1990 Medicare/CLIA final rules for proficiency testing: minimum intralaboratory performance characteristics (CV and bias) needed to pass

Abstract On March 14, 1990, the Centers for Disease Control and the Health Care Financing Administration published criteria for defining minimum performance in proficiency testing (PT). Using our previously described computer modeling technique, we determined the likelihood of passing PT under the new rules. The model relates combinations of intralaboratory CV and bias to PT performance criteria. For example, a laboratory with a bias of zero and an internal CV of 5% will pass a 10% fixed-limit PT criterion (i.e., the criterion for glucose analyses) 98% of the time when five samples are used. The model provides similar analyses for all PT criteria and all relevant combinations of CV and bias. The probability of passing PT decreases as the number of analytes tested increases, i.e., from 98% to 37% as the number of analytes increases from 1 to 20. A laboratory's internal CV has a greater effect on the outcome of PT than do the corresponding bias values. We conclude that a laboratory that operates with methods that have internal CVs less than or equal to 33% and biases less than or equal to 20% of the PT criteria will have a greater than 99% chance of passing PT.