It may come as a challenge for both non-legal and non-medical practitioners to understand the nuances of CLIA waived testing along with its implications. But first, let’s begin with the very basics, what is CLIA waived testing?
Simply put, the Clinical Laboratory Improvement Amendments (CLIA) of the Food and Drug Administration (FDA) “waive” specific test methods of certain tests. These are relatively simple tests that carry a low risk for an incorrect result. Waived tests include tests listed in the CLIA regulations, tests cleared by the FDA for home use such as home pregnancy testing kits, drug test dip cards and cups as well as tests approved for a waiver by the FDA, using the CLIA criteria.
Now that we know what CLIA waived testing means, why do we need it?
Every laboratory system, examination and assay is categorized for its level of complexity and assigned subsequent scores thereafter. It is the CLIA’s responsibility to ensure standards for clinical laboratory testing are maintained and that the test results remain accurate, reliable and relevant no matter where the test was conducted. To have a waived certification implies that the specific test is not only relatively simple to conduct, but has a low potential for displaying an erroneous result.
This means that such tests are safe to be performed at home or in non-laboratory settings thereby making it easier and economical for patients to monitor their medical conditions. Moreover, besides the privacy of one’s home, such tests can be performed in other non-laboratory settings like community health centres, counselling centres, pharmacies, ambulances, nursing homes, and physicians’ offices.
Laboratories and centres that exclusively perform waived tests are subjected to lower fees and lesser requirements. This enables them to operate at lower costs and with relatively less-trained health professionals. Such settings are also not subjected to as many routine inspections as those that perform more complex tests.
So, on what criteria are these tests analyzed?
According to CLIA standards for quality control, all tests are analyzed on the following criteria:
- Training and experience
- Knowledge required to conduct the test
- Interpretation and judgment of the results provided
- Ease of steps of operation
- Reagents and material preparation
- Test system troubleshooting and equipment maintenance and
- Quality control, calibration, proficiency of testing materials
Now that we understand more about such tests, does this imply that all waived tests are error-free?
Although one of the key components of waived tests requires them to be simple and with a low margin for error, this does not mean they are completely error-free. Mistakes can happen anywhere in the testing process and it is important for those conducting the test to ensure they follow the manufacturer’s directions. Always remember, incorrect test results have the potential to impact patients negatively.