20140530 ISBT TTBI Survey · 2014. 12. 29. · 20140530_ISBT_TTBI_Survey Author: Edward Chew...

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Update on ISBT Interna/onal Survey on Transfusion-‐transmi9ed Bacterial Infec/ons

Edward Chew & Erica Wood

On behalf of the WPs on TTID and HV

•  Rationale & construction of survey •  Demographics of respondents

•  Blood supplier(s)

•  Haemovigilance programmes

•  Transfusion-transmitted bacterial infection (TTBI)

•  Bacterial contamination of blood components

Interna/onal Survey on TTBI

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•  Variability in defini/ons of TTBI •  Variability in approach to:

–  Ini/al inves/ga/ons –  Confirmatory tes/ng –  Repor/ng of events –  Preven/ve measures

Interna/onal Survey on TTBI •  Joint initiative of:

– Haemovigilance WP – TTID WP

•  Assessment of definitions and current practices in prevention, diagnosis, management and reporting

•  Initial draft questionnaire with feedback from WP members

•  Wide distribution of final questionnaire •  First survey results reported to WP at ISBT

Congress in June 2013 •  Additional contacts emailed December 2013

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•  Haemovigilance programme



•  Future directions


Interna/onal Survey on TTBI Demographics of respondents

•  212 par/cipants in 73 countries invited to par/cipate

•  58 responses from 39 countries •  Good representa/on of countries & organisa/ons •  Some responses joint submissions from members

of the same organisa/on

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39 countries


•  58 respondents •  51 medical •  7 non-‐medical

•  27 countries had more than 1 blood supplier

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Interna/onal Survey on TTBI Haemovigilance Programmes

0 2 4 6 8 10 12 14 16 18 20

Na/onal Haemovigilance Programme

Na/onal & Regional Haemovigilance Programme

Regional Haemovigilance Programme

No Haemovigilance Programme

6

3

1

14

2

1

12

Number of Countries

Haemovigilance Programmes according to Regional/Na9onal and Voluntary/Mandatory

Voluntary

Mandatory

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Interna/onal Survey on TTBI TTBI defini/ons •  Standard definition of TTBI available for:

27/58 respondents from 17 countries –  Australia –  Belgium –  Brazil –  Canada –  Finland –  Germany –  Japan –  Jordan –  Morocco –  Netherlands (TRIP) –  New Zealand –  Portugal –  Republic of Korea –  South Africa –  Switzerland –  UK (SHOT) –  USA (CDC)

1

Revised November 2012

NHSN Biovigilance Component Hemovigilance Module Surveillance Protocol v2.1.2

www.cdc.gov/nhsn

Page 1 of 31 January 2014

National Healthcare Safety Network Biovigilance Component Hemovigilance Module Surveillance Protocol

Division of Healthcare Quality Promotion National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention Atlanta, GA, USA

31/03/2014 12:32 amTRIP Hemovigilance definitions

Page 1 of 3https://www.tripnet.nl/pages/en/definities.php

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TRIP (2008) definitions of transfusion reactions and incidentsNonhemolytic transfusion reaction (NHTR)

Rise in temperature of ≥ 2 o C (with or without rigors/chills) during or in the first two hours after a transfusion,with no other relevant symptoms or signs; OR rigors/chills with or without a rise in temperature within thesame time limits. No evidence (biochemical or blood group serological) for hemolysis, and no alternativeexplanation.

Mild (nonhemolytic) febrile reactionRise in temp. >1°C (<2°C) during or in the first two hours after a transfusion with no other relevant symptomsor signs; optional reporting to TRIP. Hemolysis testing and bacteriology negative if performed.

Acute hemolytic transfusion reactionSymptoms of hemolysis occurring within a few minutes of commencement of until 24 hours subsequent to atransfusion: one or more of the following: fever/chills, nausea/vomiting, back pain, dark or red urine,decreasing blood pressure or laboratory results indicating hemolysis within the same period.Biochemical hemolysis testing positive; bloodgroup serological testing possibly positive; bacteriologynegative.

Delayed hemolytic transfusion reactionSymptoms of hemolysis occurring longer than 24 hours after transfusion to a maximum of 28 days:unexplained drop in hemoglobin, dark urine, fever or chills etc; or biochemical hemolysis within the sameperiod. Biochemical testing and blood group serology confirm this.If new antibodies are found without biochemical confirmation of hemolysis, report as new allo-antibody.

TRALI (Transfusion-related acute lung injury)Dyspnoea and hypoxia within six hours of the transfusion; chest Xray shows bilateral pulmonary infiltrates.There are negative investigations (biochemical or blood-group serological) for hemolysis, bacteriology isnegative and no other explanation exists. Depending on the findings of tests of leukocyte serology, report isclassified as immune-mediated or unknown cause.

Transfusion-associated circulatory overload (TACO)Dyspnoea, orthopnoea, cyanosis, tachycardia >100/min. or raised central venous pressure (one or more ofthese signs) within six hours of transfusion, usually in a patient with compromised cardiac function. Chest X-ray consistent.

Anaphylactic transfusion reactionRapidly developing reaction occurring within a few seconds to minutes after the start of transfusion, withfeatures such as airway obstruction, in and expiratory stridor, fall in blood pressure ≥ 20mm Hb systolicand/or diastolic, nausea or vomiting or diarrhoea, possibly with skin rash.Hemolysis testing and bacteriology negative, test for IgA and anti-IgA.

