttavia, negli standard CEN si notano confusioni tra ambito clinico, metrologico, risultati numerici e risultati nominali, anche con contraddizioni interne. Oltre alla revisione di questi specifici documenti, potrebbero essere utili strumenti normativi specifici finalizzati a risolvere i contrasti tra i glossari di settore e le norme di base e generali, come il Vocabolario Internazionale di Metrologia e gli standard sui concetti di statistica applicata ai metodi di laboratorio.
Method evaluation is one of the critical components of the quality system that ensures the ongoing quality of a clinical laboratory. As part of implementing new methods or reviewing best practices, the peer-reviewed published literature is often searched for guidance. From the outset, Clinical Chemistry and Laboratory Medicine ( CCLM ) has a rich history of publishing methods relevant to clinical laboratory medicine. An insight into submissions, from editors’ and reviewers’ experiences, shows that authors still struggle with method evaluation, particularly the appropriate requirements for validation in clinical laboratory medicine. Here, we consider through a series of discussion points an overview of the status, challenges, and needs of method evaluation from the perspective of clinical laboratory medicine. We identify six key high-level aspects of clinical laboratory method evaluation that potentially lead to inconsistency. 1. Standardisation of terminology, 2. Selection of analytical performance specifications, 3. Experimental design of method evaluation, 4. Sample requirements of method evaluation, 5. Statistical assessment and interpretation of method evaluation data, and 6. Reporting of method evaluation data. Each of these areas requires considerable work to harmonise the practice of method evaluation in laboratory medicine, including more empirical studies to be incorporated into guidance documents that are relevant to clinical laboratories and are freely and widely available. To further close the loop, educational activities and fostering professional collaborations are essential to promote and improve the practice of method evaluation procedures.
We performed a Google image search using the search phrase “accuracy and precision” and, after removing unresponsive and duplicate web pages from the search results, found that 78 of the top 100 results use the bullseye chart to visually explain this concept. Unfortunately, we also found that 52 of those 78 results, i.e., an incredible two thirds, use a visual similar to what is shown in Fig. 1(i) or Fig. 1(ii), both of which are at best highly misleading and factually incorrect according to relevant standards and guidelines. In this figure, the black dots represent the values obtained by replicated measurements of the same measurand (the quantity intended to be measured), and the visual aims to present how close the measured values are to each other and to an agreed-upon reference value, represented by the red bullseye. In the search results, visuals similar to Fig. 1(i) and Fig. 1(ii) appeared 25 and 27 times, respectively. In the top 20 search results, which is where the great majority of users look for answers, the earliest correct visual appeared only at position 11, followed by 13, 15, and 19 in the rankings. The great majority of the 52 incorrect visuals were in non-peer-reviewed documents, reinforcing the notion that one should not believe everything one sees on the internet, although shockingly, a few were in papers published in peer-reviewed scientific venues, including one in Elsevier's Journal of Clinical Epidemiology and another one in the SCMR's Journal of Cardiovascular Magnetic Resonance, both well-cited journals. The actual numbers are probably higher, as many scientific articles are behind pay-walls and inaccessible to Google search.
Measurement uncertainty is a key component of metrology but, as it is defined, it does not apply to nominal properties. The possibility to define, evaluate, and express the uncertainty in the examination of nominal properties is then a critical prerequisite for a harmonized treatment of nominal properties in metrology. The assumption at the basis of this paper is that examination uncertainty can be understood in analogy with and as a generalization of measurement uncertainty. To this aim a foundational framework is introduced, grounded on a generic concept of evaluation uncertainty that applies equally to quantitative and non-quantitative evaluations. Based on this, a concept of examination uncertainty is presented and some examples of mathematical functions of examination uncertainty are proposed.
Scientists of disciplines in clinical laboratory sciences have long worked on a common language for efficient and safe request of investigations, report of results, and communication of experience and scientific achievements. Widening the scope, most scientific disciplines, not only clinical laboratory sciences, rely to some extent on various examinations in addition to measurements. The ‘International vocabulary of metrology – Basic and general concepts and associated terms’ (VIM), is designed for metrology, the science of measurement. The aim of this vocabulary is to suggest definitions and explanations of concepts and a selection of terms related to nominal properties
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.
La traduzione ufficiale in italiano dei documenti ISO compete a UNI nell’ambito dell’attività di normazione. Il documento SIPMeL L5Q15 non traduce integralmente alcune norme, ma propone soluzioni solo per le parole definite nei capitoli “Termini e definizioni” dei principali documenti ISO dedicati al rapporto tra laboratorio e fabbricante di dispositivi diagnostici in vitro. Le raccomandazioni di L5Q15 restano aperte ai contributi anche critici. Le parole delle norme ISO sono in grado di influenzare numerosi documenti, tra cui procedure, regolamenti, liste di riscontro (check-list). Vanno quindi introdotte con estrema attenzione. La versione italiana per giunta deve affrontare criticamente sfumature, “falsi amici”, omonimie, conflitti, ambiguità, inutili anglicismi. Non basta una semplice passiva traduzione, ma serve la scelta dei termini più efficaci, meno esposti al rischio di ambiguità, fraintendimenti o addirittura abusi. - The official translation of ISO documents into Italian is the responsibility of UNI as part of the standardization activity. The SIPMeL L5Q15 document does not fully translate some standards, but proposes solutions only for the words defined in the “Terms and definitions” chapters of the main ISO documents dedicated to the relationship between laboratory and manufacturer of in vitro diagnostic devices. The recommendations of L5Q15 remain open to contributions, including critical ones. The words of the ISO standards are able to influence numerous documents, including procedures, regulations, checklists. They must therefore be introduced with extreme care. Furthermore, the Italian version must critically address nuances, "false friends", homonyms, conflicts, ambiguities, useless anglicisms. A simple passive translation is not enough, but it is necessary to choose the most effective terms, less exposed to the risk of ambiguity, misunderstanding or even abuse.
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