Recomendaciones para el diseño e implementación de un programa de aseguramiento de la calidad de la fase preanalítica

The quality assurance of the pre-analytical phase is oriented towards two key aspects; the management of pre-analytical errors from the perspective of patient safety, and the improvement and harmonisation of procedures, based on the application of regulations and professional recommendations. Like the rest of the phases, it should include an internal quality assurance program, as well as the participation in external quality assurance programs.

The internal quality control should mainly be based on the identification of risks, systematic detection of errors, and establishment of indicators. The selection of indicators prioritising the impact on the patient, the way to detect and record errors in a systematic and easily exploitable manner, and also the variables used in the calculations, are important aspects to measure the effectiveness of improvement actions and to allow comparability between laboratories. In this sense, the external quality assurance programs of the pre-analytical phase based on the comparison of indicators are a useful tool for the design and implementation of a quality assurance program.

This document is intended as a support for each laboratory to select, implement, and evaluate its own indicators, according to the individual characteristics of its pre-analytical procedures, but without losing sight of the harmonisation between laboratories.