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Procedures Manual

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Procedures Manual PROCEDURES MANUAL Created: 02/1992 Revised: 06/1992, 11/1993, 06/1994, 10/1994, 10/1996, 10/1999, 10/2000, 06/2007, 05/2008, 11/2008, 06/2009, 06/2010, 07/2011, 06/2012, 11/2012, 06/2013, 06/2014, 06/2015, 06/2016, 06/2017 1 EBAA Procedures Manual –June 2017 TABLE OF CONTENTS A1.000 Introduction and Purpose ..................................................................................................................... 4 B1.000 Active Membership and Accreditation .................................................................................................. 5 C2.000 Training, Certification, and Continuing Education of Personnel Performing Tasks Overseen and/or Regulated by the EBAA, FDA, and Other State/Federal Agencies .................................................... 6 C3.000 Facilities ................................................................................................................................................. 8 C3.100 Eye Bank Laboratory ............................................................................................................... 8 C3.200 Equipment, Maintenance and Cleaning .................................................................................. 9 C3.300 Instruments, Cleaning and Maintenance ............................................................................. 13 C3.400 Procedures Manual ............................................................................................................... 15 C3.600 Infection Control and Personnel Safety ............................................................................... 17 C3.700 Waste Disposal ...................................................................................................................... 20 D1.000 Donor Eligibility ................................................................................................................................... 21 D1.200 Documentation on Donor Information .................................................................................. 22 D1.210 Medical Examiner/Coroner/Pathologist Documentation ..................................................... 26 D1.300 Method of Consent ................................................................................................................ 27 D1.600 Eye Maintenance Prior to Recovery ..................................................................................... 29 E1.000 Recovery, Open-Container Processing and Preservation ................................................................... 32 E1.100 Recovery .................................................................................................................................. 32 E1.110 Pre-ocular Tissue Recovery and Donor Preparatory Procedures ................... 32 E1.120 Enucleation ....................................................................................................... 39 E1.130 In situ Corneal Excision .................................................................................... 43 E1.140 Blood Drawing ................................................................................................... 48 E1.200 Open-Container Processing ................................................................................................... 51 E1.210 Whole Eye Storage for Surgical Use ................................................................ 51 E1.221 Excision of the Corneoscleral Rim from Enucleated Whole Eyes ................... 54 E1.222 Laboratory Microkeratome Anterior or Endothelial Lamellar Processing ....... 59 E1.224 Transfer of Corneal Tissue ................................................................................ 63 E1.225 Femtosecond Laser Processing of Donor Cornea ............................................ 65 E1.226 Laboratory Processing of Donor Tissue for Descemet's Membrane (Automated) Endothelial Keratoplasty (DMAEK/DMEK)…………………. 68 E1.230 Scleral Preservation .......................................................................................... 74 E1.300 Use of Short and Intermediate Term Preservation Media .................................................... 78 E1.400 Long Term Preservation ....................................................................................................... 79 F1.000 Tissue Evaluation ................................................................................................................................ 81 F1.100 Gross Examination ................................................................................................................. 81 F1.200 Slit Lamp Examination ........................................................................................................... 82 F1.300 Endothelial Cell Density ........................................................................................................ 85 G1.000 Quality Assurance ............................................................................................................................... 87 G1.150 Corrective & Preventive Action (CAPA) ................................................................................. 91 G1.100 Quality Control ........................................................................................................................ 98 G1.200 Testing ................................................................................................................................... 98 G1.210 Microbiologic Culturing ......................................................................................................... 100 G1.220 Infectious Disease Testing ................................................................................................... 103 G1.230 HIV Screening ....................................................................................................................... 105 G1.240 Hepatitis B Screening ........................................................................................................... 105 2 EBAA Procedures Manual –June 2017 G1.250 Hepatitis C Screening ........................................................................................................... 106 G1.280 Non-Required Laboratory Results ...................................................................................... 107 G1.290 Conflicting Serology Reports ............................................................................................... 107 G1.300 Tissue Recall ........................................................................................................................ 109 H1.000 Non-Surgical Donor Tissue .............................................................................................................. 111 I1.000 Storage ............................................................................................................................................... 112 J1.000 Labeling .............................................................................................................................................. 114 K1.000 Distribution of Tissue ......................................................................................................................... 116 K1.400 Returned Tissue ................................................................................................................... 118 L1.000 Documentation to Accompany Donor Tissue ................................................................................... 120 L2.000 Packaging, Sealing and Packing for Transport ................................................................................. 121 M1.050 Eye Bank Record Entry and Entry Correction ................................................................................. 123 M1.550 Adverse Reaction Reporting ............................................................................................................. 125 References ...................................................................................................................................................... 128 Reference Archive (year 2000 and previous) ................................................................................................ 134 Guidance Documents .................................................................................................................................... 138 Implementation Guidance Document, Donor Risk Assessment Interview Forms........................... 138 Effective Quality Assurance of the Donor Risk Assessment Interview ........................................... 159 Minimizing the Risk of Disease Transmission During Corneal Tissue Processing ....................... 182 Implementation Guide, Use of ISBT 128 in North American Eye Banks ........................................ 186 Guidance Document for Investigating and Reporting Adverse Reactions to the EBAA ...……….. 228 3 EBAA Procedures Manual –June 2017 A1.000 Introduction and Purpose Standardization of eye banking procedures was one of the founding missions of the Eye Bank Association of America (EBAA) when it was established in 1961. The first edition of the EBAA's Medical Standards was introduced to member eye banks in 1980. A Technician's Manual followed in 1982. The Technician's Manual served as a detailed source of information and training manual for new technicians. This Procedures Manual is not intended to replace the Technician's Manual or to serve as a training manual for new eye bank technicians. The purpose of this manual is to
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