LABMEDICO

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 Apr 08 
    Positivo e negativo: guide alla qualità degli esami qualitativi
    Positive and negative: guides to quality examinations
    DOI: 10.23736/S1825-859X.22.00139-6

    lunedì 15 novembre 2021

    decision limits and decision values

     “The generic term „reference data“ includes reference intervals, decision limits and action limits.” (DGKL https://www.dgkl.de/en/activities/sections/entscheidungsgrenzen-richtwerte/).

    The expression 'decision values' occurs frequently in ISO documents: ISO 11929-1:2019 3.12 ISO 17381:2003 3.3

    ISO/DIS 18113-4 7.16

    ISO/DIS 18113-2 7.17

    ISO/TS 20658:2017 10.1

    ISO/TS 22583:2019 A.2.

    Also "decision limits" recurs frequently in ISO documents: ISO/TS 20914:2019 introduction + 6.2 + 6.6 + 6.9

    ISO 21151:2020 introduction

    ISO 17511:2020 introduction

    ISO 12417-1:2015 annex A

    martedì 14 settembre 2021

    "Sample" is for measurement, "specimen" is for collection. "Primary sample" is misleading.


    ISO/TC 212 WG1 started the activity “13.3 Harmonization of terminology across ISO TC212”

    CLSI changed all titles related to collection from “primary samples” to “specimen”.

    ISO/DIS 15189 has 6.3.5 “Specimen collection facilities”

    ISO 6717:2021 has: “3.17 specimen… [SOURCE: ISO 15189:2012, 3.16, modified – the preferred term 'primary sample' has been deleted.]”

    ISO 20916:2019 3.47 specimen … [SOURCE:ISO 18113-1:2009, 3.54, modified — “Specimen” is the first preferred terms,

    The International Medical Device Regulators Forum (IMDRF) uses the term specimen. 1 WHO uses the term “specimen”. 2 CLSI in many documents uses the term “specimen”. 3 ILAC uses the term “specimen” in G18 and G26. 4

    CDC uses the term “specimen”.5 ISO itself in several documents uses the term specimen even in the title.6

    Therefore, "specimen” is the standard term in collection activities. “primary sample” is little more than a form of "slang"and can cause confusion with other terms.

    sample” retains its value for statistical and measurement activities.

    1Principles of In Vitro Diagnostic (IVD) Medical Devices Classification. Authoring Group: IMDRF IVD Working Group. Date: 21 January 2021 Common Data Elements for Medical Device Identification. Authoring Group: IMDRF RPS Working Group. Date: 24 March 2016 GHTF SG5 Clinical Performance Studies for IVD Medical Devices

    GHTF SG1 - Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices - 17 March 2011

    GHTF SG1 - Principles of Safety and Performance of Medical Devices - May 2005

    Glossary and Definitions of Terms Used in GHTF Documents

    GHTF SG1 Definition of the Terms Medical Device' and In Vitro Diagnostics' Medical Device's

    2World Health Organization. Regional Office for the Eastern Mediterranean. (‎1995)‎. Specimen collection and transport for microbiological investigation. https://apps.who.int/iris/handle/10665/119529 WHO Procedures for collection of clinical specimens (blood sample) during field investigation of suspected outbreaks. https://www.who.int/csr/resources/publications/ebola/blood-collect-en.pdf WHO/CDS/CSR/EDC/2000.4 Guidelines for the collection of clinical specimens during field investigation of outbreaks. https://apps.who.int/iris/bitstream/handle/10665/66348/WHO_CDS_CSR_EDC_2000.4.pdf?sequence=1

    3EP35 Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures M54-A Principles and Procedures for Detection of Fungi in Clinical Specimens—Direct Examination and Culture; Approved Guideline AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard

    AUTO02-A2 Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard—Second Edition

    AUTO07-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard

    AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard

    GP23-Ed2 Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes, Second Edition

    GP34-A Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline

    GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard—Sixth Edition

    GP41-Ed7 Collection of Diagnostic Venous Blood Specimens, Seventh Edition

    GP42-A6 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—Sixth Edition

    GP44-A4 Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline—Fourth Edition

    H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition

    M54-A Principles and Procedures for Detection of Fungi in Clinical Specimens—Direct Examination and Culture; Approved Guideline

    MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline

    4ILAC G26:11/2018 Guidance for the Implementation of a Medical Accreditation Scheme ILAC G18:04/2010 Guideline for the Formulation of Scopes of Accreditation for Laboratories

    5CDC. Specimen Collection Guidelines. https://www.cdc.gov/urdo/downloads/speccollectionguidelines.pdf CDC. Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing. Updated Feb. 26, 2021. https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html Submitting Specimens to CDC. https://www.cdc.gov/laboratory/specimen-submission/list.html

    6ISO (revised)

    ISO 20916, In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

    ISO/DIS 4307 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA (14 recurrences)

    ISO 6710:2017 Single-use containers for human venous blood specimen collection

    ISO/FDIS 6717 In Vitro Diagnostic Medical Devices — Single-Use Containers For The Collection Of Specimens From Humans Other Than Blood

    ISO 14971:2019 Medical devices — Application of risk management to medical devices. 3.7 3.10

    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards. 3.9 3.12

    ISO 17511:2020 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples. Scope, 3.21

    ISO 17822:2020 In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide. 3.30, 3.22,

    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements. 3.2

    ISO 23640:2011 In Vitro Diagnostic Medical Devices — Evaluation Of Stability Of In Vitro Diagnostic Reagents. Scope, 3.6

    ISO 21474-1:2020 In Vitro Diagnostic Medical Devices — Multiplex Molecular Testing For Nucleic Acids — Part 1: Terminology And General Requirements For Nucleic Acid Quality Evaluation. Introduction, 3.39

    ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards. 3.10, 3.13,

    ISO 20184-1:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA. Introduction, 3.12

    ISO 20184-2:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins. Introduction, 1 Scope, 3.8

    ISO 20186-2:2019 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA. Introduction, 3.18 Note1 and Note 2.

    ISO 20186-3:2019 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma. Introduction, 3.21.

    ISO 20166-1:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA. Introduction, 1 Scope, 3.13, 3.14.

    ISO 20166-2:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins. Introduction, 1 Scope, 3.10,

    ISO 20166-3:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA. Introduction, 3.12.

    ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

    ISO 22367:2020 Medical laboratories — Application of risk management to medical laboratories. 3.10,

    ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents. 1 Scope, 3.6,  

    CEN

    FprCEN/TS 17742:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma. 1 Scope

    FprCEN/TS 17747:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins. "specimen" 50 recurrences

    HL7

    HL7 FHIR (Fast Healthcare Interoperability Resources). 10.7 Resource Specimen - Content. http://www.hl7.org/fhir/specimen.html