Australian Haemovigilance Report

DATA FOR 2009-10 AND 2010-11

A Report by the National Blood Authority

Haemovigilance Advisory Committee

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Australian Haemovigilance Report, Data for 2009-10 and 2010-11 (2013) published by the National Blood Authority.

ISSN 1838-1790

This report is available online at http://www.blood.gov.au/haemovigilance-reporting

CONTENTS

ACKNOWLEDGEMENTS. 5

MESSAGE FROM THE GENERAL MANAGER OF THE NATIONAL BLOOD AUTHORITY. 6

EXECUTIVE SUMMARY. 7

Donor vigilance data for 2011-12. 7

Fresh blood product issue and usage data. 7

Haemovigilance data for 2009-10 and 2010-11. 7

Recommendations. 8

PART 01 BLOOD USE AND HAEMOVIGILANCE SYSTEMS. 9

Introduction. 9

Trends in blood product issue and usage in Australia. 10

Blood products collected and issued. 10

Demographics of blood use. 13

Clinical blood usage. 15

Australia's capacity to report haemovigilance data. 16

Haemovigilance in Australia. 16

New South Wales. 18

Victoria. 19

Queensland. 20

Western Australia. 21

South Australia. 21

Tasmania. 22

Australian Capital Territory. 24

Northern Territory. 25

Future directions in Australian haemovigilance. 27

Donor vigilance. 27

Adverse event reporting for non-fresh products. 27

PART 02 PREVIOUS AUSTRALIAN HAEMOVIGILANCE DATA AND PERFORMANCE. 29

Initial Australian Haemovigilance Report 2008. 29

Australian Haemovigilance Report 2010. 30

Scorecard - Performance to date. 30

Data. 30

Capacity. 32

Prescribing. 33

Procedural errors. 35

National blood quality and safety initiatives. 36

PART 03 DONOR VIGILANCE. 36

Review of donor adverse events 2011-12. 37

PART 04 HAEMOVIGILANCE DATA FOR 2009-10 AND 2010-11. 43

Available Australian haemovigilance data for 2009-10 and 2010-11. 43

Data source. 43

Data quality. 45

Overview of reported serious transfusion-related adverse events. 46

Transfusion risks. 46

Summary of main findings and results. 47

Severe febrile non-haemolytic transfusion reactions (FNHTR). 50

Allergic reactions (severe). 54

Anaphylactic and anaphylactoid reactions. 58

Acute haemolytic transfusion reactions (other than ABO incompatibility). 60

Delayed haemolytic transfusion reactions (DHTR). 62

Transfusion-associated circulatory overload (TACO). 64

Transfusion-related acute lung injury (TRALI). 67

Transfusion transmitted infections (TTI). 69

Post-transfusion purpura (PTP). 73

Incorrect blood component transfused (IBCT). 74

Contributory factors. 78

NSW Data. 82

PART 05 RECOMMENDATIONS. 83

National blood quality and safety initiatives. 83

Reducing human errors. 84

Data standards. 85

Reporting capacity. 86

APPENDIX I: INTERNATIONAL CONTEXT. 87

APPENDIX II: DEFINITIONS IN HAEMOVIGILANCE. 88

Sentinel event. 89

Other serious transfusion reactions and events. 89

Definitions for contributory factors. 91

APPENDIX III: DEFINITIONS OF DONOR ADVERSE EVENTS. 92

APPENDIX IV: NSW HAEMOVIGILANCE DATA FOR 2009-10 AND 2010-11. 94

APPENDIX V: ODDS RATIO DATA FOR DONOR VIGILANCE. 97

ABBREVIATIONS AND ACRONYMS. 97

REFERENCES. 99

CONTENT INDEX.

