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Aseguramiento de la calidad utilizando muestras divididas de pacientes: recomendaciones para los laboratorios de
Anne Stavelin1, Eva Rønneseth1, Anne Lise Fossum1,2
1The Norwegian Organisation for Quality Improvement of Laboratory Examinations (Noklus), 72982 Haraldsplass Deaconess Hospital , Bergen, Norway.
Clinical chemistry and laboratory medicine
|August 25, 2025
Resumen
El análisis de muestras divididas de pacientes mejora la garantía de calidad para las pruebas en el punto de atención (POCT, por sus siglas en inglés) en la atención primaria de salud. Estas directrices fáciles de usar ofrecen instrucciones claras para comparar los resultados del POCT y los de los laboratorios centrales, lo que garantiza pruebas fiables para los pacientes.
Área de la Ciencia:
- Medicina de laboratorio
- Aseguramiento de la calidad de la asistencia sanitaria primaria
Sus antecedentes:
- La adopción de pruebas en el punto de atención (POCT) en la atención primaria de salud requiere una sólida garantía de calidad (QA).
- El enfoque de muestra dividida del paciente (comparando el POCT con los resultados del laboratorio central) es una valiosa herramienta de control de calidad.
- La orientación práctica para la aplicación del análisis de muestras divididas de pacientes en la atención primaria de salud es limitada.
Objetivo del estudio:
- Desarrollar recomendaciones fáciles de usar para el personal no de laboratorio de la atención primaria de la salud.
- Proporcionar orientaciones claras sobre cuándo y cómo realizar las comparaciones de muestras divididas de pacientes.
- Establecer límites aceptables para la comparación de los resultados del TPO y del laboratorio central.
Principales métodos:
- Un grupo de expertos formuló recomendaciones basadas en la revisión de la literatura y la experiencia profesional.
- Los límites de aceptabilidad pragmática se establecieron utilizando múltiples enfoques.
- Las recomendaciones se perfeccionaron mediante una auditoría en la que participaron más de 120 empleados.
Principales resultados:
- Se recomiendan las comparaciones de muestras divididas de pacientes cuando no hay programas de EQA, el control de calidad interno es inadecuado o los resultados del POCT entran en conflicto con las expectativas clínicas.
- Los límites aceptables para la comparación de resultados se fijaron en 15% o 20%, variando según la medida.
- Se recomienda una lista de control estructurada para revisar los resultados fuera de estos límites.
Conclusiones:
- Estas representan las primeras recomendaciones publicadas y fáciles de usar para el uso de muestras divididas de pacientes en la atención primaria de salud.
- Las directrices tienen por objeto simplificar la aplicación para el personal no relacionado con el laboratorio.
- Se prevé que la adopción generalizada de estos procedimientos de control de calidad mejore la fiabilidad de los POCT.
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