Final answer:
The Clinical Laboratory Improvement Act of 1988 (CLIA '88) is a federal law that regulates laboratory testing in the United States. It establishes quality standards for clinical laboratories and categorizes tests based on their complexity. CLIA '88 also mandates proficiency testing and inspections to monitor labs' compliance.
Step-by-step explanation:
The Clinical Laboratory Improvement Act of 1988 (CLIA '88) is a federal law in the United States that regulates laboratory testing. It establishes quality standards for clinical laboratories to ensure accurate and reliable test results. CLIA '88 categorizes laboratory tests into three levels of complexity (waived, moderate, and high complexity) and requires laboratories to meet specific requirements based on their testing complexity.
For example, waived tests are simple tests with a low risk for error, such as urine pregnancy tests, while high complexity tests involve complex methodologies and a higher risk for error, such as genetic testing. CLIA '88 also mandates proficiency testing and inspections to monitor labs' performance and compliance with the law.