A Clinical Laboratory Improvement Amendment number is obtained by filing through the U.S. Department of Health and Human Resources.The SMS-166 form must be submitted in order to obtain a CLIA number, notes CMS.gov.
A CLIA number can only be requested by the owner of a medical laboratory in the United States online or by mail. The form requires specific laboratory information and signatures and must be filed through local state agencies.
The fees for obtaining a CLIA number vary by the type of certificate a laboratory is requesting. Once the application is approved, the CLIA number is provided along with a certificate. The 10 digits listed on the certificate are the state-issued CLIA number.
A CLIA number is needed before a laboratory performs any medical tests on an individual in the United States. The only exceptions to this standard are in the cases of research and clinical trials.
The CLIA program was put into place in 1988 to regulate and monitor quality laboratory testing. This program aids in the assurance that laboratory tests are performed in a timely manner and provide accurate and reliable results.
The CLIA program receives its funding from numerous laboratory organizations throughout the United States, and there are five different types of CLIA certifications as of 2015, notes CMS.gov. Forensic labs are not required to obtain a CLIA certification.