Since I perform only a few simple tests in my office, do Clinical Laboratory Improvement Amendments (CLIA) regulations apply to my practice?
Yes, CLIA does apply. However, simple tests are waived from specific CLIA requirements. These include: • dipstick or tablet urinalysis; • fecal occult blood; • ovulation test using visual color comparison; • urine pregnancy test using visual color comparison; • erythrocyte sedimentation rate; • hemoglobin by copper sulfate method; • spun microhematocrit; • blood glucose using certain devices cleared by the FDA specifically for home use; and • hemoglobin by single analyte instruments self-contained specimen/ reagents interaction with direct measurement and readout. A complete list of CLIA-waived tests is available at the CLIA Categorization of Tests web site. If you perform only these tests, a CLIA certificate of waiver is required.
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