Quality standards and internal quality control practices in medical laboratories: an IFCC global survey of member societies.
IFCC
International Federation of Clinical Chemistry and Laboratory Medicine
global survey
internal quality control
medical laboratories
quality assurance
quality management
Journal
Clinical chemistry and laboratory medicine
ISSN: 1437-4331
Titre abrégé: Clin Chem Lab Med
Pays: Germany
ID NLM: 9806306
Informations de publication
Date de publication:
27 11 2023
27 11 2023
Historique:
received:
11
05
2023
accepted:
04
06
2023
medline:
26
10
2023
pubmed:
16
6
2023
entrez:
16
6
2023
Statut:
epublish
Résumé
The trueness and precision of clinical laboratory results are ensured through total quality management systems (TQM), which primarily include internal quality control (IQC) practices. However, quality practices vary globally. To understand the current global state of IQC practice and IQC management in relation to TQM the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a survey of IFCC member countries on IQC practices and management. The survey included 16 questions regarding IQC and laboratory TQM practices and was distributed to IFCC full and affiliate member countries (n=110). A total of 46 (41.8 %) responses were received from all regions except North America. Of the responding countries, 78.3 % (n=36) had legislative regulations or accreditation requirements governing medical laboratory quality standards. However, implementation was not mandatory in 46.7 % (n=21) of responding countries. IQC practices varied considerably with 57.1 % (n=28) of respondents indicating that they run 2 levels of IQC, 66.7 % (n=24) indicating they run IQC every 24 h and 66.7 % (n=28) using assay manufacturer IQC material sources. Only 29.3 % (n=12) of respondents indicated that every medical laboratory in their country has written IQC policies and procedures. By contrast, 97.6 % (n=40) of responding countries indicated they take corrective action and result remediation in the event of IQC failure. The variability in TQM and IQC practices highlights the need for more formal programs and education to standardize and improve TQM in medical laboratories.
Identifiants
pubmed: 37327359
pii: cclm-2023-0492
doi: 10.1515/cclm-2023-0492
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2094-2101Informations de copyright
© 2023 Walter de Gruyter GmbH, Berlin/Boston.
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