Final answer:
The CLIA are federal regulations that ensure the quality of laboratory testing in the U.S. They are administered by CMS, FDA, and CDC and set standards for clinical laboratories.
Step-by-step explanation:
The Clinical Laboratory Improvement Amendments (CLIA) are federal regulations in the United States designed to ensure the quality and reliability of laboratory testing. They were passed by Congress in 1988 and are administered by three federal agencies: the Centers for Medicare & Medicaid Services (CMS), which oversees the program; the Food and Drug Administration (FDA), which categorizes tests based on complexity; and the Centers for Disease Control and Prevention (CDC), which provides research, technical support, and development of standards and guidelines. The CLIA regulations apply to all clinical laboratories in the U.S. that perform diagnostic testing on human samples, and they establish standards for the accuracy, reliability, and timeliness of patient test results.
Under CLIA, clinical laboratories are required to be certified by the federal government and must meet certain requirements regarding staffing, quality control, proficiency testing, and patient test management. The purpose of these regulations is to ensure that laboratory results are accurate and reliable to aid in proper diagnosis and treatment. They are critical to maintaining the integrity of healthcare and protecting patient welfare.
The CLIA are federal regulations enforced by the CMS, FDA, and CDC to ensure the quality of laboratory testing. These regulations are crucial for accurate diagnosis and patient care.