Certification of cholesterol measurements by the National Reference Method Laboratory Network with routine clinical specimens: Effects of network laboratory bias and imprecision

S. T. Bennett, J. H. Eckfeldt, J. D. Belcher, D. P. Connelly

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

Abstract

The National Reference Method Laboratory Network has initiated a program to certify clinical laboratory cholesterol measurement performance by using routine clinical specimens. Clinical laboratory and reference laboratory measurements of split samples are used to assess whether the clinical laboratory is meeting the Laboratory Standardization Panel's goals for accuracy and precision. We used a computer-based Monte Carlo simulation model of split-sample proficiency testing to evaluate the certification program and, in particular, to analyze the effects of reference laboratory bias and imprecision. Results of our simulations indicate that the accuracy of the certification program is strongly influenced by reference laboratory bias and less influenced by reference laboratory imprecision. The certification program is potentially highly accurate, but unless reference laboratory bias is tightly controlled, the number of classification errors may limit its utility. Moreover, the decision limit of the certification program needs to be higher than the Laboratory Standardization Panel's goal (3.5% instead of 3.0%) to ensure that an acceptably high proportion of well-performing clinical laboratories can become certified.

Original languageEnglish (US)
Pages (from-to)651-657
Number of pages7
JournalClinical chemistry
Volume38
Issue number5
DOIs
StatePublished - 1992

Keywords

  • computer-simulation models
  • proficiency testing
  • quality control
  • receiver- operating characteristic curves

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