Clinical Laboratory Improvement Amendments
Who Needs a CLIA Certificate?
Any facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate. If a facility performs tests for these purposes, regardless of whether there is reimbursement for such tests, it is considered to be a laboratory according to the definition by CLIA and must obtain and maintain CLIA certification.
Tests for which a CLIA certificate IS NOT required include:
- forensic testing
- blood draws
- specimen collections
- drug testing for purposes of employment
Basically, if you do not perform any testing on-site you do not need a CLIA certificate. However, CMS allows for certain exceptions to this rule, such as mobile units, home health agencies with multiple branches and temporary testing sites. In these cases, a separate certificate is not issued to each testing location but to a designated primary site, parent location or home base.
For more information about Who Needs a CLIA Certificate: Code of Federal Regulations (govinfo.gov)