was revised and expanded in 1988, well before genetic testing became widely used.
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).
The new regulations revised and superseded CLIA '67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.
The DHHS noted that a revision of the CLIA '67
regulations was already in progress, and the agency could address these issues.
Before 1988, under CLIA '67
, laboratories were required to do 10 percent random rescreening of negative Pap smears.
Therefore, in 1980 we became certified under CLIA '67
, and my real education of governmental regulations began.
The need to regulate all labs performing tests on human specimens became apparent to lawmakers; and throughout the '70s, amendments to CLIA '67
were proposed to stiffen personnel requirements as well as mandate inspections to certify that lab facilities met some minimum standards for accuracy and quality control.
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.
Almost half of these were facilities that were also governed by Federal requirements under Medicare and CLIA '67
If a practice wants to use uncertified personnel to do testing, and if they do not employ a medical technologist or medical technician as defined by the CLIA '67
rules, then they must obtain the services of a technical consultant.
The rules proposed for the 1988 version of CLIA were based on the very difficult and onerous rules for CLIA '67
, which were published almost simultaneously.