Quality planning and control strategy for AQT90 flex Radiometer® in point of care testing

Quality planning and control strategy for AQT90 flex Radiometer® in point of care testing

In the context of point of care testing (PoCT) and ISO 22870, internal quality control (IQC) is a crucial part of PoCT accreditation processes. Quality Control materials shall be periodically examined with a frequency that is based on the robustness of the analytical procedure and the risk of harm t...

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Bibliographic Details
Published in:Scandinavian journal of clinical and laboratory investigation Vol. 80; no. 5; pp. 427 - 432
Main Authors: Ilardo, Claudio, Reynaud, Cecile, Bonneton, Regine, Barthes, Joel
Format: Journal Article
Language:English
Published: Taylor & Francis 01-09-2020
Subjects:
Analytical run
Point of care testing
Quality control
Six Sigma
SQC Strategy
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Summary:In the context of point of care testing (PoCT) and ISO 22870, internal quality control (IQC) is a crucial part of PoCT accreditation processes. Quality Control materials shall be periodically examined with a frequency that is based on the robustness of the analytical procedure and the risk of harm to the patient from an erroneous result. We propose to apply the statistical quality control (SQC) procedure to develop an individualized QC plan for AQT90 flex instrument used in PoCT. The robustness is determined by the sigma-metric and analytical goal represented by an allowable total error (TEa) is evaluated using a Varela graphic tool. A Sigma-metric SQC run size nomogram for estimating the number of patient samples between IQC events. According to the calculated robustness we can distinguish 3 groups of parameters: HCG and CRP with large sample size per event, D-Dimer and Procalcitonin with an average sample size per event and Myoglobin. NT-proBNP. and Troponin T with a limited sample size per event. In PoCT, the SQC strategy can promote more effective, and not necessarily more frequent, IQC.
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ISSN:0036-5513
1502-7686
DOI:10.1080/00365513.2020.1768585