Australian Haemovigilance Report

DATA FOR 2011–12 AND 2012–13

A Report by the National Blood Authority

Haemovigilance Advisory Committee

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Australian Haemovigilance Report, Data for 2011–12 and 2012–13 published by the National Blood Authority.

ISSN 1838‑1790

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Caveat

When using data from this report it is important to note that information and data is not complete. Haemovigilance reporting by health service organisations is voluntary at both state and territory and national levels. For those states and territories that have reported, the number of health service organisations is unknown. For example in one jurisdiction there were no private hospitals reporting and only public hospitals in major cities. NSW (prior to 2011-12) and WA are excluded from the analysis due to the unavailability of component data for these two states. QLD data is unavailable for 2012–13. NT and ACT did not report in 2008-09.

Message from the General Manager of the National Blood Authority

On behalf of the National Blood Authority (NBA), I am pleased to present the fourth Australian Haemovigilance Report. This report provides information on transfusion-related adverse events between July 2011 and June 2013 and donation-related adverse events between July 2012 and June 2013. It is a valuable resource for clinical communities and governments.

It is widely acknowledged that haemovigilance is an important tool to improve the effective and appropriate management of blood and blood products, and to ensure the safety of Australians receiving and donating blood. In January 2013 the National Safety and Quality Health Service (NSQHS) Standards were implemented, including Standard 7 Blood and Blood Products (NSQHS Standard 7), which requires health service organisations to participate in relevant haemovigilance activities conducted at state or national level.

To ensure that patients are not unnecessarily exposed to the risks associated with transfusion the NBA embarked on a program to develop Patient Blood Management Guidelines for fresh blood. Five of the six proposed modules have now been published and the sixth is in progress. The published modules cover critical bleeding/massive transfusion, perioperative, medical, critical care and obstetrics and maternity. Improvements in the appropriate use of fresh blood products and reduction in wastage have resulted in a commensurate reduction in demand. In 2013–14 the demand for red blood cells decreased by more than eight per cent and platelets decreased by three per cent compared with the previous year.

The states and territories continue to develop their haemovigilance capacity and consistent and complete data is crucial to providing vital feedback to clinical staff to improve patient outcomes. Governments have implemented a Strategic Framework for the National Haemovigilance Program to support and enhance haemovigilance activities, define haemovigilance roles and responsibilities within Australia and identify data collection and reporting obligations at local, state/territory and national levels. To further promote haemovigilance activities in Australia, the NBA will work closely with its Haemovigilance Advisory Committee (HAC) and key stakeholders to develop tools to support haemovigilance in Australia.

This fourth report is a valuable resource for assisting in understanding the risks associated with transfusion and donation in Australia. I would like to offer sincere thanks to all contributing parties for their dedication and hard work promoting safety and quality in the Australian blood sector.

Leigh McJames

General Manager

National Blood Authority

Executive summary

This is the fourth national Australian Haemovigilance Report. It provides an overview of blood transfusion and donation-related adverse events in Australia, and recent data and information on fresh blood product issues. The report also delivers 10 key recommendations in the areas of:

• national blood quality and safety initiatives
• reducing human errors
• data standards
• reporting capacity.

Haemovigilance data for 2011-12 and 2012-13

The NBA National Haemovigilance Program and HAC continue to support the development and alignment of state level reporting systems with the recommended national haemovigilance dataset and Australian National Haemovigilance Data Dictionary.

This report includes validated adverse event data from state level systems, including the New South Wales (NSW) Health Incident Information Management System (IIMS), Victoria’s (VIC) Blood Matters Serious Transfusion Incident Reporting (STIR) program, Queensland’s (QLD) Incidents in Transfusion program (QiiT) and South Australia’s (SA) Health Safety Learning System. STIR also supports haemovigilance in Tasmania (TAS), the Australian Capital Territory (ACT) and the Northern Territory (NT). NSW has improved its haemovigilance reporting capacity since the last report and provided detailed and validated adverse event data (such as imputability and outcome severity data) for this report. QiiT provided 2011–12 data only due to the system being decommissioned in 2013. Western Australia (WA) is the only jurisdiction not contributing to the national dataset for this report.

There were 2,251 adverse events reported to the National Haemovigilance Program from 2008–09 to 2012–13. The number of reports increased from 294 in 2008–09 to 615 in 2011–12, mainly due to the improved adverse event reporting from NSW, however this dropped in 2012-13 to 429 due to QLD not providing any reports for that year. The most frequently reported adverse events are febrile non-haemolytic transfusion reactions (FNHTR) and severe allergic reactions, representing 52.6% and 25.4% of all reports respectively. The first three confirmed cases of post‑transfusion purpura (PTP) were reported in 2009–10 and 2010–11.

Notes

1. All TTIs were bacterial infections and these were reported cases but not necessarily confirmed.
2. Limited adverse event data available for NSW for 2008–09 and 2009–10. NSW only provided detailed data (such as blood products, outcome severity and imputability score) for 2011–12 and 2012–13.
3. Adverse event data unavailable for ACT and NT for 2008–09, and QLD for 2012–13.
4. Adverse event data unavailable for WA.

Donor vigilance data for 2012–13

Donor vigilance is the systematic monitoring of adverse reactions and incidents in blood donor care with a view to improving quality and safety for blood donors. This report includes donor vigilance data contributed by the Australian Red Cross Blood Service (Blood Service).

During 2012–13, there were a total of 1.32 million donations, including 0.86 million whole blood donations, 0.43 million plasma donations and 0.04 million platelet donations. There were 33,208 event reports in 2012–13, with only 1,056 of these classified as serious adverse events. The overall reported rate of donation-related adverse events was 1:40 in 2012–13. The frequency of adverse events was found to be higher in younger and female blood donors, especially those under the age of 20 years.

Fresh blood product issue data

There were 2.3 million components of fresh blood products issued in Australia in 2011–12 (1.2 million) and 2012–13 (1.1 million). Red blood cells (RBC) accounted for about two-thirds of all issues. The demand for RBCs decreased (most likely due to improved patient blood management and better inventory management), from 36.4 units per 1000 population in 2009–10 to 33.3 units per 1000 population in 2012‑13. The demand for fresh frozen plasma (FFP) also decreased during the same period, from 7.4 to 6.4 units per 1000 population. In contrast, the demand for platelets, cryoprecipitate units and cryodepleted plasma rose over the four years to 2012–13.

In the ten years to 2012–13, the NBA’s expenditure on fresh blood products increased from $243.4 million to $549.3 million. Of this, $171.9 million was due to price increases, averaging 7.8% per year. $67.2 million was due to an increase in the overall demand for fresh products over the 10 year period, averaging 3.1% a year. A further $66.8 million was a consequence of the introduction of government-approved quality and safety measures (such as the universal leucodepletion of platelets and red cells), averaging 3.1% a year.

The Australian and international data shows, despite an ageing population, the demand for RBC has started declining around the world most likely due to the improved usage of blood by health professionals.

Recommendations

The 2013 report made 10 recommendations. Nine of these recommendations remain relevant in this report and one has been amended. The ninth recommendation of ‘Conduct a scoping exercise for a national haemovigilance system’ has been completed and the Strategic Framework for the National Haemovigilance Program was the result of this exercise. The NBA and HAC have developed a three-year Haemovigilance Action Plan 2013–16 to guide the implementation of the recommendations in the following areas.

National blood quality and safety initiatives

1. Promote the recognition and management of transfusion-related adverse events.
2. Implement programs at the national, state and local hospital levels to improve reporting of serious adverse events.

Reducing human errors

3. Compliance by clinical staff with national guidelines on sample collection and administration of blood and blood products.
4. Promote the application of technological adjuncts such as portable barcode readers and/or radio-frequency identification scanners to reduce the scope for error.
5. Develop tools to encourage alignment of prescribing practice with clinical guidelines.

Data standards

6. Review and re-develop the Australian National Haemovigilance Data Dictionary.
7. Provide tools for hospitals on the application of the Australian National Haemovigilance Data Dictionary and reporting of haemovigilance data.
8. Continue to include donor vigilance data in national haemovigilance reporting.

Reporting capacity

9. Implement the Strategic Framework for the National Haemovigilance Program.
10. Maintain and improve existing capacities for haemovigilance data reporting.

Part 01 Haemovigilance data for 2011-12 and 2012-13

Introduction

The transfusion of blood and blood components is a core part of healthcare service delivery to patients. While the use of blood and blood components can be lifesaving, there are also risks associated with transfusion. In Australia, the risk of transmission of infectious disease (such as HIV, hepatitis B and C) through blood transfusions has reduced significantly in recent years through improved manufacturing and laboratory processes. However, in common with other developed countries, the non-infectious risks of transfusion, especially those related to human errors, continue to occur and affect patients’ safety and health.

The mechanisms to ensure the safety of transfusions in Australia include:

• clinical transfusion guidelines to direct transfusion practices
• state and territory audit systems to monitor guideline compliance
• jurisdictional and national transfusion education initiatives to train and update clinical staff on best transfusion practices
• development of a national patient blood management program to create leadership for the appropriate use of blood and blood products
• a National Haemovigilance Program which monitors, through state and territory haemovigilance systems, the occurrence of transfusion-related serious adverse events in patients.

Surveillance of adverse transfusion events is the cornerstone of haemovigilance systems. The World Health Organization (WHO) states that:

‘Haemovigilance is required to identify and prevent occurrence or recurrence of transfusion related unwanted events, to increase the safety, efficacy and efficiency of blood transfusion, covering all activities of the transfusion chain from donor to recipient.’^[1]

However, there are many ways in which haemovigilance is defined. A founding definition of haemovigilance was set out in Directive 2002/98/EC of the European Parliament,^[2] setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components:

‘A set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow‑up of donors’.

The International Haemovigilance Network (IHN)^[3]definition is the most widely used:

‘A set of surveillance procedures covering the whole transfusion chain (from the collection of blood and its components to the follow up of recipients), intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence or recurrence.’^[4]

Haemovigilance is now universally recognised as an integral part of safety in blood transfusion, and increasing attention is being paid to haemovigilance in many countries. The WHO Global Database on Blood Safety Summary Report 2011^[5] indicates that a national haemovigilance system was present in 13% of low-income countries, 30% of middle-income countries and 78% of high‑income countries (data based on 106 responding countries). National haemovigilance systems provide an evidence base for the improvement of transfusion practice that displays the real risks and hazards of transfusion in a given community/country and allows for the dissemination of these findings and the instigation of appropriate actions, including educational processes to prevent recurrence.

