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Florida Administrative Code (Last Updated: April 18, 2024) |
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59. Agency for Health Care Administration |
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59A. Health Facility and Agency Licensing |
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59A-1. Certification Of Organ Procurement Organizations, Tissue Banks, And Eye Banks (In Memory Of Charles Arleigh Lincoln, Ph.D.) |
1(1) No person shall 5engage in the procurement of cadaveric organs, eyes or tissues within this state 18without first being certified to operate by the AHCA.
27(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.
62(3) All persons 65seeking to apply for initial or renewal certification 73shall submit to the AHCA a completed application, 81Health Care Licensing Application, Organ Procurement, Tissue Bank, Eye Bank, AHCA Form 3140-2001, July 2014, 96which is incorporated by reference. 101This form is 104available 105at: 106http://www.flrules.org/Gateway/reference.asp?No=Ref-05305 108or http://ahca.myflorida.com/HQAlicensureforms and 111from 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.
174(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 20259A-1.009(2), 203F.A.C., to determine 206the applicant’s 208compliance with the standards.
212(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 239in Florida241.
242(6) A certified OPO, tissue bank or eye bank that proposes 253an addition 255in procurement services (i.e., retrieval, processing, storage or distribution) shall notify the AHCA 60 days prior to 272such addition274. 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 310inspection or review the inspection report from an approved accreditation organization as specified in subsection 32559A-1.009(2), 326F.A.C., 327to determine if the standards of this rule are met.
337(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.
372Rulemaking Authority 374408.819, 375765.541(2) FS. 377Law Implemented 379408.805, 380408.806, 381408.809, 382408.810, 383408.811, 384765.541, 385765.542, 386765.544 FS. 388History–New 11-26-92, Amended 8-20-96, 6-19-08, 5-18-15.
