During the ’90s, new federal rules made many physicians think twice about starting in-office labs. But doctors have grown less intimidated by the rules, and today, in-office labs are quickly becoming an indispensable feature of many physician practices.
The biggest increase is among “waived” labs, which perform easy-to-administer, fairly low-risk tests: ovulation, blood glucose, dipstick or tablet reagent urinalyses, rapid strep tests, and the like. Waived labs are attractive because they’re subject to only minimal requirements under CLIA, the Clinical Laboratory Improvement Amendments of 1988. But doctors are also establishing labs that do more complex testing like CBCs, PSAs, routine chemistry panels, and antibiotics susceptibility tests. These moderate- to high-complexity labs must adhere to a stricter set of federal requirements, including routine inspections.
Based on the typical average number of tests run in an office who usually runs these test, operating a CLIA waived lab in your office could be very profitable:
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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 (Centers for Medicare and Medicaid Services) does not conduct inspections of laboratories that offer CLIA waived testing except in case of complaints.