Metrologia, parole, procedure, incertezza

 

Laboratory Medicine, quality, accreditation and informatics

Collection of papers, presentations, posters on the topics of Laboratory Medicine, quality, accreditation and

https://zenodo.org/communities/labmed

September 1, 2023 (v1)

Journal article

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Parole della metrologia per i laboratori medici - Metrology words for medical laboratories

Pradella, Marco

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Uploaded on October 16, 2023 | Published in: Tutto Misure, 23(3), 35-38, ISSN: 2038-6974, 2023.

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December 1, 2020 (v1)

Journal article

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Taratura nei laboratori medici secondo le nuove norme ISO 17511 e ISO 21151 - Armonizzazione e standardizzazione per le misure dei dispositivi diagnostici in vitro

Pradella, Marco

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Uploaded on October 16, 2023 | Published in: Tutto Misure, 20(4), 33-35, ISSN: 2038-6974, 2020.

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August 29, 2023 (v1)

Presentation

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Developments in International Standards for the Management of Laboratory Test Results --- Sviluppi negli Standard Internazionali per la gestione dei risultati di esami di laboratorio

Marco Pradella

The issue of digital medical laboratory data can be approached from two perspectives: that of the laboratory and that of the clinician. The latter is undoubtedly more important for quality and patient safety. The clinical point of view emerges strongly from international standards. The European ones are represented by the international patient s...

Uploaded on August 29, 2023

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October 11, 2023 (extended)

Presentation

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Data of Medical Devices and In Vitro Diagnosis (IVD) - I dati dei dispositivi medici e della In Vitro Diagnosis (IVD)

Marco Pradella

8° CONGRESSO NAZIONALE SIPMeL, Dati, algoritmi e informazioni dalla Medicina di Laboratorio per il processo decisionale clinico, Riva del Garda, 9-11 Ottobre 2023 mercoledi’ 11/10/2023 09:45 – 10:30 Sessione parallela 13 a cura del Gruppo di Studio Management Sanitario-HTA, Risk e Comunicazione (GdS-MS), in collaborazione con il Gruppo di Stud...

Uploaded on September 27, 2023

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December 6, 2021 (v1)

Journal article

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Incertezza di misura nei laboratori medici - Measurement uncertainty in medical laboratories

Pradella, Marco

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Uploaded on October 16, 2023 | Published in: Tutto Misure, 21(4), 51-53, ISSN: 2038-6974, 2021.

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January 1, 2019 (v1)

Journal article

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Tradurre le norme senza tradirle: come trattare sfumature, falsi amici, omonimie, ambiguità --- Translating norms without betraying them: how to deal with nuances, false friends, homonyms, ambiguities

Pradella, Marco

No description

Uploaded on October 16, 2023 | Published in: Tutto Misure, 19(1), 71-73, ISSN: 2038-6974, 2019.

Critical issues in the glossary of CEN documents for NGS

 https://bit.ly/glossarioNGS

Criticità nel glossario dei documenti CEN per NGS
8° C ONGRESSO NAZIONALE SIPMeL - Riva del Garda, 9-11 Ottobre 2023

Poster n° 165

The European Committee for Standardisation (CEN) prepares two documents for examination workflows with NGS methods: CEN/TS 17981-2 (Examination of human RNA) and CEN/TS 17981-1 (Examination of human DNA). Critical points in the definitions of some glossary entries are studied here. In the CEN standards examined, clinical, metrological, numerical and nominal results are confused, even with internal contradictions. "Measurement sensitivity" should be applied to the numerical results of the steps that make up the NGS process, alongside the detection limit (3.29 LOD). Diagnostic sensitivity or comparability with other methods (PPA and NPA, VIM4 6.20) are different. 'Specificity' may be limited to clinical use, whereas the metrological word 'selectivity' is needed for measurement (VIM3 2.45). An ISO project (Guidance for emerging technologies) has just been initiated precisely because research methods, such as NGS, are often not designed for clinical applications. Therefore, emerging technologies entering medical laboratories should be screened from their glossary and filtered through the guidance of VIM, FDA and the statistical literature. --- Poster n° 165

Quality of massively parallel sequencing/nextgeneration sequencing (MPs/NGs) methods

Qualità dei metodi di sequenziamento massivo parallelo/sequenziamento di nuova generazione (MPS/NGS)

• May 2023
• Rivista Italiana della Medicina di Laboratorio online first(May):1-7

• DOI: 
• 10.23736/S1825-859X.23.00190-1

https://www.researchgate.net/publication/371260676_Quality_of_massively_parallel_sequencingnextgeneration_sequencing_MPsNGs_methods_-_Qualita_dei_metodi_di_sequenziamento_massivo_parallelosequenziamento_di_nuova_generazione_MPSNGS

