Terrés-Speziale AM

Language: Spanish
References: 8
Page: 59-71
PDF size: 233.54 Kb.

ABSTRACT

Background: ISO 15189: 2003 was developed in order to establish requirements for the Accreditation of Clinical Laboratory Quality Management System and Technical Competition, including standards from the pre to post examination stages. From the medical point of view the most important issue of the new norm, is the need to generate medically relevant results, making necessary for the laboratory professionals to watch for the reliability of the studies, and to become more involved on the suitable indication and utilization of the tests, and to be aware on the correct interpretation and better use of the results. Objective: To review ISO 15189: 2003 and to document the medical relevance concept and the issues that may derive from the human perspective and from the technological dimension. Material and methods: This is a revision article on which the analytical process in its three stages is evaluated. Practical definitions, formulas and examples are presented as indicators of medical relevance that can be applied on the internal and external quality control programs. Results: The basic utility of the tests of the laboratory depends fundamentally on their medical relevance, which can as be evaluated on an objective form in the internal quality programs and in the external proficiency schemes. Discussion: Medical relevance depends from the start on the decision to use the clinical laboratory tests, depending on what test is to be performed, who indicates it, why and what for is carried out, who process it and where is developed, who controls it and finally what is done with the results. When the tests are carried out under suitable conditions, in a laboratory with well established quality control programs in which objective indicators are applied, it turns out feasible to evaluate the relevance of the results through the simultaneous measurement of the biological variability and analytical variability according to the described method on this communication.

REFERENCES

1. NORMA ISO/IEC 15189:2003. Sistema de Gestión de Calidad para el Laboratorio Médico.

2. NORMA ISO/IEC 43-2:1997. Prueba de Aptitud por Comparaciones entre Laboratorios - Parte 2: Selección y uso de los Esquemas. Evaluación Externa de la Calidad por los Cuerpos de la Acreditación del Laboratorio.

3. NORMA ILAC-G13:2000. Requisitos para proveedores de ensayos de aptitud o esquemas de evaluación externa de la calidad.

4. WASPaLM-IFCC. La Acreditación del Laboratorio. Declaración de Política. Rev Mex Patol Clin 2006; 53 (3): 174-177.

5. Terrés SAM. Requisitos para proveedores de esquemas de evaluación externa de la calidad. Rev Mex Patol Clin 2006; 53 (1): 3-15.

6. Terrés SAM. Importancia de la variabilidad biológica y de la relevancia médica en ISO 15189. Rev Mex Patol Clin 2003; 50 (3): 118-128.

7. Terrés SAM. Estimación de la incertidumbre y de la variabilidad total en el laboratorio clínico. Rev Mex Patol Clin 2006; 53 (4): 185-196.

8. Terrés SAM. Six Sigma: Determinación de metas analíticas con base en la variabilidad biológica y la evolución tecnológica. Rev Mex Patol Clin 2007; 54 (1): 28-39.