Quality Requirements
2024 CLIA Acceptance Limits for Proficiency Testing
In 2019 CLIA proposed a new set of quality requirements for proficiency testing. They were updated July 11, 2022. They became official law on July 11,2024.
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Chemistry
Routine Chemistry CLIA 2024 | ||
Analyte or Test | NEW Criteria for AP | OLD AP |
Alanine aminotransferase (ALT/SGPT) | TV ± 15% or ± 6 U/L (greater) | TV ± 20% |
Albumin | TV ± 8% | TV ± 10% |
Alkaline Phosphatase | TV ± 20% | TV ± 30% |
Amylase | TV ± 20% | TV ± 30% |
AST | TV ± 15% or ± 6 U/L (greater) | TV ± 20% |
Bilirubin, total | TV ± 20% or 0.4 mg/dL (greater) | Same |
Blood gas pCO2 | TV ± 5 mm Hg or ± 8% (greater) | Same |
Blood gas pO2 | TV ± 15 mm Hg or ± 15% (greater) | TV ± 3SD |
Blood gas pH | TV ± 0.04 | Same |
B-natriuretic peptide (BNP) | TV ± 30% | None |
Pro B-natriuetic peptide (proBNP) | TV ± 30% | None |
Calcium, total | TV ± 1.0 mg/dL | Same |
Carbon dioxide | TV ± 20% | None |
Chloride | TV ± 5% | Same |
Cholesterol, total | TV ± 10% | Same |
Cholesterol, high density liprotein | TV ± 20% TV or ± 6 mg/dL (greater) | TV ± 30% |
Cholesterol, low density lipoprotein (direct) | TV ± 20% | None |
Creatine kinase (CK) | TV ± 20% | TV ± 30% |
CK-MB isoenzymes | TV ± 25% TV or ± 3 ng/mL (greater) or MB elevated (presence or absence) |
MB elevated (presence or absence) |
Creatinine | TV ± 0.2 mg/dL or ± 10% (greater) | TV ± 0.3 mg/dL or ± 15% (greater) |
Ferritin | TV ± 20% | None |
Gamma glutamyl transferase | TV ± 5 U/L or ±15% (greater) | None |
Glucose (excluding FDA home use) | TV ± 6 mg/dL or ± 8% (greater) | TV ± 6 mg/dL or ± 10% (greater) |
Hemoglobin A1c | TV ± 8% | None |
Iron, total | TV ± 15% | TV ± 20% |
Lactate dehydrogenase (LDH) | TV ± 15% | TV ± 20% |
Magnesium | TV ± 15% | TV ± 25% |
Phosphorus | TV ± 0.3 mg/dL or 10% (greater) | None |
Potassium | TV ± 0.3 mmol/L | TV ± 0.5 mmol/L |
Prostate Specific Antigen, total | TV ± 0.2 ng/mL or 20% (greater) | None |
Sodium | TV ± 4 mmol/L | Same |
Total Iron Binding Capacity (direct) | TV ± 20% | None |
Total Protein | TV ± 8% | TV ± 10% |
Triglycerides | TV ± 15% | TV ± 25% |
Troponin I | TV ± 0.9 ng/mL or 30% (greater) | None |
Troponin T | TV ± 0.2 ng/mL or 30% (greater) | None |
Urea Nitrogen | TV ± 2 mg/dL or ± 9% (greater) | Same |
Uric Acid | TV ± 10% | TV ± 17% |
Immunology
Immunology CLIA 2019-2024 | ||
Analyte or Test | NEW Criteria for AP | OLD AP |
Alpha-1 antitrypsin | TV ± 20% or positive or negative | TV ± 3 SD |
Alpha-fetoprotein (tumor marker) | TV ± 20% or positive or negative | TV ± 3 SD |
Antinuclear antibody | TV ± 2 dilutions or pos or neg | same |
Antistreptolysin O | TV ± 2 dilutions or pos or neg | same |
Anti-Human Immunodeficiency virus (HIV) | Reactive (pos) or nonreactive (neg) | Same |
Complement C3 | TV ± 15% | TV ± 3 SD |
Complement C4 | TV ± 5 mg/dL or ± 20% (greater) | TV ± 3 SD |
C-reactive protein (HS) | TV ± 1 mg/L or ± 30% (greater) | None |
HBsAg | Reactive (pos) or nonreactive (neg) | Reactive (pos) or nonreactive (neg) |
