Pathology/Lab Coding Alert

Question: How can I find out the categorization of a lab test under CLIA?

Minnesota Subscriber

Answer: You can access the Clinical Laboratory Improvement Amendments (CLIA) database at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm to search for any current, commercial test categorized under CLIA. The U.S. Food and Drug Administration (FDA) updates the list monthly.

The FDA categorizes tests as waived tests, moderate complexity tests, and high complexity tests. The categories are based on a combined score based on the knowledge, training, and level of interpretation required by those who perform the test, as well as the complexity of managing the materials, operational steps, test systems, and equipment.

Labs must be certified to perform tests of a certain category. Labs that have waived status may perform only waived tests, which are the simplest to perform and have the lowest risk of erroneous results and lower risk of serious health impacts if performed incorrectly. CLIA-waived labs should report most test codes with modifier QW (CLIA waived test).