A Safer Future
for
Emily
Queensland incidents in Transfusion (QiiT)
June 2007–2009 Report
QiiT
Queensland incidents in Transfusion
A Safer Future
for
Emily
Queensland incidents in Transfusion (QiiT)
June 2007–2009 report
QiiT
Queensland incidents in Transfusion
http://creativecommons.org/licenses/by-nd/2.5/au/
© State of Queensland (Queensland Health) 2012
ISBN: 978-1-921707-81-0
For permissions beyond the scope of this licence contact: Intellectual Property Officer, email
[email protected], phone (07) 3234 1479. For further information contact Qld Blood
Management Program at [email protected] or 3131 6534.
Design: Biotext, Canberra.
Cover image: Emily receiving a blood transfusion. Photographer: Lyle Radford
Foreword
Welcome to the June 2007–2009 report of the Queensland incidents in Transfusion (QiiT)
haemovigilance system. It is with great pleasure that I present this much-anticipated first report,
which is the first step in deepening our understanding of transfusion-associated risks and guiding
improvements in transfusion practice within Queensland.
This report, which carries the title A Safer Future for Emily, captures the story of Emily, a regular
recipient of blood transfusions. Her story highlights the importance of safe blood transfusions and
the experience of the many Queenslanders who receive blood transfusions annually. My sincere
thanks to Emily and her family for their invaluable contribution to this report.
The contribution of the 107 Queensland public and private healthcare facilities that are currently
participating in QiiT should also be recognised. Clinical staff at these facilities are to be
commended for their role in providing QiiT with vital, event-related reporting.
This report provides insight into the types of transfusion-related adverse events in Queensland
healthcare facilities between June 2007 and December 2009. Our reporting of these events gives
us an opportunity to look further into the factors and conditions that contribute to transfusion
adverse events across the state. The report tables some valuable recommendations that may
guide improvements in transfusion practice and, indeed, ensure the continued improvement of
patient outcomes.
I hope the publication of this report will not only encourage further participation in QiiT, but
also build on and extend the culture of patient safety already present in Queensland healthcare
facilities through guided improvements in transfusion practice.
Dr Jeannette Young
Chief Health Officer
Chair of Queensland Blood Advisory Council
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
iii
Contents
Foreword................................................................................................................................ iii
Acknowledgments ..................................................................................................................vii
Emily needs safe blood..............................................................................................................1
1. Executive summary and main recommendations.................................................................. 5
Main recommendations...................................................................................................... 6
Current work...................................................................................................................... 8
2.Introduction.....................................................................................................................10
3. System governance........................................................................................................... 11
4. System outline.................................................................................................................. 12
5. Overview of participation................................................................................................... 13
6. Summary of events reported ............................................................................................. 15
Validated events...............................................................................................................16
Patient demographics....................................................................................................... 17
Blood component .............................................................................................................18
Severity and imputability...................................................................................................18
Primary contributory factors and primary site...................................................................... 19
Medical officer review....................................................................................................... 20
7. Transfusion-transmitted infection...................................................................................... 21
Discussion ....................................................................................................................... 21
Summary......................................................................................................................... 22
Practice guidelines............................................................................................................23
8. Incorrect blood component transfused.............................................................................. 24
Discussion....................................................................................................................... 24
Summary......................................................................................................................... 26
Practice guidelines............................................................................................................27
9. ABO haemolytic transfusion reaction................................................................................. 28
Discussion....................................................................................................................... 28
Summary......................................................................................................................... 29
Practice guidelines........................................................................................................... 29
10. Acute non-ABO haemolytic transfusion reaction and delayed haemolytic transfusion reaction......30
Discussion....................................................................................................................... 30
Summary.......................................................................................................................... 31
Practice guidelines............................................................................................................ 31
11. Febrile non-haemolytic transfusion reactions......................................................................32
Discussion........................................................................................................................32
Summary..........................................................................................................................33
Practice guidelines............................................................................................................33
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
v
12. Severe allergic reactions and anaphylaxis.......................................................................... 34
Discussion....................................................................................................................... 34
Summary......................................................................................................................... 34
Practice guidelines............................................................................................................35
13. Acute respiratory reactions .............................................................................................. 36
Discussion....................................................................................................................... 36
Summary......................................................................................................................... 36
Practice guidelines............................................................................................................37
Appendix A Data set/definitions of transfusion adverse events............................................... 38
Appendix B QiiT transfusion reaction chart............................................................................ 40
Appendix C TRALI – information for medical officers................................................................ 41
Appendix D QiiT process (extract from pilot project)................................................................45
Appendix E RRMA classification........................................................................................... 46
Appendix F Imputability and severity scores......................................................................... 47
Appendix G Blood Products Advisory Committee information developed for IMP notifications..... 48
Abbreviations........................................................................................................................ 50
References............................................................................................................................. 51
vi
A Safer Future for Emily
Acknowledgments
The Queensland Blood Management Program (QBMP) would like to acknowledge the contribution
of the following committees, groups, agencies, departments and individuals to the QiiT
haemovigilance system and the development of this report:
•
haemovigilance coordinators at participating public and private healthcare facilities
•
clinical staff at participating public and private healthcare facilities who have reported events
and supported the haemovigilance coordinators in the completion of the QiiT
follow-up forms
•
Haemovigilance Committee members
Dr Bronwyn Williams
Royal College of Pathologists of Australasia representative
(Co-Chair)
Dr Ann Gillett
The Royal Australasian College of Physicians representative
Dr Anne Haughton
Australian Association of Pathology Practices representative
Dr Brian Bell
Directors of Medical Services Advisory Committee
representative
Dr Lance Le Ray
Directors of Medical Services Advisory Committee
representative
Ms Di Slater
Private Hospitals Association of Queensland representative
Ms Glynda Summers
Office of the Chief Nursing Officer representative
Dr John Rowell
Pathology Queensland representative
Dr John Wakefield
Queensland Health Patient Safety and Quality Improvement
Service representative
Dr Stewart Bryant
Australian Red Cross Blood Service representative
Dr Michael Fanshawe
Royal Australasian College of Obstetricians and Gynaecologists
representative
Dr Janet Draper
Royal Australasian College of Obstetricians and Gynaecologists
representative
Ms Wendy Haynes
Royal College of Nursing, Australia representative
Prof Michael Humphrey
Queensland Health Service District representative
Dr Judy Graves
Queensland Health Service District representative
Dr David Slaughter
Queensland Health Service District representative
Dr Robert Bird
Queensland Health Service District representative and
former Chair
Dr Gina Clare
Queensland Blood Management Program, Queensland Health
Dr Simon Brown
Queensland Blood Management Program, Queensland Health
(Co-Chair)
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
vii
•
QiiT Working Group members
Ms Natasha Kearey
Ms Roxina Sharma
Ms Anita Booker
Ms Magda Gouws
Dr Michelle Bryson
Ms Carey Gadischkie
Ms Lynelle Foster
Ms Sue Williams
Ms Anne Bubbers
Mr Leigh Broad
Ms Leanne Hollis
Ms Christine Long
Dr Luke Soo
Ms Kathy Toumpas
Dr Peter Mollee
Ms Rebecca Farrell
Ms Cheryl Kann Mr David Stone
Ms Janelle Toombes
•
agencies, committees, departments and programs
–– Pathology Queensland
–– Queensland Medical Laboratories (QML)
–– Sullivan Nicolaides Pathology (SNP)
–– The Australian Red Cross Blood Service (ARCBS)
–– Queensland Health Patient Safety and Quality Improvement Service
•
Ms Patricia Pennicott, Integrated Communications, Queensland Health
•
Ms Prue Law and Ms Nicole Stephensen, Queensland Health Legal Unit
•
Mr Neil Gardiner, Health Statistics Centre, Queensland Health
This report was prepared on behalf of the QBMP, Haemovigilance Committee and QiiT Working
Group by
viii
•
Dr Simon Brown
•
Ms Dal Johal
•
Ms Natalie Winter.
A Safer Future for Emily
Emily needs safe blood
Emily looks at home in the busy and confronting hospital ward, unlike many of the children
around her.
Every month for the past 12-and-a-half years, Emily has come to the Royal Children’s Hospital for
a blood transfusion.
When she was about three months old, Emily’s parents, Vernon and Tina, sought medical advice
because Emily wouldn’t eat. She was diagnosed with thalassaemia.
Thalassaemia is an inherited blood disorder
where the body cannot make enough of the
globin chains that make up haemoglobin, the
protein in red blood cells that carries oxygen.
Thalassaemia causes ineffective production
of red blood cells.
If untreated, severe thalassaemia can lead
to life-threatening anaemia, an enlarged
spleen, bone deformities and heart failure.
On a cool, sunny May morning, Emily sits
cross-legged on the hospital bed giggling
like a typical schoolgirl. This healthy-looking,
playful young teenager in denim shorts and
T-shirt, with her dark hair loosely pulled
back, laughs with her dad about a cheeky
little duck on YouTube.
As a Year 8 student, Emily is a typically
active 13-year-old who loves netball, hip hop
dancing and cheerleading when back home.
Her face lights up as she tells her dad about
what her school friends will be up to today.
But while her mates are in class, on the
netball field, or chatting and giggling on their
way home on the bus, Emily will be attached
to her intravenous ‘lifeline’ as three to four
bags of blood are pumped into her young
body over about eight hours.
Thalassaemia is usually treated with regular
blood transfusions and folate supplements.
But while transfusions can lengthen the
patient’s lifespan, they will not cure the
disorder.
‘I don’t get tired of having to go through
the transfusions. The nurses and doctors
are really lovely and it doesn’t hurt at all,’
Emily says.
Emily receives regular blood transfusions at the Royal
Children's Hospital
Photographer: Lyle Radford
‘It’s just like staying home for the day and relaxing. I sometimes do my homework, watch TV, play
games, or have a little sleep. It’s very comforting and just like a second home to me now.’
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
1
Thalassaemia occurs when there is a defect in a gene that helps control production of one of
haemoglobin’s proteins — alpha globin or beta globin. Hence, there are two types of thalassaemia
— alpha thalassaemia and beta thalassaemia.
Alpha thalassaemia occurs most commonly in people from Southeast Asia, the Middle East, China
and those of African descent. Beta thalassaemia occurs in people of Mediterranean origin, North
and West Africa, India and South-East Asia, including Pacific Island populations.
Emily has beta thalassaemia major, which means she inherited one abnormal beta globin gene
from each of her parents, who unknowingly were both carriers of the disorder.
Bone marrow transplant — the only definitive cure for thalassaemia — has been used worldwide
for about 20 years. But it has risks, depending on availability of a compatible family donor and age
and health of the recipient. It also carries very high chances of permanent infertility.
Emily has no siblings and no compatible family donor for bone marrow. The chances of finding a
suitable unrelated donor are not very high. Unrelated transplant is also significantly more risky
and more expensive.
Emily's dad, Vernon, has been accompanying her every month for more than 12 years
Photographer: Lyle Radford
2
A Safer Future for Emily
Emily’s strongest support network — her parents — are well acquainted with what their daughter
goes through every month. After more than 12 years of accompanying her to her monthly
transfusions and monitoring her ongoing treatment, these very loving parents quite rightly believe
they are reasonable experts on what is required and how it should be done.
‘One time after a transfusion Emily got a very high fever, above 40 degrees,’ says Vernon. ‘We had
to bring her back to hospital, but the staff insisted it was swine flu. We knew it wasn’t swine flu.
We knew it was an infection from the blood transfusion.
‘Getting the quantity of blood right is also important,’ he says. ‘So is the stability of staff. It’s good
to have the same people doing the transfusions for Emily.
‘If the nurses or doctors have not done Emily’s transfusions before, I won’t leave her alone at all.
It’s important for her to have the same staff who know how to do it.’
Emily pipes in: ‘The worst part is when I have a doctor or nurse who hasn’t been before and they
can’t get the needle into my vein.
‘But the best part is that everyone is really nice. It’s a good environment. And it’s easy. If it was
hard, I wouldn’t want to come.
‘The transfusions give me more stamina and keep me healthy. And it means I don’t have to have a
bone marrow transplant. I prefer the transfusions over the risk of a bone marrow transplant. This is
much better for me. And the doctors and nurses are really trustworthy.’
Then with another giggle: ‘But it would be good if they changed the TV programs, instead of
repeating the same ones, or the same segments, again and again. I can’t stand watching that
talking parrot anymore.’
When she was very young, Emily’s transfusions were done through a port-a-cath surgically
inserted under the skin on her chest with a tube connected to a large vein. But when she was old
enough, she decided to have the transfusions through an external IV line inserted in her hand, so
the port was removed.
‘Emily makes the decisions herself,’ says Vernon. ‘She is the one who goes through it, so she has
to feel comfortable.
‘It’s not right for Tina and me to decide on bone marrow. It is up to Emily. But if she hated the
transfusions, then obviously we would advise her to look at other options.’
While multiple blood transfusions help control thalassaemia symptoms, they also result in iron
overload. If not removed, the excess iron will slowly harm the body’s organs and can result in
severe morbidity, such as cardiac disease, diabetes, failure of sexual development, osteoporosis
or liver damage, as well as early mortality.
Chelation therapy removes the excess iron and is an integral part of thalassaemia treatment. But it
was one of the hardest aspects for Emily in the past.
Her chelation was initially done by desferrioxamine infusion with a thin needle for 8 to 12 hours,
five nights a week, using noisy pumps. The needle insertion site can often become painful, with
bumps, rashes, bruises and infections occurring.
