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

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

The NBA established a National Haemovigilance Program and HAC to support the continued development and alignment of jurisdictional haemovigilance reporting systems with the recommended national haemovigilance dataset. The ANHDD was developed by the HAC to standardise the data for the national haemovigilance dataset. The ANHDD is in its third iteration and is under continuous review.

Figure 7 shows a representation of the jurisdictions contributing haemovigilance data to the current report. Validated jurisdictional-level data was submitted by VIC, QLD, SA, TAS, the ACT and the NT. A small amount of relevant but incompatible data was submitted by NSW. WA is the only jurisdiction not contributing to the national dataset for the reporting period of this report from July 2009 to June 2011.

Figure 7: Jurisdictions contributing haemovigilance data to this report

Image adapted from Outline map of Australia (with state borders)
© Copyright Commonwealth of Australia (Geoscience Australia) 2010

• VIC, TAS, ACT and NT supplied validated state level haemovigilance data to the National Haemovigilance Program. The transfusion-related adverse event data is fully compliant with the data elements specified in the ANHDD.

• The SA BloodSafe program supplied validated state level haemovigilance data to the National Haemovigilance Program. SA Health clinical reporting transitioned from AIMS to Datix SLS in 2010. The ANHDD was incorporated into the development of SLS to facilitate national haemovigilance reporting. However, certain ANHDD data elements, such as age, sex and date of birth, are not mandatory for reporting and this has resulted in some missing data elements in this report.

• The QLD Blood Management Program (QBMP) also supplied validated jurisdictional-level haemovigilance data (QiiT), however there were a number of definitional and conceptual differences in the data. There was a discrepancy between the age categories used for QiiT and the national dataset. Table 17 shows the transformation used to map the QiiT age categories to those of the ANHDD. The decision was taken to align the ranges with a bias towards increasing the age category. For example, the 20-29 years QiiT category has been coded as 25-34 years in the national haemovigilance dataset. This allowed re-coding of the 28 day-1 year QiiT category and aligned with the concept that transfusion is more likely associated with increased age. De-identification of patient data at the QiiT level made it impractical to recode every incident from the original patient records according to national haemovigilance dataset standards.
• The QiiT has recently been decommissioned due to the restructure of Queensland's public health system. As a result, the ongoing supply of QLD data to the National Haemovigilance Program has now become a major issue. The NBA is working closely with Queensland Health on this issue. Meanwhile, NBA will advise transfusing hospitals on the use of ANHDD and reporting of haemovigilance data (see PART 05: RECOMMENDATIONS).

Source: NBA

• All NSW public hospitals use a centralised IIMS as their only incident reporting tool. IIMS is used to collect data and allows for the provision of reports on jurisdiction level haemovigilance incidents as one part of its broader incident information management function. It should be noted that the IIMS is not a specific haemovigilance reporting system, resulting in a lack of many important data fields required by the national haemovigilance dataset for national level reporting. The IIMS system is currently being reviewed. Capacity to report against the ANHDD data items is planned to be incorporated in the redevelopment specifications. The NSW data provided for 2009-10 and 2010-11 was not compatible with the reporting standards for this report. Relevant comment on NSW data is included in data discussions where appropriate, and the complete NSW data is presented in Appendix IV.

• WA did not contribute adverse event data to this or previous reports. WA is implementing PBM to address WA's multiple responsibilities in relation to blood transfusion. One component of the PBM program is to establish effective data collection and monitoring systems to facilitate evaluation and continuous practice improvement and risk management. WA has finalised the business requirements and tender processes for a new CIMS, which is anticipated to include haemovigilance modules.

• The adverse events definitions standardised in the ANHDD are consistent with the IHN/ISBT definitions.
• A report is included for each adverse event, not for each patient. Patients who experienced a transfusion-related adverse event more than once may be associated with more than one report.
• There is variation between states and territories in the quality and completeness of adverse event data reported to the National Haemovigilance Program: VIC, QLD, SA, TAS, ACT and NT supplied valid data; NSW supplied a small amount of relevant but incompatible data; WA did not contribute data.
• States and territories are primarily responsible for the quality of adverse event data provided to the National Haemovigilance Program. Transfusion-related adverse events should be validated at the local level. Standards for validation are developed by local institutions in conjunction with health departments. Reports of serious adverse events may go through a secondary validation process within the state and territory haemovigilance programs and health department quality units to ensure data accuracy and completeness. State and territory haemovigilance representatives, on behalf of health departments, will aggregate and de-identify data and send periodic reports to the NBA. The NBA checks the validity and completeness of the reported values. Potential errors are queried with states and territories. Corrections and resubmissions may be made in response to the data queries. The NBA does not adjust data to account for possible missing or incorrect values.
• It should be noted that the data is not complete for every reported adverse event in the national dataset. Data may be missing for some data elements, such as age, sex, time of transfusion, blood component and contributory factor. Where data elements are missing, the figures presented in the data summaries for each adverse event may be less than the total expected, or larger than the value expected for certain categories.
• In line with internationally reported trends, the Australian national haemovigilance dataset suggests that some adverse events, such as TACO, TRALI, and DHTR, are under-reported.
• Near miss data is not presented in the report. However, some states and territories, such as VIC, SA, ACT, NT and NSW, have started to collect near miss events in their systems. The report delivers a recommendation on redeveloping the ANHDD (see PART 05: RECOMMENDATIONS). This will include near miss data.
• With regard to denominator data, national information on the total number of fresh blood components transfused cannot be collected and reported. The NBA, states and territories are addressing this through data linkage exercises external to the National Haemovigilance Program.

Overview of reported serious transfusion-related adverse events

Fresh blood components have become increasingly safe as a result of stringent donor screening and selection policies and increasingly sensitive and selective product testing in Australia. The infectious risks associated with transfusion are now very small. When considering the significance of specific risks, it is often useful to compare them to the risks associated with everyday living. The transfusion risk estimates for most adverse reactions are very low when compared to everyday risks (refer to Calman scale in Table 18 and transfusion risks in Table 19). For example, the chances of acquiring bacterial sepsis from a red cell transfusion are equivalent to the chances of death from a train accident.

Table 18: The Calman chart for explaining risk (United Kingdom; risk per one year)^[30]

Risk Level	UK risk per one year
Negligible	< 1:1,000,000 such as death from a lightning strike
Minimal	1:100,000 - 1:1,000,000 such as death from a train accident
Very low	1:10,000 - 1:100,000 such as death from an accident at work
Low	1:1,000 - 1:10,000 such as death from a road accident
High	> 1:1,000 such as transmission of chickenpox to susceptible household contacts

Table 19: Transfusion risks[31]

Adverse reactions	Risk per unit transfused (unless specified)	Calman rating
Allergic reaction	1-3% of transfusions	High
Febrile non-haemolytic reaction	0.1-1% of transfusions with universal leucocyte depletion. Most frequently in patients previously alloimmunised by transfusion or pregnancy.	High
Transfusion-associated circulatory overload	Up to 1% of patients receiving transfusions	High
Bacterial sepsis, relating to:
-Platelets	At least 1:75,000	Very low
-Red cells	At least 1:500,000	Minimal
Haemolytic reactions:
-Delayed	1:2,500 - 1:11,000	Low to very low
-Acute	1:76,000	Very low
-Fatal	less than 1:1 million	Negligible
Anaphylactic reaction	1:20,000 - 1:50,000	Very low
Transfusion-related acute lung injury	1: 1,200 - 1:190,000	Low to minimal
Transfusion-associated graft versus host disease	Rare	Negligible
Post-transfusion purpura	Rare	Negligible

Table 20 shows the number of adverse events reported (independent of assigned imputability) to the National Haemovigilance Program for the three financial years 2008-09 to 2010-11. The relative incidence of the adverse events is comparable to the data of many other developed countries, with a majority of febrile reactions and allergic reactions. DHTR, AHTR, TRALI, TTI and PTP all present with very low to minimal prevalence in patients. Human errors continue to contribute to adverse events (discussed further in the section on Contributory factors).

This report details transfusion-related adverse events reported for 2009-10 and 2010-11. This summary section also reproduces data for 2008-09 (from the previous Australian Haemovigilance Report) for comparative purposes.

There were 1,207 reports of adverse events to the National Haemovigilance Program from 2008-09 to 2010-11. The improved reporting from NSW significantly contributed to the increase in the number of reports, from 294 in 2008-09 to 582 in 2010-11. The most frequently reported adverse events are FNHTR and severe allergic reactions, representing 52% and 26% of all reports respectively. The Australian data for TACO, TRALI, and DHTR indicates that these adverse events remain largely under-reported.

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

Adverse event	2008-09	2009-10	2010-11	All reports
				Number	Per cent
FNHTR	154	158	321	633	52.4%
Severe allergic reaction	87	84	142	313	25.9%
IBCT	22	23	30	75	6.2%
Anaphylactoid or anaphylactic reaction	8	12	33	53	4.4%
TACO	6	12	24	42	3.5%
DHTR	4	8	10	22	1.8%
TTI	3	18	11	32	2.7%
AHTR	7	6	2	15	1.2%
TRALI	3	8	8	19	1.6%
PTP	-	2	1	3	0.2%
Total number of reports	294	331	582	1,207	100%

Source: NBA

Notes

1. All TTIs were bacterial infections and these were reported cases but not necessarily confirmed.
2. Limited data from NSW for 2008-09 and 2009-10.

