Lab Med Online.  2021 Apr;11(2):93-100. 10.47429/lmo.2021.11.2.93.

Development of Risk Management Examples for Korean Clinical Laboratories

• Kim S
• Kim KH
• Cho SR
• Ahn J
• Lee WI

• KMID: 2525790
• DOI: http://doi.org/10.47429/lmo.2021.11.2.93

Abstract

Background
Risk management is one of the quality management efforts to provide the best medical services, but the concept is still unfamiliar to clinical laboratories in Korea. Risk management-related checklists have been introduced in the certification of good laboratory practice. In this study, we have tried to develop risk management examples using various tools, for easy understanding and efficient application of risk management in clinical laboratories.
Methods
Reference materials were reviewed to suggest the appropriate scope of risk management for Korean clinical laboratories. Several tools that are suitable for and easy to use in the clinical laboratory were chosen, based on the tools used as examples in the references. Examples of risk management have been developed for each risk management category.
Results
The scope of risk management in the clinical laboratory has been expanded to include the operation of the laboratory, not just the testing processes. Risk management categories were divided into laboratory operations (strategies, finance, and operation) and test processes (preanalytic, analytic, and postanalytic). Risk management cases were selected to include various risk management categories. Scenario analysis, failure mode and effects analysis (FMEA), failure reporting, analysis, and corrective action system (FRACAS), root cause analysis, and fishbone diagram tools were used.
Conclusions
It is expected that the risk management examples presented in this study will help each laboratory in risk management practice and preparation for certification, and ultimately improve the overall quality of the laboratory.

Keyword

Risk; Risk management; Clinical laboratory; Laboratory management; Risk-based thinking; Quality improvement

Reference

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