Workshop on Quality Systems in Ocular Tissue Banking Zagreb, Croatia January 2013 TISSUE DONATION...

Workshop on Quality Systems in Ocular Tissue BankingZagreb, Croatia January 2013

TISSUE DONATION

Dr. Esteve TriasDr. Esteve Trias

Transplant Services FoundationTransplant Services Foundation

Hospital Clínic Tissue BankHospital Clínic Tissue Bank

Barcelona, Spain Barcelona, Spain


TISSUE TRANSPLANT IMPORTANCE

More time

Number of donors

Need Quality of life

INTRODUCTION

Processing and

preservation methods


DONORS NEEDS


Brain DeathBrain Death NHBDNHBD

LivingLiving DominoDomino

INTRODUCTION

TYPES OF TISSUE DONORS


-772 beds-48 IUC beds-3 reanimation beds

Reference population 900.000 inhabitants

TISSUE DONORS HOSPITAL CLÍNIC


Where?Where?

HOSPITAL CLÍNIC

TISSUE DONORS


IUCBrain Death

HospitalEmergency departm

CadavericCardiology

DominoOrthopedicsObstetric department

Living

HOSPITAL CLÍNIC

TISSUE DONORS

Where?Where?


’99-’09X Potentiallity

1710 Deaths

HOSPITAL CLÍNIC

TISSUE DONORS


Brain Death

3-5% H Deaths45-75

Cadaveric

25-35% H Deaths466-631 (586)

HOSPITAL CLÍNIC

TISSUE DONORS

’99-’09X Potentiallity

1710 Deaths


Emergency Unit

Oncology

Internal Medicine

CV/Cardiology

Total

Others

28.5%

21.2%

8.5%

7.3%

64%

36%Emergency Unit Oncology

Internal Medicine Cardiology / Surgery

Others

TISSUE DONORS


LivingPotentiallity

LivingPotentiallity

HOSPITAL CLÍNIC

TISSUE DONORS


Domino Heart Transplant 0-25 year

Amniotic Membrane Program Caesarea 200 year

Femoral Heads

Hip replacement100 year

Cord Blood

Number of Deliveries 1500 year

Bone Marrow / PBSCActive Hematologic Unit

HOSPITAL CLÍNIC

TISSUE DONORS

LivingPotentiallity

LivingPotentiallity


71%

13%

12%

4%Brain Death

NHBD

LivingCadaver

413 TISSUE DONORS H CLÍNIC 2012

TISSUE DONORS


0

200

400

600

800

1000

1200

1400

1600

1800

2000

1999 2001 2003 2005 2007 2009

Deaths

Potentiallity

HOSPITAL CLÍNIC

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%

TISSUE DONORS


0

200

400

600

800

1000

1200

1400

1600

1800

2000

1999 2001 2003 2005 2007 2009

Deaths

Potentiallity

Detection

HOSPITAL CLÍNIC

TISSUE DONORS


0

200

400

600

800

1000

1200

1400

1600

1800

2000

1999 2001 2003 2005 2007 2009

Deaths

Potentiallity

Detection

Donors

HOSPITAL CLÍNIC

TISSUE DONORS


Medical and Social History

Physical Exam

Blood Samples

Serologies

Warm Ischaemia Time

Autopsy

Medical and Social History

Physical Exam

Blood Samples

Serologies

Warm Ischaemia Time

Autopsy

DONOR SELECTION


Hospital Donor– Clinic HistoryExtrahospitalary Donor ?

Who ask?Who answer?Questionnaire enough?

Hospital Donor– Clinic HistoryExtrahospitalary Donor ?

Who ask?Who answer?Questionnaire enough?

MEDICAL AND SOCIAL HISTORY

DONOR SELECTION


PHYSICAL EXAM

BLOOD SAMPLES

SEROLOGIES

WARM ISCHAEMIA TIME

AUTOPSY


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

Growth Hormone treatmentMEDICAL AND SOCIAL HISTORY

PHYSICAL EXAM

BLOOD SAMPLES

SEROLOGIES

WARM ISCHAEMIA TIME

AUTOPSY

DONOR SELECTION

ABSOLUTE CONTRAINDICATIONS


DONOR SELECTION

PHYSICAL EXAM


PHYSICAL EXAM

BLOOD SAMPLES

SEROLOGIES

WARM ISCHAEMIA TIME

AUTOPSY


Jaundice

Genital lesions

Non medical injection sites

Enlarged lymph nodes

Tattoo / piercing

White spots in the mouth

PHYSICAL EXAMINATION

DONOR SELECTION


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)


