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Information about the California Out-of-State Clinical Laboratory License

Who should apply for a California Out-of-State Clinical Laboratory License?

If you are a facility applying for a CLIA Certificate of Compliance or a Certificate of Accreditation for the performance of non-waived (moderate or high complexity) testing on samples originating in California but are physically located outside of California, you must apply for a California Out-of-State Clinical Laboratory License. Note that no clinical laboratory license shall be issued by the department unless the clinical laboratory is found to be in compliance with applicable state laws and regulations.

Facilities physically located in the state of California may apply for an in-state license.    

  

How to apply for a California Out-of-State Clinical Laboratory License

Fee Information:

  • Reference the Laboratory Field Services fee schedule (PDF) for up-to-date fee information. Remit payment based on the total calculated on form LAB 167 OS.

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

  • The license 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 OS (PDF)  — Application for Clinical Laboratory License (Out-of-State) 
    Please also include the required documents as listed on page 2 (items 8-11). Additional guidance on these items is included below:

    • #8

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

    • #9

      •  A copy of the analyte test method procedure (SOP) and method validation study summary as approved, signed and dated by the lab director of each test method that the laboratory anticipates will be ordered on California specimens.

    • #10

      •  A copy of the latest survey report from CLIA (CMS, State Agent) or an accrediting organization (CAP, COLA, The Joint Commission) and the laboratory's Plan of Correction for each deficiency cited. Accredited laboratories must submit a copy of the accrediting organization certificate with the expiration date.

      • For a newly formed laboratory that intends to become accredited and has not yet been surveyed, provide proof of enrollment with an accrediting organization.

      • If the laboratory intends to obtain a Certificate of Compliance and be surveyed by the CLIA State Agent, provide evidence that the State Agent has been notified.

    • #11

      •  A copy of proficiency testing (PT) results for three previous testing events for each analyte that the laboratory anticipates will be ordered on California specimens.

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

      • If CAP is your external PT provider, you may send the “All Analytes Summary” and indicate the analytes that will apply to California specimen testing.

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

      • If any of the commercial or twice yearly method verification testing samples received an “unsatisfactory” or “failed” score, the laboratory must submit a copy of the follow-up investigation to determine the root cause, the findings and corrective action.

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

      • If there is no commercial PT provider available, and the laboratory has not yet performed the twice yearly method verification, then submit a copy of the laboratory's method verification State of Procedures.

  • LAB 144A (PDF) Laboratory Testing Declaration
    Indicate which analytes the laboratory expects will be ordered on CA specimens. Include the names of manufacturer(s) of the instrumentation (if any) that will perform the testing on each of these analytes. Lastly include an estimate of the total test volume of each analyte the laboratory anticipates will be ordered on California specimens within the first 12 months after the California laboratory license is issued.   

  • LAB 1513 (PDF) Disclosure of Ownership and Control Interest Statement         
    Please submit the name of each owner, which is defined as anyone with five percent or more stake in the laboratory. For owners that are legally created entities, submit the following documents described below. 

    • Corporation:

      • Submit a copy of the formal filing of the creation of the corporation with the Secretary of State.

      • Submit a copy of the Articles of Incorporation.

      • Submit the names of the corporate officers, and the names and addresses of the board of directors.       

    • Limited Liability Company:

      • Submit a copy of the Operating Agreement or Articles of Organization.

      • Submit a copy of the Secretary of State filing.

    • Partnership:

      • Submit a copy of the partnership agreement.

      • Submit names of the individuals/parties forming the partnership.

      • Submit the Secretary of State filing.

    • Non-profit or government agency:

      • Submit a list of members of the board of directors as they are considered the owners.

      • Submit a copy of the federal tax ID form given to non-profit organizations.

    • Tax EIN/ID number submitted should match the number indicated in the CLIA database.
  • LAB 116 OS (PDF)  — Laboratory Personnel Report
    This form must list all persons directing, supervising, performing testing, and releasing results of testing performed on specimens from California. If you submit a database printout, please complete the top of the LAB 116 OS form and state that a list of personnel is attached.

  • LAB 167 OS (PDF) — Annual Test Volume Derived from California Specimens Only
    This form is to provide an estimate of the volume of each analyte the laboratory anticipates will be ordered on only California specimens within the first 12 months after the California laboratory license is issued. Provide a total for all analytes within the appropriate specialty/subspecialty. Do not submit the test volume totals derived from all clients for the previous 12 months.

  • LAB 168 OS (PDF) — Laboratory Personnel Qualification Form
    Each testing person listed on LAB 116 OS must submit a completed form which must be signed and dated by the individual and co-signed and dated by the laboratory director. Note that Item 11 must be fully completed. All persons will be evaluated for equivalency to the California requirements for testing personnel. Please note: California has required testing persons to have obtained a Bachelor degree (after January 01, 1965) with a rare exception. Training and experience is also necessary. California law for personnel is included on this web page. Additional documentation may be requested.

  • LAB 183 (PDF) — Director's Attestation
    Submit a completed, signed, and dated LAB 183 form for each laboratory director and:

    • CV or resume

    • If an MD - a copy of the director’s MD license for the state in which the lab resides

    • If a PhD – a copy of the PhD diploma

    • If a PhD – documentation of a professional organization approved by CLIA

    • Note that this individual need not hold a California director’s license

  

Submit the California out-of-state clinical laboratory license application fee and all required documents and state forms to:

CDPH – Laboratory Field Services
Attn: Out-of-State Laboratory Licensing Program
850 Marina Bay Parkway, Bldg P, 1st Floor
Richmond, CA 94804-6403

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

 

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