CLSI continues to ignore important error sources in its evaluation protocols

The majority of errors in the laboratory are not analytical errors but pre- and post-analytical errors. These errors are due to process failures such as using too little sample, analyzing a hemolyzed sample, or failing to withhold results if QC is out.

It is unbelievable to me that EP23 – CLSI’s newest document on risk management specifically excludes pre- and post-analytical errors (see introduction). In a previous post, I commented that EP23 ignored pre- and post-analytical errors but didn’t realize that this exclusion is actually written into the document. Crazy. There are already a slew of CLSI standards to deal with analytical error and risk management is the perfect way to reduce the risk of pre- and post-analytical errors.

And now there is new push back about CLSI’s revised document about total error (EP21-A2). The complaint is about EP21 dealing with “pre- and post- analytical error sources, including those which are not due to the test method”. So if a patient is harmed because a clinician made an incorrect medical decision due to an error in the lab test result, who would try to say that the error was not due to the test method (because it was pre- or post- analytical). Crazy, again. Back in 1987, the ADA (American Diabetes Association) came out with a standard for glucose meters, whose goal was for “total error (user plus analytical)”.

 

 

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