CLIA stands for Clinical Laboratory Improvement Amendments, which was passed by the United States Congress in 1988.
Prior to 1988, roughly 25% of patient testing conducted in laboratories was not meeting minimum quality requirements. Studies showed that the laboratories that followed minimum quality standards performed better than the laboratories that did not.
The CLIA standards were created in order to ensure that a patient's test results would be accurate, timely and reliable, regardless of where in the United States the test would be performed.
How are tests categorized?
Tests are classified according to level of complexity. These three levels are waived, moderate or high.
Laboratory requirements are based on the complexity of the test. The more complex a test is, the more stringent the requirements are. Examples of some requirement standards are facility administration, personnel qualifications, quality control and quality assessment.
What is CLIA waived?
Tests that meet certain provisions may be waived, which means that they are simple lab procedures cleared for home use by the Food and Drug Administration.
These tests must be accurate and easy, making it unlikely for mistakes to occur. Should someone perform these tests incorrectly, there should be no reasonable risk of harm.
What tests are CLIA waived?
Congress revised CLIA waiver provisions to automatically clear tests that the FDA clears for home use. These tests are:
1. Non-automated urinalysis that uses a dipstick or tablet for bilirubin, glucose, hemoglobin, leukocytes, nitrite, ketone, pH, protein, specific gravity and urobilinogen.
2. Fecal occult blood
3. Urine pregnancy tests that use visual color comparison
4. Ovulation tests that use visual color comparison
5. Non-automated tests for erythrocyte sedimentation rates
6. Non-automated tests for hemoglobin-copper sulfate
7. Blood glucose by glucose monitoring devices for home use
8. Spun microhematocrit
9. Hemoglobin by single analyte instruments
The most common CLIA waived tests are urine pregnancy tests, over-the-counter blood glucose tests, urine dipstick and tablet tests, and ovulation tests.
How does one apply for a CLIA Certificate of Waiver?
The CLIA Application for Certification Form, or CMS-116, is available at the Centers for Medicare & Medicaid Services (CMS) website. Complete this form and mail it to the local State Agency of where your lab is located.
Process time for CLIA certification takes approximately two months once the form has been received. Once Form CMS-116 is submitted to the State Agency and is processed, you will be issued a fee remittance coupon. The fee remittance coupon will indicate your CLIA ID, the amount to be paid for the certificate, as well as any other fees.
Contact your State Agency to see if there are any additional forms that are necessary for the registration process.
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