Grand Rapids Popcorn Recalls PCA's 30# Cases of Medium Chop Granulated Peanuts Sold in Michigan and Florida because of Possible Health Risk - February 5, 2009 Close

BACKGROUND SCREENING ALERT
Effective 7/1/2008 Background Screening Request
Fees through the Agency will INCREASE.
Level 2 Requests will be $43.25.
Click here for more information

Organ Procurement Organizations, Tissue and Eye Banks

Applications:

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

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.

New Requirements Effective 7/1/2009:

  • Voluntary Board Member Affidavits are no longer required (see page 67 in changes in law)
  • The Laboratory Director, Chief Financial Officer and controlling interest as defined under section 409.803 (7), Florida Statutes, must submit social security numbers. Forms are currently being revised, but until they can be revised, please submit on a separate piece of paper. [see section 408.806(1)(a), Florida Statutes]
  • Affidavit for background screening for covered employees may be submitted with the application rather than annually. Annual Background Screening Affidavit
  • Renewal applications submitted more than 120 before the expiration date must be returned to the applicant and cannot be accepted by the Agency

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.

 

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).

Statute/Rule Authority

NOTE: If after reviewing the application forms and statutory and rule requirements on our website you have additional questions, please call (850) 487-3109. Staff will be happy to answer questions that clarify the requirements as they apply to your specific situation, but cannot walk you through the application. Filling out the application is part of your responsibility as an applicant. The Agency's role in this process is to evaluate your application and, if there are elements missing from your application once submitted, provide you with an omissions response that gives you another opportunity to complete the application successfully. If you need extensive assistance in filling out your application, we would advise you to retain an attorney or a government relations consultant to assist you.