The sensitivity of the CLIA-waived test was 80%, compared with 82% for the moderately complex test
. The specificity of the waived test was 95%; the specificity of the moderately complex test
was not calculated because not all results were verified by culturing.
As an example, Kay explained a moderately complex test
that five years ago took seven reagents, 15 steps and 20 minutes for results.
If a lab chooses a moderately complex test
menu and instrumentation, the entire testing staff can legally consist of high school graduates.
The bill would further exempt individuals performing moderately complex tests
in hospital, reference lab, and POL settings, provided that the lab director has certain practices and procedures in place and the individual performing the tests holds one of the following certifications: CMA(AAMA), RMA(AMT), or COLT(AMT).
Two tests (Quidel Quickvue Influenza test and ZymeTx Zstatflu test [R]) can be performed in any physician's office, and three are classified as moderately complex tests
(Biostar FLU OIA; Becton-Dickinson Directigen Flu A+B; and Becton-Dickinson Directigen Flu A [TM]).
In addition to the daily QC, any laboratory that carries out moderately complex tests
is required to perform calibration verification (CV) on its instrument.
However, when the final rules for CLIA '88 were first published (57FR7165), there was disagreement over whether the rules exempted moderately complex tests
, as well.
The Clinical Laboratory Improvement Act (CLIA) states calibration verification is only required for "modified" moderately complex tests
. Since CAP does not recognize "moderate complexity"--everything is high complexity--I am confused.
While no one is quite sure how many POLs were performing moderately complex tests
before CLIA '88 was implemented, we know only 40% of POLs now are doing moderately complex tests
The Health Care Financing Administration (HCFA) explained its offset to the inspection requirements of CLIA this way: "Because physicians have extensive medical training greater than that required by these regulations for personnel performing moderately complex tests
, and because these tests are done in the context of a patient examination, we believe there is assurance that accuracy of testing can be maintained despite the lack of routine inspections."
To use the manufacturer's instructions for QC of moderately complex tests
, the laboratory must follow these requirements:
Labs performing only moderately complex tests
must have employees who qualify and can perform specific functions in four areas.