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CLSI Offers Online Workshop on IQCP Guidance From CMS

Wayne, Pennsylvania, USA—December 2013—The Clinical and Laboratory Standards Institute (CLSI), has released its first online workshop. EP23™ Online Workshop: Risk-Based Tools to Meet IQCP Requirements imparts the knowledge and skills necessary for the successful implementation of CLSI document EP23-A™—Laboratory Quality Control Based on Risk Management; Approved Guideline.

The CLSI guideline EP23-A was created through a consensus process that included individuals representing the Centers for Medicare & Medicaid Services (CMS), the US Food and Drug Administration, the Centers for Disease Control and Prevention, as well as leading industry and health care professionals. The document enables laboratories to perform “The Right QC” based on risk, and guides laboratorians through the process of gathering the right information needed, performing a risk assessment, creating a quality control (QC) plan, and reviewing the plan for effectiveness.Major concepts from the EP23 guideline have been adopted by CMS through the Clinical Laboratory Improvement Amendments (CLIA) interpretive guidelines and are included in a new QC option for laboratories based on risk management. This new option, called an individualized quality control plan (IQCP), provides the ability to customize QC policies and procedures based on the test system used. As the current version of equivalent QC in the CLIA guidance will no longer be an acceptable option for compliance, the CLSI EP23 Online Workshop is an invaluable tool to guide users through the process of establishing an IQCP.

James H. Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology, and Immunology, and Medical Director of Clinical Chemistry at the Vanderbilt University School of Medicine, highlights, “The CLSI EP23 online program allows attendees to learn the principles of risk management and how to apply those principles to develop an IQCP that will meet the new CMS QC interpretive guidelines. The CLSI online program is available around the clock, so attendees can learn at their convenience and pace.”

This fun and interesting online workshop allows for anyone, anywhere, anytime to learn about EP23 and its intent to help simplify QC based on risk management. The program consists of self-paced lessons followed by a homework assignment, an online classroom session, and an evaluation section. Participants can choose from online classroom sessions available at different times during each month.

The workshop was created by EP23 experts and can be completed in approximately five hours for 5.0 P.A.C.E.® continuing education credits. In addition to the indispensable information provided in the online content, the purchase of the workshop includes an EP23 Implementation Workbook, an EP23 Worksheet Template and Worksheet Sample, and an EP23 Quick Guide.

For more information about EP23 and the Online Workshop, visit the CLSI website at

CLSI is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at or call 610.688.0100.



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