About two years ago, Emily started on oral iron chelator drugs instead and now finds chelation
much easier.
Vernon downplays the impact of Emily’s medical condition on the close-knit family.
‘There is no impact. Apart from the fact that I have to put up with her music on the way to the
hospital,’ he laughs.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
3
‘Seriously, it’s just the way it is. Obviously, we would prefer she didn’t have it, but it has no impact
on the family and it doesn’t affect her school work either.’
Emily only recently told her close friends about her thalassaemia and regular blood transfusions.
‘If I get tired at school, I just don’t show it. I just show it at home. I have always kept it a secret. But
my friends have been really good. They don’t tease me.’
The family is acutely aware that Emily’s numerous and regular blood transfusions significantly
expose her to the risk of adverse reactions or incidents. They rely on the hospital and staff to
ensure she receives safe blood and that she stays safe with every transfusion.
According to Medical Officer Simon Brown at the Royal Children’s Hospital’s Haematology and
Oncology Department, Australia has one of the safest blood supplies in the world.
‘But voluntary reporting of any haemovigilance incidents across both public and private hospitals
can improve the safety of blood transfusions by detecting and detailing the unexpected effects of
transfusion.’
A significant proportion of incidents are often unavoidable adverse reactions to fresh blood
and blood components, such as allergic reactions and febrile non-haemolytic transfusion
reactions (fever).
Other incidents can include bacterial infections, incorrect blood components, inappropriate
specification or unnecessary transfusion, haemolytic reactions, transfusion-associated acute
lung injuries or graft-versus-host disease and post-transfusion purpura (when the body produces
alloantibodies to the introduced platelets).
‘Queensland Health promotes an excellent culture of learning,’ says Simon.
‘Haemovigilance encourages this learning culture where we can learn from what has happened and
constantly improve patient care. Through haemovigilance, Queensland Health is taking a leading
role in improving patient care in both public and private hospitals.’
Emily’s future depends on it.
4
A Safer Future for Emily
1. Executive summary and
main recommendations
The implementation of QiiT commenced in the last quarter of 2008. By 31 December 2009, all
15 health service districts in Queensland Health, 107 public and private healthcare facilities and
the state’s main pathology providers had agreed to participate in the program.
The role of QiiT is to capture events relating to the administration of fresh blood and blood
components in clinical areas and to contribute data to the National Haemovigilance System
administered by the National Blood Authority. The information collected by QiiT complements the
safety data already collated by the Australian Red Cross Blood Service (ARCBS).
The 230 events reviewed for this report include those reported to QiiT from the start of the pilot
project on 1 June 2007 to 31 December 2009. Staff from the Queensland Blood Management
Program (QBMP) and the QiiT Working Group have undertaken an analysis and review of
these events.
The aim of this review was to validate the events and to allow for recommendations by the QiiT
Working Group and the Haemovigilance Committee. The recommendations aim to delineate
areas for improvement in transfusion practice and avenues by which these improvements may be
addressed in Queensland healthcare facilities.
The review validated 129 of the 230 events reported to QiiT. The summary data for these events
is detailed in Chapter 6. The review of the individual categories of events that make up the QiiT
data set (Appendix A) are described in detail in Chapters 7–13. The recommendations formulated
from the 129 validated events have been divided into the main recommendations and practice
recommendations at the end of each specific category chapter.
The current rate of reporting to QiiT is encouraging and compares favourably with reporting
rates for the UK haemovigilance scheme, Serious Hazards of Transfusion (SHOT), which has
been in operation since 1996. The readiness of facilities to participate and report to QiiT reflects
the culture of safety that underpins Queensland’s healthcare systems. This culture reflects the
considerable work invested in patient safety by both private and public healthcare providers,
in particular the work of the Patient Safety and Quality Improvement Service and patient safety
officers in Queensland Health.
Of the validated QiiT events, a significant proportion can be attributed to unavoidable
adverse reactions to fresh blood and blood components, such as allergic reactions and febrile
non‑haemolytic transfusion reactions. The ARCBS, together with all Australian governments,
continues to invest in initiatives to minimise the known risks of administering fresh blood and
blood components, including universal leucodepletion and the bacterial screening of platelets.
Despite this investment, it is imperative that clinical staff appreciate that the avoidance of
inappropriate transfusions is equally important in reducing unnecessary adverse events related to
blood transfusions.
A survey of the pilot sites during the QiiT pilot project revealed that 11 per cent of the 289 clinical
staff surveyed had witnessed a transfusion reaction in the preceding month. While the majority of
these transfusion reactions are minor, the overlap in symptoms and signs between both minor and
life-threatening transfusion reactions mean that clinical staff need to be able to formulate correct
management plans to ensure potentially life-threatening events are not missed; for example, ABO
haemolytic transfusion reaction, transfusion-transmitted bacterial sepsis or transfusion-related
acute lung injury.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
5
The events reported to QiiT have shown a marked variation in the management and investigation
of transfusion reactions, which has led the Haemovigilance Committee to recommend that further
work be undertaken to address inconsistencies in this area.
Finally, it is salient to note that incidents continue to be reported of patients receiving fresh
blood and blood components intended for other patients (detailed in Chapter 8 ‘Incorrect blood
component transfused’ and Chapter 9 ‘ABO haemolytic transfusion reactions’). This scenario can,
in the worst case, result in an ABO haemolytic transfusion reaction and even death.
Evidence from international haemovigilance systems clearly shows that human error is a major
factor in both events of incorrect blood component transfused and ABO haemolytic transfusion
reactions. On current evidence, the data from QiiT seems to reflect the experience of other
haemovigilance systems and suggests that ABO haemolytic transfusion reactions will continue
to be reported. This was reinforced by the findings of an audit of the administration of red cell
transfusions in Queensland healthcare facilities.1
The UK and French haemovigilance systems estimate that both incorrect blood component
transfused and ABO haemolytic transfusion reactions will be fatal in between one in 1.5 million
and one in 1.8 million red cell transfusions.2, 3 This means the administration of blood is a
comparatively safe procedure, with respect to safety in health care, and is equivalent to the
risks of receiving an anaesthetic.4 A challenge for such safe procedures is to ensure healthcare
professionals remain diligent to the potential risks, and this forms a significant rationale for
haemovigilance systems.
Despite the relative safety of blood transfusions, haemovigilance systems appear to be able
to reduce the frequency of transfusion-related fatalities. The SHOT report for 2008 revealed
that fatalities related to transfusion have continued to fall after the introduction of the UK
haemovigilance system.
These safety improvements are only achievable by the dissemination of reports such as this
to all staff involved in the transfusion chain, as well as health service managers. Queensland
Health has a commitment to the sharing of information relating to adverse events. Therefore, this
report is primarily written for clinical staff employed by private and public healthcare providers in
Queensland. However, it is also of value to the wider community, especially those with an interest
in the safe delivery of transfusions.
With this in mind, it is important that the health system continues to learn from the experience of
countries where haemovigilance has a long pedigree, and that clinical staff realise the importance
of adhering to the national guidelines for the administration of blood and blood products, as
published by the ANZSBT/RNCA in 2004.5
Main recommendations
The following recommendations have been grouped to reflect the level of the healthcare system
best positioned to implement these recommendations.
Clinical staff
1. Clinical staff must ensure that all documentation during the transfusion process is clear and
adequate. This includes the correct labelling of blood samples and request forms, prescription
of blood and blood components, collection and administration of blood and blood products
and patient observations during transfusions. This is essential for ensuring that the correct
patient receives the correct blood component and that the blood component, from donor to
recipient, is traceable.
2. Clinical staff should consider undertaking the BloodSafe e-Learning Australia program.
6
A Safer Future for Emily
3. Clinical staff should read and adhere to the national guidelines on collection
and administration of blood and guidelines on the appropriate use of blood and
blood components.
4. Clinical staff should ensure that elective transfusions are not performed out of hours
unless clinically indicated and in accordance with guidelines on appropriate use of
blood components.
Healthcare providers
1. Healthcare providers should consider the provision of local governance structures for
transfusion medicine at their facilities (for example, hospital transfusion committees, hospital
transfusion teams and a lead clinician for transfusion services).
2. All healthcare facilities and pathology service providers in Queensland should actively
participate in the Queensland haemovigilance system.
Tertiary educational institutions and medical colleges
1. Universities and colleges should consider reviewing transfusion practice content in
nursing undergraduate courses, specifically about the administration of blood and blood
components, correct patient identification and bedside checks, and the accurate and complete
documentation of transfusion episodes.
2. Medical colleges and schools should consider reviewing undergraduate and
postgraduate course content about the management of transfusion reactions and correct
patient identification.
Queensland Health
1. Queensland Health should develop a set of standardised clinical guidelines/pathways for the
management of transfusion reactions.
2. Queensland Health should encourage all public and private healthcare facilities and pathology
service providers to participate in the Queensland haemovigilance system.
3. Queensland Health should promote the development of appropriate local governance
structures for transfusion medicine in public and private healthcare facilities (for example,
hospital transfusion committees, hospital transfusion teams and a lead clinician for
transfusion services). This will promote the local ownership of transfusion practice through
auditing, training, incident review and blood management programs.
4. As part of an overall e-health implementation strategy, Queensland Health should investigate
solutions that support the ordering of blood and blood components by clinical staff, and the
traceability of blood and blood components, and minimise patient identification errors.
National
1. The National e-Learning Transfusion Advisory Committee should consider the development
of a module on the management of transfusion reactions for the BloodSafe e-Learning
Australia program.
2. The jurisdictional blood committee should review the need for legislation equivalent to the
European Union Blood Directive,6 particularly in relation to Article 14, which relates to the
traceability of blood and blood components from the donor to the recipient and vice versa.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
7
Current work
The process of implementing Queensland’s haemovigilance system, together with the continual
review of events submitted to QiiT, have resulted in the identification of several key issues about
transfusion practice in Queensland. A considerable body of work has already started to address
these issues. This work is outlined below.
a) Documentation and traceability of products
The analysis of QiiT events has identified events where the final fate of the blood component
was not recorded in the hospital chart. This means that the blood component cannot be traced
categorically to a patient. This issue of traceability is not new, indeed traceability is one of the
articles of the European Blood Directive (Article 14 ­— 2002/98/EC).6 This requires hospital blood
banks by law to ‘ensure that blood and blood products … can be traced from donor to recipient
and vice versa’. In response to the passing of the European Blood Directive as law in 2005,
many National Health Service (NHS) blood banks have invested in technology for the electronic
recording of the final fate of blood products — when they are hung and connected to a patient. The
Queensland Blood Management Program has facilitated the sharing of relevant information with
stakeholders, including the Queensland Blood Advisory Council, Laboratory Information Systems
and Solutions, and Clinical and Statewide Services Division.
b) Irradiated blood components
Multiple events of patients receiving non-irradiated blood and blood components, when they are
at risk of developing the potentially fatal complication of transfusion-associated graft-versushost disease, have been reported to QiiT. These events highlight communication problems
with the inadequate completion of blood request forms and the transfer of data electronically
between blood banks. Discussion of this issue by the Haemovigilance Committee has led to the
development of a patient leaflet, card and cognitive aid to empower the patient as an additional
advocate for the correct prescription and request of blood and blood components they require.
c) Management of transfusion reactions
Significant variability in the management of transfusion reactions has been identified from events
submitted to QiiT. Work in this area includes:
•
development of the QiiT transfusion reaction chart (Appendix B)
•
distribution of information for medical staff on transfusion-related acute lung injury
(Appendix C)
•
a request to the national steering group for the BloodSafe e-Learning Australia program to
develop a module on the management of transfusion reactions
•
commencement of work by the Blood Products Advisory Committee to develop guidelines on
transfusion reactions
•
surveys of medical schools and junior doctors to inform development and
implementation guidelines.
d) Patient identification issues
The Queensland Blood Management Program has worked in conjunction with the Patient Safety
and Quality Improvement Service and other key stakeholders to prepare an options paper
on patient identification issues. This area continues to be important in blood transfusion, as
evidenced by the number of ‘wrong blood in tube’ near-miss events, events of incorrect blood
component transfused, ABO haemolytic transfusion reactions as detailed in the previous report
— Audit of the collection and administration of blood and blood products (October 2007).1 The
8
A Safer Future for Emily
Queensland Blood Management Program has been facilitating the sharing of information about
potential IT systems to address patient identification issues and other areas of blood transfusion
practice (see (a) above). e) Appropriate use of blood and blood components
Several side-effects of blood and blood components, such as allergic reactions and febrile nonhaemolytic transfusion reactions, are a feature of giving a biological product. However, it is
known from national and international studies that the rate of inappropriate transfusion of blood
and blood components is 10–50 per cent.7-11 The reduction of inappropriate transfusions offers
an opportunity for quality improvement for patients by reducing their exposure to the known
risks of blood transfusions. The Queensland Blood Management Program is currently developing
strategies to support more effective blood use.
f) Training
In addition to multiple visits by Queensland Blood Management Program team to healthcare
facilities during the rollout of QiiT, the team has also delivered several educational talks to
healthcare professionals and presentations at scientific meetings. The Queensland Blood
Management Program sponsored the BloodSafe e-Learning Australia package on the Queensland
Health Electronic Publishing Service (QHEPS) and has promoted this transfusion training package
across the state. There has been significant use of this resource, with 9209 clinical staff having
completed the package in Queensland. Individual health service districts and healthcare facilities
are commended for implementation of this resource as a training tool for staff.
g) Governance
The implementation of adequate governance structures at the hospital level must underpin
any effort to improve transfusion safety (for example, hospital transfusion committees (HTCs)
or their equivalent). The importance of these governance structures is highlighted in the UK by
the Department of Health circular, Better Blood Transfusion: Safe and Appropriate Use of Blood
(HSC 2007/001). The initiatives detailed in this circular have led to a steady increase in healthcare
facilities implementing HTCs and transfusion teams. This has occurred at a time of decreasing
red cell use and transfusion-related fatalities.12 Similar improvements in the local governance
of transfusion practice have been evident since the introduction of the mandatory criteria 1.5.5
(relating to blood and blood components) in Evaluation and Quality Improvement Program
(EQuIP) 4 by the Australian Council on Healthcare Standards. The Queensland Blood Management
Program is now working in conjunction with the Blood Products Advisory Committee to develop
appropriate terms of reference, key performance indicators and benchmarking indicators for
use by HTCs.
h) Communication
Communication of data back to clinical and laboratory staff is key to the success of any
haemovigilance system. In recognition of this, the Queensland Blood Management Program has:
•
released quarterly QiiT newsletters
•
undertaken a survey of haemovigilance coordinators across the state to gauge the performance
of the system and the QiiT team
•
developed a Queensland Health forum site for Queensland Health staff on QHEPS
•
provided a biannual audit report to participating healthcare facilities
•
submitted key performance indicators for the QiiT system to the Queensland Blood Advisory
Council.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
9
2.Introduction
The Queensland Government, as a cosignatory of the National Blood Agreement, has a
responsibility ‘to promote safe, high-quality management and use of blood products, bloodrelated products and blood-related services…’ In order to meet these and other obligations
contained in the agreement, Queensland Health established the Queensland Blood Management
Program, within Clinical and Statewide Services (CaSS).
