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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.
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 state agency for the state in which your laboratory is located.
Staff performing the testing would need to be employed by the \u201cowner\u201d of the certificate, in this case the local public health department or clinic. CLIA certificates are not only a requirement for COVID-19 testing. CLIA Certificates of Waivers are required for other laboratory testing done in schools.
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.
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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.
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.
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 state agency for the state in which your laboratory is located.
What is waived testing? By the CLIA law, waived tests are those tests that are determined by CDC or FDA to be so simple that there is little risk of error. Some testing methods for glucose and cholesterol are waived along with pregnancy tests, fecal occult blood tests, some urine tests, etc.
The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.

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