Red blood cells were the components most often implicated in adverse events for the last three financial years, accounting for 68.4% (683 of 998) of the reports from VIC, QLD, SA, TAS, ACT and NT (Figure 8). The number of adverse events related to FFP transfusions increased from 29 reports in 2009-10 to 61 (41 severe allergic reactions) in 2010-11. In 23 events, the blood component type(s) was not specified. Only a very small proportion of adverse events were related to the transfusion of whole blood (rarely used in Australia), cryoprecipitate and cryodepleted plasma. Please note that WA and NSW are excluded from analysis due to the unavailability of blood component data for these two states.

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

Source: NBA

Note: Blood product component data unavailable for NSW and WA.

Table 21 details the numbers of adverse events by blood component and Table 22 details the mortality and morbidity data for 2008-11. Please note that WA and NSW are excluded from analysis due to the unavailability of blood component and outcome severity data for these two states.

Despite the increase in the number of reported events in 2009-10 and 2010-11, the number of deaths dropped from 2 in 2008-09 (1 death relating to allergic reaction and 1 death relating to TACO) to 0 in 2009-10 and 2010-11. The number of adverse events with life threatening severity also dropped significantly for most event types, FNHTR and severe allergic reaction particularly, from 30 in 2008-09 to 5 in 2009-10 and 4 in 2010-11. In contrast, the cases with severe morbidity rose from 11 in 2008-09 to 31 in 2009-10 and 45 in 2010-11. The cases with minor morbidity also had a large increase from 33 in 2008-09 to 208 in 2009-10 and 308 in 2010-11.

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

Adverse event/ year	Whole blood	Red blood cells	Platelets	Fresh frozen plasma	Cryodepleted plasma	Cryoprecipitate	Unknown	Total
FNHTR
2008-09	-	134	15	2	-	-	3	154
2009-10	-	143	14	1	-	-	-	158
2010-11	-	170	27	3	-	-	6	206
Allergic
2008-09	-	40	19	27	-	1	-	87
2009-10	-	30	27	25	1	1	-	84
2010-11	-	33	27	41	1	-	1	103
IBCT
2008-09	-	14	1	3	-	-	4	22
2009-10	1	16	5	-	-	-	1	23
2010-11	-	18	4	3	-	-	1	26
Anaphylactic
2008-09	-	1	2	2	1	-	2	8
2009-10	-	5	1	1	-	-	-	7
2010-11	-	13	3	9	-	-	-	25
TACO
2008-09	-	2	-	1	-	-	3	6
2009-10	-	8	-	-	-	-	-	8
2010-11	-	10	-	4	-	-	-	14
DHTR
2008-09	-	1	3	-	-	-	-	4
2009-10	-	8	-	-	-	-	-	8
2010-11	-	6	-	1	-	-	-	7
Bacterial TTI
2008-09	-	1	1	-	-	-	1	3
2009-10	-	2	5	-	-	-	-	7
2010-11	-	4	5	-	-	-	-	9
TRALI
2008-09		1	-	1	-	-	1	3
2009-10	-	2	1	2	-	-	-	5
2010-11	-	5	-	-	-	-	-	5
AHTR
2008-09	-	7	-	-	-	-	-	7
2009-10	-	6	-	-	-	-	-	6
2010-11	-	1	-	-	-	-	-	1
PTP
2009-10	-	2	-	-	-	-	-	2
Total	1	683	160	126	3	2	23	998

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Blood product component data unavailable for WA and NSW.

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

	FNHTR	Allergic	IBCT	Anaphylactic	TACO	DHTR	Bacterial TTI		AHTR	TRALI	PTP	Total
Death
2008-09	-	1	-	-	1	-	-	-		-	-	2
2009-10	-	-	-	-	-	-	-	-		-	-	-
2010-11	-	-	-	-	-	-	-	-		-	-	-
Life threatening
2008-09	5	16	1	3	-	-	1	2		2	-	30
2009-10	-	1	-	2	-	1	-	-		1	-	5
2010-11	-	-	1	1	1	-	1	-		-	-	4
Severe morbidity
2008-09	3	8	-	-	-	-	-	-		-	-	11
2009-10	6	4	2	4	3	3	1	5		2	1	31
2010-11	12	9	2	6	9	1	2	1		3	-	45
Minor morbidity
2008-09	14	16	2	1	-	-	-	-		-	-	33
2009-10	122	58	13	1	5	4	2	1		1	1	208
2010-11	184	87	8	15	4	5	3	-		2	-	308
No morbidity
2008-09	77	29	17	3	1	4	1	4		-	-	136
2009-10	29	21	8	-	-	-	4	-		1	-	63
2010-11	9	7	14	2	-	1	3	-		-	-	36
Outcome not available
2008-09	55	17	2	1	4		1	1		1	-	82
2009-10	1	-	-		-		-	-		-	-	1
2010-11	1	-	1	1	-		-	-		-	-	3
Total	518	274	71	40	28	19	19	14		13	2	998

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Outcome severity data unavailable for WA and NSW.

Severe febrile non-haemolytic transfusion reactions (FNHTR)

2009-10 Data Summary

2009-10 Data Summary (n=158)
Age		Sex				Day of Transfusion
0-4 years	7	Male			34	Week day			121
5-14 years	4	Female			37	Weekend			37
15-24 years	3	Uncategorised			87	Unknown			-
25-34 years	5
35-44 years	3	Facility Location				Time of Transfusion
45-54 years	2	Major City			132	Between 7am and 7pm			55
55-64 years	9	Inner Regional			18	Between 7pm and 7am			17
65-74 years	8	Outer Regional			7	Unknown			86
75+ years	31	Remote			1
Not specified	86	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			5	Whole blood			-
Life threatening	-	Unlikely / Possible			44	Red cells			143
Severe morbidity	6	Likely / Probable			108	Platelets			14
Minor morbidity	122	Confirmed / Certain			1	Fresh Frozen Plasma			1
No morbidity	29	N/A / Not assessable			-	Cryoprecipitate			-
Outcome not available	1					Cryodepleted plasma			-
NSW
Number of reports	-

2010-11 Data Summary

2010-11 Data Summary (n=321)
Age		Sex				Day of Transfusion
0-4 years	3	Male			54	Week day			159
5-14 years	3	Female			46	Weekend			47
15-24 years	5	Uncategorised			106	Unknown			-
25-34 years	9
35-44 years	8	Facility Location				Time of Transfusion
45-54 years	12	Major City			166	Between 7am and 7pm			77
55-64 years	10	Inner Regional			29	Between 7pm and 7am			29
65-74 years	23	Outer Regional			9	Unknown			100
75+ years	34	Remote			2
Not specified	99	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			15	Whole blood			-
Life threatening	-	Unlikely / Possible			47	Red cells			170
Severe morbidity	12	Likely / Probable			127	Platelets			27
Minor morbidity	184	Confirmed / Certain			11	Fresh Frozen Plasma			3
No morbidity	9	N/A / Not assessable			6	Cryoprecipitate			-
Outcome not available	1					Cryodepleted plasma			-
NSW
Number of reports	115

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Age, sex and time of transfusion data is unavailable for SA.
3. Data element values (such as age, sex) missing for NSW.
4. Data unavailable for WA.

FNHTR (see Appendix II: Definitions in haemovigilance) are the most common transfusion-related adverse events reported in Australia. The incidence rates for FNHTR have been reported at less than 1% with current methods that use single-donor apheresis units and leucoreduced products.^{[32], [33]} In combined financial years 2008-09 through 2010-11, there were 633 FNHTRs reported to the National Haemovigilance Program, accounting for more than half (52%) of total reports (1,207).

In the three financial years to 2010-11:

• The number of FNHTRs more than doubled, from 154 in 2008-09 to 321 in 2010-11, mainly due to increased reporting of this event from NSW and other states. There were no deaths associated with this event and the number of cases reporting life-threatening severity dropped from five in 2008-09 to zero in 2009-10 and 2010-11.
• The number of reports of minor morbidity had a large increase from 14 in 2008-09 to 188 in 2010-11. This may indicate an increased awareness of collecting and reporting FNHTR events at a hospital level and a state level, however there is still room for improvement in collection.
• The number of reports of outcome not available dropped significantly from 55 in 2008-09 to 1 in 2009-10 and 1 in 2010-11.
• The majority of cases were related to red cell transfusion.
• Data for age, sex, facility location, date and time of transfusion were all within expected distributions.
• The lack of SA data for age, sex and transfusion time attributed to the increased numbers of unknown/unspecified cases for these categories in 2009-10 and 2010-11.

In the period 2009-10 to 2010-11, around 68% of FNHTRs were assigned an imputability score of likely/probable or confirmed/certain, including seven cases with severe morbidity.

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

Clinical Outcome Severity	Imputability						Total
		Excluded	Unlikely / Possible	Likely / Probable	Confirmed / Certain	N/A / Not assessable
Severe morbidity
2009-10		-	5	1	-	-	6
2010-11		-	6	5	1	-	12
Minor morbidity
2009-10		4	25	92	1	-	122
2010-11		15	38	118	9	4	184
No morbidity
2009-10		-	14	15	-	-	29
2010-11		-	3	4	1	1	9
Outcome not available
2009-10		1	-	-	-	-	1
2010-11		-	-	-	-	1	1
Total		20	91	235	12	6	364

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Outcome severity and imputability data unavailable for WA and NSW.

