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