California

CLIA Certificate Application Process:

Clinical laboratories and facilities performing clinical laboratory testing must apply for and receive both a state registration or license and a federal CLIA certificate. For exceptions and exemptions to this requirement, please refer to the Regulations and Statutes Enforced by LFS webpage.

Instructions on how to apply for a clinical laboratory registration or license and federal CLIA certificate for waived, provider performed microscopy procedures, moderate or high complexity testing are found on the Laboratory Field Services (LFS) Clinical Laboratory Facilities webpage. 

CLIA Federal & State Regulation

CLIA Regulation and Guidance
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).

Regulations and Statutes Enforced by LFS
Regulations and statutes that pertain to LFS regulatory responsibility.

Title 17. Public Health. Division 1. State Department of Health Services. Chapter 2. Laboratories

“(a) All persons performing, supervising, consulting on, or directing clinical laboratory tests or examinations in California shall meet the requirements for performing, supervising, consulting on, or directing laboratory tests or examinations as set forth in Chapter 3 for the type and complexity of tests performed and irrespective of whether the clinical laboratory is operated under a CLIA certificate or under a state license or registration.”

“(b) An application for licensure to direct a clinical laboratory or to perform clinical laboratory tests or examinations under Chapter 3 shall be considered complete when the following is provided to the department:

(1) Name and address of the applicant, including city, state and zip code; and

(2) Social security number of the applicant (Pursuant to the authority found in Section 1224 of the Business and Professions Code and in Section 100275 of the Health and Safety Code, and as required by Section 17520 of the Family Code, it is mandatory to provide the social security number. The social security number will be used for purposes of identification.); and

(3) Gender and birthdate; and

(4) License for which the applicant is applying; and

(5) Whether the applicant has or has not been convicted of any felonies or misdemeanors other than minor traffic violations; and

(6) Documentation of the applicant’s education including:

(A) Name, address, major course of study, dates of attendance, number of credits, and degree/completion date for all colleges and universities attended by the applicant; and

(B) Official transcripts from the registrar of all accredited colleges or universities attended by the applicant showing all courses, course credits, degrees conferred and date of conference; and

(C) Official transcripts from non-United States colleges or universities which are not in English shall be returned to the applicant to obtain translation from a translation service approved in the United States for legal or government documents.

(7) Documentation of the applicant’s training including:

(A) Name and address of training program, dates of training, specialty and subspecialty areas of training, length of time in each specialty and subspecialty area of training; and

(B) Signed documentation from the training program director that this training has been successfully completed; and

(8) Documentation of the applicant’s experience, appropriate to the specific license for which the applicant is applying, including the following:

(A) Facility name, address, dates of employment, number of hours per week employed, the specialties and subspecialties in which clinical laboratory tests or examinations were performed and a description of clinical laboratory tests or examinations performed; and

(B) Signed documentation of such experience from the director of the laboratory; and

(9) Evidence of satisfactory performance on a licensing examination pursuant to Section 1029; and

(10) Signature of the applicant, telephone number and date of application; and

(11) Payment of license application fee pursuant to Business and Professions Code Section 1300.”

Clinical Laboratories are required to submit their CLIA Application for Certification (CMS-116), Form LAB

182 Attestation of each Owner, Form LAB 183 Attestation of each Laboratory Director. These completed forms can be uploaded to the application portal, which can be accessed here.

State payment of $113 is due at the time of submission, and federal payment is collected later. The certificate will be mailed after all payments have been collected.

Online Access to CLIA Certificates

CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool.  All certificates generated after September 27, 2023 should be available for download.  Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top).  When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.

https://www.cdph.ca.gov/Programs/OSPHLD/LFS/CDPH%20Document%20Library/IssuesSpecificCALabLaw.pdf