What is the main requirement of the Clinical Laboratory Improvement Amendment (CLIA) of 1988?

The main requirement of the Clinical Laboratory Improvement Amendment (CLIA) of 1988 is that only CLIA-certified laboratories can perform tests on human specimens for the purpose of diagnosis, prevention, or treatment of disease, or for the assessment of health. This certification ensures that labs meet specific quality standards, which helps maintain the accuracy and reliability of lab results across the healthcare system.

The intent of CLIA is to improve the quality of laboratory testing, thus enhancing patient safety and care. By requiring CLIA certification, the regulation ensures that all testing performed in laboratories is subject to federal oversight and compliance with established quality standards, which are crucial for laboratories that handle tests relevant to patient care, including those servicing Medicare beneficiaries.

Overall, this certification reflects a commitment to high standards in laboratory testing and ensures that providers meet rigorous guidelines to safely provide these essential services.