Applications and appropriate fees 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

Organ Procurement Organizations, Tissue and Eye Banks

Applications:

Complete the information in the forms below for an initial or renewal application. Instructions are included with each form.

Recommended forms

For initial, renewal and *change of ownership applications:
Organ and Tissue Recommended Application Form (PDF)


Additional Required Forms for Organ and Tissue Providers (FORMS USED BY PROVIDERS AS REQUIRED BY LAW )

NOTE: Agency letters are often sent to applicants by certified mail. All letters are sent to the mailing address provided on the application. After submitting your application, please be prepared to accept and sign for any certified mail sent by the Agency. If the certified letter is sent back to the Agency as undeliverable or, in the case of those sent to the post office box, not accepted or not picked up, the application could be denied.

If there will be a change of ownership at your facility an application is required to be filed 60 days prior to the effective date of the change. *Change of 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 a licensee is in any manner transferred or otherwise assigned. This paragraph does not apply to a licensee that is publicly traded on a recognized stock exchange.
    [see s. 408.803(5), Florida Statutes]
    NOTE: Change of ownership applications must be filed 60 days prior to the effective date of the change. [see s. 408.807, Florida Statutes and s. 59A-35.070, Florida Administrative Cod

Initial/Renewal Requirements

  • Completed Application for Certification.
  • 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 physician licensed in the state in which the facility is located.)
  • 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).
  • 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.
  • OPOs 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.

Background Screening:

Level 2 Background Screening must be completed for the agency director and the 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.

Download Adverse Reaction Forms:

OPOs must be a member of the United Network of Organ Sharing (UNOS).

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FDA has posted a recall on its website for the Abbott Prism HIV O Plus test designed to detect HIV-1 in blood and organ donations. The company initiated the recall of lot number 87334M500, list number 03L68-68, because of calibration failures when the product is "out of specification high." Baxter has requested that customers who have an alternative lot discontinue use of the affected lot and discard remaining inventory. Customers without an alternative lot are being asked to continue use of the product until a replacement kit arrives. Learn more.




Reporting Medicaid Fraud