The current definition of FNHTR used by the HAC in the ANHDD aligns with the definitions used by the IHN and the ISBT Working Party on Haemovigilance. However, there is still some divergence between the definitions in use. The VIC STIR system uses a higher temperature threshold than specified by the ANHDD; STIR specifies a fever >38.5°C or a change of 1.5°C above baseline to reflect more severe adverse events. This STIR definition matches that of the New Zealand Blood National Haemovigilance Programme. This results in some FNHTR incidents that are reportable to the National Haemovigilance Program being screened out by STIR.

Clinically confounding factors may complicate diagnosis and reporting of FNHTR. Examples are described in the case studies below. Fever may also accompany other acute transfusion reactions, including acute haemolytic transfusion reactions, infusion of a bacterially contaminated blood component or TRALI. The diagnosis of FNHTR is generally a diagnosis of exclusion requiring a flexible approach.

Difficulties with diagnosis and the burden of reporting for this common event may justify higher reporting thresholds. The ISBT suggests that for the purpose of international comparisons, only the most severe cases of FNHTR should be reported (fever ≥39°C oral or equivalent and a change of ≥2°C from pre-transfusion value; chills/rigors).

Allergic reactions (severe)

2009-10 Data Summary

2009-10 Data Summary (n=84)
Age		Sex				Day of Transfusion
0-4 years	3	Male			26	Week day			66
5-14 years	3	Female			25	Weekend			18
15-24 years	3	Uncategorised			33	Unknown			-
25-34 years	4
35-44 years	5	Facility Location				Time of Transfusion
45-54 years	10	Major City			74	Between 7am and 7pm			39
55-64 years	8	Inner Regional			7	Between 7pm and 7am			14
65-74 years	7	Outer Regional			1	Unknown			31
75+ years	8	Remote			1
Not specified	33	Very Remote			1
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			-	Whole blood			-
Life threatening	1	Unlikely / Possible			12	Red cells			30
Severe morbidity	4	Likely / Probable			59	Platelets			27
Minor morbidity	58	Confirmed / Certain			13	Fresh Frozen Plasma			25
No morbidity	21	N/A / Not assessable			-	Cryoprecipitate			1
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	-

2010-11 Data Summary

2010-11 Data Summary (n=142)
Age		Sex				Day of Transfusion
0-4 years	4	Male			30	Week day			80
5-14 years	-	Female			34	Weekend			23
15-24 years	4	Uncategorised			39	Unknown			-
25-34 years	5
35-44 years	2	Facility Location				Time of Transfusion
45-54 years	12	Major City			80	Between 7am and 7pm			58
55-64 years	6	Inner Regional			20	Between 7pm and 7am			11
65-74 years	12	Outer Regional			3	Unknown			34
75+ years	21	Remote			-
Not specified	37	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			3	Whole blood			-
Life threatening	-	Unlikely / Possible			8	Red cells			33
Severe morbidity	9	Likely / Probable			68	Platelets			27
Minor morbidity	87	Confirmed / Certain			23	Fresh Frozen Plasma			41
No morbidity	7	N/A / Not assessable			1	Cryoprecipitate			1
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	39

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Age, sex and time of transfusion data is unavailable for SA.
3. Data element values (such as age, sex) missing for NSW.
4. Data unavailable for WA.

Allergic reactions (see APPENDIX II: DEFINITIONS IN HAEMOVIGILANCE) are the second most common transfusion-related adverse events reported in Australia. From 2008-09 to 2010-11, there were 313 reports to the National Haemovigilance Program, accounting for 26% of all reports (1207).

In the three financial years to 2010-11:

• The number of severe allergic reactions rose by 63% from 87 in 2008-09 to 142 in 2010-11, mainly due to increased reporting of this event from NSW.
• There was one death in 2008-09 and no deaths in 2009-10 or 2010-11. The number of cases reporting life-threatening severity also dropped from 16 in 2008-09 to 1 in 2009-10 and 0 in 2010-11.
• The number of cases reporting minor morbidity increased from 16 in 2008-09 to 87 in 2010-11.

The lack of SA data for age, sex and transfusion time contributed to the large numbers of unknown/unspecified cases across these categories.

In the period of 2009-10 to 2010-11, 87% of cases were assigned an imputability score of likely/probable or confirmed/certain, including 12 cases with severe morbidity. The only case with life threatening severity in 2009-10 was assigned an imputability score of unlikely/possible.

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

Clinical Outcome Severity	Imputability						Total
		Excluded	Unlikely / Possible	Likely / Probable	Confirmed / Certain	N/A / Not assessable
Death
2009-10		-	-	-	-	-	-
2010-11		-	-	-	-	-	-
Life threatening
2009-10		-	1	-	-	-	1
2010-11		-	-	-	-	-	-
Severe morbidity
2009-10		-	-	3	1	-	4
2010-11		-	1	6	2	-	9
Minor morbidity
2009-10		-	7	39	12	-	58
2010-11		3	7	56	20	1	87
No morbidity
2009-10		-	4	17	-	-	21
2010-11		-	-	6	1	-	7
Outcome not available
2009-10		-	-	-	-	-	-
2010-11		-	-	-	-	-	-
Total		3	20	127	36	1	187

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Outcome severity and imputability data unavailable for WA and NSW.

Symptoms of allergic reactions may include urticaria (hives), oedema, pruritis, and angioedema. Urticarial reactions are presumably due to soluble antigens in the donor unit to which the recipient has been previously sensitised, and are typically dose-dependent.

Allergic reactions are a common complication of blood transfusion. These reactions have historically been estimated to occur in 1-3% of transfusions. Leucoreduction has no effect on decreasing these rates^[34], suggesting that cytokines released from white blood cells during storage are likely not responsible. Unless the patient has a history of transfusion-related severe allergic reactions, these incidents are difficult to predict.

The management depends on the severity of the reaction, and consideration of other causes (such as latex or drug allergy) may be required. The following case studies illustrate the clinical presentation of a transfusion-related severe allergic reaction.

Anaphylactic and anaphylactoid reactions

2009-10 Data Summary

2009-10 Data Summary (n=12)
Age		Sex				Day of Transfusion
0-4 years	-	Male			3	Week day			5
5-14 years	1	Female			4	Weekend			2
15-24 years	-	Uncategorised			-	Unknown			-
25-34 years	-
35-44 years	-	Facility Location				Time of Transfusion
45-54 years	1	Major City			7	Between 7am and 7pm			3
55-64 years	1	Inner Regional			-	Between 7pm and 7am			4
65-74 years	-	Outer Regional			-	Unknown			-
75+ years	4	Remote			-
Not specified	-	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			-	Whole blood			-
Life threatening	2	Unlikely / Possible			3	Red cells			5
Severe morbidity	4	Likely / Probable			1	Platelets			1
Minor morbidity	1	Confirmed / Certain			-	Fresh Frozen Plasma			1
No morbidity	-	N/A / Not assessable			3	Cryoprecipitate			-
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	5

2010-11 Data Summary

2010-11 Data Summary (n=33)
Age		Sex				Day of Transfusion
0-4 years	-	Male			9	Week day			17
5-14 years	-	Female			5	Weekend			8
15-24 years	4	Uncategorised			11	Unknown			-
25-34 years	2
35-44 years	1	Facility Location				Time of Transfusion
45-54 years	3	Major City			22	Between 7am and 7pm			1
55-64 years	2	Inner Regional			2	Between 7pm and 7am			4
65-74 years	2	Outer Regional			1	Unknown			11
75+ years	-	Remote			-
Not specified	11	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			-	Whole blood			-
Life threatening	1	Unlikely / Possible			4	Red cells			13
Severe morbidity	6	Likely / Probable			16	Platelets			3
Minor morbidity	15	Confirmed / Certain			5	Fresh Frozen Plasma			9
No morbidity	2	N/A / Not assessable			-	Cryoprecipitate			-
Outcome not available	1					Cryodepleted plasma			-
NSW
Number of reports	8

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Age, sex and time of transfusion data is unavailable for SA.
3. Data element values (such as age, sex) missing for NSW.
4. Data unavailable for WA.

In the three financial years, 2008-09 to 2010-11, there were 53 reports of anaphylactic and anaphylactoid reactions to the National Haemovigilance Program, accounting for 4.4 % of all reports (1207). The number of cases rose from 8 in 2008-09 to 33 in 2010-11. One life threatening case was confirmed to be related to fresh frozen plasma transfusion for 2010-11.

In the period 2009-10 to 2010-11, 22 out of 32 cases were assigned an imputability score of likely/probable or confirmed/certain, including one case of life threatening (confirmed/certain) and six cases with severe morbidity. Another two cases with life threatening severity were assigned an imputability score of unlikely/possible.

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

Clinical Outcome Severity	Imputability						Total
		Excluded	Unlikely / Possible	Likely / Probable	Confirmed / Certain	N/A / Not assessable
Death
2009-10		-	-	-	-	-	-
2010-11		-	-	-	-	-	-
Life threatening
2009-10		-	2	-	-	-	2
2010-11		-	-	-	1	-	1
Severe morbidity
2009-10		-	-	1	-	3	4
2010-11		-	1	3	2	-	6
Minor morbidity
2009-10		-	1	-	-	-	1
2010-11		-	1	12	2	-	15
No morbidity
2009-10		-	-	-	-	-	-
2010-11		-	1	1	-	-	2
Outcome not available
2009-10		-	-	-	-	-	-
2010-11		-	1	-	-	-	1
Total		-	7	17	5	3	32

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Outcome severity and imputability data unavailable for WA and NSW.

