ISO 15189:2012 establishes the requirements for clinical sample management, ensuring quality of process and laboratory information management. The accreditation authority, ENAC in Spain, established the requirements for the authorized use of the label in reports issued by accredited laboratories. These recommendations are applicable to the postanalytical processes and the professionals involved. The Standard requires laboratories to define and document the duration and conditions of sample retention. Laboratories are also required to design an internal quality control scheme to verify whether postanalytical activities attain the expected standards. Information management requirements are also established and laboratories are required to design a contingency plan to ensure the communication of laboratory results. Instructions are finally provided about the correct use of the accreditation label in laboratory reports. A range of nations and scientific societies support that clinical laboratories should be required to obtain accreditation. With ISO 15189 being the most specific standard for demonstrating technical performance, a clear understanding of its requirements is essential for proper implementation.

Introduction: Communication of laboratory critical risk results is essential for patient safety, as it allows early decision making. Our aims were: 1) to retrospectively evaluate the current protocol for telephone notification of critical risk results in terms of rates, efficiency and recipient satisfaction, 2) to assess their use in clinical decision making and 3) to suggest alternative tools for a better assessment of notification protocols. Materials and methods: The biochemical critical risk result notifications reported during 12 months by routine and STAT laboratories in a tertiary care hospital were reviewed. Total number of reports, time for the notification and main magnitudes with critical risk results were calculated. The use of notifications in clinical decision making was assessed by reviewing medical records. Satisfaction with the notification protocol was assessed through an online questionnaire to requesting physicians and nurses. Results: Critical result was yielded by 0.1% of total laboratory tests. Median time for notification was 3.2 min (STAT) and 16.9 min (routine). The magnitudes with a greater number of critical results were glucose and potassium for routine analyses, and troponin, sodium for STAT. Most notifications were not reflected in the medical records. Overall mean satisfaction with the protocol was 4.2/5. Conclusion: The results obtained indicate that the current protocol is appropriate. Nevertheless, there are some limitations that hamper the evaluation of the impact on clinical decision making. Alternatives were proposed for a proper and precise evaluation.

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ResumenEl objeto de este trabajo es establecer unas consideraciones para facilitar la gestión del proceso posanalítico respecto a la revisión, notificación y comunicación de los resultados, de acuerdo con los requisitos de la Norma UNE-EN ISO 15189:2013. El ámbito de aplicación incluye las actividades del proceso posanalítico del laboratorio clínico, así como el personal implicado en él (dirección y personal del laboratorio). Se indican los criterios y la información necesaria para realizar la revisión y validación de los resultados de las pruebas analíticas y así enviar a los destinatarios informes claros, asegurando siempre una transcripción fidedigna de los resultados e incluyendo toda la información necesaria para su correcta interpretación. Asimismo, se describen los requisitos para una correcta comunicación de los resultados del laboratorio, haciendo especial hincapié en la comunicación de aquellos resultados alarmantes o críticos. En algunos países de Europa es obligatoria la acreditación, total o parcial, de los laboratorios clínicos, siguiendo la Norma ISO 15189 y esta parece ser la hoja de ruta marcada en otros muchos países. Por ello, es indispensable la comprensión de sus requisitos para realizar una implementación progresiva y más fácil.