The Queensland Blood Management Program, in meeting its obligations, identified the need
to support the clinical governance framework for transfusion practice within Queensland. It
proposed the development of a statewide haemovigilance system, which has been defined as
‘the detection, gathering and analysis of information regarding untoward and unexpected effects
of blood transfusion’ (Guide on Preparation, Use and Quality Assurance of Blood Components,
Recommendation No. R (95)15, 9th ed. 2003). This proposal was supported by public and private
health service providers, the ARCBS and pathology providers. A pilot system, modelled on
international haemovigilance systems, was trialled during 2007 with positive results.13 This system
was later endorsed by the Queensland Health Executive Management Team and the rollout of the
system to Queensland’s public and private healthcare facilities began. The system was aptly titled
‘Queensland incidents in Transfusion’ (QiiT).
The QiiT haemovigilance system, together with other Australian states and territories, contributes
data to the National Haemovigilance System, as established by the National Blood Authority.
The objectives of this national haemovigilance system are to ‘provide documented evidence
for improvement of practice, to know what the real risks/hazards of transfusion are in a given
community/country, to disseminate the findings and to take appropriate action as well as instigate
appropriate education processes to prevent their recurrence’.14 Queensland’s contribution
of data to the national system, together with the development of this report and associated
recommendations, provide an opportunity to look further into the factors and conditions that
contribute to transfusion adverse events.
10
A Safer Future for Emily
3. System governance
The Queensland Blood Advisory Council is an advisory committee which supports the role of the
Queensland Blood Management Program. The Queensland Blood Board is chaired by Queensland’s
Chief Health Officer and its membership includes representatives from both the public and private
healthcare sectors.
The Haemovigilance Committee, a sub-committee of the Queensland Blood Advisory Council, is
the governing body for the QiiT system. Membership to this committee is voluntary and currently
includes a range of blood sector stakeholders. The work of the Haemovigilance Committee is
centred on the provision of high-level strategic direction for the development and maintenance
of QiiT. The committee provides policy advice to the Queensland Blood Advisory Council on QiiT,
as well as the production and dissemination of information to stakeholders on the operation and
findings of QiiT, with the support of the QiiT Working Group.
The QiiT Working Group is a sub-committee of the Haemovigilance Committee and is responsible
for the further analysis and review of certain events reported to QiiT, as well as appropriate
recommendations on events. Membership of the QiiT Working Group is also voluntary and consists
of nursing, pathology, medical and patient safety representatives employed in both the public and
private healthcare sectors.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
11
4. System outline
The QiiT haemovigilance system collects de-identified data on incidents with the transfusion of
fresh blood and blood components (for example, red cell, fresh frozen plasma, cryoprecipitate and
platelets) in clinical areas. The ARCBS collects data on adverse events within the blood collection
service, therefore this does not form part of the data set collected for QiiT.
QiiT has adopted several strategies to minimise the impact of reporting transfusion-related
adverse events on the workload of clinical staff, including:
1. using existing incident reporting systems (for example, PRIME in public healthcare facilities),
thus avoiding duplicate reporting
2. limiting the QiiT data set — the type of events reported
3. developing follow-up forms that collect data for the validation and analysis of events, and help
clinical staff in the local analysis of events.
The QiiT process is outlined in Appendix D.
12
A Safer Future for Emily
5. Overview of participation
As of 31 December 2009, all of Queensland’s health service districts, as well as 75 public
healthcare facilities and 32 private healthcare facilities, had agreed to participate in QiiT.
Participation in QiiT is voluntary, and nine healthcare facilities have declined participation.
Estimates at this time suggested 36 public and 9 private healthcare facilities that perform blood
transfusions were yet to be contacted or yet to agree to participate in the system (Table 1). This
estimate represents 30 per cent of all QiiT eligible healthcare facilities.
Table 1
Public
Participation of healthcare facilities in the QiiT haemovigilance system
Eligible to participate
Participating
Not yet participating
Percentage remaining
111
75
36
32%
Private
41
32
9
22%
Overall
152
107
45
30%
The Rural, Remote and Metropolitan Areas
system is a classification system that describes
the areas of medical practice within Australia
(Appendix E). The system divides the rural,
remote and metropolitan areas, according to city
status, population, rurality and remoteness. The
spread of the 107 healthcare facilities currently
participating in QiiT is charted in Figure 1.
RRMA 5
15%
RRMA 1
26%
RRMA 4
10%
RRMA 3
24%
Figure 1
RRMA 2
25%
Distribution of participating
healthcare facilities according to
Rural, Remote and Metropolitan
Areas (RRMA) classification
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
13
A computer monitor and blood treatment equipment in a hospital pathology lab
Photographer: Michael Marston
14
A Safer Future for Emily
6. Summary of events reported
From 1 June 2007 until 31 December 2009, 230 events were submitted to QiiT. Of these 230 events,
129 were classified as valid when compared with the data set definitions (Appendix A). Of the
remaining 101 events reported to QiiT, 33 events could not be analysed, as the follow-up form was
not returned, 9 events were reported in duplicate, and 59 events were considered invalid when
assessed against the data set definitions.
Key factors that contributed to events being deemed invalid include:
•
insufficient detail available to make a decision, despite attempts to locate further details in the
patients records by the haemovigilance coordinator
•
data provided did not fit the data set definitions as prescribed by QiiT (Appendix A) — every
attempt was made to validate reported events, including in some cases obtaining more
information from the reporting centre or the reassigning of events to another category.
The distribution of the 230 events reported to QiiT is shown in Figure 2.
58
60
54
50
40
34
30
Figure 2
4
3
2
2
1
Post-transfusion purpura
ABO haemolytic
transfusion reaction
Transfusion-associated
graft-versus-host disease
6
Anaphylaxis/anaphylactoid
reaction
Acute non-ABO
haemolytic transfusion
reaction
Incorrect blood component
transfused
Severe allergic reaction
Bacterial
contamination/TTI
Febrile non-haemolytic
transfusion reaction
0
9
Transfusion-related acute
lung injury
13
10
Delayed haemolytic
transfusion reaction
20
Transfusion associated
cardiac overload
Number of events
43
Distribution of events reported to QiiT between June 2007 and December 2009 classified by
category (n = 229)
Note: one event outside the data set and later classified as invalid is not included in this analysis. Transfusion-transmitted
infection definition includes bacterial contamination. All transfusion-transmitted infection (TTI) events received by QiiT
related to potential bacterial contamination. For event category definitions, please refer to Appendix A.
Although transfusion-transmitted infection was the most frequently reported adverse event,
all events were due either to initial machine positive reporting or confirmed events of bacterial
contamination, as detected through the bacterial screening of platelets introduced by the ARCBS
in early 2008. No confirmed events of transfusion-transmitted infections were reported to QiiT up
to 31 December 2009.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
15
Validated events
Of the 129 events classified as valid, the two most frequently reported event categories were
bacterial contamination (reported within the transfusion-transmitted infections category) and
severe allergic reaction. The spread of the 129 validated events across the QiiT data set is shown
in Figure 3.
39
40
35
31
Number of events
30
26
25
20
18
15
Figure 3
2
2
2
1
1
Delayed haemolytic
transfusion reaction
Transfusion-associated
cadiac overload
Post-transfusion purpura
Acute non-ABO haemolytic
transfusion reaction
3
Transfusion-related
acute lung injury
Incorrect blood component
transfused
Febrile non-haemolytic
transfusion reaction
Severe allergic reaction
Bacterial contamination
of blood product
0
ABO haemolytic
transfusion reaction
4
5
Anaphylaxis/anaphylactoid
reaction
10
Distribution of validated events reported to QiiT (n = 129)
For event category definitions, please refer to Appendix A.
Of the validated events, 18 were reassigned from the original event category. For the final
validated category, the number of events reassigned during the review process included five as
severe allergic reaction/anaphylaxis, three each as transfusion-related acute lung injury and ABO
haemolytic transfusion reaction, six as febrile non-haemolytic transfusion reaction and one as
bacterial contamination.
There were no events of transfusion-associated graft-versus-host disease reported to QiiT. There
was one event validated as post-transfusion purpura, but this case was assigned a low imputability
score (level 2 — possible) as the cause of the thrombocytopenia was, upon review, considered
to be due to causes other than the transfusion. Neither transfusion-associated graft-versus-host
disease nor post-transfusion purpura will be discussed further in this report.
16
A Safer Future for Emily
Patient demographics
The age distribution of the 129 validated events is shown in Figure 4. The age distribution of events
is consistent with the reported demographics of transfusions in Australia and internationally.15, 16
With respect to the demographics of events reported to haemovigilance systems in the UK Serious
Hazards of Transfusion (SHOT) system, the number of events reported per 100 000 transfusions
was significantly higher in children less than 18 years old, and particularly for infants under
12 months.17 The comparative figures for the incidence of adverse events for adults, children under
18 years and infants under 12 months are 13 per 100 000, 18 per 100 000 and 37 per 100 000 units
of red cells issued, respectively. Importantly, the age ranges used for QiiT will allow analysis of
outcomes for neonates, infants and children.
While the number of events reported to QiiT (so far) is relatively small, by selecting suitable age
ranges it will be possible to perform a similar analysis in the future. Of the three events reported
as involving neonates, two were due to an incorrect volume being infused and the third was due
to an incorrect blood component transfused event where the neonate did not receive blood of the
correct specification.
40
35
30
Age frequency
25
20
15
10
Figure 4
Not specified
>80 years
70–79 years
60–69 years
50 –59 years
40–49 years
30–39 years
20–29 years
10–19 years
1–4 years
28 days – 1 year
0
< 28 days
5
Age
Age distribution of validated events reported to QiiT (n = 129)
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
17
Of the 129 validated events reported to QiiT, the
number of events involving males and females
was 70 and 48 respectively (Figure 5). For the
remaining 11 events, the gender of the patient
was not specified.
Female
37%
Blood component
Figure 6 shows the distribution of the
primary blood component associated with
the 129 validated events. Most events were
associated with the transfusion of red cells, as
would be expected from the relative number
of different blood components issued by the
ARCBS in Queensland. The frequency of events
associated with the transfusion of platelets
can, in part, be attributed to the introduction
of bacterial screening of platelets and the
collection of data on bacterial contamination
as a component of the transfusion-transmitted
infection category.
Five events involved the infusion of multiple
blood and blood components, in addition to
the primary blood component. The multiple
components were red cells with platelets (2), red
cells with fresh frozen plasma (1), red cells and
cryodepleted plasma (1) and platelets with both
red cells and fresh frozen plasma (1).
Male
54%
Unknown
9%
Figure 5
Cryodepleted
plasma
1%
Fresh frozen plasma
17%
Unspecified 5%
Red cells
50%
Platelets
26%
Severity and imputability
Part of the validation process includes
assessment of the severity of the reaction
and an assessment of the likelihood that the
reaction is related to the administration of the
blood component (imputability). (See Appendix F
for severity score and imputability grades.)
The severity and imputability scores for these
events are shown in Figures 7 and 8.
Gender distribution of validated
events reported to QiiT (n = 129)
Whole blood 1%
Figure 6
Distribution of primary blood
and blood components linked to
validated events (n = 129)
Of the 129 validated events reported, one resulted in death. This fatality was validated as a
possible case of transfusion-associated cardiac overload, but review of the case assigned a
low imputability score (level 2 — possible) as the transfusion of the blood component was not
considered the likeliest cause of death as the patient had significant medical co-morbidities.
A further six events (two anaphylaxis, one severe allergic, two transfusion-related acute lung
injuries and one ABO haemolytic transfusion reaction) were classified as immediate vital (Grade 3).