Anaphylaxis is an acute hypersensitivity reaction that can present as, or rapidly progress to, a severe life-threatening reaction.^[35] Anaphylactoid reactions are clinically indistinguishable from anaphylaxis reactions, but differ in their immune mechanism. A distinction between anaphylaxis and anaphylactoid reaction is impossible on the basis of clinical signs and symptoms alone; a clinical definition cannot differentiate between the two.

This position is consistent with recent suggestions for a revised nomenclature for allergy, issued by the European Academy of Allergy and Clinical Immunology (EAACI) and World Allergy Organization referring to anaphylactoid reactions simply as 'non-allergic anaphylaxis'.^{[36] [37] [38]} Diagnosis of anaphylactic and anaphylactoid reactions can be difficult, and an international symposium recently acknowledged that a widely accepted definition of anaphylaxis is lacking, which contributes to the wide variation in standards of diagnosis and management.^[38]

The British Committee for Standards in Haematology (BCSH) has the following recommendations on the treatment of anaphylactic and anaphylactoid reactions in the UK:^[39]

• adrenaline (epinephrine) is the first line drug in anaphylaxis
• antihistamine and hydrocortisone may have a role in shortening the anaphylactic reaction and preventing recurrence
• the history of patients who have experienced an anaphylactic reaction should be discussed with an allergist or immunologist, in keeping with UK resuscitation council guidelines.

Acute haemolytic transfusion reactions (other than ABO incompatibility)

2009-10 Data Summary

2009-10 Data Summary (n=6)
Age		Sex				Day of Transfusion
0-4 years	-	Male			4	Week day			5
5-14 years	1	Female			2	Weekend			1
15-24 years	-	Uncategorised			-	Unknown			-
25-34 years	-
35-44 years	-	Facility Location				Time of Transfusion
45-54 years	-	Major City			5	Between 7am and 7pm			6
55-64 years	1	Inner Regional			1	Between 7pm and 7am			-
65-74 years	2	Outer Regional			-	Unknown			-
75+ years	2	Remote			-
Not specified	-	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			-	Whole blood			-
Life threatening	-	Unlikely / Possible			1	Red cells			6
Severe morbidity	5	Likely / Probable			1	Platelets			-
Minor morbidity	1	Confirmed / Certain			4	Fresh Frozen Plasma			-
No morbidity	-	N/A / Not assessable			-	Cryoprecipitate			-
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	-

2010-11 Data Summary

2010-11 Data Summary (n=2)
Age		Sex				Day of Transfusion
0-4 years	-	Male			-	Week day			1
5-14 years	-	Female			1	Weekend			-
15-24 years	-	Uncategorised			-	Unknown			-
25-34 years	-
35-44 years	-	Facility Location				Time of Transfusion
45-54 years	-	Major City			1	Between 7am and 7pm			1
55-64 years	-	Inner Regional			-	Between 7pm and 7am			-
65-74 years	1	Outer Regional			-	Unknown			-
75+ years	-	Remote			-
Not specified	-	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			-	Whole blood			-
Life threatening	-	Unlikely / Possible			-	Red cells			1
Severe morbidity	1	Likely / Probable			-	Platelets			-
Minor morbidity	-	Confirmed / Certain			1	Fresh Frozen Plasma			-
No morbidity	-	N/A / Not assessable			-	Cryoprecipitate			-
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	1

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Age, sex and time of transfusion data is unavailable for SA.
3. Data element values (such as age, sex) missing for NSW.
4. Data unavailable for WA.

Acute transfusion reactions occur by definition within 24 hours of transfusion. Diagnosis of an acute haemolytic transfusion reaction can be difficult, as reactions are often seen in patients with concurrent illnesses that may have other causes for their symptoms. The risk of acute haemolytic transfusion is low, estimated to be 1 in 76,000 transfusions (refer to transfusion risks in Table 19).

Adverse events attributed to transfusion of ABO incompatible components can cause acute haemolytic transfusion reactions, but are categorised as incorrect blood component transfused (IBCT) as that is the key error. Transfusion of ABO incompatible components to a patient is considered a 'sentinel event' and is subject to other reporting requirements in addition to the National Haemovigilance Program.

Acute transfusion reactions may have immune or non-immune aetiology; blood group serology usually shows abnormal results but absence of immunological findings does not exclude acute haemolytic transfusion reactions. These reactions may also be due to erythrocyte auto-antibodies in the recipient or to non-immunological factors like mechanical factors inducing haemolysis (including malfunction of a pump, of a blood warmer or use of hypotonic solutions).

From 2009-10 to 2010-11, there were 8 reports to the National Haemovigilance Program, with 6 cases reporting severe morbidity imputed as confirmed/certain or likely/probable. All cases were related to RBC transfusion. The National Haemovigilance Program has not gathered data on the particular red cell antibodies associated with haemolytic transfusion reactions.

Delayed haemolytic transfusion reactions (DHTR)

2009-10 Data Summary

2009-10 Data Summary (n=8)
Age		Sex				Day of Transfusion
0-4 years	-	Male			2	Week day			7
5-14 years	-	Female			6	Weekend			1
15-24 years	-	Uncategorised			-	Unknown			-
25-34 years	1
35-44 years	-	Facility Location				Time of Transfusion
45-54 years	1	Major City			7	Between 7am and 7pm			4
55-64 years	3	Inner Regional			-	Between 7pm and 7am			4
65-74 years	2	Outer Regional			1	Unknown			-
75+ years	1	Remote			-
Not specified	-	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			-	Whole blood			-
Life threatening	1	Unlikely / Possible			1	Red cells			8
Severe morbidity	3	Likely / Probable			1	Platelets			-
Minor morbidity	4	Confirmed / Certain			5	Fresh Frozen Plasma			-
No morbidity	-	N/A / Not assessable			1	Cryoprecipitate			-
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	-

2010-11 Data Summary

2010-11 Data Summary (n=10)
Age		Sex				Day of Transfusion
0-4 years	-	Male			1	Week day			6
5-14 years	-	Female			6	Weekend			1
15-24 years	1	Uncategorised			-	Unknown			-
25-34 years	2
35-44 years	-	Facility Location				Time of Transfusion
45-54 years	1	Major City			5	Between 7am and 7pm			5
55-64 years	2	Inner Regional			1	Between 7pm and 7am			2
65-74 years	1	Outer Regional			1	Unknown			-
75+ years	-	Remote			-
Not specified	-	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			-	Whole blood			-
Life threatening	-	Unlikely / Possible			1	Red cells			6
Severe morbidity	1	Likely / Probable			1	Platelets			-
Minor morbidity	5	Confirmed / Certain			5	Fresh Frozen Plasma			1
No morbidity	1	N/A / Not assessable			-	Cryoprecipitate			-
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	3

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Age, sex and time of transfusion data is unavailable for SA.
3. Data element values (such as age, sex) missing for NSW.
4. Data unavailable for WA.

In contrast to the acute haemolytic transfusion reactions, DHTR are triggered by the production or re-emergence of antibodies following transfusion and therefore are not generally detectable at the time of pre-transfusion compatibility testing.

In the three financial years to 2010-11:

• there were 22 reports of DHTR to the National Haemovigilance Program, accounting for 1.8% of total reports (1,207)
• there was one reported case of life-threatening severity in 2009-10 and this was assigned an imputability score of confirmed/certain
• the majority of cases were related to red cell transfusion
• the majority of patients were females.

DHTR are relatively common when compared with acute haemolytic transfusion reactions, but may be difficult to diagnose and easily missed as presentation may be remote (in time and place) from the causal transfusion. UK data has suggested that DHTR were responsible for 10.2% of all serious transfusion-related hazards between 1996 and 2003.^[40] Researchers have observed that DHTR are probably under-reported and under-recognised in the UK.^[41]

The current figures for Australia imply that DHTR may be severely under-recognised and/or under-reported. The National Haemovigilance Program does not currently gather data on the specific antibodies associated with haemolytic transfusion reactions.

Current national level haemovigilance reporting in Australia does not consider the delay period between the transfusion and the reaction. This may be addressed in future reporting. UK data reported the interval in days between the implicated transfusion and clinical signs or symptoms of a DHTR to have a median of 8 days with a range of 2 to 18 days. Anti-Jk(a) is the single most common red cell specificity implicated in both acute and delayed reactions.^[42] Treatment of DHTR remains challenging. Immunosuppressive medication has been reported to be useful by some but not by others. The mainstay of treatment is to minimise RBC transfusions as much as possible.^[43]

Transfusion-associated circulatory overload (TACO)

2009-10 Data Summary

2009-10 Data Summary (n=12)
Age		Sex				Day of Transfusion
0-4 years	-	Male			2	Week day			6
5-14 years	-	Female			4	Weekend			2
15-24 years	-	Uncategorised			2	Unknown			-
25-34 years	-
35-44 years	-	Facility Location				Time of Transfusion
45-54 years	-	Major City			6	Between 7am and 7pm			6
55-64 years	1	Inner Regional			2	Between 7pm and 7am			-
65-74 years	-	Outer Regional			-	Unknown			2
75+ years	5	Remote			-
Not specified	2	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			1	Whole blood			-
Life threatening	-	Unlikely / Possible			4	Red cells			8
Severe morbidity	3	Likely / Probable			2	Platelets			-
Minor morbidity	5	Confirmed / Certain			-	Fresh Frozen Plasma			-
No morbidity	-	N/A / Not assessable			1	Cryoprecipitate			-
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	4

2010-11 Data Summary

2010-11 Data Summary (n=24)
Age		Sex				Day of Transfusion
0-4 years	-	Male			7	Week day			11
5-14 years	-	Female			5	Weekend			3
15-24 years	-	Uncategorised			2	Unknown			-
25-34 years	-
35-44 years	-	Facility Location				Time of Transfusion
45-54 years	1	Major City			9	Between 7am and 7pm			7
55-64 years	-	Inner Regional			4	Between 7pm and 7am			5
65-74 years	4	Outer Regional			1	Unknown			2
75+ years	7	Remote			-
Not specified	2	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			-	Whole blood			-
Life threatening	1	Unlikely / Possible			6	Red cells			10
Severe morbidity	9	Likely / Probable			7	Platelets			-
Minor morbidity	4	Confirmed / Certain			1	Fresh Frozen Plasma			4
No morbidity	-	N/A / Not assessable			-	Cryoprecipitate			-
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	10

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Age, sex and time of transfusion data is unavailable for SA.
3. Data element values (such as age, sex) missing for NSW.
4. Data unavailable for WA.

