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CMS 116 Applications should be mailed to:

Laboratory Unit
Agency for Health Care Administration
Bureau of Health Facility Regulation
2727 Mahan Drive, Mail Stop #32
Tallahassee, FL 32308

Phone: 850.487.3109

Do not submit a fee with the application. The CLIA program will send a bill. All payments are sent directly to the CLIA program, not the Agency.

Florida Clinical Waived Laboratories:

The State of Florida requirement for waived laboratories to hold a Certificate of Exemption license was removed from Florida law effective July 1, 2009.

Any laboratory conducting waived tests only must have a valid CLIA Certificate of Waiver. To apply for a CLIA Certificate of Waiver complete a Centers for Medicare and Medicaid Services Form CMS-116 and mail it to the Agency at the address in the blue box to the right.

To check to see if a test is "waived", CMS advises that it can be checked on the Food and Drug Administration's website and provides a PDF file of waived laboratory tests as well.

Any laboratory that uses a microscope in testing or that is performing a test that is not classified as "waived", must seek a "non-waived" laboratory license and CLIA certificate under the specialty or subspecialty of the tests it is performing . State and federal regulations provide guidance for who may and may not perform these tests as well as what laboratories are required to do to perform these tests.

Examples of waived tests include:

  • Dip stick urinalysis or tablet reagent urinalysis (non-automated or certain automated analyzers)
  • Fecal occult blood
  • Urine pregnancy tests
  • Erythrocyte sedimentation rate (ESR) non-automated
  • Blood glucose- devices cleared by the Food and Drug Administration of home use

Federal Requirements for a Certificate of Waiver:

The Centers for Medicare and Medicaid Services (CMS) administers the CLIA laboratory certification program in conjunction with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). All facilities performing any clinical laboratory testing are required to obtain a CLIA certificate. Waived testing laboratories:

  • Employs methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible.
  • Pose no reasonable risk of harm to the patient if the test is performed incorrectly.
  • Are cleared by the FDA for home use.
  • Conduct testing that is considered non-technical requiring little or no difficulty.

Requirements for Laboratories Performing Only Waived Tests:

  • CLIA Certificate of Waiver renewed every 2 years.
  • Follow manufacturer's instructions and document tests performed.
  • Waived laboratories are not inspected except on a random basis for the CLIA program.
  • There are no requirements for directors of waived laboratories.
  • Submit a new Form CMS-116 for:
    • Initial Application
    • Reinstatement Application if there is a gap in service
  • Written notification of changes (always provide the CLIA ID number):
    • Change in name of the laboratory.
    • Change in address, whether street address or mailing address
    • Change in telephone or fax number
    • Change in Ownership
    • Change in Tax ID
    • Reinstatement if these is no gap in service (please call our office if you are unsure if there is a gap)
    • Change in accrediation organization
    • Voluntary closure/termination

      NOTE: A Form CMS-116 can be submitted when written notification is required. If the CMS-116 is used in lieu of written notification, it must be completed in it entirety to be accepted. Written notification includes email, fax or hard copy letter.

Requests for duplicate federal CLIA certificates and state licenses:

Federal CLIA certificates:

  • Upon request for a duplicate CLIA certificate, the Agency will provide the laboratory with a notice indicating the certificate is valid or active. A new certificate will not be issued by the CLIA program. Please call 850.487.3109 to request notice that your CLIA certificate is valid or active.
  • If the laboratory has never received a certificate. please call the Laboratory Unit at 850.487.3109 and let staff know that you never received your certificate.
  • If the laboratory has changed address or other demographic information, please do not request a new certificate. The laboratory should have documentation indicating it notified the state to update the record as well as the notice from the state that the information was updated. Florida requires such notification to be sent via certified mail. [see section 59A-7, Florida Administrative Code]

State Licensure


Who to Contact:  Area maps and unit contacts

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