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Clinical Laboratory Improvement Amendments (CIA) How to Obtain a CIA Certificate of Waiver When is a CIA Certificate of Waiver Required? NOTE: Congress passed the Clinical Laboratory Improvement Amendments
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The Clinical Laboratory Improvement Amendments (CLIA) are federal regulatory standards enforced by the Centers for Medicare and Medicaid Services (CMS) to ensure quality laboratory testing.
All clinical laboratories in the United States that perform testing on human specimens for health assessment or to diagnose, prevent, or treat disease are required to comply with CLIA.
Clinical laboratories must submit the necessary forms and documentation electronically through the CMS CLIA online portal.
The purpose of CLIA is to ensure accurate, reliable, and timely laboratory testing to protect patient safety and improve healthcare quality.
CLIA requires laboratories to report information related to their personnel qualifications, quality control procedures, test methods, and proficiency testing results.
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