Hikmet Can Çubukçu, Marc Thelen, Mario Plebani, Mauro Panteghini
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IFCC recommendations for internal quality control practice: a missed opportunity.
The IFCC Task Force on Global Lab Quality (TF-GLQ) has recently released a new guidance for internal quality control (IQC) practice through an approach translating the general principles as stated in the ISO 15189:2022 standard to a series of practical recommendations. The paper contains however important inaccuracies and shortcomings that, in our opinion, make it a missed opportunity for providing a updated guidance for laboratory professionals. In particular, four important issues are discussed: a) how to design IQC strategies in the traceability era, b) how to define IQC acceptance limits, c) how to estimate measurement uncertainty using IQC data, and d) how to manage comparability between the results provided by different analyzers in the same laboratory. Our analysis underscores the necessity for a more systematic, updated, and evidence-based approach to produce an IQC recommendation in line with the IFCC tradition.
期刊介绍:
Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically.
CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France).
Topics:
- clinical biochemistry
- clinical genomics and molecular biology
- clinical haematology and coagulation
- clinical immunology and autoimmunity
- clinical microbiology
- drug monitoring and analysis
- evaluation of diagnostic biomarkers
- disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes)
- new reagents, instrumentation and technologies
- new methodologies
- reference materials and methods
- reference values and decision limits
- quality and safety in laboratory medicine
- translational laboratory medicine
- clinical metrology
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