18
A Safer Future for Emily
Grade 4, 1%
Level 4, 3%
Not assessable, 9%
Not assessable, 3%
Grade 3, 5%
Level 3
25%
Grade 0
36%
Grade 1
49%
Figure 7
Level 1
50%
Level 2
19%
Severity scores for validated events
(n = 129)
Grade 0 – absence of clinical signs; Grade 1 – absence
of immediate or long-term vital threat; Grade 3 –
immediate vital; Grade 4 – death.
Figure 8
Imputability scores for validated
events (n = 129)
Level 1 – unlikely; Level 2 – possible; Level 3 – likely/
probable; Level 4 – certain.
Primary contributory factors and primary site
The primary contributory factors for the validated events reported to QiiT are shown in Figure 9.
The largest group is ‘product (not process related)’. These refer to events where the reaction
is a known unavoidable side effect of transfusing blood and blood components; for example,
allergic reactions and febrile non-haemolytic transfusion reactions. For some events, there was
more than one contributory factor — the additional contributory factors are discussed in the
relevant chapters.
The data relating to primary site refers either to where the reaction took place (for those
unavoidable known side effects) or where the primary contributory factor occurred. The vast
majority of events occurred in the clinical area (86 events), with only five events occurring in the
laboratory. The events relating to detection of bacteria in platelets by the Blood Service have been
excluded from the figures for primary site.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
19
70
65
60
Number of events
50
40
30
20
11
10
0
Product
(not process
related)
Figure 9
Prescribing/
ordering
4
4
3
2
1
Pre-transfusion
testing and
dispensing
Administration
of product
Deliberate
clinical
decision
Did not adhere
to hospital
transfusion
procedures
Transfusion in
emergency
setting
Primary contributory factor for validated events (n = 129)
Medical officer review
The QiiT follow-up forms for febrile nonhaemolytic transfusion reaction, transfusionassociated cardiac overload, severe allergic
and anaphylaxis/anaphylactoid reaction, acute
non-ABO haemolytic transfusion reaction and
ABO haemolytic transfusion reaction gather
information about the time taken for the medical
officer to review the patient after the onset of the
transfusion reaction.
For the 129 validated events reported to QiiT,
68 of the follow-up forms included this question.
In 28 of these events, this question was left blank
or the time taken to review was unknown. Of the
remaining 40 events (Figure 10):
20
•
in 10 events, the patient was not reviewed
•
in 24 events, the patient was reviewed within
30 minutes
•
in two events, the patient was reviewed
between 30 and 60 minutes
•
in four events, the patient was reviewed after
60 minutes.
A Safer Future for Emily
Not reviewed
25%
>1 hour
9.5%
<30 minutes
60%
>30 minutes
5%
Figure 10
Time taken until medical officer
review (n = 40)
7. Transfusion-transmitted infection
Discussion
Category/
categories
Male/female ratio
Severity
Implicated blood
components
Imputability
Time of
transfusion
Age
Transfusion-transmitted
infection (TTI)
Gender
Data summary
Total number of events:
20:15
Unknown
4
<28 days
0
28 days – 1 year
0
1–9 years
1
10–29 years
0
30–49 years
6
50–69 years
16
70–79 years
7
80+ years
3
Unknown
6
In core hours
(8.30am – 5.30pm)
23
Out of core hours
(5.30pm – 8.30am)
11
Unknown
5
Level 1
0
Level 2
9
Level 3
0
Level 4
26
Not assessable
4
Red cells
6
Platelets
22
Fresh frozen plasma
1
Multiple components
1
Unknown
9
Grade 0
29
Grade 1
0
Grade 2
0
Grade 3
0
Grade 4
Not assessable
Primary
error
39
Product not process
Other
0
10
1
38
Note: For event category definitions, please
refer to Appendix A. For imputability and
severity definitions, refer to Appendix F.
There were no events of transfusion-transmitted
infections reported to QiiT up to 31 December 2009. The
39 events validated in this category were all events of
bacterial contamination of a blood component that was
transfused to a patient. Of these 39 events, all but one
of the blood components had positive identification
of the bacteria by the ARCBS as part of their bacterial
screening of platelets.
For the 38 events of bacterial contamination identified
by the ARCBS, the assigned imputability was level 4
only for those 26 events where the patient received a
platelet component that had been directly sampled and
used to inoculate the BacT/ALERT Automated Microbial
Detection system. For events related to the transfusion
of fresh frozen plasma or red cells, a lower imputability
was assigned to reflect that the positive culture result
was obtained from sampling of an associated platelet
pool, and not from direct sampling of the red cells or
fresh frozen plasma.
All of the 38 patients who received a blood component
with an associated positive culture from the ARCBS’s
screening program were Grade 0 (Appendix F) on
the severity grade for the ‘reaction’. The organisms
identified from the cultures in these 38 events were
Propionibacterium sp. (4), Corynebacterium sp. (32),
Staphylococcus hominis (1), and Staphylococcus sp.
plus Micrococcus sp. (1).
The only other case of bacterial contamination of a
blood component was the finding of Sphingomonas
paucimobilis in the culture taken from a red cell unit
after a reaction initially thought to be a non-ABO
haemolytic reaction. Subsequent investigations did
not confirm a haemolytic transfusion reaction and the
positive culture from the red cell unit was an incidental
finding, with no evidence the patient had a transfusiontransmitted infection with this organism.
Following a review of the follow-up form for transfusiontransmitted infections, the form was amended to
capture details of the events after notification of medical
officers of the initial machine positive (IMP) notification
by pathology staff. The amended form was used for 14 of
the events validated for this report. Table 2 summarises
this data.
The data in Table 2 is only a small sample of patients
(n = 14) and for five events it is not known if antibiotics
were prescribed after the IMP notification. Of the
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
21
remaining nine events, five patients were already on antibiotics and three had antibiotics
prescribed following the IMP notification. The data shows some variation in practice that likely
reflects the patient’s medical co-morbidities and variation in medical practice to this new
clinical scenario.
Only one patient developed a fever 24 hours after the infusion of platelets. This patient had a
positive blood culture from the day before the platelet transfusion and was already receiving
broad-spectrum antibiotics.
Table 2
Analysis of 14 events of bacterial contamination. All 14 patients received platelets.
No antibiotics
Antibiotics
prescribed after IMP prescribed after
notification
IMP notification
Total
On antibiotics
before IMP
notification
Unknown
Total
1
3
5
5
14
Inpatient/outpatient/unknown
1/ 0 / 0
2/1/0
5/0/0
4/0/1
12 / 1 / 1
Reviewed by medical officer
yes/no/unknown
0/0/1
3/0/0
4/0/1
0/0/5
7/0/7
Blood culture done/not done/
unknown
0/1/0
2/1/0
0/5/0
0/4/1
2 / 11 / 1
Pyrexia yes/no/unknown
0/0/1
0/3/0
1/3/1
0/0/5
1/6/7
IMP – initial machine positive
Of the 38 events identified from positive cultures by the ARCBS, follow-up of the events for QiiT
evidence for administration of the blood component was not documented in the medical charts for
six patients. As these ‘contaminated’ components randomly enter the healthcare system, the lack
of traceability for the final fate of 16 per cent of these components is likely to reflect the true error
rate in traceability, using the current paper-based methods of documentation.
Summary
The introduction of bacterial screening of platelets by the ARCBS is an important advance in
minimising the risk of bacterial-transmitted transfusion reactions. Bacterial contamination
of platelet components occurs in about one in 3000 platelet products, and the rate of septic
transfusion reactions following platelet transfusions is about one in 25 000.18, 19
The introduction of bacterial screening has reduced the exposure of patients to blood components
contaminated with bacteria. Even in those patients who receive contaminated components as
defined by a positive culture in the screening system (BacT/ALERT), the risks of developing a septic
transfusion reaction are low.18, 19 In the Netherlands, one patient out of 158 patients who received
a transfusion of platelets found to be culture-positive developed a reaction, and this reaction was
thought unlikely to be due to the bacterial contamination.
The data submitted to QiiT, and the more extensive data collected by the ARCBS are consistent
with the data from the Netherlands, and reflect the low pathogenicity of the diphtheroids
(Propionibacterium sp. and Corynebacterium sp.), the most common organisms grown.
The implementation of the BacT/ALERT screening of platelet products does not totally protect
recipients against developing a septic transfusion reaction18 and clinical staff must continue to be
vigilant for this often fatal complication of transfusion.
When the platelet screening program was implemented by the ARCBS, the Blood Product
Advisory Committee developed clinical guidelines that were distributed to all pathology providers
22
A Safer Future for Emily
(Appendix G). This guidance was to be distributed by pathology providers when they notified
clinical staff of the IMP to aid the management of the patient who has received the potentially
contaminated blood component.
Finally, the 16 per cent lack of traceability of the final fate of the bacterially contaminated
components is similar to previously reported rates of traceability.20, 21 Electronic systems to track
and manage blood product stocks both within and after they are issued from the blood bank have
the potential to dramatically improve traceability.22 Implementation of these systems has occurred
in European countries after the introduction of the EU Directive (Directive 2002/98/EC).6
Practice guidelines
•
Healthcare facilities should have procedures in place based on the national guidelines for the
administration of blood5 that specify the standards for recording and documenting transfusions
of blood products in medical charts.
•
Clinical staff should refer to the advice from pathology providers when notified of an IMP
(potentially contaminated blood component) for guidance in the management of the patients
who have received the implicated blood component.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
23
8. Incorrect blood component transfused
Discussion
Imputability
Time of
transfusion
Age
categories
Gender Category/
Data summary
Incorrect blood component
transfused
Total number of events:
Male/female ratio
Implicated blood
components
Severity
10:7
Unknown
1
<28 days
1
28 days – 1 year
2
1–9 years
0
10–29 years
3
30–49 years
2
50–69 years
8
70–79 years
2
80+ years
0
Unknown
0
In core hours
(8.30am – 5.30pm)
13
Out of core hours
(5.30pm – 8.30am)
5
Level 1
0
Level 2
0
Level 3
0
Level 4
18
Not assessable
Primary error
18
0
Red cells
11
Platelets
2
Fresh frozen plasma
2
Multiple components
1
Whole blood
1
Unknown
1
Grade 0
17
Grade 1
1
Grade 2
0
Grade 3
0
Grade 4
By definition, no incorrect blood component
transfused events were associated with any adverse
outcome for the patient.
Although the QiiT data set does not include nearmiss events related to the incorrect labelling of blood
samples or wrong blood in tube (WBIT) events, the
collection of data from a subset of the healthcare
facilities participating in QiiT has allowed the
inclusion of some data on WBIT events. The number
of WBIT events reported to QiiT up until 31 December
2009 is 273. These WBIT events are only those that
have been detected by pathology laboratories due to
inconsistencies in laboratory results; for example, a
change in ABO blood group between tests.
International data has shown that labelling errors
of blood samples are very common, with one in
165 samples affected, and that WBIT events occur in
one in 2000 blood samples.23 To put this in a local
context, Pathology Queensland registers about
2.2 million blood samples each year. Therefore,
although a significant proportion of WBIT samples are
detected by pathology providers, it is likely that many
samples are not detected and this could result in:
•
prescribing of blood products for test results that
do not belong to the intended patient, leading to
inappropriate transfusions
0
•
missing an alloantibody on the antibody screen
Not assessable
0
•
Administration of
product
potentially an ABO or Rh D mismatched
transfusion.
2
Deliberate clinical
decision
2
Prescribing/ordering
Pre-transfusion
testing and
dispensing
11
3
Note: For event category definitions, please
refer to Appendix A. For imputability and
severity definitions, refer to Appendix F.
24
Eighteen events were validated under the incorrect
blood component transfused category. Analysis of
these 18 events identified four broad contributory
factors that had led to the events — failures of
checking processes and procedures, failure to share
clinical information, events related to deliberate
clinical decisions and one case that highlighted the
need for forward planning. Each of these four areas is
discussed below.
A Safer Future for Emily
Clinical staff should be aware of the potential
consequences of mislabelling samples sent to
pathology.
There were five events that
fell into this broad category
of incorrect blood component
transfused. Two events related to
the failure of checks to identify
incorrect settings on infusion
devices resulting in the wrong
volume being infused. This was a
particular problem for neonates
and children where pumps are
routinely used to deliver the
correct volume of the blood
component.
Two patients received the wrong
blood component. In one case,
a patient was prescribed and
administered a blood component
that was required by another
patient on the ward.
In one case, the cross-match
labels for two units of red cells
were transposed in the laboratory.
The first unit was transfused
without the error being detected
by the bedside checks, but when
the second unit was taken to the
ward the correct bedside checking
process detected the discrepancy
between the blood unit number
on the blood bag and the crossmatch label. Fortunately, both
units were intended for the same
patient, but a similar labelling
error and failure of bedside
checks could have resulted in
a patient receiving blood of the
incorrect blood group.
Case one*
Case two*
A blood bank was contacted at
midnight for an emergency supply of
blood for a neonate born prematurely
with hydrops due to haemolytic
disease. The supply of red cells
was complicated by the emergency
nature of the situation. According
to ANZSBT guidelines, the red cells
should be less than five days old
and used within 24 hours following
irradiation. The existing blood stocks
in the hospital did not hold irradiated
blood compatible with these national
guidelines, and in view of the clinical
urgency, red cells that did not meet
the criteria for age or time from
irradiation had to be transfused. No
adverse effect was experienced by the
neonate.
A 24-year-old woman (blood group A)
was transfused group O red cells
meant for another patient on another
ward. Both patients shared the same
surname. Fortunately, the error was
picked up when the blood was collected
for the other patient (blood group O).
If the error had not been picked up
when the blood was collected for the
other patient it could have resulted
in a potentially fatal transfusion of
group A red cells to an individual who
required group O red cells.
