TISSUE DONATION Dr. Esteve Trias Transplant Services Foundation Hospital Clínic Tissue Bank Barcelona, Spain Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 INTRODUCTION TISSUE TRANSPLANT IMPORTANCE Processing and preservation methods More time Number of donors Need Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Quality of life DONORS Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 NEEDS INTRODUCTION TYPES OF TISSUE DONORS Brain Death Living Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 NHBD Domino TISSUE DONORS HOSPITAL CLÍNIC -772 beds -48 IUC beds -3 reanimation beds Reference population 900.000 inhabitants Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 TISSUE DONORS HOSPITAL CLÍNIC Where? Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 TISSUE DONORS HOSPITAL CLÍNIC Where? Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 IUC Brain Death Hospital Emergency departm Cadaveric Cardiology Domino Orthopedics Obstetric department Living TISSUE DONORS HOSPITAL CLÍNIC ’99-’09 X Potentiallity 1710 Deaths Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 TISSUE DONORS HOSPITAL CLÍNIC ’99-’09 X Potentiallity 1710 Deaths Brain Death 3-5% H Deaths 45-75 Cadaveric 25-35% H Deaths 466-631 (586) Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 TISSUE DONORS Emergency Unit 28.5% Oncology 21.2% Internal Medicine 8.5% CV/Cardiology 7.3% Total 64% Others 36% Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Emergency Unit Internal Medicine Others Oncology Cardiology / Surgery TISSUE DONORS HOSPITAL CLÍNIC Living Potentiallity Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 TISSUE DONORS HOSPITAL CLÍNIC Living Potentiallity Domino Heart Transplant 0-25 year Amniotic Membrane Program Caesarea 200 year Femoral Heads Hip replacement 100 year Cord Blood Number of Deliveries 1500 year Bone Marrow / PBSC Active Hematologic Unit Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 TISSUE DONORS 413 TISSUE DONORS H CLÍNIC 2012 12% 13% 4% 71% Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Brain Death NHBD Living Cadaver TISSUE DONORS HOSPITAL CLÍNIC 2000 1800 1600 1400 1200 1000 800 Deaths Potentiallity 600 400 200 0 1999 2001 2003 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 2005 2007 2009 TISSUE DONORS Hospital Deaths 1866 >80 years old 631 33,81% Sepsis 326 17.47% HIV / Serologíes + 183 9,81% Haematologic Neopl. 138 7.39% Exclusion Criteria 1278 68,5% Potential Donors 586 31,5% Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 TISSUE DONORS HOSPITAL CLÍNIC 2000 1800 1600 1400 1200 1000 800 Deaths Potentiallity Detection 600 400 200 0 1999 2001 2003 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 2005 2007 2009 TISSUE DONORS HOSPITAL CLÍNIC 2000 1800 1600 1400 Deaths 1200 1000 800 Potentiallity Detection Donors 600 400 200 0 1999 2001 2003 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 2005 2007 2009 DONOR SELECTION Medical and Social History Physical Exam Blood Samples Serologies Warm Ischaemia Time Autopsy Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 DONOR SELECTION MEDICAL AND SOCIAL HISTORY Hospital Donor– Clinic History Extrahospitalary Donor ? Who ask? Who answer? Questionnaire enough? MEDICAL AND SOCIAL HISTORY PHYSICAL EXAM BLOOD SAMPLES SEROLOGIES Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 WARM ISCHAEMIA TIME AUTOPSY DONOR SELECTION ABSOLUTE CONTRAINDICATIONS Unknown cause of death Cancer (Except corneas) leukemia, linfoma... Sepsis: virus, bacteria and fungi Collagenosis Neurologic disease or unknown sistemic disease Trauma, infections o chronic tissue pathology Risk factors for HIV or BHV or CHV MEDICAL AND SOCIAL HISTORY Growth Hormone treatment PHYSICAL EXAM BLOOD SAMPLES SEROLOGIES Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 WARM ISCHAEMIA TIME AUTOPSY DONOR