2019 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.
For expert guidance on PT goals, consider the New Poor Lab's Guide to the Regulations
Chemistry
| Routine Chemistry CLIA 2019 | ||
| Analyte or Test | NEW Criteria for AP | OLD AP |
| Alanine aminotransferase (ALT/SGPT) | TV ± 15% | TV ± 20% |
| Albumin | TV ± 8% | TV ± 10% |
| Alkaline Phosphatase | TV ± 20% | TV ± 30% |
| Amylase | TV ± 10% | TV ± 30% |
| AST | TV ± 15% | TV ± 20% |
| Bilirubin, total | TV ±20% | TV ± 20% or 0.4 mg/dL (greater) |
| Blood gas pCO2 | TV ± 5mm 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 ± 30% |
| Cholesterol, low density lipoprotein (direct) | TV ± 20% | None |
| Creatine kinase (CK) | TV ± 20% | TV ± 30% |
| CK-MB isoenzymes | MB elevated (presence or absence) | Same |
| or TV ± 25% (greater) | or TV ± 3SD | |
| 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 ± 8% | TV ± 6 mg/dL or ± 10% (greater) |
| Hemoglobin A1c | TV ± 10% | 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 | ||
| 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 ± 3 SD or positive or negative | TV ± 2 dilutions or pos or neg |
| Antistreptolysin O | TV ± 3 SD or positive or negative | TV ± 2 dilutions or pos or neg |
| Anti-Human Immunodeficiency virus (HIV) | Reactive (pos) or nonreactive (neg) | Same |
| Complement C3 | TV ± 15% or positive or negative | 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) |
| HB3Ag | 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 ± 15% | TV ± 3SD |
| IgE | TV ± 20% | TV ± 3SD |
| IgG | TV ± 20% | TV ± 3SD |
| IgM | TV ± 20% | TV ± 3SD |
| Infectious mononucleosis | Positive or negative | TV ± 2 dilutions or pos or neg |
| Rhematoid factor | TV ± 3 SD or positive or negative | TV ± 2 dilutions or pos or neg |
| Rubella | TV ± 3 SD or positive or negative | TV ± 2 dilutions or pos or neg |
Endocrinology
| Endocrinology CLIA 2019 | ||
| Analyte or Test | NEW Criteria for AP | OLD AP |
| Cancer antigen (CA) 125 | TV ± 20% | None |
| Carcinoembryonic antigen (CEA) | TV ± 15% | 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 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% | TV ± 30% |
Toxicology
| Toxicology CLIA 2019 | ||
| Analyte or Test | NEW Criteria for AP | OLD AP |
| Acetaminophen | TV ± 15% | 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% | TV ± 25% |
| Digoxin | TV ± 15% or ± 2 ng/mL (greater) | None |
| Gentamicin | TV ± 25% | Same |
| Lithium | TV ± 15% | TV ± 0.3 mmol/L or 20% (greater) |
| Phenobarbital | TV ± 15% | TV ± 20% |
| Phenytoin | TV ± 15% or ± 2 mcg/dL (greater) | TV ± 25% |
| Salicylate | TV ± 15% | 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 2019 | ||
| 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 | Same |
| Erythrocyte count | TV ± 4% | TV ± 6% |
| Hematocrit | TV ± 4% | TV ± 6% |
| Hemoglobin | TV ± 4% | TV ± 7% |
| Leukocyte count | TV ± 5% | TV ± 15% |
| Platelet count | TV ± 25% | Same |
| Fibrinogen | TV ± 20% | Same |
| Partial thromboplastin time | TV ± 15% | Same |
| Prothrombin time | TV ± 15% | Same |