Answer: B - The Clinical Laboratory Improvement Amendment, CLIA 88, requires every clinical laboratory in the US to document the education and continuing education of each of its employees. In addition, CLIA 88 requires documentation of all procedural steps of all lab testing conducted in that clinical laboratory. If the laboratory is conducting moderate to complex testing, the facility must also undergo biannual inspections. Phlebotomists should have a basic understanding of CLIA 88 and its impact on the facility in which they are employed. CLIA 88 also establishes what tests phlebotomists are permitted to perform.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) is a federal regulation that sets standards for all laboratory testing performed on humans in the United States, including in medical facilities. CLIA 88 establishes quality standards for laboratory testing to ensure patient test results' accuracy, reliability, and timeliness.
Medical professionals should be familiar with CLIA 88 because it impacts their practice and the laboratory tests they order for their patients. CLIA 88 requires all laboratory tests to be performed in a manner that ensures their accuracy, reliability, and timeliness. This includes ensuring the qualifications of laboratory personnel, establishing standard operating procedures, and implementing quality control procedures.
CLIA 88 also requires laboratories to be licensed by the Centers for Medicare and Medicaid Services (CMS), and sets the criteria for laboratory certification based on the complexity of the tests performed. In addition, laboratories must meet specific standards for personnel, equipment, facilities, and quality control procedures and must undergo regular inspections to maintain their certification.
