CPB Certified Professional Biller Certification Practice Exam

Which entity oversees the regulation of laboratory testing and standards in healthcare?

1. Centers for Disease Control and Prevention

2. Centers of Medicare and Medicaid Services

3. Clinical Laboratory Improvement Act

4. Food and Drug Administration

The correct answer is: Clinical Laboratory Improvement Act

The Clinical Laboratory Improvement Act (CLIA) specifically regulates laboratory testing and establishes standards for laboratory practices in healthcare. CLIA was enacted to ensure the accuracy, reliability, and timeliness of patient test results across all types of clinical laboratories. This law sets forth requirements for laboratory quality and personnel qualifications, thereby safeguarding public health by ensuring that laboratory tests are performed correctly. While the other entities mentioned play significant roles in healthcare, they do not have the same focused regulatory authority over laboratory testing as CLIA. The Centers for Disease Control and Prevention engages in public health and disease control efforts but does not directly oversee laboratory standards. The Centers for Medicare and Medicaid Services administers federal healthcare programs, which include some aspects of laboratory services, but its primary role is not the regulation of laboratory standards. The Food and Drug Administration is involved in the regulation of medical devices and drugs, including some laboratory tests, but it is primarily focused on safety and efficacy rather than routine laboratory quality standards. Therefore, the Clinical Laboratory Improvement Act is the correct choice for overseeing laboratory testing and standards in healthcare.