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

venerdì 16 aprile 2021

articolo Parole in lingua italiana per norme ISO

LETTERA .	.
La Rivista Italiana della Medicina di Laboratorio 2021 Marzo;17(1):42-6
Parole in lingua italiana per norme ISO: le raccomandazioni SIPMeL
https://www.minervamedica.it/it/riviste/medicina-laboratorio/articolo.php?cod=R54Y2021N01A0042 La traduzione ufficiale in italiano dei documenti ISO compete a UNI nell'ambito dell'attività di normazione. Il documento 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

sabato 20 marzo 2021

progetto Accreditamento laboratori medici

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

Project

Accreditamento laboratori medici

Marco Pradella

Goal: Facilitare il percorso di laboratori medici, POCT e punti prelievo per l'accreditamento ISO 15189 e ISO 22870.

Alliance of IVD manufacturer and medical laboratory for quality control of results

February 2021
Advances in Laboratory Medicine / Avances en Medicina de Laboratorio 2020(Ahead of Print)

DOI:
10.1515/almed-2020-0079

License
CC BY 4.0

Project:
Accreditamento laboratori medici

La alianza entre el fabricante de IVD y el laboratorio clínico en el control de calidad de los resultados - Alliance of IVD manufacturer and medical laboratory for quality control of results -- Advances in Laboratory Medicine / Avances en Medicina de Laboratorio | Ahead of Print

December 2020
Advances in Laboratory Medicine / Avances en Medicina de Laboratorio

DOI:
10.1515/almed-2020-0107

License
CC BY 4.0