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Risk management in the clinical laboratory
Sarah W Njoroge1, James H Nichols1
1Department of Pathology, Microbiology, and Immunology, Vanderbilt University School of Medicine, Nashville, TN, USA.
Annals of Laboratory Medicine
|July 2, 2014
Summary
Clinical laboratory risk management, guided by CLSI guideline EP23-A, enhances test accuracy. Implementing risk management plans helps prevent errors, ensuring reliable patient test results.
Area of Science:
- Clinical Laboratory Science
- Quality Management Systems
- Medical Diagnostics
Background:
- Clinical laboratory tests are crucial for medical decisions, demanding high reliability and accuracy.
- Errors can occur during pre-analytical, analytical, and post-analytical phases of laboratory testing.
- Proactive error detection and prevention are vital to avoid patient harm.
Purpose of the Study:
- To introduce risk management principles to clinical laboratories.
- To summarize the application of risk management in laboratory settings.
- To describe quality control activities for valid test results.
Main Methods:
- Adoption of the Clinical and Laboratory Standards Institute (CLSI) guideline EP23-A.
- Application of risk management principles adapted from the manufacturing industry.
- Development of laboratory-specific risk management plans with control processes.
Main Results:
- Laboratories are encouraged to identify specific risks and implement control processes.
- Continuous monitoring and modification of control processes are necessary.
- Risk management aims to maintain errors at a clinically acceptable level.
Conclusions:
- Risk management is essential for ensuring the reliability and accuracy of clinical laboratory testing.
- CLSI guideline EP23-A provides a framework for implementing risk management in labs.
- Effective quality control activities, integrated with risk management, lead to valid test results.
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