LABORATORY FIELD SERVICES

California Out-of-State Clinical Laboratory License

Who should apply?

Laboratories that are physically located outside of California.
Laboratories that perform diagnostic testing on specimens originating in California.
Laboratories performing moderate and/or high complexity testing on specimens originating in California.

Applications must be submitted online.

Out-of-State Initial Application Requirements

For sites located in states outside California, upload the appropriate documents and information requirements in your online application.

Important Reminders

All forms must be completed, filled out and dated. Supporting documents may be submitted in electronic format.
Complete all applicable sections of the forms and provide dated signatures where required. Supporting documents may be submitted via email to LFScc@cdph.ca.gov. Incomplete forms, missing information, and/or insufficient documentation will delay processing.
After our initial review, applicants will be given 30 days to correct any deficiencies. Failure to satisfy the Department's requirements will result in the abandonment of the application and/or termination of the license.
The application fee is non-refundable and will not be credited to your account if the application is abandoned, denied, or withdrawn.

Contact Us:

Submit your inquiry or request more information

References

> California Laws Regulating Out-of-State Laboratories - Effective January 01, 1996

California Business and Professions Code

Section 1241 (a) This chapter applies to all clinical laboratories in California or receiving biological specimens originating in California for the purpose of performing a clinical laboratory test or examination, and to all persons performing clinical laboratory tests or examinations or engaging in clinical laboratory practice in California or on biological specimens originating in California, except as provided in subdivision (b).

Section 1300 (p) In addition to the payment of registration or licensure fees, a clinical laboratory located outside of the State of California shall reimburse the department for travel and per diem to perform any necessary onsite inspections at the clinical laboratory in order to ensure compliance with this chapter.

California Code of Regulations 17 CCR § 1039.2. Clinical Laboratory Personnel Requirements

(a) All persons performing, supervising, consulting on, or directing clinical laboratory tests or examination 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) All persons performing, supervising, consulting on, or directing clinical laboratory tests or examinations outside California on biological specimens originating in California and irrespective of whether the clinical laboratory where the tests or examinations are performed is operated under a CLIA certificate or under a state license or registration, shall meet all personnel requirements set forth in Chapter 3 for the type and complexity of testing performed, or shall provide evidence to the department that they substantially meet those requirements by documenting inclusion, Licensure or certification in a class of personnel similar to those required in Chapter 3 or requiring equivalent standards.

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