SELECTION PHYSICAL EXAM MEDICAL AND SOCIAL HISTORY PHYSICAL EXAM BLOOD SAMPLES SEROLOGIES Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 WARM ISCHAEMIA TIME AUTOPSY DONOR SELECTION PHYSICAL EXAMINATION Jaundice Genital lesions Non medical injection sites Enlarged lymph nodes Tattoo / piercing White spots in the mouth Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 DONOR SELECTION PHYSICAL EXAMINATION Enlarged liver Insertion trauma / perianal lesions Rash / scab / skin lesion (non-genital) Blue / purple (gray/black) spots / lesions Trauma / Infection to potential retrieval sites Abnormal ocular findings (icterus, scarring) Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 DONOR SELECTION PHYSICAL EXAMINATION TxC DONOR IDENTIFICATION John Smith 30/11/1963 MH:1000456372 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 RECOVERY TEAM DONOR SELECTION BLOOD SAMPLES SEROLOGIES BLOOD GROUP HEMOGRAM BIOCHEMISTRY GONODOTROPHINE HORMONE BLOOD CULTURES MEDICAL AND SOCIAL HISTORY PHYSICAL EXAM BLOOD SAMPLES SEROLOGIES Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 WARM ISCHAEMIA TIME AUTOPSY DONOR SELECTION BLOOD SAMPLES Time from death to blood sample. Avoid hemolisis < 6 - 24 h False Positives Hemodilution Transfusion 48h previous to sample False Negatives MEDICAL AND SOCIAL HISTORY PHYSICAL EXAM BLOOD SAMPLES SEROLOGIES Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 WARM ISCHAEMIA TIME AUTOPSY Date/hour blood extraction DONOR Weight......Kg Plasma volume=Donor weight....../0.025= ml Blood volume =Donor weight....../0.015= ml A. Transfussed blood previous 48h: Red cells concentrate/48h Total bloodl Reconstructed Blood ml ml ml Total A= B. Total Volume colloids previous 48h: Dextrane Plasma Plattelets Albumine..... ml ml ml ml Total B= ml ml ml ml Total C= C. Cristalloids Volume infussed previous 1h: Saline serum Dextrose Ringer Others....... Donor viability 1.- B+C>Plasmatic Volume yes no 2.- A+B+C>Blood Volume yes no Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 DONOR SELECTION SEROLOGIES Ab HIV 1-2 Ag HIV 1 Ag HBVs Ab HBVc Ab HCV Ab CMV Lues: VDRL, RPR Ab HTLV I/II PCR HIV PCR HCV PCR HBV Chagas ? MEDICAL AND SOCIAL HISTORY PHYSICAL EXAM BLOOD SAMPLES SEROLOGIES Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 WARM ISCHAEMIA TIME AUTOPSY DONOR SELECTION WARM ISCHAEMIA TIME Not refrigerated Refrigerated at 4ºC < 6 h 12 -15 h Post Cardiac Arrest 24 h Post Cardiac Arrest MEDICAL AND SOCIAL HISTORY PHYSICAL EXAM BLOOD SAMPLES SEROLOGIES Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 WARM ISCHAEMIA TIME AUTOPSY DONOR SELECTION AUTOPSY If unknown Cause of Death Mandatory Always recommended MEDICAL AND SOCIAL HISTORY PHYSICAL EXAM BLOOD SAMPLES SEROLOGIES Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 WARM ISCHAEMIA TIME AUTOPSY Date 13-XI-2005 Male 44 years old affected Aortic valve disease, stenosis, Admitted for valvular surgery PA: Colostomy 1998 Smoker 25 cig/day Hypercollesterol / Hypertension Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Date 13-XI-2005 Male 44 years old affected Aortic valve disease, stenosis, Admitted for valvular surgery PA: Colostomy 1998 Smoker 25 cig/day Hypercollesterol / Hypertension 14-XI-2005 Extracorporeal circulation – Heart valve surgery – Mechanical prosthesis Intensive Unit Care - Anticoagulation treatment Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Date 13-XI-2005 Male 44 years old affected Aortic valve disease, stenosis, Admitted for valvular surgery PA: Colostomy 1998 Smoker 25 cig/day Hypercollesterol / Hypertension 14-XI-2005 Extracorporeal circulation – Heart valve surgery – Mechanical prosthesis Intensive Unit Care - Anticoagulation treatment 19-XI-2005 Good evolution - Moved to Cardiology ward Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Date 13-XI-2005 Male 