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
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āāāNew Federal āCLIA 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)ā.
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How to apply for a Federal CLIA...
Certificate of Waiver or
Certificate for Provider Performed Microscopy Procedures
View Process Flowchart
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California Clinical Laboratory License
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Fee Coupon and Federal CLIA Certificate
- After 2ā3 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 certificateā is issued. Post this at the facility address on the certificate and begin patient testing.
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How to apply for a Federal CLIA...
Certificate of Compliance or
Certificate of Accreditation
View Process Flowchart
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California Clinical Laboratory License
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Federal CLIA Certificate of Registration (CoR)
- Upon review, LFS will forward the application to the LFS onsite licensure section.
- After 2ā3 weeks, a
fee cāoupon from CMSā 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.
- Pāayment can be made via
Pay.govā 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.
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Federal CLIA Certificate of Compliance/Accreditation
- After 6ā9 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
Pāāay.govā 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 organizationā (AO), the AO will conduct the inspection for Certificate of Accreditation.
- After passing the inspection, a
Certificate Fee coupon will be issued by CMS.
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Payment can be made via
Pay.govā or mail to the coupon address.
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Receive the
federal CLIAā certificate and post at the facility that was inspected. This replaces the federal CLIA CoR from Step 2.
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āāāRenewal of Federal āCLIA Certification CMS or its representatives may conduct inspections on a biannual basis. The frequency of inspections depends on the laboratoryās compliance history. The federal CLIA certification renewal is
biannual and is processed separately from California laboratory license/registrationās annual renewal. āāāāāāāāā
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Renew Certificate of Waiver, or PPMP
View Process Flowchart
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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.govā 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.
Renew Certificate of Compliance
View Process Flowchart
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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.govā 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.govā 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.
Renew Certificate of Accreditation
View Process Flowchart
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The laboratoryās Accrediting Organization will issue a
Validation Survey Fee coupon invoice through CMS. Payment can be made via
Pay.govā 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.govā 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.
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āāāUpdating of Federal CLIA InformationThe information on your federal CLIA should match with the California Laboratory License information.
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How to Update 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 Changesā 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 organizationā as applicable.ā
When to Update Information
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.āāā