59A-1.005 : Standards for OPOs, Tissue Banks and Eye Banks - Florida Administrative Rules, Law, Code, Register

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Rule Title: Standards for OPOs, Tissue Banks and Eye Banks
Department:	AGENCY FOR HEALTH CARE ADMINISTRATION	Add to MyFLRules Favorites
Division:	Health Facility and Agency Licensing
Chapter:	CERTIFICATION OF ORGAN PROCUREMENT ORGANIZATIONS, TISSUE BANKS, AND EYE BANKS (IN MEMORY OF CHARLES ARLEIGH LINCOLN, PH.D.)

Latest version of the final adopted rule presented in Florida Administrative Code (FAC):

	Effective Date:	1/17/2018
	History Notes:	Rulemaking Authority 765.541(2) FS. Law Implemented 765.541, 765.542, 765.543, 765.545 FS. History–New 11-26-92, Amended 8-20-96, 1-17-18.
	References in this version:	Ref-09009 OPTN policies, effective April 6, 2017 Ref-09010 “PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Transmission Through Organ Transplantation”, as published in Public Health Reports/July-August 2013/Volume 128 Ref-09011 21 CFR Part 1270, 2010 Edition Ref-09012 21 CFR Part 1271, 2012 Edition Ref-09014 42 CFR Parts 413, 441, 486, and 498, effective May 31, 2006 Ref-09015 Occupational Safety and Health Administration (OSHA) rules 29 Code of Federal Regulations (CFR) Part 1910.1030, effective April 3, 2012 Ref-09016 FDA Guidance for Industry “Eligibility Determination for Donors of Human Cells, Tissues and Cellular and Tissue-based Products (HCT / Ps)”, August 2007

