Fla. Admin. Code Ann. R. 59A-1.004 - Certification Procedure

(1) No person shall engage in the procurement of cadaveric organs, eyes or tissues within this state without first being certified to operate by the AHCA.

(2) A dentist or physician using tissue processed by a tissue bank, but who is not involved in the retrieval, processing and distribution of tissue, is not required to be certified pursuant to these rules.

(3) All persons seeking to apply for initial or renewal certification shall submit to the AHCA a completed application, Health Care Licensing Application, Organ Procurement, Tissue Bank, Eye Bank, AHCA Form 3140-2001, July 2014, which is incorporated by reference. This form is available at: http://www.flrules.org/Gateway/reference.asp?No=Ref-05305 or http://ahca.myflorida.com/HQAlicensureforms and from the Agency for Health Care Administration, 2727 Mahan Drive, MS #32, Tallahassee, Florida 32308. An application for initial certification, including change of ownership, shall be accompanied with a check or money order in the amount of $1, 000 for an OPO or tissue bank and $500 for an eye bank. Application fees shall be made payable to the AHCA and are non-refundable.

(4) Upon receipt of a completed initial application, the AHCA shall conduct an inspection or review the inspection report from an approved accreditation organization as specified in subsection 59A-1.009(2), F.A.C., to determine the applicant's compliance with the standards.

(5) A limited certificate may be issued to a tissue bank or eye bank certifying only those components of procurement which the bank has chosen to perform in Florida.

(6) A certified OPO, tissue bank or eye bank that proposes an addition in procurement services (i.e., retrieval, processing, storage or distribution) shall notify the AHCA 60 days prior to such addition. This notification shall include an explanation in the change of any aspect of the procurement process and how this change affects the agency's operations. Prior to the addition of services, the AHCA shall conduct an inspection or review the inspection report from an approved accreditation organization as specified in subsection 59A-1.009(2), F.A.C., to determine if the standards of this rule are met.

(7) A certificate holder shall notify the AHCA of impending closure 90 days prior to such closure and shall be responsible for advising the AHCA as to the placement of inventory and disposition of records.

Notes

Fla. Admin. Code Ann. R. 59A-1.004

Rulemaking Authority 408.819, 765.541(2) FS. Law Implemented 408.805, 408.806, 408.809, 408.810, 408.811, 765.541, 765.542, 765.544 FS.

New 11-26-92, Amended 8-20-96, 6-19-08, Amended by Florida Register Volume 41, Number 087, May 5, 2015 effective 5/18/2015.

New 11-26-92, Amended 8-20-96, 6-19-08, 5-18-15.