Ruby Grantham, Manager
Laboratory and In-Home Services Unit
NEW: COVID-19 Testing and Laboratory Director Qualifications
Upon EUA approval and release by the FDA, a laboratory test (including a COVID-19 test) is assigned a complexity: waived, moderate or high complexity.Laboratory director qualifications are dependent on the complexity of the test and can be found in 42 CFR 493.
For pharmacists in Florida, the federal requirements in §493.1405(a) and §493.1443(a) are satisfied based on the issuance of
Emergency Order DOH No. 20-006, however §493.1405(b) and §493.1443(b) must still be met.
CLIA applicants (including those that intend on administering COVID-19 tests) must provide the test name, type and manufacturer to determine whether the test is waived, moderate or high complexity for the purposes of assessing that the certificate type being requested is appropriate for the test being performed and that the lab director meets the required qualifications.
The clinical laboratory is required to comply with state regulations governing laboratory director and personnel qualification requirements if applicable, in addition to federal regulations under 42 C.F.R. 493. State clinical laboratory personnel regulations can be accessed at Chapter 483, Part II, Florida Statutes. For more information on state clinical laboratory personnel requirements, visit the Florida Department of Health, Board of Clinical Laboratory Personnel.
For questions regarding test complexity and laboratory director requirements, please contact the Laboratory and In-Home Services Unit at Labstaff@ahca.myflorida.com
Effective July 1, 2018, the Agency will discontinue the licensure program for non-waived laboratories.
The physical location where examinations on fluids, tissues or cells, taken from the human body are performed to provide information or materials for use in the diagnosis, prevention, or treatment of a disease or the identification or assessment of a medical or physical condition.
A clinical laboratory that performs testing other than those which have been determined to qualify for a certificate of waiver under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), and the federal rules adopted thereunder.
A test system, assay or examination that the U.S. Department of Health and Human Services has determined meets the CLIA statutory criteria as specified for waiver under section 353(d)(3) of the Public Health Service Act.
Federal Certification for Clinical Laboratories (CLIA)
Effective July 1, 2018, the State of Florida no longer requires a state license for clinical laboratory services, however the federal CLIA program is still in effect. CLIA certification is required for facilities that test clinical specimens for the purpose of diagnosis, treatment, or prevention of disease.
Clinical Laboratory Improvement Amendments of 1988 (CLIA)
The Federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), at 42 CFR 493, define a clinical laboratory as any facility that examines materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings. Any facility that meets this definition must have the appropriate CLIA certificate to perform laboratory tests. If a facility is only collecting specimens, a CLIA certificate is not required.
Click here for Information on how to apply for a CLIA certificate.
Click here for the CLIA Application for Certification, Form CMS-116.NOTE: The CLIA 116 Application was revised in September 2017. Our office will no longer accept previous versions of the application.
You must have a CLIA certificate even if you perform only one waived laboratory test. It does not matter if you charge for the test or not, you must have a CLIA certificate. If you perform a test and do not have a CLIA certificate you will be in violation of federal law. If your facility only collects specimens to be sent out for testing at another facility, then CLIA certification is not required for your facility. Laboratories performing research only testing, laboratories operated directly by the Federal Government (i.e. VA, DoD), or laboratories participating in a drug-free workplace program do not require CLIA certification.
There are four types of CLIA certification for laboratories, depending on the type of testing performed:
Step One – Application Submission
Complete all sections of the CLIA Application for Certification, Form CMS-116 including an email address where correspondence can be received. An incomplete application will result in an omission letter and delay the approval of the application. On page 3 of the application, you are required to list the tests that you are going to perform and indicate an estimated test volume. This is strictly an estimate. A number/test volume must be indicated for the application to be considered complete.
For questions regarding a multiple site exception, please contact the Laboratory and In-Home Services Unit at (850) 412-4500 and ask to speak with a laboratory consultant.
Provide documentation of the laboratory director’s credentials as required:
The completed CLIA Application for Certification, Form CMS-116 and any required documentation can be emailed or mailed to the Agency:
Do not send the payment with the application. Once your CLIA Application for Certification, Form CMS-116 has been received and approved, CMS will send an invoice (CLIA user fee coupon) to the mailing address reported on the application.
Step Two – Application Review
Applications will be reviewed within 30 days of receipt. If the application and all required documentation is complete, it will be entered into the federal CLIA system. If the application or required documentation is not complete, an email will be sent to the applicant notifying them of apparent errors or omissions and requesting a response. If the applicant fails to respond to omissions timely, the application may be administratively withdrawn.
