Aida Elargoubi1, Maha Mastouri1, Mohamed Fadhel Najjar2. 1. Faculté de pharmacie, Laboratoire de microbiologie, Hôpital Fattouma Bourguiba, Monastir, Tunisie. 2. Faculté de pharmacie, Laboratoire de biochimie, Hôpital Fattouma Bourguiba, Monastir, Tunisie.
Abstract
UNLABELLED: We propose in this work to study the details of the preanalytical phase (PAP) in microbiology, in order to determinate gaps with the requirement of good laboratory practice guideline (GLPG), causes of dysfunction and actions to improve its quality in our establishment. METHODS: This study was carried out in the microbiology laboratory of the University Hospital of Monastir. We conducted a self-assessment grid and a satisfaction survey phlebotomist staff. A literature review was conducted in accordance with the requirements of normative and regulatory documents (ISO 15189 standard and GLPG). The analysis of non-conformities was performed by the method of 5M and the risk analysis by the preliminary risk analysis (PRA). RESULTS: The results show that the fault lies primarily in the management of human resources. The cause analysis puts the focus on a lack of awareness and training of the responsible staff. Risk analysis reveals another failure in the communication between laboratory and clinicians, and in the formulation of methods (procedures, instructions…). CONCLUSION: The Study of the PPA in details shows that all steps are critical. Indeed, the management of this phase requires the application of the requirements of the GLPG and awareness of a total quality management.
UNLABELLED: We propose in this work to study the details of the preanalytical phase (PAP) in microbiology, in order to determinate gaps with the requirement of good laboratory practice guideline (GLPG), causes of dysfunction and actions to improve its quality in our establishment. METHODS: This study was carried out in the microbiology laboratory of the University Hospital of Monastir. We conducted a self-assessment grid and a satisfaction survey phlebotomist staff. A literature review was conducted in accordance with the requirements of normative and regulatory documents (ISO 15189 standard and GLPG). The analysis of non-conformities was performed by the method of 5M and the risk analysis by the preliminary risk analysis (PRA). RESULTS: The results show that the fault lies primarily in the management of human resources. The cause analysis puts the focus on a lack of awareness and training of the responsible staff. Risk analysis reveals another failure in the communication between laboratory and clinicians, and in the formulation of methods (procedures, instructions…). CONCLUSION: The Study of the PPA in details shows that all steps are critical. Indeed, the management of this phase requires the application of the requirements of the GLPG and awareness of a total quality management.