DONOR SELECTION


TxC RECOVERY TEAM

DONOR IDENTIFICATION

John Smith

30/11/1963

MH:1000456372

DONOR SELECTION



SEROLOGIES

BLOOD GROUP

HEMOGRAM

BIOCHEMISTRY

GONODOTROPHINE HORMONE

BLOOD CULTURES


PHYSICAL EXAM

BLOOD SAMPLES

SEROLOGIES

WARM ISCHAEMIA TIME

AUTOPSY

DONOR SELECTION

BLOOD SAMPLES


Time from death to blood sample. Avoid hemolisis < 6 - 24 hFalse Positives

HemodilutionTransfusion 48h previous to sampleFalse Negatives

Time from death to blood sample. Avoid hemolisis < 6 - 24 hFalse Positives

HemodilutionTransfusion 48h previous to sampleFalse Negatives

BLOOD SAMPLES

DONOR SELECTION


PHYSICAL EXAM

BLOOD SAMPLES

SEROLOGIES

WARM ISCHAEMIA TIME

AUTOPSY


A. Transfussed blood previous 48h:Red cells concentrate/48h mlTotal bloodl ml

Reconstructed Blood ml Total A=

B. Total Volume colloids previous 48h:Dextrane mlPlasma mlPlattelets mlAlbumine..... ml Total B=

C. Cristalloids Volume infussed previous 1h:Saline serum mlDextrose mlRinger mlOthers....... ml Total C=

Donor viability

1.- B+C>Plasmatic Volume yes no

2.- A+B+C>Blood Volume yes no

Date/hour blood extraction Weight......Kg

Plasma volume=Donor weight....../0.025= ml

Blood volume =Donor weight....../0.015= mlDONOR


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 ?


PHYSICAL EXAM

BLOOD SAMPLES

SEROLOGIES

WARM ISCHAEMIA TIME

AUTOPSY

DONOR SELECTION



PHYSICAL EXAM

BLOOD SAMPLES

SEROLOGIES

WARM ISCHAEMIA TIME

AUTOPSY

Not refrigerated

12 -15 h Post Cardiac Arrest

Refrigerated at 4ºC < 6 h

24 h Post Cardiac Arrest

DONOR SELECTION

WARM ISCHAEMIA TIME


If unknown Cause of DeathMandatory

Always recommended

If unknown Cause of DeathMandatory

Always recommended

AUTOPSY

DONOR SELECTION


PHYSICAL EXAM

BLOOD SAMPLES

SEROLOGIES

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


Date



Smoker 25 cig/day


14-XI-2005Extracorporeal circulation – Heart valve surgery – Mechanical prosthesis

Intensive Unit Care - Anticoagulation treatment


Date



Smoker 25 cig/day




19-XI-2005 Good evolution - Moved to Cardiology ward


Date



Smoker 25 cig/day





21-XI-2005 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…


Date



Smoker 25 cig/day





21-XI-2005

26-XI-2005

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…

Irreversibility – Tracheotomy and moved to Neurologic ward


g

Date

27-XI-2005Fever 38ºC, xr: Condensation left basal lung, possible Pneumonia

Blood Cultures. Ceftriaxone and Clindamicine treatment.

Good analitical and xr evolution - normothermia


g

Date



29-XI-2005 Good analitical and xr evolution - normothermia

7:30 am

Auricular Flutter, instability - Cardioversion 10:30 am

Alert for Cardiac arrest – Ventricular Fibrilation

Defibrilation 300J – 360J – 360J – Asystolia

Advanced Ressuscitation Maneouvres 30 minuts – unsuccesfull.

Death 13:00

12:30 pm


g

Date



29-XI-2005 Good analitical and xr evolution - normothermia

7:30 am

Auricular Flutter, instability - Cardioversion 10:30 am

Alert for Cardiac arrest – Ventricular Fibrilation

Defibrilation 300J – 360J – 360J – Asystolia

Advanced Ressuscitation Maneouvres 30 minuts – unsuccesfull.

Death 13:00

12:30 pm


PHYSICAL EXAM

BLOOD SAMPLES

SEROLOGIES

WARM ISCHAEMIA TIME

AUTOPSY


. Age: 2y-no upper limit

. No antecedents of:

retinoblastomeintraocular neoplasia herpes queratopaty ulcers or infections cornea surgery—individual evaluation

OCULAR TISSUE

SELECTION CRITERIA


AMNIOTIC MEMBRANE

. Age: Fertil woman

. No antecedents of:

uncontrolled pregnancyhª obstétrica con alteraciones pregnancy<34 weeksamniorresis>12h before birthduración parto>24hmother fever - newborn infection

SELECTION CRITERIA


DONOR QUALITY CONTROL

Serologies, blood

cultures...