Available Australian haemovigilance data for 2011-12 and 2012-13

The NBA established a National Haemovigilance Program and the HAC to support the continued development and alignment of jurisdictional haemovigilance reporting systems with the recommended national haemovigilance dataset. The Australian National Haemovigilance Data Dictionary (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 1 shows a representation of the jurisdictions contributing haemovigilance data to the current report. Validated jurisdictional‑level data was submitted by NSW, VIC, QLD, SA, TAS, the ACT and the NT. QLD contributed 2011–12 data only. WA is the only jurisdiction which did not contribute to the national dataset for the reporting period 1 July 2011 to 30 June 2013.

Figure 1: Jurisdictions contributing haemovigilance data to this report

Note: QLD contributed 2011–12 data only.

Victoria, Tasmania, Australian Capital Territory and Northern Territory

• VIC and TAS have supplied validated state level haemovigilance data to the National Haemovigilance Program since 2008–09 and the ACT and NT have contributed since 2009–10. The data provided by these states and territories is fully compliant with the data elements specified in the ANHDD.

South Australia

• The SA BloodSafe program has supplied validated state level haemovigilance data to the National Haemovigilance Program since 2008–09. SA recently made the ANHDD data elements such as age, sex and date of birth mandatory in the Datix Safety Learning System (SLS) to improve the completeness of data for national haemovigilance reporting.

Queensland

• The QLD Blood Management Program (QBMP) supplied validated jurisdictional‑level haemovigilance data (QiiT) from 2008–09 to 2011–12; 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 1 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 ongoing supply of QLD data to the National Haemovigilance Program has now become a major issue due to the cessation of the centralised haemovigilance system (QiiT). As a result, QLD 2012–13 data was not available for this report. The NBA has provided assistance to QLD Health to develop the Haemovigilance Data Collection Tool. QLD Heath has used the tool to improve reporting capacity for future reports.

New South Wales

• NSW has contributed to the National Haemovigilance Program by performing a targeted analysis of transfusion-related adverse events as reported in IIMS since 2008–09. However, the IIMS is not a specific haemovigilance reporting system and many important data fields required by the national haemovigilance dataset are lacking for national level reporting. As a result, the NSW data provided for the previous reports was not comparable with the data provided by other states and territories. NSW has improved the haemovigilance reporting capacity since the last report and provided detailed and validated state level data (such as imputability and outcome severity data) for this report.

Western Australia

• Adverse event data in WA is collected and analysed on an individual hospital or health service basis and was not contributed to this or previous reports. WA is developing a reporting tool and process for the collection of haemovigilance data aligned with the ANHDD. Implementation is intended to facilitate the generation of state-level haemovigilance reports and provision of WA data for national reporting.

Data quality

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.

• There is variation between states and territories in the quality and completeness of adverse event data reported to the National Haemovigilance Program due to the voluntary nature of reporting. Data is not complete for every reported adverse event in the national dataset and even missing for some data elements:
  • NSW, VIC, QLD, SA, TAS, ACT and NT supplied validated data.
  • WA did not contribute data.
  • QLD data is unavailable for 2012–13.
  • Sex and facility location data is unavailable for NSW.
  • Time of transfusion data is unavailable for NSW and SA.
  • Contributory factors are not identified for most of the adverse events reported by QLD and SA.
• 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.
• 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.
• With regard to denominator data, national information on the total number of fresh blood components transfused has not been 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 advserse events

Transfusion risks

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 according to the Blood Service is high for allergic reaction, FNHTR and TACO; however it is very low for the other adverse events when compared to everyday risks (refer to Calman scale in Table 2 and transfusion risks in Table 3). For example, the chances of acquiring bacterial sepsis from a red cell transfusion are equivalent to the chances of death from a train accident according to the Calman chart risk per one year in Table 2.

Summary of main findings and results

This report details transfusion-related adverse events reported for 2011–12 and 2012–13. This summary section also reproduces data for 2008–09, 2009–10 and 2010–11 (from the previous Australian Haemovigilance Report) for comparative purposes.

Table 4 shows the number of adverse events reported (independent of assigned imputability) to the National Haemovigilance Program for the five financial years 2008–09 to 2012–13. 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).

Notes

1. All TTIs were bacterial infections and these were reported cases but not necessarily confirmed.
2. Limited adverse event data available for NSW for 2008–09 and 2009–10. NSW only provided detailed data (such as blood products, outcome severity and imputability score) for 2011–12 and 2012–13.
3. Adverse event data unavailable for ACT and NT for 2008–09, and QLD for 2012–13.
4. Adverse event data unavailable for WA.

There were 2,251 reports of adverse events to the National Haemovigilance Program from 2008–09 to 2012–13 (Table 4). The improved reporting from NSW significantly contributed to the increase in the number of reports, from 294 in 2008–09 to 615 in 2011–12, however this dropped in 2012-13 to 429 due to QLD not providing any reports for that year. The most frequently reported adverse events are FNHTR and severe allergic reactions, representing 52.6% and 25.4% of all reports respectively. No PTP cases were reported for the collection period of this report. The Australian data for TACO, TRALI, and DHTR indicates that these adverse events are suspected to be under‑reported.

From 2008–09 to 2012–13, 2,019 reports specified the blood products involved (Figure 2). Blood product information is unknown for 23 reports and not provided for 209 reports which were all contributed by NSW for 2009–10 and 2010–11. Red blood cells were the products most often implicated in adverse events for the last three financial years, accounting for 71.9% of the reports (1,451 of 2,019). Only a very small proportion of adverse events were related to the transfusion of whole blood (rarely used in Australia), cryoprecipitate and cryodepleted plasma. WA and NSW (prior to 2011-12) are excluded from the analysis due to the unavailability of blood component data for these two states.

Figure 2: Blood products implicated in serious adverse events, 2008–09 to 2012–13

Notes:

1. Blood product data unavailable for NSW from 2008–09 to 2010–11, ACT and NT for 2008–09, and QLD for 2012–13.
2. Blood product data unavailable for WA.
3. Unknown products excluded from analysis.

Table 5 details the numbers of adverse events by blood product reported for 2008–09 to 2012–13. Table 6 details the Clinical outcome severity data reported by adverse events for 2008–09 to 2012–13.

Two cases of death (TACO and allergic reaction) were reported to National Haemovigilance Program in 2008–09. The number of adverse events reported with life threatening severity also dropped, from a total of 30 in 2008–09 to 10 in 2011–12 and 4 in 2012–13. Improved transfusion practice and better management of adverse events may contribute to the reduction of reported deaths and life threatening cases in Australia. In contrast, the cases with severe morbidity rose from 11 in 2008–09 to 55 in 2011–12 due to the increased reporting for most adverse events, but dropped to 42 in 2012–13 due to the unavailability of QLD data. The cases with minor morbidity had an increase from 33 in 2008–09 to 471 in 2011–12, most likely due to increased awareness of collecting and reporting non-serious adverse events such as FNHTRs and minor allergic reactions; and then dropped to 323 in 2012–13 due to the unavailability of QLD data.

Notes

1. Blood product data unavailable for WA.
2. Blood product data unavailable for ACT and NT for 2008–09, NSW from 2008–09 to 2010–11, and QLD for 2012–13.

Notes

1. Clinical outcome severity data unavailable for ACT and NT for 2008–09, NSW from 2008–09 to 2010–11, and QLD for 2012–13.
2. Clinical outcome severity data unavailable for WA.

Febrile non‑haemolytic transfusion reactions (FNHTR)

Notes

1. QLD data is unavailable for 2012–13.
2. Sex and facility location data is unavailable for NSW.
3. Time of transfusion data is unavailable for NSW and SA.
4. Data is unavailable for WA.
5. Uncategorised refers to those reports where no data was provided.

FNHTR (see Appendix II: Definitions in haemovigilance) is the most common transfusion-related adverse event 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.^[8],[9] In combined financial years 2011–12 and 2012–13, 551 FNHTRs were reported to the National Haemovigilance Program, accounting for more than half (52.8%) of the total reports (1,044) for this period.

In the five financial years to 2012–13:

• The number of FNHTRs more than doubled, from 154 in 2008–09 to 321 in 2010–11 and 320 in 2011–12, mainly due to increased reporting of this event from NSW, QLD and SA. The number of FNHTRs dropped in 2012–13 due to the unavailability of QLD data.
• Despite the increase in the number of reported FNHTRs, the number of cases reporting life threatening severity dropped from five in 2008‑09 to one (imputability=likely/probable) in 2011–12 and zero in 2012–13.
• The number of reports of minor morbidity had an increase from 14 in 2008–09 to 306 in 2011‑12. This may indicate an increased awareness of collecting and reporting FNHTR events at a hospital level and a state level, and inclusion of NSW data. The number dropped in 2012–13, due to the unavailability of QLD data.
• The number of reports of outcome not available dropped from 55 in 2008–09 to 1 in 2011‑12 and 8 in 2012–13.
• The majority of cases were related to red cell transfusion.

The lack of SA and NSW data for transfusion time and NSW data for sex and facility location contributed to the increased numbers of unknown/uncategorised cases for these categories in 2011–12 and 2012–13.

In the period 2011–12 and 2012–13, around 49.0% of FNHTRs (270) were assigned an imputability score of likely/probable or confirmed/certain, including 12 cases with severe morbidity and one case with life threatening severity.

Notes

1. Outcome severity and imputability data unavailable for QLD for 2012–13.
2. Outcome severity and imputability data unavailable for WA.

The current definition of FNHTR used by the HAC 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. 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).

Clinical recommendation

The ANZSBT Guidelines for the Administration of Blood Products recommends that a temperature rise to ≥38°C or ≥1°C above baseline (if baseline ≥37°C) should prompt the interruption (stopping) of the transfusion and a clinical assessment of the patient.^[10]

The Blood Service provides guidance on the recognition, investigation and management of FNHTR.^[11]

• When to suspect this adverse reaction?

  Patients present with an unexpected temperature rise (≥38°C or ≥1°C above baseline, if baseline ≥37°C) during or shortly after transfusion. This is usually an isolated finding. Occasionally the fever is accompanied by chills.

  Chills, rigors, increased respiratory rate, change in blood pressure, anxiety and a headache may accompany this reaction but occur in several more serious transfusion reactions also, the most serious being acute haemolytic reaction, transfusion associated sepsis and TRALI. FNHTR is a diagnosis of exclusion. This occurs in 0.1% to 1% of transfusions with leucocyte depletion.

• Usual causes?

  Cytokine accumulation during storage of cellular components (especially in platelet units) is thought to be the most common event leading to symptoms of FNHTRs. Cytokines are released by white cells and pre-storage leucodepletion has reduced this risk.

