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Title: Διεθνή πρότυπα ποιότητας (ISO) για τον έλεγχο της ακρίβειας και της αναπαραγωγιμότητας των εργαστηριακών εξετάσεων
Authors: Καρκαλούσος, Πέτρος
Item type: Journal article
Keywords: Medical laboratories--Quality control;International Standard Organization;External quality control;Statistical quality control;Ποιοτικός έλεγχος ιατρικών εργαστηρίων;Διεθνής Οργανισμός Προτυποποίησης;Εξωτερικός ποιοτικός έλεγχος;Στατιστικός ποιοτικός έλεγχος
Subjects: Medicine
Quality control
Ποιοτικός έλεγχος
Issue Date: 6-May-2015
Date of availability: 6-May-2015
Language: Greek
Citation: Καρκαλούσος, Π. (2001) Διεθνή πρότυπα ποιότητας (ISO) για τον έλεγχο της ακρίβειας και της αναπαραγωγιµότητας των εργαστηριακών εξετάσεων. "Δελτίο Ελληνικής Μικροβιολογικής Εταιρείας", 46 (1), σ. 71-86. Διαθέσιμο στο: [Έγινε Πρόσβαση: 06/05/2015].
Journal: Δελτίο Ελληνικής Μικροβιολογικής Εταιρείας
Type of Journal: With a review process (peer review)
Table of contents: The reliability of laboratory results is checked with internal and external quality control. The users of the analyzers carry out internal quality control in each laboratory, which checks the repetition of the laboratory results within run or between run. On the opposite, a national or international institute monitors the external quality control, which checks the accuracy and the reproducibility of a large number of biochemical laboratories. Accuracy and reproducibility can be estimated by two ways. The first way is the chemical analysis of the control material by reference methods. The other way is special statistical tests. Today statistical analysis is quite popular but unfortunately some times is also unreliable. The reliability of external quality control depends on the repetition of each laboratory. Laboratories must already have good results from their internal quality program. Laboratories with no good internal control must not participate in external quality programs. The International Standards Organization (ISO) proposes statistical methods for the verification of the accuracy and reproducibility. Unlike the most popular external quality control programs in Greece, ISO standards (ISO 5725-1, 5725-2, 5725-3, 5725-4, 5725-5) demand many repetitive results for each test. So the reference laboratory estimates the inter-laboratory variability before the final calculation of the target value and the reproducibility of all laboratories in the program. Before any further calculation, the reference laboratory must eliminate the laboratories with unacceptable variance or mean values. ISO 5725-2 proposes three different statistical tests for this target. The two Mandel tests check the laboratories for bad repetition (test k) and extreme mean values (test h). Cochan test checks the laboratories for bad repetition (like test k) and Grubb test checks for extreme mean values (like test h). Special statistical tables facilitate the estimation of statistical importance of all tests. Any laboratory, which has extreme mean value or standard deviation (repetition), cannot be used for the final calculations of target value and reproducibility.
Access scheme: Publicly accessible
License: Αναφορά Δημιουργού-Μη Εμπορική Χρήση-Όχι Παράγωγα Έργα 3.0 Ηνωμένες Πολιτείες
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