What's EP23-P, you ask? It's the guideline for Laboratory Quality Control based on Risk Management. It's the last piece in a trio of guidelines that were launched several years ago to help justify the Equivalent/ "equivocal" QC (EqvQC) practices from the CLIA Final Rule. EP18, EP22, and EP23 were intended to be quickly adopted and, in some ways, retroactively justify, the EqvQC protocols and policies. But, as it quickly became apparent that there wasn't a extant scientific basis on which to build a justification, these guidelines morphed into something else. in a way, the committees were able to concentrate on developing true consensus guidelines, rather than trying to fit a square peg into a round hole
Several important points that Dr. Nichols made:
- Risk Management is something that we do everyday. All of us do some kind of risk management in our daily lives. In the laboratory, we do Risk Management. The EP guidelines are simply creating a more formal protocol.
- Don't expect that the acceptance of CLSI EP18, EP22, EP23, which will occur sometime in early 2011, will lead to the acceptance of EqvQC protocols. It's particularly important to note that CMS is holding off on publishing the next edition of the State Operators Manual until the CLSI guidelines are finished. (To me, this means that CMS will end up modifying their protocols to fit the guidelines, not vice versa.)
- Don't expect hard and fast rules for Risk Management out of these guidelines. While EP18, EP22, and EP23 have their own examples of risk assessment tables, these are not carved in stone. Your laboratory can create its own risk assessment tables. This explains why the EP18 risk assessment table doesn't agree with the tables used in EP22 and EP23. It's not important that they match. what is important is that your laboratory chooses a risk assessment table that it is comfortable with and sticks to it.
- Don't expect that these Risk Management guidelines will always justify reducing QC frequency. When properly done, Risk Managment may actually mandate that you increase the amount and frequency of QC you are doing (Dr. Nichols gave the example of testing in the ER, where test results produce immediate clinical decisions, as a place where the CLIA minimum of 2 controls per day is wholly inadequate.)
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