CMS regulates all laboratory testing (except research) performed in the United States. Depending on the type of testing that is done in the laboratory, different types of certification may be required. In most states, if a clinical practice only does CLIA waived testing, a certificate of waiver is required. If the physician adds other tests that are not CLIA waived, a different type of certificate may be required.
A CLIA waived test has been reviewed by the FDA and CMS to determine that errors in operation will be minimized and that inaccurate test results will not endanger the life of the patient. A CLIA waiver is specific to the manufacturer and the product. Each test method is individually examined before a CLIA waiver is granted.
Note: Your state may have additional requirements. Be sure to contact your local agency before applying. A state locator link is provided below.
National Center for Medicare & Medicaid Services/CLIA
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STATE SURVEY AGENCY CONTACTS
This is the form you will need to apply for CLIA-waived status. Also be sure to contact your local office to determine additional information.
CMS is the Center for Medicare & Medicaid Services. Formerly known as the Health Care Financing Administration (HCFA), it is the federal agency responsible for administering CLIA (Clinical Laboratory Improvement Amendments) and several other health-related programs.
Reach out to your local Stat Technologies sales representative or simply contact us for more information on how to obtain CLIA status in your state.