DONOR SELECTION


DONOR QUALITY CONTROLNo tissue pathology

Tissue Culture

Preservation

TISSUE QUALITY CONTROL

Serologies, blood

cultures...

DONOR SELECTION


DONOR QUALITY CONTROLNo tissue pathology

Tissue Culture

Preservation

TISSUE QUALITY CONTROL

Serologies, blood

cultures...

VIABILITY

DISTRIBUTION RecipientsTraceabilityTraceability

DONOR SELECTION


EXTRACTION DISTRIBUTIONNO TRANSMISSION

E.E.B.A

E.B.A.A.

E.A.T.B

A.A.T.B

DONOR SELECTION


Donor

Heart Valves Corneas Bones

Recipients

Follow up Follow up

DONOR SELECTION


NO TRANSMISSION ?

UNKNOWN BUT...

DONOR SELECTION


Thanks to Ted Eastlund for provide me his slides and material


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

DISEASE TRANSMISSION

ARE TISSUES AND CELLS SAFE?


523197

675370

12790921281259

710064

906153

208219243787

337338

0

200000

400000

600000

800000

1000000

1200000

1400000

1994 1995 1996 1999 2000 2001 2002 2003 2007

Nº

Inje

rto

s T

x

Bone

SourceUSA data: AATB Annual Surveys2007.


Donation /medicaland social history

Tissue recoveryTissue transportation

Donor suitability

Tissue processingTissue implantation

• Window period• Cross-contamination• False negatives at the end• Human errors•………

POSSIBLE INFECTION


______Bacteria__ _______Tuberculosis_______ Epstein-Barr VirusFresh Cornea Frozen Bone * Fresh NerveFresh Cartilage Cryopreserved Heart valve Frozen Tendon*Frozen Bone * Frozen Pericardium*Fresh SkinCryopreserved Heart valve

* Could have been treated with gamma irradiation and prevented


INFECTION DISEASE TRANSMISSION BY TISSUE ALLOGRAFTS


___HIV-1___ _Hepatitis C____ ____Hepatitis B____ Frozen Bone* Frozen Bone* Fresh Cornea Frozen Tendon* Frozen Tendon* Cryopreserved Heart valve Cryopreserved Vein





_____Rabies______ ___ _CJD____ Yeast, Fungus_____

Fresh Cornea Freeze-dried Dura Fresh Cornea Organ-associated Artery Fresh Cornea Cryopreserved Heart Valve

Cytomegalovirus Herpes simplex HTLV-I___Fresh Skin Fresh Cornea Frozen Bone*





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

• 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


HCV Transmission by Organ & Tissue Allografts from a Seronegative Donor

(anti-HCV NEG, HCV RNA POS)

CadavericOrgan &Tissue Donor

ORGAN RECIPIENTS -- OCT 2000Lung HCV infectionLiver?Heart --died earlyKidney HCV InfectionKidney?

TISSUE RECIPIENTSCorneas (Italy)---- Oct 2000Saphenous Vein HCV infection ----2001Tibialis Tendon HCV Infection---- 2001Patellar Tendons HCV infection ---2002SkinBone (gamma irradiation)

AnnalsAnnals of Internal Medicine 2005; Vol 143: pages 648-654of Internal Medicine 2005; Vol 143: pages 648-654


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; 143:648-654Ann Intern Medicine 2005; 143:648-654


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


Copyright restrictions may apply.

McGeorge, A. J. et al. Arch Ophthalmol 2002;120:1379-1383.

Recipient’s right eye at time of excisional biopsyJune 1992

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

B, Postoperative appearance in September 1992 See iris defect.


New emergent infections diseases

Lymphocytic Choriomeningitis Virus Infection in Organ Transplant Recipients. Massachusetts, Rhode Island, 2005

West Nile Virus Infections in Organ Transplant recipients-New York and Pennsylvania, August-September, 2005

MMWR vol 54 /May 26, 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


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


• 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



• Unusual bacteria acquired from tissue bank processing environment– Contaminated HBSS washing reagent: Frozen

pericardium– Environment: Frozen tendon*

……………………………………………

* Reported in 2006



Donation /medicaland social history

Tissue recoveryTissue transportation

Donor suitability

Tissue processingTissue implantation

• Window period• Cross-contamination• False negatives at the end• Human errors•………

POSSIBLE INFECTION


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 TISSUE DONATION...

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