If a hospital performs clinical testing and does not comply with CLIA, what policies might it be violating?

Question

Quizplus · Accepted Answer

The Clinical Laboratory Improvement Amendments (CLIA) set standards for all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. Non-compliance with CLIA can violate the Conditions of Participation for Hospitals for Laboratory Services, which require compliance with federal standards for laboratory testing. It directly violates the Clinical Laboratory Improvement Act itself, which is the source of the regulations. While the Occupational Safety and Health Act (OSHA) primarily focuses on worker safety, it can be implicated in laboratory settings for ensuring a safe working environment, which could intersect with CLIA compliance in terms of handling specimens and ensuring laboratory safety.

If a Hospital Performs Clinical Testing and Does Not Comply