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National Intelligence Report

Current CLIA ‘Hot Spots’ & What They Mean for Labs
March 31, 2008

Main ArticleNumber of Labs Subject to Routine Inspections

This year marks the 20th anniversary of the CLIA program, the most sweeping change in the regulation of clinical laboratory testing in the nation’s history. For the first time, all testing of human specimens for disease or health status was made subject to federal oversight. Currently, 200,667 labs are enrolled in CLIA (in 1994, 150,000), according to the Centers for Medicare & Medicaid Services.

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