Physician office laboratory

The 1988 Amendments to the Clinical Laboratory Improvement Act (42 U.S.C. sec 263A) subjected the physician office laboratory to the same regulations as independent laboratories. The Amendments require, among other things, certification for all physician office labs except those performing only simple procedures (as defined by the FDA). The Amendments also subjected the POLs to unannounced laboratory inspections. Sometimes called “physician-owned laboratory.”


 


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