Federal CLIA Certificate

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Overview

This process involves compliance with the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988, which requires that all laboratories testing human specimens be certified by the federal government. The Los Angeles LFS Office manages the federal CLIA program in California.

The mission of the Clinical Laboratory Improvement Amendments (CLIA) section of Laboratory Field Services is to ensure compliance with State and federal clinical laboratory laws and regulations by performing biannual onsite inspections to ensure accuracy and reliability of laboratory test results and conducting review of laboratory performed proficiency testing results.

The Centers for Medicare & Medicaid Services (CMS) regulates and ensures quality laboratory testing through the Clinical Laboratory Improvement Amendments (CLIA) program. Laboratory Field Services (LFS) implements the federal CLIA program in the State of California, and this program inspects and monitors clinical laboratories to ensure compliance of both state and federal CLIA regulations.

More information about CLIA on CMS.gov.

Federal CLIA and State Laboratory Licensing

The State of California Business and Professions Code (BPC) section 1265 (a) requires that a laboratory testing site has a California clinical laboratory license in addition to having a federal CLIA certificate which is a federal requirement.

For a California facility to perform testing on California specimens,
there are 2 laboratory testing licenses required:

 

Certificate Types

• Facilities performing federal CLIA Certificate of Waiver
• Facilities performing Provider Performed Microscopy Procedures
• Facilities performing Moderate or High complexity testing; Certificate of Compliance
• Facilities applying for federal CLIA Certificate of Accreditation

 

​	​​​New Federal ​CLIA Certification Follow the appropriate steps below to apply for a federal CLIA certificate. For additional information on how to complete a CMS 116 federal form, refer to the Certification Quick Start Guide (PDF)​.

Certificate of Waiver or
Certificate for Provider Performed Microscopy Procedures

View Process Flowchart

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​ California Clinical Laboratory License First, apply for a California laboratory license through the LFS online application system​.​ Upload the federal CLIA application form, CMS 116 (PDF), in the online application. Additional documents may be requested​. Pay for the California Laboratory License fee in the online application. Refer to the California License Fee Schedule (LFS). California Laboratory License​ is issue​d. Print and post this at the facility address stated on the certificate. Renew the California laboratory license online, every year.

​ Fee Coupon and Federal CLIA Certificate After 2–3 weeks, a fee coupon from CMS will be issued with the federal CLIA identification number and the amount due. Payment can be made via Pay.gov or mail to the coupon address. A federal CLIA certificate​ is issued. Post this at the facility address on the certificate and begin patient testing.

Certificate of Compliance or
Certificate of Accreditation

View Process Flowchart

​ ​​​​​​	​ California Clinical Laboratory License First, apply for a California laboratory license through the LFS online application system. Upload the federal CLIA application form, CMS 116 (PDF)​, in the online application. Additional requirements may be acquired. Pay for the California Laboratory License fee in the online application. Refer to the California License Fee Schedule (LFS). California Laboratory License​ is issue​d. ​​ Print and post this at the facility address on the certificate. Renew the California laboratory license online, every year.
​	​ Federal CLIA Certificate of Registration (CoR) Upon review, LFS will forward the application to the LFS onsite licensure section. After 2–3 weeks, a fee c​oupon from CMS​ will be issued with the federal CLIA identification number and the amount due for the federal CLIA Certificate of Registration (CoR). A CoR is a prerequisite for a Certificate of Compliance/Accreditation. P​ayment can be made via Pay.gov​ or mail to the coupon address. Federal CLIA Certificate of Registration is issued. See FAQs below this page for more information about CoR. Post this at the facility address on the certificate. Begin patient testing.
	​ Federal CLIA Certificate of Compliance/Accreditation After 6–9 months, CMS will send a Compliance Survey Fee coupon based on the estimated volume in the Certificate of Compliance application. Payment can be made via P​​ay.gov​ or mail to the coupon address. After payment, an onsite inspection or compliance survey will be scheduled. If the laboratory is accredited by an approved accreditation organization​ (AO), the AO will conduct the inspection for Certificate of Accreditation. After passing the inspection, a Certificate Fee coupon will be issued by CMS. Payment can be made via Pay.gov​ or mail to the coupon address. Receive the federal CLIA​ certificate and post at the facility that was inspected. This replaces the federal CLIA CoR from Step 2.

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​​​Renewal of Federal ​CLIA Certification CMS or its representatives may conduct inspections on a biannual basis. The frequency of inspections depends on the laboratory’s compliance history. The federal CLIA certification renewal is biannual and is processed separately from California laboratory license/registration’s annual renewal. ​​​​​​​​​

View Process Flowchart

• Both Certificate of Waiver and PPMP are not routinely surveyed. The CMS office will issue a fee coupon invoice 6 months before the federal CLIA Certificate expires.

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• Payment can be made via Pay.gov​ or mail to the coupon address.

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• The renewed certificate will only be issued a few weeks prior to the expiration of the current certificate. Post this at the facility address on the certificate and replace the expired certificate.

View Process Flowchart

• The CMS office will issue a Compliance Survey Fee coupon invoice 12 months before the federal CLIA Certificate expires. Payment can be made via Pay.gov​ or mail to the coupon address.

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• An inspection will be scheduled. If the laboratory passed the inspection, CMS will issue a Certificate Fee coupon based on the testing volume. Payment can be made via Pay.gov​ or mail to the coupon address.

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• The renewed federal CLIA certificate is issued. Post this at the facility address on the certificate and replace the expired certificate.

View Process Flowchart

• The laboratory’s Accrediting Organization will issue a Validation Survey Fee coupon invoice through CMS. Payment can be made via Pay.gov​ or mail to the coupon address.

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• An inspection will be scheduled. If the laboratory passed the inspection, CMS will issue an Certificate Fee coupon. Payment can be made via Pay.gov​ or mail to the coupon address.

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• The renewed federal CLIA certificate is issued. Post this at the facility address on the certificate and replace the expired certificate.
  

​	​​​Updating of Federal CLIA Information The information on your federal CLIA should match with the California Laboratory License information.

To update your federal CLIA information such as...

• Laboratory Director,
  
• Ownership,
  
• Address,
  
• Specialties/Subspecialties,
  
• Adding secondary site(s) to a multisite license,
  
• and other changes,

Please refer to: Submit Changes​ webpage for the appropriate requirements. No fees are required, except if changing the certificate type or adding secondary sites. We, LFS, will update your information with CMS. However, you must notify the accreditation organization​ as applicable.​

Notify LFS within 30 days when you have changes in the following: mailing address, facility address, laboratory director, ownership/Tax ID, closure, or minor changes.

Notify LFS immediately if you have changes in the type of tests that might require you to update your federal Certificate Type and that requires appropriate initial application fees.​​​