44 years old affected Aortic valve disease, stenosis, Admitted for valvular surgery PA: Colostomy 1998 Smoker 25 cig/day Hypercollesterol / Hypertension 14-XI-2005 Extracorporeal circulation – Heart valve surgery – Mechanical prosthesis Intensive Unit Care - Anticoagulation treatment 19-XI-2005 21-XI-2005 Good evolution - Moved to Cardiology ward Sudden Neurological damage– Cranial TC:(Brain haemorrhage, it’s not possible to discard Arterial-venous Malformation vs Cranial Tumor) Intensive Unit Care re-admission, treatment barbiturics, steroids… Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Date 13-XI-2005 Male 44 years old affected Aortic valve disease, stenosis, Admitted for valvular surgery PA: Colostomy 1998 Smoker 25 cig/day Hypercollesterol / Hypertension 14-XI-2005 Extracorporeal circulation – Heart valve surgery – Mechanical prosthesis Intensive Unit Care - Anticoagulation treatment 19-XI-2005 21-XI-2005 Good evolution - Moved to Cardiology ward Sudden Neurological damage– Cranial TC:(Brain haemorrhage, it’s not possible to discard Arterial-venous Malformation vs Cranial Tumor) Intensive Unit Care re-admission, treatment barbiturics, steroids… 26-XI-2005 Irreversibility – Tracheotomy and moved to Neurologic ward Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Date 27-XI-2005 Fever 38ºC, xr: Condensation left basal lung, possible Pneumonia Blood Cultures. Ceftriaxone and Clindamicine treatment. Good analitical and xr evolution - normothermia g Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Date 27-XI-2005 Fever 38ºC, xr: Condensation left basal lung, possible Pneumonia Blood Cultures. Ceftriaxone and Clindamicine treatment. 29-XI-2005 Good analitical and xr evolution - normothermia 7:30 am 10:30 am Auricular Flutter, instability - Cardioversion 12:30 pm Alert for Cardiac arrest – Ventricular Fibrilation g Defibrilation 300J – 360J – 360J – Asystolia Advanced Ressuscitation Maneouvres 30 minuts – unsuccesfull. Death 13:00 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Date 27-XI-2005 Fever 38ºC, xr: Condensation left basal lung, possible Pneumonia Blood Cultures. Ceftriaxone and Clindamicine treatment. 29-XI-2005 Good analitical and xr evolution - normothermia 7:30 am 10:30 am Auricular Flutter, instability - Cardioversion 12:30 pm Alert for Cardiac arrest – Ventricular Fibrilation g Defibrilation 300J – 360J – 360J – Asystolia Advanced Ressuscitation Maneouvres 30 minuts – unsuccesfull. Death 13:00 MEDICAL AND SOCIAL HISTORY PHYSICAL EXAM BLOOD SAMPLES SEROLOGIES WARM ISCHAEMIA TIME AUTOPSY Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 OCULAR TISSUE SELECTION CRITERIA . Age: 2y-no upper limit . No antecedents of: retinoblastome intraocular neoplasia herpes queratopaty ulcers or infections cornea surgery—individual evaluation Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 AMNIOTIC MEMBRANE SELECTION CRITERIA . Age: Fertil woman . No antecedents of: uncontrolled pregnancy hª obstétrica con alteraciones pregnancy<34 weeks amniorresis>12h before birth duración parto>24h mother fever - newborn infection Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 DONOR SELECTION DONOR QUALITY CONTROL Serologies, blood cultures... Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 DONOR SELECTION DONOR QUALITY CONTROL Serologies, blood cultures... Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 TISSUE QUALITY CONTROL No tissue pathology Tissue Culture Preservation DONOR SELECTION DONOR QUALITY CONTROL TISSUE QUALITY CONTROL Serologies, blood cultures... No tissue pathology Tissue Culture Preservation VIABILITY Traceability DISTRIBUTION Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Recipients DONOR SELECTION NO TRANSMISSION EXTRACTION DISTRIBUTION E.E.B.A E.B.A.A. E.A.T.B A.A.T.B Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 DONOR SELECTION Donor Heart Valves Corneas Recipients Follow up Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Bones DONOR SELECTION NO TRANSMISSION UNKNOWN BUT... Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 ? Thanks to Ted Eastlund for provide me his slides and material Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 DISEASE TRANSMISSION ARE TISSUES AND CELLS SAFE? Cambridge dicctionary: Safe: not dangerous or likely to cause harm Webster dicctionary: Safe: free from harm, injury or risk It seems that tissues and cells are safe ……………………or not Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 1400000 12 7 9 0 9 2 12 8 12 5 9 Nº Injertos Tx 1200000 1000000 9 0 6 15 3 800000 675370 600000 7 10 0 6 4 5 2 3 19 7 400000 337338 243787 200000 2 0 8 2 19 0 1994 1995 1996 1999 2000 2001 2002 2003 2007 SourceUSA data: AATB Annual Surveys2007. Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Bone Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 POSSIBLE INFECTION Tissue transportation Tissue recovery Donation /medical and social history • Window period • Cross-contamination • False negatives at the end • Human errors •……… Tissue implantation Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Donor suitability Tissue processing Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 DISEASE TRANSMISSION INFECTION DISEASE TRANSMISSION BY TISSUE ALLOGRAFTS ______Bacteria__ _______Tuberculosis_______ Epstein-Barr Virus Fresh Cornea Frozen Bone * Fresh Nerve Fresh Cartilage Cryopreserved Heart valve Frozen Tendon* Frozen Bone * Frozen Pericardium* Fresh Skin Cryopreserved Heart valve * Could have been treated with gamma irradiation and prevented Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 DISEASE TRANSMISSION INFECTION DISEASE TRANSMISSION BY TISSUE ALLOGRAFTS ___HIV-1___ Frozen Bone* Frozen Tendon* _Hepatitis C____ Frozen Bone* Frozen Tendon* Cryopreserved Vein ____Hepatitis B____ Fresh Cornea Cryopreserved Heart valve * Could have been treated with gamma irradiation and prevented Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 DISEASE TRANSMISSION INFECTION DISEASE TRANSMISSION BY TISSUE ALLOGRAFTS _____Rabies______ ___ _CJD____ Fresh Cornea Organ-associated Artery Cytomegalovirus Fresh Skin Yeast, Fungus_____ Freeze-dried Dura Fresh Cornea Fresh Cornea Cryopreserved Heart Valve Herpes simplex Fresh Cornea HTLV-I___ Frozen Bone* * Could have been treated with gamma irradiation and prevented Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 DISEASE TRANSMISSION Allograft characteristics affecting ability to transmit disease • Nonviable Allograft – Bone – Costal cartilage – Dura mater – Fascia – Ear ossicles – Tendon • Non-viable Acellular – Connective tissue • Can be disinfected, processed, sterilized Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 • Viable Allograft -- Heart valve and vessels (?) – Cornea – Articular Cartilage – Skin – Marrow – Stem cells – Blood transfusion • Contains viable cells • May be antibiotic treated • Cannot be sterilized The most worrisome tissue allografts are those that are not heavily disinfected or sterilized Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 HCV Transmission by Organ & Tissue Allografts from a Seronegative Donor (anti-HCV NEG, HCV RNA POS) Cadaveric Organ & Tissue Donor ORGAN RECIPIENTS -- OCT 2000 Lung HCV infection Liver? Heart --died early Kidney HCV Infection Kidney? TISSUE RECIPIENTS Corneas (Italy)---- Oct 2000 Saphenous Vein HCV infection ----2001 Tibialis Tendon HCV Infection---- 2001 Patellar Tendons HCV infection ---2002 Skin Bone (gamma irradiation) Annals of Internal Medicine 2005; Vol 143: pages 648-654 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 HCV FROM SERONEG DONOR: 37 Recipient follow-up • 32 TISSUE RECIPIENTS TESTED • 3 Previously