CLIA Requirements for Analytical Quality 1992
The tables below contain information on CLIA proficiency testing criteria for acceptable analytical performance, as printed in the Federal Register. NOTE: This page shows goals that will EXPIRE in July 2024. The new goals take effect on January 1st, 2025, when proficiency testing organizations begin enforcing the new goals.
For more guidance on CLIA, consider 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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