What is a requirement for a CLIA-waived test?

A requirement for a CLIA-waived test is that quality controls must be performed on each new shipment of reagents. This practice ensures that the test performs accurately and reliably with the specific reagents being used, maintaining the integrity of the testing process. Quality control measures are crucial in point-of-care testing, as they help to verify that the testing system produces valid and dependable results, which is essential for patient safety and effective clinical decision-making.

By implementing these quality control procedures, facilities can uphold the standards necessary for CLIA-waived tests, which are designed to be simple and safe for use in various settings outside of traditional laboratories. This approach minimizes the risk of errors that could arise from using faulty reagents and contributes to the overall quality of patient care.