Transfusion of significant volumes of blood components, especially to patients with reduced cardiopulmonary reserve capacity (children and adults with cardiopulmonary disease) can lead to overload of the circulatory system, termed TACO.

In the three financial years to 2010-11, there were 42 reports of TACO to the National Haemovigilance Program, accounting for 3.5% of total reports (1,207). The number of cases rose from 6 in 2008-09 to 24 in 2010-11. One death occurred in 2008-09 and no deaths in 2009-10 or 2010-11. Only one case with life threatening severity was reported in 2010-11 but it was classified as unlikely/possible to be related to blood transfusion. The majority of cases were related to red cell transfusion. The figures also indicate that elderly patients aged 65 and above are at high risk of TACO and this is consistent with international findings.

In the period of 2009-10 to 2010-11, 10 out of 22 cases were assigned an imputability score of likely/probable or confirmed/certain, including six cases with severe morbidity.

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

Clinical Outcome Severity	Imputability						Total
		Excluded	Unlikely / Possible	Likely / Probable	Confirmed / Certain	N/A / Not assessable
Death
2009-10		-	-	-	-	-	-
2010-11		-	-	-	-	-	-
Life threatening
2009-10		-	-	-	-	-	-
2010-11		-	1	-	-	-	1
Severe morbidity
2009-10		-	1	1	-	1	3
2010-11		-	4	4	1	-	9
Minor morbidity
2009-10		1	3	1	-	-	5
2010-11			1	3			4
No morbidity
2009-10		-	-	-	-	-	-
2010-11		-	-	-	-	-	-
Outcome not available
2009-10		-	-	-	-	-	-
2010-11		-	-	-	-	-	-
Total		1	10	9	1	1	22

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Outcome severity and imputability data unavailable for WA and NSW.

Patients at the highest risk for TACO include those younger than 3 and those older than 60 years of age, particularly those with underlying cardiac dysfunction.^[44] TACO can occur after relatively small volumes of red blood cells (one unit or less) are transfused to these patients. To avoid this complication, transfusion speed and volume must be monitored very carefully.

At presentation, distinguishing TACO and TRALI can be particularly difficult. The clinical presentation is similar, and there are no diagnostic tests that reliably discriminate. Furthermore, a patient may simultaneously suffer both TACO and TRALI and this adds to the complexity. The therapy and management of the patient, and the implications for the donor, in the two different reactions are quite dissimilar.

TACO remains the leading cause of potentially avoidable mortality and major morbidity associated with blood transfusions in the UK. In 2011^[42] the mortality rate was 0.7 per 1,000,000 components issued and the major morbidity rate was 8.1 per 1,000,000 components issued.

TACO incident estimates have ranged from approximates of 0.0003% to 8% of transfusions depending upon patient population and reporting method.^[45] These rates suggest that TACO is as common an adverse event as FNHTR. However, the number of TACO events (36) reported to the National Haemovigilance Program in 2009-10 and 2010-11 is much lower than that of FNHTR (479). The reasons for the under-reporting of TACO in Australia may relate to a combination of factors:

• circulatory overload from fluid infusion (including blood transfusion) is common in elderly patients and patients with heart failure and managed along similar lines - TACO is seen as a complication of fluid infusion rather than blood transfusion
• hospital staff view it as a routine medical management issue (fluids management), rather than an adverse event following transfusion hence do not see the need to report it
• it is common but routinely managed, and as such it is unlikely to be reported
• issues relating to reporting within hospitals and subsequent reporting to jurisdictional and national haemovigilance programs.

Increased awareness of TACO by clinical staff is needed as this adverse event is common, potentially lethal and, in many cases, is an avoidable complication of blood transfusion.

The NBA PBM Guidelines Module 3: Medical has a practice point on the recognition and management of TACO:

The UK SHOT report also recommends that all measures must be taken to reduce the risk of TACO.^[42] These include pre-transfusion clinical assessment to identify patients at increased risk of TACO in whom particular consideration should be given to the appropriateness of transfusion, the rate of transfusion and diuretic cover. Careful attention to fluid balance is essential and must be documented.

Transfusion-related acute lung injury (TRALI)

2009-10 Data Summary

2009-10 Data Summary (n=8)
Age		Sex				Day of Transfusion
0-4 years	-	Male			2	Week day			5
5-14 years	-	Female			3	Weekend			-
15-24 years	1	Uncategorised			-	Unknown			-
25-34 years	1
35-44 years	-	Facility Location				Time of Transfusion
45-54 years	-	Major City			5	Between 7am and 7pm			3
55-64 years	1	Inner Regional			-	Between 7pm and 7am			2
65-74 years	-	Outer Regional			-	Unknown			-
75+ years	2	Remote			-
Not specified	-	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			-	Whole blood			-
Life threatening	1	Unlikely / Possible			1	Red cells			2
Severe morbidity	2	Likely / Probable			1	Platelets			1
Minor morbidity	1	Confirmed / Certain			2	Fresh Frozen Plasma			2
No morbidity	1	N/A / Not assessable			1	Cryoprecipitate			-
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	3

2010-11 Data Summary

2010-11 Data Summary (n=8)
Age		Sex				Day of Transfusion
0-4 years	-	Male			2	Week day			3
5-14 years	-	Female			2	Weekend			2
15-24 years	-	Uncategorised			1	Unknown			-
25-34 years	-
35-44 years	1	Facility Location				Time of Transfusion
45-54 years	1	Major City			3	Between 7am and 7pm			-
55-64 years	-	Inner Regional			2	Between 7pm and 7am			-
65-74 years	-	Outer Regional			-	Unknown			-
75+ years	2	Remote			-
Not specified	1	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			-	Whole blood			-
Life threatening	-	Unlikely / Possible			-	Red cells			5
Severe morbidity	3	Likely / Probable			2	Platelets			-
Minor morbidity	2	Confirmed / Certain			3	Fresh Frozen Plasma			-
No morbidity	-	N/A / Not assessable			-	Cryoprecipitate			-
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	3

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Age, sex and time of transfusion data is unavailable for SA.
3. Data element values (such as age, sex) missing for NSW.
4. Data unavailable for WA.

TRALI presents with respiratory distress, hypoxemia, rales on listening to the lungs (abnormal rattle or crackling sound heard with a stethoscope during breathing, caused by fluid in the lungs), and diffuse bilateral infiltrates on chest radiograph. The respiratory distress can be severe enough to require mechanical ventilation and other features may include hypotension, fever, and transient leukopenia.

In the three financial years to 2010-11, there were 19 reports to the National Haemovigilance Program of suspected TRALI, accounting for 1.6% of total reports (1,207). The number of cases reporting life threatening severity dropped from two in 2008-09 to one with an imputability score of unlikely/possible in 2009-10 and zero in 2010-11.

The true incidence of TRALI is unknown, because a standard definition^[46]was not developed until 2005 by the National Heart, Lung, and Blood Institute. Early reports quoted an incidence of 1 per 5,000 transfused blood components,^[47] with subsequent reports ranging from 1 per 432 pooled whole-blood-derived platelets to 1 per 557,000 RBCs.^[48] The 17^th edition of the AABB Technical Manual cites an incidence range from 1:12,000 to 1:190,000 transfusions.^[49]

TRALI is a significant cause of mortality and morbidity in patients who receive blood components, particularly plasma-containing components. With the decrease in the risk of transfusion transmitted HIV, Hepatitis C Virus (HCV) and bacterial contamination, TRALI has become the leading cause of transfusion-related mortality reported to the US Food and Drug Administration (FDA). In combined fiscal years 2007-08 to 2011-12, TRALI accounted for 43% of transfusion-related deaths[50] in the US.

TRALI is difficult to diagnose because there is no specific test for it and it is easily confused with alternative causes of acute lung injury (ALI) and TACO. Distinguishing TRALI and TACO at presentation can be particularly difficult. The clinical features are similar, and there are no diagnostic tests that reliably discriminate. Furthermore, a patient may simultaneously suffer both TRALI and TACO and this adds to the complexity. However, the therapy and management of the patient, and the implications for the donor, in the two reactions are very different.

