Periodicidad semestral: flujo continuo.
ISSN - Electrónico: 2661-6947 / DOI: 10.36015 • LILACS BIREME (19784); LATINDEX (20666)
INTRODUCCIÓN: El laboratorio clínico busca estandarizar procesos que garanticen resultados precisos y confiables. La métrica Sigma se ha posicionado como una herramienta eficaz para evaluar el desempeño analítico, al identificar defectos que los métodos tradicionales de control de calidad no detectan. Un valor Sigma ≥6 se considera desempeño de clase mundial; sin embargo, su aplicación en hematología es aún limitada.
OBJETIVOS: Evaluar el rendimiento analítico de parámetros hematológicos mediante la métrica Sigma en analizadores Mindray® CAL 6000 y BC 6200, con el fin de identificar oportunidades de mejora y optimizar la frecuencia del control de calidad.
MATERIALES Y MÉTODOS: Se desarrolló un estudio observacional retrospectivo (transversal), utilizando datos de control interno de calidad (CCI) registrados entre julio y diciembre de 2024 en la plataforma Mindray’s Innolab HCP®. El cálculo de Sigma se realizó con la fórmula: Sigma = (valor del ETa% - Sesgo%)/CV%, tomando los límites de error total admisible (ETa) de la guía CLIA. Se calculó el sesgo y el coeficiente de variación. Los parámetros leucocitos (WBC), hemoglobina (HGB) y plaquetas (PLT) alcanzaron un Sigma ≥6, lo que refleja desempeño de clase mundial. Los eritrocitos (RBC) obtuvieron Sigma ≥5, considerado bueno, con necesidad de ajuste, mientras que el hematocrito (HCT) mostró Sigma ≥3, correspondiente a desempeño marginal.
RESULTADOS: Parámetros como hemoglobina, leucocitos y plaquetas mostraron alto desempeño, mientras que hematocrito y eritrocitos revelaron errores aleatorios y sistemáticos corregibles. Estos resultados justifican ajustar la frecuencia del control de calidad según el Sigma obtenido, mejorando la eficiencia, reduciendo costos y promoviendo decisiones basadas en evidencia mediante su integración con modelos como el ciclo de Deming.
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