Waived and PPM laboratories can apply directly for their certificate because they are not subject to what?

Waived and provider-performed microscopy (PPM) laboratories are classified under the Clinical Laboratory Improvement Amendments (CLIA) regulations. These laboratories can apply directly for their certificates primarily because they do not undergo routine inspections like other laboratory types, such as moderate and high-complexity laboratories.

The rationale behind this exemption is that waived tests are typically simple procedures with a low risk of error. As a result, these labs are deemed to require less oversight in terms of inspections, thus allowing for a more straightforward application for certification.

Not being subject to routine inspections significantly eases the process for these laboratories, making it more accessible for them to operate without the burden of compliance checks that are necessary for more complex laboratory operations.