CLIA and Quality Requirements
2024 CLIA Acceptance Limits for Proficiency Testing
In 2019 CLIA proposed a new set of quality requirements for proficiency testing. In July 11, 2022, the updated those goals. In July 11, 2024, those goals became official.
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 ± 0.3 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/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/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 |
| Tyroid 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 |
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 |