CLIA 88
The following information was taken from the "Federal Register", Feb 28, Vol 57; No 40. This outline of key points of the
regulation first appeared in "POL NEWS UPDATE" on March 16, 1992.
The final CLIA-88 regulations were published in the Federal Register on Feb. 28, 1992. On Jan 19, 1993
additions to the original regulation were published.
The complexity models stand at 4 regulatory levels - waiver, physician performed microscopy, moderately complexity and
high complexity. A list of tests categories is at the end of this document. HFCA released a
complete test list that matches laboratory analyzers and tests to complexity levels in July 1993.
Copies of all Federal Registers are available from POC Consults. Call for information if you
would like a more comprehensive look at the CLIA regulations.