What type of tests require skill to perform and interpret, and are therefore regulated?

Tests that are classified as nonwaived require skilled personnel to perform and interpret because they involve more complex procedures that can significantly influence patient results. These tests often require a higher level of training, understanding of laboratory techniques, and the ability to troubleshoot any issues that arise during testing. Due to the intricacies involved, nonwaived tests undergo strict regulation to ensure accuracy, reliability, and safety in clinical practice. This regulation often encompasses quality control measures, proficiency testing, and adherence to standard operating procedures, all aimed at maintaining the integrity of the testing process.

In contrast, waived tests are simpler and deemed to pose minimal risk regarding erroneous results; thus, they can be performed by untrained personnel without the same level of oversight. The distinction between waived and nonwaived tests is essential in laboratory medicine, clearly indicating which tests require specialized knowledge and regulatory compliance.