Step Three – Application Fee
Once the completed application has been entered into the federal CLIA system, an invoice (CLIA user fee coupon) will be generated by the federal contractor and mailed to the facility at the mailing address listed on the CMS-116. Fee coupons are generated by the federal contractor.
Step Four – CLIA Certificate Issuance
When the invoice (CLIA user fee coupon) has been paid and processed by the CLIA program, the CLIA certificate will be mailed out. When the laboratory receives the CLIA certificate, they may start testing and billing for the test(s) performed.
Step Five – CLIA Survey
The laboratory must have completed a minimum of 90 days of testing before a survey can be scheduled and conducted. There is a reasonable expectation that when the CLIA certificate is issued, the applicant can and will begin testing. Failure to submit to a survey may result in termination of the CLIA certificate.
The CLIA certificate will not be issued until the CLIA fees have been paid.
CLIA fees can be paid via mail or online. Please note that you must have the fee coupon before you can pay the fees, whether online or by mail. Payments cannot be made by phone with the state agency.
Via Online: The CLIA invoice (CLIA user fee coupon) may be paid online at: https://www.pay.gov/public/form/start/55598674.
Via Mail: Submit the payment along with the CLIA user fee coupon to the following address. The CLIA number should be included on the check or money order.
CLIA Laboratory Program
Please note a CLIA Fee increase went into effect on 1/7/19.
The invoice will only contain the mailing address of the facility. If there is a separate mailing address listed on the CMS-116, then that will be the address shown on the invoice. If there is no separate mailing address listed, then the facility address will appear on the invoice.
New CLIA certificates are mailed out approximately three weeks before the current certificate expires. If new a new certificate isnot received before your current certificate expires, please contact the Laboratory and In-Home Services Unit at (850) 412-4500.
The certificate renewal process is automatic for any existing CLIA certificate. CMS will mail out the renewal invoice approximately 6 months prior to the expiration date of the current certificate. There will be a total of 3 invoices mailed out, every two months prior to the expiration date of the current certificate. Once the payment is processed, CMS will not mail the new certificate until approximately 3 weeks prior to the current expiration date, regardless of when the payment was processed.
Changes that Require Submission of a new CMS-116 (applies to Certificates of PPM, Compliance and Accreditation only)
A new form CMS-116 must be completed and submitted for the following laboratory changes. The CMS-116 must be completed and signed by the laboratory director.
For changes to multiple labs, a CMS-116 signed by the laboratory director must be submitted for each lab and must contain the information required above.
Changes for which Written Notification is Acceptable
Written notification must be submitted on letterhead signed by the laboratory director and must include the laboratory name and address, CLIA number, name of the Laboratory Director, and the effective date of the requested change.
Note: In lieu of written notification, a new completed CMS 116 is also acceptable.
Via Email: Send requests for changes and any required supporting documentation to Labstaff@ahca.myflorida.com. Please submit only one change per email.
Via Mail: Send requests for changes and any required supporting documentation to:
Agency for Health Care Administration
For changes to multiple labs, a letter signed by the laboratory director must be submitted for each lab and must contain the information required above.
A new CLIA certificate will not be issued for changes to CLIA certificates. A confirmation letter will be sent to be used in place of the CLIA certificate until the CLIA certificate is renewed.
If you need a copy of an existing CLIA certificate then you may contact our office to request a copy. Reprinted certificates are generated and mailed from the federal contractor and may take up to 3 weeks to arrive. However, reprinted certificates are not available if the request is made within 6 months of the current expiration date.
Written notification must be submitted on letterhead signed by the laboratory director and must include the laboratory name and address, CLIA number, name of the Laboratory Director and/or Owner, and the effective date of voluntary closure/termination.
To file a complaint against a clinical laboratory or allegations of non-compliance with CLIA regulations, please contact the Agency for Health Care Administration’s Complaint Hotline at (888) 419-3456.
This information is confidential under federal law, including 42 CFR Sections 431.300-.307 and the Health Insurance Portability and Accountability Act of 1996. You must file a FOIA (Freedom of Information Act) request with the Centers for Medicare & Medicaid Services. Instructions on filing a CMS FOIA request can be accessed at the following link: https://www.cms.gov/Regulations-and-Guidance/Legislation/FOIA/filehow.html
The Agency for Health Care Administration (Agency) requires all licensees providing residential or inpatient services to use an Agency approved database for reporting its emergency status, planning or operations. The Agency approved database for reporting this information is the Emergency Status System (ESS).