Other allergic reactionAllergic phenomena such as itching, redness or urticaria but without respiratory, cardiovascular orgastrointestinal features, arising from a few minutes of starting transfusion until a few hours after itscompletion. Hemolysis testing and bacteriology negative if performed.

New allo-antibodyAfter receiving a transfusion, demonstration of clinically relevant antibodies against blood cells (irregularantibodies, HLA or HPA antibodies) that were not present previously (as far as is known in that hospital).

Post-transfusion bacteremia/sepsisClinical symptoms of bacteremia/sepsis arising during, directly after or some time subsequent to a bloodtransfusion, for which there is a relevant, positive blood culture of the patient with or without a causal relation

Table of

Assessment of the Reports of Serious Adverse

Transfusion Reactions pursuant to Section 63 c AMG

(Arzneimittelgesetz, German Medicinal Products Act)

// HAEMOVIGILANCE REPORT OF THE PAUL-EHRLICH-INSTITUT //

2010

Federal Institute for Vaccines and Biomedicines

CCDRCCDRCanada Communicable Disease Report

ISSN 1188-4169

Volume: 34S1 January 2008 Supplement

Guideline for Investigation of Suspected Transfusion

Transmitted BacterialContamination








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Interna/onal Survey on TTBI Transfusion-‐transmi9ed Bacterial Infec/ons

What clinical symptoms and signs might suggest

or be consistent with a potential case of TTBI?

Interna/onal Survey on TTBI TTBI symptoms

12

20

14

19

26

25

31

17

42

16

38

41

48

19

2

23

21

11

13

8

16

2

23

6

4

1

1

2

1

3

2

1

27

36

20

18

20

18

18

22

14

17

13

13

10

0 10 20 30 40 50 60

No symptoms

Others

Pain at infusion site

Lumbar/back pain

Agita/on and/or confusion

Hypoxia

Shortness of breath

Bradycardia

Tachycardia

Hypertension

Hypotension

Rigors

Fever

Number of responses

Symptoms and signs

Symptoms and signs consistent with a TTBI

Yes

No

Maybe

Not answered

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Interna/onal Survey on TTBI TTBI:

•  Other symptoms / signs: •  Nausea, vomiting •  Abdominal pain •  Diarrhoea •  Oliguria, renal failure •  Headache, encephalitis, meningitis •  Jaundice •  Myalgia, arthralgia •  Cyanosis •  Shock •  Chest pain •  DIC •  Death


What tests are required / performed to investigate

a suspected clinical case of TTBI?

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8

12

6

9

26

26

32

34

44

44

48

17

25

34

27

15

15

10

12

3

3

1

33

21

18

22

17

17

16

12

11

11

9

0 10 20 30 40 50 60 70

Other

Molecular test (eg pulsed-‐field gel electrophoresis)

Urine culture of the recipient

Chest X-‐ray of the recipient

Haemolysis screen of the recipient

Full blood count of the recipient

Blood group & an/body screen of recipient

Gram stain of implicated component

Blood culture of the recipient

Culture of any associated blood component prepared from

Culture of implicated component

Number of responses

Tests

Tests performed for inves9ga9on of a poten9al TTBI

Yes

No

Not answered


•  25 / 37 do not routinely perform molecular tests •  Other tests performed:

•  Visual inspection (haemolysis) •  CRP •  Antibiotic testing •  Serotyping •  Pulsed-field electrophoresis •  Sequence comparisons of isolates •  Verax PGD testing •  Exclude other transfusion reactions

•  Imputability for TTBI assigned: •  Locally (20 / 46 respondents) •  HVP (9 / 46 respondents) •  Joint hospital and HVP (13 / 46 respondents) •  Other (2) •  Not specified (2)

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For the purpose of reporting to HV Programmes:

•  32 / 40 respondents differentiate between suspected and confirmed cases

•  30 / 32 report suspected but not confirmed cases to their HV Programmes

•  38 / 40 respondents report confirmed cases to their HV Programmes








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Interna/onal Survey on TTBI Bacterial Contamina/on of Blood Components

What measures are in place at the time of blood

collection / preparation to reduce the risk of TTBI?


0 5 10 15 20 25 30 35 40 45 50

Diversion Pouch

Skin Prepara/on

Donor Health Assessment

Donor Ques/onnaire

44

50

43

50

4

6

Measures at the Time of Blood Collec9on / Prepara9on to Reduce Risk of TTBI

Yes

No

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Other measures to reduce bacterial contamination: •  CRP of donors •  Pathogen reduction technology •  Short expiry •  Visual inspection •  Bacterial surveillance of PC / outdated PC •  Random culture of blood products


0 5 10 15 20 25 30

Yes

No

Not known

25 3

20

3

2

Rou9ne Screening for Bacterial Contamina9on of Blood Components with a Sample Taken for Tes9ng Prior to Release

Blood Supplier Both

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Interna/onal Survey on TTBI Summary

•  International survey providing a snapshot of practices around the world

•  Variation in TTBI definitions used

•  Variation in practices for prevention, management and investigation of TTBI

•  Summary of different definitions

•  Basis for possible standardised definition in the future

Interna/onal Survey on TTBI Summary

20140530 ISBT TTBI Survey · 2014. 12. 29. · 20140530_ISBT_TTBI_Survey Author: Edward Chew...

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