[UNE-EN ISO 15189 accreditation of the preanalytical phase of a clinical laboratory]

Description of the procedures followed in Catlab's pre-analytical area for UNE-EN ISO 15189 accreditation, and implementation of quality indicators to evaluate the standard requirements in the pre-analytical phase processes.

Description of Catlab's 2 self-developed computer applications: Catlab Program Incidents (CPI) and Refrigerator Management Program (RMP). Both of them, among other applications, documentation and quality indicators, had enabled us to achieve UNE-EN ISO 15189 accreditation and have traceability in the pre-analytical phase.

Results of 4 quality indicators are shown. In the customers satisfaction measurement indicator, 97.3% clinicians value positively (quite/lot) different aspects of the laboratory. The indicator of pre-analytical incidents went from 7.2% in 2011 down to 4.4% in 2014. In the prompt transport of late arrival samples, 3 of the routes (33%) did not reach the acceptable target. And finally, the indicator of default opening time of sample coolers, 100% of the routes reached the desired objective in the second quarter of 2014.

The use of those applications, allowed us to design quality control indicators of the processes in the pre-analytical phase; from sample extraction to its analytical process in the laboratory, enhancing the collaboration with extraction sites, and allowing improvement actions to be established.