What Is Involved in Getting a CLIA Certification?


Quick Answer

Obtaining a Clinical Laboratory Improvement Amendments, or CLIA, certification involves obtaining and filling SMS-166 Form, submitting the form to a relevant state agency, and paying the application fee, according to the Houston Chronicle. Allowing the agency time to review the application and issue a certificate completes the process.

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Full Answer

Obtaining the SMS-166 Form involves downloading the form from the official website of the U.S. Department of Health and Human Services, notes the Houston Chronicle. After obtaining the form, the lab owner fills in all the necessary information and appends his signature to the form before submission. Submitting the form involves sending the form to a state agency that has jurisdiction over the laboratory through an email. The application fee accompanies the application; each CLIA certificate type has its own fee amount. The types of CLIA certificates include waiver certificate, microscopy procedures certificate, certificate of accreditation, certificate of registration and certificate of compliance.

A CLIA certificate is a document indicating a laboratory's qualifications to test human specimens based on federal standards, states the Houston Chronicle. The U.S. Department of Health and Human Services issues the certificate. The certificate is a requirement for each lab that tests human specimens. However, it is not a requirement for labs that perform forensic tests and those with certification from the Substance Abuse and Mental Health Administration.

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