Certified Tissue Bank Specialist (CTBS) Practice Test

Communicable and infectious disease testing must be completed at a laboratory which is:

1. AATB accredited and FDA registered

2. CLIA certified and AATB accredited

3. CLIA certified and FDA registered

4. AATB accredited and FDA registered

The correct answer is: CLIA certified and FDA registered

Communicable and infectious disease testing must be conducted at a laboratory that is CLIA certified and FDA registered. CLIA, which stands for the Clinical Laboratory Improvement Amendments, establishes quality standards for laboratory testing to ensure accuracy, reliability, and timeliness of test results. This certification is crucial for any laboratory performing tests on human specimens, including those for infectious diseases, as it assures compliance with federal regulations regarding laboratory testing. Additionally, FDA registration is important because it ensures that the laboratory adheres to safety and efficacy standards set by the Food and Drug Administration. This includes using approved methods for testing and ensuring that laboratory practices are in line with regulatory guidelines that protect public health. While AATB accreditation is robust for tissue banking practices and indicates that a lab meets specific standards for quality and safety, it is not directly tied to the requirements for conducting communicable disease testing. Therefore, the correct choice emphasizes the essential requirements of CLIA certification and FDA registration as foundational for laboratories engaged in infectious disease testing.