Organ Procurement Organizations, Tissue and Eye Banks
State certification is required for in state and out-of-state organ procurement
organizations (OPOs), tissue banks, and eye banks that retrieve, process, store
or distribute organs and tissues in Florida. Out-of-state OPOs that procure
organs through a Florida-based OPO are not required to obtain state certification,
but must have a working agreement with a Florida-based OPO.
Background Screening:
Level 2 Background Screening must be completed for the laboratory director and the chief financial officer prior to approving the initial application and then repeated every five years. Please go to the background screening section of this web site for additional documentation that must be submitted with your application. Fingerprint cards are available by contacting the Laboratory Unit at 850-487-3109. Other fingerprint cards may not be acceptable.
Annual Affidavit of Background Screening Compliance
Each non - waived laboratory is required by section 435.04(05), Florida Statutes(2006) to submit an affidavit of compliance with this section. A recommended form is available at this the link below.
Director’s Qualifications
Director qualifications must be submitted for all physician and non - physician laboratory directors.
The State of Florida requirements for laboratory directors can be found at the
Florida Administrative Code (See Chapter 59A-7 for Clinical Laboratory Rules) website:
http://www.flrules.org/gateway/ChapterHome.asp?Chapter=59A-7
CLIA requirements for directors of moderate complexity testing are at the following link: http://www.phppo.cdc.gov/clia/regs/subpart_m.aspx#493.1405,
CLIA requirements for directors of high complexity testing the requirements are at this link: http://www.phppo.cdc.gov/clia/regs/subpart_m.aspx#493.1443.
OPOs must be a member of the United Network
of Organ Sharing (UNOS).
Applications:
Complete the information in the forms below for an initial or renewal application. Instructions are included with each form.
Initial/Renewal Requirements
- Completed Application for Certification.
- Completed Health Care Licensing Application, Addendum , Voluntary Board Member Affidavit, and Affidavit of Compliance with Background Screening Requirements
- A copy of the floor plan showing all areas of operation (8 1/2 x 11 paper).
Do not send architectural drawings. (Not required for renewal applications.)
- Donor selection criteria. (Submit for renewal applications only if the criteria
has changed or the form revised.)
- Social and health history forms. (Submit for renewal applications only if
the form has been revised.)
- Consent forms (telephone and in person consent). Submit for renewal applications
only if the form has been revised.)
- Copy of medical director's state license and resume or curriculum vitae
(Medical director must be a surgeon.)
- Copy of the current CLIA certificate for any labs to be used.
- A cover letter specifying which services you plan to provide (tissue recovery,
processing, storage, distribution). (Not required for renewal applications
unless the services to be provided are to change.)
- If accredited, a copy of the accreditation certificate.
- Copies of any other related state license. For example, if you are filing
as a tissue bank and are licensed in New York or California, provide a copy
of that tissue bank license.
- If registered with the FDA, a copy of the registration certificate.
- OPSs should submit proof they are certified by the Centers for Medicare
and Medicaid Services.
- Renewal applications must be submitted at least 60 days prior to the expiration
of the current certificate.
Statute/Rule Authority
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