History of this Rule since Jan. 6, 2006

Section	Description	ID	Publish Date

Final 59A-1.005	Standards for OPOs, Tissue Banks and Eye Banks	19913923	Effective: 01/17/2018
Change 59A-1.005	Standards for OPOs, Tissue Banks and Eye Banks	19750284	11/17/2017 Vol. 43/223
Proposed 59A-1.005	The Agency is proposing to amend the rules governing organ, eye and tissue procurement organizations to include the current industry standards, to remove outdated requirements and to incorporate recommendations of the Organ ....	19128999	6/29/2017 Vol. 43/126
Workshop 59A-1.005	Standards for organ, tissue and eye procurement organizations. March 31, 2017 at 9:00 to 11:00 A.M. ET; call-in option at 1-888-670-3525 .... Agency for Health Care Administration, Conference Room C, 2727 ....	18739156	3/16/2017 Vol. 43/52
Workshop 59A-1.005	Standards for organ, tissue and eye procurement organizations. December 12, 2016 at 1:00 PM - 3:00 PM EST Agency for Health Care Administration, Conference Room B, 2727 ....	18277436	11/18/2016 Vol. 42/225
Variances 59A-1.005	that on October 24, 2016, the Agency for Health Care Administration rendered an order on the petition for variance or waiver filed by the American Association of Tissue Banks et al. on July 29, 2016 and advertised in Vol. ....	18198478	10/28/2016 Vol. 42/211
Variances 59A-1.005	that on October 14, 2016, the Agency for Health Care Administration entered an order on the petition for variance or waiver filed by The Eye Bank Association of America et al. on July 19, 2016 and advertised in Vol. 42, ....	18179369	10/24/2016 Vol. 42/207
Variances 59A-1.005	extension of temporary Waiver to Rule 59A-1.005(35)(a)2, Florida Administrative Code, from The American Association of Tissue Banks on behalf of the Petitioners Alamo Tissue Service, Allosource, Inc., Allotech, LLC, Axogen, ....	17890600	8/16/2016 Vol. 42/159
Variances 59A-1.005	Variance or Waiver from Rule 59A-1.005(35)(a)2, Florida Administrative Code, from the Eye Bank Association of America on behalf of the Petitioners Alabama Eye Bank, Florida Lions Eye Bank, International Sight Restoration, ....	17823670	7/29/2016 Vol. 42/147
Development 59A-1.005	The Agency is proposing to amend the rules governing organ, eye and tissue procurement organizations to include the current industry standards, to remove outdated requirements and to incorporate recommendations of the Organ ....	17591646	6/1/2016 Vol. 42/106
Variances 59A-1.005	Variance or Waiver from Rule 59A-1.005(35)(a)2, Florida Administrative Code from the Eye Bank Association of America on behalf of the Petitioners Alabama Eye Bank, Doheny Eye & Tissue Transplant Bank, Florida Lions Eye Bank, ....	15235807	11/3/2014 Vol. 40/214
Variances 59A-1.005	that on October 1, 2014, the Agency for Health Care Administration entered a Final Order on the petition for waiver filed by the American Association of Tissue Banks et al. on August 5, 2014 and advertised in Vol. 40, No. ....	15156461	10/8/2014 Vol. 40/196
Variances 59A-1.005	Extension of Temporary Waiver to Rule 59A-1.005(35)(a)2, Florida Administrative Code from The American Association of Tissue Banks on behalf of the Petitioners Alamo Tissue Service, Allosource, Inc., Allotech, LLC, Axogen, ....	14918908	8/12/2014 Vol. 40/156
Variances 59A-1.005	Variance or Waiver from of Rule 59A-1.005(34), Florida Administrative Code, from Community Tissue Services. The petition requests a permanent waiver of rule provisions precluding donors with a history of tuberculosis as ....	12615158	2/6/2013 Vol. 39/25
Variances 59A-1.005	Variance or Waiver from Rule 59A-1.005(35), Florida Administrative Code, from Eye Bank Association of America on behalf of Petitioners ALABAMA EYE BANK, FLORIDA LIONS EYE BANK, INTERNATIONAL SIGHT RESTORATION, INC., ROCKY ....	11540980	6/1/2012 Vol. 38/22
Variances 59A-1.005	Variance or Waiver of sub-sub-subparagraph 59A-1.005(1)(a)2.g.3, Florida Administrative Code, from Ozburn-Hessey Logistics, LLC. The petition requests a variance of rule provisions requiring the tissue bank’s medical director ....	10864890	1/6/2012 Vol. 38/01
Variances 59A-1.005	Variance or Waiver from of subsection 59A-1.005(35), Florida Administrative Code, from ALLOGRAFT INNOVATIONS, LLC. The petition requests a variance of rule provisions requiring HTLV testing for donor tissue. The specific ....	9836884	4/22/2011 Vol. 37/16
Variances 59A-1.005	Variance from or Waiver of subsection 59A-1.005(3), Florida Administrative Code, from the Wright Medical Technologies, Inc. The petition requests a variance or waiver of the rule requiring the medical Director of a tissue ....	9814671	4/15/2011 Vol. 37/15
Variances 59A-1.005	Variance or Waiver from of sub-subparagraph 59A-1.005(1)(a)2.g., 3., Florida Administrative Code, from ISOTIS ORTHOBIOLOGICS, INC. The petition requests a variance of rule provisions requiring the tissue bank’s medical director ....	9814574	4/15/2011 Vol. 37/15
Variances 59A-1.005	A Final Order granting the Petition for Variance or Waiver from subparagraph 59A-1.005(35)(a)2., F.A.C., filed by Tissue Banks International, Inc. on June 30, 2010 and advertised in Vol. 36, No. 30, Florida Administrative ....	9264681	10/22/2010 Vol. 36/42
Variances 59A-1.005	Variance or Waiver from subsection 59A-1.005(35), Florida Administrative Code, from Alphatec Spine, Inc. The petition requests a variance of rule provisions requiring HTLV testing for donor tissue. The specific provision ....	9264584	10/22/2010 Vol. 36/42
Variances 59A-1.005	Variance or Waiver from of subsection 59A-1.005(35), Florida Administrative Code, from INTERNATIONAL SIGHT RESTORATION, INC. The petition requests a variance of rule provisions requiring HTLV testing for donor tissue. The ....	9185044	10/1/2010 Vol. 36/39
Variances 59A-1.005	Variance or Waiver from of subsection 59A-1.005(35), Florida Administrative Code, from INTERNATIONAL BIOLOGICS. The petition requests a variance of rule provisions requiring HTLV testing for donor tissue. The specific provision ....	9131112	9/17/2010 Vol. 36/37
Variances 59A-1.005	Variance or Waiver from of subsection 59A-1.005(35), Florida Administrative Code, from ALLOSOURCE, INC. The petition requests a variance of rule provisions requiring HTLV testing for donor tissue. The specific provision ....	9038962	8/27/2010 Vol. 36/34
Variances 59A-1.005	Variance or Waiver of Rule 59A-1.005, Florida Administrative Code, from ROCKY MOUNTAIN LIONS EYE BANK. The petition requests a variance or waiver of rule provisions that require FDA-licensed HTLV testing for donor tissue. ....	8977658	8/13/2010 Vol. 36/32
Variances 59A-1.005	Variance or Waiver from of subsection 59A-1.005(35), Florida Administrative Code, from SURGICAL TISSUE NETWORK, INC. d/b/a TISSUENET. The petition requests a variance of rule provisions requiring HTLV testing for donor tissue. ....	8930807	7/30/2010 Vol. 36/30
Variances 59A-1.005	Variance or Waiver from of subsection 59A-1.005(35), Florida Administrative Code, from TISSUE BANKS INTERNATIONAL, INCORPORATED. The petition requests a variance of rule provisions requiring HTLV testing for donor tissue. ....	8920622	7/30/2010 Vol. 36/30
Variances 59A-1.005	Variance or Waiver from of subsection 59A-1.005(35), Florida Administrative Code, from ISTO Technologies, Inc. The petition requests a variance of rule provisions requiring HTLV testing for donor tissue. The specific provision ....	8723712	6/4/2010 Vol. 36/22
Variances 59A-1.005	Variance or Waiver from of subsection 59A-1.005(35), Florida Administrative Code, from AXOGEN, INC.; BACTERIN INTERNATIONL, INC.; BONE BANK ALLOGRAFTS; COMMUNITY TISSUE SERVICES-CALIFORNIA; COMMUNITY TISSUE SERVICES-DAYTON; ....	8723615	6/4/2010 Vol. 36/22
Variances 59A-1.005	variance from of subsection 59A-1.005(35), Florida Administrative Code, from the Musculoskeletal Transplant Foundation. The petition requests a variance of rule provisions requiring HTLV testing for donor tissue. The specific ....	8324848	3/5/2010 Vol. 36/09
Final 59A-1.005	Standards for OPOs, Tissue Banks and Eye Banks	1805090	Effective: 08/20/1996

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