CLSI and conflict of interest


CLSI (Clinical And Laboratory and Standards Institute) formerly NCCLS, develops consensus based standards in laboratory medicine.

I have previously commented on a standard that CLSI cancelled (EP11 – Uniformity of Claims) even though it had passed the consensus process.

As head of the working group on revising EP21 (Total Error), I receive all of the consensus comments. One of them, accompanied by a reject vote is troubling and comes from the chairholder of the Area Committee on Evaluation Protocols.

The chairholder seems to be unfamiliar with EP21 since he treats it as if it were a new document. It has been out for six years with the current draft a minor revision. One would have hoped that the chairholder would be more familiar with documents he is supposed to manage (e.g. EP21). Moreover, to comment largely about the existing document after the working group has completed its revision is poor management.

The chairholder’s comments made me question how someone with such little knowledge about these topics could be the area committee chair. EP21 is an extremely simple standard. All one does is plot differences between a candidate and comparative method. There is no mathematical modeling like more involved total error methods. Yet the comment was that this standard is too complicated. So perhaps this is a tactic –  if something is simple, call it complicated. Other comments followed this pattern.

But the real problem is the chairholder’s complaint that EP21 is a departure from Westgard’s method for estimating total error. As a standard, EP21 relies on peer reviewed literature. Apparently, the area committee chair is unfamiliar with this literature (1-8) but the concern is that the commentator’s company has a financial relationship with Westgard’s company. This conflict of interest should not be allowed to occur at CLSI.


  1. Jan S. Krouwer: Estimating Total Analytical Error and Its Sources: Techniques to Improve Method Evaluation. Arch Pathol Lab Med., 116, 726-731 (1992).
  2. Jan S. Krouwer and Katherine L Monti: A Simple Graphical Method to Evaluate Laboratory Assays, Eur. J. Clin. Chem. and Clin. Biochem., 33, 525-527 (1995).
  3. Jan S. Krouwer: Evaluation of Assay Systems. Clin. Chem. News, 27, 10-14 March 2001
  4. Jan S. Krouwer: Setting Performance Goals and Evaluating Total Analytical Error for Diagnostic Assays. Clin. Chem., 48: 919-927 (2002).
  5. Jan S. Krouwer: Recommendation to treat continuous variable errors like attribute errors. Clin Chem Lab Med 2006;44(7):797–798.
  6. Jan S. Krouwer: How to Improve Total Error Modeling by Accounting for Error Sources Beyond Imprecision and Bias, Clin. Chem., 47, 1329-30 (2001).
  7. Jan S. Krouwer: Problems with the NCEP (National Cholesterol Education Program) Recommendations for Cholesterol Analytical Performance. Arch Pathol Lab Med 127, 1249 (2003).
  8. Jan S. Krouwer: A recommended improvement for specifying and estimating serum creatinine performance. Clin Chem 2007;53:1715-1716.

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