Labs: THE WRONG INSTRUCTIONS COULD LEAD TO A CLIA CITATION
What labs should watch for on tests that could be waived or moderate complexity.
Labs had better not stumble on test systems that can be categorized as either waived or moderate complexity - the wrong move could leave them saddled with a Clinical Laboratory Improvement Amendments citation.
In a Nov. 13 letter to state survey agency directors (Ref: S&C-04-05), the Centers for Medicare & Medicaid Services points out that labs might not always be using the proper instructions for tests that can be considered waived or moderate complexity.
Labs with a certificate of waiver or a certificate...
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