Further analysis of this case
could highlight issues about
communication, planning of blood
bank inventories, facilities for
irradiation of blood components
or supply issues. Appropriate local
analysis of such events is required
to identify system failures that could
help to prevent similar situations in
the future. There are opportunities
for improving clinical and laboratory
services by learning from events
where no harm is caused to the
patient. It is recommended that all
healthcare staff attend appropriate
training (for example, the HEAPS
course offered by the Patient Safety
Centre) and participate in incident
reporting and local analysis of events.
CASE STUDY
1. Failure of checking
processes and
procedures
So how did this happen? When the
blood was collected from the blood
bank, the wrong unit was picked
up from the blood fridge due to the
identical surnames. The laboratory
staff then issued the unit using the
surname on the cross match label
(which was stuck to red cell unit),
rather than the patient ID which had
been brought to the blood bank by
the nursing staff. This meant that the
discrepancy in the first name, date of
birth and UR number was not picked
up. This error then continued to the
bedside where adequate bedside
checks were not performed and the
blood was transfused. All these events
occurred within core working hours on
a weekday.
* The data in this case study has been used in a
de-identified manner to create this typical case
example. This is not an actual case, however, it
can be used to accurately illustrate key findings.
2.Information-sharing
There were 10 events where the lack of sharing of clinical information resulted in the incorrect
blood component being transfused. In eight of these events, patients received blood of the
incorrect specification; for example, non-irradiated or CMV-negative blood components (total
of 20 units). These transfusions potentially could have resulted in transfusion-associated graftversus-host disease or CMV infections in susceptible patient groups; for example, patients
receiving chemotherapy. In two events, clinical staff failed to follow hospital protocols and inform
the blood bank staff of special requirements for patients undergoing specific medical procedures.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
25
CASE STUDY
Case three*
A 65-year-old man receiving
fludarabine for non-Hodgkin’s
lymphoma should have received
irradiated blood components to
prevent possible transfusionassociated graft-versus-host disease.
However, the request forms sent to
the blood bank failed to contain the
information that the patient required
irradiated blood components and
the patient received 10 units of
non-irradiated red blood cells. The
need for irradiated blood had been
placed on the patient’s laboratory
file as a ‘flag’ to remind laboratory
staff to select irradiated blood. But
the patient’s care was transferred
to another hospital and the flag
indicating the need for irradiated
blood did not automatically transfer
between the laboratory information
systems.
components are requested. This is the
responsibility of the staff requesting
the blood components. Patient
groups who require irradiated blood
components are listed in the national
ANZSBT guidelines.
The laboratory IT system flag serves
as an additional check to remind
laboratory staff to issue irradiated
blood. But such ‘flags’ may not be
transferred between blood bank
laboratories at different healthcare
facilities, so medical staff must
ensure their local blood bank staff are
aware of these special requirements.
Transfusion-associated graft-versushost disease has been associated with
use of red cells, platelets and whole
blood, but not fresh frozen plasma
or cryoprecipitate. The mortality rate
is high (90 per cent) if transfusionassociated graft-versus-host disease
develops.
Where patients received nonirradiated or CMV-negative blood
components contrary to their
medical requirements, the main
contributory factor was the
medical officers’ failure to detail
the need for these products
on the request form to blood
bank staff. Another contributory
factor was the lack of transfer
of relevant alerts stored on
pathology laboratory information
systems between laboratories.
3. Deliberate clinical
decision
Sometimes the supply of blood
components does not match
demand. In these situations,
clinicians may make deliberate
clinical decisions to administer
Rh D positive blood components
to patients who are Rh D
negative. This could potentially
The request form and prescription
* The data in this case study has been used in a
result in a patient developing
de-identified manner to create this typical case
should indicate the need for
example. This is not an actual case, however, it
anti-D antibodies that could
irradiated blood each time blood
can be used to accurately illustrate key findings.
complicate cross-matching
for future transfusions. This is
of particular concern in Rh D
negative women of child-bearing age due to the risk of the development of Rh haemolytic disease
of the newborn due to anti-D.
All attempts are made to minimise the risks of these deliberate clinical decisions, including the
administration of anti-D prophylaxis within 72 hours of the transfusion to prevent allo-anti-D
forming, when clinically appropriate.
In one case reported to QiiT, the prophylactic anti-D was not administered within 72 hours, but
allo-anti-D did not subsequently develop in the patient. In one case, the Rh D positive red cells
were given when the pre-transfusion haemoglobin was more than 100 g/L, and potentially the
transfusion could have been delayed until Rh D negative red cells were available.
Summary
Incorrect blood component transfused events are among those events most commonly reported
to haemovigilance systems.24, 25 Such events, and those of wrong blood in tube events, highlight
the errors that occur across the pathway of administering blood products, and have allowed
discussion of the common errors and potential solutions to some of the weaknesses in the
system.3, 26
Data from Serious Hazards of Transfusion (SHOT) shows that about 70 per cent of incorrect blood
component transfused events occur in the clinical area and that more than 50 per cent of events
involve more than one contributory factor.25 The most common single contributory factor is failure
of the final patient identification check (27 per cent of events). Of note, in 87 per cent of these
26
A Safer Future for Emily
events, previous contributory factors could have been detected by the correct procedure during the
bedside check. This data from SHOT is mirrored by the findings of an audit of the collection and
administration of blood and blood product transfusions in Queensland.1
The events reported to QiiT are consistent with the findings from other haemovigilance systems
and show that the clinical area is associated with most of the contributory factors in events of
incorrect blood component transfused (14 of 18 events).
On review of the events to QiiT, some potential future solutions to reduce the frequency of incorrect
blood component transfused events include:
•
adaptation of the 3Cs (ensuring correct patient, correct site and side, correct procedure) to the
final bedside check
•
ensuring transmission of relevant transfusion alerts between pathology laboratories
•
electronic ordering of blood products with in-built forcing functions to ensure special
requirements and appropriateness of transfusion are dealt with when ordering blood products
•
engaging consumers of healthcare services to be aware of and participate in procedures, such
as patient identification checks
•
full implementation of written informed consent for transfusions, to allow a further opportunity
to review the appropriateness of the transfusion by the clinical staff and patient
•
use of technology to reduce human errors at critical steps in the transfusion pathway, such as
the administration of blood products at the bedside
•
zero tolerance of mislabelled samples received by pathology.
Practice guidelines
•
Healthcare facilities should develop and implement procedures:
•
–– that outline the minimum standards of patient identification and procedure required for the
collection of blood products
–– for formally checking the identification of the patient against the blood component label at
the bedside. This procedure should reference the national administration guidelines.5
The blood component should be spiked and the transfusion connected to the patient’s
intravenous line (hung) immediately after the correct checks are performed at the bedside. If
for any reason there is a delay between performing the checks at the bedside and the blood
component being spiked and hung, the checks should be repeated at the bedside immediately
before the component is spiked and hung.
•
The blood component should be hung by one of the staff members participating in the
bedside checks.
•
Blood products should always be administered against a written prescription.
•
Laboratory IT systems should be checked for special requirements for each patient receiving
blood products.
•
Hospital procedures for ordering and administering blood products should ensure that
irradiated and other special requirement blood components are always given where
appropriate. The procedure must clearly state the need for a medical officer to clearly request
and prescribe these products when indicated.
•
Where Rh D positive blood components have to be administered to Rh D negative patients in
emergency situations, and where administration of anti-D prophylaxis is clinically indicated to
prevent allo-anti-D formation, the anti-D prophylaxis should be administered within 72 hours.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
27
9. ABO haemolytic transfusion reaction
Discussion
Category/
categories
Male/female ratio
Primary error
Severity
Implicated blood
components
Imputability
Time of
transfusion
Age
ABO haemolytic transfusion
reaction (ABO HTR)
Gender
Data summary
Total number of events:
4
2:2
Unknown
0
<28 days
0
28 days – 1 year
0
1–9 years
0
10–29 years
0
30–49 years
0
50–69 years
3
70–79 years
1
80+ years
0
Unknown
0
In core hours
(8.30am – 5.30pm)
2
Out of core hours
(5.30pm – 8.30am)
2
Level 1
0
Level 2
1
Level 3
0
Level 4
3
Not assessable
0
5. poor communication between team members
Red cells
3
6. lack of a prescription/IV order form for the
transfusions
Unknown
1
Grade 0
0
Grade 1
3
7. failure to verify and cross-check the patient
identification on red cell unit label and wristband
with the patient’s verbal verification of their name
and date of birth
Grade 2
0
8. incorrect patient identification taken to blood bank
Grade 3
1
Grade 4
0
Not assessable
0
Administration of
product
1
Deliberate clinical
decision
1
Did not adhere to
hospital transfusion
procedures
2
Note: For event category definitions, please
refer to Appendix A. For imputability and
severity definitions, refer to Appendix F.
28
There were four validated events within the ABO
haemolytic transfusion reaction category. In three of the
four events, the reaction was related to the transfusion
of ABO incompatible red cells, with an imputability
score of four (certain). None of these three events
were fatal.
A Safer Future for Emily
The fourth case involved a reaction after infusion of
major ABO mismatched stem cells. In this case, the
reaction was felt unlikely to be an ABO haemolytic
transfusion reaction, although this could not be fully
excluded. The hospital protocol was followed and
appropriate steps were taken to minimise the risks of an
ABO haemolytic transfusion reaction.
Contributory factors for the three ABO incompatible
transfusions were:
1. two of the three red cell transfusions occurred
outside working hours
2. final ‘bedside’ checks were performed in a side
room distant to the patient
3. staff hanging the blood were not involved in the
final checking process
4. emergency situation
9. bedside checks were only performed between the
red cell unit and cross-match form, not with the
patient’s ID.
The signs and symptoms presented in these
events included a marked drop in blood pressure,
characteristic haemoglobinuria and a drop in
haptoglobin. In one case, the patient reported back
pain, was experiencing rigors and became tachycardic
and pyrexial after receiving 20 mL of blood.
The incidence of ABO haemolytic
reactions is about one in
150 000 transfusions and a
fatal case occurs in about one
in 1.5 million allogeneic red
cell units transfused.2 Like
many events of incorrect blood
component transfused, the
events of acute ABO haemolytic
transfusion reactions highlight
the many errors that can
occur in administering blood.
Particularly relevant are the
human factors involved. These
three events highlight many of
the contributory factors in ABO
haemolytic transfusion reactions
and incorrect blood component
transfused events, and which
have been observed in other
haemovigilance systems.2, 3, 24, 25
Case one*
A 36-year-old man who had been
operated on that afternoon was
found to have a haemoglobin level of
70 g/L. The medical officer asked for
a two-unit transfusion of red cells that
evening.
When the blood was due for
collection, the registered nurse (RN)
caring for the patient was called to
a second patient in the four-bed bay
who was receiving a transfusion and
had developed acute shortness of
breath and dropped their oxygen
saturations to 80 per cent on room air.
The RN asked the agency nurse whose
patient she had been called to see, to
go to the blood bank and collect the
blood for the post-operative patient.
The agency nurse asked the name of
the patient and requested a sticker
with the patient’s identification.
However, the RN was busy with the
patient suffering an acute reaction
and said the medical chart was on
the desk outside. The agency nurse
picked up a patient’s sticker and
collected the blood and cross-match
form from Blood Bank.
On returning to the ward, the two
RNs on night duty were drawing up
hydrocortisone for the patient who
had suffered the acute transfusion
reaction. The agency nurse gave
the unit of red cells to the RNs who
performed the checks of the blood
unit against the cross-match form
in the side room. They then called
the agency nurse and asked her to
hang the blood. The bedside checks
were not completed at the bedside,
and the 36-year-old man who was
blood group O was transfused
group A red cells meant for another
patient. Despite developing signs and
symptoms of a haemolytic reaction,
the patient made a full recovery.
CASE STUDY
Summary
An audit of the collection and
administration of blood and
* The data in this case study has been used in a
blood products has previously
de-identified manner to create this typical case
example. This is not an actual case, however, it
catalogued the numerous nearcan be used to accurately illustrate key findings.
misses during this complex
pathway.1 In these audits, only
one out of 37 had the correct
checks performed. Therefore, the
combination of human factors and a complex pathway both contribute to the observed incidence of
incorrect blood component transfused events and ABO haemolytic transfusion reactions.
Practice guidelines
•
Healthcare facilities should develop and implement procedures:
•
–– that outline the minimum standards of patient identification and procedure required for the
collection of blood products
–– for formally checking the identification of the patient against the blood component label at
the bedside. This procedure should reference the national administration guidelines.5
The blood component should be spiked and the transfusion connected to the patient’s
intravenous line (hung) immediately after the correct checks are performed at the bedside.
If for any reason there is a delay between performing the checks at the bedside and the blood
component being spiked and hung, the checks should be repeated at the bedside immediately
before the component is spiked and hung.
•
The blood component should be hung by one of the staff members participating in the
bedside checks.
