Quintana-Ponce S, Rea-Vázquez MG, Barlandas-Rendón NRE

Language: Spanish
References: 9
Page: 214-218
PDF size: 290.40 Kb.

ABSTRACT

Introduction: The clinical laboratory (CL) in Mexico has the Guide of Metrological Traceability of Values Assigned to the Calibrators and Control Material Employed by the Clinical Laboratory (Guide of Metrological Traceability), which allows identifying the routes of traceability and shows the comparability of measurements. Objective: To know the impact of the Technical Guide of Metrological Traceability in the accreditation process with the Mexican Norm NMX-EC-15189-IMNC/ISO 15189. Material and methods: The research is descriptive, transversal, using a survey as a tool and a questionnaire as an instrument, which were previously validated. It was applied to 44 accredited clinical laboratories and three blood banks (BB). Results: The main problems identified for the implementation of the ISO 15189 proved to be the demonstration of the traceability of the calibrators and the validation and verification of methods. Fifty-eight percent of CL mentioned that the two available technical guides have facilitated the implementation of these technical requirements. Fifty-one percent of the staff of the CL has knowledge about the traceability of the measurements and the uncertainty of measurement. Conclusion: In Mexico, the CL has technical documents which provide knowledge and implementation of critical technical requirements of the standard ISO 15189, such as traceability and the uncertainty of measurement, being these tools used by 96% of the accredited CL and BB.

REFERENCES

1. Entidad Mexicana de Acreditación y CENAM. Guía de trazabilidad metrológica de los valores asignados a los calibradores y material de control empleados por el laboratorio clínico. 2015.

2. In vitro diagnostic medical devices —Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials. ISO 17511: 2003.

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8. Quintana-Ponce S. Experiencia en la acreditación de laboratorios clínicos y bancos de sangre en México. The Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (eJIFCC). 2015; 26 (4): 259-263.

9. Entidad Mexicana de Acreditación y CENAM. Guía para la validación y la verificación de los procedimientos de examen cuantitativos empleados por laboratorio clínico. 2008.