In two memoranda dated November 4, 2011 and March 9, 2012 the US Centers for Medicare and Medicaid Services (CMS) have informed laboratories of their intention to provide a new optional basis for laboratory quality control plans. Guidance on this option is available as a revised standard, titled “Laboratory Quality Control Based on Risk Management” which was developed in collaboration between CMS and the Clinical and Laboratory Standards Institute (CLSI). This standard, designated EP23-A, was approved in October 2011.
Over the next several years clinical laboratories will have the opportunity to develop risk-based quality control procedures. Laboratories which choose to not follow EP23 can continue to meet the traditional QC requirements of 42 CFR 493.1256(d)(3), along with the manufacturer’s requirements as detailed in package inserts.
It should be noted that EP23 does not specify one particular method of risk analysis, and laboratory directors who are considering EP23 should be aware of both the potential benefits and pitfalls of risk analysis methods. An interesting recent article by James Westgard titled “Is Risk Analysis Reliable?” points to research findings on some of the ways that Failure Mode and Effects Analysis (FMEA) can itself fail.
CLSI has been promoting EP23-A through a series of web-based and in-person seminars. Artel’s Senior Scientific Manager, Dr. George Rodrigues will join me as we attend the CLSI training course in Boston and we will let you know what we learn.
A. Bjoern Carle, Ph.D., is the PCS Product Manager at Artel, where he supports product development, scientific marketing, regulatory affairs, and technical training efforts. Dr. Carle earned his Vordiplom (B.S.) in Chemistry at the University of Stuttgart (Stuttgart, Germany), his M.S. and PhD in Organic Chemistry at the University of Cincinnati (Cincinnati, OH), and performed post-doctoral research at Harvard Medical School / Massachusetts General Hospital (Boston, MA). He can be contacted at 207-854-0860.