As dyspnoea after a transfusion is often believed to be due to another cause (such as TACO, allergic reaction) or because there are other risk factors present for acute lung injury, TRALI is often overlooked. Typical clinical features are hypoxaemia, hypotension, fever and severe bilateral pulmonary infiltrates within 6 hours of completing a transfusion.

Early recognition allows the transfusion to be stopped immediately and oxygen and supportive therapy to be commenced. As the underlying pathology involves microvascular injury, use of diuretics may be detrimental and some patients benefit from fluid administration.

In Australia, recognising TRALI allows notification of the Blood Service and testing of the blood component and/or donor for anti-HLA and anti-granulocyte antibodies. Donors of blood components implicated in cases of TRALI often contain anti-leukocyte allo-antibodies (anti-HLA and anti-granulocyte) that are thought to be important in the pathogenesis of TRALI in a significant number of cases. Recognition of these donors by the Blood Service allows appropriate recall of implicated blood components and exclusion of the donor.

From July 2007, Australia commenced the production of male predominant FFP, cryoprecipitate and cryodepleted plasma as a risk reduction strategy for TRALI. With current levels of TRALI reporting it is not possible to comment on any potential impact of this policy on the incidence of TRALI in Australia.

All UK Blood Services use male donors to provide 100% FFP and plasma for platelet pooling. The SHOT UK Steering Group reports that the risk of highly likely/probable TRALI due to FFP has fallen from 15.5 per million units issued (1999-2004) to 3.2 per million (2005-06).[51] The New Zealand Blood Service^[52] has also reduced the risk of TRALI through the production of FFP from males with no history of blood transfusion and introduction of HLA antibodies screening for female plateletpheresis donors.

Transfusion transmitted infections (TTI)

2009-10 Data Summary

2009-10 Data Summary (n=18)
Age		Sex				Day of Transfusion
0-4 years	1	Male			6	Week day			7
5-14 years	-	Female			1	Weekend			-
15-24 years	-	Uncategorised			-	Unknown			-
25-34 years	-
35-44 years	-	Facility Location				Time of Transfusion
45-54 years	1	Major City			4	Between 7am and 7pm			7
55-64 years	-	Inner Regional			2	Between 7pm and 7am			-
65-74 years	1	Outer Regional			1	Unknown			-
75+ years	4	Remote			-
Not specified	-	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			1	Whole blood			-
Life threatening	-	Unlikely / Possible			1	Red cells			2
Severe morbidity	1	Likely / Probable			-	Platelets			5
Minor morbidity	2	Confirmed / Certain			5	Fresh Frozen Plasma			-
No morbidity	4	N/A / Not assessable			-	Cryoprecipitate			-
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	11

2010-11 Data Summary

2010-11 Data Summary (n=11)
Age		Sex				Day of Transfusion
0-4 years	-	Male			3	Week day			7
5-14 years	1	Female			5	Weekend			2
15-24 years	-	Uncategorised			1	Unknown			-
25-34 years	-
35-44 years	-	Facility Location				Time of Transfusion
45-54 years	1	Major City			4	Between 7am and 7pm			8
55-64 years	4	Inner Regional			4	Between 7pm and 7am			-
65-74 years	3	Outer Regional			1	Unknown			1
75+ years	-	Remote			-
Not specified	-	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death		Excluded				Whole blood
Life threatening	1	Unlikely / Possible			5	Red cells			4
Severe morbidity	2	Likely / Probable			1	Platelets			5
Minor morbidity	3	Confirmed / Certain			3	Fresh Frozen Plasma			-
No morbidity	3	N/A / Not assessable			-	Cryoprecipitate			-
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	2

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Age, sex and time of transfusion data is unavailable for SA.
3. Data element values (such as age, sex) missing for NSW.
4. Data unavailable for WA.

The National Haemovigilance Program allows the reporting of four distinct TTI categories:

• Transfusion transmitted infections - Bacterial
• Transfusion transmitted infections - Viral
• Transfusion transmitted infections - Parasitic
• Transfusion transmitted infections - Other (such as Creutzfeldt-Jakob disease).

From 2008-09 to 2010-11:

• there were 32 reports of TTI to the National Haemovigilance Program, all of which were related to bacterial infections but not necessarily confirmed
• there were no reports of any TTI resulting from viral or parasitically contaminated components
• there was an increase in the reports of TTIs from 3 in 2008-09 to 18 in 2009-10 and a decrease to 11 in 2010-11
• there were 2 cases (one in 2008-09 and one in 2010-11) with life threatening severity reported.

All cases of life threatening severity and severe morbidity which occurred in 2009-10 and 2010-11 were assigned an imputability score of unlikely/possible.

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

Clinical Outcome Severity	Imputability						Total
		Excluded	Unlikely / Possible	Likely / Probable	Confirmed / Certain	N/A / Not assessable
Death
2009-10		-	-	-	-	-	-
2010-11		-	-	-	-	-	-
Life threatening
2009-10		-	-	-	-	-	-
2010-11		-	1	-	-	-	1
Severe morbidity
2009-10		-	1	-	-	-	1
2010-11		-	2	-	-	-	2
Minor morbidity
2009-10		1	0	-	1	-	2
2010-11		-	-	1	2	-	3
No morbidity
2009-10		-	-		4	-	4
2010-11		-	2	-	1	-	3
Outcome not available
2009-10		-	-	-	-	-	-
2010-11		-	-	-	-	-	-
Total		1	6	1	8	-	16

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Outcome severity and imputability data unavailable for WA and NSW.

In Australia, the mandatory tests provided by the Blood Service for all blood donations are for ABO and Rh(D) blood groups, red cell antibodies, and the following infections: human immunodeficiency virus (HIV) I and II, hepatitis B and C, human T-cell lymphotrophic virus (HTLV) I and II, and syphilis. Test results are checked before blood components are released for clinical use or further manufacture. Only donations that have satisfactory blood group results, are non-reactive for infectious disease screening and meet other defined specifications are released. If an infectious disease screening test is confirmed reactive, the donation is destroyed.

The viral risk estimates presented in Table 28 have recently been revised based on Blood Service data from 1 January 2010 to 31 December 2011. These estimates are updated annually. The risk of viral TTI in Australia is exceedingly low.

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

Agent and testing standard	Window Period (Days)	Estimate of residual risk 'per unit'
HIV (antibody + NAT)	5.6	Less than 1 in 1 million
HCV (antibody + NAT)	3.1	Less than 1 in 1 million
HBV (HBsAg)	23.9	Approximately 1 in 764,000
HTLV I & II (antibody)	51	Less than 1 in 1 million
Variant Creutzfeldt-Jakob Disease (vCJD) [No testing]	Not available	Possible. Not yet reported in Australia.
Malaria (antibody)	7-14	Less than 1 in 1 million
Note: The risk estimates for HIV, HCV, HBV and HTLV are based on Blood Service data from 1 January 2010 to 31 December 2011.

Currently, the risks of bacterial TTI^[53] are significantly greater than those of viral TTI from screened agents. Bacterial contamination of blood components may result from the introduction of low concentrations of skin bacteria at the time of phlebotomy, or less commonly, from undiagnosed donor bacteraemia, or very rarely, during blood processing. Transfusion-associated bacterial sepsis is caused more frequently by contaminated platelets than by red cell components because many species of bacteria can proliferate to critical levels under the room temperature conditions used for platelet storage.

Bacterial contamination of platelet components is recognised as the most significant residual infectious risk of blood transfusion in developed countries. There were no severe cases (such as death, life threatening or severe morbidity) related to platelet transfusion in Australia in 2009-10 or 2010-11.

Australia and many developed countries have developed effective strategies to reduce the bacterial contamination of blood components.

In Australia, the major components of the management strategies for TTI include the pre-donation questionnaire, identification of factors associated with TTI risk, skin disinfection prior to blood donation, use of diversion pouches in collection kits to minimise the risk of bacterial infection and screening for antibody, antigen and viral nucleic acids. In April 2008, the Blood Service commenced pre-release bacterial contamination screening of 100% of platelet components.

In the UK in 2011, bacteria screening for platelet donations was rolled out in National Health Service Blood and Transplant (NHSBT) in 2011. The UK Blood Service also maintained high standards of collection, processing and program vigilance. Strategies to reduce the bacterial contamination of blood components are under continual review in the UK.^[42] There were no proven reports of TTI to the UK SHOT Program in 2010 or 2011, indicating that bacterial and viral screening is effective in improving the safety of the UK blood supply.

Post-transfusion purpura (PTP)

2009-10 Data Summary

2009-10 Data Summary (n=2)
Age		Sex				Day of Transfusion
0-4 years	-	Male			-	Week day			2
5-14 years	-	Female			2	Weekend			-
15-24 years	-	Uncategorised			-	Unknown			-
25-34 years	-
35-44 years	-	Facility Location				Time of Transfusion
45-54 years	-	Major City			1	Between 7am and 7pm			2
55-64 years	-	Inner Regional			1	Between 7pm and 7am			-
65-74 years	-	Outer Regional			-	Unknown			-
75+ years	1	Remote
Not specified	1	Very Remote
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			-	Whole blood			-
Life threatening	-	Unlikely / Possible			1	Red cells			2
Severe morbidity	1	Likely / Probable			-	Platelets			-
Minor morbidity	1	Confirmed / Certain			1	Fresh Frozen Plasma			-
No morbidity	-	N/A / Not assessable			-	Cryoprecipitate			-
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	-
2010-11 Data Summary
NSW
Number of reports	1

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Age, sex and time of transfusion data is unavailable for SA.
3. Data element values (such as age, sex) missing for NSW.
4. Data unavailable for WA.

