This document provides guidance based on risk management for laboratories to develop quality control (QC) plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test.
CLSI Publishes New Guideline: Laboratory Quality Control Based on Risk Management (EP23-A)
Wayne, Pennsylvania, USA—October 2011—The Clinical and Laboratory Standards Institute (CLSI) recently published Laboratory Quality Control Based on Risk Management; Approved Guideline (EP23-A). This document provides guidance based on risk management for laboratories to develop quality control (QC) plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test.
“EP23 is intended to provide laboratories with the fundamentals and tools to develop quality control plans based on risk management,” says James H. Nichols, PhD, DABCC, FACB, Medical Director, Clinical Chemistry at Baystate Health in Springfield, Massachusetts, USA, and Chairholder of the document development committee. “These plans consider what could go wrong with laboratory analysis and take into account specific device capabilities (control processes engineered by the manufacturer into the device or instrument), package-insert recommendations, literature about the test, the laboratory setting, operator experience, how the test will be utilized in medical care, and local quality regulations in order to develop a customized control strategy that minimizes risk.”
In addition, James O. Westgard, PhD, FACB, Co-founder and Principal of Westgard QC, Inc., in Madison, Wisconsin, USA, and author of the book Six Sigma Risk Analysis, had this to say about the new document: “Taken together with the basics of analytical quality management, the idea of a QC plan utilizing risk management should be helpful to a laboratory for understanding how various QC mechanisms and measures can be combined to provide a comprehensive methodology for assuring quality.”
The effectiveness of the laboratory QC plan is monitored to detect trends, identify corrective actions, and provide continuous quality improvement. “With increased reliance of laboratory instrumentation and point-of-care devices on built-in checks and internal controls, laboratories need to balance the availability of internal controls with the use of liquid-based controls and other control processes to optimize prevention and detection of potential errors (or hazards) when using laboratory instrumentation,” Dr. Nichols adds. “EP23 provides a toolbox of available types of controls and discusses the advantages and limitations of each control process.”
Other experts agree that EP23 represents the most up-to-date research and viewpoints on laboratory QC. “This document encompasses contemporary and forward-thinking QC concepts that were developed through a consensus process,” explains Judith A. Yost, MA, MT(ASCP), Director, Division Laboratory Services, Centers for Medicare & Medicaid Services in Baltimore, Maryland, USA. “The document will offer laboratories, that choose to apply its lessons greater flexibility in customizing the design of their QC plans to their environments.”
Those using this guideline will receive an overview of the QC tools available to the laboratory and discover their advantages and limitations. Through this instruction, laboratorians will learn to determine QC procedures that are both appropriate and effective for the test being performed. As a result, this guideline will help laboratory professionals develop a QC plan that can improve efficiency in the laboratory through preventing errors, detecting weaknesses, and minimizing risk. In addition to the EP23 document a workbook entitled EP23-A Implementation Workbook, A Practical Guide for Laboratory Quality Control Based on Risk Management has been developed. More information on the document, workbook, and related educational webinars can be found on the CLSI website at www.clsi.org.