Risk analysis and management of non-conformities of the pre-analytical phase in a university testing laboratory of bacteriology

Abstract

Due to the great deal of attention given to patient's security, it is necessary to reduce non-conformities in pre-analytical phase, so the laboratories of medical bacteriology that can ensure the quality of examination results can contribute to diagnosis and prescription of treatment and patient safety. It is important that these laboratories collect and exploit statistics of the non-conformities rates which occur during pre-analytical phase in order to implement improvement plans. This study was done in a period of 10 months in a laboratory of bacteriology in a university hospital center. It aims to control the nonconformity rates of the biological samples found, show their nature and causes and to assess their criticality. Results obtained showed that overall rate of non-conformities identified in the year 2012 were 2.5% (310 samples from 12 398). 61% of the recorded errors concerned both the identification of biological samples and patient's identity. 29% was on conveyance and 10% on the quality and quantity of samples. The setting up of the corrective and preventive actions plan was done by the application of Pareto law. The adoption of the Failure Mode, Effects and Criticality Analysis (FMECA) approach was meant for the risks analysis linked to these dysfunctions at pre-analytic phase. Anomalies of heterogeneity during this pre-analytic phase of the studied laboratory suggest the requirement of more rigorous methodology and exploitation of the projected indicators with suitable technologies to assess non-conformity and to follow quality improvements. Finally, to improve exams quality in laboratories, an organization and a quality action plan are proposed to ensure the management and control of the non-conformities occurring during the pre-analytic phase.