Desarrollo e Implementación de un Programa de Aseguramiento de la Calidad del Proceso Analítico de los Métodos de Hematología, Química Clínica e Inmunología del Laboratorio Echandi, para la Redefinición de Especificaciones Analíticas, Durante el Periodo de Noviembre 2022 a Mayo 2023
Fecha
2023-07-23
Tipo
tesis
Autores
González Morales, Julio Andrés
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Resumen
El objetivo principal de este trabajo fue desarrollar e implementar un programa de aseguramiento de la calidad del proceso analítico en los métodos de hematología, química clínica e inmunología que se encuentran dentro del alcance de acreditación del Laboratorio Echandi, esto con el objetivo de redefinir los requerimientos de calidad que están establecidos. En una primera etapa se evaluó el desempeño inicial de los métodos de ensayo a través del análisis retrospectivo de las especificaciones de desempeño, las cuales fueron contrastadas frente a los requerimientos de calidad de ESa, EAa y ETa, y analizadas con el cálculo de la métrica de desempeño sigma.
El programa de aseguramiento de la calidad desarrollado se conforma de un nuevo esquema de control estadístico de la calidad, de procedimientos para evaluar resultados de control de calidad fuera de especificación y de la implementación de estrategias de monitoreo del control de calidad interno en diferentes puntos críticos de control definidos en el proceso analítico. Con el análisis estadístico realizado y el cálculo de la métrica sigma, se definió un esquema de control estadístico de la calidad, utilizando los gráficos de error sistemático para definir las reglas de decisión de Westgard, la cantidad de mediciones de niveles de control y de corridas analíticas necesarias para obtener una probabilidad de detección del error superior a 90% y una probabilidad de falso rechazo inferior a 3%.
Posterior a un periodo de tres meses de implementación del programa de aseguramiento de la calidad en el proceso analítico, se analizaron los resultados del control interno y externo de calidad, y se obtuvo los siguientes resultados: veinticuatro ensayos tuvieron un aumento significativo en el desempeño sigma, en seis ensayos se mantuvo el desempeño sigma inicial y en siete métodos de ensayo se presentó una disminución del valor sigma, sin embargo, el desempeño sigma se mantuvo excelente (mayor a un valor 5 sigma).
Se seleccionaron un total de diecisiete métodos de ensayo para ser propuesta una nueva meta de calidad, ocho ensayos de química clínica, cuatro ensayos de inmunología y todos los ensayos de hematología. Se concluye que la aplicación del nuevo programa de aseguramiento de la calidad analítica aplicado en los métodos de ensayo que se encuentran dentro del alcance de acreditación del Laboratorio Echandi permitió mejorar sustancialmente el desempeño sigma de la mayoría de los ensayos analizados y con esto se logró proponer nuevos requisitos de calidad.
This research project aimed to develop and implement a quality assurance program for the analytical process in hematology, clinical chemistry, and immunology test procedures, that are within the scope of accreditation of the Echandi Laboratory. This was done with the aim of redefining the quality requirements that are already established. In a first stage, the initial performance of test procedures was evaluated through the retrospective analysis of the performance specifications, which were contrasted against the allowable systematic, random, and total error requirements, and analyzed with the sigma metric calculation. The developed quality assurance program consists of a new statistical quality control program, procedures to evaluate out-of-control situations and the implementation of internal quality control monitoring strategies at different critical control points defined in the analytical process. With the statistical analysis performed and the calculation of the sigma metric, a quality control strategy was defined by using systematic error charts to establish the quality control Westgard rules, the numbers of control measurements and analytical runs needed to achieve a probability error detection greater than 90%, and a probability of false rejection lower than 3%. Following a three-month period of implementing the quality assurance program in the analytical process, the results of internal and external quality control were analyzed, yielding the following outcomes: twenty-four tests showed a significant increase in sigma performance, six tests maintained their initial sigma performance, and seven test procedures experienced a decrease in sigma value; however, the sigma performance remained excellent (greater than a 5-sigma value). A total of seventeen test procedures were selected to propose a new quality goal, including eight clinical chemistry tests procedures, four immunology tests, and all hematology tests. It is concluded that the application of the new analytical quality assurance program applied to the test methods that are within the scope of accreditation of the Echandi Laboratory significantly improved the sigma performance of most of the analyzed test procedures; thereby, allowing for the proposal of new quality requirements.
This research project aimed to develop and implement a quality assurance program for the analytical process in hematology, clinical chemistry, and immunology test procedures, that are within the scope of accreditation of the Echandi Laboratory. This was done with the aim of redefining the quality requirements that are already established. In a first stage, the initial performance of test procedures was evaluated through the retrospective analysis of the performance specifications, which were contrasted against the allowable systematic, random, and total error requirements, and analyzed with the sigma metric calculation. The developed quality assurance program consists of a new statistical quality control program, procedures to evaluate out-of-control situations and the implementation of internal quality control monitoring strategies at different critical control points defined in the analytical process. With the statistical analysis performed and the calculation of the sigma metric, a quality control strategy was defined by using systematic error charts to establish the quality control Westgard rules, the numbers of control measurements and analytical runs needed to achieve a probability error detection greater than 90%, and a probability of false rejection lower than 3%. Following a three-month period of implementing the quality assurance program in the analytical process, the results of internal and external quality control were analyzed, yielding the following outcomes: twenty-four tests showed a significant increase in sigma performance, six tests maintained their initial sigma performance, and seven test procedures experienced a decrease in sigma value; however, the sigma performance remained excellent (greater than a 5-sigma value). A total of seventeen test procedures were selected to propose a new quality goal, including eight clinical chemistry tests procedures, four immunology tests, and all hematology tests. It is concluded that the application of the new analytical quality assurance program applied to the test methods that are within the scope of accreditation of the Echandi Laboratory significantly improved the sigma performance of most of the analyzed test procedures; thereby, allowing for the proposal of new quality requirements.
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Palabras clave
Calidad, Aseguramiento de Calidad, Métrica seis sigma, Control estadístico de la calidad, Control interno de calidad, Control externo de calidad