UNI EN ISO 15189:2023: focus su POCT ed incertezza di misura

 UNI EN ISO 15189:2023: focus on POCT and measurement uncertainty

• June 2023

• DOI: 
• 10.13140/RG.2.2.30940.56964

• Conference: ACCREDIA: The accreditation of medical laboratories in accordance with UNI EN ISO 15189:2023, Rome June 16, 2023, via Regina Margherita 262

Precisione e incertezza dei risultati: esempi di applicazione delle Raccomandazioni SIPMeL

Precision and uncertainty of results: examples of application of SIPMeL Recommendations

• DOI: 
• 10.13140/RG.2.2.22315.52006

• Conference: 6° Congresso Nazionale SIPMeL "La Centralità della Medicina di Laboratorio nei Percorsi Assistenziali" --- 1 - 3 - 13 - 15 dicembre 2021 (ore 14.00 – 19.30) in modalità virtual congress

Nuove norme tecniche nazionali e internazionali per l'informatica del laboratorio medico: un quadro generale

 New national and international technical standards for medical laboratory informatics: an overview

• February 2023

• DOI: 
• 10.23736/S1825-859X.23.00170-6
• La Rivista Italiana della Medicina di Laboratorio 2022 Dicembre;18(4):233-40

DOI: 10.23736/S1825-859X.23.00170-6

https://bit.ly/infoLabMed2023

POCT: l'aggiornamento delle normative

POCT: updating regulations

• February 2023

• DOI: 
• 10.13140/RG.2.2.16620.64641

• Conference: LA GOVERNANCE DEI POCT NELL’EVOLUZIONE DELLA DIAGNOSTICA DECENTRATA - SIPMeL - 24 Febbraio 2023, Genova

Pacchetto ISO laboratori medici • Nuova ISO 15189 • POCT da 22870 a nuova 15189 con SIPMeL • POCT in nuova ISO 15189 ---- ISO package medical laboratories - New ISO 15189 - POCT 22870 to new 15189 with SIPMeL - POCT in new ISO 15189 

https://youtu.be/gLDpuSNz0tw

Novità sulle norme ISO per l'accreditamento del Point of Care

News on ISO standards for the accreditation of the Point of Care

• October 2022

• DOI: 
• 10.13140/RG.2.2.22846.97602

• Conference: 7° CONGRESSO NAZIONALE SIPMeL Medicina di Laboratorio: nuove complessità e future strategie - Corso precongressuale 1 a cura del Gruppo di Studio Point of care testing (GdS-PoCT) Evoluzione della diagnostica decentrata: aumento della domanda, capacità di risposta e regolamentazione dei PoCT --- https://www.congressosipmel2022.it/

• Project: 
• Accreditamento laboratori medici

New Guides for Uncertainty of Qualitative Results

The Journal of Applied Laboratory Medicine 8(1):217-218

https://doi.org/10.1093/jalm/jfac087

• Project: 
• Accreditamento laboratori medici

The Eurachem/Cooperation on International Traceability in Analytical Chemistry (CITAC) guide “Evaluating Performance and Uncertainty in Qualitative Chemical Analysis” has recently been published (1).

a number of criticisms of the guide have recently been reported, including the lack of the repeatability and reproducibility components for the accuracy of the methods (2).

 the International Organization for Standardization (ISO) has published ISO/TR 27877, which is devoted properly to statistical analysis for evaluating the precision of binary measurement methods and their results (3).

The approach for medical laboratories should be simple, low burden, as designed by ISO 20914, but inclusive of qualitative tests (tests with nominal results), and tests with ordinal results alongside numerical results of the internal response signal(s).

New ISO standards for medical biology laboratories, prescriptions and deviations

September 2022

Annales de Biologie Clinique 80(5):451-453

• DOI: 
• 10.1684/abc.2022.1755

• Project: 
• Accreditamento laboratori medici
• https://www.researchgate.net/publication/365943899_New_ISO_standards_for_medical_biology_laboratories_prescriptions_and_deviations

Sviluppi e criticità nei nuovi standard ISO per il Laboratorio Medico

Developments and Critical Issues in the New ISO Standards for the Medical Laboratory

• October 2022

• DOI: 
• 10.13140/RG.2.2.14995.76320

• Conference: 7° Congresso Nazionale SIPMeL 2022 MEDICINA DI LABORATORIO: NUOVE COMPLESSITA’ E FUTURE STRATEGIE 17-18-19 ottobre 2022
• At: Riva del Garda (TN) presso il Centro Congressi - Parco Lido

• Project: 
• Accreditamento laboratori medici