Tools, Technologies and Training for Healthcare Laboratories

Quality Requirements

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.

 

 

Poor Lab's Guide to the Regulations
The Poor Lab's Guide to the Regulations

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:

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 (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%

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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 or ± 20% (greater)
Phenobarbital Target value ± 20%
Phenytoin Target value ± 25%
Primidone Target value ± 25%
Procainamide (and metabolite) Target value ± 25%
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 time Target ± 15%
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 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)

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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 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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