Hemovigilance: are we

making a difference?

Johanna C. Wiersum-Osselton, MD PhDTRIP Hemovigilance and biovigilance and Sanquin

No financial conflicts of interest

Disclaimer

• Views expressed in this presentation do notnecessarily reflect those of TRIP, Sanquin or anyother organisation with which I am affiliated

1990s: Tainted blood

• Fear of infections

• Desire for transparency

Global Database on Blood Safety

Infection tested Countries with

incomplete testing$

Range

HIV 7 countries 91.6% to 99.7%

HBV 9 countries 26.8% to 98.5%

HCV 11 countries 17.5% to 99%

Syphilis 9 countries* 66.0% to 98.4%

$7 countries were unable to provide a % of coverage

*3 European countries no longer routinely test for syphilis as a result of

policy change

Global status report on blood safety and availability

2016. Geneva: World Health Organization; 2017.

2013 data from156 of 195 Member States

Reports to TRIP(from 2003, all severity levels)

• >95% participation

• Nearly all hospitals have transfusion safety officer

0.00

0.50

1.00

1.50

2.00

2.50

3.00

3.50

4.00

4.50

0

500

1000

1500

2000

2500

3000

2002

2003

2004

2005

2006

2007

2008

2009

2010

2017

Report

s p

er

1000 u

nits d

istr

ibute

d

Report

s p

er

year

Totalreports

Seriousreports(grade2,3,4)

Reportsper 1000units

Errors and incidents

SHOT Report 2000/1 Figure 4

Reports to SHOT in

2016 (Figure 3.3)

Possibly

preventable 121

Not preventable 282

Errors 2688

IBCT (213)

67,6%

French data (ANSM rapport d’activité d’hémovigilance 2016)

TR with RBC TR with plts TR with plasma Incidence, all bp

Fig. 31: ABO incompatible transfusions (imp. definite, probable), 2010-2016

Num

ber

of

transfu

sio

nre

actions

Incid

ence

per

100,0

00 t

ransfu

sio

ns

IHN, ISTARE

TRALI, TACO, TAD

0

20

40

60

80

100

120

20

02

20

03

20

04

20

05

20

06

20

07

20

08

20

09

20

10

20

11

20

12

20

13

20

14

20

15

20

16

20

17

Transfusion-associated acute lunginjury (TRALI)

Transfusion-associated circulatoryoverload (TACO)

Transfusion-associated dyspnea(TAD)

Variant CJD

• Donor eligibility

• Universal leukodepletion as precautionarymeasure

• Concerns about medicinal plasma products

Seed et al, Vox Sanguinis 2018 April 113(3):220-231

Global Database on Blood Safety

GDBS: haemovigilance

WHO region (total no

of countries)

% hospitals

with

transfusion

committee (*)

% hospitals

participating in

adverse

reaction

reporting (*)

Haemovigilance

system (n/*)

Africa (46-47) 14% (33) 17% (26) 26% (12/42)

Americas (35) 20% (13) 91% (12) 14% (35)

Eastern Mediterranean

(20-21)

57% (13) 32% (9) 35% (7/20)

Europe (53) 92% (23) 99% (12) 77% (33/43)

South-East Asia (11) 57% (7) 59% (5) 46% (5/11)

Western Pacific (27) 25% (20) 37% (20) 32% (8/25)

Total (195) 39% (70/180)

*number of countries providing data

Global status report on blood safety and availability

2016. Geneva: World Health Organization; 2017.

DonorsData from PEI, 2015

Breakdown according to IHN-ISBT-AABB definitions

“Vasovagal reactions without loss of consciousness (LOC)

were the most frequent donor reactions with 46%.”

DonorsData from PEI, 2015 (2)

“Major differences existed between the donation centres with

regard to the reports. These were probably due to different

judgements of the severity of the reaction”

Guidance to support

severity assessment

under preparation

Yes and no

What is HV?

• Surveillance system

• A science?

• It is not an intervention

• What are the outputs to be?

What would we miss if we did not have HV?

• Variable reporting

• Data quality, validation

• Severity assessment

• Learning from errors, bringing about change

• Reporting fatigue

• Need for new outcome measures

Issues (non-exhaustive)

AfSBT 19-22 June 2018

Lack of blood

Traceability

Allo-immunisation and DHTR

TACO in pediatric patients

Would you volunteer?

IHN HV Quality Task Force

– Develop standards for HV systems

– Develop definitions for outcomes

• With ISBT HV working party

• Work with AfSBT on inability/failure to transfuse(list of key reasons)

• Is there a relevant indicator for management of donor iron status?

– Periodic quality audit using vignettes forclassification

– ……..

IHN vision, mission and strategic goals

Thank you

Colleagues at TRIP and Sanquin

All HV contacts in the Netherlands

and abroad