Purpura occurs when small blood vessels leak blood under the skin, most commonly when the platelet count in the blood is low (thrombocytopenia). Purpura presents as purple-coloured spots and patches that occur on the skin, organs, and in mucus membranes, including the lining of the mouth.

Purpura can have many causes, but PTP is an immune-mediated complication of transfusion. Onset is typically within 12 days of transfusion. PTP is confirmed by the detection of platelet specific-antibodies in the recipient's blood, and detection of the antithetical antigen on the donor platelets, or by a positive platelet cross-match. Antibodies against HPA-1a are the most common cause of PTP.

It is the first time that three confirmed cases of this rare transfusion-related adverse reaction were reported to the National Haemovigilance Program. One case was classified as severe morbidity and one as minor morbidity. Both cases were related to red blood cell transfusion. Classification information was not provided for the third case.

Incorrect blood component transfused (IBCT)

2009-10 Data Summary

2009-10 Data Summary (n=23)
Age		Sex				Day of Transfusion
0-4 years	5	Male			14	Week day			18
5-14 years	-	Female			8	Weekend			5
15-24 years	1	Uncategorised			1	Unknown			-
25-34 years	2
35-44 years	1	Facility Location				Time of Transfusion
45-54 years	2	Major City			17	Between 7am and 7pm			17
55-64 years	1	Inner Regional			6	Between 7pm and 7am			5
65-74 years	7	Outer Regional			-	Unknown			1
75+ years	3	Remote			-
Not specified	1	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			-	Whole blood			1
Life threatening	-	Unlikely / Possible			-	Red cells			16
Severe morbidity	2	Likely / Probable			-	Platelets			5
Minor morbidity	13	Confirmed / Certain			19	Fresh Frozen Plasma			-
No morbidity	8	N/A / Not assessable			4	Cryoprecipitate			-
Outcome not available	-					Cryodepleted plasma			-
NSW
Number of reports	-

2010-11 Data Summary

2010-11 Data Summary (n=30)
Age		Sex				Day of Transfusion
0-4 years	2	Male			13	Week day			17
5-14 years	-	Female			13	Weekend			9
15-24 years	4	Uncategorised			-	Unknown			-
25-34 years	2
35-44 years	2	Facility Location				Time of Transfusion
45-54 years	4	Major City			18	Between 7am and 7pm			20
55-64 years	2	Inner Regional			6	Between 7pm and 7am			6
65-74 years	5	Outer Regional			1	Unknown			-
75+ years	5	Remote			1
Not specified	-	Very Remote			-
Clinical Outcome Severity		Imputability				Blood Component
Death	-	Excluded			1	Whole blood			-
Life threatening	1	Unlikely / Possible			1	Red cells			18
Severe morbidity	2	Likely / Probable			2	Platelets			4
Minor morbidity	8	Confirmed / Certain			18	Fresh Frozen Plasma			3
No morbidity	14	N/A / Not assessable			4	Cryoprecipitate			-
Outcome not available	1					Cryodepleted plasma			-
NSW
Number of reports	4

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Age, sex and time of transfusion data is unavailable for SA.
3. Data element values (such as age, sex) missing for NSW.
4. Data unavailable for WA.

IBCT occurs when a patient receives a blood component intended for another patient or a blood component where special requirements (such as CMV-negative or irradiated component) are not met. It should be noted that adverse events attributed to transfusion of ABO incompatible components are included in this category. Such events could equally be described as acute haemolytic transfusion reactions, but are included here because the key failure is IBCT. Transfusion of ABO incompatible components to a patient is considered a 'sentinel event' and is also subject to other reporting requirements.

In the three financial years to 2010-11:

• there were 75 reports of IBCT to the National Haemovigilance Program, accounting for 6.2% of all reports (1,207)
• there were two cases reporting life threatening severity, with one in 2008-09 and another in 2010-11
• the majority of cases were related to red cell transfusion.

In the period of 2009-10 to 2010-11, the majority of cases (39 out of 49) were assigned an imputability score of confirmed/certain. The only case with life threatening severity was confirmed to be related to red cell transfusion. Incidence was independent of patient age and sex, blood component, facility location, day and time of transfusion.

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

Clinical Outcome Severity	Imputability						Total
		Excluded	Unlikely / Possible	Likely / Probable	Confirmed / Certain	N/A / Not assessable
Death
2009-10		-	-	-	-	-	-
2010-11		-	-	-	-	-	-
Life threatening
2009-10		-	-	-	-	-	-
2010-11		-	-	-	1	-	1
Severe morbidity
2009-10		-	-	-	1	1	2
2010-11		-	-	-	2	-	2
Minor morbidity
2009-10		-	-	-	10	3	13
2010-11		1	-	-	5	2	8
No morbidity
2009-10		-	-	-	8	-	8
2010-11		-	1	2	9	2	14
Outcome not available
2009-10		-	-	-	-	-	-
2010-11		-	-	-	1	-	1
Total		1	1	2	37	8	49

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, SA, TAS, ACT and NT.
2. Outcome severity and imputability data unavailable for WA and NSW.

Table 30 details the contributory factors for reported IBCT events for 2008-09 to 2010-11. In 2008-09, 'prescribing/ordering' was the most frequent factor that contributed to IBCT adverse events. For 2009-10 and 2010-11, the most frequently cited contributory factors were 'prescribing/ordering', 'specimen collection/labelling', 'administration of product', and 'procedure did not adhere to hospital transfusing guidelines'. This data highlights the range of problems that contribute to IBCT events, and the key observation for IBCT is that staff should conform to their local facility guidelines for transfusing.

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

Contributory Factor	2008-09	2009-10	2010-11
None identified	-	-	-
Product characteristic	3	-	4
Transfusion in emergency setting	-	1	4
Deliberate clinical decision	5	3	-
Prescribing/ordering	13	12	5
Specimen collection/labelling	7	12	11
Laboratory (testing/dispensing)	8	7	5
Transport, storage, handling	-	1	-
Administration of product	5	12	8
Procedure did not adhere to hospital transfusion guidelines	2	13	14
Indications did not meet hospital transfusion guidelines	6	5	2
Other	4	5	8

Source: NBA

Haemovigilance data and clinical studies cite three major areas of error that jeopardise safe transfusion:

1. accurate patient identification and proper labelling of pre-transfusion specimens
2. appropriate decision-making regarding the clinical use of blood components
3. accurate bedside verification that the correct blood is to be given to the intended recipient.

The SHOT UK scheme showed that approximately 70% of IBCT event errors took place in clinical areas, the most frequent error being failure of the final patient ID check at bedside.

IBCT represents failure of the hospital system, which needs to be identified and subsequently corrected to prevent similar events happening in the future. For this reason, the recent NSQHS Standard 7 states that adverse blood and blood product incidents should be reported to and reviewed by the highest level of governance in the health service organisation.

There are also electronic systems that can increase compliance in pre-transfusion sampling and administration, and reduce the risk of human error.^{[54] [55]} The Australian Haemovigilance Report 2010 recommended the investigation and use of technology, such as portable barcode readers and/or radio-frequency identification scanners, to reduce the scope for error.

This report delivers several recommendations on human errors (see PART 05: RECOMMENDATIONS).

The following case study illustrates:

• a failure of bedside administration check to ensure the correct component was given to the correct patient
• the feasibility of using 2D barcode and patient safety software to improve blood administration and reduce human errors.

Contributory factors

Contributory factors

Summary Data	2009-10	2010-11
Contributory Factors	Number of reports	Number of reports
None identified	15	34
*Product characteristic	136	172
*Transfusion in emergency setting	7	17
*Deliberate clinical decision	6	1
*Prescribing/ordering	27	10
*Specimen collection/labelling	13	11
*Laboratory (testing/dispensing)	10	5
*Transport, storage, handling	1	-
*Administration of product	14	9
*Indications do not meet guidelines	18	15
*Procedure did not adhere to facility transfusion guidelines	30	16
Other	11	16

Source: NBA

Notes

1. Table presents aggregate data from VIC, QLD, TAS, ACT and NT.
2. Contributory factor data are unavailable for NSW, SA and WA.
3. * refers to human errors.

The National Haemovigilance Program requests that where applicable states and territories report data on factors contributing to each adverse event. The contributory factor categories defined seek to mirror key stages of the transfusion chain. Definitions for contributory factors can be found in Table 38. It should be noted that:

• these categories are not mutually exclusive and more than one contributory factor may be associated with an adverse event
• most factors are related to human errors which could have been avoided
• the most notable difference between the Australian national data and UK data is that 'near miss' events are included in the UK national dataset. This difference will be addressed through the implementation of NSQHS Standard 7^[56]which requires that 'reporting on blood and blood product incidents (including near miss) is included in regular (local, state and national) incident reports'
• VIC, QLD, TAS, NT and ACT reported validated and complete contributory factor data to the National Haemovigilance Program.

The following analysis is based on the data provided by VIC, QLD, TAS, NT and ACT.