•
Out-of-hours elective transfusions are best avoided and should be performed only when
clinically indicated and in accordance with guidelines on appropriate use of blood components.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
29
10.Acute non-ABO haemolytic
transfusion reaction and delayed
haemolytic transfusion reaction
Discussion
Primary
error
Severity
Implicated
blood
components
Imputability
Time of
transfusion
Age
Gender
Category/
categories
Data summary
Acute non-ABO haemolytic
transfusion reaction
and delayed haemolytic
transfusion reaction
Total number of events:
Male/female ratio
3
0:2
Unknown
1
<28 days
0
28 days – 1 year
0
1–9 years
0
10–29 years
0
30–49 years
0
50–69 years
3
70–79 years
0
80+ years
0
Unknown
0
In core hours
(8.30am – 5.30pm)
2
Out of core hours
(5.30pm – 8.30am)
1
Level 1
0
Level 2
0
Level 3
1
Level 4
2
Not assessable
0
Red cells
3
Grade 0
1
Grade 1
2
Grade 2
0
Grade 3
0
Grade 4
0
Not assessable
0
Product not process
1
Other
1
Laboratory
1
Note: For event category definitions, please refer
to Appendix A. For imputability and severity
definitions, refer to Appendix F.
30
A Safer Future for Emily
The three events validated included one acute nonABO haemolytic transfusion reaction and two events
of a delayed haemolytic transfusion reaction. The
antibodies identified were anti-C and papain only
anti-e (acute non-ABO haemolytic transfusion reaction)
and anti-Jka and anti-c,E for the other
two events.
In the case of the acute non-ABO haemolytic
transfusion reaction, there was a history of anti-C,
which was undetectable at the time of the transfusion.
Just before the transfusion, the patient was receiving
high-dose chemotherapy for an underlying malignancy.
Two months after the transfusion, serology detected an
anti-C and a papain only anti-e.
For the two events validated as delayed haemolytic
transfusion reaction, the patients presented seven
and nine days post-transfusion. One patient had
haemoglobinuria. In both events, the post-transfusion
direct anti-globulin test was positive and spherocytes
were present on the blood film. The antibody screens
performed pre-transfusion were both negative.
Case one*
These three events are characteristic of haemolytic transfusion
reactions caused by antibodies to non-ABO blood group antigens. In
the first 10 years of Serious Hazards of Transfusion (SHOT), antibodies
to Kidd and Rh blood groups accounted for 53 per cent and 38 per cent
of all delayed haemolytic transfusion reactions reported.25
Practice guidelines
•
Previous laboratory transfusion records, including previous
antibodies detected, should be available at all times.
A 70-year-old man had recently been
diagnosed with myelodysplasia
and had started regular red cell
transfusions. Ten days after his
latest transfusion of three units of
allogeneic red cells, the man called
the day unit to say his urine was dark
and his wife had noticed his eyes were
yellow. The haematologist reviewed
the patient that day. The patient was
jaundiced and his urine was red and
positive for blood on urinalysis. A full
blood count and blood film revealed
the haemoglobin had fallen to the
pre-transfusion level and there were
spherocytes on the blood film. The
direct anti-globulin test (DAT) was
positive and an antibody screen
identified an anti-Fya that had not
been present in the antibody screen
pre-transfusion.
CASE STUDY
Summary
* The data in this case study has been used in a
de-identified manner to create this typical case
example. This is not an actual case, however, it
can be used to accurately illustrate key findings.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
31
11.Febrile non-haemolytic
transfusion reactions
Discussion
Category/
categories
Male/female ratio
Primary
error
Severity
Implicated blood
components
Imputability
Time of
transfusion
Age
Febrile non-haemolytic
transfusion reaction
Gender
Data summary
Total number of events:
26
17:9
Unknown
0
<28 days
0
28 days – 1 year
0
1–9 years
0
10–29 years
5
30–49 years
3
50–69 years
7
70–79 years
5
80+ years
6
Unknown
0
In core hours
(8.30am – 5.30pm)
12
Out of core hours
(5.30pm – 8.30am)
11
Unknown
3
Level 1
3
Level 2
7
Level 3
12
Level 4
4
Not assessable
0
Red cells
25
Fresh frozen plasma
1
Grade 0
0
Grade 1
25
Grade 2
0
Grade 3
0
Grade 4
0
Not assessable
1
Product not process
26
Note: For event category definitions, please
refer to Appendix A. For imputability and
severity definitions, refer to Appendix F.
32
A Safer Future for Emily
A total of 26 of the 230 events reported to QiiT were
validated as febrile non-haemolytic transfusion
reactions. The variability in the imputability of these
validated events highlights that some patients have
coexistent infections (related to their underlying
medical or surgical diagnosis) that has confounded the
interpretation of a fever that was temporally related to
the administration of a fresh blood component.
One validated case followed the administration of fresh
frozen plasma. Although fresh frozen plasma is thought
unlikely to cause a febrile non-haemolytic transfusion
reaction, in the event reported the patient developed
a fever soon after the start of the transfusion. There
was no evidence of an alternative cause for the fever.
Interestingly, there have been other isolated febrile
reactions that have been reported in association with
fresh frozen plasma.12
The validated events of febrile non-haemolytic
transfusion reaction were further reviewed to ascertain
if they were ‘severe’ — that the patient exhibited
a body temperature rise of more than 2 °C or an
increase in body temperature of more than 1 °C with
rigors (Table 3).27 Eighteen of the 26 events met the
requirements of this definition and were therefore
classified as ‘severe’.
The data shows variability in the investigation and
management of ‘severe’ events. The variability in
practice revealed by this data may reflect the potential
differences expressed by experts in transfusion
medicine,28, 29 and the differing advice clinical staff
may receive from pathology providers. Although the
number of events is relatively small, in the majority of
events classified as ‘not severe’ the transfusion was not
restarted, as compared with those events sub-classified
as ‘severe’. However, the severity of the transfusion
reaction was Grade 1 in all events where the data was
available.
Table 3
Sub-classification of febrile non-haemolytic transfusion reaction events.
(Severe events had either a body temperature rise of more than 2 °C, or an increase in body
temperature of more than 1 °C associated with rigors. )
Severe
Not severe
Investigated for HTR
Product cultured
Patient cultured
Did not restart
transfusion
Reviewed by MO
16/18 (88.9%)
8/18 (44.4%)
10/18 (55.6%)
10/18 (55.6%)
10/18 (55.6%)
5/8 (62.5%)
1/8 (7.8%)
4/8 (50%)
6/8 (75%)
3/8 (37.5%)
HTR = haemolytic transfusion reaction, MO = medical officer
The introduction of universal pre-storage leucodepletion for red cells and platelets by the ARCBS
will have reduced the frequency of febrile non-haemolytic transfusion reactions.30 The overall
incidence of febrile non-haemolytic transfusion reactions with pre-storage leucodepleted blood
and blood components is more than 1 per cent, but as seen from the events reported to QiiT, it
makes up the second largest group of transfusion-related adverse events.
Case one*
Febrile non-haemolytic transfusion reactions remain a common sideeffect of transfusions. A febrile non-haemolytic transfusion reaction
is considered a diagnosis of exclusion (where other causes for a fever
post-transfusion have been investigated and found to be negative).
The rarity of alternative causes for a post-transfusion fever may
impact on the experience of clinical staff and this may be reflected in
the variation of investigation and management of this common posttransfusion scenario.
If this bias is influencing clinical decision-making, an alternative to
the current guidelines for the management of a post-transfusion fever
is needed to aid clinical staff and ensure the correct management.
Practice guidelines
•
The definition of febrile non-haemolytic transfusion reaction in
the QiiT data set includes the statement ‘or change of more than
1 °C from pre-transfusion level’ in reference to body temperature.
This increase in body temperature only applies in events where the
pre‑transfusion body temperature is more than 37 °C. •
The investigation and management of transfusion reactions should
adhere to hospital procedures.
A 24-year-old female developed
rigors and a fever while receiving
the second unit of red blood cells.
Her temperature rose from 36.4 °C
to 38.1 °C during the transfusion
and there was no preceding history
of fever or infection. Although a
haemolytic transfusion reaction
(HTR) was considered, review of
the patient’s chart failed to find
clear documentation of the time
the reaction occurred or whether
the patient was reviewed by a
medical officer. Despite the fever
and consideration of an HTR, no
laboratory investigations for an
HTR were undertaken and no blood
cultures were taken from the patient
or the blood bag. The patient was
given paracetamol, antihistamine and
hydrocortisone for this reaction. The
red cell transfusion was restarted and
subsequently completed.
CASE STUDY
Summary
* The data in this case study has been used in a
de-identified manner to create this typical case
example. This is not an actual case, however, it
can be used to accurately illustrate key findings.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
33
12.Severe allergic reactions
and anaphylaxis
Discussion
Imputability
Time of
transfusion
Age
Gender Category/
categories
Data summary
Severe allergic reaction and
anaphylaxis/anaphylactoid reaction
Total number of events:
Male/female ratio
33
17:11
Unknown
5
<28 days
0
28 days – 1 year
0
1–9 years
0
10–29 years
5
30–49 years
7
50–69 years
15
70–79 years
2
80+ years
1
Unknown
3
In core hours
(8.30am – 5.30pm)
17
Out of core hours
(5.30pm – 8.30am)
15
Unknown
1
Level 1
0
Level 2
4
Level 3
17
Level 4
12
Primary
error
Severity
Implicated blood
components
Not assessable
Red cells
10
Platelets
4
Fresh frozen plasma
13
Cryoprecipitate
1
Cryoprecipitate plasma
1
Multiple components
3
Unknown
1
Grade 0
0
Grade 1
30
Grade 2
0
Grade 3
3
Grade 4
0
Not assessable
0
Product not process
Administration of
product
Note: For event category definitions, please
refer to Appendix A. For imputability and
severity definitions, refer to Appendix F.
34
0
A Safer Future for Emily
32
1
Allergic reactions complicating transfusions are
common adverse events and this is reflected in the
30 validated events of severe allergic reactions and 3
validated events of anaphylaxis reported to QiiT. The
incidence of urticaria during transfusion is known to be
up to 3 per cent,31 while anaphylaxis is much rarer, with
an incidence of about one in 50 000 transfusions.32 The
events below highlight the heterogeneity of allergic
reactions complicating transfusion.
Two events of anaphylaxis complicating transfusions
were validated. In the first case, the patient received
intravenous (IV) adrenaline, while in the second case
the patient received IV fluids, IV steroids and an oral
antihistamine.
In the first case, the investigations included a chest
X-ray and in the second case (where the patient's blood
pressure fell to 60/20 mmHg and oxygen saturations
fell to less than 93 per cent), only blood cultures were
performed. IgA deficiency may be a contributing factor
in such cases, but IgA levels were not checked in
either case.
Summary
Allergic reactions during transfusions are common. As
with the events of febrile non-haemolytic transfusion
reaction and acute respiratory reactions reported to
QiiT, the two most severe events of severe allergic
reactions/anaphylaxis highlight the variability in the
investigation of transfusion reactions.
•
Patients with significant severe
allergic reactions and all
patients suffering anaphylaxis/
anaphylactoid reactions
associated with transfusions
should be investigated
for the underlying cause,
particularly anti-IgA antibodies
complicating IgA deficiency.
•
An alert should be placed in
the patient’s medical chart if
they have suffered a significant
severe allergic reaction or
anaphylaxis/anaphylactoid
reaction associated with
a transfusion of a blood
component. This alert will help
guide the future management
of transfusions in such
patients.
•
Case one*
Case two*
A 27-year-old woman received two
units of red cells post-operatively.
During the second unit, she
complained of itchiness over both
arms, which then spread over her
back and finally to the rest of her
body. A red rash, with a few hives,
then developed and she complained
of a ‘burning tongue’. Examination
of the tongue revealed no swelling.
There was no alteration in her blood
pressure, pulse or oxygen saturations
during or after the reaction. She was
given an oral antihistamine, and the
symptoms resolved within two hours.
No investigations were performed.
A 43-year-old man received a pool
of platelets for chemotherapyinduced thrombocytopenia. During
the transfusion, he developed an
urticarial rash, pruritus and shortness
of breath. His blood pressure fell
from 120/70 mmHg to 96/45 mmHg
and his pulse increased from 86 to
138. He remained apyrexial and his
oxygen saturations did not drop. Both
an antihistamine and intravenous
hydrocortisone were administered.
Investigations revealed negative
blood cultures and a normal chest
X-ray. His symptoms resolved within
three hours.
CASE STUDY
Practice guidelines
* The data in this case study has been used in a
de-identified manner to create this typical case
example. This is not an actual case, however, it
can be used to accurately illustrate key findings.
The investigation and
management of transfusion
reactions should adhere to
hospital procedures.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
35
13.Acute respiratory reactions
Discussion
Primary
error
Severity
Implicated blood
components
Imputability
Time of
transfusion
Age
Gender
Category/
categories
Data summary
Transfusion-related acute lung
injury (TRALI) and Transfusionassociated cardiac overload
(TACO)
Total number of events:
Male/female ratio
5
4:1
Unknown
0
<28 days
0
28 days – 1 year
0
1–9 years
0
10–29 years
2
30–49 years
0
50–69 years
1
70–79 years
1
80+ years
1
Unknown
0
In core hours
(8.30am – 5.30pm)
4
Out of core hours
(5.30pm – 8.30am)
1
Level 1
1
Level 2
2
Level 3
2
Level 4
0
Not assessable
0
Red cells
1
Platelets
1
Fresh frozen plasma
3
Grade 0
0
Grade 1
0
Grade 2
2
Grade 3
2
Grade 4
1
Not assessable
0
Product not process
1
Administration of
product
4
Note: For event category definitions, please
refer to Appendix A. For imputability and
severity definitions, refer to Appendix F.
36
A Safer Future for Emily
Five events were validated as transfusion-associated
cardiac overload (2) or transfusion-related acute lung
injury (3). Of these five events, four had evidence of
hypoxia, with a significant fall in oxygen saturation
measured by pulse oximetry. The trough oxygen
saturations in these four events were 43 per cent, 79 per
cent (2) and 86 per cent.
