What You Need to Know About CLIA Waived Tests
When you need to get some lab tests done, either for yourself or for your home, you may encounter laboratories or facilities that declare themselves to offer CLIA waived tests. They would also probably have a certificate saying that hanging on a wall. But perhaps the question you may have would be: What are CLIA waived tests?
CLIA stands for Clinical Laboratory Improvement Amendments. It was a set of regulations passed by the United States government in 1988. Its purpose was to set and control the standards for clinical laboratory testing on any specimen or sample derived from the human body. Clinical trials and basic research, on the other hand, are excluded from CLIA regulation.
The goal of CLIA is to make sure that test results done in a clinical laboratory are timely, accurate and reliable. A clinical laboratory as defined under the CLIA law is a place where tests on specimens taken from the human body are conducted for the purposes of diagnosing and treating a disease.
The government agency that has jurisdiction when it comes to CLIA 1988 is the Centers for Medicare and Medicaid Services or CMS. The CMS performs supervisory and regulating tasks when it comes to CLIA, including granting certificates for CLIA waived testing in approved laboratories.
What Do CLIA Waived Tests Mean?
There are some kinds of lab tests that are considered to be CLIA waived. When a test is CLIA waived, it means that the test itself is so simple and accurate in itself that it is impossible to produce incorrect results in conducting them.
A test can also be CLIA waived if it is proven that it does not do any harm to the human body. In addition, a test becomes automatically CLIA waived if the Food and Drug Authority has approved its use at home.
The specific tests that are deemed to be CLIA waived are:
1. Non-automated urinalysis using dipstick or tablet reagents
2. Ovulation tests
3. Urine pregnancy tests
4. Fecal occult blood
5. Hemoglobin-copper sulfate
6. Erythrocyte sedimentation rate
7. Blood glucose monitoring utilizing devices specifically for home use
8. Spun microhematocrit
9. Hemoglobin testing done through devices with self-contained features and which give readout results via direct measurement
Laboratories that give CLIA waived tests have to renew their certification every two years and they have to conduct their tests in a controlled environment. The CMS does not conduct inspections of laboratories that offer CLIA waived testing except in case of complaints.
In other words, CLIA waived tests are safe as long as the instructions provided by their manufacturer are closely followed. If you need to send samples to a lab for a procedure that falls under the list of CLIA waived tests or if you need to use a home testing kit, no harm should come out of it. But if it did, you can always contact the CMS or the FDA to file a complaint.