LABMEDICO

martedì 16 agosto 2022

Quality of medical laboratories, development of new ISO standards

 

Marco Pradella - Italian Society of Clinical Pathology and Laboratory Medicine (SIPMeL), National Commission on Quality and Accreditation


Keywords: accreditation; medical laboratories; ISO 15189


Quality and competence requirements for medical laboratories are defined by ISO document 15189.

Alongside this, ISO has a substantial package of standards for medical laboratories.

These months ISO 15189 is undergoing revision, expected conclusion at the end of 2022. The revision takes ISO/IEC 17025:2017 as a model and inherits from ISO 9001:2015 innovations such as risk-based thinking, from ISO 17025 impartiality, confidentiality, complaint handling, management systems. Thus, there is a deep connection between the requirements of medical, forensic, anti-doping and food laboratories. In addition, the new text should be less prescriptive, risk-based, and more patient care-oriented.

ISO/CASCO (Committee on Conformity Assessment) recommends the inclusion of ISO 22870 (POCT) and references to ISO 15190 (health and safety), ISO 22367 (risk management), ISO/TS 20658 (withdrawals). In addition, the new 15189 should be less prescriptive, risk-based, and patient care-oriented, linked to ISO documents such as 17511 (calibrations), 20914 (uncertainty), and the molecular methods package developed by ISO/TC/212 WG4.

Other important ISO documents affecting medical laboratories are ISO 15198 (quality control), ISO 21151 (calibrations), ISO 15193 (reference methods), ISO 15195 (reference laboratories), ISO 35001 (biohazard), ISO 17822 (genomics in microbiology), ISO 20776 (antibiograms), ISO 17518 and ISO 19001 (dyes), ISO 17593 (anticoagulant monitoring), ISO 22583 (POCT supervisors), ISO 11073-90101 (POCT informatics), ISO 23640 (reagent stability), the ISO 18113X series (instrument and reagent documentation), ISO 20416 device aftermarket surveillance).

SIPMeL has long been committed to raising awareness and understanding of ISO requirements in medical laboratories. Dedicated articles are collected on the Internet page https://bit.ly/ISO15189RIMeL.

Other references in: http://dx.doi.org/10.13140/RG.2.2.19680.97286

lunedì 8 agosto 2022

B-295 "Specimen" is the Standard term for Collection, "Sample" is the Standard term for Statistics and Measurement Methods

  • Conference: 2022 AACC ANNUAL SCIENTIFIC MEETING + CLINICAL LAB EXPO - JULY 24-28 CHICAGO, IL
  • At: JULY 24-28 CHICAGO, IL
    https://www.researchgate.net/publication/362176668_Specimen_is_the_Standard_term_for_Collection_Sample_is_the_Standard_term_for_Statistics_and_Measurement_Methods
    https://www.abstractsonline.com/pp8/#!/10594/presentation/487 
    https://cattendee.abstractsonline.com/meeting/10594/Presentation/487
  • Affiliation: American Association for Clinical Chemistry
  • B-116. Does the Eurachem/CITAC Uncertainty of Qualitative Results Guide Comply with ISO Standards?

  • Conference: 2022 AACC Annual Scientific Meeting -- JULY 24-28 CHICAGO, IL -- Session B - Analytical Techniques and Applications
  • lunedì 9 maggio 2022

    Recommendations for laboratory results in post-examination processes: critical points - SIPMeL 2021 Poster 86

     Recommendations for laboratory results in post-examination processes: critical points

    • December 2021

    mercoledì 5 gennaio 2022

    articoli accreditamento laboratori medici su RIMeL

    https://www.researchgate.net/project/Accreditamento-laboratori-medici 


    La Rivista Italiana della Medicina di Laboratorio 2022 Marzo;18(1):60-7
    Positivo e negativo: guide alla qualità degli esami qualitativi
    Positive and negative: guides to quality examinations
    DOI: 10.23736/S1825-859X.22.00139-6