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The Quality of Laboratory Testing Today
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2006
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MeasurementLaboratory Testing TodayEducationUnited StatesLogistic AnalysisProficiency TestingDiagnostic TestClinical EpidemiologyClinical TrialsExperimental TestingLaboratory ManagementApplied MeasurementBiostatisticsClinical ChemistryInstrumentationDisease AssessmentLaboratory MedicineClinical EvaluationLaboratory MethodAnalytic QualityDiagnostic CriterionOutcomes ResearchLaboratory ComparisonsEpidemiologySoftware TestingClinical MeasurementMedicine
The study assessed the analytic quality of laboratory testing in the United States using proficiency testing survey data from CLIA‑compliant national programs. The authors evaluated regulated and nonregulated tests—cholesterol, glucose, calcium, fibrinogen, prothrombin time, INR, glycohemoglobin, and PSA—using proficiency testing data and σ‑scale performance metrics based on CLIA criteria. The results show that laboratory test quality falls short of world‑class standards, indicating a need for better measurement performance and stricter quality control beyond the CLIA minimum of two daily levels.
To assess the analytic quality of laboratory testing in the United States, we obtained proficiency testing survey results from several national programs that comply with Clinical Laboratory Improvement Amendments (CLIA) regulations. We studied regulated tests (cholesterol, glucose, calcium, fibrinogen, and prothrombin time) and nonregulated tests (international normalized ratio [INR], glycohemoglobin, and prostate-specific antigen [PSA]). Quality was assessed on the σ scale with a benchmark for minimum process performance of 3 σ and a goal for world-class quality of 6 σ. Based on the CLIA criteria for acceptable performance in proficiency testing (allowable total errors [TEa]), the national quality of cholesterol testing values as 2.9 to 3.0; glucose (TEa = 10%) estimated σ (TEa = 10%), 2.9 to 3.3; calcium (TEa = 1.0 mg/dL), 2.8 to 3.0; prothrombin time (TEa = 15%), 1.8; INR (TEa = 20%), 2.4 to 3.5; fibrinogen (TEa = 20%), 1.8 to 3.2; glycohemoglobin (TEa = 10%), 1.9 to 2.6; and PSA (TEa = 10%), 1.2 to 1.8. The analytic quality of laboratory tests requires improvement in measurement performance and more intensive quality control monitoring than the CLIA minimum of 2 levels per day.