  FNHTR is also caused by the presence of recipient antibodies (raised as a result of previous transfusions or pregnancies) reacting to donor human leucocyte antigens (HLA) or other antigens. These antigens are present on donor lymphocytes, granulocytes, or platelets.

• Investigation

  Clinically assess the transfused patient for fever, chills, rigors and headache.

  Acute haemolytic reaction may need exclusion.

  Direct antiglobulin test (DAT), blood count and repeat ABO grouping may be indicated.

  Consider investigations for transfusion associated sepsis.

  In patients with repeated FNHTR, investigation for HLA antibodies may be useful.

• What to do?

  Stop transfusion immediately and follow other steps for managing suspected transfusion reactions.

  Treat the fever with an antipyretic. However, avoid aspirin in thrombocytopenic and paediatric patients.

  Consider and exclude other causes, as fever alone may be the first manifestation of a life threatening reaction.

  Rule out acute haemolytic reaction, transfusion associated sepsis and TRALI.

  Recommencement of the transfusion, at a slow rate, is possible if other causes of a fever have been excluded.

Allergic reactions

Notes

1. QLD data is unavailable for 2012–13.
2. Sex and facility location data is unavailable for NSW.
3. Time of transfusion data is unavailable for NSW and SA.
4. Data is unavailable for WA.
5. Uncategorised refers to those reports where no data was provided.

Allergic reactions (see Appendix II: Definitions in haemovigilance) are the second most common transfusion-related adverse events reported in Australia. In combined financial years 2011–12 and 2012‑13, 258 allergic reactions were reported to the National Haemovigilance Program, accounting for 24.7% of the reports (1,044) for this period. The number of allergic reactions dropped from 147 in 2011–12 to 111 in 2012–13 due to the unavailability of QLD data.

In the five financial years to 2012–13:

• The number of severe allergic reactions reported rose by 69.0% from 87 in 2008–09 to 147 in 2011–12, mainly due to increased reporting of this event from NSW, QLD and SA. The number of allergic reactions dropped in 2012–13 due to the unavailability of QLD data.
• There was one reported death in 2008–09 and no reported deaths from 2009–10 to 2012–13. The number of cases reported with life threatening severity dropped from 16 in 2008–09 to 2 in 2011–12 and 0 in 2012‑13.
• The number of cases reported with minor morbidity increased from 16 in 2008–09 to 128 due to the inclusion of NSW data in 2011‑12 and dropped to 96 in 2012-13 (likely due to the unavailability of QLD data).

The lack of SA and NSW data for transfusion time and NSW data for facility location contributed to large numbers of unknown/uncategorised cases for two categories in 2011–12 and 2012–13.

In the period 2011–12 to 2012–13, 80.6% of cases (208) were assigned an imputability score of likely/probable or confirmed/certain, including 20 cases with severe morbidity and two with life threatening severity. The confirmed case of life threatening severity was related to the transfusion of red cells.

Notes

1. Outcome severity and imputability data unavailable for QLD for 2012–13.
2. Outcome severity and imputability data unavailable for WA.

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. Leucoreduction has no effect on decreasing incidence rates,^[12] 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.

Clinical recommendation

The Blood Service provides guidance on the recognition, investigation and management of severe allergic reactions.^[13]

• When to suspect these adverse reactions?

  This reaction can range from one lesion to widespread urticarial lesions. This is commonly the only symptom but may be associated with mild upper respiratory symptoms, nausea, vomiting, abdominal cramps or diarrhoea. This occurs in 1–3% of transfusions.

• Usual causes?

  Hypersensitivity to allergens or plasma proteins in the transfused unit.

• Investigation

  Generally no investigations are required.

  If there is more than simple urticaria, haemolysis should be excluded: DAT, blood count and repeat ABO grouping may be indicated.

• What to do?

  Stop transfusion immediately and follow other steps for managing suspected transfusion reactions.

  Antihistamines may be given and once the reaction subsides, continue transfusion at a slow rate and complete within 4 hours of commencement.

  Consult a haematologist before administering additional blood packs.

  Consider premedication and/or washed red cells if the patient has recurrent allergic reactions to transfusion.

Anaphylactic or anaphylactoid reactions

Notes

1. QLD data is unavailable for 2012–13.
2. Sex and facility location data is unavailable for NSW.
3. Time of transfusion data is unavailable for NSW and SA.
4. Data is unavailable for WA.
5. Uncategorised refers to those reports where no data was provided.

An anaphylactic reaction involves a severe, life threatening, generalised or systemic hypersensitivity reaction characterised by rapidly developing airway and/or breathing and/or circulation problems usually associated with skin and mucosal changes.^[14]

From 2011–12 to 2012–13, there were 29 reports of anaphylactic or anaphylactoid reactions to the National Haemovigilance Program, accounting for 2.8% of all reports (1,044) for this period. The number of cases rose from 8 in 2008–09 to 33 in 2010–11 and then dropped to 16 in 2011–12. It dropped further in 2012–13 due to the unavailability of QLD data.

In the period 2011–12 to 2012–13, 22 out of 29 cases were assigned an imputability score of likely/probable or confirmed/certain, including five cases of life threatening severity and seven cases with severe morbidity. Two confirmed cases of life threatening severity were related to the transfusion of platelets and red cells respectively.

Notes

1. Outcome severity and imputability data unavailable for QLD for 2012–13.
2. Outcome severity and imputability data unavailable for WA.

Anaphylaxis is an acute hypersensitivity reaction that can present as, or rapidly progress to, a severe life threatening reaction.^[15] Anaphylactoid reactions are clinically indistinguishable from anaphylaxis reactions, but differ in their immune mechanism. Distinguishing between anaphylaxis and anaphylactoid reactions is impossible on the basis of clinical signs and symptoms alone; a clinical definition cannot differentiate between the two.

This position is consistent with 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’.^{[16],[17],[18]} 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.¹⁸

Clinical recommendation

The Blood Service provides guidance on the recognition, investigation and management of anaphylactic reactions.^[19]

• When to suspect these adverse reactions?

  Reactions usually begin within 1 to 45 minutes after the start of the transfusion.

  Patients present with a sudden onset of severe hypotension, cough, bronchospasm (respiratory distress and wheezing), laryngospasm, angioedema, urticaria, nausea, abdominal cramps, vomiting, diarrhoea, shock and loss of consciousness. This may be a fatal reaction.

  This occurs in 1:20,000 to 1:50,000 of transfusions.

• Usual causes?

  Anaphylactic transfusion reactions can occur when IgE antibody in the patient interacts with an allergen, usually a plasma protein in the blood component.

  The following mechanisms have been implicated in anaphylactic reactions:

  • IgA-deficient patients who have anti-IgA antibodies
  • patient antibodies to plasma proteins (such as IgG, albumin, haptoglobin, transferrin, C3, C4 or cytokines)
  • transfusing an allergen to a sensitised patient (for example, penicillin or nuts consumed by a donor)
  • rarely the transfusion of IgE antibodies from a donor to an allergen present in the recipient.
• Investigation

  Anaphylaxis usually has a typical clinical presentation. Occasionally the differential diagnosis is acute haemolysis.

  DAT, blood count and repeat ABO grouping may be indicated.

  Check the recipient’s pretransfusion sample for IgA deficiency and presence of anti-IgA antibodies.

• What to do?

  Stop transfusion immediately and follow other steps for managing suspected transfusion reactions. This may become a medical emergency.

  Maintain open airway and intravenous line, support blood pressure.

  Administer supplemental oxygen, antihistamines, adrenaline and corticosteroids as required, resuscitation may also be necessary.

  Consult a haematologist before administering additional blood packs. To prevent recurrent anaphyaxis the following options may be considered:

  • pre-medication with steroids and antihistamine
  • if patient is IgA deficient with anti-IgA, the use of IgA-deficient or washed blood components is recommended.

Acute haemolytic transfusion reactions (other than ABO incompatibility)

Notes

1. QLD data is unavailable for 2012–13.
2. Sex and facility location data is unavailable for NSW.
3. Time of transfusion data is unavailable for NSW and SA.
4. Data is unavailable for WA.
5. Uncategorised refers to those reports where no data was provided.

Acute haemolytic transfusion reactions (AHTR) occur by definition within 24 hours of transfusion. Diagnosis of an AHTR can be difficult, as reactions are often seen in patients with concurrent illnesses that may have other causes for their symptoms.

Adverse events attributed to transfusion of ABO incompatible components can cause AHTRs, 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.

From 2011–12 to 2012–13, there were 12 reports to the National Haemovigilance Program, with three cases of severe morbidity and one case of life threatening severity imputed as confirmed/certain. 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.

Clinical recommendation

The Blood Service provides guidance on the recognition, investigation and management of anaphylactic reactions.^[20]

• When to suspect these adverse reactions?

  It characteristically begins with an increase in temperature and pulse rate.

  Symptoms may include chills, rigors, dyspnoea, chest and/or flank pain, discomfort at infusion site, sense of dread, abnormal bleeding and may progress rapidly to shock.

  Instability of blood pressure is frequently seen. Transfused patients develop oliguria, haemoglobinuria and haemoglobinaemia.

• Usual causes?

  Acute haemolytic transfusion reactions occur at an incidence of 1:76,000 transfusions and may be associated with:

  • ABO/Rh mismatch patient antibodies to plasma proteins (such as IgG, albumin, haptoglobin, transferrin, C3, C4 or cytokines)
  • red cell alloantibodies (non-ABO) as a result of patient immunisation from previous pregnancy or transfusion
  • rare cases when Group O donor platelets with high titres of anti-A and/or anti-B are transfused to a non-Group O recipient.
• Investigation

  Clinically assess patients for common features of haemolysis occurring within 24 hours of transfusion.

  Check clerical records, such as ABO typing of patient and unit.

  Repeat patient ABO grouping in both pre- and post-transfusion samples.

• What to do?

  Stop transfusion immediately and follow other steps for managing suspected transfusion reactions. Seek urgent medical assistance. Maintain blood pressure and renal output.

  Induce diuresis with intravenous fluids and diuretics.

  This may become a medical emergency so support blood pressure and maintain an open airway.

Delayed haemolytic transfusion reactions (DHTR)

Notes

1. QLD data is unavailable for 2012–13.
2. Sex and facility location data is unavailable for NSW.
3. Time of transfusion data is unavailable for NSW and SA.
4. Data is unavailable for WA.
5. Uncategorised refers to those reports where no data was provided.

In contrast to AHTR, delayed 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. From 2011–12 to 2012–13, there were 23 reports of DHTR to the National Haemovigilance Program, accounting for 2.2% of all reports (1,044) for this period.

