ASCP (American Society for Clinical Pathology) Phlebotomy Technician Certification Practice Exam

The agency responsible for overseeing the categorization of laboratory tests based on their complexity and the risk to patients in case of errors is the Clinical Laboratory Improvement Amendments (CLIA). CLIA establishes quality standards for laboratory testing to ensure reliability and accuracy in laboratory results. This framework categorizes tests into three complexity levels: waived tests, moderate complexity tests, and high complexity tests. Each category has specific regulatory requirements and standards to minimize patient risk and ensure the safety and efficacy of laboratory practices. The Centers for Disease Control and Prevention (CDC) primarily focuses on public health and safety issues, disease prevention, and health promotion, but does not regulate laboratory test categorization. The Food and Drug Administration (FDA) is involved in the regulation of medical devices, which includes some laboratory tests, but its primary role is not the categorization of tests for complexity and risk. The National Institutes of Health (NIH) focuses on biomedical research and does not oversee laboratory test regulations or categorization. Therefore, CLIA's role in overseeing laboratory test standards and classifications is crucial for maintaining quality and protecting patient safety in clinical laboratory settings.