Opinion for the court filed by Circuit Judge WALD.
WALD, Circuit Judge:
In 1992, the United States Department of Health and Human Services ("HHS" or "agency") issued regulations implementing the 1988 Clinical Laboratory Improvement Amendments ("CLIA" or "Act"), which expands and strengthens federal regulation of laboratories that perform clinical tests on specimens from the human body. The specific regulations at issue here pertain to two key components of...
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