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La Rivista Italiana della Medicina di Laboratorio 2021 Dec 22

DOI: 10.23736/S1825-859X.21.00127-4

Copyright © 2021 EDIZIONI MINERVA MEDICA

language: Italian

Clinical inconsistency of test results: a procedure to review the analitycal quality

Mauro STELLA, Rodolfo PESSINA, Maria C. MAGNANINI, Edoardo BIXIO, Raffaella COZZANI, Fabio FACCO

Laboratorio Centrale Analisi, IRCCS G. Gaslini, Genova, Italia


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BACKGROUND: The apparent mismatch of analytical results with the patient's clinical status can create distrust on the laboratory by the attending physician; in turn, this inconsistency can be an opportunity to review the analytical path, from instrumental settings to quality assessment for the laboratory staff.
METHODS: The study was focused on instrumental settings for automatic controls of abnormal performance, repeatability of tests with dubious results, analyses of internal quality controls (ICQ) by using Westgard multirules to identify casual and systematic violations and reports of external quality assessment scheme (EQAS).
RESULTS: The analytical phase was found to be reliable, with precise and accurate result. The re-testing of fresh and correctly stored samples gave identical results.
CONCLUSIONS: Besides addressing an useful retraining for laboratory operators, this paper documents the reliability of the analytical phase and it can be used as a procedural model. The authors highlight the need for information exchange to the construction of a precision diagnostic path, which allows the laboratory doctor to have all the elements available, also relating to the pre-analytical variables, for the validation of a result.


KEY WORDS: Analytical phase; Analytical reliability; Quality assessment; EQAS; IQC

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