Application of Failure Modes and Effects Analysis (FMEA) During the Pre-analytical Phase in a Greek Biochemistry Laboratory

Quality Assurance in the Era of Individualized Medicine

2020

The main role that clinical laboratories play in the detection, diagnosis, and treatment of diseases is clearly evident. Clinical laboratories need to sustain a commitment to quality and demonstrate a certifiable level of compliance. Many strategies are used to reduce laboratory errors, including internal QC procedures, external quality assessment programs, implementation of QIs and six-sigma methodology. All strategies should be consistent with the requirements of the international standard for medical laboratory accreditation and suitable for promoting corrective/preventive actions. They must promote total quality and patient safety and be consistent with the definition of a laboratory error. Harmonization process is in progress; however, further efforts must be made. Total quality management must be evaluated periodically. For a patient-centered approach, there is the need to assure that each and every step of the total testing process is correctly performed, that weaknesses are recognized, and that corrective and preventive actions are designed and implemented.

The Clinical Laboratory and the Commitment to Quality

Quality Assurance in the Era of Individualized Medicine

2020

The Implementation of Clinical Laboratory Quality Indicators in the Era of the COVID-19 Pandemic

Advances in Healthcare Information Systems and Administration

Kalliora

et al. 2022

The use of quality indicators (QIs) and risk assessment are valuable tools for maintaining the quality of laboratory tests. Both are requirements of ISO 15189: 2012 and are usually based on standard statistical and empirical data. In this chapter, the authors focus on evaluating clinical laboratory quality indicators in the era of the COVID-19 pandemic. The goal is to pose and discuss, based on the authors' experience, the quality evaluation and risk assessment through the collection, study, and analysis of quality indicators covering the pre-analytical, analytical, and post-analytical phases of the laboratory testing process. QIs were evaluated using the Six Sigma method. Moreover, FMEA risk analysis was performed, and the degree of risk priority was assessed using the Pareto method. The results show that in the analytical phase, the laboratory's performance is satisfactory, while the pre-and post-analytical phases need further preventive/corrective actions.

Quality Indicators for the Performance Evaluation at a Biochemistry Laboratory

Athanasiadou

International Journal of Reliable and Quality E-Healthcare

et al. 2020

The use of quality indicators and risk evaluation are valuable tools for maintaining the quality of laboratory tests. There are both requirements of ISO 15189: 2012 and are usually based on common statistical and empirical data. The purpose of the present study was the quality quantification and risk evaluation through the collection, study, and analysis of quality indicators covering the pre-analytical, analytical, and post-analytical phases of the laboratory testing process. Statistical data was collected for the period from 1/12/2017 to 28/2/2018, using the LIS of Biochemical Laboratory. QIs were evaluated using the Six Sigma method and the Pareto statistical tool. FMEA risk analysis was performed, while the degree of risk priority with the Pareto method. The results show that in the analytical phase the QIs give us satisfactory values, while those in the pre- and post- analytical phases need further preventive/corrective actions in order to overcome the problems raised by the QIs. Thus, the fully automatization and computerization of the laboratory is needed.