Florida Administrative Code
59 - AGENCY FOR HEALTH CARE ADMINISTRATION
59A - Health Facility and Agency Licensing
Chapter 59A-1 - CERTIFICATION OF ORGAN PROCUREMENT ORGANIZATIONS, TISSUE BANKS, AND EYE BANKS (IN MEMORY OF CHARLES ARLEIGH LINCOLN, PH.D.)
Section 59A-1.009 - Inspections; Acceptance of Accreditation Inspection Reports; Annual Reporting Requirements

(1) The AHCA may inspect each organ procurement organization, tissue bank and eye bank on no less than a biennial period. The AHCA is permitted at its sole discretion to inspect any organ procurement organization, eye bank or tissue bank by on-site inspection, off-site inspection or acceptance of documentation from an accreditation inspection that includes the approved accreditation organization inspector's report of findings, the organization's responses and the final determination. The purpose of these inspections is to:

(2) Acceptance of Accreditation Organization Inspection Reports.

(3) If, as the result of an inspection in response to a complaint, the AHCA determines that an agency is out of compliance with the standards in Rule 59A-1.005, F.A.C., or other sections of this rule, the AHCA shall take administrative action as specified in subsection 59A-1.012(1), F.A.C. If the agency remains out of compliance with the standards and rules of this chapter upon subsequent inspection by the AHCA, further administrative action as specified in subsection 59A-1.012(1), F.A.C., shall be taken.

(4) Each certified agency shall submit to the AHCA its most recently completed annual audit within 30 days after the anniversary date of certification.

(5) Each certified OPO shall submit to the AHCA the Annual Report for Organ Procurement, Distribution, Revenues and Expenses, AHCA Form 3140-2002-APR 2008, incorporated herein by reference and available at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Laboratory_Licensure/organ.shtml, within 30 days after the anniversary date of certification.

(6) Each certified tissue bank shall submit to the AHCA the Annual Report for Tissue Procurement, Distribution, Revenues and Expenses, AHCA Form 3140-2004-DEC 2008, incorporated herein by reference and available at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Laboratory_Licensure/organ.shtml, within 30 days after the anniversary date of certification.

(7) Each certified eye bank shall submit to the AHCA the Annual Report for Eye Procurement, Distribution, Revenues and Expenses, AHCA FORM 3140-2005-DEC 2008, incorporated herein by reference and available at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Laboratory_Licensure/organ.shtml, within 30 days after the anniversary date of certification.

(8) These forms shall be available on the Agency website at: www.licensing_cert.shtml, or from the Agency for Health Care Administration, Division of Health Quality Assurance, Laboratory Licensure Unit, 2727 Mahan Drive, MS #32, Tallahassee, Florida 32308. The data to be submitted to the AHCA are described in subsection 59A-1.005(17), F.A.C. All reported donor information shall be based on the previous calendar year. All revenue and expense information shall be based on the most recently completed fiscal or operational year.