CLIA- Clinical Laboratories Improvement Amendments Questions and Answers(A+ Solution guide)

CLIA- Clinical Laboratories Improvement Amendments - Established in 1988 to ensure quality of diagnostic testing through laboratory regulations. CLIA develops their standards and regulations with support from the FDA- Food & Drug Administration, CDC- Centers for Disease Control & Prevention, and CMS- Centers for Medicare and Medicaid Services. CLIA-Waived - The most common designation for ambulatory care and is the lowest of complexity. These tests could be performed in the home environment or easily conducted in the medical office. Commission on Office Laboratory Accreditation (COLA) - An independent accreditor for laboratories; it focuses on meeting CLIA regulations with a goal of providing the best care to the patient. Additional accreditors approved under CLIA can be found at Moderate & High Complexity - These tests are considered nonwaived. Labs performing these tests must have a CLIA certificate and undergo inspections to ensure standards are being met. These test are typically performed in a reference or hospital laboratory.