Pathology/Lab Coding Alert

Your lab's Clinical Laboratory Improvement Amendments (CLIA) certification level can dictate both lab methods and lab coding for certain analyses. Watch out for test systems that CLIA categorizes as either waived or moderate complexity. If the lab follows the wrong instructions, you could get the code wrong, and/or your lab could be slapped with a citation for operating outside of its CLIA certification level.

Labs and Tests Categorized by Complexity

The Food and Drug Administration (FDA) categorizes most approved lab test systems into one of three categories: high complexity, moderate complexity or waived. But a few tests fall into both the waived and the moderate-complexity grouping, depending on certain performance criteria.

CLIA also categorizes and certifies labs based on the complexity of tests they can perform. "Labs that hold a CLIA certificate of waiver or a certificate for provider-performed microscopy [PPM] cannot perform moderate- or high-complexity tests, but must limit themselves to approved waived tests," says  Stan Werner, MT (ASCP), administrative director of Peterson Clinical Laboratory in Manhattan, Kan.

Follow the Proper Manufacturer's Instructions

So what's a waived or PPM lab to do when a single test kit can be either waived or moderate complexity? The answer is, follow the waived instructions. Doing so leads to correct coding and to compliance with CLIA certification.

For example, many pregnancy test kits are waived if performed on urine specimens, but moderate complexity if performed on serum. That means a waived or PPM lab can only perform the test on urine specimens and must follow the manufacturer's instructions for urine.

The test instructions may also dictate the code. For instance, the Stanbio QuPID Plus Pregnancy Test for serum is a qualitative hCG test that you'd report as 84703 (Gonadotropin, chorionic [hCG]; qualitative). The FDA lists this test as moderate complexity. The same kit, however, performed on a urine specimen identifies hCG by visual color comparison, so you should report CPT 81025 (Urine pregnancy test, by visual color comparison methods), which is a waived test.

Bottom line: Labs should test and code commensurate with their CLIA certification level.