Posted by Sten Westgard, MS
Dr. Westgard had the pleasure of taking part in the Bio-Rad industry workshop on July 17th, which was focused on Quality Control for the Future - Risk Management EP23 for Laboratories.
2012 is the "launch" year for CLSI's new EP23 guideline. EP23 may have been accepted as a guideline last year, but the marketing and promotion of the guideline is taking place in strength this year.
The current issue of Clinical Lab News even had an "advertorial" devoted to EP23, a 2-page spread of promotional description. This is an unusual step for CLSI, adopting a promotional and advertising approach for their guidelines. The traditional way to introduce and promulgate a CLSI guideline is to publish scientific articles about them, not launch an ad campaign. (The core guidelines around method validation, EP5 and EP9 for instance, never got their own centerfold in a trade journal. Evidently times are changing.)
EP23 is about Risk, Risk Analysis, Risk Management, and techniques like Failure Mode Effect Assessment (FMEA). How risky is it to reduce your QC frequency? EP23 is the guideline that's supposed to help you decide. Is running QC once a month good enough for your patients? Is it an acceptable risk if you find out a day, a week, or a month later that the test result you reported to the clinician was the wrong result? Well, that's the risk you will decide to run with EP23.
Dr. Westgard discussed some of these Risk concepts and how to make them as quantitative and evidence-based as possible. Dr. Curt Parvin discussed an even more rigorous approach, a formula which could in fact determine the optimal frequency of running QC. Whether Parvin's approach will be adopted as part of EP23's implementation remains an open question.
We are still waiting to hear the other shoe drop on EP23, because while the guideline has been published, the CMS implementation of it has not been officially described. While CMS and CLSI are talking about how it might be implemented, and giving out bullet points on why we should accept "Risk QC Plans," no specifics have been released in the regulations (when specifics do appear, they will appear in the SOM, the State Operations Manual). Then we'll have to wait for yet another shoe to drop, as it will take time for CAP, TJC, and COLA to figure out how it's possible to inspect labs that choose EP23. As we've seen in previous regulatory changes, the accrediation agencies will probably initially resist the adoption of "Risk QC" into laboratory practice, but ultimately they will get "deemed" into accepting it - CMS will force them to accept these practices as part of the deeming process.
Dr. Parvin and Dr. Westgard
Thanks to Bio-Rad for sponsoring this workshop on this topic. It's a new and evolving development in quality management, and the last decade has been a roller coaster ride (Hello EQC, Goodbye EQC, Hello Risk QC, and then?).
In other words, stay tuned.
Some useful links: