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The development of haemovigilance and the relation to safety of

transfusion practice in the UK

Dr Clare Taylor PhD FRCP FRCPath Medical Director of SHOT Consultant Haematologist

TRIP symposium 27 th November 2008


SHOT

Serious Hazards Of Transfusion


SHOT • UK wide, independent, professionally led confidential, anonymised haemovigilance scheme for reporting serious hazards of transfusion of blood and blood components

• Independent of the NBS, WBS, SNBTS and NIBTS

• Affiliated to the RCPath • Funded by the UK Transfusion Forum • Team based in Manchester, outpost in London


Prior to 1996 • Incidence of major complications of blood transfusion unknown

• Not covered by a confidential inquiry or yellow card system as for drugs


SHOT • In 1990s growing awareness of safety issues in blood transfusion especially HIV, HCV, hospital errors

• Working group set up in 1994 to consider haemovigilance – SHOT launched 1996

• SHOT report first published for 19961997 data • Increasing number of reports each year • Evolution of new categories reflecting reports • Eleventh report (2007 data) published July 2008


Definition of Haemovigilance EUD • HV shall mean a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients and the epidemiological follow up of donors

EHN • A set of surveillance procedures from the collection of blood and it’s components to the follow up of the recipients, to collect and assess information on unexpected and undesirable effects resulting from the therapeutic use of labile blood components and to prevent their occurrence or recurrence


Aims of Haemovigilance • Identify trends in adverse reactions and events • Inform policy within transfusion services, DH, EU • Target areas for improvement of practice

• Aid production of clinical guidelines for use of blood components • Promote development of suitable education and training • Identify and promote standards of practice

• Stimulate research and detailed audit • Raise awareness of transfusion hazards and their prevention

• Be an ‘early warning’ of new complications • Improve safety of transfusion for patients


SHOT’s role • Collects data directly from reporters in hospitals on adverse reactions and incidents arising anywhere in the transfusion process

• Direct liaison with reporters to ensure accuracy of reported data

• Data analysis and publication of annual report and scientific papers

• Recommendations made based on SHOT data to improve patient safety

• Report with recommendations sent to ‘effectors’ for action e.g. DH, EU, MHRA, NBTC, Royal Colleges and Specialist Societies, NHS Trust CEOs


Recommendations 19971998

• Need for a national body with relevant expertise and resource to advise government of priorities for improvement in blood safety • MSBTO formed 2001, and SaBTO 2008.


IBCT

Largest reporting category


SHOT cases 2007


Cumulative cases 1996 2007


Total number of reports to SHOT TOTAL

0 100 200 300 400 500 600 700

1996/1997

1997/1998

1998/1999

1999/2000

2000/2001

200102 (15 m

ths)

2003 2004 2005

2006 2007

TOTAL



• Basic epidemiological research is needed into the timing and location of transfusions in the hospital setting

National Comparative Audit commenced, first audit published 2003


2001 2002 IBCT • 552 errors in 346 cases • Major ABO incompatibility in 32 cases • 19 D incompatible • 103 bedside errors, with 15 major ABO incompatibility • Severe morbidity in 2 cases and death possibly related in 1 case

• Failure of bedside check in 30% cases



• An ongoing programme of education and training to all staff involved in transfusion (reiterated subsequent years) • SHOT, NPSA and NBTC collaboration to reduce ABO incompatible transfusion, 2004

• Statutory training, BSQR, November 2005 • Training and competency mandated by NPSA SPN14 November 2006 (endorsed by SHOT)


ABO incompatible red cell transfusions

0

5

10

15

20

25

30

35

40

19961997 19971998 19981999 19992000 20002001 20012002 (15 mths) 2003 2004 2005 2006 2007


Bacterial transmission



• Strategies to prevent transfusion transmitted bacterial infections should be given priority • Diversion of first 20mls of blood commenced in 2002


Bacterial transmission • In 6 years from 1996 to 2002 , 24 bacterial transmissions (6 fatal) were reported to SHOT • 6 cases in 19981999, 5 in 19992000

• Two methods were shown to reduce bacterial contamination of donated blood • Diversion of initial 20 mls of blood

• De Korte et al, Vox Sang 2002; 83:1316 • Improved donor arm cleaning procedure

• McDonald et al, Vox Sang 2001; 8:135141

• Evaluation of a combination of both was subsequently carried out


Value of the two interventions • 1 Evaluation of diversion of first 20mls blood and existing arm cleaning procedures • Culture of diverted blood showed 21/1409 (1.5%) contaminated after arm cleaning, but only 10/1409 post diversion, a reduction of 52%.

• 2 Evaluation of diversion of first 20mls of blood with improved arm cleaning • Culture of diverted blood showed 9/1409 (0.6%) contaminated after improved arm cleaning, but only 6/1409 post diversion, a 33% reduction.


Outcome • Study shows that diversion alone would reduce bacterial contamination from 1.5% to 0.6%

• Improved arm cleansing alone would reduce contamination rates to 0.6%

• Combining improved arm cleaning with diversion would reduce rate of bacterial contamination from 1.5% to 0.3%

• McDonald et al, Vox Sang 2004; 86: 178182


Confirmed bacterial TTI


TRALI


TRALI

• Leading cause of transfusion related mortality and major morbidity

• Caused by HLA/HNA abs – main source is donor plasma: o A donor with a history of transfusion (excluded since April 2004 unless Tx pre 1980 only)

o A female donor with a history of pregnancy – abs in 1015%


TRALI – relative risk from different components 19962003

8.16 6.86 1.76 Relative risk compared to red cells

1:68 000 1:81,000 1:317,000 1:556,000 Risk/ component issued

1,842,000 2,515,000 634,000 18,370,000 Components issued (000s)

27 31 2 33 TRALI cases

Platelets FFP/ Cryosup

Cryoppt Red cells



• UK transfusion services should take all steps possible to reduce the risk of TRALI from blood components especially FFP and platelets • Switch to preferential issue of male FFP from October 2003


TRALI


TRALI: Effect of Male FFP


TRALI: Summary q Mortality remains lowest since reporting began

q No cases due to FFP 2005 – 2007: preferential use of male FFP

q Female donors implicated in all cases where concordant leucocyte abs.

q Further actions to reduce TRALI risk of platelet transfusions q Preferential recruitment of male apheresis donors q Screening of female apheresis donors q Higher proportion of apheresis platelet donors q Replacement of 70% plasma in platelets with plateletadditive solution.


Components initiatives

• Bacterial TTI and TRALI are excellent examples of the utility of SHOT data

• Change in transfusion services components policy based on SHOT data

• Demonstrable improvement in outcomes as a result


Current and new initiatives

Outcomes awaited….


Medical education

Inappropriate and unnecessary transfusion


Types of IBCT event 19967

• Errors fell into 3 categories (63 reports) • Requesting blood and/or sampling the patient (8) • Laboratory errors – grouping, crossmatching and labelling (21)

• Collection of blood from storage site (usually blood bank) and administration (34). The majority of errors (54%) were attributed to the wrong unit being withdrawn from an blood bank refrigerator to take to the clinical unit, or the bedside pretransfusion checks


IBCT events 2007 (all resulting in transfusion to patient)

• Administration of wrong blood 24 • Wrong blood in tube 7 • Inappropriate or unnecessary transfusion 50 • Handling and storage errors 118 • Special requirements not met cmv/irrad 76 • Special requirements not met other 17 • Additional lab errors 40

• Including ABO and D incompatible

TOTAL 332


Inappropriate or unnecessary transfusion

• 50 cases reported in 2007 • 47/50 involved medical staff • 28 transfusions based on a wrong Hb interpretation

• Drip arm • POCT Hb incorrect • Transposition of WCC and HB • Other transcription errors

• 2 based on incorrect INR or platelet count from POCT • 3 based on erroneous results from main lab (excl. WBIT) • 17 related to poor basic knowledge and prescribing

• Poor or absent patient assessment, inappropriate decision making • Incorrect (excessive) dose, volume or rate • Inadequate knowledge of indications and triggers for components


Special requirements not met

• 76 cases related to CMV and irradiation • 49 of these relate to clinical errors and omissions


Inappropriate transfusion causing patient harm

0

10

20

30

40

50

60

70

80

inappropiate Tx

19961997 19971998 19981999 19992000 20002001 20012002 (15 mths) 2003 2004 2005 2006 2007


Special requirements not met

0

20

40

60

80

100

120

140

160

special requirements not met

19961997 19971998 19981999 19992000 20002001 200102 (15 mths) 2003 2004 2005 2006


Recommendations 2006 and 2007 • Inclusion of transfusion medicine in core curriculum for junior doctors • Delivered as a two stage process – basic working knowledge for Foundation Year 1 and 2 doctors and in depth for specialist trainees

• Specialty accredited laboratory and clinical staff in all hospitals • Appropriate skill mix, BMSs and TPs to obtain qualifications in transfusion medicine, eg BBTS

Royal Colleges and Specialist Societies sub committee of NBTC addressing this


Participation

Still incomplete



• SHOT reporting should be made a requirement of CPA • This is now standard H2.1d.


EU Directives transcribed • UK Blood Safety and Quality Regulations 2005 (SI 50) • Became law November 2005

• Amendment 2005 (SI 2898)

• Amendment 2006 (SI 2013)


Total number of reports to SHOT TOTAL

0 100 200 300 400 500 600 700

1996/1997

1997/1998

1998/1999

1999/2000

2000/2001

200102 (15 m

ths)

2003 2004 2005

2006 2007

TOTAL


BSQR

• Making haemovigilance reporting statutory may have contradictory effects • (Temporary) decrease overall in number of reports (in 2006, now up again)

• Increase in some subsets of reports e.g. ATR • No improvement in participation


Participation in SHOT

Total of 1,110 incidents reported to SHOT in 2007 from 212/308 (69%) registered hospital users of SABRE

30% nonreporters to SHOT (approx)

25% nonreporters to MHRA (approx)

No change between 2005 (pre BSQR) and 2007

But nonreporters include high users

403

308 279

212

124 96

0

50

100

150

200

250

300

350

400

450 2005 2007

No reports Reports Total


Recommendations 2006 and 2007

• Comprehensive SHOT reporting by all hospitals • Participation in haemovigilance must be improved as it is mandatory in the UK and the rest of Europe. Hospitals not sending I data are in breach of European and UK legislation.

Blood Consultative Committee of MHRA, and SHOT with DH are now developing an initiative to improve participation. First ‘for cause’ MHRA inspections based on SABRE to take place.


Lab based incidents


Adverse events originating in the hospital transfusion laboratory

• 121 adverse events altogether • IBCT 96

• Wrong blood 15 • Wrong group selected for SCT patient 5 • Other pretransfusion testing errors 20 • Special requirements not met 36 • Handling and storage errors 20

• Anti D 24 • HTR 1


Laboratory initiative • Approximately one third of all error related cases originated in hospital transfusion laboratories over 10 years – fairly static

• Resulted in recent collaborative initiative between NBTCs, IBMS, BBTS, RCPath and SHOT to identify causes of problem and set minimum standards for laboratory staffing, skillmix, training and competencies, workload, automation etc to reduce error rate

• Future impact can be assessed through SHOT data


SHOT timeline


Policy of male donors of FFP commenced 1st case of vCJD transmission by transfusion

Peak incidence of TRALI 2003 National Comparative Audit of bedside transfusion

Diversion first 20mls of donation Better Blood Transfusion II Appropriate Use, HTTs

Recommends transfusion should only be prescribed by authorised clinicians 2002 HTLV1 testing

Blood Stocks Management Scheme

NBTC formed, and RTC network

Rec. more dedicated Transfusion Consultants, TPs 2001 Hepatitis C ruling

USA plasma for fractionated products

1999 Universal leucodepletion of components in UK

Recommends National investment in transfusion IT 1998 Better Blood Transf. initiative HTC, SHOT

SHOT reporting commences 1996

Working party on blood transfusion safety set up 1994 HCV transmissions in Ireland from AntiD

1992 Testing for HCV on UK blood donors

SHOT related events YEAR UK blood transfusion events


SHOT working closely with Competent Authority, MHRA 2008 First year of mandatory reporting AE to EU

Launch of Nat. Transfusion Lab. Collaborative 4th case report of vCJD transmission by transfusion

SHOT in Obstetrics produced 2007 Better Blood Transfusion III

ABO incompatible transfusion at all time low

100% male donors FFP WBS, SNBTS, NIBTS, 86% NBS

SHOT in Children produced NPSA SPN 14 Right Blood Right Patient

Decrease in SHOT reports sent 2006 3rd case report of vCJD transmission by transfusion

Scottish Elearning package from EUB group

Reduction in UK blood usage 15% in last 5 years

November BSQR become law in UK

Reduction in cases of TRALI reported 2005 USA MB treated plasma for all children under 16

Emergency Blood Management Plan

Exclusion of previously transfused blood donors

2nd case report of vCJD transmission by transfusion

CMOs report contains chapter on blood transfusion

ABO incompatible transfusion USA MB treated plasma for all children born after 1/1/96

SHOT/NPSA/NBTC workshop aimed at reducing 2004 Blood Conservation Strategy Document via DoH

SHOT related events YR UK blood transfusion events


What has been the impact of SHOT?

• Identification of trends and patterns of AIs reported in UK • ABO • TRALI • ‘IBCT’

• To make interventions based on haemovigilance data and demonstrate their effectiveness

• ABO campaign, NPSA SPN • Reduction of bacterial contamination • Male FFP to reduce TRALI

• To plan future initiatives to improve safety for patients • Medical education • Participation in Haemovigilance • NTLC


IBCT and ABO incompatible cases


Mortality – definitely attributed to transfusion

0

2

4

6

8

10

12

14

Mortality

19961997 19971998 19981999 19992000 20002001 20012002 (15 mths) 2003 2004 2005 2006 2007


Mortality – definitely or possibly attributed

0

2

4

6

8

10

12

14

16

18

Total

19961997 19971998 19981999 19992000 20002001 20012002 (15 mths) 2003 2004 2005 2006 2007


Thanks • Dr Hannah Cohen, Steering Group Chair • Steering Group and Standing Working Group • Hilary Jones – Research Analyst • Tony Davies – SHOT transfusion liaison practitioner • David Mold – Operations Manager • Kathryn Gradwell and Vicky Peake, SHOT office information officers

• NBS for accommodation in Manchester and London • UK Transfusion Forum for funding • HTTs for reporting


TRIP rapport 2007

27 November 2008 Martin Schipperus


Situatie nu

Bestuur beroepsverenigingen

TRIP bureau

Ziekenhuis bloedtf. comm.

Ziekenhuis Hemovigilantie functionaris

clinici

Sanquin HV

programma

Sanquin Bloedbank

KCD Afd KAM

mogelijk productgerelateerde bijwerkingen

recall & lookback

Bevoegde autoriteit:

IGZ calamiteit


Calamiteiten en ernstige bijwerkingen/voorvallen

Product gerelateerd

Ziekenhuis

IGZ Inspectie voor de Gezondheidszorg

Sanquin Bloedbank

TRIP Landelijk Hemovigilantie Bureau


Vervolg • Let op: IGZ zal met de Raad van Bestuur communiceren!

• IGZ en Sanquin kunnen actuele versie (pdf) van al hun meldingen inzien / downloaden.

• Door TRIP nummer kunnen meldingen eenvoudig ‘ontdubbeld’ worden.

• Wijzig bij voorkeur niet de status ‘melding is tevens’ (ook indien later feitelijk niet meer verplicht).

• Stuur opnieuw door aan instantie bij definitief worden van de melding (liever niet bij elke wijziging!)


N.B.

• TRIP stuurt geen meldingen door naar Sanquin of IGZ! (behalve in de vorm van een geanonimiseerd overzicht)


Wanneer gaat het in?

1. 5 januari 2009 wordt de doorzendfunctionaliteit actief.

2. Binnenkort informeert IGZ en TRIP alle RvB van de ziekenhuizen met een gezamenlijke brief.


Expert committee TRIP

EC


Beoordeling meldingen door EC

• 30 maal aanvullende vragen gesteld door TRIP.

• 8 maal verandering categorie melding • 8 maal verandering ernstgraad of imputabiliteit

• 2 maal blijvend verschil van mening over imputabiliteit TRALI melding: rapport vermeldt uiteindelijk oordeel EC

insert your department, conference or presentation title donderdag 28 juni 2007 ACRP Intermediate GCP course

GCP

TRIP vragen


Typen melding

0 400 800 1200

1600 2000 2400

2002 2003 2004 2005 2006 2007

Bijna ongeluk

Incid ent zonder klinisch gevolg

Incid ent met klinisch gevolg

IBCT zonder klinisch gevo lg


Typen meldingen 20027

91,0%

3,4% 2,3% 0,5%

0,2% 2,6% Transfusiereactie

IBCT* met klinisch gevolg

IBCT* zonder klinisch gevolg

Incident met klinisch gevolg

Incident zonder klinisch gevolg

Bijna ongeluk


Ernst graad meldingen


Imputabiliteit meldingen


Meldingen per categorie ziekenhuis


TRALI


Reactie 2003 2004 2005 2006 2007 07 06

NHTR 318 344 435 490 412 55 AHTR 8 14 9 17 10 7 VHTR 19 14 12 14 11 3 TRALI 6 9 17 25 30 +5 Volume overbelasting 7 6 27 34 27 7 Anaphylactische TR 8 21 26 19 50 +31 Andere allergische reactie 132 171 219 222 185 37 Hemosiderose 0 0 3 5 3 2 Bacteriële contaminatie 9 5 10 7 22 +15 Virale besmetting 5 7 8 7 7 0 Milde koortsreactie 326 341 375 362 284 78 Nieuwe antistofvorming 244 428 571 607 564 43 Overige reactie 54 64 67 61 50 11

Incident IBCT 34 37 60 64 60 4 Overig incident 5 14 53 87 102 +15 Bijna ongeluk 31 62 79 77 69 8 Pos. bacteriële screening 60 10* 13* 27* 24* 3 TOTAAL 1267 1547 1984 2127 1910 217


23/30


Zonder Xthorax geen TRALI!