The three lowest oxygen saturations were seen in
the three events that were subsequently reclassified
as possible events of transfusion-related acute lung
injury. Transfusion-related acute lung injury was not
considered in the differential diagnosis of these four
events with hypoxia, and the three events that were
reclassified had been reported to QiiT as a severe
allergic reaction, anaphylaxis and a febrile nonhaemolytic transfusion reaction.
Two of the four events had a chest X-ray at the time of
the reaction; one was reported as showing bilateral
pleural effusions (validated as possible transfusionassociated cardiac overload) and the other as showing
pulmonary oedema (validated as possible transfusionrelated acute lung injury).
Although there was insufficient evidence to conclude
that the two events of transfusion-associated cardiac
overload were definitely related to the transfusion, both
patients were more than 70 years of age, had positive
fluid balances before the transfusion started, and had a
history of cardiac disease. Neither case was prescribed
diuretics as pre-medication for the transfusion.
The differential diagnoses considered in these five
events were transfusion-associated cardiac overload,
allergic reaction/anaphylaxis, pulmonary embolism and
febrile reaction (with negative patient blood cultures).
Summary
Acute respiratory complications after transfusions
of fresh blood components are significant causes of
morbidity. Transfusion-related acute lung injury was
the leading cause of transfusion-associated death
in data collected by the United States Food and Drug
Administration33 and both transfusion-related acute
lung injury and transfusion-associated cardiac overload
accounted for 25 per cent each of the fatal transfusion
reactions reported to the French haemovigilance system
in 2002 and 2003.24
The five events reported to QiiT highlight several issues:
2. Clinical indicators suggesting a risk of developing transfusionassociated cardiac overload may not be acted on.
3. The low imputability scores for these events reflect the lack of
appropriate investigations at the time of the reaction and prevent
a clear conclusion on the nature of the reaction.
4. None of the possible events of transfusion-related acute lung
injury were referred to the ARCBS at the time of the reaction for
serological investigation of the donors.
As with other categories of events reported to QiiT, there is an
indication that the investigation and management of these acute
respiratory transfusion reactions may not be optimal. As a result of
these concerns and the experience of underreporting of transfusionrelated acute lung injury in other countries, information about
transfusion-related acute lung injury was circulated to senior medical
staff within Queensland in 2009. The information circulated is
reproduced in Appendix C.
Practice guidelines
Case one*
A 55-year-old man on ICU with
multiple fractures was prescribed
fresh frozen plasma (FFP). The patient
was fully conscious and receiving
30 per cent inspired oxygen to
maintain his oxygen saturations at
95 per cent. Within 15 minutes of
starting the fresh frozen plasma,
the oxygen saturations fell to 48 per
cent. This was associated with an
increase in body temperature by
1 °C and rigors. The patient was
reviewed promptly and received
hydrocortisone. It took nine hours for
the oxygen saturations and inspired
oxygen requirements to return to the
pre-FFP levels. Blood cultures were
taken and subsequently found to be
negative. Review of routine chest
X-rays (CXR) performed each morning
revealed a normal CXR before the
reaction and a CXR showing bilateral
shadowing the morning after the
reaction.
•
In events of suspected transfusion-related acute lung injury, the
transfusion laboratory that supplied the blood component should
be notified so they can inform the ARCBS. This will allow for the
investigation of implicated donors and appropriate management of
donors who have positive serology by the Blood Service.
•
Patients at risk of cardiac overload (for example, due to age,
pre-existing co-morbidities, current fluid balance etc) need to be identified and medically
reviewed before transfusion to allow appropriate management (for example, rate of transfusion,
prophylactic diuretics) to prevent transfusion-associated cardiac overload.
•
Transfusion-related acute lung injury should be considered in all patients receiving fresh blood
components that contain plasma, who exhibit relevant signs and/or symptoms of acute lung
injury (hypoxia, bilateral infiltrates on chest x-ray and no signs of heart failure) within six hours
of a transfusion.
CASE STUDY
1. Transfusion-related acute lung injury is often overlooked in
the differential diagnosis of acute respiratory complications of
transfusion.
* The data in this case study has been used in a
de-identified manner to create this typical case
example. This is not an actual case, however, it
can be used to accurately illustrate key findings.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
37
Appendix A Data set/definitions
of transfusion adverse events
Problem
Definition
1. ABO haemolytic
transfusion reaction
(sentinel event)
Haemolytic transfusion reaction due to transfusion of an ABO incompatible blood
component or plasma component
Features (for categories 1–3) that suggest a haemolytic transfusion reaction are one or
more of:
•
fever and other symptoms/signs of haemolysis (for example, jaundice, dyspnoea,
flank or back pain, tachycardia, hypotension, haemoglobinuria)
•
inadequate rise in post-transfusion Hb
•
fall in Hb level
•
rise in LDH level
•
rise in bilirubin, decreased haptoglobin
and confirmed by a positive direct antiglobulin test (DAT) and positive cross-match not
detectable pre-transfusion
2. Acute non-ABO
haemolytic transfusion
reaction
Haemolytic transfusion reaction (not due to ABO incompatibility) occurring within
24 hours of a transfusion
3. Delayed haemolytic
transfusion reaction
Haemolytic transfusion reaction occurring 24 hours to 28 days after the transfusion
4.Transfusion-related
acute lung injury
Occurrence of acute respiratory distress and bilateral pulmonary infiltrates on CXR
with no evidence of circulatory overload or other potential cause within six hours of
transfusion of a blood component or plasma component
5.Transfusion-transmitted
infection
A post-transfusion infection (viral (TTVI), bacterial (TTBI) or parasitic (TTPI)) not present
in the recipient before transfusion of a blood component or plasma component
and present in either one of the components transfused or the donor of one of the
transfused components. TTBI includes:
(See features above)
(See features above)
Bacterial contamination of blood product — detection and confirmation of bacteria
in a blood component or plasma component, which has either not been transfused to
the intended patient or was transfused, but no bacteria was detected in cultures of the
recipient’s blood
38
6. Severe allergic reaction
One or more of rash, dyspnoea (stridor, cyanosis, wheezing), angioedema,
generalised pruritus and/or urticaria, without hypertension during or within
24 hours of a transfusion of a blood component or a plasma component that requires
pharmacological treatment
7.Anaphylaxis/
anaphylactoid reaction
Allergic reaction (one or more of rash, wheezing, dyspnoea, stridor, angioedema,
generalised pruritus and/or urticaria) with hypotension (drop in systolic blood
pressure of equal to or more than 30 mmHg) during or within 24 hours of a transfusion
of a blood component or plasma component
8.Transfusion-associated
graft-versus-host
disease
Development of symptoms and signs (fever, erythematous skin rash, hepatic
dysfunction, diarrhoea and bone marrow hypoplasia/pancytopenia) 1–6 weeks
following transfusion with no other apparent cause — the diagnosis is confirmed by
skin and/or bone marrow biopsy appearances and/or the demonstration of genetic
chimerism in the recipient’s peripheral blood lymphocytes
9.Post-transfusion
purpura
An acute episode of thrombocytopenia occurring within 12 days of a transfusion (red
cells or plasma) and confirmed by the presence of platelet-specific alloantibodies
(usually anti-HPA1a) in recipient’s blood and presence of antithetical antigen on donor
platelets or by positive platelet cross-match
A Safer Future for Emily
Problem
Definition
10. Incorrect blood
component transfused
When a blood component or plasma component was:
11.Transfusion-associated
cardiac overload
•
Either administered to the wrong patient and there was no harm to the patient
•
Or did not meet the appropriate requirements (expired, irradiated, CMV negative,
leucodepleted etc) for the intended recipient
Features any four of the following:
•
respiratory distress
•
tachycardia
•
increased blood pressure
•
acute or worsening pulmonary oedema, typical signs of cardiogenic lung oedema in
the chest X-ray
•
evidence of a positive fluid balance and/or a known compromised cardiac status
occurring within 12 hours of transfusion
12. Febrile non-haemolytic
transfusion reaction
Presents with one or more of the following during or within four hours of transfusion
without any other cause, such as haemolytic transfusion reaction or infection:
•
fever (of more than 38 °C or change of more than 1 °C from pre-transfusion level)
•
chills
•
cold
•
rigor
other symptoms of discomfort
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
39
40
A Safer Future for Emily
(dyspnoea, ↓ oxygen
saturation)
Shortness of breath
Epinephrine (MD order)
Chest x-ray (CXR)
Urinalysis
(viii) Hypotension
AND/OR
(vii) Hypertension
With:
(vi) ≥39°C
OR
1 clotted & 2 EDTA +
signed request form
(v) <39°C and other
symptoms (e.g. rigors,
hypotension)
+ 1 additional clotted
Monitor patient status; antipyretic
+ 1 additional ELFT

+ 1 additional ELFT
FBC
Culture of product
DAT
G&S

DIC screen
Full blood count (FBC)
If haemolysis reported see (v) above
If bacterial contamination suspected
start antibiotics immediately
Oxygen, possible intubation and
ventilation, vasopressors
Assess CXR for pulmonary infiltrates
Consult medical staff
DO NOT RESTART
Diuretics, oxygen, sit patient upright
Consult medical staff
DO NOT RESTART
Monitor for hypotension, renal failure
and DIC
If haemolysis reported send blood for
coagulation, FBC, U&E, bilirubin, LDH
and haptoglobin
Pethidine (MD order) for rigors and
monitor BP
If bacterial contamination suspected
start antibiotics immediately
DO NOT RESTART
DAT
Culture of product
G&S
None
Transfusion reaction chart modified from ANZSBT & RCNA Guidelines for the administration of blood components 2004.
From Queensland Blood Management Program, Clinical and Statewide Services. Contact 07 3636 2075.
Version 3.2 December 2009
 + 1 additional clotted
 + 1 additional Heparin
CXR
Urinalysis
Blood culture from patient
Offending unit(s)
1 clotted & 2 EDTA +
signed request form

1 citrate
Urinalysis
Blood culture from patient
Offending unit(s)
Reaction slip only (if used
locally)
(iv) 38°C to <39°C and
NO other symptoms
As above
Consult medical staff – antipyretic and
restart slowly if product viable. Record
pulse/BP/temp every 15 minutes for
first hour. If no improvement/worse –
STOP and call medical staff (see
below)
As (ii) above
As (ii) above +
Dyspnoea / airway
obstruction
+ 1 additional FBC
+ 1 additional ELFT
(iii) >2/3 body with


+ 1 additional
Heparin
DO NOT RESTART
Consult medical staff – antihistamine,
corticosteroid therapy
Culture of product
DO NOT RESTART
Direct antiglobulin test
(DAT)
If worsens or no improvement after
30 minutes STOP, seek medical
advice and manage as (ii) below.
Consult medical staff – antihistamine
and proceed slowly if product viable.
Further management
Group & screen (G&S)
None
Blood Bank
testing done
OR
+ 1 additional EDTA
+ 1 additional clotted
Offending unit(s) and
reaction slip
1 clotted and 1 EDTA +
signed request form
Reaction slip only (if used
locally)
call Blood Bank and send
Investigation



(ii) >2/3 body and no
other symptoms
 Indicates additional testing required at all Public Hospitals
7. Save urine passed
by patient
6. Notify Blood Bank
staff
5. Notify medical staff
4. Re-check patient
identity (including
wristband) with
details on product
label
3. Check vital signs –
monitor respiration,
pulse, BP and
temperature every
15 minutes
2. Keep vein open
(KVO) with saline
using a new giving
set
Fever (≥38°C and ↑ of
at least 1°C from
baseline)
For all reactions in
this table:
1. STOP transfusion,
leaving giving set
attached
Urticaria (hives) or rash
Action
(i) Localised or <2/3
body and NO other
symptoms/signs
Suspected transfusion reaction signs
and symptoms
(Report incident)
AHTR or TTBI
OR
(Report incident)
Transfusion related
acute lung injury
(TRALI)
(Report incident)
Circulatory overload
(Report incident)
Acute haemolytic
transfusion reaction
(AHTR)
OR
Transfusion transmitted
bacterial infection
(TTBI)(Report incident)
(Report incident)
Febrile non-haemolytic
transfusion reaction
(FNHTR)
(Report incident)
Anaphylaxis
(Report incident)
Severe allergic
Minor allergic
Report in hospital
reporting system
Usually within first
15 minutes but
may be later
Within 6 hours of
transfusion
Within several
hours of
transfusion
Usually within the
first 15 minutes,
but may be later
During transfusion;
usually towards the
end
Usually early in
transfusion
Usually early in
transfusion
During transfusion;
up to 2-3 hours
from start
Timing of
symptoms
(1mL/kg/h maximum 4 h/bag) and diuretics
Slow transfusion rate for subsequent
transfusion
Also consider leucodepleted product
Premed with antipyretic only after 2 episodes
Request IgA (+anti-IgA if indicated)
May require special blood products
Premed with antihistamines +/- corticosteroid,
plasma depletion or washed cells may be
required
Premed with antihistamine only after 2
episodes
(Note: special requirements for blood
products should be discussed with Blood
Bank or Haematologist)
Implications for future transfusions
Transfusion Reaction Chart
‘Possible’
aetiology
Appendix B QiiT transfusion
reaction chart
Appendix C TRALI – information
for medical officers
Dear Colleague,
Re: Transfusion related acute lung injury (TRALI)
TRALI is the leading cause of death related to transfusion of blood and blood components, and I
am writing to you to:
1. help increase awareness of this potentially fatal complication of transfusion, which is often
overlooked in patients developing respiratory problems post-transfusion,
2. emphasise that reducing inappropriate use of blood and blood components is an essential
measure in reducing the occurrence of TRALI and preventing deaths due to this
complication, and
3. ensure that you are aware of the need to report cases to the ARCBS for investigation (via
your hospital Blood Bank) to identify implicated donors as a method to reduce the incidence
of TRALI.
