The real world--regulations and ethics.

The Medical Devices Amendment was published in 1976, when the Food & Drug Administration regulations were amended to include devices, basically to protect the public. I’m also going to talk about CLIA 1988 (Clinical Laboratory Improvement Act), which was passed by Congress in 1988 and regulates laboratory operation. It really has not yet been implemented, although it took effect on January 1st of this year. Last, we must include Medicare regulations, which relate to the laboratory by controlling how they impose charges and costs. In hospitals, we are in addition regulated by the Joint Commission for Accreditation of Hospitals. We are now subject to state and local legislation, which may be supplanted by Federal legislation. More than half the states and the City of New York not only regulate how laboratories operate, but regulate the credentials of those individuals who are involved in the testing. I am sure these are insurance regulations, which relate to the laborator3a During our discussion, you may bring up other regulations. I was thinking of medical necessity programs, which recommend which test array is reimbursable for a particular disease for health insurance purposes.