Posted by Sten Westgard, MS
As we wait for more details about EP23 and how CMS and CLIA will actually enforce the implementation of Risk QC, the latest morsels to emerge are quite tantalizing.
On the CLSI website, a Q&A has been posted. Here is one interesting bit:
"3. Is there a planned format for documenting the EP23 QCP to present to surveyors?
There is no specific format that is required for the presentation of a QCP. The example in EP23 and those currently being drafted for future education will present some options, but laboratory directors have flexibility in the formatting of their QCPs. There may be some elements, components, or data that the Centers for Medicare & Medicaid Services (CMS) will look for when assessing compliance, but nothing standard."
This is an interesting question and an even more intriguing answer. The new standard will have "nothing standard" about its implementation. Presumably labs that use the workbooks sold by CLSI will be able to fulfill any requirements for proper design of Individual QC Plans.
So why won't there be a standard QC Plan format?
With EQC, labs were required to perform validation protocols, known as Options 1, 2, and 3. These protocols had specific requirements for data collection and duration, and in fact those protocols were one of the key failures in EQC, since they were unscientific and arbitrary.
There is an old North Dakota joke that comes to mind:
"What did the North Dakotan do when he learned most accidents occur within five miles of home?
The most obvious remedy to the problem with EQC validation protocols would have been to develop a new standard with more scientific validation protocols. This answer may indicate that the opposite lesson may have been learned: avoid any specific, standard protocol for validation, so that there's nothing to scrutinize or evaluate.
There's a good argument to be made that the EP23 standard and its protocols need to be flexible to accommodate all the different types of laboratories that will implement it. There's also a good argument to be made that we have to be able to establish some minimum level of performance in laboratory testing through this or any guideline. The challenge is to strike the best balance of practical, flexible, and safe.
That said, this is only a Q&A, a short answer that we might be over-interpreting. We are still waiting to hear how Risk QC, Individual QC Plans, and Risk Analysis will be rolled out in the regulations. We've got at least 2 years before EQC is eliminated and IQCPs come into full force. I'm sure it's going to be an interesting two years...
*[Dr. Westgard is from North Dakota, thus it's not too terrible that he gave me a book of North Dakota jokes when I was young. It is, however, definitely strange that I still remember them.]