What does the Clinical Laboratory Improvement Amendment (CLIA) specifically require from laboratories?

The Clinical Laboratory Improvement Amendment (CLIA) establishes quality standards for laboratory testing to ensure the safety and accuracy of laboratory results. A crucial requirement under CLIA is that laboratories must be CLIA certified in order to provide services to Medicare patients. This certification verifies that the laboratory meets specific standards of quality and is qualified to conduct clinical tests. Without this certification, laboratories would not be able to participate in the Medicare program, which is vital for many patients who depend on these services for their health care.

This certification process involves rigorous inspections and compliance with quality control measures, reflecting the overall commitment to high standards in medical testing. Thus, the requirement for laboratories to be CLIA certified before they can bill Medicare clients is foundational for maintaining patient care quality and the integrity of laboratory results.