The correct answer to all of these questions is false. Being a CLIA waived or provider performed microscopy (PPM) lab does not mean there aren't specific regulatory criteria for the physician office laboratory (POL) to adhere to.
Under the CLIA regulations, POLs with a certificate of waiver (COW) may perform only those tests that have been classified as waived. POLs with a PPM certificate may perform tests, using a microscope, during the course of a patient visit on specimens that are not easily transportable, along with the waived tests.
Waived labs are required by CLIA to:
The number and types of tests waived under CLIA have increased from eight tests to approximately 40 since the inception of the program in 1992. As a result, the number of waived labs has grown exponentially from the total 171,000 laboratories enrolled.
PPM labs are required by CLIA to:
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Clinical Laboratory Improvement Amendments (CLIA)