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