Which certificate allows a laboratory to conduct moderate- to high-complexity testing until compliance is determined?

The correct certificate that allows a laboratory to conduct moderate- to high-complexity testing while awaiting compliance determination is the Certificate of Registration. This certificate is part of the Clinical Laboratory Improvement Amendments (CLIA) regulations in the United States. Laboratories that hold a Certificate of Registration are permitted to perform tests as they work towards obtaining a full Certificate of Compliance. This is particularly important for laboratories as it allows them to begin testing and generating results while still in the process of meeting all necessary regulatory requirements.

The Certificate of Waiver, by contrast, is issued to laboratories performing only tests that are deemed simple or low-risk, and it does not apply to moderate- or high-complexity testing. The Certificate for Provider-performed Microscopy Procedures is specifically for certain microscopy testing conducted by providers, which is also not applicable to general moderate- to high-complexity testing requirements. The Certificate of Compliance is granted once a laboratory has successfully demonstrated compliance with the CLIA standards, but does not allow for testing prior to this compliance determination. Thus, the focus on the Certificate of Registration enables immediate functionality in testing capabilities while compliance conditions are being finalized.