CLIA88 美国临床分析质量要求.docVIP

CLIA Requirements for Analytical Quality The tables below contain information on CLIA proficiency testing criteria for acceptable analytical performance, as printed in the Federal Register February 28, 1992;57(40):7002-186. These guidelines for acceptable performance can be used as Analytical Quality Requirements in the Westgard QC Design and Planning process. Routine Chemistry Test or Analyte Acceptable Performance Alanine aminotransferase Target value ± 20% Albumin Target value ± 10% Alkaline phosphatase Target value ± 30% Amylase Target value ± 30% Aspartate aminotransferase (AST) Target value ± 20% Bilirubin, total Target value ± 0.4 mg/dL or ± 20% (greater) Blood gas p02 Target value ± 3 SD Blood gas pCO2 Target value ± 5 mm Hg or ± 8% (greater) Blood gas pH Target value ± 0.04 Calcium, total Target value ± 1.0 mg/dL Chloride Target value ± 5% Cholesterol, total Target value ± 10% Cholesterol, high dens. lipoprotein Target value ± 30% Creatine kinase Target value ± 30% Creatine kinase isoenzymes MB elevated (present or absent) or Target value ± 3 SD Creatinine Creatinine Target value ± 0.3 mg/dL or ± 15% (greater) Glucose Target value ± 6 mg/dL or ± 10% (greater) Iron, total Target value ± 20% Lactate dehydrogenase (LDH) Target value ± 20% LDH isoenzymes LDH1/LDH2 (+ or -) or Target value ± 30% Magnesium Target value ± 25% Potassium Target value ± 0.5 mmol/L Sodium Target value ± 4 mmol/L Total protein Target value ± 10% Triglycerides Target value ± 25% Urea Nitrogen Target value ± 2 mg/dL or ± 9% (greater) Uric acid Target value ± 17% Toxicology Alcohol, blood Target value ± 25% Blood lead Target value ± 10% or ± 4 mcg/dL (greater) Carbamazepine Target value ± 25% Digoxin Target value ± 20% or ± 0.2 ng/mL (greater) Ethosuximide Target value ± 20% Gentamicin Target value ± 25% Lithium Target value ± 0.3 mmol/L or ± 20% (greater) Phenobarbital Target value ± 20% Phenytoin Target value ± 25% Primidone Target value ± 25% Procainamide (and metabolite) Target valu