Resistance in CLSI standards

November 18, 2009

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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It means just what I choose it to mean

November 14, 2009

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I previously commented that the title of EP23 makes no sense.

The EP23 subcommittee’s response to my comment is that my use of “quality control” is not what is meant in EP23.

EP22 and EP23 were originally proposed to deal with CMS’s proposal for equivalent quality control. This use of quality control clearly meant running 2 liquid control samples per day for each assay. This is how I used the term quality control, how it is used in principle in virtually any text about quality control  (which is of course uses quality control for processes other than the clinical laboratory), and how most people will understand it.

EP23 now defines quality control as “part of quality management focused on fulfilling quality requirements (ISO 9000).  Curiously, their cited reference  contains the following:

“ISO. An action to eliminate the cause of a detected non-conformity or other undesirable situation. ISO 9000. Geneva, Switzerland: International Organization for Standardization; 2005  3.6.5.”

This is the definition of a corrective action.

The problem is that EP23 is calling all corrective actions and preventive actions “quality control.” Perhaps this is to conform to some ISO terminology – I don’t have ISO 9000:2005. This is unnecessarily confusing and almost everyone will misinterpret what EP23 calls quality control.