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January 2024


The International Council for Standardisation in Haematology (ICSH) is pleased to announce the publication of a new ICSH review of internal quality control policy for blood cell counters.


Contributors


Richard McCafferty  |  George Cembrowski  |  Barbara de la Salle  | Mingting Peng  |  Eloisa Urrechaga


Introduction


This paper is a report of an ICSH review of policies and practices for internal quality control (IQC) policy for haematology cell counters among regulatory bodies, cell counter manufacturers and diagnostic laboratories. It includes a discussion of the study findings and links to separate ICSH guidance for such policies and practices. The application of internal quality control (IQC) methods is an essential pre-requisite for all clinical laboratory testing including the blood count (Full Blood Count, FBC, or Complete Blood Count, CBC).


....continue reading at Wiley Online Library -



First published: 12 January 2024


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January 2024


The International Council for Standardisation in Haematology is pleased to announce the publication of a new ICSH guidance for internal quality control policy for blood cell counters.


Contributors

Richard McCafferty  |  George Cembrowski  |  Barbara de la Salle  | Mingting Peng  |  Eloisa Urrechaga


Abstract: This paper is a description of the ICSH guidance for internal quality control (IQC)policy for blood cell counters. It follows from and links to a separate ICSH review for such policies and practices.


The ICSH has gathered information regarding the current state of practice through review of published guidance from regulatory bodies, a questionnaire to six major cell counter manufacturers and a survey issued to 191 diagnostic laboratories in four countries (China, the Republic of Ireland,Spain, and the United Kingdom) on their IQC practice and approach to the use of commercial IQC materials. This has revealed diversity both in guidance and in practice around the world. There is diversity in guidance from regulatory organizations in regard to IQC methods each recommends, clinical levels to use and frequency to run commercial controls, and finally recommended sources of commercial control materials.


The diversity in practice among clinical laboratories spans the areas of IQC methods used, derivation of target values, and action limits used with commercial control materials, and frequency of running commercial controls materials. These findings and their implications for IQC Practice are addressed in this guidance document, which proposes a harmonized approach to address the issues faced by diagnostic laboratories


....continue reading at Wiley Online Library - https://onlinelibrary.wiley.com/doi/epdf/10.1111/ijlh.14212


First published: January 2024


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ISSN - 1751-5521

eISSN - 1751-553X




December 2023


The International Council for Standardisation in Haematology is pleased to announce the publication of a new report of the ICSH working group for Standardization of Reticulocyte Parameters

The ICSH Working Group Contributors


Amrom E. Obstfeld | Bruce H. Davis | Jin-Yeong Han | Eloisa Urrechaga


Abstract


Introduction: The International Council for Standardization in Haematology

convened a working group to assess and propose improvements upon the state of

standardization and harmonization of reticulocyte parameters among commercial

hematology analyzers.


Methods: An international group of laboratory hematologists prospectively collected

and analyzed clinical samples using locally available IVD commercial hematology analyzers. Eight hundred and fifty-five total samples were collected at 6 sites using 9 distinct analyzer types. Samples were assessed for reticulocyte percent (RET%),

immature reticulocyte fraction (IRF), and reticulocyte hemoglobin content (RHC).

Method comparison and regression statistics were calculated. These analyses were

used to determine whether statistical recalibration offered a potential avenue for

increasing comparability between these methods.


Results: While methods producing reticulocyte percent were the most comparable in

this study, the state of harmonization for the IRF and RHC was reduced with pearson

correlation coefficients ranging from 0.955 to 0.77 and 0.927 and 0.680, respectively. Nevertheless, use of parameters from the Passing Bablok regression substantially improved the comparability of the results. In addition, precision data was

derived which also demonstrated substantial differences between analyzer systems.


Conclusion: While reticulocyte counting is correlated between the automated

methods evaluated in this study, the current state of harmonization of other reticulocyte parameters is not as strong. A major challenge in moving this field forward is the

need for commutable materials to facilitate comparisons between analyzers not

co-located. A potential alternate approach to improve the current state would be

instrument re-calibration. However, this is challenging both technically and due to

national regulatory frameworks.


....continue reading at Wiley Online Library - https://onlinelibrary.wiley.com/doi/abs/10.1111/ijlh.14209


First published: 06 December 2023


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