No staining technique (immunohistochemistry included) is considered high
complexity testing under CLIA. In fact, under HCFA's final rules, they are
not considered testing at all. The only "CLIA" testing that occurs in the
AP is the interpretation. This means cytotechs and pathologists are testing
personnel. Histotechs are not. The gross examination is somewhat gray. It
is certainly testing on "gross only" specimens. On specimens with a
microscopic interpretation this is less clear. HCFA (Heath Care Financing
Administration www.hcfa.gov) is the regulatory agency responsible for CLIA
enforcement.

Bert Dotson