Acreditación según la norma UNE-EN ISO 15189, de la fase preanalítica del laboratorio de análisis clínicos Catlab / UNE-EN ISO 15189 accreditation of the preanalytical phase of a clinical laboratory

Objetivos. Describir los procedimientos para conseguir la acreditación UNE-EN ISO 15189 en el área preanalítica de Catlab Viladecavalls y establecer indicadores de calidad que permitan evaluar los requisitos de la norma en los procesos de la fase preanalítica. Material y métodos. Se describen los programas informáticos propios Programa de Incidencias de Catlab (PI) y Programa de Gestión de Neveras (GIN) que, junto con otros programas comerciales, documentación e indicadores de calidad permitieron alcanzar la acreditación UNE-EN ISO 15189 y tener trazabilidad en la fase preanalítica. Resultados. Se muestran resultados de 4 de los indicadores de calidad de la fase preanalítica. En el indicador de la medida de satisfacción del cliente, un 97,3% de los clínicos valoraban positivamente (bastante/mucho) distintos aspectos del laboratorio. En el indicador de incidencias preanalíticas se pasó del 7,2% en el 2011 al 4,4% en el 2014. En referencia al indicador de transporte de muestras llegadas con retraso, 3 de las rutas de mensajería (33%) no cumplían con el objetivo aceptable. Finalmente el indicador de incumplimiento de tiempo de apertura de neveras de muestras refleja que, a partir del segundo trimestre del año 2014, el 100% de las rutas cumplían el objetivo deseable. Conclusiones. La utilización de estos programas ha permitido diseñar indicadores de calidad para controlar los procesos preanalíticos, desde la extracción de la muestra hasta su proceso analítico en el laboratorio, facilitar la colaboración con los centros de extracción y establecer acciones de mejora (AU)

Objectives. Description of the procedures followed in Catlab's pre-analytical area for UNE-EN ISO 15189 accreditation, and implementation of quality indicators to evaluate the standard requirements in the pre-analytical phase processes. Material and methods. Description of Catlab's 2 self-developed computer applications: Catlab Program Incidents (CPI) and Refrigerator Management Program (RMP). Both of them, among other applications, documentation and quality indicators, had enabled us to achieve UNE-EN ISO 15189 accreditation and have traceability in the pre-analytical phase. Results. Results of 4 quality indicators are shown. In the customers satisfaction measurement indicator, 97.3% clinicians value positively (quite/lot) different aspects of the laboratory. The indicator of pre-analytical incidents went from 7.2% in 2011 down to 4.4% in 2014. In the prompt transport of late arrival samples, 3 of the routes (33%) did not reach the acceptable target. And finally, the indicator of default opening time of sample coolers, 100% of the routes reached the desired objective in the second quarter of 2014. Conclusions. The use of those applications, allowed us to design quality control indicators of the processes in the pre-analytical phase; from sample extraction to its analytical process in the laboratory, enhancing the collaboration with extraction sites, and allowing improvement actions to be established (AU)

[UNE-EN ISO 15189 accreditation of the preanalytical phase of a clinical laboratory]. / Acreditación según la norma UNE-EN ISO 15189, de la fase preanalítica del laboratorio de análisis clínicos Catlab.

OBJECTIVES: Description of the procedures followed in Catlab's pre-analytical area for UNE-EN ISO 15189 accreditation, and implementation of quality indicators to evaluate the standard requirements in the pre-analytical phase processes. MATERIAL AND METHODS: Description of Catlab's 2 self-developed computer applications: Catlab Program Incidents (CPI) and Refrigerator Management Program (RMP). Both of them, among other applications, documentation and quality indicators, had enabled us to achieve UNE-EN ISO 15189 accreditation and have traceability in the pre-analytical phase. RESULTS: Results of 4 quality indicators are shown. In the customers satisfaction measurement indicator, 97.3% clinicians value positively (quite/lot) different aspects of the laboratory. The indicator of pre-analytical incidents went from 7.2% in 2011 down to 4.4% in 2014. In the prompt transport of late arrival samples, 3 of the routes (33%) did not reach the acceptable target. And finally, the indicator of default opening time of sample coolers, 100% of the routes reached the desired objective in the second quarter of 2014. CONCLUSIONS: The use of those applications, allowed us to design quality control indicators of the processes in the pre-analytical phase; from sample extraction to its analytical process in the laboratory, enhancing the collaboration with extraction sites, and allowing improvement actions to be established.