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If you do not have online access and do not have information about your State Agency, you may contact the CLIA program at 410-786-3531 for the address and phone number of your State Agency.
The CLIA application (Form CMS-116) collects information about your laboratory's operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory requirements for CLIA. This information will also provide an overview of your facility's laboratory operation.
What is CLIA? The Clinical Laboratory Improvement Amendments of 1988 (CLIA) is a federal program governed by the Centers for Medicare & Medicaid Services (CMS). Its purpose is to establish quality standards for clinical laboratory testing to ensure that patient test results are accurate and reliable.
The Texas Health and Human Services Commission (HHSC), on behalf of the CMS CLIA program, uses Form 3225 to process CLIA certificate applications. Applicants must forward a completed Form 3225 to their appropriate CLIA State Agency regional office for HHSC to accept and process their CLIA application.
You can enroll your laboratory in the CLIA program by completing an application (Form CMS-116) available on the CMS CLIA website or from your local State Agency. Send your completed application to the address of the local State Agency for the State in which your laboratory is located.
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2:53 12:00 How to Complete a CMS 116 Application - YouTube YouTube Start of suggested clip End of suggested clip Process. Section 1 general information section 1 contains fields to enter a facility's demographicMoreProcess. Section 1 general information section 1 contains fields to enter a facility's demographic information the first part of this section describes the purpose of the application.
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
CLIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with the federal Centers for Medicare & Medicaid Services (CMS) and obtain CLIA certification.
CLIA requires that waived tests must be simple and have a low risk for an incorrect result.
Can I transfer my CLIA certificate to the new owners? Yes. The new owners can request a transfer by completing a CMS-116 Application Form and a CLIA Ownership Information form" found under CERTIFICATION & FEES on webpage.

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