In the five financial years to 2012–13:

• The number of DHTRs increased from 4 in 2008–09 to 17 in 2011–12 and then dropped to 6 in 2012–13 (mainly due to the unavailability of QLD data).
• The majority of cases were related to red cell transfusion.
• The majority of affected 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.^[21] Researchers have observed that DHTRs are probably under‑reported and under‑recognised in the UK.^[22]

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 specifically implicated in both acute and delayed reactions.^[23] 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.^[24]

Clinical recommendation

The Blood Service provides guidance on the recognition, investigation and management of DHTRs.^[25]

• When to suspect these adverse reactions?

  Patients may present with unexplained fever and anaemia usually 2 to 14 days after transfusion of a red cell component.

  The patient may also have jaundice, high bilirubin, high liver function tests (LDH), reticulocytosis, spherocytosis, positive antibody screen and a positive DAT.

  It occurs in 1:2,500 to 1:11,000 of transfusions.

• Usual causes?

  After transfusion, transplantation or pregnancy, a patient may make an antibody to a red cell antigen that they lack. If the patient is later exposed to a red cell transfusion which expresses this antigen a DHTR may occur.

  DHTRs may also occur with transfusion transmitted malaria and babesiosis.

  The clinical severity of a DHTR depends on the immunogenicity or dose of the antigen. Blood group antibodies associated with DHTRs include those of the Kidd, Duffy, Kell and MNS systems, in order of decreasing frequency.

• Investigation

  Request a DAT, antibody screen, LDH and markers of haemolysis (eg serum haptoglobin, bilirubin).

• What to do?

  Most delayed haemolytic reactions have a benign course and require no treatment however life threatening haemolysis with severe anaemia and renal failure may occur.

  If an antibody is identified, you may request antigen-negative blood if further transfusion is needed.

Transfusion‑associated circulatory overload (TACO)

Notes

1. QLD data is unavailable for 2012–13.
2. Sex and facility location data is unavailable for NSW.
3. Time of transfusion data is unavailable for NSW and SA.
4. Data is unavailable for WA.
5. Uncategorised refers to those reports where no data was provided.

Over transfusion and rapid transfusion 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.

From 2011–12 to 2012–13, there were 44 reports of TACO to the National Haemovigilance Program, accounting for 4.2% of all reports (1,044) for this period. The number of cases rose from 6 in 2008–09 to 27 in 2011–12. The number of reported cases dropped in 2012–13 due to the unavailability of QLD data. One death was reported in 2008–09 and there have been no deaths reported since then. The majority of cases were related to red cell transfusion. The reported figures also indicate that patients aged 65 and above are at high risk of TACO and this is consistent with international findings.

In the period 2011–12 to 2012–13, 30 out of 44 cases were assigned an imputability score of likely/probable or confirmed/certain, including 15 cases with severe morbidity. Three cases with life threatening severity were reported in 2011–12 but none of the cases was confirmed to be related to blood transfusion.

Notes

1. Outcome severity and imputability data unavailable for QLD for 2012–13.
2. Outcome severity and imputability data unavailable for WA.

Patients at the highest risk for TACO include those younger than three and those older than 60 years of age, particularly those with underlying cardiac dysfunction.^[26] 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.

Published TACO incident estimates have ranged from approximates of 0.0003% to 8% of transfusions depending upon patient population and reporting method.^[27] These rates suggest that TACO is as common an adverse event as FNHTR. However, the number of TACO events (44) reported to the National Haemovigilance Program in 2011–12 and 2012–13 is much lower than that of FNHTR (531). 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.

TACO is one of the leading causes of potentially avoidable mortality and major morbidity associated with blood transfusions in many countries including the UK, the Netherlands, the US and Canada (refer to Appendix I: International Context for details).

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

Clinical recommendation

The ANZSBT Guidelines for the Administration of Blood Products recommends that children less than 30kg should have the volume of blood prescribed in mL and the volume should be calculated on the child’s weight and the desired haemoglobin to prevent TACO.¹⁰

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

Text in the above image: PRACTICE POINT — heart failure PP7 - In all patients with heart failure, there is an increased risk of transfusion-associated circulatory overload. This needs to be considered in all transfusion decisions. Where indicated, transfusion should be of a single unit of RBC followed by reassessment of clinical efficacy and fluid status. For further guidance on how to manage patients with heart failure, refer to general medical or ACS sections, as appropriate (R1, R3, PP3—PP6).

The Blood Service provides guidance on the recognition, investigation and management of TACO.^[28]

• When to suspect this adverse reaction?

  The clinical features of TACO can include dyspnoea, orthopnea, cyanosis, tachycardia, increased blood pressure and pulmonary oedema and may develop within 1 to 2 hours of transfusion.

  TACO occurs in less than 1% of patients receiving transfusions. Patients over 60 years of age, infants and severely anaemic patients are particularly susceptible.

• Usual causes?

  This is usually due to rapid or massive transfusion of blood in patients with diminished cardiac reserve or chronic anaemia.

• Investigation

  TACO is frequently confused with TRALI as a key feature of both is pulmonary oedema and it is possible for these complications to occur concurrently. Hypertension is a constant feature in TACO whereas it is infrequent and transient in TRALI.

  Perform a chest X-ray and if septal lines, cephalisation and enlarged vascular pedicles (>65 mm) are present, these findings are more consistent with circulatory overload.

  Clinically assess patients for distended neck veins, S3 murmur on cardiac examination and peripheral oedema as these are also consistent with circulatory overload.

• What to do

  Stop transfusion immediately and follow steps for managing suspected transfusion reactions.

  Place the patient in an upright position and treat symptoms with oxygen, diuretics and other cardiac failure therapy.

  In susceptible patients at risk for TACO (paediatric patients, patients with severe anaemia and patients with congestive heart failure), transfusion should be administered slowly and consideration given to use of a diuretic.

Transfusion‑related acute lung injury (TRALI)

Notes

1. QLD data is unavailable for 2012–13.
2. Sex and facility location data is unavailable for NSW.
3. Time of transfusion data is unavailable for NSW and SA.
4. Data is unavailable for WA.
5. Uncategorised refers to those reports where no data was provided.

TRALI is a serious transfusion-associated adverse event leading to pulmonary oedema and respiratory distress. From 2011–12 to 2012–13, there were five suspected cases of TRALI reported to the National Haemovigilance Program, accounting for 0.5% of all reports (1,044). The number of cases reporting life threatening severity dropped from two in 2008–09 to zero in 2011–12 and 2012–13.

TRALI is the common cause of mortality and morbidity in patients who receive blood components, particularly plasma‑containing components. Female donors were implicated in these cases. Countries such as Australia, the UK and New Zealand Blood Service have introduced risk reduction strategies to reduce the TRALI cases.

• From July 2007, the Blood Service commenced deferring blood donors implicated in confirmed TRALI cases, suspending pooled platelets in platelet additive solution and introducing male-only plasma. The supply of 100% male plasma was achieved in 2012. With current levels of TRALI reporting it is impossible to comment on any potential impact of this policy on the incidence of TRALI in Australia.
• All UK Blood Services moved to 100% FFP from male donors, suspension of platelet pools and preferably recruitment of male apheresis platelet donors. The newly recruited female platelet donors are screened for HLA or human neutrophil antigen (HNA) antibodies and rested after pregnancies. With the introduction of these strategies, the number of TRALI cases has decreased from a peak of 36 suspected cases (seven deaths) in 2003 to 11 suspected cases (no deaths) in 2012.^[29]
• The New Zealand Blood Service has reduced the risk of TRALI through implementing clinical FFP from only male donors in 2008, HLA antibody screening of female plateletpheresis donors in July 2012, and extending the male only policy to include cryoprecipitate and cryodepleted plasma by the end of 2013.^[30] The number of TRALI cases has decreased from 10 in 2005 to 2 in 2012.

Clinical recommendation

The ANZSBT Guidelines for the Administration of Blood Products identify that TRALI can occur unpredictably and progress rapidly, therefore further indicating the need for close observation throughout the transfusion. TRALIs must be reported to the institution’s incident reporting system and reviewed by the hospital transfusion committee or other defined governance committee.

The Blood Service provides guidance on the recognition, investigation and management of TRALI.^[31]

• When to suspect this adverse reaction?

  Acute onset of fever, chills, dyspnoea, tachypnoea, tachycardia, hypotension, hypoxaemia and noncardiogenic bilateral pulmonary oedema leading to respiratory failure during or within 6 hours of transfusion.

  TRALI has been implicated in transfusion of unfractionated plasma-containing components (red cells, platelets and plasma).

  Its incidence is variably reported between 1:1,200 to 1:190,000 transfusions with estimates around 1:10,000 most commonly reported.

• Usual causes?

  The most widely held pathogenesis theory is that HLA or HNA antibodies found in the donor’s plasma are directed against the recipient’s leucocyte antigen.

  The antigen-antibody reaction activates neutrophils in the lung microcirculation, releasing oxidases and proteases that damage blood vessels and make them leak. Biological response modifiers, such as biologically active lipids can accumulate in some cellular components during storage and may also induce TRALI in susceptible patients.

• Investigation

  TRALI has many clinical features in common with fluid overload or cardiogenic pulmonary oedema and careful clinical assessment is required.

  Acute haemolytic reaction or transfusion associated sepsis may have similar initial clinical findings. DAT, blood count and repeat ABO grouping may be indicated.

  Once TRALI is clinically suspected, test the donor and recipient serum for HLA and HNA antibodies and perform an HLA type on the recipient as demonstration of these antibodies supports diagnosis. TRALI testing is specialised and contact with the Blood Service is necessary.

  Chest X-ray will show bilateral interstitial infiltrates.

• What to do?

  Stop transfusion immediately and follow other steps for managing suspected transfusion reactions.

  Provide cardiovascular and airway support. Administer supplemental oxygen and employ ventilation as necessary. Diuretics are not beneficial.

  This may become a medical emergency; support blood pressure and maintain an open airway.

  Notify your Transfusion Service Provider to contact the Blood Service so related components from the same donor can be quarantined and tested to prevent TRALI in other recipients.

Transfusion transmitted infections (TTI)

Notes

1. QLD data is unavailable for 2012–13.
2. Sex and facility location data is unavailable for NSW.
3. Time of transfusion data is unavailable for NSW and SA.
4. Data is unavailable for WA.
5. Uncategorised refers to those reports where no data was provided.

The National Haemovigilance Program allows the reporting of four distinct TTI categories: bacterial, viral, parasitic and other (such as Creutzfeldt‑Jakob disease).