Waarde BNP en NTproBNP bij differentiatie TRALI en TACO

• Brain Natriuretic peptide en Nterminal pro BNP

• “Useful diagnostic marker” AA Tobian et al Transfusion Jun 2008

• “limited diagnostic value” G Li et al Transfusion 14 Oct 2008


Reactie 2003 2004 2005 2006 2007 07 06




Anafylactische reactie

• Toename 19 50 door aanscherpen definitie:

• (Ernstige) reactie optredend enkele seconden tot minuten na de start van de transfusie , met verschijnselen zoals luchtwegobstructie, in en expiratoire stridor, bloeddrukdaling, misselijkheid of braken of diarree, eventueel rugpijn, huiduitslag


Relatie met soort bloedproduct Erytrocyten 10

Trombocyten 24

Plasma 10

Combinatie 6


Andere allergische reacties • 20 meldingen allergische reactie die samengaan met temperatuurstijging

• M.A. Poposky 2007: temperatuur stijging hoort niet bij een allergische reactie.

• TRIP: allergische reactie kan soms gepaard gaan met temperatuurstijging!


PPOC project aanvraag allergische TR

• “Anaphylactic transfusion reactions: phenotype, epidemiology and causal factors related to patient, blood component or donor”

• Anneke Brand, Jo Wiersum


Reactie 2003 2004 2005 2006 2007 07 06




Wijzigingen meldcategorie bacteriële besmetting

• Per januari 2008 i.p.v. bacteriële contaminatie: • Posttransfusie bacteriëmie / sepsis

Het ontstaan van klinische symptomen van bacteriëmie / sepsis tijdens, aansluitend aan of enige tijd na een bloedtransfusie, waarbij een relevante positieve bloedkweek van de patiënt wordt verkregen en al dan niet een oorzakelijk verband met een toegediend bloedproduct kan worden gelegd.

• Melding positieve bacteriologische screening Signalering door de producent dat er een positieve bacteriologische screening is gevonden, maar bacteriële contaminatie is niet geconfirmeerd door een positieve kweek van het betreffende materiaal of van andere producten uit dezelfde donatie.

• Bacteriële contaminatie bloedproduct Het volgens de regelen der kunst aantonen van een relevante hoeveelheid bacteriën in (een restant van) bloedproduct of de bacteriologische screeningsfles van trombocytenproducten, dan wel materiaal van dezelfde donatie, met behulp van laboratoriumtechnieken en bij voorkeur met uittypering van de betreffende bacteriestam(men)


Twee routes, drie categorieën

Verschijnselen patiënt È

Tijdsrelatie met transfusie È

Uitslag bloedkweek positief È

Posttransfusie bacteriëmie/sepsis

transfusiereactie

Ç Uittypering micro

organisme Ç

Uitslag kweek bloedproduct of

confirmatie Sanquin

Ç Andere reden verschijnselen

Imputabiliteit ?

Positieve screening Sanquin È

Bloedproduct is / wordt toegediend

incident

È Confirmatie Sanquin / positieve uitslag

kweek bloedprod.ZH È

Bacteriële contaminatie bloedproduct

È Geen confirmatie Sanquin / geen

positieve uitslag kweek bloedprod.ZH

È Melding positieve

bacteriële screening

nevencategorie?

Ç Verschijnselen

patiënt

Ç Omstandigheden die verschijnselen kunnen

beïnvloeden


Belangrijke gegevens bij bacteriële besmetting

• Screening Sanquin • Verschijnselen patiënt • Tijdsrelatie • Kweekuitslagen

• Confirmatie Sanquin • Bloedkweek patiënt • Kweek (restant) bloedproduct door ZH

• Uittypering microorganismen • Andere oorzaken • Maskerende omstandigheden • Ingestelde behandeling


Oud bloed gevaarlijk?


Old Blood = Bad Blood?

