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.

Go Paperless, apply online!

Mail-in Requirements for OOS Initial Application

For sites located in states outside California, complete the application form (LAB 144 OS) and submit the appropriate documents requested below. There are recent changes in the requirements. Read and follow the instructions described below.

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application fee is non-refundable and will not be credited to your account if the application is abandoned, denied, or withdrawn.

mail

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

California Department of Public Health
Laboratory Field Services
Attn: Out-of-State Laboratory Licensing Program
850 Marina Bay Parkway, Bldg. P, 1st Floor
Richmond, CA 94804

Contact Details

For questions please contact:
By email: LFScc@cdph.ca.gov
By telephone: (510) 620-3800

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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