Developing risk-based quality control plans: an overview of CLSI EP23-A

Area of Science:

• Clinical Laboratory Science
• Quality Management Systems

Background:

• Quality control (QC) in clinical laboratories has evolved beyond traditional QC sample testing.
• There is an increasing focus on managing the risks associated with reporting inaccurate patient results.
• Risk management techniques are crucial for implementing an expanded QC vision.

Purpose of the Study:

• To outline the steps for developing a risk-based quality control (QC) plan.
• To provide guidance on implementing and utilizing a risk-based QC strategy in clinical laboratories.
• To build upon the foundation laid by the Clinical and Laboratory Standards Institute (CLSI) EP23-A guideline.

Main Methods:

• The article outlines a systematic approach to risk-based QC plan development.
• It details the practical application of risk management principles within the clinical laboratory setting.
• Guidance is provided based on the EP23 model for laboratory quality control.

Main Results:

• A clear framework for creating and employing risk-based QC plans is presented.
• The methodology facilitates proactive identification and mitigation of potential errors in patient testing.
• Implementation of this model enhances overall laboratory quality and patient safety.

Conclusions:

• Risk-based quality control is essential for modern clinical laboratories.
• Adopting a risk-based approach improves the management of potential errors in patient results.
• The EP23 model provides a robust framework for developing effective QC plans.