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Laboratory Field Services

Information about California Clinical Laboratory Licensure

Who should apply for a California Clinical Laboratory License and CLIA Certificate?

If you are applying for a CLIA Certificate of Compliance or a Certificate of Accreditation for the performance of non-waived (moderate or high complexity) testing, you must apply for a California 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 applying for a CLIA Certificate of Waiver or Certificate for Provider Performed Microscopy Procedures (PPMP), must apply for a state registration, not a state license.

 

How to apply for a California Clinical Laboratory License

Fee Information:

  • 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.

  • Reference the state laboratory fee schedule (PDF) for up-to-date fee information.

  • Note: The federal CLIA program will bill you separately for the CLIA certification fee.

 

State forms 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.

Other Requirements:

  • Articles of incorporation which include all owners' name(s), a corporation or partnership agreement, if applicable. Include a separate sheet with the names and home addresses of the board members.

  • Proficiency Testing, Facility Administration, and Quality Systems Requirements: Download Checklist (PDF) Submit all applicable items to verify that your facility meets the requirements in accordance with Business and Professions Code (BPC) Section 1220.

  • Documentation of the director's qualifications (Note: A laboratory director may direct no more laboratories than permitted by CLIA.)

    • For moderate complexity testing, a physician licensed after Feb. 28, 1992:

      • Documentation of at least one year training or experience directing or supervising non-waived laboratory testing.

      • OR

    • For high complexity testing, documentation of at least one year of laboratory training during medical residency or two years experience directing or supervising high complexity testing.

    • For Dermatopathology, Histopathology other than Dermatopathology, and Anatomic/Clinical Pathology, submit a copy of the respective board certification. 

 

Federal forms to complete and submit:

 

 Mail to:

California Department of Public Health
Laboratory Field Services
850 Marina Bay Pkwy, Bldg. P-1st Floor
Richmond, CA 94804-6403

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

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