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LABORATORY FIELD SERVICES

Federal CLIA Certificate

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Map of U.S.A. highlighting California emphasizing that Laboratory Field Services is the CLIA agent in California. 

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:

One, a California Laboratory License as a State requirement and LFS implemented. Plus, two, a Federal CLIA Certification as a Federal requirement, and CMS implemented. 

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

Click to go to the FDA CLIA database to determine the test category. 


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​​​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)​.

How to apply for a Federal CLIA...

Certificate of Waiver or
Certificate for Provider Performed Microscopy Procedures


View Process Flowchart


​​​​Step 1 in obtaining a COC or COA
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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.

Step 2 in obtaining a COC or COA
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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.

How to apply for a Federal CLIA...

Certificate of Compliance or
Certificate of Accreditation


View Process Flowchart

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​​​​​​Step 1 in obtaining a COC or COA
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California Clinical Laboratory License


​Step 2 in obtaining a COC or COA
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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.

Step 3 in obtaining a COC or COA
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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. ​​​​​​​​​

Renew Certificate of Waiver, or PPMP

View Process Flowchart

  • Step 1 on renewing CoW or PPMPBoth 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.
  • Step 2 on renewing CoW or PPMPPayment can be made via Pay.gov​ or mail to the coupon address.
  • Step 3 on renewing CoW or PPMPThe 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

  • Step 1 on renewing CoCThe 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.
  • Step 2 on renewing CoCAn 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.
  • Step 3 on renewing CoCThe 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

  • Step 1 on renewing CoAThe 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.
  • Step 2 on renewing CoAAn 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.
  • Step 3 on renewing CoAThe renewed federal CLIA certificate is issued. Post this at the facility address on the certificate and replace the expired certificate.


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​​​Updating of Federal CLIA Information

The information on your federal CLIA should match with the California Laboratory License information.

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 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.​


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.​​​


Resources​​​​​​​

Fee Schedule

Contact LFSCLIA@cdph.ca.gov​ if you are inquiring about federal CLIA fees. Please note that LFS does not process federal CLIA payments.​


Certificate Copy

For a copy of the federal CLIA certificate, or issues, and corrections, contact LFSCLIA@cdph.ca.gov​

For a copy of California laboratory license, refer to: Reprint Certificate (PDF)​


Go Paperless!

Opt in to receive payment invoice and federal CLIA certificate by email. On the CMS 116 (PDF)​ form, check the box, ā€œReceive notifications including electronic certificates via emailā€ to opt in and provide an email address.

Excerpt of CMS 116 showing the email address and a marked checkbox for opting in

This can be requested anytime in your license cycle. Email the form to the Richmond LFS office.​​​​​​




CMS Brochure

Find out about certificate types, approved Accrediting Organizations, Exceptions, and other important information on this printable brochure.

CMS Brochure (PDF)

Complaint Reporting

Refer to How to File a Complaint (PDF)​. Then, proceed to LFS Clinical Laboratory Complaints Program​ to find the requirements/instructions.


Forms

State and federal forms can be downloaded
from LFS Forms​ webpage.


Reactivation

Submit a CMS 116 (PDF)​ to the Richmond LFS office specifying ā€œReactivationā€ on Section I .​


Status

Log in​ to view the status of your initial application.


Closing

If not renewing, refer to LFS Submit Changes​ webpage and scroll down to ā€œBasic Changesā€ in  Other Changes.​​​​​​​​​​​​​​​​​​​​​​​​​​​​


Contact LFS

The Richmond Campus

The Richmond Campus 

phone icon​​ ​email icon
​(510) 620-3800
​LFScc@cdph.ca.gov​​​​

The​ Richmond LFS office, handles...

  • the California Clinical Laboratory License applications,
  • federal CLIA initial applications,
  • majority of customer inquiries,
  • state laboratory license payments,
  • and other administration related services.

Please note: This office does NOT process any federal CLIA payments.​​​

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The Los Angeles Office

LFS Los Angeles Office 

phone icon​​ ​email icon
​(213) 620-6160 ​LFSCLIA@cdph.ca.gov​​​​​

The​ Los Angeles LFS office, handles...

  • the State and Federal inspections,
  • federal CLIA payment inquiries,
  • federal CLIA certificate inquiries,
  • other federal CLIA related issues.

Please note: This office does NOT process any federal CLIA payments or California Laboratory License payments. Please do NOT send check payments to this office to avoid delay.​​​​​​​​​

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