Resistance in CLSI standards

As a consultant, much of my work are projects that I suggest. As might be expected, I have to sell people on these ideas. Sometimes, it is clear that stated objections are not the real reason the client doesn’t want to do the project. This is known as resistance and takes on many forms such as “great idea, let’s do it on the next project” or “great idea, but our problem is different” or “I just don’t understand.”

There have been some reject votes for the revised CLSI total error standard, EP21. Based on several discussions, the two major objections look like resistance. Here’s why.

The first objection is that EP21 is too complicated. Now the people who voted to reject EP21 are all senior people in the field of clinical chemistry. EP21 involves graphing differences between a new and comparison method. In one plot the differences are manipulated with subtractions. This is probably the simplest of all the CLSI evaluation documents.

The second objection is that the revised document includes total error from any source that is present in the evaluation protocol (not just analytical error). So what does this mean? Well, if one were going to evaluate a POC device such as a glucose meter which had fingersticks as a valid sample mode, the evaluation should employ fingersticks as the sampling method for the POC glucose meter under test. It is likely that the comparison method would be a laboratory glucose instrument using a venous sample. This means that differences between test and comparison will include errors due to improper fingerstick technique, which is a user error, not an analytical error. This is appropriate because the goal of the evaluation is to estimate performance in routine use.

So what were the objections? We can’t be expected to evaluate all pre- and post-analytical errors such as problems with the LIS. Let’s develop a new standard for pre- and post-analytical errors.

But the revised EP21 does not suggest evaluating all pre- and post-analytical errors, it advises one not to exclude the opportunity for relevant errors in the protocol, such as the glucose example above.

The consultant’s task is to expose objections that have no merit.


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