CHEST 2008: American College of Chest Physicians 74th Annual Scientific Assembly October 25 30, 2008, Philadelphia, Pennsylvania


Presentatie CHEST symposium 2008

• Raquel Nahra, M.D., of Sparks Medical Center in Fort Smith, Ark.,

• After adjusting for numerous factors known to contribute to infection risk, patients given at least one unit of blood had an odds ratio of 2.9 (95% CI 1.4 to 6.0) of developing nosocomial infection, reported.

• If the first unit of transfused blood was older than four weeks, the odds ratio for nosocomial infection was 2.1 (95% CI 1.1 to 4.5).


IJzer de boosdoener ? • 1 eenheid erytrocyten: 200 mg ijzer ??

• Gemeten in 16 eenheden gemiddeld 24,9 μmol/l ijzer (8.0 – 83.0 μmol/l )

• Gemiddeld 375 mg/eenheid (120 1252 mg)


Nieuwe definitie nodig?

• Transfusie Geinduceerde Infectie (TGI) • Transfusion Induced Infection (TII):

• Onstaan of verergering van een infectie (ergens in het lichaam) na toediening van een transfusie.


Reactie 2003 2004 2005 2006 2007 07 06




Start PPOC project

• “Risk factors for alloimmunization after erythrocyte transfusion: a case control study”

• Jaap Jan Zwaginga

• Samenwerking Sanquin, LUMC, TRIP

• Patiënten die antistoffen ontwikkelen • Vergelijken met controle patiënten


Reactie 2003 2004 2005 2006 2007 07 06




Overige Reacties • Transfusie gerelateerde kortademigheid • Transfusion associated Dyspnoea (TAD):

• 7 patienten wel dyspneu maar geen TRALI door EC bij overige reacties ingedeeld.

• TAD misschien een nieuwe TRIP categorie?


Incidenten


Verkeerd bloedproduct toegediend 60 x verkeerd bloedproduct

17 x verwisseling

5 x ABO incompatibel

1 x ABO/Rh incompatibel

2 x Rh incompatibel

1 x TR (graad 1)

7 x onbestraald 15 x IRRA incompatibel

11 x niet volgens richtlijn (K, Rh, Parvo)

2x ander product

identificatie

8 x Andere redenen


Hemovigilantie bloedbesparende technieken

• Pilot in 6 ziekenhuizen: nog 4 vacatures

• Zie notitie: bloedbesparende technieken op TRIP website onder “formulieren”


Graad 4 TR


Indicaties

• Volgen van de CBO richtlijn 2004

• Landelijk project “naleven indicaties” (CBO &TRIP)

• Taak BTC en hemovigilantie functionaris en medewerker

• Scholing en audit !


Plasma verbruik HagaZiekenhuis

0

200

400

600

800

2IC LEY_OK 15A 7B 12B overige

geen aangetoonde stoll ings deficientie totaal plasma


0

2 0 0

4 0 0

6 0 0

8 0 0

a na ic u in t h lk s e h o ve r ig e

geen aangetoonde s tollings deficientie totaal plasma


Melden van ernstige bijwerkingen en voorvallen

Jaaroverzich t

Calamiteit Calamiteit

Voorval len en b ijwerk ingen Recall & lookback

Ziekenhuizen Weefsel instell ingen

Bestuur Adviescommis ie

Nationaal TRIP bureau

Inspectie voor de gezondheidszorg


EUSTITE project EUSTITE (European Union Standards and Training in the Inspection of Tissue Establishments) is een samenwerkingsproject van de EU en de WHO op het gebied van materialen ter ondersteuning van weefselvigilantie en van training van inspecteurs van weefselinstellingen.

EUSTITE project Vigilance & Surveillance : • standaardisatie van de meldingsprocedure in EU • 1 juli 2008 tot 1 juli 2009 • meldingen van ernstige, ongewenste bijwerkingen of voorvallen • ‘Impact assessment tool’ • extra informatie: ∙ de kans op herhaling van de bijwerking of het voorval

∙ de (potentiële) consequentie voor de patiënt, werkwijze of de voorraad weefsels of cellen

www.eustite.org “Vigilance and Surveillance – Tools and Guidance” bij de “Tools for Vigilance and Surveillance of Human Tissues and Cells”.


dr s. Pauline Zijlker , ar ts

Mar jan Happel, ver loskundige

Ineke van den Berg, CRC

Coördinator dr s. Jo Wier sumOsselton, ar ts

M & G

drs. Anita van Tilborgh, ar ts

Mw. Ingr id van VeenRottier , secretaresse

of - tripnet

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