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.

Accuracy and precision of hemoglobin point‐of‐care testing during major pediatric surgery

“…All values were within the requested range (SD 0.5 g/dL) of the published proficiency testing program (Clinical Laboratory Improvement Act 1990, Ehrmeyer et al. , 1990).…”

Discrepancies in Electrolyte Measurements by Direct and Indirect Ion Selective Electrodes due to Interferences by Proteins and Lipids

“…This limit is well within range given by the U.S. Clinical Laboratory Improvement Amendments (CLIA) 1988 guidelines for K + . 20 For Na + , the limit given by the CLIA guidelines is ±4 mmol/L. 15 In spite of taking ± 5 mmol/L as our limit, which is more than the recommended limit, the number of samples showing disagreement were high.…”

Accuracy of a Portable Blood Gas Analyzer Incorporating Optodes for Canine Blood

“…To examine agreement between new and old methods of clinical measurement, Bland and Altman suggested that if the data points encompassed by the mean differences Ϯ 2 SD are not clinically important, then the 2 methods may be used interchangeably. 4 MacIntyre, who demonstrated accuracy of the OPTI 1 for human blood, used the following criteria for further evaluation of interchangeability of instruments, according to the criteria necessary to pass proficiency testing 5 : 80% of data points should be within Ϯ 0.04 pH unit, Ϯ 5 mm Hg of a PCO 2 , and Ϯ 15.51 mm Hg of a PO 2 of a standard analyzer. 2 All the data points of this study encompassed by the mean difference Ϯ 2 SD on the Bland-Altman plots met the criteria defined by MacIntyre (Fig 1A-C).…”