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CLIA Laboratory Classifications
Small Volume Laboratories
- Schedule A Low Volume: performs not more than 2000 tests annually.
Medium Volume Laboratories
- Schedule D: performs tests in at least 4 specialties with a total volume of more than 10,000 but not more than 25,000 annually.
- Schedule E: performs more than 25,000, but not more than 50,000 tests annually.
- Schedule F: performs more than 50,000, but not more than 75,000 tests annually.
- Schedule G: performs more than 75,000, but not more than 100,000 tests annually.
Large Volume Laboratories
- Schedule H: performs more than 100,000, but not more than 500,000 tests annually.
- Schedule I: performs more than 500,000, but not more than 1,000,000 tests annually.
- Schedule J: performs more than 1,000,000 tests annually.
Specialties
- Microbiology: Bacteriology, Mycobacteriology, Mycology, Parasitology, Virology
- Serology: Syphilis Serology, General Immunology
- Chemistry: Routine Chemistry, Endocrinology, Toxicology, Urinalysis
- Hematology
- Immunohematology: ABO Grouping and Rh typing, Unexpected antibody detection, Compatibility testing, Unexpected antibody identification
- Pathology: Cytology, Histopathology, Oral Pathology
- Radiobioassay
- Histocompatibility
- Cytogenetics
CLIA and Other Regulatory Information
Good Laboratory Practices for Waived Testing Sites
CLIA Waived and PPM Tests Defined
CLIA Laboratory Classifications
Changing the Status of a Laboratory
CMS Statistics (*PDF file)
(*PDF file. About PDFs)
