To determine if your facility is exempt from having a California clinical laboratory registration/license, it must meet one of the numbered criteria below:
1. Testing site meets ALL 3 conditions:
- CLIA certification was established before January 1, 1996,
- Continuously operational with no termination, and
- No changes in the CLIA certificate type.
(If you need help determining if you qualify for #1, please email
2. Owned and operated by the United States of America.
Public health laboratories.
4. Laboratories that perform clinical laboratory tests or examinations for
forensic purposes only.
5. Laboratories that perform clinical laboratory tests or examinations for research and teaching purposes only and do not report or use patient specific results for the diagnosis, prevention, or treatment of any disease or impairment of, or for the assessment of health of, an individual.
6. Laboratories that perform clinical laboratory tests or examinations certified by the
National Institutes on Drug Abuse only for those certified tests or examinations. However, all other clinical laboratory tests or examinations conducted by the laboratory are subject to this chapter.
7. Laboratories that register with the State Department of Health Care Services pursuant to subdivision (c) to perform
blood glucose testing for the purposes of monitoring a minor
child diagnosed with diabetes if the person performing the test has been entrusted with the care and control of the child by the child’s parent or legal guardian and provided that certain conditions have been met BPC 1241(b) (6) (A-F).
8. Inactive laboratories or laboratories that do not perform clinical laboratory tests.
If you determine you facility is exempt, you may email us and indicate the criteria in which you qualify and we will review that information.
If not exempt…
If you do not qualify to be exempt, you have to submit a set of requirements for an initial application. To know the requirements, refer to the “New Application” link on our web under the appropriate complexity testing.
Not being able to reply to the notices we sent you may result in the termination of your CLIA certificate, as you must also comply with the State regulations. CLIA certification is a requirement for Medicare and MediCal reimbursement for waived or PPMP testing.
Additional information on BPC sections 1265 (a) and 1241 is available on the LFS web site at: