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Pathology/Lab Coding Alert

Reader Questions:

Find CLIA-Waived List for Your Lab

Published on Wed Apr 06, 2011

Question: We are a CLIA waived lab. How can we find out if a specific test kit is something we're approved to use in our lab?Kansas SubscriberAnswer: You can find a complete online list of approved tests for waived labs under the Clinical Laboratory Improvement Amendments (CLIA). The Food and Drug Administration (FDA) categorizes tests, and makes available a quarterly update of any new tests approved for waived-status labs.CMS posts the CLIA waived list, which you can find at www.cms.gov/CLIA/10_Categorization_of_Tests.asp#TopOfPage. Click on the link for "List of Waived Tests."Caution: Test manufacturers may provide information that their kit is CLIA-waived, but you should always check the authoritative FDA list to ensure that you have correct information.The latest: Your lab will have 16 new tests that you'll be able to report as CLIA-waived, thanks to a recent CMS transmittal on the matter. According to MLN Matters article MM7266, CMS will now consider [...]
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