Clinical and Laboratory Standards Institute guideline EP23—Laboratory Quality Control Based on Risk Management provides recommendations based on risk management for laboratories to develop quality control plans (QCPs) tailored to the combination of measuring system, laboratory setting, and clinical application of the test. Regulatory requirements, information provided by the developer, information pertaining to the laboratory environment, and medical requirements for the test results are evaluated, using risk-management principles, to develop a QCP tailored to the combination of measuring system, laboratory environment, and clinical application. The effectiveness of the laboratory QCP is monitored to detect trends, identify corrective actions, and provide continual quality improvement opportunities. The advantages and limitations of various QC processes are discussed.

This guideline replaces the previous edition of the approved guideline, EP23-A, published in 2011. Several changes were made in this edition, including: 

• Aligning EP23 with international standards and an IQCP 

• Incorporating detectability in the RA 

• Replacing the hypothetical “glucose concentration measurement on an automated measuring system” example with a real-world example of a QCP for a noninstrumented single-use device, instrumented single-use device, and exempt microbiological media

This guideline is intended for global use in laboratories to help determine QC procedures that are appropriate and effective for the test being performed. Developers will also find it useful for understanding laboratory QC requirements and how they will be assessed. The use of risk management is broadly applicable to all processes in the laboratory and can be used beyond the focus of QC. This guideline describes good laboratory practice for developing and maintaining a quality control plan (QCP) for medical laboratory testing using internationally recognized risk-management principles. An individual QCP should be established, maintained, and modified as needed for each measuring system. The QCP is based on the performance required for the intended medical application of the test results. Risk mitigation information obtained from the developerand identified by the laboratory, applicable regulatory and accreditation requirements, and the individual health care and laboratory setting are considered in the development of a QCP. 

This guideline supports the development of an individualized quality control plan (IQCP) under Clinical Laboratory Improvement Amendments requirements and provides guidance for implementing risk management. This guideline might not satisfy the requirements of all regulatory, accreditation, or certification organizations. Laboratories need to comply with all applicable requirements when developing QCPs.