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Regulated Analyte List
If you are performing testing for any of the analytes or tests listed below, you must be enrolled in PT for those analytes or tests:
(Note: you must be enrolled in PT for the full extent of testing being performed, e.g., gram stain, acid fast stain, wet mount, primary inoculation, direct antigen testing, isolation, identification and susceptibility.)
HEMATOLOGY
Cell identification or white blood cell differential
Erythrocyte count
Hematocrit (excluding spun microhematocrit)
Hemoglobin (excluding HemaCue)
Leukocyte count
Platelet count
Fibrinogen
Partial thromboplastin time
Prothrombin time
Erythrocyte count
Hematocrit (excluding spun microhematocrit)
Hemoglobin (excluding HemaCue)
Leukocyte count
Platelet count
Fibrinogen
Partial thromboplastin time
Prothrombin time
DIAGNOSTIC IMMUNOLOGY
General Immunology
Alpha-1-antitrypsin
Alpha-fetoprotein (tumor marker)
Antinuclear antibody
Antistreptolysin O - quantitative
Anti-human immunodeficiency virus (HIV)
Complement C3
Complement C4
Hepatitis markers (HBsAG,anti-HBc, HBeAg)
IgA
IgG
IgE
IgM
Infectious mononucleosis
Rheumatoid factor
Rubella
Alpha-fetoprotein (tumor marker)
Antinuclear antibody
Antistreptolysin O - quantitative
Anti-human immunodeficiency virus (HIV)
Complement C3
Complement C4
Hepatitis markers (HBsAG,anti-HBc, HBeAg)
IgA
IgG
IgE
IgM
Infectious mononucleosis
Rheumatoid factor
Rubella
Syphilis Serology
Qualitative and quantitative
CHEMISTRY
Routine Chemistry
Alanine aminotransferase (ALT/SGPT)
Albumin
Alkaline phosphatase
Amylase
Aspartate aminotransferase (AST/SGOT)
Bilirubin, total
Blood gas (pH, pO2 and pCO2)
Calcium, total
Chloride
Cholesterol, total
Cholesterol, high density lipoprotein
Creatine kinase
Creatine kinase isoenzymes
Creatinine
Glucose (excluding measurements on devices cleared by FDA specifically for home use)
Iron, total
Lactate dehydrogenase (LDH)
LDH isoenzymes
Magnesium
Potassium
Sodium
Total Protein
Triglycerides
Urea Nitrogen (BUN)
Uric Acid
Albumin
Alkaline phosphatase
Amylase
Aspartate aminotransferase (AST/SGOT)
Bilirubin, total
Blood gas (pH, pO2 and pCO2)
Calcium, total
Chloride
Cholesterol, total
Cholesterol, high density lipoprotein
Creatine kinase
Creatine kinase isoenzymes
Creatinine
Glucose (excluding measurements on devices cleared by FDA specifically for home use)
Iron, total
Lactate dehydrogenase (LDH)
LDH isoenzymes
Magnesium
Potassium
Sodium
Total Protein
Triglycerides
Urea Nitrogen (BUN)
Uric Acid
Endocrinology
Cortisol
Free Thyroxine
Human chorionic gonadotropin (excluding color comparison tests for urine specimens)
T3 Uptake
Triiodothyronine
Thyroid Stimulating Hormone
Thyroxine
Free Thyroxine
Human chorionic gonadotropin (excluding color comparison tests for urine specimens)
T3 Uptake
Triiodothyronine
Thyroid Stimulating Hormone
Thyroxine
Toxicology
Alcohol (blood)
Blood lead
Carbamazepine
Digoxin
Ethosuximide
Gentamicin
Lithium
Phenobarbital
Phenytoin
Primidone
Procainamide (and metabolites)
Quinidine
Theophylline
Tobramycin
Valproic Acid
Blood lead
Carbamazepine
Digoxin
Ethosuximide
Gentamicin
Lithium
Phenobarbital
Phenytoin
Primidone
Procainamide (and metabolites)
Quinidine
Theophylline
Tobramycin
Valproic Acid
IMMUNOHEMATOLOGY
ABO group (excluding subgroups)
D(Rho) typing
Unexpected antibody detection
Compatibility testing
Antibody identification
D(Rho) typing
Unexpected antibody detection
Compatibility testing
Antibody identification
MICROBIOLOGY
Bacteriology
Mycobacteriology
Mycology
Parasitology
Virology
Mycobacteriology
Mycology
Parasitology
Virology
CLIA and Other Regulatory Information
Good Laboratory Practices for Waived Testing Sites
CLIA Waived and PPM Tests Defined
Regulated Analyte List
CLIA Laboratory Classifications
Changing the Status of a Laboratory
CMS Statistics (*PDF file)
(*PDF file. About PDFs)
