CLIA Proficiency Testing criteria
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.
CLIA Final Rules for Quality System
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.
You can skip ahead to specific areas of laboratory tests by clicking
on the listed items:
Routine Chemistry
Toxicology
Hematology
Endocrinology
General Immunology
Note: Analytical Quality Requirements are a plus/minus percentage. Some browsers may not display the
plus/minus character (it should appear right here, ±. If it does not, your browser does not support this
character).
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 Target value ± 20%
(AST)
Bilirubin, total Target value ± 0.4 mg/dL
or ± 20% (greater)
Blood gas p02 Target value ± 3 SD
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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. Target value ±
30%
lipoprotein
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 Target value ± 20%
(LDH)
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%
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Note: Analytical Quality Requirements are a plus/minus percentage. Some browsers may not display the
plus/minus character (it should appear right here, ±. If it does not, your browser does not support this
character).
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
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or ± 20% (greater)
Phenobarbital Target value ± 20%
Phenytoin Target value ± 25%
Primidone Target value ± 25%
Procainamide (and Target value ± 25%
metabolite)
Quinidine Target value ± 25%
Theophylline Target value ± 25%
Tobramycin Target value ± 25%
Valproic acid Target value ± 25%
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Note: Analytical Quality Requirements are a plus/minus percentage. Some browsers may not display the
plus/minus character (it should appear right here, ±. If it does not, your browser does not support this
character).
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 Target ± 15%
time
Prothrombin time Target ± 15%
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Note: Analytical Quality Requirements are a plus/minus percentage. Some browsers may not display the
plus/minus character (it should appear right here, ±. If it does not, your browser does not support this
character).
Endocrinology
Test or Analyte Acceptable Performance
Cortisol Target value ± 25%
Free thyroxine Target value ± 3 SD
Human chorionic Target value ± 3 SD or
gonadotropin (positive or negative)
T3 uptake Target value ± 3 SD by
method
Triiodothyronine Target value ± 3 SD
Thyroid stimulating Target value ± 3 SD
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hormone
Thyroxine Target value ± 20% or 1.0
mcg/dL (greater)
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Note: Analytical Quality Requirements are a plus/minus percentage. Some browsers may not display the
plus/minus character (it should appear right here, ±. If it does not, your browser does not support this
character).
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 Reaction or nonreactive
Immunodeficiency virus
Complement C3 Target value ± 3 SD
Complement C4 Target value ± 3 SD
Hepatitis (HBsAg, Reactive (positive) or
anti-HBc, HBeAg) 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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