CLIA-Waived Testing and Laboratory Procedures

Vocabulary flashcards covering CLIA regulations, laboratory testing complexity levels, and clinical procedures based on the lecture transcript.

Food and Drug Administration (FDA)

The federal agency that requires all testing performed in all testing facilities to meet federal guidelines and determines the complexity of laboratory tests.

CLIA (Clinical Laboratory Improvement Amendments)

Federal regulations established in 1988 to ensure the quality of diagnostic testing through laboratory standards.

CLIA-Waived Testing

The simplest form of testing with the lowest level of complexity that poses no reasonable risk of harm to the patient if performed incorrectly.

Nonwaived Tests

Moderate- and high-complexity laboratory tests that require a CLIA certificate and regular inspections, typically performed in reference or hospital laboratories.

Provider-Performed Microscopy Procedures

CLIA-approved microscopic screenings of specimens, such as urine or body excretions, categorized as moderate-complexity testing that allows providers to form a preliminary diagnosis.

Ambulatory Care Centers

Healthcare settings that typically perform CLIA-waived testing, where medical assistants are trained to conduct tests upon a provider's request.