CLIA waiver is a regulatory term and point of care testing (POCT) refers to the location where the testing occurs. In other words, POCT means the testing isn’t happening in a central laboratory, it’s happening closer to the patient. Some POCT tests are waived, others can be designated as moderately complex or highly complex.
What Does CLIA Waiver Mean?
CLIA stands for the Clinical Laboratory Improvements Amendments. It’s a series of regulations at the federal level that control clinical diagnostic testing. The Center for Medicare and Medicaid Services uses CLIA to regulate patient testing.
There are different levels of regulatory approval within CLIA:
- High Complexity
- Moderate Complexity
- CLIA Waiver
The CDC explains the different levels of complexity here.
Why is CLIA Waiver Important?
CLIA waiver widely expands the audience that is able to administer a test. With waived tests, the educational, compliance and QC requirements aren’t as steep.
Is it Easy to Get Waived Status?
In short, you’re essentially proving that the likelihood of a false result are “negligible.” One way of thinking about it is you’re proving that it’s difficult for errors to occur: whether it’s an issue with the test’s performance or it’s someone’s ability to properly administer and interpret the test.
Some say that the future of POCT is uncertain. Here’s a good article from Dr. Kent B. Lewandrowski from Massachusetts General Hospital, MD on the future of POCT.