Background
TRALI is a significant cause of mortality and morbidity in patients who receive blood products,
particularly plasma-containing products. If TRALI is not recognised and treated appropriately, it can
frequently result in death. Despite the growing recognition of TRALI it is clear that TRALI is often
misdiagnosed or overlooked. For example, data from the Queensland Health incident reporting
system (PRIME) show that no cases of TRALI were reported during the 12 months to December
2007. Given that in Queensland, approximately 250,000 units of blood products are transfused
each year, a conservative estimate for the expected number of reports of TRALI in QH hospitals
would be 12 cases per year.
Data from the US Food and Drugs Administration (FDA) for 2005 and 2006 show that of all
transfusion related fatalities reported to the FDA, TRALI was the leading cause of death,
accounting for 56% of transfusion related deaths. The exact frequency of TRALI is not known, but
international haemovigilance systems have demonstrated increased numbers of cases reported as
clinicians become more aware of this potentially lethal complication.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
41
Estimates of the incidents of TRALI are 1 in 1000 to 1 in 5000 units transfused, and the mortality
rate is between 5% and 25%. Once recent study of critically ill patients demonstrated 8% of
patients developed acute lung injury with 6 hours of transfusion (1).
Why is it important to recognise TRALI?
As dyspnoea after a transfusion is often believed to be due to another cause, e.g. circulatory
overload, allergic reaction etc., or because there are other risk factors present for acute lung injury,
TRALI is often overlooked.
Criteria for the clinical diagnosis of TRALI (see attached) have been published (2). Typical clinical
features are hypoxaemia, hypotension, fever and severe bilateral pulmonary infiltrates within
6 hours of completing a transfusion.
.
Early recognition allows the transfusion to be stopped immediately and commencement of oxygen
and supportive therapy. As the underlying pathology involves microvascular injury, use of diuretics
may be detrimental and some patients benefit from fluid administration.
Recognising TRALI allows notification of the Australian Red Cross Blood Service (ARCBS) and
testing of the blood component and/or donor for anti-HLA and anti-granulocyte antibodies.
Donors of blood products implicated in cases of TRALI often contain anti-leukocyte allo-antibodies
(anti-HLA and anti-granulocyte) that are thought to be important in the pathogenesis of TRALI in a
significant number of cases. Recognition of these donors by the ARCBS allows appropriate
exclusion of implicated blood products.
What can you do?
•
•
•
•
Reduce the exposure of patients to fresh frozen plasma, platelets and red cells by ensuring
appropriate use of blood products. All blood products used should be prescribed in
accordance with the National Health and Medical Research Council (NHRMC) national
guidelines.
Ensure clinical colleagues are aware of TRALI, as a complication of transfusing fresh blood
products, e.g. fresh frozen plasma, cryoprecipitate, platelets and red cells.
Notify your blood bank if TRALI is clinically suspected, so that testing of the blood
component and/or donor can be arranged through ARCBS.
Notify cases of TRALI to the Queensland haemovigilance system (Queensland incidents in
Transfusion – QiiT) via your hospital clinical incident reporting system.
The ARCBS has introduced a minimisation strategy that aims to increase to the proportion of
clinical fresh frozen plasma (FFP) that is sourced only from male donors (who have lower
incidence of anti-leukocyte antibodies). Currently, the ARCBS has been able to collect 90% of all
clinical FFP from male donors. This will help reduce the likelihood of TRALI. Other strategies
identified as reducing the risk of TRALI, e.g. use of solvent detergent treated FFP, are not currently
available in Australia.
2
42
A Safer Future for Emily
However, ensuring appropriate use of fresh blood products will form an important part of avoiding
patient’s exposure to unnecessary transfusions (3,4) and can be effected through local governance
of transfusion practice.
Yours sincerely,
Dr Simon A Brown
Clinical Advisor Queensland Blood Management Program
On behalf of Queensland Blood Advisory Council
07/04/2009
References
1. Gajic O et al. Am J Resp Crit Care Med 2007, 176; 886-891.
2. Kleinmann S et al. Transfusion 2004, 44; 1774-1789.
3. Rubin GL et al. Med J Aust 2001, 175; 354-358.
4. Schonfield WN et al. Med J Aust 2003, 178; 117-121.
3
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
43
Transfusion related acute lung injury (TRALI)
1. Recommended criteria for TRALI and possible TRALI
a) Criteria for TRALI
(i)
(ii)
(iii)
(iv)
Acute lung injury (ALI)*
No pre-existing ALI* before transfusion
During or within 6 hours of transfusion
No temporal relationship to other risk factor for ALI
b) Possible TRALI
(i)
(ii)
(iii)
(iv)
ALI*
No pre-existing ALI* before transfusion
During or within 6 hours of transfusion
Temporal relationship to other risk factor for ALI
* Acute lung injury (ALI) – definition of ALI:
1. Acute onset
2. Hypoxia – oxygen saturation <90% on air measured by pulse oximetry
or other clinical evidence of hypoxaemia
3. Bilateral infiltrates on chest X-ray
4. No evidence of circulatory overload (left atrial hypertension)
2. Comparison of features of TRALI and transfusion associated
cardiac overload
Feature
Body temperature
Blood pressure
Neck veins
Ejection fraction
PA occlusion pressure
Fluid balance
Response to diuretic
WBC
TRALI
Can be raised
Hypotension
Unchanged
Normal, decreased
≤ 18mmHg
Any
Minimal
Transient reduction
Overload
Unchanged
Hypertension
Can be distended
Decreased
> 18 mmHg
Positive
Significant
Unchanged
Adapted from: Skeate & Eastlund. Curr Opin Hematol 2007, 14: 682-687; Kleinman et
al. Transfusion 2004, 44: 1774-1789.
44
A Safer Future for Emily
Appendix D QiiT process
(extract from pilot project)
The QiiT haemovigilance system DOES NOT replace the existing hospital incident reporting system.
QiiT works in conjunction with the existing hospital incident-reporting system.
Figure 2.2 describes the process of reporting a transfusion incident through QiiT. The QiiT process
is based on established procedures for incident-reporting and is operated by the QiiT staff at the
Queensland Blood Management Program (QBMP).
Participating Facility
QBMP QiiT Program
incident
immediate action
incident reported
incident notified to QiiT staff at QBMP
initial data entered into QiiT database
local haemovigilance coordinator
receives and facilitates completion
of the follow up form
incident assigned unique QiiT number
follow up form entered into QiiT database
QiiT incident feedback indicating
final assessment of incident is
sent to facility
QiiT team performs incident analysis
and validation of incident with
assistance from QiiT working
group as required
QiiT report distributed to stakeholders
QiiT team prepares QiiT report biennially
Figure 2.2 QiiT process of incident-reporting and analysis
The medical, nursing or hospital staff who responded to the transfusion incident, report the
incident according to the local hospital procedures. Systems within the hospital initiate (i) a local
systems analysis of the incident and (ii) the QiiT process. In the public sector, the QiiT process
initiates automatically through an electronic feed from PRIME to the QiiT staff. In the private sector,
the hospital’s haemovigilance coordinator contacts the QiiT staff by mail, phone or email.
The QiiT staff at the QBMP log the incident and provide the hospital’s haemovigilance coordinator
with the appropriate follow up form. The haemovigilance coordinator facilitates the local
haemovigilance follow-up activities and then returns the completed form to the QiiT staff for
further analysis at a state and national level.
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
45
Appendix E RRMA classification
Department of Health and Ageing
46
RRMA 1
Capital cities
RRMA 2
Other metropolitan centres (urban centre population of more than 100 000)
RRMA 3
Large rural centres (urban centre population 25 000 to 99 000)
RRMA 4
Small rural centre (urban centre population 10 000 to 24 999)
RRMA 5
Other rural centres (urban centre population of fewer than 10 000)
RRMA 6
Remote centres (urban centre population of more than 4999)
RRMA 7
Other remote centres (urban centre population of fewer than 5000)
A Safer Future for Emily
Appendix F Imputability and
severity scores
Severity scores
Grade 0
no effect; absence of clinical signs
Grade 1
absence of immediate or long-term vital threat
Grade 2
long-term morbidity
Grade 3
immediate vital
Grade 4
death
Imputability scores
Level 0
excluded
Level 1
unlikely
Level 2
possible
Level 3
likely/probable
Level 4
certain
N/A
not assessable
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
47
Appendix G Blood Products
Advisory Committee information
developed for IMP notifications
June 2009
Dear Doctor,
Clinician Advisory — Bacterial Contamination Screening
You have been alerted that a unit of platelets transfused to your patient is potentially
contaminated with bacteria (initial machine positive (IMP) notification). In May 2008, the
ARCBS commenced bacterial screening of platelet products to decrease the incidence of
transfusion of contaminated units.
Recommendations
•
The clinical condition of the patient should be urgently appraised. This might involve
delegation of a clinician to urgently review inpatients or rapid contact with outpatients to
ascertain whether they have symptoms suggesting sepsis.
•
Asymptomatic patients should then be followed up at their next routine review, but
told to report for urgent medical review should they develop fever or other symptoms
suggesting sepsis.
•
Patients with symptoms or signs suggesting possible bacterial sepsis should be
managed urgently with blood cultures and other septic screens as clinically indicated
and rapid initiation of broad spectrum intravenous antibiotics (e.g. in neutropenic
patients ticarcillin/clavulanate plus gentamicin, in non neutropenic patients ticarcillin/
clavulanate, If penicillin allergic an alternative such as vancomycin plus gentamicin or
ceftazidime should be considered).
Please note: Currently, about 75 per cent IMP notifications will be found to be false positive
(no bacteria confirmed).
In the initial six months of bacterial screening (April to October 2008), Australian Red Cross
ARCBS (ARCBS) tested 60,868 platelet components. Of these, 732 (1.2 per cent) were IMP,
with 72 (0.11 per cent) confirmed to be positive, with organism identification.
Causes of bacterial contamination*
The most common organisms cultured in bacterial screening of platelets in Australia in
order of frequency were: Propionibacterium (73.1 per cent), Staphylococcus (11.1 per cent),
Corynebacterium (6.5 per cent), Micrococcus (2.8 per cent), Streptococcus (2.8 per cent),
Klebsiella (1.9 per cent) and Ralstonia (0.9 per cent). The largest group, Propionibacterium,
only grows in anaerobic media, with a mean time to detection of 101 hours after incubation.
This organism is generally regarded as clinically insignificant. The mean time to detection of
all other organisms was 42 hours in aerobic, and 61 hours in anaerobic culture. This means
that 45 per cent of platelet units which are confirmed to be contaminated or indeterminate
can be withdrawn from inventory before transfusion.
Subsequent notification of the veracity of the result, with Gram stain, identification and
sensitivities will be provided.
48
A Safer Future for Emily
Bacterial contamination usually occurs at venipuncture, with the most common organisms
being skin commensals. Less commonly, donors might have been bacteraemic or less
commonly again, bacteria might have been introduced during product handling.
For further assistance and advice, please contact:
•
Your local haematologist
•
Your local infectious diseases physician
•
ARCBS transfusion medicine specialist 07 3838 9234 (office hours) or 07 3838 9010
(after hours)
*Reference for all data quoted in this document:
Finding the bugs in platelets: bacterial contamination screening in Australia 2009,
Presentation from ISBT ARCBS, Melbourne Victoria. P Hetzel, S Winzar, J Derks, R Burfoot, T
Johnson, P Mock, T Smith, S Ismay, P Rodgers. M Borosak
Queensland incidents in Transfusion (QiiT) June 2007–2009 report
49
Abbreviations
50
ANZSBT
Australian and New Zealand Society of Blood Transfusion
ARCBS
The Australian Red Cross Blood Service
BPAC
Blood Products Advisory Committee
EU
European Union
FNHTR
febrile non-haemolytic transfusion reaction
HEAPS
human error and patient safety
HTR
haemolytic transfusion reaction
IMP
initial machine positive
PRIME
Queensland Health Clinical Incident Management Information System
RRMA
Rural, Remote and Metropolitan Areas classification
SHOT
Serious Hazards of Transfusion
TRALI
transfusion-related acute lung injury
UK
United Kingdom
QBMP
Queensland Blood Management Program
QHEPS
Queensland Health Electronic Publishing Service
QiiT
Queensland incidents in Transfusion
A Safer Future for Emily
References
1. QBMP, PSC. Audit of the collection and administration of blood and blood products.
Queensland Health; October 2007.
2. Andreu G, Morel P, Forestier F, et al. Haemovigilance network in France: organization and
analysis of immediate transfusion incident reports from 1994 to 1998. Transfusion. Oct
2002;42(10):1356-1364.
3. Stainsby D, Russell J, Cohen H, Lilleyman J. Reducing adverse events in blood transfusion. Br J
Haematol. Oct 2005;131(1):8-12.
4. Amalberti R, Auroy Y, Berwick D, Barach P. Five system barriers to achieving ultrasafe health
care. Ann Intern Med. 2005 May 3;142(9):756-64.
5. Aiello J, Thorp D, Davis K. Guidelines for the Administration of Blood Components. Australian &
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A Safer Future for Emily