anti-HBc | Reactive (pos) or nonreactive (neg) | Reactive (pos) or nonreactive (neg) |
HBeAg | Reactive (pos) or nonreactive (neg) | Reactive (pos) or nonreactive (neg) |
Anti-HBs | Reactive (pos) or nonreactive (neg) | Reactive (pos) or nonreactive (neg) |
Anti-HCV | Reactive (pos) or nonreactive (neg) | Reactive (pos) or nonreactive (neg) |
IgA | TV ± 20% | TV ± 3SD |
IgE | TV ± 20% | TV ± 3SD |
IgG | TV ± 20% | TV ± 3SD |
IgM | TV ± 20% | TV ± 3SD |
Infectious mononucleosis | TV ± 2 dilutions or pos or neg | same |
Rhematoid factor | TV ± 2 dilutions or pos or neg | same |
Rubella | TV ± 2 dilutions or pos or neg or immune or nonimmune |
same |
Endocrinology
Endocrinology CLIA 2024 | ||
Analyte or Test | NEW Criteria for AP | OLD AP |
Cancer antigen (CA) 125 | TV ± 20% | None |
Carcinoembryonic antigen (CEA) | TV ± 15% or ± 1 ng/dL (greater) | None |
Cortisol | TV ± 20% | TV ± 25% |
Estradiol | TV ± 30% | None |
Folate, serum | TV ± 1 ng/mL or ± 30% (greater) | None |
Follicle stimulating hormone | TV ± 2 IU/L or ± 18% (greater) | None |
Free throxine | TV ± 0.3 ng/dL or ± 15% (greater) | TV ± 3SD |
Human chorionic gonadotropin | TV ± 18% or ± 3 mIU/mL (greater) or positive or negative |
TV ± 3SD or positive or negative |
Luteinizing hormone | TV ± 20% | None |
Parathyroid hormone | TV ± 30% | None |
Progesterone | TV ± 25% | None |
Prolactin | TV ± 20% | None |
Testosterone | TV ± 20 ng/dL or ±30% (greater) | None |
T3 uptake | TV ± 18% | TV ± 3SD |
Triiodothyronine | TV ± 30% | TV ± 3SD |
Thyroid stimulating hormone | TV ± 20% or ± 0.2 mIU/L (greater) | TV ± 3SD |
Thyroxine | TV ± 20% or ± 1.0 mcg/dL (greater) | Same |
Vitamin B12 | TV ± 25% or ± 30 pg/mL (greater) | TV ± 30% |
Toxicology
Toxicology CLIA 2024 | ||
Analyte or Test | NEW Criteria for AP | OLD AP |
Acetaminophen | TV ± 15% or or ± 3 mcg/mL (greater) | None |
Alcohol, blood | TV ± 20% | TV ± 25% |
Blood lead | TV ± 10% or 2mcg/dL (greater) | TV ± 10% or ±4 mcg/dL (greater) |
Carbamazepine | TV ± 20% or ± 1.0 mcg/mL (greater) | TV ± 25% |
Digoxin | TV ± 15% or ± 0.2 ng/mL (greater) | None |
Gentamicin | TV ± 25% | Same |
Lithium | TV ± 15% or ± 0.3 mmol/L (greater) | TV ± 0.3 mmol/L or 20% (greater) |
Phenobarbital | TV ± 15% or ± 2 mcg/mL (greater) | TV ± 20% |
Phenytoin | TV ± 15% or ± 2 mcg/mL (greater) | TV ± 25% |
Salicylate | TV ± 15% or ± 2 mcg/mL (greater) | None |
Theophylline | TV ± 20% | TV ± 25% |
Tobramycin | TV ± 20% | TV ± 25% |
Valproic acid | TV ± 20% | TV ± 25% |
Vancomycin | TV ± 15% or ± 2 mcg/mL (greater) | None |
Hematology
Hematology CLIA 2024 | ||
Analyte or Test | NEW Criteria for AP | OLD AP |
Cell identification | 80% or greater consensus | 90% or greater consensus |
White blood cell differential | TV ± 3 SD based on the % of different types of white blood cells in the samples |
Same |
Erythrocyte count | TV ± 4% | TV ± 6% |
Hematocrit | TV ± 4% | TV ± 6% |
Hemoglobin | TV ± 4% | TV ± 7% |
Leukocyte count | TV ± 10% | TV ± 15% |
Platelet count | TV ± 25% | Same |
Fibrinogen | TV ± 20% | Same |
Partial thromboplastin time | TV ± 15% | Same |
Prothrombin time | TV ± 15% | Same |