From 2011–12 to 2012–13, there were 17 suspected cases of TTI reported to the National Haemovigilance Program, all of which were related to bacterial infections. Only three cases reported were confirmed to be TTIs, with two related to the transfusion of platelets and one related to the transfusion of red cells. There were no reports of any TTI resulting from viral or parasitically contaminated components. There was an increase in the reports of suspected TTI from 3 in 2008–09 to 18 in 2009–10, and a decrease to 12 in 2011–12. The number of TTI dropped further in 2012–13 due to the unavailability of QLD data.

Notes

1. Outcome severity and imputability data unavailable for QLD for 2012–13.
2. Outcome severity and imputability data unavailable for WA.

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‑lymphotrophic virus (HTLV) I and II, and syphilis. The Blood Service also performs a test for reported residence in, or travel to, an area with malaria. 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 Blood Service notifies donors of any abnormal results on infectious disease and red cell antibody screening once testing is completed, usually within 2 weeks. The donor is advised about the health implications of positive tests.

The viral risk estimates presented in the following table have recently been revised based on Blood Service data from 1 January 2012 to 31 December 2013. These estimates are updated annually. The risk of viral TTI in Australia is exceedingly low. The predicted risk of transmission per unit transfused for HIV, HCV, HTLV and malaria remains substantially less than the 1 in 1 million threshold considered as ‘negligible’. The risk for HBV remains very low but has increased to approximately 1 in 468,000 per unit transfused due to the introduction of a more sensible test for HBV DNA. The actual risk of HBV transmission would be predicted to have declined from the point of the new test's implementation in August 2013. To date there have been no reported cases of vCJD in Australia.

Notes

1. The risk estimates for HIV, HCV and HBV are based on Blood Service data from 1 January 2012 to 31 December 2013.
2. The HTLV estimates are based on data for the period 1 January 2010 to 31 December 2013.

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 needle insertion, 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. As a result, there were no confirmed severe cases (such as death, life threatening or severe morbidity) related to platelet transfusion reported in Australia from 2008–09 to 2012–13.

Bacteria screening for platelet donations was rolled out in the UK’s National Health Service Blood and Transplant (NHSBT) in 2011. Strategies to reduce the bacterial contamination of blood components are under continual review in the UK.^[23] There were two undetermined cases of bacterial TTIs reported to the UK SHOT Program in 2012 and no proven cases in 2013, indicating that bacterial and viral screening is effective in improving the safety of the UK blood supply.

Clinical recommendation

The Blood Service provides guidance on the recognition, investigation and management of transfusion associated sepsis.^[32]

• When to suspect this adverse reaction?

  Clinical features of transfusion associated sepsis suggesting the possibility of bacterial contamination and/or endotoxin reaction may include rigors, high fever, severe chills, hypotension, tachycardia, nausea and vomiting, dyspnoea, or circulatory collapse during or soon after transfusion.

  In severe cases, the patient may develop shock with accompanying renal failure and disseminated intravascular coagulation (DIC). This reaction may be fatal.

  Bacterial infections are reported to occur in at least 1:75,000 platelet transfusions and at least 1:500,000 red cell transfusions. Bacterial infection is more common with:

  • platelets (as these are stored at room temperature)
  • previously frozen components thawed by immersion in a water bath
  • red cell components stored for several weeks.
• Usual causes?

  Blood components may be contaminated by:

  • bacteria from the donor’s skin during the collection procedure
  • unrecognised bacteraemia in the donor
  • contamination from the environment
  • contamination during the preparation of components
  • contamination of ports during the thawing of frozen products in a water bath
  • both gram-positive and gram-negative organisms have been implicated in transfusion associated sepsis with serious morbidity and mortality occurring most frequently with gram-negative bacteria
  • organisms capable of multiplying at low temperatures and those using citrate as a nutrient are most often associated with red cell contamination, especially Yersinia enterocolitica.
• Investigation

  Request for blood cultures from the patient, and perform culture and Gram Stain on the remainder of the blood component.

  The key to diagnosing transfusion related sepsis is culturing the same organism from the patient and component.

  Keep the blood bag and giving set (sealed) for further investigation.

• What to do?

  Stop transfusion immediately and follow other steps for managing suspected transfusion reactions. Start broad-spectrum antibiotics once cultures have been taken, including cover for staphylococcal infections.

  Provide cardiovascular support.

  Send blood pack to the Transfusion Service Provider for urgent culture and Gram Stain.

  Advise Transfusion Service Provider to notify the Blood Service to ensure quarantining and testing of related components from the same donation/donor.

Case study 1: Transfusion transmitted bacterial infection

A 43 year old female with acute myeloid leukaemia required platelet transfusion for severe thrombocytopenia (platelet count of 5x10⁹/L) following a recent stem cell transplant. Approximately 30 minutes after the commencement of transfusion with a 4 day old leucodepleted pooled platelet concentrate she experienced fever, rigors, distress and vomiting. A transfusion reaction was suspected and the platelet transfusion was ceased. Blood cultures were taken and the patient was commenced on empirical antibiotic therapy with meropenem and vancomycin. The patient had been previously well and bacterial cultures performed several days earlier were negative.

A suspected transfusion transmitted bacterial infection was reported to the hospital blood bank and the Blood Service. The Blood Service immediately initiated a recall of the other components manufactured from the whole blood donations.

Gram stain of the implicated residual platelet component showed Gram positive cocci. Bacterial cultures from the patient and from the residual platelet component were both positive for Staphylococcus aureus.

The Blood Service performs bacterial contamination screening on all platelet components at 24 hours post manufacture and platelets are supplied culture negative to date. Review of the bacterial contamination screening testing of the implicated pooled platelet was negative after 7 days of culture. The red cell and plasma components from the 4 whole blood donations were able to be recalled for culture; they were all negative. The 4 donors were contacted to determine if they remained well post donation; no factors relating to bacterial infection were identified.

This is a high probability case of transfusion transmitted bacterial infection as the patient and residual platelet component cultures were both positive for the same organism following transfusion.

Platelet components are the most likely product to be contaminated due to their storage conditions at room temperature, neutral pH and high glucose concentration. There have been three cases of transfusion transmitted bacterial infection associated with platelets since the implementation of routine bacterial contamination testing of platelets by the Blood Service in April 2008. Implicated organisms included Staphylococcal species, which are well known skin contaminants, and Bacillus species which are an environmental contaminant. In all these cases the bacterial contamination screening performed by the Blood Service was negative after 7 days of culture representing a false negative culture. False negative culture results can occur because the level of bacterial contamination at 24 hours post manufacture can be very low.

This case illustrates the need for treating clinicians to consider the possibility of transfusion transmitted bacterial infection when patients develop symptoms consistent with a severe transfusion reaction during or shortly after transfusion. Suspected transfusion transmitted bacterial infections should be immediately reported to the Blood Service to allow timely recall of other implicated blood components to reduce the risk of other patient harm. A prompt Gram stain on the implicated pack will also assist in the prompt diagnosis and in the targeting of antibiotic therapy.

Incorrect blood component transfused (IBCT)

Notes

1. QLD data is unavailable for 2012–13.
2. Sex and facility location data is unavailable for NSW.
3. Time of transfusion data is unavailable for NSW and SA.
4. Data is unavailable for WA.
5. Uncategorised refers to those reports where no data was provided.

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.

From 2011–12 to 2012–13:

• There were 105 reports of IBCT to the National Haemovigilance Program, accounting for 10.1% of all reports (1,044) for this period.
• The number of cases dropped in 2012–13 due to the unavailability of QLD data.
• The majority of cases were related to red cell transfusion.
• The majority of cases (85 out of 105) were not assessed for imputability scores and NSW reported most of the cases (82).
• The life threatening case reported in 2012–13 was confirmed to be related to the transfusion of red cells.

Notes

1. Outcome severity and imputability data unavailable for QLD for 2012–13.
2. Outcome severity and imputability data unavailable for WA.

Table 14 details the contributory factors for reported IBCT events for 2008–09 to 2012–13:

• 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’.
• For 2011–12 and 2012–13, the most frequent factors that contributed to IBCT events were ‘laboratory (testing/dispensing)’ and ‘indications did not meet hospital transfusion guidelines’.

This reported data highlights the range of problems that contribute to IBCT events, and the key observation for IBCT is that staff should conform to local facility guidelines for prescribing, labelling, laboratory testing and transfusing.

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

• accurate patient identification and proper labelling of pre‑transfusion specimens
• appropriate decision‑making regarding the clinical use of blood components
• 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 Standard 7 Blood and Blood Products of the National Safety and Quality Health Service Standards (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. The Australian Haemovigilance Report 2013 delivered several recommendations on reducing human errors:

• Clinical staff should comply with the national guidelines on sample collection and administration of blood and blood products.
• Develop tools to encourage alignment of prescribing practice with clinical guidelines.
• Promote the application of technical adjuncts such as portable barcode readers and/or radio-frequency identification scanners to reduce the scope for error.

The case study below demonstrates:

• an IBCT can occur as result of a series of process failures
• the multi-disciplinary nature of the transfusion process and the importance of education across all disciplines
• the importance of adhering to health service policy and procedures at all times
• 2D barcoding and patient safety software can reduce human errors.

Case study 2: Incorrect blood product was given to patient due to a series of process failures

Description

A 96 year old man was admitted with a fractured neck of femur, scheduled for surgery that afternoon. The patient’s international normalised ratio (INR) was elevated at 1.6, and the decision was made to treat this elevated level with a unit of FFP prior to surgery.

The medical officer (MO) went to the laboratory to collect the unit of FFP. On arrival the scientist pointed to where the FFP was located and requested the MO to sign the unit out of the laboratory in the blood register. The unit collected by the MO was allocated for another patient and labelling not yet completed. The MO signed the unit out against his patient details in the blood register without checking the product details matched. He then took the unit to the ward.

On return to the ward the MO handed the FFP to the nurse caring for the patient, who was unaware of the request for transfusion. The nurse noted the lack of paperwork accompanying the FFP and sent the patient services attendant (PSA), with the unit, back to the laboratory to collect the appropriate paperwork.

The PSA returned and stated that there was no paperwork for this FFP unit and that it did not need to be checked, although the laboratory staff stated they did not speak to the PSA regarding the FFP.

The nurses on the ward took the word of the PSA that they did not need the paper work, and checked the FFP to the patient. The unit was group O, the patient’s blood group was group A, therefore making this an incompatible transfusion. The staff were unaware of this at the time as both medical and nursing staff were under the impression that O was the universal group for FFP as well as red cells.

Later the laboratory staff noted the FFP for the patient was still in the fridge and when they checked the register realised the error. They immediately rang the ward; however the product had already been administered.