• The most frequent contributory factor was 'product characteristic', accounting for 136 adverse events in 2009-10 and 172 in 2010-11. A blood component may contribute to an adverse reaction due to an inherent but not necessarily faulty characteristic, such as an allergic or immunological reaction to a component. Individual patient characteristics play an important role in this factor. Patients with previous transfusions and pregnancies are at increased risk of FNHTR, allergic and anaphylactic reactions. Since this factor is related to both individual patient characteristic and component characteristic, the current terminology and definition may not be appropriate and could lead to confusion for data collectors and users.
• In 2009-10, there were 37 adverse event reports (12% of reports) that cited one or more contributory factors that could have been avoided. The most important contributory factors cited were 'prescribing/ordering', 'indications do not meet guidelines' and 'procedure did not adhere to transfusion guidelines'. Together, this data suggests that inappropriate use of blood components was a contributory factor for a significant number of preventable transfusion-related adverse events.
• In 2010-11, there were 43 adverse event reports (11% of reports) that cited one or more contributory factors that could have been avoided. Contributory factors were cited across the transfusion chain, and the main factors included 'prescribing/ordering', 'specimen collection/labelling', 'laboratory testing/dispensing', 'administration of product', 'clinical indications for transfusion that did not meet facility transfusion guidelines' and 'procedures that did not adhere to facility transfusion guidelines'.
• Interestingly, the number of reports related to prescribing ('prescribing/ordering' and 'indications do not meet guidelines') dropped from 17 to 7 from 2009-10 to 2010-11. In the context of increased reporting, it is possible that this could indicate improved adherence to practice guidelines. Conversely, reports relating to the safety of procedures ('specimen collection/labelling' and 'procedure did not adhere to facility transfusion guidelines') remained as a significant contributory factor.
• Table 31 and Table 32 show that 'procedure did not adhere to facility transfusion guidelines' impacted:
  • 27 IBCT adverse events with 13 in 2009-10 and 14 in 2010-11
  • 6 FNHTRs with 5 in 2009-10 and 1 in 2010-11
  • 7 severe allergic reactions in 2009-10
  • 3 acute haemolytic transfusion reactions in 2009-10
  • 1 anaphylactoid or anaphylactic reaction in 2009-10
  • 1 TACO reaction in 2010-11
  • 1 DHTR in 2009-10.
• The clinical outcome severities related to 'procedure did not adhere to facility transfusion guidelines' included:
  • 2 cases reporting life threatening severity with 1 in 2009-10 and 1 in 2010-11
  • 12 cases reporting severe morbidity with 9 in 2009-10 and 3 in 2010-11
  • 21 cases reporting minor morbidity with 15 in 2009-10 and 6 in 2010-11
  • 10 cases reporting no morbidity with 5 in 2009-10 and 5 in 2010-11.

A key observation from the data is for staff to conform to their local facility guidelines for transfusing. The NSQHS Standard 7 recommended that the facility guidelines should be consistent with the following national evidence-based guidelines:

• ANZSBT Guidelines for the Administration of Blood Products
• ANZSBT Guidelines for Pre-Transfusion Laboratory Practice
• Australian Red Cross Blood Service Blood Component Information Circular
• Australian Red Cross Blood Service Blood Components and Products
• Australian Standard for Medical Refrigeration Equipment - For the Storage of Blood and Blood Products
• BloodSafe eLearning Australia module on Transporting Blood
• National Pathology Accreditation Advisory Council Requirement for Transfusion Laboratory Practice
• NBA PBM Guidelines.

Despite the improvement of national and local facility guidelines for transfusing, human errors continue to contribute significantly to transfusion-related risks to patients in Australia and other developed countries. The VIC STIR program^[57] reported that human error related adverse events, including IBCT, WBIT and near miss events, accounted for 46% of all reports (404) during 2009-11. The SHOT Annual Report 2011^[42] reported that procedural or human errors, including IBCT, inappropriate and unnecessary transfusion, handling and storage errors and ABO incompatible red cell transfusions, represented 51% (5,031) of the cumulative number of cases (9,925) reviewed from 1996-97 to 2010-11.

NSQHS Standard 7 recommended the following strategies (refer to Action 7.2.1) to reduce the risk of human error:

• identify the risks associated with transfusion, particularly risks relating to human errors
• redesign the system to reduce the potential for patient harm
• regularly and comprehensively review systems for effective and appropriate prescribing, sample collection, cross-matching, transport and storage, and product administration to identify and address weaknesses that create the potential for error and patient harm.

This report also delivers a recommendation to reconsider the definitions in the ANHDD, including those for contributory factors.

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

Contributory Factors	Adverse event										Clinical outcome severity
	FNHTR	Severe Allergic reaction	IBCT	Anaphylactic / Anaphylactoid	Acute HTR (not ABO)	TACO	DHTR	TTI Bacterial	TRALI	PTP	Outcome not available	No morbidity	Minor morbidity	Severe morbidity	Life threatening	Death
None identified	1	-	-	-	1	3	5	1	3	1	-	1	6	7	1	-
Product characteristic	69	53	-	7	1	2	1	1	1	1	1	45	72	14	4	-
Transfusion in emergency setting	1	4	1	1	-	-	-	-	-	-	-	2	2	2	1	-
Deliberate clinical decision	1	2	3	-	-	-	-	-	-	-	-	4	2	-	-	-
Prescribing/ordering	4	5	12	1	3	1	1	-	-	-	-	12	6	8	1	-
Specimen collection/labelling	-	-	12	-	1	-	-	-	-	-	-	-	10	3	-	-
Laboratory (testing/dispensing)	2	-	7	-	-	-	-	-	1	-	-	2	6	2	-	-
Transport, storage, handling	-	-	1	-	-	-	-	-	-	-	-	-	1	-	-	-
Administration of product	1	-	12	-	1	-	-	-	-	-	-	-	11	3	-	-
Indications do not meet guidelines	5	3	5	2	-	-	1	1	1	-	1	5	6	6	-	-
Procedure did not adhere to facility transfusion guidelines	5	7	13	1	3	-	1	-	-	-	-	5	15	9	1	-
Other	1	-	5	-	-	-	-	4	-	-	-	4	6	-	-	-

Source: NBA

Note: NSW, SA and WA contributory factor data is unavailable.

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

Contributory Factors	Adverse event									Clinical outcome severity
	FNHTR	Severe Allergic reaction	IBCT	Anaphylactic / Anaphylactoid	Acute HTR (not ABO)	TACO	DHTR	TTI Bacterial	TRALI	Outcome not available	No morbidity	Minor morbidity	Severe morbidity	Life threatening	Death
None identified	2	7	-	3	1	7	5	6	3	-	5	13	13	3	-
Product characteristic	99	54	4	9	-	1	2	3	1	-	17	132	24	-	-
Transfusion in emergency setting	4	6	4	1	-	2	-	-	-	1	2	9	4	1	-
Deliberate clinical decision	-	1	-	-	-	-	-	-	-	-	-	1	-	-	-
Prescribing/ordering	2	1	5	1	-	-	-	1	-	-	5	4	1	-	-
Specimen collection/labelling	-	-	11	-	-	-	-	-	-	1	1	6	2	1	-
Laboratory (testing/dispensing)	-	-	5	-	-	-	-	-	-	1	-	2	1	1	-
Transport, storage, handling	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Administration of product	-	-	8	-	-	1	-	-	-	-	1	5	2	1	-
Indications do not meet guidelines	3	6	2	3	-	1	-	-	-	-	1	6	8	-	-
Procedure did not adhere to facility transfusion guidelines	1	-	14	-	-	1	-	-	-	1	5	6	3	1	-
Other	3	4	8	-	-	-	-	1	-	1	2	10	2	1	-

Source: NBA

Note: NSW, SA and WA contributory fact data is unavailable.

Haemovigilance data supplied by NSW was collected through the public hospital IIMS which was designed to capture information relating to a range of incidents. IIMS is not a specific haemovigilance reporting system and data on adverse events and incidents cannot be associated with any demographic or other data.

The NSW incident data does offer some insight into the types of errors that occur and the relative prevalence reported. Table 33 summarises the NSW Haemovigilance incident data for 1 July 2009 to 30 June 2011. The most prevalent incidents were Mislabelled (2009-10 only, n=153/305) and Mislabelled/Documentation/Consent (2010-11 only, n=1116/1253). From the data supplied, it is not possible to link these incidents to any patient harm or adverse event, but given the absolute numbers of complications reported (see Table 41 and Table 42 in Appendix IV) it is highly likely that these incidents led to a significant number of the reported complications.

There were other incidents reported that would also have a significant chance of causing patient harm; wrong blood or component administered to wrong patient (n=0 in 2009-10, n=6 in 2010-11) and wrong patient (n=24 in 2009-10, n=5 in 2010-11).

The NSW data also supports the conclusion that procedural or human errors, including IBCT, inappropriate and unnecessary transfusion, and dispensing errors, are strong contributory factors to transfusion-related adverse events.

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

Incidents	Number of reports
	2009-10	2010-11
Dispensing of expired or unsuitable component	16	19
Dispensing of expired or unsuitable component & Fever >39oC	0	1
Incorrect administration of blood or component dosage	17	8
Incorrect administration procedure	40	46
Incorrect equipment	22	19
Incorrect infusion rate	26	15
Mislabelled (2009-10 only)	153	-
Mislabelled/Documentation/Consent (2010-11 only)	-	1,116
Taking blood sample from incorrect patient	1	13
Wrong blood dispensed	5	5
Wrong blood or component administered to wrong patient	0	6
Wrong component ordered (2009-10 only)	1	-
Wrong patient	24	5
Total	305	1,253