Ensure that you have the correct application type identified
There are four (4) application types:
Types 1 - 3 are contained within the same application form.
- Initial applications - filed by entities seeking to establish a laboratory and by laboratories that had to cease testing because an application to renew the license was not received by the Agency before the license expired. Initial applications are also filed by existing laboratories that perform only waived testing seeking to upgrade a federal CLIA Certificate of Waiver to a laboratory that performs non-waived testing.
- Change of ownership applications - must be filed at least 60 days prior to the effective date of the change. If they are not, then the laboratory will be operating without a license, which is a criminal offense and subject to fines.
NOTE: Change in Ownership means an event in which the licensee sells or otherwise transfers its ownership to a different individual or entity as evidenced by a change in federal employer identification number or taxpayer identification number, or an event in which 51 percent or more of the ownership, shares, membership, or controlling interest of the licensee is in any manner transferred or otherwise assigned. This does not apply to a licensee that is publicly traded on a recognized stock exchange. [see Section 408.803(5), Florida Statute]
- Renewal applications - filed by existing laboratories seeking to renew their license. If your license has expired, a renewal application will not be accepted because an initial application is required (see "initial applicaitons" above).
- Addition of Specialty/Subspecialty application -filed if you wish to add or remove a specialty or subspecialty. This is a separate application form. Fees may be required depending on what is being added and the volume to testing being preformed.
Application forms are available online: http://ahca.myflorida.com/MCHQ/HQALicensureForms/index.shtml#lab
Requests for duplicate federal CLIA certificates or amended/replacement state licenses:
Federal CLIA certificates:
- A duplicate CLIA certificate will not be issued. The Agency will provide the laboratory with a notice indicating the certificate is valid or active.
- If the laboratory has never received a certificate, please let the Laboratory Unit staff know.
- If the laboratory has a change in address or other demographic information, do not request a new certificate. Once the Agency receives your notification of the update, the laboratory will receive a notice from the state that the information was updated.
Changes during state licensing period and requests for an amended/replacement state license:
Note: Changes of Ownership are not requests to amend or replace a license (per 59A-35.040 and 59A-35.050, F.A.C.).
- Requires written notification to the Agency and
- Assessed a $25 fee (per 59A-35.040 and 59A-35.050, F.A.C.)