As a result the patient had a mild rise in bilirubin, and his procedure was delayed as a precaution and to monitor the patient for further sequelae.

Recommendations from the health service

• All staff who collect blood and blood products from the laboratory must be trained and have knowledge of correct processes for blood collection, including taking appropriate documentation to identify the patient and the product required.
• Staff collecting blood and blood products must collect from the collection fridge where all products are labelled and ready for collection, and not collect directly from the laboratory.
• Education of all medical and nursing staff regarding the appropriate use of FFP and the compatibility of blood groups for FFP, including the use of I-transfuse factsheet ‘I need to know about Fresh Frozen Plasma’ http://www.transfusion.com.au/fact_sheets.

Summary

This case study demonstrates that serious errors often occur as a result of a series of process failures rather than a single event failure. It also demonstrates the multi-disciplinary nature of the transfusion process and the importance of education across all disciplines. This event also highlights the importance of adhering to health service policy and procedures at all times.

The use of patient safety software and 2D barcoding to identify patient and product can also assist in the reduction of errors in which mis-identification of either the patient or the product occurs and should be considered in all areas involved in transfusion.

Contributory factors

Notes

1. QLD data is unavailable for 2012–13.
2. Contributory factors are not identified for most of the adverse events reported by QLD and SA.
3. Contributory factor data is unavailable for WA.
4. * refers to human errors.

The National Haemovigilance Program requests that states and territories report data on factors contributing to each adverse event where applicable. The contributory factor categories defined seek to mirror key stages of the transfusion chain. Definitions for contributory factors can be found in Table 39 in Appendix II: Definitions in haemovigilance. 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.
• Contributory factors are not identified for most of the adverse events reported by QLD and SA.
• Near miss data is not presented in the report. However, some states and territories, such as VIC, SA, ACT, NT and NSW, have collected near miss events in their systems. All states and territories will be required to collect and report near miss data through the implementation of NSQHS Standard 7.^[33]

The data in this report shows:

• The most frequent contributory factor was ‘product characteristic’, accounting for 186 adverse events in 2011–12 and 191 in 2012–13. 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 characteristics and component characteristics, the current terminology and definition may not be appropriate and could lead to confusion for data collectors and users.
• There were 67 adverse event reports (10.9%) that cited one or more preventable contributory factors other than ‘product characteristic’ for 2011–12 and 85 reports (19.8%) for 2012–13. The most common contributory factors cited were ‘administration of product’, ‘laboratory (testing/dispensing)’, and ‘procedure did not adhere to hospital transfusion guidelines’.
• Despite the unavailability of QLD data for 2012–13, ‘administration of product’ remained a factor in 2012–13 and the number of reports increased to 46 from 16 in 2011–12.
• Table 16 and Table 17 show that ‘administration of product’ impacted:
  • 25 severe allergic reactions with 5 in 2011–12 and 20 in 2012–13
  • 19 FNHTRs with 3 in 2011–12 and 16 in 2012–13
  • 14 IBCT adverse events with 5 in 2011–12 and 9 in 2012–13
  • 2 anaphylactic or anaphylactoid reactions in 2011–12
  • 2 TACOs with 1 in 2011–12 and 1 in 2012–13.
• The clinical outcome severities related to ‘administration of product’ included:
  • 6 cases reporting severe morbidity with 3 in 2011–12 and 3 in 2012–13
  • 52 cases reporting minor morbidity with 11 in 2011–12 and 41 in 2012–13
  • 2 cases reporting no morbidity in 2012–13.
• ‘Laboratory (testing/dispensing) contributed to 46 events with 24 in 2011–12 and 22 in 2012–13 and was related to 5 severe morbidity cases with 3 in 2011–12 and 2 in 2012–13.
• ‘Procedure did not adhere to hospital transfusion guidelines’ was related to one severe morbidity case in 2011–12 and one life threatening case and one severe morbidity case in 2012–13.

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

• ANZSBT Guidelines for the Administration of Blood Products 2nd ed
• 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 reported^[34] 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^[23] 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 (Action 7.2.1) recommended the following strategies 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 Australian Haemovigilance Report 2013 delivered a recommendation to reconsider the definitions in the ANHDD, including those for contributory factors.

Notes

1. Contributory factors are not identified for most of the adverse events reported by QLD and SA for 2011–12.
2. Contributory factor data is unavailable for WA for 2011–12.

Notes

1. Contributory factors are not identified for most of the adverse events reported by SA for 2012–13.
2. Contributory factor data is unavailable for QLD and WA for 2012–13.

Part 02 Recommendations

The 2013 report made 10 recommendations. Nine of these recommendations remain relevant in this report and one has been amended. The ninth recommendation of ‘Conduct a scoping exercise for a national haemovigilance system’ has been completed and the Strategic Framework for the National Haemovigilance Program was the result of this exercise. The NBA and HAC have developed a three-year Haemovigilance Action Plan from 2013–14 to 2015–16 to guide the implementation of the recommendations in the following areas.

National blood quality and safety initiatives

1. Promote the recognition and management of transfusion-related adverse events.
2. Implement programs at the national, state and local hospital levels to improve reporting of serious adverse events.

Reducing human errors

3. Clinical staff should comply with national guidelines on sample collection and administration of blood and blood products.
4. Promote the application of technological adjuncts such as portable barcode readers and/or radio-frequency identification scanners to reduce the scope for error.
5. Develop tools to encourage alignment of prescribing practice with clinical guidelines.

Data standards

6. Review and re-develop the Australian National Haemovigilance Data Dictionary.
7. Provide tools for hospitals on the application of Australian National Haemovigilance Data Dictionary and reporting of haemovigilance data.
8. Continue to include donor vigilance data in national haemovigilance reporting.

Reporting capacity

9. Implement the Strategic Framework for the National Haemovigilance Program.
10. Maintain and improve existing capacities for haemovigilance data reporting.

National blood quality and safety initiatives

Haemovigilance has become a more routine part of clinical practice in Australia. The data to date suggests a focus on those events that are most common (such as FNHTR and severe allergic reactions) and that cause the greatest numbers of severe patient outcomes (such as TACO and anaphylactic reactions).

In relative terms, the Australian data suggests that TACO and TRALI, which account for disproportionate numbers of life threatening and severe morbidity events, are likely under‑reported. National quality and safety initiatives should be developed with the aim of helping clinical staff to recognise and manage these events and support alignment of hospital transfusion practice and incident reporting with the NSQHS Standard 7.

Reducing human errors

Human errors continue to contribute significantly to transfusion-related risks to patients. Further effort is required to ensure clinical staff comply with national guidelines on the collection and administration of blood and blood products. Data on ‘near miss’ events (an adverse event that is discovered before the start of a transfusion) would be useful to focus efforts to reduce human errors, and transfusing facilities are now required by NSQHS Standard 7 Safety and Quality Improvement Guide to record near miss events in haemovigilance data. Research suggests that technological adjuncts such as portable barcode readers and/or radio‑frequency identification scanners also reduce the scope for human errors. Clinical staff should also be supported in their efforts with tools such as a defined blood order/prescription form to encourage alignment of prescribing with clinical guidelines.

Data standards

Data standards should be revised and updated as haemovigilance matures in Australia. The ANHDD will be revised/reviewed in 2014–15, and published/distributed in 2015–16. The NBA will develop a set of other tools for hospitals from 2015–16 to assist with the application of the data dictionary and improve haemovigilance data collection and reporting. The haemovigilance report will continue to include donor vigilance data.

Reporting capacity

The mechanisms to collect, record, review and analyse haemovigilance data in Australia are fragmented. This allows varied approaches to data definitions and data validation processes, and has seen haemovigilance reporting develop at different rates in states and territories.

The NBA, assisted by state and territory health departments and the JBC, developed the Strategic Framework for the National Haemovigilance Program as part of the scoping exercise described in the 2013 report. The Strategic Framework has been endorsed by the JBC and published on the NBA website. The NBA has developed a communication plan for the Strategic Framework. The NBA will work in collaboration with HAC and key stakeholders to develop a work plan to support the implementation of the Strategic Framework. States and territories should continue to maintain existing systems and improve capacities for haemovigilance data reporting.

Part 03 Donor Vigilance

The data contained in this report has been collected and the report compiled by the Blood Service using data gathered from adverse events reported via the Donor Adverse Event (DAE) database. Collection staff are responsible for the immediate management of adverse reactions which occur at the blood donor centre and for registration of these adverse events. Medical Services staff are responsible for registering events which are reported to the Blood Service after the donor has left the donor centre. Events are classified by a centralised team according to standard definitions which are largely based on definitions endorsed by the International Society of Blood Transfusion (ISBT) Haemovigilance Working Party. Donors are followed up by Medical Services staff according to the type and severity of reaction reported (refer to Appendix III: Definition of Donor Adverse Events). Donor haemovigilance data and trends are regularly monitored by the Donor and Product Safety Advisory Committee and the Blood Service Clinical Governance Committee to evaluate the impact of changes in donor selection criteria, donation processes and interventions to improve donor safety. There is also regular reporting to the Blood Service Executive and Board.

Review of donor adverse events 2012–13

Whilst blood donation is generally a very safe process, there are recognised donor complications which can occur. Donor haemovigilance systems permit monitoring of donor safety and evaluation of the success of interventions designed to further improve donor safety. International benchmarking of donor adverse events is important but not straightforward because of different adverse event definitions, different collection processes and probably most importantly differences in reporting compliance. Estimates of adverse event incidence in blood donors based on published international studies range considerably from 5% to 33%^[35],[36] and based on these rates Australia benchmarks favourably.

During 2012–13 there were a total of 1,322,883 donations, including 858,594 whole blood donations, 427,945 plasmapheresis donations and 36,344 plateletpheresis donations. Total donation associated events and serious donation-related events are shown in Figure 3 below.

Figure 3: Total donation-associated events and serious donation-related events 2008–09 to 2012–13

There were 33,208 adverse events reported with the vast majority of these being classified as mild, such as the donor feeling faint for a few minutes. Adverse events can occur during and after the donation. Events which occur in the donor centre are termed immediate events. Events which occur after the donor has left the donor centre are classified as delayed events. Serious adverse events are those events where the donor requires external medical or hospital referral for the management of the adverse event and such events may be either immediate or delayed. The overall reported rate of donation-related adverse events was 1:40 in 2012–13.

