The Clinical Laboratory Improvement Amendments (CLIA) are U.S. federal regulations established in 1988 to ensure the quality and accuracy of laboratory testing. These amendments set standards for laboratory testing, including personnel qualifications, quality control, and proficiency testing, to protect public health and safety. CLIA applies to all clinical laboratories, including those performing tests for hospitals, physicians, and research institutions. Laboratories must obtain a CLIA certificate, which indicates compliance with the established standards. Regular inspections and assessments help maintain the integrity of laboratory results, which are crucial for patient diagnosis and treatment.