1. Go to our Log In page.
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3. Follow the instructions that you receive in your email.

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Business and Professions Code 1265 (d) lists four categories. Examples of the documents we typically require are listed under each category.

(1) Laboratories that are not at a fixed location, that is, laboratories that move from one testing site to another, such as mobile units providing laboratory testing, health screening fairs, or other temporary testing locations, may apply for and obtain one license or registration for the designated primary site or home base, using the address of that primary site.

Note:

• Your application will require further review.

(2) Not-for-profit, or federal, state, or local government laboratories that engage in limited (not more than a combination of 15 moderately complex or waived tests, as defined under CLIA, per license) public health testing may apply for and obtain a single license or registration.

Provide:

• 501(c)(3) IRS verification of non-profit status
• List of tests performed

(3) Laboratories within a hospital that are located at contiguous buildings on the same campus and under common direction, may file a single application or multiple applications for a license or registration of laboratory locations within the same campus or street address.

Note:

• Your application will require further review.

(4) Locations within a single street and city address that are under common ownership may apply for and obtain a single license or registration or multiple licenses or registrations, at the discretion of the owner or owners.

Note:

• ​Your application will require further review.​

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  LFScc@cdph.ca.gov)

2. Owned and operated by the United States of America.

3. 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 exempt…

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.

If ignored…

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.

You are seeing this error message because your email is saved as a secondary email in an account under our Personnel Licensing system (PERL).

A laboratory may have more than one user account associated with their license or registration information in the online application system. No two user accounts may be associated with the same email.

An email address can be used to create a CDPH account which can be used to access multiple systems. Select one of the three options below:

1. Use your existing Personnel Licensing account to access Laboratory Facilities.

A. From the CDPH Licensing Portal/Home, click Laboratory Facilities. (If you don’t find this screen, click Home on the upper right part of the screen.) 

 

2. Delete this email from your existing account.

1. Log in to your Personnel Licensing account.
2. Click your initials on the upper right corner of the screen. (If you do not see your initials in a circle in the upper right corner of the screen you will need to zoom out your browser view using the CTRL and minus (-) keys on your keyboard, or by accessing your browser’s view settings.)
3. Select “View Profile.”
   
4. Click the “Update Profile” button.
5. Under “Communication Details” delete the email address you used to sign up for your Laboratory Facilities account.
6. Click “Next” then “Close."
7. Log out, then log in to your account with Laboratory Facilities. You should be able to move on to linking your facilities.

3. Use an unassociated email address.

If you received an email with subject line: “Additional Information Requested For xxx-0000” and the status of your application is "Pending-AdditionalInfo" – it means we are requesting additional information to complete your application.

To upload the requested document(s) to your online application including editing the business and site information, please read the instructions: How to Upload Requested Items​