All clinical laboratories performing tests on California specimens must have a federal CLIA certificate and either a California State license or California State registration.

LFS uses prefix codes to identify the different types of laboratories in our state database (see table below).

Laboratories that choose deemed status with a State-approved accreditation organization (AO) have different prefixes (3rd column) from laboratories that choose state oversight. For more information on deemed status, see questions 22-24.

Mail applications for State license or registration and federal CLIA certificate together to Laboratory Field Services (LFS).

To apply for a new license you must submit an application, including forms and supporting documents listed below, along with a non-refundable application fee. An incomplete or incorrect application packet will delay the processing, review, and approval of an application.

LFS may abandon any incomplete/incorrect application after 30 days if the applicant cannot be reached, is unresponsive, or fails to provide requested information.

For the full set of application instructions please visit the initial clinical laboratory license application page.

Any laboratory testing on specimens originating from California must apply for a California State license. To apply for a new license for an out-of-state (OOS) laboratory you must submit an application, including forms and supporting documents.

LFS may abandon any incomplete/incorrect application after 30 days if the applicant cannot be reached, is unresponsive, or fails to provide requested information.

For the full set of application instructions please visit the initial out-of-state clinical laboratory license application page.

Any laboratory testing on specimens originating from California must apply for a license. A new license for Out-of-State (OOS) requires submitting several forms, documents and fee. An incomplete or incorrect application packet will delay the processing, review, and approval of an application.

LFS may abandon any incomplete/incorrect application after 30 days if the applicant cannot be reached, is unresponsive, or fails to provide requested information.

The following is the median turnaround time for applications:
• Initial license: 60-90 days
• Initial registration: 60-90 days
• Renewal of existing license: 60-90 days
• Renewal of existing registration: 60-90 days

Note: LFS processes applications in the order in which the completed packets are received. There is no process for expediting an application.

Notices are automatically generated by our system, and may have been generated prior to receipt of the application and fee. If you wish to follow-up on a payment, please follow the instructions to question # 11.

• Determine the expected or 'best guess' total test volume derived from the anticipated number of California specimens to be received from the first year after the laboratory is licensed by LFS.

• Visit the Laboratory Field Services fee information page and access the Laboratory Field Services fee schedule.

• Look for the test volume in the second volume under the "License Fee - Graduated (Based on Volume) table and then find the fee amount in the third column titled 'Initial Application Fee'.

• Submit a check payable to "CDPH-LFS."

Fees are non-refundable. However, for overpayments, a credit is applied towards the next renewal cycle.

Inquiries about specific applications can be sent to:

If you wish to dispute a payment, please provide the following information to the appropriate group email box listed in question # 11 for the type of application for which the fee was sent:

• Copy of cashed/cancelled check (front and back)
• Laboratory Name and contact information
• Package tracking number (if available)
• State ID and/or CLIA ID

A laboratory license must be renewed each year by submitting the renewal packet and fee. A renewal packet with the necessary forms and fee amount are mailed out 75 days before the expiration date. If a renewal packet has not been received, forms and additional laboratory license renewal information is found on the clinical laboratory license renewal page.

A registration must be renewed each year by submitting a renewal packet and fee. A renewal packet with the necessary forms and fee amount are mailed out 75 days before the expiration date. If a renewal packet has not been received, forms and additional laboratory registration renewal information is found on the clinical laboratory registration renewal page.

Visit the change of directorship page for licensed laboratories for additional information and instructions.

Visit the change of ownership page for licensed laboratories for additional information and instructions.

Visit the change of directorship page for registered laboratories for additional information and instructions.

Visit the change of ownership page for registered laboratories for additional information and instructions.

To report a change of laboratory address, submit a completed LAB 193 "Notification of Laboratory Change" (PDF) form or a letter of notification on the laboratory's letterhead stating the location change and effective date. Either document must be signed and dated by both owner or authorized representative and laboratory director.

For licensed Laboratory:

• Submit a list of new test(s) and new specialty
• New specialty requires submitting evidence such as the acknowledgement letter that laboratory has notified the regional CLIA office, or State Agent, of the addition.

For registered Laboratory:

• LFS does not need to be notified for additional waived or PPMP tests.

• For in State, complete form LAB 116 or,
• For Out of State, LAB 116 OS and LAB 168 OS form for each new employee that is signed and dated by the employee and laboratory director.

Note: Additional documentation may be required.

Under Section 1223 of the BPC, the Department (CDPH) has approved accrediting organizations to inspect laboratories. This allows a laboratory to choose licensure and inspection by the Department or certification of deemed status and inspection by an accrediting organization.

Note: The chosen accrediting organization will conduct inspections as part of the accreditation process.

List of approved accrediting organizations (PDF)

The current state approved accrediting organizations are CAP, COLA, TJC and AABB. Download a list of

Private nonprofit laboratory accrediting organizations approved by the California Department of Public Health (PDF)

In order to apply for a certificate of deemed status, a laboratory must:

• Provide proof of enrollment or a copy of the laboratory's current certificate of accreditation.
• Possess or have applied for a current CLIA Certificate of Accreditation, Certificate of Waiver or Certificate of PPMP.

• During the initial or renewal cycle, submit a completed application packet to LFS (see questions under Application, Fees, and Renewal).

• Pay the state application fee for initial license or registration or renewal.

Note: If a laboratory's license is in the process of revocation or has been revoked, the laboratory may not apply for a certificate of deemed status.

Contact us by email: LFScc@cdph.ca.gov

You can file a complaint by completing and submitting a completed  LAB 163 (PDF) form to LFSabcomplaints@cdph.ca.gov