What type of testing requires a laboratory to enroll in the CLIA program?

The correct answer indicates that laboratories performing moderate to high-complexity testing must enroll in the CLIA (Clinical Laboratory Improvement Amendments) program. This requirement is grounded in the need to ensure the accuracy, reliability, and timeliness of testing results produced by laboratories, which are critical for patient care and safety.

Moderate to high-complexity tests often involve more sophisticated procedures, instrumentation, and expertise than lower-complexity tests. As such, they pose a greater risk if performed inaccurately, which is why CLIA sets forth stringent quality standards and regulatory requirements for these types of tests. Laboratories must demonstrate compliance with detailed operational procedures, quality control measures, and proficiency testing to maintain their enrollment in the CLIA program.

Low-complexity tests do not require the same level of regulatory oversight, thus making enrollment in the CLIA program unnecessary for those laboratories. This distinction is essential to understanding the comprehensive regulatory landscape surrounding laboratory testing and ensuring that patients receive reliable diagnostic information.