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Quality Requirements

2024 CLIA Proposed Acceptance Limits for Proficiency Testing

In 2019 CLIA proposed a new set  of quality requirements for proficiency testing. Here's what was listed in the Federal Register for public comment. UPDATED! July 11, 2022: new goals slated for implementation in 2024! 23 changes for the 2024 goals - highlight in bold!!

2021 Poor Labs Guide

For expert guidance on PT goals, consider the New Poor Lab's Guide to the Regulations

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 ± 10% 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 ± 0.2 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/dL 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/dL 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 ± 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/dL (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/dL (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/dL (greater) TV ± 25%
Salicylate TV ± 15% or ± 2 mcg/dL (greater) None
Theophylline TV ± 20% TV ± 25%
Tobramycin TV ± 20% TV ± 25%
Valproic acid TV ± 20% TV ± 25%
Vancomycin TV ± 15% or ± 2 mcg/dL (greater) None
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