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  CLIA Regulated Analytes

 

 

 

Updated June 4, 2010

Participation in proficiency testing is required for analytes listed in the CLIA’ 88 regulation and analyzed by non-waived methods. As such, these analytes require enrollment in a Centers for Medicare and Medicaid Services (CMS) approved proficiency testing (PT) program. The frequency for this required PT is five challenges three times per year (exception is Mycobacteriology which requires five challenges two times per year). Following is a list of the analytes regulated by CMS.

Routine Chemistry

  • Alanine Aminotransferase (ALT)
  • Albumin
  • Alkaline Phosphatase
  • Amylase
  • Aspartate Aminotransferase (AST)
  • Bilirubin, Total
  • Blood Gases (pH/pO2/PCO2)
  • Calcium, Total
  • Chloride
  • Cholesterol, Total
  • Cholesterol, HDL
  • Creatine Kinase
  • Creatine Kinase, Isoenzyme (CKMB)
  • Creatinine
  • Glucose (excluding devices cleared by FDA for home use)
  • Iron, Total
  • Lactate Dehydrogenase (LDH)
  • LDH, Isoenzyme
  • Magnesium
  • Potassium
  • Sodium
  • Protein, Total
  • Triglycerides
  • Urea Nitrogen (BUN)
  • Uric Acid

Endocrinology

  • Cortisol
  • Free Thyroxine (Free T4)
  • Human Chorionic Gonadotropin (hCG) (exluding urine qualitative hCG)
  • T3 Uptake
  • Triiodothyronine (T3)
  • Thyroid Stimulating Hormone (TSH)
  • Thyroxine (T4)

Toxicology

  • Alcohol (Blood)
  • Lead (Blood)
  • Carbamazepine
  • Digoxin
  • Ethosuximide
  • Gentamicin
  • Lithium
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Procainamide (and metabolite)
  • Quinidine
  • Theophylline
  • Tobramycin
  • Valproic Acid

Diagnostic Immunology

Syphilis Serology

General Immunology

  • Alpha-1-Antitrypsin
  • Alpha-fetoprotein (tumor marker)
  • Antinuclear Antibody
  • Anti-Streptolysin O
  • Anti-Human Immunodeficiency Virus (HIV)
  • Complement C3
  • Complement C4
  • HbsAg
  • Anti-HBc
  • Hbe-Ag
  • IgA
  • IgG
  • IgE
  • IgM
  • Infectious Mononucleosis
  • Rheumatoid Factor
  • Rubella

 

Hematology

  • Cell ID/ White Blood Cell Differential (manual and automated)
  • Erythrocyte (RBC) Count
  • Hematocrit (excluding spun Microhematocrits)
  • Hemoglobin (excluding single-analyte instruments)
  • Leukocyte (WBC) Count
  • Platelet Count
  • Fibrinogen
  • Partial Thromboplastin Time
  • Prothrombin Time

Immunohematology

  • Unexpected Antibody Detection
  • ABO Group (excluding subgroups)
  • D(Rh)Typing
  • Antibody Identification
  • Compatibility Testing

Microbiology

Bacteriology

  • Antimicrobal Susceptibility Testing
  • Bacterial Antigen Detection
  • Bacterial Identification (aerobic/anaerobic from various sources)
  • Gram Stain

Mycobacteriology

  • Acid Fast Smears/Culture/ID/Antimycobacterial Susceptibility Testing
  • Isolation and identification of mycobacteria by culture

Mycology

  • Culture for Yeast or Fungal ID at genus or species level

Parasitology

  • Parasite identification (wet mount, concentration and/or permenant stain, immunoassay)

Virology

  • Virus Detection (by culture or antigen testing)

For all other 'non-regulated' analytes, CLIA dictates that the laboratory must have a quality assurance plan that establishes the accuracy and reliability of the testing at least twice per year. The CAP Surveys and EXCEL proficiency testing programs offer a wide array of products to conveniently assist laboratories in fulfilling this requirement. It is also important for laboratories to check with their state and other accrediting agencies they may use as they may mandate additional requirements.