The Blood Service has implemented a number of strategies to enhance reporting compliance by donors as well as donor centre and Medical Services staff. In November 2012, new standard operating procedures were introduced in which reporting requirements for adverse events changed to include the mandatory reporting of all citrate related reactions in apheresis donors. This change coincided with the roll-out of e‑learning modules to all Collections and Medical Services staff to improve their understanding of the causes of adverse reactions, to enhance recognition and management of adverse reactions, and to emphasise the importance of adverse events reporting. Since January 2011 a donor wellness check has been in place whereby every time a donor returns to donate they are asked whether they experienced any problems related to their previous donation. Following this there has been a sustained increase in the number of delayed vasovagal reactions reported. The rate of delayed events for all collection types has increased by approximately 50%. The impact of this reporting can be seen in Table 22 and Figure 4.

Figure 4: Impact of donor wellness question—whole blood delayed vasovagal reactions September 2010–June 2013

Note: Includes events occurring between 1/7/12 and 30/6/13, but reported up until 30/9/13

Table 23 shows the rate of adverse events by donation type, and the rate per 10,000 donations for 2012–13.

Vasovagal reactions and bruising/haematoma are the most frequent complications associated with blood donation. Plasmapheresis donations are associated with the lowest frequency of adverse reactions, and platelet donations with the highest frequency. The incidence of the different types of adverse events for all donations is shown in Table 24.

Notes

1. *Calculated for apheresis collections only.
2. **Includes injuries sustained in falls during fainting, headaches during and after donation, cramps, palpitations or awareness of heart beat, nausea or abdominal pain during or immediately following procedure, onset of wheeze or asthma during donation, prolonged fatigue following donation.

Serious complications of blood donation

Serious complications related to blood donation are events resulting in any of the following:

• hospitalisation if it is attributable to the reaction, based on the evaluation of hospital medical staff
• attendance at a healthcare facility to manage a complication and to prevent ongoing impairment
• involvement in an accident (with or without significant injury) if the accident was probably or definitely related to the donation
• death following a donation complication if the death was probably, possibly or definitely related to the donation.

During 2012–13 there were 451 hospital referrals and 605 general practitioner (GP) referrals for donation-related complications (Table 25). There were no donation associated deaths. The commonest reason for both hospital and GP referral was slow recovery from a vasovagal reaction; nerve irritation due to a large haematoma was the commonest reason for referral for phlebotomy injury, followed by painful arm following donation (Table 26). Table 27 details donor complication rates by severity per 10,000 donations 2012–13.

Note: * Other includes injuries sustained during a faint, such as head injuries, fractures and dental injuries, and also constitutional symptoms such as extreme fatigue and palpitations on minimal exertion experienced by some donors in the days immediately following blood donation.

Donor gender and age and adverse reactions to donation

The frequency of donation associated events is higher in younger blood donors and in female blood donors, especially those under the age of 20 years. The frequency of reactions in 16–17 year old females is one in every eight donations, and in 16–17 year old males, one in every 14 donations. This trend is consistent with international published data.^[37],^[38] Safety and wellbeing of youth donors is a key area of focus for the Blood Service. There is a steady reduction in the likelihood of a donation reaction with increasing age (see Table 28 below).

Performance in relation to international blood services

There are significant challenges in benchmarking Australia’s adverse events rate with event rates reported by international blood services as a result of variations in the classification of donation associated events and also because of variations in reporting requirements between blood services and variable compliance with these requirements. Estimates of adverse event incidence in blood donors based on published international studies range from 5 to 33%^35,36 and based on these rates the Blood Service benchmarks favourably. However there remains considerable value in benchmarking initiatives to reduce adverse events. For this reason the Blood Service regularly benchmarks with blood services in America, Canada, Europe and Asia Pacific. Taking into consideration the significant challenges identified above, the focus is primarily on the review of strategies and initiatives being implemented to reduce adverse event rates and the impact of such interventions on local adverse event trends, rather than a comparison of absolute adverse event rates. The Blood Service is participating in work led by the ISBT Haemovigilance Working Party to improve the comparability of absolute adverse event rates.

Interventions directed at reducing the risk of adverse events

1. Donor education via http://donateblood.com.au and on the Donor Questionnaire Form provides advice on preparation for blood donation (pre-donation salty snacks and adequate fluid intake) and on strategies to minimise the risk of a reaction during and after donation (use of applied muscle tension, rest and fluid intake, avoidance of strenuous physical activity and alcohol post donation)
2. Provision of specific information cards to donors at the time of an adverse event detailing immediate management and preventative actions relevant to subsequent donations
3. Permanent deferral of donors with significant risk of recurrence of serious adverse reactions
4. Use of a mid-donation saline protocol for plasma donors which includes the administration of 500mL of saline to reduce the risk of vasovagal reactions
5. Using a stepwise approach to increasing collection volume for plasmapheresis donors donating plasma for fractionation based on nomograms* for per cent Total Blood Volume
6. Using a stepwise approach for plasmapheresis donors donating Clinical Fresh Frozen Plasma with end saline, also based on a nomogram for Total Blood Volume
7. Using a “whole blood nomogram” with reduced volume whole blood collection for donors with low total blood volume
8. Use of specific guidelines for managing young donors – females under 20 years of age are not recruited to plasma donation
9. Provision of pre-donation oral calcium supplements for plateletpheresis donors to reduce the frequency and severity of citrate reactions
10. Communication with comparable international blood services to ensure ‘best practice’ protocols
11. Formal clinical governance processes including review of staff scope of practice and training, the conduct of clinical audits, robust data capture and analysis of adverse events, regular management and external review of donor adverse event trends with corrective action taken as required
12. Implementation of initiatives to reduce the risk of iron deficiency associated with blood donation, including supporting research to identify other potential mitigation measures
13. External review and approval of donor selection guidelines and collection protocols by the TGA.

Note: *A nomogram is a chart or graph used to show relationships between several variables (such as height and weight) to enable a third value (the collection volume, which is based on the total blood volume) to be read directly at the intersection point of the first two values.

Planned initiatives directed at reducing the risk of adverse events

14. Youth donors (aged 16 and 17 years) will be restricted to one donation per annum from 1 January 2014 to reduce the risk of iron deficiency and number of vasovagal reactions
15. Pain experienced during a difficult phlebotomy does contribute to vasovagal reactions. A trial involving the use of vein visualisation technology conducted in 2013–14 and the impact on donor adverse event rates will be analysed
16. Two pilots of iron supplementation to reduce the risk of iron deficiency associated with blood donation commenced in 2013–14.

Case study 3: Delayed vasovagal reaction in a regular blood donor

The donor, a 53 year old woman, contacted the Blood Service approximately 6 hours after a whole blood donation to report that she had fainted 5 hours after donation, and continued to feel light‑headed and weak.

The donor was in good health and was not taking any medication. She had been a blood donor for 14 years and had made 33 uneventful donations. On the day of donation she had eaten breakfast and lunch and had drunk 4-5 glasses of water and a cup of tea during the morning prior to her 2pm appointment. This was no different from her usual pre-donation preparation. She reported on her questionnaire and at interview that she was feeling healthy and well, and had no recent illnesses. The donor weighed 69kg and her height was 166cm (estimated total blood volume 4.1L). Her pre-donation blood pressure was 138/82mmHg and her pre-donation capillary Hb was 136g/L.

The donation commenced at 2.21pm and 471mL of whole blood was collected in 8 minutes. She felt well immediately following donation, and after resting briefly on the couch, she went to the refreshment area where she drank one glass of cordial and ate a muffin. She remained in the refreshment area for about 5 minutes. Following donation she went shopping for about 2 hours and then travelled home by bus. She felt well throughout this time. Her only fluid consumption after leaving the blood donor centre was a half a glass of water consumed whilst she was preparing the evening meal.

The donor started feeling unwell immediately following her evening meal during which she had drunk approximately half a glass of red wine. She fainted when she stood up to go to the bathroom. Her partner informed her that she was unconscious for “about 30 seconds”. Immediately after regaining consciousness she attempted to move to a chair, and she fainted again. She remained on the floor for about 20 minutes and then moved to a chair. It was at this stage she contacted the Blood Service Medical Officer.

The Medical Officer advised the donor to remain semi-recumbent, to attempt to drink at least 2 glasses of cold water over the next 20 minutes, and instructed the donor in the use of applied muscle tension (repeated contraction of the thigh muscles which reduces peripheral venous pooling associated with vasovagal reactions and enhances venous return). She was advised to increase her intake of cool fluids over the next 3 hours, and to avoid hot baths or showers and was advised that she must not drive for at least the next 8 hours.

At follow up the next day, the donor reported that her symptoms of dizziness and sweating had resolved rapidly after she had used applied muscle tension; she had complied with the advice to drink additional cold, non-alcoholic fluids, and felt “back to normal” within 90 minutes.

Delayed vasovagal reaction is a well-recognised complication of blood donation, occurring in 0.34% of whole blood donors. It is thought that they occur as a result of failure of the donor’s normal compensatory reflexes to respond to the volume loss associated with donation. Inadequate fluid intake post donation, prolonged standing, high environmental temperature, and alcohol ingestion all increase the risk of a delayed vasovagal reaction. Delayed reactions occur more frequently in female donors than in male donors (incidence 0.58% in females compared to 0.10% in male donors) and are more likely to be associated with loss of consciousness than immediate vasovagal reactions. Unlike immediate vasovagal reactions, the risk of a delayed reaction is not significantly higher in first time and inexperienced donors compared to experienced and older donors. It is possible that experienced donors are less vigilant about following advice to increase their fluid intake following donation, thereby increasing the risk of a delayed reaction.

Donors are provided with information on the risk of delayed reactions and advice on prevention, in particular advice on maintaining post donation fluid intake, and avoidance of known precipitants such as overheating, prolonged standing and drinking alcohol.

Part 04 Previous Australian haemovigilance report performance

Scorecard – Performance to date

The 2013 report delivered 10 key recommendations in the areas of national blood quality and safety initiatives, reducing human errors, data standards and reporting capacity. The following provides an update on the status of those strategies to be delivered against each recommendation.

National blood quality and safety initiatives

Reducing human errors

Data standards

Reporting capacity

Future directions in Australian haemovigilance

Adverse event reporting for non‑fresh products

This report is confined to haemovigilance with respect to fresh blood components, such as red blood cells, platelets, fresh frozen plasma, cryodepleted plasma and cryoprecipitate. The Australian medical community also makes significant use of many plasma and recombinant products.

A range of valuable products is manufactured from plasma through the process of fractionation, in which different proteins found in blood plasma are separated, purified and concentrated into distinct therapeutic products. Most plasma derived products supplied in Australia are manufactured from plasma collected by the Blood Service and fractionated by CSL Behring. Some are imported.

Alternative recombinant product versions of plasma derived products are also available. These are manufactured by the expression of equivalent proteins from genetically engineered cell lines.

