This table contains 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 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 |
|
|
Theophylline |
Target value ±; 25% |
|
Tobramycin |
Target value ±; 25% |
|
Procainamide (and metabolite) |
Target value ±; 25% |
|
Quinidine |
Target value ±; 25% |
|
Valproic acid |
Target value ±; 25% |
|
Hematology |
|
|
Test or Analyte |
Acceptable Performance |
|
Cell identification |
90% or greater consensus on identification |
|
White cell differentiation |
Target ±; 3 SD based on percentage of different types of white cells |
|
Erythrocyte count |
Target ±; 6% |
|
Hematocrit |
Target ±; 6% |
|
Hemoglobin |
Target ±; 7% |
|
Leukocyte count |
Target ±; 15% |
|
Platelet count |
Target ±; 25% |
|
Fibrinogen |
Target ±; 20% |
|
Partial thromboplastin time |
Target ±; 15% |
|
Prothrombin time |
Target ±; 15% |
|
Endocrinology |
|
|
Test or Analyte |
Acceptable Performance |
|
Cortisol |
Target value ±; 25% |
|
Free thyroxine |
Target value ±; 3 SD |
|
Human chorionic gonadotropin |
Target value ±; 3 SD or (positive or negative) |
|
T3 uptake |
Target value ±; 3 SD by method |
|
Triiodothyronine |
Target value ±; 3 SD |
|
Thyroid stimulating hormone |
Target value ±; 3 SD |
|
Thyroxine |
Target value ±; 20% or 1.0 mcg/dL (greater) |
|
General immunology |
|
|
Test or Analyte |
Acceptable Performance |
|
Alpha-1 antitrypsin |
Target value ±; 3 SD |
|
Alpha-fetoprotein |
Target value ±; 3 SD |
|
Antinuclear antibody |
Target value ±; 2 dilution or (pos. or neg.) |
|
Antistreptolysin O |
Target value ±; 2 dilution or (pos. or neg.) |
|
Anti-Human Immunodeficiency virus |
Reaction or nonreactive |
|
Complement C3 |
Target value ±; 3 SD |
|
Complement C4 |
Target value ±; 3 SD |
|
Hepatitis (HBsAg, anti-HBc, HBeAg) |
Reactive (positive) or nonreactive (negative) |
|
IgA |
Target value ±; 3 SD |
|
IgE |
Target value ±; 3 SD |
|
IgG |
Target value ±; 25% |
|
IgM |
Target value ±; 3 SD |
|
Infectious mononucleosis |
Target value ±; 2 dilution or (pos. or neg.) |
|
Rheumatoid factor |
Target value ±; 2 dilution or (pos. or neg.) |
|
Rubella |
Target value ±; 2 dilution or (pos. or neg.) |
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