Skip Navigation LinksRenewal-OOS-ClinicalLaboratoryLicense

Laboratory Field Services

Out-of-State Clinical Laboratory License Renewal Instructions

These instructions apply to clinical laboratories seeking to renew their out-of-state clinical laboratory license.

 

Renewal application packets must include ALL of the following:

Fee Information:

  • Reference the Laboratory Field Services fee schedule (PDF) for up-to-date fee information. Submit the fee indicated on the fee invoice. Do not send a fee based on your current test volume as indicated on the form submitted with your current renewal.

  • License renewal application fee must be submitted in the form of a check or money order made payable to: California Department of Public Health.

  • The license renewal application fee is non-refundable and is subject to change with each fiscal year.

 

State forms and documents to complete and submit:

All signatures must be original. Copies are not accepted. Forms listed below can also be found on the LFS forms page.  

  • LAB 144 ROS (PDF)  — Application for Renewal of Clinical Laboratory License (Out-of-State) 
    Please also include the required documents as listed on page 3 (items 10-13). Additional guidance on these items is included below:

    • #10

      • A copy of the most recent CLIA certificate from CMS or State license if located in a CLIA exempt state. The copy should include the approved specialties.

    • #11

      • For the addition of new tests and any new CLIA test specialty, submit copy of the laboratory’s notification to CMS/AO and AO and/or acknowledgement letter from CMS/AO.

    • #12

      • A copy of the latest survey report from CLIA (CMS, State agent) or accrediting body’s (COLA, The Joint Commission, CAP), which should include citations, plan of correction, and the accrediting body certificate with expiration date.

    • #13

      • A copy of proficiency testing (PT) results/scores for previous three testing events for analytes that are ordered on California specimens.

      • Submit PT results only for analytes ordered on California specimens – the results may not include your entire test menu.

      • If CAP is your external PT provider, you may send the "All Analytes Summary" and indicate which analytes are ordered on California specimens.

      • If commercial proficiency testing is not available, the laboratory is required to perform at least twice yearly method verification to verify the accuracy of the test results.

      • If any commercial or method verification testing samples received an "unsatisfactory" or "failed" score, the laboratory must submit a copy of the follow up investigation, findings, and corrective action.

      • For a new lab that has not completed a PT testing event, provide proof of enrollment with a PT provider.

      • If there is no commercial PT provider available, then submit a copy of the lab’s internal PT SOP.

  

Please mail all forms, supporting documents, and fee to the address below:

California Department of Public Health
Laboratory Field Services
850 Marina Bay Parkway
Building P, 1st Floor
Richmond, CA 94804

 For additional information you may contact LFSfacoutofstate@cdph.ca.gov.

 

​​ ​​
Page Last Updated :