European and US clinical laboratory quality

I am somewhat skeptical about the statement in a recent Westgard essay which suggests that Europeans  who use ISO 15189 to help with accreditation are more likely to improve quality in their laboratories than US laboratories, who just try to meet minimum CLIA standards. ISO 15189 is much like ISO 9001, which  is used for businesses. I have previously written that ISO 9001 certification plays no role in improving quality for diagnostic companies (1). As an example of ISO 15189 guidance – albeit in the version I have which is from 2002 – under the section “Resolution of complaints”, ISO 15189 says the laboratory should have a policy and procedures for the resolution of complaints. In ISO 17025, which is a similar standard, virtually the identical passage occurs.

Westgard mentions that clinical laboratories need a way to estimate uncertainty that is more practical than the ISO GUM standard and mentions a CLSI subcommittee which is working on this. A more practical way will be unlikely. I was on that subcommittee. I didn’t want to participate at first, since I don’t agree that clinical laboratories should estimate uncertainty according to GUM (2). However, the chair holder wanted me for my contrarian stance, so I joined. I must say that I enjoyed being on the subcommittee, which had a lot of smart people and an open dialog. However, I was unable to convince anyone of my point of view and therefore resigned, because it would make no sense to be both an author of this document and reference 2. The last version of this document I saw was 80 pages long (half of it an Appendix) with many equations. This version will not be understood by most (any?) clinical laboratories. However, there is a CLSI document that allows one to estimate uncertainty intervals easily, EP21A, although not according to GUM.

What is needed to improve clinical laboratory quality anywhere? Policies that emphasize measuring error rates such as FRACAS (3).


  1. Krouwer JS: ISO 9001 has had no effect on quality in the in-vitro medical diagnostics industry. Accred. Qual. Assur. 2004;9:39-43.
  2. Krouwer JS: A Critique of the GUM Method of Estimating and Reporting Uncertainty in Diagnostic Assays Clin. Chem., 49:1818 -1821 (2003).
  3. Krouwer JS: Using a Learning Curve Approach to Reduce Laboratory Error, Accred. Qual. Assur., 7: 461-467 (2002).



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