What does CLIA require for laboratories to operate?

The requirement for laboratories to operate under the Clinical Laboratory Improvement Amendments (CLIA) is that they must obtain certifications from the federal government. CLIA was enacted to ensure that laboratory testing is accurate, reliable, and timely, which is essential for patient care.

Under CLIA, the federal government sets quality standards for laboratory testing across the United States. Laboratories are required to be certified by the Centers for Medicare & Medicaid Services (CMS) in order to perform tests on human specimens. This certification process evaluates various aspects of laboratory operations, including personnel qualifications, quality control, proficiency testing, and overall laboratory management.

State or local certifications alone do not meet the federal standards set by CLIA. While state regulations may apply and complement CLIA standards, the overarching requirement is that laboratories must have federal certification to ensure nationwide consistency and quality in laboratory testing services. This federal oversight helps protect public health and safety by ensuring reliable laboratory results, which are critical for accurate diagnosis and treatment.