New Waived Tests
October 2nd, 2012
The Food and Drug Administration has added to its list of tests that may be performed under a CLIA Waiver. For the full list visit: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/analyteswaived.cfm.
The complete list may also be found on the CMS website at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2553CP.pdf
Even if a physician's office performs only waived tests, it is still necessary to have a CLIA number; and to follow good laboratory practices.
The Centers for Disease Control has publushed a booklet on Good Laboratory Practices for Waived Testing Sites. It may be downloaded at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5413a1.htm
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