When must quality control for waived tests be performed according to CAP?

Quality control for waived tests is crucial to ensuring the accuracy and reliability of test results. According to the College of American Pathologists (CAP) guidelines, quality control must be performed when specified by the test manufacturer. This requirement is in place because the manufacturer provides specific instructions and protocols based on the test's design, intended use, and performance characteristics. Adhering to these specifications ensures that the tests are conducted under the proper conditions and that results remain valid and within acceptable ranges.

The guidelines by the manufacturer usually include the frequency and methods for conducting quality control, which might vary depending on the specific tests and their characteristics. Following the manufacturer's specifications aligns with best practices in laboratory testing and helps maintain compliance with regulatory standards.