ABB modified its certification categories to be consistent with changes in the CLIA '67
and CLIA '88 regulations, for example, by changing the director certification designation from CLD (Clinical Laboratory Director) to HCLD (High-complexity Clinical Laboratory Director).
was revised and expanded in 1988, well before genetic testing became widely used.
The new regulations revised and superseded CLIA '67
and set standards designed to improve quality and to expand federal oversight to include virtually all laboratories in the United States that conduct testing on human specimens for health assessment or for the diagnosis, prevention, or treatment of disease.
Most important, it extended CLIA '67
regulations to a large number of previously unregulated sites.
The requirement for calibration verification (see "Tips from the clinical experts," December 2003, page 30) has been a confusing concept since the publication of the final rules for CLIA '67
in 1990 by the Centers for Medicare and Medicaid Services, (then HCFA).
Therefore, in 1980 we became certified under CLIA '67
, and my real education of governmental regulations began.
Before 1988, under CLIA '67
, laboratories were required to do 10 percent random rescreening of negative Pap smears.
had established minimum quality requirements for clinical laboratories engaged in interstate commerce to participate in Medicare; but these requirements - collectively known as the Clinical Laboratory Improvement Act of 1967 (CLIA '67
) - covered only those labs doing business across state lines - only a fraction of all U.S.
There was an exemption under Medicare for laboratories that performed fewer than 100 tests of an analyte each year from outside their practice, and CLIA '67
applied to laboratories involved in interstate commerce.
Laboratorians who have lived through CLIA '67
don't have a good sense of how a POL operates or of what to expect from an in inspection.
Participation in PT was mandated by the Social Security Act of 1965 and its associated Medicare regulatory programs, as well as by CLIA '67
. During the two decades that followed, most clinical laboratories instituted various preanalytical and analytical practices to improve PT performance.
Almost half of these were facilities that were also governed by Federal requirements under Medicare and CLIA '67
. With the implementation of CLIA '88 regulations, however, the number of laboratories requiring monitoring by LFS soared past 16,000.