Applying for the CLIA Waiver

A lot has changed with the CLIA Laboratory folks as of recently. The paper form of application can no longer be used and everything must be done via an electronic application and it is far more difficult than once was. Here are some links, and instructions to help you get started with this time-consuming task:

Please visit our New Online Application webpage for instructions and information. Please visit the Processing Time Frame webpage for more information. Thank you for your patience.

General Guides:

Create an Account and Log in(https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/ELLFS_CreateAccount.aspx)

We are not a “laboratory”, why do we need a license?

California and federal law consider any site where clinical laboratory testing is performed to be a laboratory. Clinical laboratory testing is testing used to detect, identify, or monitor disease to prevent, diagnose, monitor, or treat disease or assess the health of an individual. This includes simple or “waived” tests such as hemoglobin A1C, pregnancy, and dipstick urine tests. Regardless of the number of times a facility is performing these tests, the facility is a laboratory and requires California licensure and federal CLIA certification.

Multiple user accounts for the same business in ELLFS

A laboratory or business may have more than one user account associated with their license or registration information in the online application system. However, each user account must be tied to a unique email address.

How to Create an Online Account

To create an account in the new online licensing system (ELLFS), follow the steps below:

1. Click on Create an Account or go to https://accountportal.cdph.ca.gov/Licensing.aspx?App=Licensing

2. Complete the Registration Information (be sure to take note of your password)

3. Click “I’m not a robot” (complete the CAPTCHA if prompted)

4. Click “Submit” to complete the account creation process

5. A pop-up will appear with your username. Make note of your username, then, click “Close” to continue

6. You will return to the log in page. Enter your username and password

7. Click “Log in”.

For additional help, refer to the user manual: https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/ELLFS_CreateAccount.aspx

How to Log In and Access Online Account

1. Click on Log In or go to https://mylicense.cdph.ca.gov/prweb/PRWebLDAP1

2. If this is your first time accessing your account, click on “Laboratory Facilities” and agree to the privacy disclaimer

How to complete ownership information in ELLFS for businesses without individual shareholders or owners

To proceed with the application, list owners or entities with 5% or more ownership of the laboratory. The total can be less than 100% since information about owners with 1-4% ownership is not needed. A LAB 182 form will be required for all individuals or businesses listed as “Owner.”. An “Authorized Representative” may complete and sign a LAB 182 on behalf any owner, if authorized to do so, but they do need not to complete a LAB 182 of their own. Laboratory Field Services is unable to offer further advice in this regard, as it is beyond our scope of expertise to know the operations of another business.

What is an Authorized Representative?

An Authorized Representative (AR) is someone who is authorized to submit a clinical laboratory application on behalf of the owner and/or laboratory director. An authorized representative may also be someone who has the authority to sign clinical laboratory application forms on behalf of the owner. There can be more than one AR listed on the application depending on the authority given to them by the business. For example, the AR that applies does not need to be the same AR to sign on behalf of the owner.

LAB 182 Request

To proceed with the application, whoever was authorized to sign as owner on form LAB 155R should now sign LAB 182. An “Authorized Representative” may complete and sign the LAB 182 on behalf of any owner, if authorized to do so. An Authorized Representative is an individual acting as an agent of the business and is submitting the application on behalf of the business.