By the CLIA law, waived laboratories perform only tests that are determined by FDA or CDC to be so simple that there is little risk of error. Laboratories with a PPMP certificate perform tests, using a microscope, during the course of a patient visit on specimens that are not easily transportable.
Waived laboratories must meet only the following requirements under CLIA:
Pay applicable certificate fees biennially (every two years)
Follow manufacturers' test instructions
The number and types of tests waived under CLIA have increased from 8 tests to approximately 40 since the inception of the program in 1992; thereby, the number of waived laboratories has grown exponentially from 20% to 59% of the total 183,992 laboratories enrolled.
PPMP laboratories must meet only the following requirements under CLIA:
Enroll in the CLIA program
Pay applicable certificate fees biennially
Certain quality and administrative requirements.
PPMP laboratories represent 21% of the laboratories in the country; thus, 80% of the laboratories have no direct routine oversight. The regulations, however, do provide for inspections of waived and PPMP laboratories under certain circumstances.
