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Órgano oficial de difusión de la Federación Mexicana de Patología Clínica, AC y de la Asociación Latinoamericana de Patología Clínica/Medicina de Laboratorio

2003, Number 3

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Rev Mex Patol Clin Med Lab 2003; 50 (3)

Importance of the biological variability and the medically relevant in the Norm ISO-15189

Terrés-Speziale AM

Language: Spanish
References: 37
Page: 118-128
PDF size: 78.16 Kb.


ABSTRACT

Background: Each day it is becoming more evident that clinical diagnosis is the cornerstone of medical attention, since prognosis and treatment depend heavily on it. Even that clinical laboratories play a central role on clinical diagnosis it should be understood that this is a multidisciplinary process where physicians suspect, departments support and laboratories reject or confirm. In order to be relevant, laboratory data must be medically relevant and globally comparable. Objective: In this paper we review available information on biological and analytic variability in order to discuss medical implications on the establishment of performance indicators for quality control and proficiency programs including available methodologies for establishing relevant reference limits. Methodology: This is a revision of available national and international publications including also the results of a Reference Laboratory located in Mexico City on the evaluation of biological and analytical variability applying Tonks formula and Aspen criteria. Results: Simultaneous evaluation of biological and analytical variability allows clinical laboratory personnel to warranty that delivered data are within rational reference limits that satisfy requisites for medical relevance and global comparison. Discussion: Up to day, ISO-9002-2000 standards regulate clinical laboratories certification globally. These standards have been questioned for several reasons by laboratory professionals; in consequence, on the near future they will be replaced by Standard 15189 that in development by TC/212. On the new document medical relevance and global comparison of clinical laboratories is reinforced as the most important issues to be addressed and accomplished.


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