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)

Intercambiabilidad de resultados entre los diferentes laboratorios clínicos Catlab / Comparability study of analytical results between a group of clinical laboratories

Objetivo. Describir el estudio de la intercambiabilidad de los resultados de las magnitudes de bioquímica que se procesan indistintamente en los 4 laboratorios de Catlab. Material y métodos. Se establecieron requisitos de calidad de coeficiente de variación y error total (CV% y ET%). Se verificó, con materiales de control comercial, el cumplimiento del CV% en cada magnitud y para cada analizador de cada laboratorio y se estudió la intercambiabilidad con muestras recientes de suero. Se analizaron las diferencias con una aplicación en Microsoft Access® que genera gráficos de Bland-Altman modificados. Resultados. La intercomparación de las 32 magnitudes que se realizan en más de un laboratorio o analizador generó 306 gráficas de Bland-Altman: 101 (33,1%) cumplían directamente el requisito de ET% establecido a partir de la variabilidad biológica y 205 (66,9%) requirieron revisión. Se reprocesaron los datos según los requisitos mínimos de consenso de la Asociación Española de Farmacéuticos Analistas (AEFA), la Sociedad Española de Bioquímica Clínica y Enfermedad Molecular (SEQC), la Asociación Española de Biopatología Médica (AEBM) y de la Sociedad Española de Hematología y Hemoterapia (SEHH) de octubre del 2013. Aplicándolos, 170 comparaciones (56%) cumplían directamente los requisitos y 136 (44%) requerían revisión. Al valorar el número de puntos que excedían el requisito, los errores aleatorios, el intervalo de resultados en el que se detectaban discrepancias y el intervalo de decisión clínica se consideró que todos los resultados se podían aceptar y que las 32 magnitudes eran intercambiables en todos los centros y analizadores. Conclusiones. A partir del requisito de consenso de las 4 sociedades, los resultados de todas las magnitudes comparadas eran intercambiables. No obstante, cada uno de los laboratorios debe cumplir con criterios más estrictos de error total (AU)

Objective. To describe the study of the comparability of the measurements levels of biological tests processed in biochemistry in Catlab's 4 laboratories. Material and methods. Quality requirements, coefficients of variation and total error (CV% and TE %) were established. Controls were verified with the precision requirements (CV%) in each test and each individual laboratory analyser. Fresh serum samples were used for the comparability study. The differences were analysed using a Microsoft Access® application that produces modified Bland-Altman plots. Results. The comparison of 32 biological parameters that are performed in more than one laboratory and/or analyser generated 306 Bland-Altman graphs. Of these, 101 (33.1%) fell within the accepted range of values based on biological variability, and 205 (66.9%) required revision. Data were re-analysed based on consensus minimum specifications for analytical quality (consensus of the Asociación Española de Farmacéuticos Analistas (AEFA), the Sociedad Española de Bioquímica Clínica y Patología Molecular (SEQC), the Asociación Española de Biopatología Médica (AEBM) and the Sociedad Española de Hematología y Hemoterapia (SEHH), October 2013). With the new specifications, 170 comparisons (56%) fitted the requirements and 136 (44%) required additional review. Taking into account the number of points that exceeded the requirement, random errors, range of results in which discrepancies were detected, and range of clinical decision, it was shown that the 44% that required review were acceptable, and the 32 tests were comparable in all laboratories and analysers. Conclusions. The analysis of the results showed that the consensus requirements of the 4 scientific societies were met. However, each laboratory should aim to meet stricter criteria for total error (AU)

[Comparability study of analytical results between a group of clinical laboratories]. / Intercambiabilidad de resultados entre los diferentes laboratorios clínicos Catlab.

OBJECTIVE: To describe the study of the comparability of the measurements levels of biological tests processed in biochemistry in Catlab's 4 laboratories. MATERIAL AND METHODS: Quality requirements, coefficients of variation and total error (CV% and TE %) were established. Controls were verified with the precision requirements (CV%) in each test and each individual laboratory analyser. Fresh serum samples were used for the comparability study. The differences were analysed using a Microsoft Access® application that produces modified Bland-Altman plots. RESULTS: The comparison of 32 biological parameters that are performed in more than one laboratory and/or analyser generated 306 Bland-Altman graphs. Of these, 101 (33.1%) fell within the accepted range of values based on biological variability, and 205 (66.9%) required revision. Data were re-analysed based on consensus minimum specifications for analytical quality (consensus of the Asociación Española de Farmacéuticos Analistas (AEFA), the Sociedad Española de Bioquímica Clínica y Patología Molecular (SEQC), the Asociación Española de Biopatología Médica (AEBM) and the Sociedad Española de Hematología y Hemoterapia (SEHH), October 2013). With the new specifications, 170 comparisons (56%) fitted the requirements and 136 (44%) required additional review. Taking into account the number of points that exceeded the requirement, random errors, range of results in which discrepancies were detected, and range of clinical decision, it was shown that the 44% that required review were acceptable, and the 32 tests were comparable in all laboratories and analysers. CONCLUSIONS: The analysis of the results showed that the consensus requirements of the 4 scientific societies were met. However, each laboratory should aim to meet stricter criteria for total error.

[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.