Ability of the 1(2)s rule to detect substandard performance in interlaboratory proficiency testing.

The most common evaluation criterion used by regulatory and voluntary interlaboratory proficiency testing (PT) programs to judge the quality of chemistry results is based on the group mean +/- 2.0 standard deviations (SD), the 1(2)s rule. The mean and SD are those of the selected PT population. Through computer simulations we have quantified, for the first time, the ability of the 1(2)s criterion to detect "acceptable" as well as substandard ("unacceptable") intralaboratory performance by PT. We found that the 1(2)s rule correctly identifies "acceptable" performance--i.e., low intralaboratory coefficient of variation (CV) values and small bias values--greater than 90% of the time. However, this criterion fails to detect laboratories with "unacceptable" bias and (or) CV at least 23% of the time. The high failure rate of the 1(2)s rule raises serious questions about its appropriateness for use by PT programs.