HCV infected • 1 recipients not found (bone, bone-tendon recipient) • FIVE of 27 were HCV RNA POS genotype 1a – 1 (?2) of 2 saphenous vein recipients (reported to CV tissue bank 2001 but bank thought it was not from vein) – 1 of 3 tibialis tendon recipients – 3 of 3 bone-tendon-bone recipients • 22 of 27 were NEG (2 skin recipients and 16 recipients of irradiated bone ) MMWR 2003;52:273, Ann Intern Medicine 2005; 143:648-654 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Papillary Adenocarcinoma of the Iris Transmitted by Corneal Transplantation Arch Ophthalmol. 2002;120:1379-1383 • Nov 1990. 22 yr old Male : received corneal graft for keratoconus • Apr 1992. No signs or symptoms. 20/20 vision • June 1992 (19 mo later) Saw MD because of a 2-week history of – slight right eye irritation – discoloration of his iris. • Aug 1992 mass approximately 4.0 x 2.5 mm, arising from the iris. – Initially thought to be foreign body granulomatous reaction • One week later: rapid growth: Excisional Biopsy – poorly differentiated adenocarcinoma – Radiation therapy to eye (10 000 rad (100 Gy) of 125iodine plaque radiotherapy to a depth of 3 mm at the limbus) • 2002 (10 yr later). No recurrence Vision 20/30 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Recipient’s right eye at time of excisional biopsy June 1992 McGeorge, A. J. et al. Arch Ophthalmol 2002;120:1379-1383. A, Preoperative appearance in June 1992. The mass is at 6- to 8-o'clock positions on the iris and into the anterior chamber angle Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 B, Postoperative appearance in September 1992 See iris defect. Copyright restrictions may apply. New emergent infections diseases Lymphocytic Choriomeningitis Virus Infection in Organ Transplant Recipients. Massachusetts, Rhode Island, 2005 MMWR vol 54 /May 26, 2005 West Nile Virus Infections in Organ Transplant recipients-New York and Pennsylvania, August-September, 2005 MMWR vol 54 /October 14, 2005 Be careful with tuberculosis: an increase of infected cases Transplantation transmitted tuberculosis. MMWR vol 57/ April 4, 2008 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Sources of Infections Transmitted by Tissue Allografts from Deceased Donors • Newly Infected donor – Sero negative window • HCV: frozen bone, frozen tendons & saphenous vein*, • HIV : frozen bone & tendon – Wrongly diagnosed but systemic acute illness in symptomatic donor • Grp A Streptococcus Toxic shock syndrome: frozen tendon* • Rabies: fresh cornea, fresh artery* • CJD: dura, fresh cornea * Occurring or reported in 2002, 2003, 2005 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Sources of Infections Transmitted by Tissue Allografts from Deceased Donors • Postmortem endogenous contamination of donor tissue at time of tissue recovery (non infected donor) – Yeast: frozen heart valves (1998) – Bacteria: fresh cartilage*, frozen tendon* – Bacteria, yeast : cornea* * Reported in 2002, 2003, 2006 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Sources of Infections Transmitted by Tissue Allografts from Deceased Donors • Unusual bacteria acquired from tissue bank processing environment – Contaminated HBSS washing reagent: Frozen pericardium – Environment: Frozen tendon* …………………………………………… * Reported in 2006 Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 POSSIBLE INFECTION Tissue transportation Tissue recovery Donation /medical and social history • Window period • Cross-contamination • False negatives at the end • Human errors •……… Tissue implantation Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 Donor suitability Tissue processing The risk of infectious disease transmission from tissue allograft transplants is low and mainly with fresh or minimally processed allografts Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013