Important plasma and recombinant products are:

• intravenous and subcutaneous immunoglobulin
• hyperimmune immunoglobulin products
• albumin products
• clotting factors and other products.

Health professionals are required to report adverse events that occur as a result of administration of all blood and blood products. It is a requirement under NSQHS Standard 7^[33] to report all adverse events into that facility's incident management and investigation system, as well as to the state and/or national haemovigilance system. As plasma and recombinant products are classified as medicines, reports of adverse events are directed to the TGA.^[39]

The TGA maintains a reporting service for adverse events or defects in medicines in Australia. The reporting is mandatory for sponsors (serious adverse events only) and voluntary for other groups such as hospitals and general practitioners. The TGA publishes annual adverse event statistics. In 2013, the TGA receives over 17,500 adverse event reports of which 55% were by sponsors, 4% by general practitioners and 10% by hospitals. The TGA also publishes the adverse event data received through the Database of Adverse Event Notifications. Information on TGA reporting can be found on the TGA’s website^[40] and reports can be submitted in various ways.

Products for haemophilia and bleeding disorders

The Australian Bleeding Disorders Registry (ABDR)^[41] was introduced in December 2008. The ABDR was further developed (to Version 4) in August 2012. A patient self-recording module, MyABDR, was launched in February 2014.

The ABDR is a clinical registry for patients in Australia with bleeding disorders. It is administered by the NBA, and used on a daily basis by clinicians in all Australian haemophilia treatment centres to assist in managing the treatment of people with bleeding disorders and to gain a better understanding of the incidence and prevalence of bleeding disorders.

The ABDR includes information on the following types of adverse events:

• an allergic or acute reaction possibly linked to a treatment administered to the patient
• a transfusion transmitted infection possibly linked to a treatment administered to the patient
• a malignancy possibly acquired from a treatment administered to the patient
• thrombosis possibly caused by a treatment administered to the patient
• the development of an inhibitor possibly caused by a treatment administered to the patient
• death of the patient possibly linked to a treatment administered to the patient
• poor efficacy or other adverse events possibly linked to a treatment administered to the patient.

The NBA produces ABDR annual reports and adverse event reporting will become more prominent as the dataset matures.

Intravenous immunoglobulin (IVIg)

Intravenous immunoglobulin (IVIg) is a fractionated blood product made from pooled human plasma. It is registered for use in Australia for the treatment of a number of diseases where immunoglobulin replacement or immune modulation therapy is indicated. IVIg is used to treat a growing number of unregistered indications where there is some evidence for its utility. IVIg is a life-saving therapy in appropriately selected patients and clinical circumstances.

Since the 1980s, the demand for IVIg has greatly increased, both internationally and in Australia. In the late 1990s, worldwide shortages prompted action by Australian governments to ensure that IVIg was available for those patients most in need. Since that time, strategies to ensure supply have included:

• rationalising the use of IVIg by specifying conditions and limiting IVIg access under the national blood arrangements to those patients meeting the specified conditions and eligibility criteria
• increasing the manufacture of IVIg in Australia
• importing IVIg from overseas.

The continual significant annual growth in IVIg usage, the high cost of IVIg products and the potential for supply shortages have all maintained the focus of Australian governments on ensuring use remains consistent with an evidence‑based approach and that IVIg is able to be accessed under the National Blood Arrangements for those patients with the greatest clinical need.

The Criteria for the clinical use of intravenous immunoglobulin^[42] in Australia describes current arrangements for access to IVIg funded under the national blood arrangements and the conditions for its use. The criteria have been developed to help clinicians and medical professionals identify the conditions and circumstances for which the use of IVIg is appropriate and funded.

The TGA collects information from hospitals and general practitioners on IVIg-related adverse reactions occurring in Australia. The NBA may work with the TGA on the inclusion of such data in future reports.

Part 05 Fresh blood product use and haemovigilance systems

Trends in fresh blood product issues in Australia

In line with many developed countries Australia has made increasing progress towards improving the efficiency of blood utilisation and clinical transfusion practice. Transfusion-related clinical practice improvement programs in a number of states and territories have continued to develop in areas such as appropriate use of blood, clinical governance, haemovigilance and ongoing education of clinical and associated health care professionals.

Fresh blood products issued

The NBA coordinates the purchase and supply of blood and blood products on behalf of all Australian governments in accordance with government policies in the National Blood Agreement and National Blood Authority Act 2003.

In Australia, blood is voluntarily donated free from financial incentive. The Blood Service collects and processes blood and distributes blood products to Australian health providers. The Blood Service is funded by all Australian governments through the NBA which contracts the Blood Service under a Deed of Agreement.

The Therapeutic Goods Administration (TGA) regulates blood and plasma manufacturing activities and monitors any serious adverse transfusion events that may be product-related.

From 2011–12 to 2012–13, there were about 2.3 million components of fresh blood products issued in Australia. The demand for RBC remained high, accounting for about two-thirds of all issues. The demand for blood products varied across states and territories. NSW accounted for 32.5% of all issues, followed by VIC (25.4%) and QLD (21.2%). NT accounted for less than 1.0% of all issues.

Notes

1. FFP=Fresh frozen plasma
2. RBC=Red blood cell
3. Totals may not add up due to rounding.

The following tables and figures show that:

• The demand for RBC declined by 4.7%, from 801,295 in 2011–12 to 763,542 in 2012–13. The issues of RBC per 1000 population also dropped from 35.6 per 1000 population in 2011–12 to 33.3 in 2012–13. The decline in RBC demand is likely to demonstrate initial successes in programs to improve appropriate use and reduce wastage.
• The platelet demand in 2012–13 was consistent with the demand in 2011–12 with only 0.3% growth. In contrast, the issues of platelets per 1000 population decreased slightly from 6.0% in 2010–11 to 5.9% in 2012–13. The constrained growth is again likely to be the result of the initial success of programs to improve appropriate use and reduce wastage.
• The demand for FFP decreased by 7.2% from 2011-12 to 2012-13.
• The demand for cryoprecipitate units rose steadily over the past four years to 2012–13. Cryoprecipitate is increasingly used in the treatment of massive bleeding and this may drive an increase in demand in the coming years.
• The demand for cryodepleted plasma units increased by 21.2%, from to 13,756 in 2010–11 to 16,675 in 2012–13 after a slight decrease between 2010–11 and 2011–12. It remains difficult to forecast the demand for this blood product because this product is used episodically in a very small number of patients with thrombotic thrombocytopenic purpura.

Declining demand for RBC was also reported by other countries including the United Kingdom (UK), New Zealand (NZ) and the Netherlands during similar periods.

• RBC issues declined by 5.5% from 2011 to 2013 in the UK.
• The transfusion rate for RBC decreased by 8.9% from 2010 to 2012 in NZ.
• A declining trend of about 7% in the number of distributed RBCs was seen in the Netherlands from 2010 to 2012.

Note: RBC=Red blood cell

Notes

1. RBC=Red blood cell
2. ABS population data^[43] for December quarters 2009, 2010, 2011 and 2012 are used for the calculation of figures in this table.

Figure 5: Total red blood cell issues in Australia, 2009–10 to 2012–13

Figure 6: Total red blood cell issues per 1000 population, 2009–10 to 2012–13

Demographics of blood use

Australia’s population grew by 1.8% to 23,130,900 during the year ended 30 June 2013. The growth rate has declined since the peak of 2.2% for the calendar year ended 31 December 2008.^[44] Increases in population will inevitably result in increased future demand for health care services.

Australia’s population, similar to that of most developed countries, is ageing as a result of sustained low birth rates and increasing life expectancy. This is resulting in proportionally fewer children (less than 15 years of age) in the population. The median age (the age at which half the population is older and half is younger) of the Australian population increased by 4.3 years over the last two decades, from 33.0 years at 30 June 1993 to 37.3 years at 30 June 2013. Between 30 June 2012 and 30 June 2013 the median age remained steady at 37.3 years. Over the next several decades, population ageing is projected to have significant implications for Australia in many spheres, including increased demands and spending on the health system.^[45]

Australia enjoys one of the highest life expectancies in the world. In 2012 it was ranked sixth overall at 82.1 among Organisation for Economic Co‑operation and Development (OECD) countries after Japan (83.2 years), Iceland (83.0), Switzerland (82.8), Spain (82.5) and Italy (82.3).^[46]

In the 12 months to 30 June 2013, the number of people aged 65 years and over in Australia increased by 120,100 people, representing a 3.7% increase. The proportion of the population aged 65 years and over increased from 11.6% to 14.4% between 30 June 1993 and 30 June 2013. This is projected to increase more rapidly over the next decade, as further cohorts of baby boomers turn 65. In the 12 months to 30 June 2013, the number of people aged 85 years and over increased by 19,300 (4.6%) to reach 439,600. Over the two decades to 30 June 2013, the number of people aged 85 years and over increased by 159% compared with a total population growth of 31% for the same period.⁸

The rise in the elderly population of Australia has a tangible effect on the nation’s blood supply needs. There is a correlation between patient age and blood component use and this is illustrated by a range of data available from the Australian Institute of Health and Welfare (AIHW).

The AIHW publishes data relating to transfusion of blood and immunoglobulin on an annual basis. There are, however, a number of limitations^[47] with respect to the analysis and the potential use of this data for blood supply demand planning:

• there is a 12 month delay before the data becomes available in the public domain
• information is only collected for patients who have been admitted to hospital
• information collected only relates to the number of transfusion procedures for blood and immunoglobulin. No information is collected regarding the actual number of units of blood components or plasma derived blood products transfused during each of these transfusion procedures
• other than for red blood cells, platelets and perhaps whole blood, the other sub‑coded data cannot be related to any specific blood component or plasma derived blood product such as ‘coagulation factors’, ‘blood expanders’, and ‘other serum’
• differences in coding and reporting practices across hospitals and jurisdictions are likely to affect the quality of the data collected and may result in some under‑reporting.

Despite the limitations, the AIHW data provides some insight into Australian transfusion trends.

As shown in Figure 7 below, the majority of RBC transfusion procedures in 2010–11 and 2011–12 occurred in patients aged 65 years and over. A similar trend was also observed for other blood products (Table 37, Table 38) for the same period.

Source: AIHW National Hospital Morbidity Database

Figure 7: RBC transfusions by patient age, 2010–11 and 2011–12

This phenomenon is not unique to Australia. Epidemiological information from the United States, England, and Denmark highlighted similar age and sex distributions of transfused patients:^[48]

• most of the red cell components were transfused to older recipients
• the distribution between men and women was approximately equal
• the distribution for platelets was over a wider age range
• the distribution for plasma was also directed to the elderly.