TABLES

Table 1: Fresh blood products issued in Australia, 2009-10 and 2010-11. 10

Table 2: Fresh blood products issued in Australia, 2007-08 to 2010-11. 11

Table 3: Fresh blood products issued per 1000 population, 2007-08 to 2010-11. 12

Table 4: ICD-10-AM / ACHI transfusion procedures by patient age, 2008-09. 14

Table 5: ICD-10-AM / ACHI transfusion procedures by patient age, 2009-10. 15

Table 6: Progress against data recommendations of Australian Haemovigilance Report 2010. 31

Table 7: Progress against capacity recommendations of Australian Haemovigilance Report 2010. 32

Table 8: Progress against prescribing recommendations of Australian Haemovigilance Report 2010. 34

Table 9: Progress against recommendations of Australian Haemovigilance Report 2010 on procedural errors 35

Table 10: Progress against recommendations of Australian Haemovigilance Report 2010 on national blood quality and safety initiatives. 36

Table 11: Impact of the donor wellness question. 38

Table 12: Donor adverse events per procedure 2011-12. 38

Table 13: Donation associated events by category and frequency for 2011-12. 38

Table 14: Summary of external medical referrals 2011-12. 39

Table 15: Reasons for external medical referrals 2011-12. 39

Table 16: Donor complication rate by severity per 10,000 donations 2011-12. 39

Table 17: Transformation of age categories between QiiT and ANHDD standards. 44

Table 18: The Calman chart for explaining risk (United Kingdom; risk per one year). 46

Table 19: Transfusion risks. 46

Table 20: Australian adverse event data, 2008-09 to 2010-11. 47

Table 21: Numbers of adverse events by blood component, 2008-09 to 2010-11. 48

Table 22: Mortality and morbidity data, 2008-09 to 2010-11. 49

Table 23: FNHTR clinical outcome severity by imputability, 2009-10 and 2010-11. 51

Table 24: Severe allergic reaction clinical outcome severity by imputability, 2009-10 and 2010-11. 56

Table 25: Anaphylactic and anaphylactoid reactions clinical outcome severity by imputability, 2009-10 and 2010-11 59

Table 26: TACO clinical outcome severity by imputability, 2009-10 and 2010-11. 65

Table 27: TTI clinical outcome severity by imputability, 2009-10 and 2010-11. 71

Table 28: Blood Service residual risk estimates for transfusion-transmitted infections. 71

Table 29: IBCT clinical outcome severity by imputability, 2009-10 and 2010-11. 75

Table 30: Contributory factors cited in IBCT, 2008-09 to 2010-11. 76

Table 31: Contributory factors cited by adverse event and by clinical outcome severity, 2009-10. 81

Table 32: Contributory factors cited by adverse event and by clinical outcome severity, 2010-11. 81

Table 33: NSW Haemovigilance incident data for 1 July 2009 to 30 June 2011. 82

Table 34: Recommendations on national blood quality and safety initiatives. 84

Table 35: Recommendations on reducing human errors. 84

Table 36: Recommendations on data standards. 85

Table 37: Recommendations on reporting capacity. 86

Table 38: ANHDD definitions for contributory factors. 91

Table 39: Definitions for donor adverse events. 92

Table 40: Alignment of events between Australian and international categories. 93

Table 41: NSW haemovigilance data for 1 July 2009 to 30 June 2010. 95

Table 42: NSW haemovigilance data for 1 July 2010 to 30 June 2011. 96

Table 43: Data used for the calculation of odds ratio, 2011-12. 97

FIGURES

Figure 1: Total red blood cell issues in Australia, 2007-08 to 2010-11. 12

Figure 2: Total red blood cell issues per 1000 population, 2007-08 to 2010-11. 13

Figure 3: Red cell transfusions by patient age, 2008-09 and 2009-10. 14

Figure 4: Total donation associated events and serious donation related events. 37

Figure 5: Odds ratio for vasovagal reactions associated with all donation types 2011-12 (females). 41

Figure 6: Odds ratio for vasovagal reactions associated with all donation types 2011-12 (males). 41

Figure 7: Jurisdictions contributing haemovigilance data to this report. 43

Figure 8: Blood components implicated in serious adverse events, 2008-09 to 2010-11. 48